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What in the world are the owners of KFC, Carl's Jr. and other fast-food places thinking by manning their drive-thru's (and often their in-store counters) with people who barely speak English intelligibly?
When I FINALLY basically said, "The heck with it!" in frustration and stopped trying to ask questions of the heavily-accented woman taking my order and drove onward to the pick-up window it sure appeared, from what I could see, that a majority of this KFC's employees might speak English as poorly, or even worse, than the woman who took my order.
In this day and age when the economy is awful and so many Americans who speak English very well are out of work, how in the world do people such as the one who took my order this week get these jobs? I can just imagine what would happen in Mexico were an American who barely spoke understandable Spanish assigned to take customers' orders at a drive-thru -- the customers would be outraged 1. that a non-Mexican was given the job, and 2. that the outsider holding the job couldn't even speak proper Spanish.


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Shirley Ann Davis, 76, Kokomo, passed away at 5:52 p.m., Sunday, March 31, 2013, at Caring Hands Health and Rehab. She was born July 6, 1936, in Kokomo, to the late Clifford and Oleta (Livingston) McCoy.
Shirley lived with her grandparents, Ralph and Georgia Livingston. She attended Kokomo High School. Shirley worked in the health care profession as a nurse's assistant for more than 15 years. The most important achievement in her life, though, was her children and grandchildren. She thoroughly enjoyed spending time with them, and going fishing. The family wishes to extend a special thanks to New Hope Hospice, and the staff at Caring Hands Health and Rehab.
She is survived by her five children, Kenny (Deb) Taylor Jr., Bunker Hill, Norma (John) Nantroup, Kokomo, Mike (Sandy) Abney, Russiaville, Bobby Abney, Marion, Jill (Jamie) Bieber, Kokomo; grandchildren, Matt Hayden, Lindsay Nantroup, Jeremy (Lori) Bieber, Jesse Bieber (Alli Padrick), Jennifer Bieber, Misty (Josh) Becraft, Teri Melton (Adam Buffum), Brandon Jolly, Darin Abney, and Bo Abney; niece, Patricia (Junior) Thorpe, Galveston; nephews, George (Toni) Slaughter, Frankfort, James (Nadine) Slaughter, Plainfield; several great-grandchildren, and great-nieces and great-nephews.
She was preceded in death by her parents; sister, Bonnie Nead; grandson, Chad Abney; and nephew, Steven Slaughter.
Due to Shirley's wishes there are no scheduled services. You are invited to read Shirley's obituary at www.ellersmortuary.com, where you may sign the guest book or share a personal message with the family. Ellers Mortuary, Webster Street Chapel, 3400 S. Webster St., is in charge of arrangements.


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Our rabbis, educator, staff, and lay-leaders help guide and help our community to create personally fulfilling expressions of their Judaism. We offer a choice of programming designed for the needs of our diverse congregation. We emphasize the value of life-long learning. We believe that being a Reform Jew means having the responsibility and freedom to seek and to choose the Jewish way of life most comfortable to the individual. Reform Jews embark on a life-long spiritual adventure of discovery and reward.
Rockdale Temple was founded by a small group of Jews who had settled in Cincinnati, then a frontier town. Their first meeting took place in 1824. These leaders recognized the need for a synagogue and efforts were made to raise funds for a building. In 1836 our first home at Sixth and Broadway was consecrated. In 1852 another synagogue was built on the same site. As the Jewish community grew and moved to other parts of the city, the congregation also moved, first to Eighth and Mound Streets, then to Rockdale and Harvey Avenues and, in 1969, to the present location on Ridge Road in Amberley Village.
For thirty-one years, readers or cantors conducted services. In 1855, Dr. Max Lilienthal was elected as our first permanent rabbi. Under Dr. Lilienthal's leadership many reforms were introduced into the previously orthodox service and the congregation was actively involved in the beginnings of the Reform movement. Since that time there have been nine rabbis and Rabbi Sigma Faye Coran now serves the congregation. Throughout the long history of the congregation distinguished rabbis have relied on remarkably able and committed lay leadership. Rabbis and members have participated actively in communal activities in the Jewish and general community.
A progressive spirit and recognition of the need for change and growth characterize Rockdale Temple's goals. There is outreach to a diverse membership. In addition to the religious school, the congregation participates in the Cincinnati Reform Jewish High School. The Sisterhood (Women of Reform Judaism), the Brotherhood (Men of Reform Judaism), and the youth groups facilitate activities which enhance congregational life. Various adult education programs are offered with many issues addressed in evening classes. The human experience is the constant in the history of K. K. Bene Israel. 190th Gala Celebration Video & Tribute Book
Click here to view the Tribute Book
190th Gala Celebration Video & Tribute Book
Click here to view the Tribute Book
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The median home value in Hedwig Village, TX is $640,200.
This is
higher than
the county median home value of $131,000.
The national median home value is $170,100.
The average price of homes sold in Hedwig Village, TX is $640,200.
Approximately 66.15% of Hedwig Village homes are owned,
compared to 23.47% rented, while
10.38% are vacant.
Hedwig Village real estate listings include condos, townhomes, and single family homes for sale.
Commercial properties are also available.
If you see a property you're interested in, contact a Hedwig Village real estate agent to arrange a tour today!
Learn more about Hedwig Village Real Estate.
Elegant 5 bedroom home with stately library / music room, living room with French doors that open to a covered patio that surrounds the master, living & family rooms! Picturesque views of the lush landscaping & Magnolia trees from the living & family room which offers an open concept! Stunning island kitchen with Thermador double ovens and refrigerator, Viking Professional 6 burner gas cook top & granite counters! Master bath with Bain Ultra Bubble Air tub as, game room with balcony and more!
Real Living The Hatmaker Group
1021 61st Street, Suite 100-B
Galveston, TX 77551
Email Us | Visit our Real Estate Website


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What happens when men with prostate cancer and prostatic intraepithelial neoplasia (PIN) are placed on a relatively low-fat diet supplemented with ground flaxseeds?
Images thanks to National Cancer Institute via Wikimedia Commons
Why is there such a huge disparity in prostate cancer rates? The incidence of the clinically malignant prostate cancer is highest in African Americans, some 30-fold greater than in Japanese men, and 120 times greater than seen in Chinese men in Shanghai. Well, in general terms the ''Western diet'' is one in which animal protein and fat consumption is high, whereas the ''fiber'' intake is low. In contrast, the proportion of the total caloric intake from animal fat in the more vegetarian-style ''Oriental diet'' is low and the fiber content is higher. So maybe diet is playing a role in some of these diseases. But these healthier diets are not just low in animal proteins and fat and high in starch and fiber, they are also rich in weak plant estrogens, of which there are two types. We hear a lot about the soy isoflavones, but less about the other group lignans. This study found higher levels of lignans in the prostate fluids of men in countries with relatively low rates of prostate cancer and in vitro studies showed lignans can slow the growth of prostate cancer cells in a petri dish,so a pilot study was performed on flaxseed supplementation in men with prostate cancer before surgery. Why flaxseeds? Because while lignans are found throughout the plant kingdom, flax has up to 800 times more than any other food. So they took a bunch of men with prostate cancer about a month before they were scheduled for surgery to get their prostates removed and started them on a relatively low fat diet with 3 tablespoons a day of ground flax seed to see what effect that might have on the growth of their tumors. Though they were skeptical that they would observe any differences in tumor biology in the diet-treated patients with such a short-term dietary intervention, they found significantly lower cancer proliferation rates and significantly higher rates of cancer cell death. That was compared to so-called historical controls, meaning compared to what the kind of growth one typically sees in their situation, not to actual randomized control group, but a few years later a study was published in which men were their own controls. These were men who just got their prostates biopsied and were scheduled to get repeat biopsies in six months. So they did the same thing, after the first biopsy, they reduced the fat in their diet and put them on ground flaxseeds to see if it made their repeat biopsy look any different. These were men with what's called PIN, which is like the prostate equivalent of ductal carcinoma in situ in the breast, precancerous changes. That's why they were getting repeat biopsies, to make sure it wasn't spreading. And this is what they found. Significant drop in PSA levels, which is a biomarker of prostate cell growth, drop in cholesterol, which is what one would expect with a lower fat diet and all that extra fiber, and the most important, a significant decrease in the cellular proliferation rate. In fact in two of the men, their PSA levels dropped so much they didn't even have to go through with the second biopsy. There hasn't been much research on this kind of prostatic hyperplasia, with only four epidemiologic studies reported at the time. They yielded varying findings, with increased risk associated with higher energy, protein, and animal product intake, and decreased risk related to the consumption of alcohol, fruit, and green and yellow vegetables—in sum, a low-fat, plant-based diet, high in phytoestrogens.
To see any graphs, charts, graphics, images, and quotes to which Dr. Greger may be referring watch the above video. This is just an approximation of the audio contributed by Jonathan Hodgson.
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Slowing the Growth of Cancer is good, but how about Cancer Reversal Through Diet? In other words, if one plant could do that, what about a whole diet chocked full of plants? See my video series that goes from Ex Vivo Cancer Proliferation Bioassay (actually Engineering a Cure) to The Answer to the Pritikin Puzzle. And for benign prostate gland enlargement Prostate vs. Plants, and Prostate vs. a Plant-Based Diet (with background in Some Prostates Are Larger than Others).
What about for breast cancer? See Breast Cancer Survival and Lignan Intake. More on these wonderful seeds in Flax and Fecal Flora, my smoothies (A Better Breakfast), and the oldie but goodie Just the Flax, Ma'am. What about chia? Find out which is better in Flaxseeds vs. Chia Seeds.
Since the dietary intervention involved both reducing fat intake and flaxseed consumption, how do we know the flax had anything to do with it? That's the subject of the next video Was It the Flaxseed, Fat Restriction, or both?
For more context, check out my blog posts: Flaxseeds for Prostate Cancer, Treating Sensitive Skin From the Inside Out, and Flax and Breast Cancer Survival
If you haven't yet, you can subscribe to my videos for free by clicking here.


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McGehee to Rangers?
The link takes you to a NY Post article by George King III. He claims that a 'one NL executive' says that the Rangers are interested in Casey McGehee playing 1B, enabling a Mitch Moreland/Wade Davis trade. No idea who could even come back in that trade.


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Antonia Novello was born in Fajardo, Puerto Rico in 1944 and moved to Michigan in 1970.
Novello was the first Hispanic and the first woman to serve as surgeon general of the United States. She was named to the post by President George H. W. Bush in 1990, and served until 1993.
Novello earned her M. D. degree at the University of Puerto Rico in 1970. She then moved to the University of Michigan to complete her internship and residency, and then received a fellowship from the Georgetown University School of Medicine.
During her tenure as surgeon general, Novello focused on health issues affecting children, women and minorities. She also challenged the tobacco industry over marketing tactics which appealed to children, most notably the "Joe Camel" cartoon character.
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Life insurance is one of the most important ways you can provide for your family. However, it's important to make sure you update beneficiary information. If you aren't careful, someone that you'd rather not benefit from your policy — like your ex — will receive the money.
The Supreme Court recently heard a case that involved a former federal employee's life insurance policy. The beneficiary on the policy was his ex-wife; he never changed the information after his divorce, nor did he change it after his remarriage.
The widow in the case challenged the payout, since the law in Virginia (where the couple lived) protects against such situations. However, the life insurance policy was a federal benefit, so the Supreme Court ruled that the state law didn't apply. Now, the ex-wife will receive the life insurance benefit instead of the widow.
[Check Your Credit: Don't Guess. Know.® Get your free credit report and score. No credit card required.
What can you learn from this? In many cases, the beneficiary you have listed on your accounts is the one who receives the payout. This is true of a number of accounts, from tax-advantaged retirement accounts to life insurance policies. The listed beneficiary trumps even what you have written in a will.
As you prepare your assets, it's important to review your beneficiary information. Even though some states offer protection so that an ex doesn't receive preference over a current spouse, you don't want to rely on that flimsy protection. Your best bet is to make sure that your accounts and policies list your beneficiary of choice.
In many cases, there are certain forms to fill out in order to designate a new beneficiary. Make sure you find out the proper procedure. Anytime you experience a major life event, check all of your accounts to confirm the beneficiary information, and make changes as needed.


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Essential oil, fresh zest
Aromatherapeutic Benefits: Purification, Joy, Calming, Sedative, Soothing
Relief from Stress.
The colored portion of the peel or the essential oil releases the familiar,
sweet, citrusy odor. Like neroli, this fragrance is ideal for self-purification,
transforming personal atmosphere and environment into peace and joy, and
produces an increase in available bioelectrical energy needed for mundane and
magical working.


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What I Can Do For You
I can help you reach your target web audience. This doesn't just mean giving you the tools you need, but also showing you how to use them. More often than not, the "geek" that sets up your new tools cannot show you how to use them in an easy to understand manner. That's what makes my services a little something extra.
- Adding new functionality to your current website (i.e. a blog)
- Creating custom web applications
- Showing you how to take advantage of the tools you already have
- Showing you how "Web 2.0″ can help you reach your audience
I hold myself to a high standard for both educating clients and writing clean code. That means that my clients will understand what they need to know and the applications they are using are easy to maintain.


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There's no need for heartbreak warfare. It's called 'I love you' — 'I love you too'. 'I need more love' — 'You got more love', and you can get through life like that. Shouldn't you just, on days where you want more love, be like 'I had a bad dream that you were sleeping around, it's really irrational, but just love me extra today'. Why can't we just have this thing where you say, 'Just love me extra today'. If I was with somebody and they said 'Love me extra today', I would love them extra forever.
John Mayer, Atlanta, 2010. ((via gotoheavenfortheclimate)


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Remodelers lobby Washington, Y2K fix for QuickBooks, EPA cracks down on lead paint, bad siding suit decided, energy code trade-offs
Tariffs on drilled studs may be reinstated, Arizona OSHA found liable in job-site death, becoming an expert witness, tax law on sub vs. employee
Contractor develops college construction technology program, new asbestos study confirms health hazards
States ponder adoption of Model Energy Code, on-line building permits, foam adhesives for roof sheathing, true cost of comp claims
California condo debacle, builder returns to Vietnam, new OSHA scaffold standard
Limiting your liability
Coping with swings in lumber prices, back supports cut injuries, spray foam insulation outperforms fiberglass in extreme cold
Working contractors who cut corners on staging risk large fines and serious injury. A scaffolding sub explains how to safely set up pipe staging, pump jacks, and wall and roof brackets.
It's hard to do good work in the dark. Here's an overview of products to light up the job site, from hand-held and string lights to powerful stanchion lights.
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2014 Hanley Wood Media, Inc. All rights reserved.


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RxNorm Names
(human immunoglobulin g)
[Bio Products Laboratory Limited]
Permanent Link:http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=6c3ce068-59f0-413b-9f93-85fb597d55e5
|DEA Schedule
|Marketing Status
|Biologic Licensing Application
These highlights do not include all the information needed to use Gammaplex® safely and effectively. See full prescribing information for Gammaplex GAMMAPLEX, IMMUNE GLOBULIN INTRAVENOUS (HUMAN), 5% LIQUID
Initial U.S. Approval: 2009
WARNING: THROMBOSIS, RENAL DYSFUNCTION and ACUTE RENAL FAILURE
See full prescribing information for complete boxed warning.
Gammaplex does not contain sucrose (5.1).
For patients at risk of thrombosis, renal dysfunction or acute renal failure, administer Gammaplex at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity (2.3, 5.1).
Ensure that patients with pre-existing renal insufficiency are not volume depleted; discontinue Gammaplex if renal function deteriorates (2.3. 5.1).
For patients at risk of renal dysfunction, thrombotic events or volume overload, administer Gammaplex at the minimum infusion rate practicable (2.3, 5.1 5.2, 5.8).
Gammaplex is a liquid solution containing 5% IgG (50 mg/mL). (3)
To report SUSPECTED ADVERSE REACTIONS, contact BPL Inc. (1-866-398-0825), FDA (1-800-FDA-1088) or www.fda.gov/medwatch
See 17 for PATIENT COUNSELING INFORMATION.
Revised: 6/2014
WARNING: THROMBOSIS, RENAL DYSFUNCTION and ACUTE RENAL FAILURE
- Thrombosis may occur with immune globulin products, including Gammaplex. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling central vascular catheters, hyperviscosity and cardiovascular risk factors. Thrombosis may occur in the absence of known risk factors [see Warnings and Precautions (5.2), Patient Counseling Information (17)].
- Renal dysfunction, acute renal failure, osmotic nephrosis, and death may occur in predisposed patients who receive immune globulin intravenous (lGIV) products, including Gammaplex1.
Patients predisposed to renal dysfunction include those with any degree of pre-existing renal insufficiency, diabetes mellitus, age greater than 65, volume depletion, sepsis, paraproteinemia, or patients receiving known nephrotoxic drugs [see Warnings and Precautions (5.1)]. Renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV products containing sucrose. Gammaplex does not contain sucrose.
For patients at risk of thrombosis, renal dysfunction or acute renal failure, administer Gammaplex at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity [see Dosage and Administration (2.3), Warnings and Precautions (5.1)].
1.1 Primary Humoral Immunodeficiency (PI)
Gammaplex is an Immune Globulin Intravenous (Human), 5% Liquid indicated for replacement therapy in adults with primary humoral immunodeficiency (PI). This includes, but is not limited to, the humoral immune defect in common variable immunodeficiency, X-linked agammaglobulinemia, congenital agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.
For Intravenous Use Only
2.1 Preparation and Handling
- Gammaplex is a clear or slightly opalescent, colorless solution. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if the solution is cloudy or turbid, or if it contains particulate matter.
- Do not freeze, and do not use any solution that has been frozen.
- Gammaplex should be at room temperature (up to 25°C [77°F]) at the time of administration.
- Do not use Gammaplex beyond the expiration date on the product label.
- The Gammaplex vial is for single use only. Due to the absence of anti-microbial preservatives, promptly administer Gammaplex after piercing the cap. Dispose of partially used or unused product.
- Infuse Gammaplex using a separate infusion line.
- Do not mix Gammaplex with other intravenous medications (including normal saline) or other IGIV products.
- An infusion pump may be used to control the rate of administration.
- If large doses of Gammaplex are to be administered, several vials may be pooled using aseptic technique. Begin infusion within 2 hours after pooling.
2.2 Recommended Dose
Treatment of Primary Humoral Immunodeficiency
As there are significant differences in the half-life of IgG among patients with PI, the frequency and amount of immunoglobulin therapy may vary from patient to patient. The proper amount can be determined by monitoring clinical response.
The recommended dose of Gammaplex for patients with PI is 300 to 800 mg/kg (6 to 16 mL/kg), administered every 3 to 4 weeks. Adjust the dosage over time to achieve the desired serum trough levels and clinical response. If a patient misses a dose, administer the missed dose as soon as possible, and then resume scheduled treatments every 3 or 4 weeks, as applicable.
Treatment of Chronic Immune Thrombocytopenic Purpura
The recommended dose of Gammaplex for patients with ITP is 1 g/kg (20 mL/kg) on 2 consecutive days, providing a total dose of 2 g/kg. Carefully consider the relative risks and benefits before prescribing the high dose regimen (i.e. 1 g/kg/day for 2 days) in patients at increased risk of thrombosis, hemolysis, acute kidney injury, or volume overload [see Warnings and Precautions (5)]. Adequate data on the platelet response to the low dose regimen (e.g. 400 mg/kg per day for 5 consecutive days) are not available for Gammaplex.
2.3 Administration
- Hydrate the patient adequately prior to the initiation of infusion.
- Due to the absence of anti-microbial preservatives, promptly administer Gammaplex after piercing the cap.
- Infuse Gammaplex intravenously using an intravenous infusion set. See Table 1 for recommended infusion rates.
|Initial infusion rate for first 15 minutes
|Maintenance infusion rate (if tolerated)
|PI or ITP
|0.5 mg/kg/min (0.01 mL/kg/min)
|Increase gradually every 15 minutes to 4 mg/kg/min (0.08 mL/kg/min)
- Monitor vital signs throughout the infusion.
- Slow or stop the infusion if adverse reactions occur.
- If symptoms subside, the infusion may be resumed at a lower rate that is comfortable for the patient.
- The observation time of patients after Gammaplex administration may vary. If the patient (a) has not received Gammaplex or another IgG product, (b) is switched from an alternative IGIV product or (c) has had a long interval since the previous infusion, prolong the observation time for adverse reactions after Gammaplex infusion.
- Certain severe adverse reactions may be related to the rate of infusion. Slowing or stopping the infusion often allows the reaction to disappear.
- Ensure that patients with pre-existing renal insufficiency are not volume depleted.
- For patients at increased risk of renal dysfunction, thrombotic events, or volume overload, administer Gammaplex at the minimum infusion rate practicable. Consider discontinuing Gammaplex administration if renal function deteriorates [see Boxed Warning, Warnings and Precautions (5.1, 5.2, 5.8)].
- Gammaplex is contraindicated in patients who have had an anaphylactic or severe systemic reaction to the administration of human immune globulin.
- Gammaplex is contraindicated in patients with hereditary intolerance to fructose, also in infants and neonates for whom sucrose or fructose tolerance has not been established.
- Gammaplex is contraindicated in IgA-deficient patients with antibodies to IgA and a history of hypersensitivity.
5.1 Renal Dysfunction / Failure
Acute renal dysfunction/failure, osmotic nephropathy, and death1 may occur upon use of human IGIV products. Ensure that patients are not volume depleted before administering Gammaplex. In patients who are at risk of developing renal dysfunction, because of pre-existing renal insufficiency, predisposition to acute renal failure (such as diabetes mellitus, hypovolemia, overweight, use of concomitant nephrotoxic medicinal products or age >65 years), administer Gammaplex at the minimum infusion rate practicable [see Dosage and Administration (2.3)].
Periodic monitoring of renal function and urine output is particularly important in patients judged to be at increased risk of developing acute renal failure. Assess renal function, including measurement of blood urea nitrogen (BUN) and serum creatinine, before the initial infusion of Gammaplex and at appropriate intervals thereafter. If renal function deteriorates, consider discontinuing Gammaplex.
5.2 Thrombotic Events
Thrombosis may occur following treatment with immune globulin products, including Gammaplex2. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling central vascular catheters, hyperviscosity and cardiovascular risk factors. Thrombosis may occur in the absence of known risk factors.
Consider baseline assessment of blood viscosity in patients at risk for hyperviscosity, including those with cryoglobulins, fasting chylomicronemia / markedly high triacylglycerols (triglycerides), or monoclonal gammopathies. For patients at risk of thrombosis, administer Gammaplex at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity [see Boxed Warning, Dosage and Administration (2.3), Patient Counseling Information (17)].
5.3 Hypersensitivity
Severe hypersensitivity reactions may occur [see Contraindications (4)]. In case of hypersensitivity, discontinue Gammaplex infusion immediately and institute appropriate treatment. Medications such as epinephrine should be available for immediate treatment of acute hypersensitivity reactions.
Gammaplex contains trace amounts of IgA (<10 μg/mL) [see Description (11)]. Patients with known antibodies to IgA may have a greater risk of developing potentially severe hypersensitivity and anaphylactic reactions. Gammaplex is contraindicated in patients with antibodies against IgA and a history of hypersensitivity reaction [see Contraindications (4)].
5.4 Hyperproteinemia, Increased Serum Viscosity, and Hyponatremia
Hyperproteinemia, increased serum viscosity, and hyponatremia may occur in patients receiving IGIV therapy. It is critical to clinically distinguish true hyponatremia from a pseudohyponatremia that is associated with or causally related to hyperproteinemia with concomitant decreased calculated serum osmolality or elevated osmolar gap, because treatment aimed at decreasing serum free water in patients with pseudohyponatremia may lead to volume depletion, a further increase in serum viscosity, and a possible predisposition to thrombotic events2.
5.5 Aseptic Meningitis Syndrome (AMS)
AMS may occur with IGIV treatment. AMS usually begins within several hours to 2 days following IGIV treatment. Discontinuation of IGIV treatment has resulted in remission of AMS within several days without sequelae. 3
AMS is characterized by the following signs and symptoms: severe headache, nuchal rigidity, drowsiness, fever, photophobia, painful eye movements, nausea, and vomiting [see Patient Counseling Information (17)]. Cerebrospinal fluid (CSF) studies frequently reveal pleocytosis up to several thousand cells per cubic millimeter, predominantly from the granulocytic series, and elevated protein levels up to several hundred mg/dL, but negative culture results. Conduct a thorough neurological examination on patients exhibiting such signs and symptoms, including CSF studies, to rule out other causes of meningitis. AMS may occur more frequently in association with high doses (2 g/kg) and/or rapid infusion of IGIV.
5.6 Hemolysis
Gammaplex may contain blood group antibodies that can act as hemolysins and induce in vivo coating of red blood cells (RBCs) with immunoglobulin, causing a positive direct antiglobulin test (DAT) (Coombs' test) result and hemolysis 4. Delayed hemolytic anemia can develop subsequent to IGIV therapy due to enhanced RBC sequestration and acute hemolysis, consistent with intravascular hemolysis, has been reported. 5 Cases of severe hemolysis-related renal dysfunction/failure or disseminated intravascular coagulation have occurred following infusion of IGIV.
The following risk factors may be associated with the development of hemolysis following IGIV administration: high doses (e.g., ≥2 g/kg), given either as a single administration or divided over several days, and non-O blood group 6. Other individual patient factors, such as an underlying inflammatory state (as may be reflected by, for example, elevated C-reactive protein or erythrocyte sedimentation rate), have been hypothesized to increase the risk of hemolysis following administration of IGIV 7, but their role is uncertain. Hemolysis has been reported following administration of IGIV for a variety of indications, including ITP and PI. 4
Closely monitor patients for clinical signs and symptoms of hemolysis, particularly patients with risk factors noted above. Consider appropriate laboratory testing in higher risk patients, including measurement of hemoglobin or hematocrit prior to infusion and within approximately 36 to 96 hours post infusion. If clinical signs and symptoms of hemolysis or a significant drop in hemoglobin or hematocrit have been observed, perform confirmatory laboratory testing. If transfusion is indicated for patients who develop hemolysis with clinically compromising anemia after receiving IGIV, perform adequate cross-matching to avoid exacerbating on-going hemolysis.
5.7 Transfusion-related Acute Lung Injury (TRALI)
Noncardiogenic pulmonary edema may occur in patients following IGIV treatment 8. TRALI is characterized by severe respiratory distress, pulmonary edema, hypoxemia, normal left ventricular function and fever. Symptoms typically appear within 1 to 6 hours following treatment.
Monitor patients for pulmonary adverse reactions. If TRALI is suspected, perform appropriate tests for the presence of anti-neutrophil antibodies in both the product and the patient's serum.
TRALI may be managed using oxygen therapy with adequate ventilatory support.
5.8 Volume Overload
Carefully consider the relative risks and benefits before prescribing the high dose regimen (for chronic ITP) in patients at increased risk of volume overload.
5.9 Transmissible Infectious Agents
Because Gammaplex is made from human blood, it may carry a risk of transmitting infectious agents, e.g., viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent. No cases of transmission of viral diseases or CJD have been associated with the use of Gammaplex. All infections suspected by a physician possibly to have been transmitted by this product should be reported by the physician or other healthcare providers to BPL Inc. 1-866-398-0825.
Before prescribing Gammaplex, the physician should discuss the risks and benefits of its use with the patient [see Patient Counseling Information (17)].
5.10 Laboratory Tests
- After infusion of immunoglobulin, the transitory rise of the various passively transferred antibodies in the patient's blood may yield positive serological testing results, with the potential for misleading interpretation.
- Passive transmission of antibodies to erythrocyte antigens (e.g., A, B, and D) may cause a positive direct or indirect antiglobulin (Coombs') test.
- Clinically assess patients with known renal dysfunction, diabetes mellitus, age greater than 65, volume depletion, sepsis, paraproteinemia, or those receiving nephrotoxic agents, and monitor as appropriate (BUN, serum creatinine, urine output) during therapy with Gammaplex.
- Consider baseline assessment of blood viscosity in patients at risk for hyperviscosity, including those with polycythemia, cryoglobulins, fasting chylomicronemia/markedly high triglycerides, or monoclonal gammopathies.
- Consider measuring hemoglobin or hematocrit at baseline an approximately 36 to 96 hours post infusion in patients at higher risk of hemolysis. If signs and/or symptoms of hemolysis are present after an infusion of Gammaplex, perform appropriate laboratory testing for confirmation.
- If TRALI is suspected, perform appropriate tests for the presence of anti-neutrophil antibodies in both the product and patient's serum.
Serious adverse reactions (ARs) observed in clinical trial subjects with primary humoral immunodeficiency (PI) were thrombosis and chest pain. [see Warnings and Precautions (5.2)].
Serious ARs observed in clinical trial subjects with immune thrombocytopenic purpura (ITP) were headache, vomiting and dehydration.
The following potential serious ARs are described below and/or elsewhere in the labeling:
- Thrombotic Events [see Warnings and Precautions (5.2)]
- Hemolysis [see Warnings and Precautions (5.6)]
The most common ARs observed in the PI clinical trial were headache (18 subjects, 36%), pyrexia (8 subjects, 16%), fatigue (6 subjects, 12%), nausea (6 subjects, 12%), hypertension (3 subjects, 6%), chills (3 subjects, 6%), myalgia (3 subjects, 6%), pain (4 subjects, 8%), and vomiting (3 subjects, 6%).
The most common ARs observed in the chronic ITP clinical trial were headache (12 subjects, 34%), vomiting (8 subjects, 23%), nausea (5 subjects, 14%), pyrexia (5 subjects, 14%), pruritus (2 subjects, 6%) and arthralgia (2 subjects, 6%).
6.1 Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
Treatment of Primary Humoral Immunodeficiency
In a multicenter, open-label, non-randomized clinical trial, 50 subjects with primary humoral immunodeficiency received doses of Gammaplex ranging from 279 to 799 mg/kg every 21 days (mean dose 465 mg/kg) or 28 days (mean dose 458 mg/kg), for up to 12 months [see Clinical Studies (14.1)]. Routine premedication was not allowed. Of the 703 infusions administered, 2 (4%) subjects received premedication (antipyretic, antihistamine, or antiemetic agent) prior to 2 courses of treatment, because of experience with consecutive infusion-related ARs.
Twenty-four subjects (48%) had an AR at some time during the clinical trial that was considered product-related. Of these 24 subjects, three had ARs that were considered definitely related to Gammaplex including headache, pyrexia, tachycardia, chest discomfort, and hypertension. More subjects with the 21-day infusion cycle had at least one AR (14 of 22 subjects, 64%) than subjects with the 28-day infusion cycle (10 of 28 subjects, 36%). The total number of ARs during infusion or within 72 hours of infusion was 237 (a rate of 0.34 ARs per infusion), reflecting that some subjects experienced more than one AR during the observation period. The percentage of Gammaplex infusions with one or more ARs within 72 hours of infusion was 21%. The upper bound of the 1-sided 97.5% confidence interval for this percentage was 24%, which was below the pre-specified upper limit of 40% for this safety endpoint.
The most common ARs observed in this clinical trial were headache (18 subjects, 36%), fatigue (6 subjects, 12%), nausea (6 subjects, 12%), pyrexia (6 subjects, 12%), pain (4 subjects, 8%), hypertension (3 subjects, 6%), chills (3 subjects, 6%), myalgia (3 subjects, 6%) and vomiting (3 subjects, 6%). Two subjects experienced serious ARs (thrombosis and chest pain). Table 2 lists the ARs that occurred in more than 5% of the subjects.
Forty-seven of the 50 subjects enrolled in this clinical trial had a negative direct antiglobulin test (DAT) at baseline. Of these 47 subjects, 4 (9%) developed a positive DAT at some time during the clinical trial. However, no subjects showed evidence of hemolytic anemia.
There was no evidence of transmission of hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV) or parvovirus B19 during this clinical trial.
|Adverse Reactions
|Subjects (%)
|Infusions (%)
|PI [n=50]
|PI [n=703]
|18 (36%)
|53 (7.5%)
|8 (16%)
|10 (1.4%)
|8 (16%)
|9 (1.3%)
|6 (12%)
|9 (1.3%)
|6 (12%)
|7 (1.0%)
|Nasal Congestion
|5 (10%)
|3 (0.4%)
|4 (8%)
|5 (0.7%)
|3 (6%)
|3 (0.4%)
|3 (6%)
|5 (0.7%)
|3 (6%)
|4 (0.6%)
|3 (6%)
|3 (0.4%)
|Muscle spasms
|3 (6%)
|2 (0.3%)
|3 (6%)
|3 (0.4%)
|Upper respiratory tract infection
|3 (6%)
|5 (0.7%)
Treatment of Chronic Immune Thrombocytopenic Purpura
In a multicenter, open-label, non-randomized clinical trial, 35 subjects with chronic immune thrombocytopenic purpura were treated with a nominal dose of 1,000 mg/kg on each of two consecutive days (total dose 2,000 mg/kg). Doses of Gammaplex ranged from 482 to 1149 mg/kg on an infusion day. The median total dose per subject was 2035 mg/kg. Pre-medication with antihistamine or analgesic drugs was permitted if required, but corticosteroids were not permitted prior to infusion as pre-medication. Ten subjects received corticosteroids for ITP during the trial and one additional subject received corticosteroids as pre-medication in violation of the protocol. All 35 subjects received at least one infusion of clinical trial drug, and all but one subject completed the first course of treatment.
Twenty-four subjects (69%) reported at least one AR (103 in total); the most commonly reported being headache (12 subjects, 34%), vomiting (8 subjects, 23%), nausea (5 subjects, 14%), pyrexia (5 subjects, 14%), pruritus (2 subjects, 6%), dehydration (2 subjects, 6%) and arthralgia (2 subjects, 6%). Three subjects experienced a total of five serious ARs. Of the five serious ARs, one subject had three concurrently (vomiting, dehydration and headache) and two subjects each had one serious AR (headache). One of these latter two subjects discontinued from the clinical trial because of the severe headache. Table 3 lists the ARs in more than 5% of subjects.
Based on a review of clinical and laboratory data, 4/35 subjects (11%) with drops in hemoglobin exceeding 2 g/dL following administration of Gammaplex were considered to have experienced suspected treatment-emergent hemolysis. Milder treatment-emergent hemolysis could not be excluded for an additional 7 subjects, giving a total of 11 of 35 subjects (31%) for whom hemolysis could not be excluded (not including an additional two subjects who lacked follow-up testing for hemolysis, so their hemolysis status was considered unassessable). Data for two subjects were consistent with possible intravascular hemolysis, including one subject who may also have had an element of extravascular hemolysis. Nine of the possible hemolysis cases were mild and appeared consistent with possible extravascular hemolysis.
There was no evidence of transmission of HBV, HCV, HIV and parvovirus B19 during this clinical trial.
|Adverse Reactions
|Subjects (%)
|Infusions (%)
|ITP [n=35]
|ITP [n=94]
|12 (34%)
|15 (16%)
|8 (23%)
|9 (9.6%)
|5 (14%)
|5 (5.3%)
|5 (14%)
|7 (7.4%)
|2 (6%)
|2 (2.1%)
|Abdominal pain upper
|2 (6%)
|2 (2.1%)
|2 (6%)
|2 (2.1%)
|2 (6%)
|2 (2.1%)
|2 (6%)
|2 (2.1%)
|2 (6%)
|2 (2.1%)
|2 (6%)
|1 (1.1%)
|2 (6%)
|3 (3.2%)
|2 (6%)
|2 (2.1%)
|2 (6%)
|2 (2.1%)
|2 (6%)
|1 (1.1%)
|Neck pain
|2 (6%)
|1 (1.1%)
6.2 Postmarketing Experience
Because adverse reactions are voluntarily reported post-approval from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to product exposure.
In addition to the adverse reactions identified in clinical studies [see Adverse Reactions (6.1)], the following adverse reactions have been identified during postmarketing use of Gammaplex:
- Infusion reactions: Dizziness, back pain, flushing
- Respiratory: Pulmonary embolism, dyspnea
- Cardiovascular: Myocardial infarction
- Integumentary: Rash, urticaria
The following adverse reactions have been identified during post-marketing use of intravenous immune globulins 9:
- Infusion reactions: hypersensitivity (e.g., anaphylaxis), headache, diarrhea, tachycardia, fever, fatigue, dizziness, malaise, chills, flushing, urticaria or other skin reactions, wheezing or other chest discomfort, nausea, vomiting, rigors, back pain, myalgia, arthralgia, and changes in blood pressure
- Renal: Acute renal dysfunction/failure, osmotic nephropathy
- Respiratory: Apnea, Acute Respiratory Distress Syndrome (ARDS), TRALI, cyanosis, hypoxemia, pulmonary edema, dyspnea, bronchospasm
- Cardiovascular: Cardiac arrest, thromboembolism, vascular collapse, hypotension
- Neurological: Coma, loss of consciousness, seizures, tremor, aseptic meningitis syndrome
- Integumentary: Stevens-Johnson syndrome, epidermolysis, erythema multiforme, dermatitis (e.g., bullous dermatitis)
- Hematologic: Pancytopenia, leukopenia, hemolysis, positive direct antiglobulin (Coombs') test
- Gastrointestinal: Hepatic dysfunction, abdominal pain
- General/Body as a Whole: pyrexia, rigors
- Transitory rise of the various passively transferred antibodies in the patient's blood after infusion of immunoglobulin may yield positive serological testing results, with the potential for misleading interpretation. Passive transmission of antibodies to erythrocyte antigens (e.g., A, B, and D) may cause a positive direct or indirect antiglobulin (Coombs') test.
- Passive transfer of antibodies may transiently interfere with the immune response to live virus vaccines such as measles, mumps, rubella and varicella. 10, 11 Inform the immunizing physician of recent therapy with Gammaplex so that appropriate measures may be taken [see Patient Counseling Information (17)].
8.1 Pregnancy
Pregnancy Category C. Animal reproduction studies have not been conducted with Gammaplex. It is also not known whether Gammaplex can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Gammaplex should be given to a pregnant woman only if clearly needed. Immunoglobulins cross the placenta from maternal circulation increasingly after 30 weeks of gestation 12.
8.4 Pediatric Use
Treatment of Primary Humoral Immunodeficiency
Gammaplex was evaluated in six (6) pediatric patients with primary humoral immunodeficiency (2 between ages of 9 and 10, and 4 between ages 12 and 16). This number of pediatric patients was too small for separate evaluation from the adult patients for safety or efficacy [see Clinical Studies (14)]. The indication for treatment of Primary Humoral Immunodeficiency is therefore limited to adults only.
Treatment of Chronic Immune Thrombocytopenic Purpura
Gammaplex was evaluated in three (3) pediatric subjects with chronic immune thrombocytopenic purpura (two aged 6 and one aged 12). This number of pediatric patients was too small for separate evaluation from the adult patients for safety or efficacy [see Clinical Studies (14)]. The indication for treatment of Chronic Immune Thrombocytopenic Purpura is therefore limited to adults only.
8.5 Geriatric Use
Use caution when administering Gammaplex to patients age 65 and over who are judged to be at increased risk of developing renal insufficiency or thrombotic events [see Boxed Warning, Warnings and Precautions (5.1, 5.2)]. Do not exceed recommended doses, and administer Gammaplex at the minimum infusion rate practicable.
Eight (8) patients with primary humoral immunodeficiency at or over the age of 65 were included within the clinical evaluation of Gammaplex. This number of geriatric patients was too small for separate evaluation from the younger patients for safety or efficacy [see Clinical Studies (14)].
Overdosage may lead to fluid overload and hyperviscosity, particularly in the elderly and in patients with renal impairment.
Gammaplex is a ready to use sterile solution of polyclonal human Immunoglobulin G for intravenous administration that contains sorbitol, glycine and polysorbate 80 as stabilizers. Specifically, Gammaplex contains approximately 5 g normal human immunoglobulin and 5 g D-sorbitol in 100 mL of buffer solution containing: 0.6 g glycine, 0.2 g sodium acetate, 0.3 g sodium chloride and ~5 mg polysorbate 80. Immunoglobulin G purity is > 95%, the pH is in the range of 4.8 to 5.1, and osmolality is not less than 240 mOsmol/kg (typically 420 to 500 mOsmol/kg). The distribution of the four IgG subclasses is approximately 64% IgG1, 30% IgG2, 5% IgG3, and 1% IgG4. The content of IgA is lower than 10 μg/mL. The anti-D and anti-A/anti-B hemagglutinin content of the drug product is strictly controlled to specification. Gammaplex contains no reducing carbohydrate stabilizers (e.g. sucrose, maltose) and no preservative.
Gammaplex is prepared from large pools of human plasma by a combination of cold ethanol fractionation and ion exchange chromatography. Fab functions tested include antigen binding activity, and Fc functions tested include complement activation and rubella antibody-mediated hemolysis.
Gammaplex is manufactured from plasma, obtained from healthy US donors, who have passed viral screening tests. All donors are subjected to medical examinations, laboratory tests, and a review of their medical history before being allowed to donate blood or plasma.
All plasma donations are screened for antibody to HIV-1/2 and HCV, and hepatitis B surface antigen (HBsAg). Additional testing of donations is carried out in plasma mini-pools (512 donations per pool) that undergo nucleic acid amplification testing (NAT) for HIV, hepatitis B virus (HBV), HCV, hepatitis A virus (HAV) and Parvovirus B19.
Further testing is carried out on the manufacturing pools for HBsAg, and antibody to HIV-1/2; HCV and Parvovirus B19 are also tested by NAT, with the limit for B19 set to not exceed 104 IU B19 DNA per mL plasma.
There are three processing steps specifically designed to remove or inactivate viruses:
1) Solvent/Detergent treatment is targeted to enveloped viruses;
2) A virus filtration step designed to remove small viruses including non-enveloped viruses, on a size exclusion basis; and
3) The terminal low pH incubation step is identified as contributing to the overall viral clearance capacity for enveloped and non-enveloped viruses.
The capacity of the manufacturing process to remove and/or inactivate enveloped and non-enveloped viruses has been validated by laboratory spiking studies on a scaled down process model. Overall virus reduction was calculated only from steps that were mechanistically independent from each other.
In addition, each step was validated to provide robust virus reduction. The table below presents the contribution of each process step to virus reduction and the overall process reduction.
(Envelope/ Genome)
|Process Log10 Reduction of Virus (LRV) over manufacturing step
|Solvent Detergent
|20 nm filtration
|Terminal low pH/elevated temperature incubation
|Total LRV
|HIV: Human immunodeficiency virus
SIN: Sindbis virus, model for hepatitis C virus (HCV)
WNV: West Nile Virus
BVDV: Bovine viral diarrhea virus, model for HCV
IBR: Infectious bovine rhinotracheitis, bovine herpesvirus model for enveloped DNA viruses including hepatitis B
HAV: Hepatitis A virus
EMC: Encephalomyocarditis, model for HAV
CPV: Canine parvovirus, model for human parvovirus B19
NA: Not applicable, solvent detergent step is limited to the inactivation of enveloped viruses
I: Inactivation by the product intermediate precluded the accurate estimation of the removal of these viruses by the filtration step
NT: Not tested
B19: Viral clearance of Human Parvovirus B19 was investigated experimentally at the 20 nm filtration step. The estimated Log reduction Factor obtained was 6.0
12.1 Mechanism of Action
Treatment of Primary Humoral Immunodeficiency - Gammaplex is a replacement therapy for primary humoral immunodeficiency. It acts through a broad spectrum of opsonic and neutralizing IgG antibodies against pathogens and their toxins involving antigen binding and effector functions 13,14. However, the mechanism of action in PI has not been fully elucidated.
12.3 Pharmacokinetics
Treatment of Primary Humoral Immunodeficiency
In the clinical trial assessing safety and efficacy in primary humoral immunodeficiency, the pharmacokinetics (PK) of Gammaplex was assessed after administration to 24 subjects on 21- or 28-day infusion cycles. Blood samples for PK analysis were obtained after Infusion 9 for subjects on a 21-day schedule (9 subjects) and after Infusion 7 for subjects on a 28-day schedule (15 subjects), i.e. during the sixth month after initiation of Gammaplex treatment.
The mean dose (range) for those on the 21-day schedule was 476 mg/kg (range: 330 to 721 mg/kg), and 468 mg/kg (range: 324 to 799 mg/kg) for those on the 28-day schedule. Table 5 summarizes the PK parameters of Gammaplex, measured as serum concentrations of total IgG.
Treatment of Chronic Immune Thrombocytopenic Purpura
Although the clinical trial in chronic immune thrombocytopenic purpura did not perform a formal PK analysis, a post-hoc analysis was undertaken using the total IgG levels to confirm exposure of the subjects to the product. As in the PI clinical trial, Table 5 summarizes the PK parameters of Gammaplex measured as serum concentrations of total IgG in subjects with ITP.
|Parameter (unit)
|21-day Dosing Interval
|28-day Dosing Interval
|Dosing (1st treatment course only) (n=30) †, ‡
(95% confidence intervals)
(95% confidence intervals)
(95% confidence intervals)
|Cmax (mg/dL)
|Tmax (hr)
|AUC (days*mg/dL)
|Half-Life (days)
|Clearance (dL/days/kg)
|Volume of Distribution (dL/kg)
14.1 Treatment of Primary Humoral immunodeficiency
In a Phase 3 multicenter, open-label clinical trial to evaluate the efficacy, safety, and pharmacokinetics of Gammaplex in primary humoral immunodeficiency, 50 subjects on regular IGIV replacement therapy for at least 3 months prior to participation were treated for 12 months at 21-day (22 subjects) or 28-day (28 subjects) dosing intervals. Of the 50 subjects, 26 were male and 24 were female, and 46 were Caucasian. They were in the age range of 9 to 78 years.
Doses ranged from 279 mg/kg to 799 mg/kg. The mean dose (range) for the 21-day interval was 465 mg/kg (330 - 693 mg/kg); the mean dose (range) for the 28-day interval was 458 mg/kg (326 - 790 mg/kg). Subjects received a total of 703 infusions of Gammaplex. The maximum infusion rate allowed during this clinical trial was 0.08 mL/kg/min (4 mg/kg/min).
The efficacy analysis was based on the annual rate of acute serious bacterial infections (aSBIs), defined as pneumonia, bacteremia/ septicemia, osteomyelitis/septic arthritis, visceral abscess, and bacterial meningitis, per subject per year 15. Other efficacy analyses were based on the annual rate of infections, antibiotic use, days out of work/school/day care or unable to perform normal activities due to illness, and days of hospitalization.
During the 12-month clinical trial period, no serious acute bacterial infections occurred in any subject with an onset date between the first infusion of Gammaplex and the first follow-up visit, inclusive. Thus, the mean event rate of serious, acute, bacterial infections per year was zero (with an upper 1-sided 99% confidence interval of 0.101).
|Clinical Analyses for Efficacy
|Number of Subjects
|Total Number of Subject Days
|Duration of exposure in all tables relating to GMX01 was calculated as the difference between the date of the last visit (first follow-up visit) i.e. approximately 10-14 days following the last dose of Gammaplex and the date of the first Gammaplex infusion (plus one day).
|Annual rate of confirmed serious acute bacterial infections*
|0 /subject year †
|Annual rate of other infections (median)
|3.07 infections/subject year
|Antibiotic use (therapeutic)
|Number of subjects (%)
|40 (80%)
|Annual rate
|47.2 days/subject year
|Out of work/school/day care or unable to perform normal activities due to illness
|Number of subjects (%)
|23 (46%)
|Number of days (%)
|394 (2.36%)
|Annual rate
|8.73 days/subject year
|Number of subjects (%)
|4 (8%)
|Number of days (%)
|29 (0.17%)
|Annual rate
|0.75 days/subject year
14.2 Treatment of Chronic Immune Thrombocytopenic Purpura
In a Phase 3 multicenter, open-label clinical trial to evaluate the efficacy and safety of Gammaplex in chronic immune thrombocytopenic purpura, of the 35 subjects enrolled from various ethnic groups, 9 were male and 26 were female. The age range was between 6 and 69 years. Subjects received intravenous infusions on two consecutive days (1 course) and then observed for a further 30 days. Individuals were given the option of a further two courses of treatment (if required), where only safety variables were assessed. Doses of Gammaplex ranged from 482 to 1149 mg/kg on Day 1 and Day 2. The median total dose per subject was 2035 mg/kg. Subjects received a total of 94 infusions (48 treatment courses). All 35 subjects received at least one infusion of clinical trial drug, and all but one subject completed the first course of treatment.
The primary analysis was based on the platelet count achieved by Day 9 after the first course of treatment with Gammaplex, response being defined as a platelet count of 50 × 109/L or greater. Response to treatment on or before Day 9 was achieved by 29 of 35 subjects (82.9%), and the one-sided 97.5% lower confidence limit of the response rate was 66.4%, which met the a priori success criterion that required it to be greater than 60%.
Efficacy analyses included the duration of response, and changes in the incidences of bleeding or hemorrhage. At Day 32, the median (+ SD) platelet count (24 + [90] × 109/L) was still higher than the baseline value, and 11 of 33 subjects (33.3%) continued to show response of platelet counts of 50 × 109/L or greater. The median duration of platelet count response for the responders was 10 days.
|Number of days in clinical trial
|Day 1
|Day 2
|Day 3
|Day 5
|Day 9
|Day 14
|Day 21
|Day 32
|Gammaplex infusions given on Days 1 and 2.
|Median Platelet count (× 109/L)
(Std Dev)
|Number (n/N) and percent of subjects with a platelet count ≥ 50 ×109/L
There was an increase in platelet counts for the majority of subjects, and an overall reduction in the manifestations of bleeding after treatment compared to baseline (Day 1). Petechiae, hematomas and gastrointestinal, pulmonary and genitourinary bleeds were all either reduced or absent by Day 32.
There were no thromboembolic episodes in the clinical trial; and vital signs, biochemical, hematological and virology tests did not reveal any unexpected pathophysiology or toxicity.
- Gupta N, Ahmed I, Nissel-Horowitz S, Patel D, Mehrotra B. Intravenous gammaglobulin-associated acute renal failure. Am J Hematol 2001; 66:151-152.
- Dalakas MC. High-dose intravenous immunoglobulin and serum viscosity: risk of precipitating thromboembolic events. Neurology 1994; 44:223-226.
- Gabor EP. Meningitis and skin reaction after intravenous immune globulin therapy. Ann Intern Med 1997; 127:1130.
- Wilson JR, Bhoopalam N, Fisher M. Hemolytic anemia associated with intravenous immunoglobulin. Muscle Nerve 1997; 20:1142-1145.
- Kessary-Shoham H, Levy Y, Shoenfeld Y, Lorber M, Gershon H. In vivo administration of intravenous immunoglobulin (IVIg) can lead to enhanced erythrocyte sequestration. J Autoimmun 1999; 13:129-135.
- Kahwaji J, Barker E, Pepkowitz S, et al. Acute Hemolysis After High-Dose Intravenous Immunoglobulin Therapy in Highly HLA Sensitized Patients. Clin J Am Soc Nephrol 2009;4:1993-1997.
- Daw Z, Padmore R, Neurath D, et al. Hemolytic transfusion reactions after administration of intravenous immune (gamma) globulin: A case series analysis. Transfusion 2008;48:1598-1601.
- Rizk A, Gorson KC, Kenney L, Weinstein R. Transfusion-related acute lung injury after the infusion of IVIG. Transfusion 2001; 41:264-268.
- Pierce LR, Jain N. Risks associated with the use of intravenous immunoglobulin. Trans Med Rev 2003; 17:241-251.
- Siber GA, Werner BG, Halsey NA, Reid R, Almeido-Hill J, Garrett SC, Thompson C, Santosham M. Interference of immune globulin with measles and rubella immunization. J Pediatr 1993; 122:204-211.
- Salisbury D, Ramsay M, Noakes K, eds. Immunisation against infectious disease. The Stationery Office (TSO), London: UK Department of Health, 2009; p426,
- Sidiropoulos D, Herrmann U, Morell A, von Muralt G, Barandun S. Transplacental passage of intravenous immunoglobulin in the last trimester of pregnancy. J Pediatr 1986; 109:505-508.
- Wood P, Stanworth S, Burton J, Jones A, Peckham DG, Chapel H. Recognition, clinical diagnosis and management of patients with primary antibody deficiencies: a systematic review. Clin Exp Immunol 2007; 149:410-423.
- Simon H, Späth P. IVIG – Mechanisms of action. Allergy 2003; 58(7):543-52.
- Center for Biologics Evaluation and Research. Guidance for Industry: Safety, Efficacy, and Pharmacokinetic Studies to Support Marketing of Immune Globulin Intravenous (Human) as Replacement Therapy for Primary Humoral Immunodeficiency. Rockville, MD: U.S. Department of Health and Human Services, Food and Drug Administration; July, 2008.
Gammaplex is supplied in a single use, clear Type II glass bottle, closed with a stopper and oversealed with a tamper-evident cap.
The components used in the packaging for Gammaplex are latex free.
The following presentations of Gammaplex are available:
|NDC Number
|Grams and Fill Size
|Each vial has a label with a peel-off strip showing the product name and batch number.
|2.5 g in 50 mL
|5 g in 100 mL
|10 g in 200 mL
|20 g in 400 mL
Inform patients to immediately report the following signs and symptoms to their healthcare professional:
- Decreased urine output, sudden weight gain, fluid retention/edema, and/or shortness of breath [see Warnings and Precautions (5.1)].
- Acute chest pain, shortness of breath, leg pain, and swelling of the legs/feet [see Warnings and Precautions (5.2)].
- Severe headache, neck stiffness, drowsiness, fever, sensitivity to light, painful eye movements, nausea and vomiting [see Warnings and Precautions (5.5)].
- Increased heart rate, fatigue, yellowing of skin or eyes, dark-colored urine [see Warnings and Precautions (5.6)].
- Trouble breathing, chest pain, blue lips or extremities, fever [see Warnings and Precautions (5.7)].
Inform patients that Gammaplex is made from human plasma and may contain infectious agents that can cause disease. While the risk that Gammaplex can transmit an infection has been reduced by screening plasma donors for prior exposure, testing donated plasma, and inactivating or removing certain viruses during manufacturing, patients should report any symptoms that concern them [see Warnings and Precautions (5.9)].
Inform patients that Gammaplex can interfere with their immune response to live viral vaccines (e.g., measles, mumps, and rubella), and instruct patients to notify their healthcare professional of this potential interaction when they are receiving vaccinations [see Drug Interactions (7)].
Instruct patients to immediately report symptoms of thrombosis. These symptoms may include: pain and/or swelling of an arm or leg with warmth over the affected area, discoloration of an arm or leg, unexplained shortness of breath, chest pain or discomfort that worsens on deep breathing, unexplained rapid pulse, numbness or weakness on one side of the body.
Manufactured by:
Bio Products Laboratory Limited
Dagger Lane
United Kingdom.
US License No. 1811
U.S. Distributor:
BPL Inc.
8601 Six Forks Road, Suite 400
North Carolina 27615
Bio Products Laboratory Limited
Dagger Lane, Elstree, Herts., WD6 3BX, U.K.
Tel: 1-866-398-0825
PRINCIPAL DISPLAY PANEL - 50 mL Bottle Label
Immune Globulin Intravenous (Human)
2.5 g
50 mL
- No preservative.
Directions for use:
Read enclosed package insert
before use. Use immediately
after piercing cap.
- Rx ONLY.
U.S. License No. 1811
Maximum infusion rate 0.08 mL/kg per minute.
This product may transmit infectious agents.
Store between 2° and 25°C
(35.6° and 77°F) protected from light.
Distributor: BPL Inc. 8601 Six Forks Road,
Suite 400, Raleigh, NC 27615 USA 866-398-0825
Manufactured by: Bio Products Laboratory Ltd.
Dagger Lane, Elstree, Herts WD6 3BX U.K.
human immunoglobulin g solution
|Labeler - Bio Products Laboratory Limited (216845337)
|Business Operations
|Bio Products Laboratory Limited


text: Friday Jam - The Coco Butter Kids pt I 06/21/2013 09:45 AM 06/21/2013 09:47 AM <br>The Coco Butter Kids play the Friday Jam! The Coco Butter Kids play the Friday Jam! Copyright 2013 Nexstar Broadcasting, Inc. All rights reserved. Page: [[$index + 1]] morning show morning show features the morning show the morning show - friday jam


text:
Agents of Change
One of Google's executives came up with a video that teaches children the logic behind computer programing using recreation and without them realising it.
The turtle videogame that teaches children how to program /
In recent decades, computer programming has become one of the most interesting technical instruments for any professional. Any person who possesses this skill will almost certainly find a job: understanding the code language used in technological devices is an essential educational complement, and one of the most profitable skills within the employment market. This is the alphabetisation of the twentieth century, knowing, creating and learning.
Nowadays programming is beginning to be considered one of the main resources of socioeconomic mobility, since in addition to its ability to be profitable, it is also available for countless people. Generally associated with complex mathematical calculations, or with the outstanding genius of those who practice it, this understanding is transforming, to the degree that currently programmers are teaching people how to use this social weapon, at a low cost.
Alluding to this undeniable need, Dan Shapiro, an exec from Google, created a game where four year olds can understand the logic behind programing; he was inspired by his own four year old son. Shapiro submitted his initiative through the fund-raising platform Kickstarter, which managed to raise over 25 thousand dollars in just over 5 hours, and after only 24 hours it raised 80 thousand dollars —proof of a collective culture that values the teaching of programming.
This videogame is called Robot Turtles and consists of moving a turtle towards a jewel. In the process they liberate cards that, through symbols, specify what the character can and can't do— which allows them to create their own code in order to win a prize. This is an intuitive game which can also be bought on Kickstarter for 30 dollars.
Shapiro himself has declared that programming is the new superpower and that any person who knows it can have huge professional opportunities. It would seem that teaching programing should be established as an educational right for new generations, and apparently, fortunately, the collective thought agrees.Tagged: programming, education and new technologies, computing, videogames, Agents of Change, Robot Turtles programming videogame


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Melanie Rossomando of New Jersey said she had a good reason to jump from a stalled boardwalk ride: to get out of the path of an oncoming thunderstorm.
"In my mind it was a metal death-trap," Rossomando said.
Rossomando was at the Jersey Shore to celebrate her birthday.
She was on the Sky Ride at Seaside Heights when she saw the fast moving storm approaching.
"We were three seats away from getting off and then it stopped," Rossomando said.
The teen started screaming as she saw lightning and decided that staying in the all-metal contraption was way too dangerous.
Rossomando dropped her belongings and vaulted off the chairlift and fell to the beach below.
Someone shot video of the terrifying moments on their phone.
Rossomando told Fox 5 that she suffered some bumps and bruises but was doing fine.
"Thank God I didn't break anything," Rossomando said.
The Casino Pier amusement park's chair ride was in standby mode when the power went out.
Rossomando said he supports her daughter's decision to trust her instincts and jump.
"It was self-preservation because you could see a little lightning and someone did get killed in Monmouth County from lightning in that storm," Pete Rossomando said.


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Lanta House
Lanta house is located at the center of Saladan Village or what they called the shopping center. In here, you can find restaurants, internet cafes, travel agencies and diving shops with just a few steps from our guesthouse.
It is a simple guesthouse, a clean and a very comfortable place to stay. It was provided and is suitable for those friendly backpackers who want to save money while enjoying their holiday here in Lanta. We offer you a very low price in which we knew that everybody can afford. Rooms are equipped with air condition. All are non- smoking rooms with double bed. Bathroom are shared .We offer you also unlimited Wi-Fi which can be used 24 hours, and complimentary that includes everyday coffee & tea
our guesthouse is a walking distance. Its just 5 minutes walk from the pier and about 10 minutes walk from where the minibus will drop you!
Please Note:
SUPERIOR SINGLE PRIVATE = 1 Single Bed with Air-condition+Window , Shared Bathroom, Free WIFI, Coffee& Tea
SUPERIOR DOUBLE BED PRIVATE = 1 Double Bed with Air-condition+Window, Shared Bathroom, Free WIFI, Coffee& Tea
STANDARD SINGLE PRIVATE = 1 Single Bed with Air-condition, Shared Bathroom, Free WIFI, Coffee& Tea
STANDARD DOUBLE BED PRIVATE = 1 Double Bed with Air-condition, Shared Bathroom, Free WIFI, Coffee& Tea
BASIC SINGLE PRIVATE = 1 Single Bed with Fan, Shared Bathroom, Free WIFI, Coffee& Tea
BASIC DOUBLE BED PRIVATE = 1 Double Bed with Fan, Shared Bathroom, Free WIFI, Coffee& Tea
Disponibilidad y preciosPara ver la disponibilidad y los precios, selecciona las fechas y pincha "Actualizar fechas"
Instalaciones & Políticas de Pensión
- Restricciones de edad
- Aire acondicionado
- Desayuno no incluido
- La tarjeta de crédito no ha sido aceptada
- Acceso gratuito a Internet
- Wifi gratuito
- Sin límite de hora
- No fumadores
- Toallas incluidas
Política de cancelaciónEsta propiedad cuenta con una política de cancelación de 2 días. Si no se realiza la cancelación dentro de ese plazo se aplicará un recargo de anulación igual a la primera noche de tu estancia.
Leer información importante de GuesthouseEsta propiedad cuenta con Términos y condiciones específicos.
- Cancellation policy must be notify us by writing in advance 48 hrs before original arrival date, otherwise
the cost of cancellation at 1 night will be charged and cannot be refund or waived.
- Guest must settle the full payment covered the period of staying before check-in
- Early Check-out will be charged full period of your stay
- No Show will be charged 1 night of your staying
IndicacionesMostrar mapaOcultar mapa
Guest coming from Phuket, Krabi, or Phi Phi by boat, upon arriving at the pier just walk directly following the main road for about 2 minutes and there you can see our small sign board �LANTA HOUSE � While those who are coming from Phuket, Krabi or Trang by minibus just let the driver know the name of our guesthouse and he can send you directly in here.


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Where: Adirondack Folk School, Lake Luzerne, NY
Adirondack Folk School51 Main Street, Lake Luzerne, NY
Phone: (518) 696-2400
Email: firstname.lastname@example.com
Website: www.adirondackfolkschool.org
Learn basic 19th Century American tinsmithing. Students will first learn about safety using tools and sharp materials, then learn to use the tools, transcribe patterns, & cut sheet metal. Make reproductions of colonial items. Ages 11 and up.#250-0803


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Every year in December I start doing Christmas themed Freebie Fridays. So it may surprise you that I am doing a Christmas themed Freebie Friday early on in November. I am going to pretend that I am doing this because I am terribly practical and want to make sure you have plenty of time to create these advent calendars in time for December 1st (let's not mention that I'm a crazy Christmas fanatic and would do Christmas all year round if it didn't freak people right out).
Click here to see Better Homes and Gardens slide-show of advent calendar ideas.
This funky little advent calendar from So you Wanna Be a Domestic Goddess recycles styrofoam.
Click here for another advent calendar with recycling in mind, this one designed by Cyndi Lavin. It uses re-purposed tins to create a really cool retro look.
If you like the tin idea, you could try this calendar made from scrapbook tins by Beate Johns.
This magnet advent calendar uses stuff found at the dollar store (pound shop).
This cone garland advent calendar designed by Julie Ree looks so cool, and refined.
If you've got stars in your eyes, try this star garland advent calendar from DIY Father.
This embroidered advent calendar from All Sorts would be a bit of work but so lovely.
If you've got tons of Halloween candy left over from last weekend, why not use it up by making this advent calendar. What a great way to enjoy the candy slowly instead of eating it all at once, just cause it's there, and thereby causing a sugar induced coma. Awesome.
Enjoy the countdown!


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TEAMS: Brooklyn Nets, Boston Celtics
Brooklyn Nets guard Joe Johnson broke out a wicked crossover move that nearly brought Boston Celtics forward Paul Pierce to the floor during the fourth quarter of Wednesday night's NBA game at the TD Bank Center. Johnson led the Nets with 18 points to help carry them to a 95-83 victory. Video via. H/T Cosby. Visit us at http://holdoutsports.com and Follow @HoldoutSports !function(d,s,id){var js,fjs=d.getElementsByTagName(s)[0];if(!d.getElementById(id)){js=d.createElement(s);js.id=id;js.src="http://feedproxy.google.com//platform.twitter.com/widgets.js";fjs.parentNode.insertBefore(js,fjs);}}(document,"script","twitter-wjs"); on Twitter.
Paul Pierce's Terrible No Good Week
Joe Johnson hit Paul Pierce with a crossover that sent Pierce to his knees
Joe Johnson Drops Paul Pierce With Crossover
Video: Jameer Nelson breaks Paul Pierce's ankle into a million pieces
Video: Paul Pierce gets dropped by crossover for second time in less than a week
Joe Johnson Toasts Paul Pierce With Some Fancy Dribbling
RedsArmy presents Fan Friday #32: "#TeamCeltics"
Joe Johnson Crossover Cripples Paul Pierce & Mr. Skin's Top NSFW Scenes Of 2012
Celtics, Nets Could Have Foundation of Serious Rivalry Brewing In Wake of Wednesday's Scuffle
Taking Stock: Celtics – Nets
Boston Celtics creating adversity for themselves….again!
Rondo #6 most popular NBA jersey
Video: Three at the Buzzer: Rondo-less Celtics Blowout Blazers 96-78
How we see it goin' down: Celtics – Nets
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President Teresa Sullivan also made a big announcement about the campaign for the University of Virginia during Sunday's final exercises.
She told the crowd the capital campaign exceeded its goal of raising $3 billion.
Sullivan called it the most ambitious capital campaign in the history of higher public education. The effort began in October of 2006.
The campaign's funds have built the John Paul Jones Arena and paid for the first phase of rotunda renovations.
University of Virginia Press Release
University of Virginia leaders joined with students, family, alumni and friends on Sunday in celebrating a shared success in one of the nation's most ambitious higher-education philanthropic efforts.
President Teresa A. Sullivan during Final Exercises congratulated and thanked the thousands of people who played a part in helping the Campaign for the University of Virginia meet and exceed its $3 billion goal.
"In October 2006, under the direction of my predecessor John Casteen, and with the backing of the Board of Visitors, the University officially launched the most ambitious capital campaign in the history of public higher education, with a goal of raising $3 billion to support the people and programs of the University," Sullivan said. "All of us who care about this University and its future are incredibly grateful to everyone who has made the success of this campaign possible."
Reaching the goal helps to ensure today's University will continue to serve the people of Virginia, while strengthening its reputation among the world's best institutions of higher education; and it also provides momentum to protect U.Va. for future generations, she said.
"Today is a wonderful day for the University of Virginia," said Campaign Chair Gordon F. Rainey Jr. "Because of the tireless efforts of so many loyal and generous supporters, we are confident in a secure future for the University." Rainey, a former rector of the University, is a 1962 graduate of U.Va. and a 1967 graduate of the School of Law.
Funds from the campaign have benefitted and will continue to benefit strategic priorities in every school and program on Grounds, as well as University-wide initiatives.
"We could say so much to so many people involved in this effort. But the simplest and most appropriate thing to say today is simply, 'Thank you,'" said John L. Nau III, chair of the Board of Visitors' Advancement and Communications Committee, campaign vice-chair, the first chair of the University's Council of Foundations and a 1968 graduate of U.Va.
Campaign gifts came from across the Commonwealth and, indeed, from across the globe. They included thousands of small contributions, many large contributions, and transformative, multimillion-dollar gifts. Supporters of the University bequeathed shares in companies to the University, transferred ownership of art, rare and historic maps, and real estate.
"Reaching a goal this ambitious takes a sustained effort by many people, inside and outside the organization," said Robert D. Sweeney, senior vice president for university advancement. "I'm amazed at the level of dedication and support. This achievement signals so strongly that the best days are ahead for this University."
Since its launch, the campaign has provided resources for many programs, centers and initiatives, benefitting thousands of students and helping ensure that U.Va. has world-class faculty, provides extraordinary patient care, pursues research that improves society and offers modern facilities that will last for generations.
The Campaign for the University of Virginia has received gifts from more than 220,000 donors (individuals and organizations). More than 92,000 alumni have participated, as well as 29,000 parents of students and 2,600 faculty and staff members, both current and former.
Campaign gifts have created more than 1,000 new endowments, including 514 endowed scholarships, 63 endowed professorships and 97 endowed fellowships. Just in the last week, the University received a gift at the Darden School of Business for a military fellows program that will fund a comprehensive program to support scholarship aid for military veterans.
Campaign highlights include:
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text: Human Machine Interface: a vital factor in the world of automationAs your single-source provider, Siemens' human machine interface technology SIMATIC HMI is engineered to meet the increasingly complex processes of your machines and systems. SIMATIC HMI is optimized to meet your specific human machine interface needs using open and standardized interfaces in hardware and software, which allow efficient integration into your automation systems.Innovative HMI displaysLearn more about innovative operator control and monitoring with widescreen displays and integrated multi-touch functions! more informationSIMATIC Apps simply cleverUse your smartphone or tablet computer for easy access to information and services all around commissioning, operation and maintenance of your Siemens system more information new: SmartClient App also available for iOS


text:
Alpha Chi Honor Society
Advisor: Dr. Robin Schutt, Associate Professor, email@example.com
Co-Advisor: Assistant Provost, Karen Arnold, email@example.com
Co-Advisor: Student Activities Coordinator, Melissa Hague, firstname.lastname@example.com
Alpha Chi membership is a prestigious honor reserved for only the top 10% of Bachelor and Master's students in all academic fields. Alpha Chi recognizes and promotes scholarship and those elements of character that make scholarship effective for good. The top 10% is based on quarterly cumulative GPAs. As a member, your academic excellence will be recognized with the a membership certificate, personalized membership card, lapel pin, notation of membership on your diploma and transcripts, and the privilege of wearing regalia at graduation that sets you apart as a Alpha Chi member. An induction ceremony is held annually at NEIT in April.


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Well, it's that silly season again. Rumors and proposals are rampant. A lot of players are mentioned as available and another ton are tossed around by fans, all seeking to build a better mousetrap. The real trick is to piece together what is doable and at the same time inch the team closer to the goal - Banner 18.
The latest from the Celtics revolves around "who is on the bus." It appears that the current "locks" are Rondo, Green, and Sullinger. I can agree with and support this core. A week ago, I would also have assumed that Bradley was in that group. His name though has started to pop up as available recently, about the same time as the emergence of Chris Johnson. Interesting or unrelated? Regardless, let's start with the first three and work from there.
Rondo of course is a four time All-Star, Sully is "the Kevin Love of the East" (according to Roy Hibbert) and Green is a fine third fiddle. The glaring hole is at Center.
Many, but not all fans have missed the rumblings that Brooklyn still wants to "win now" and to do that they might be willing to part with Brook Lopez. At only 25, he has one All-Star appearance, gives you around 20 points and 7 rebounds a game, and is starting to become a real defensive presence at the rim. There is a big risk in will he be able to stay healthy. His last foot operation included a procedure to reposition an adjacent bone so that his foot should not continue to be a problem. Conventional wisdom would say wait and see if it works. Doing so might make it impossible to pry him loose. So I think if there is a chance to land him, you have to go for it.
While the desire might be to keep Green, I don't see any path to Lopez without Green being included. And when you look at the upcoming free agents, Small forward includes some names such as Trevor Ariza, Luol Deng, Danny Granger, and wait for it .... Paul Pierce.
There are several possible paths to get it done. A direct trade of Brandon Bass and Green works. Golden State is rumored to be interested in Bass and is also rumored to possibly trade anyone not named Curry or Bogut. So Bass and Green to GSW and David Lee to the Nets works. Better (for the Celtics) would be Bass and Green for Washington's 13-30 pick and Emeka Okafor to Brooklyn, but this doesn't fit their "win now" mandate.
The point is, this would not be impossible to pull off and would give Boston an All-Star at the 1 & the 5 with another potential All-Star at the 4. In the end, I believe Trader Danny will follow the conservative route and not pursue it.
What I see as more likely trades considering the rumored core being kept would be something along these lines. With the rumors out of Charlotte, knowing they the need an upgrade at both forward slots and that they are looking for a reliable shooter, I could see Kris Humphries and Avery Bradley for the $13.2 M expiring Ben Gordon along with at least the Detroit 9-30 and possibly the Portland 13-30 as well. Gordon could keep Kieth Bogans company. The pick(s) is important here as you will see below.
The next move would be Bass to the Suns (rumored interested party) for Slava Kravtsov and the Washington 13-30 pick. Phoenix was unwilling to move that pick with Okafor for Pau Gasol as it was too much. However they were willing to include a lesser pick. The Bass deal would still leave them the assets in place to maybe pull off the Gasol deal at the eleventh hour, so they might well go for it.
So the trades cut an additional $6.2M from the payroll going into the summer, but why the two and possibly three picks in addition to the two the Celtics already have? Because many seem to think Trader Danny should go after Gordon Hayward.
Utah is in full rebuild mode. They have signaled that they want to keep Hayward and have plenty of cap space next year to match any offer. Unless they get an offer that they can't refuse. Say something along the lines of a small contract like Joel Anthony for salary matching and two first round picks, maybe the Detroit 9-30 from above and Boston's pick with top four protection. (If Embiid, Parker, Wiggins, and Exum are the prizes and everyone else are just very good prospects, does it matter that much where you pick if it isn't top four?) If they don't go for it, you still have the picks and the cap space to pull off something at the draft or the off season.
Think big because anything is possible. Ideally, you end up with All-Stars or potential All-Stars at at least four starting slots. Then you round out the roster with some guys playing above their pay grade. Maybe a Ryan Kelly from the Lakers, a Nate Wolters with the Bucks, or another kid out of Dayton playing well for New Orleans, Brian Roberts.
Perhaps not all of this happens, in fact maybe none. And if it doesn't, I am content to keep our guys and see where it goes. But there are enough quality pieces to shuffle around that this is likely the worst season we may have to endure for a while.


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During my first BFA class today, we were assigned either an artist or a movement to research. By chance, I received the name Frauke Stegmann, a name with which I was unfamiliar. However, after doing some research, I found Stegmann's work to be rather intriguing. Take a look for yourself!
Below, I've copied and pasted her design philosophy, which is taken from an interview with Elle Decoration:
'My work is very influenced by the craft movement that emerged during the late 1990s and early 2000s. At the time there was a strong feeling that digital technology was increasingly dominating the creation and production of graphic design, resulting in a "flat" superficiality. A growing number of designers started looking to the physical act of making, thus "craft" – the act, not the aesthetic – became a way of bringing back a type of depth and tactility to printed matter, and incorporating a sense of the handmade into new technology.
I also adhere to the broader DIY movement, which encourages individuals to produce goods themselves, thereby protesting corporate exploitative labour and environmental practices while empowering individuals to become producers rather than just consumers. These days companies have to consider green and social issues, so maybe one day it will become possible again to do work with a clean conscience for multinational corporations.' -Frauke Stegmann


text:
The Society of Physics Students (SPS) is a professional association explicitly designed for students. Membership, through collegiate chapters, is open to anyone interested in physics. The only requirement for membership is that you be interested in physics. Besides physics majors, our members include majors in chemistry, computer science, engineering, geology, mathematics, medicine, and other fields. Within SPS is housed Sigma Pi Sigma, the national physics honor society, which elects members on the basis of outstanding academic achievement.
This unique two-in-one society operates within the American Institute of Physics, an umbrella organization for ten other professional science societies.
Upon payment of your $24.00 national dues, you will receive:
Spring 2014 Officers:
President - Jamie HamesVice President - Stephen WhitfieldSecretary - Gabby BrizelTreasurer- Bradley Tidwell
Spring Schedule of Events
MARCH3/4 Speaker, Astronaut Buzz Aldrin, lunar module pilot, 7 p.m. Leonard Auditorium3/15 Arcadia Elementary School Outreach SPACE party3/28 Guest Speaker, Dr. Moffett from Furman University, Astronomy, 11:30 a.m. - 1 p.m. RMSC122
APRIL4/15 Lunar Eclipse Star viewing Event4/17 Outreach, Elementary School rocket launch4/24 Guest Speaker, TBA
5/2 Radiotelescope trip5/6 End of the year Banquet
Rocket Launch at Goodall Center:
Jupiter and its moons by Jamie Hames:
Fall 2013 Halloween Carnival:
Visit to Furman Observatory, November 2013:
Super Hero Outreach Event with Girls & Boys Club of Spartanburg:
Space Party, Arcadia Elementary School 2014
Main Event 2014


text:
When IT managers think of content management, they tend to think of documents, websites, intranets, and SharePoint . But now -- thanks to the popularity of YouTube -- video is emerging as yet another form of enterprise content to be managed.
"Video is not a fringe format anymore. Increasingly, information workers consume video in the workplace for training purposes, technical help, and real-time communication with colleagues and customers," according to a recent Forrester Research report.
[ Discover what's new in business applications with InfoWorld's Technology: Applications newsletter. | Get the latest insight on the tech news that matters from InfoWorld's Tech Watch blog. ]
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text:
To Be Enviable
Recent Plays: 18,418
Size: 247 KB
- Report
- Full Screen
- Full Screen
- How To Play
- Favourite
So you wanna be the envy of all the girls in your hood? Well here's a game designed to inspire you on how to be enviable. Have fun!Game controls: Mouse - To interact.
Thanks, Game Reported!
Please give a brief description of what is wrong with the game


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Landau Scrubs move with you all day long. This scrub top has a V-neck with set-in sleeves. Features four pockets with pencil/instrument division and 4" side vents. Made of Polyester/Cotton.
The material is super soft, yet super durable! I know this is a quality company, that's why I chose this brand :)
Ordered a large according to size chart measurements...just got it in the mail and it's big enough to fit two of me inside. Definitely need to size down at least one size. However, material feels soft and good quality.
OK. material is thick. Will work only in winter in AZ
This top fits great and is comfortable. I love the double pockets. The neckline is not so low that I feel uncomfortable if I have to bend forward.
I had a special order with embroidered name to the right chest. But the embroidery was on the side of my breast and low. I called and spoke with CSR and was informed I would be contacted. It has been 2 weeks and I haven't heard from or been contacted in any way by anyone regarding the issue.


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UCF Metropolitan Center for Regional Studies director Linda Chapin, Greater Orlando Aviation Authority chairman Jeff Fuqua, Orange County Comptroller Martha Haynie, Orlando Regional Healthcare president John Hillenmeyer, Florida Hospital president Lars Houmann, former Lt. Gov. Toni Jennings, retired restaurant exec Rick Walsh, Bishop Tom Wenski
A quick-hit rundown of others who received multiple votes:
Jim Atchison, Ron Blocker, Bob Brown, Val Demings, Carmen Dominguez, Bill Donegan, Helen Donegan, Karen Dyer, Ray Gilley, Charlie Gray, Jim Greer, Charlotte Hall, the Rev. Joel Hunter, Ajit Lalchandani, Lawson Lamar, Rich Maladecki, Henry Maldonado, Mark NeJame, Tico Perez, Jim Philips, Kathy Ramsberger, John Reed, Gary Sain, Ann Sonntag, David Siegel, Mike Thomas, Ed Timberlake, Craig Ustler, Bob Vander Weide
The rest of the list
16. Dick Batchelor, consultant and former legislator
17. Jim Seneff, CNL Financial Group CEO
18. Fred Leonhardt, GrayRobinson partner
19. Dan Webster, state senate majority leader
20. Andy Gardiner, state legislator
21. Jane Healy, Orlando Sentinel editorial page editor
22. Kathy Waltz, Orlando Sentinel publisher
23. John Morgan, attorney
24. Teresa Jacobs, Orange County commissioner
25. Harvey Massey, pest-control executive


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I'm trying to install the ArxWizards, but keep on reciving this error attached. I'm working with autocad 2012 and visual studio 2010.
any suggestion?
Solved! Go to Solution.
Can you please try setting the User Access Control Settings (UAC) to "Never Notify" and then start the ArxWizards installer ?
A system restart may be required after the UAC setting is modified.
Hope this helps.
Developer Technical Services
Autodesk Developer Network
hi Balaji,
thanks for respond. Installation did work after I did what you said, so thanks. Now, I enter the Visual Studio starting a new project, but in the New Project dialog/Visual C# Projects there is no "AutoCAD Managed C# Project" template.
The AutoCAD .Net Wizard is different from the ObjectARX Wizard.
You can get it from the Developer Center. Here is the link :
AutoCAD .Net Wizard
Balaji, you are tha man! It works! thanks...
thank,it is almost not been mention in chinese web site,you help me a lot.