text:
- human immunoglobulin g injection, solution
HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use FLEBOGAMMA 5% DIF safely and effectively. See full prescribing information for FLEBOGAMMA 5% DIF.
FLEBOGAMMA 5% DIF [Immune Globulin Intravenous (Human)], For intravenous administration, 5% Liquid Preparation Initial U.S. Approval: 2006 WARNING: THROMBOSIS, RENAL DYSFUNCTION, and ACUTE RENAL FAILURESee full prescribing information for complete boxed warning.
INDICATIONS AND USAGEFlebogamma 5% DIF is an Immune Globulin Intravenous (Human), indicated for treatment of Primary (inherited) Immunodeficiency (PI). [1] DOSAGE AND ADMINISTRATIONFor Intravenous Use Only
DOSAGE FORMS AND STRENGTHSLiquid preparation containing 5% IgG (50 mg/mL). [3] CONTRAINDICATIONSWARNINGS AND PRECAUTIONS
ADVERSE REACTIONSThe most common adverse reactions (reported in ≥ 5% of clinical trial subjects) were: headache, pyrexia/fever, pain, infusion site reactions, diarrhea, rigors or chills, urticaria and infusion site inflammation. [6] To report SUSPECTED ADVERSE REACTIONS, contact Grifols Biologicals at 1- 888-GRIFOLS (1-888-474-3657) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. DRUG INTERACTIONSPassive transfer of antibodies may transiently interfere with the immune response to live virus vaccines, such as measles, mumps, and rubella. [7] USE IN SPECIFIC POPULATIONS
See 17 for PATIENT COUNSELING INFORMATION. Revised: 9/2013 |
Flebogamma 5% DIF is an Immune Globulin Intravenous (Human) 5% preparation that is indicated for the treatment of Primary Immunodeficiency (PI) including the humoral immune defect in common variable immunodeficiency, x-linked agammaglobulinemia, severe combined immunodeficiency, and Wiskott-Aldrich syndrome.
For Intravenous Use Only
Treatment of Primary Immunodeficiency (PI)
Dose | Initial Infusion Rate | Maintenance Dose Rate (if tolerated) |
300 to 600 mg/kg body weight (6.0 to 12.0 mL/kg) administered every 3 to 4 weeks | 0.01 mL/kg/minute (0.5 mg/kg/min) | Increase to 0.10 mL/kg/minute (5 mg/kg/min) |
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. Dosing should be adjusted according to the clinical response.
The dosage may be adjusted over time to achieve the desired trough IgG levels and clinical responses. No randomized controlled trial data are available to determine an optimum target trough serum IgG level.
The recommended initial infusion rate of Flebogamma 5% DIF is 0.01 mL/kg body weight/minute (0.5 mg/kg/minute). If the infusion is well-tolerated, during the first 30 minutes, the rate may be gradually increased to a maximum of 0.10 mL/kg/minute (5 mg/kg/minute).
Monitor patient vital signs throughout the infusion. Slow or stop infusion if adverse reactions occur. If symptoms subside promptly, the infusion may be resumed at a lower rate that is comfortable for the patient.
Flebogamma 5% DIF is a liquid preparation containing 5% IgG (50 mg/mL).
Severe hypersensitivity reactions and anaphylactic reactions with a fall in blood pressure may occur, even in patients who had tolerated previous treatment with IGIV (see Contraindications [4]). If hypersensitivity reaction develops, discontinue Flebogamma 5% DIF infusion immediately and institute appropriate treatment.
Flebogamma 5% DIF contains trace amounts of IgA (less than 50 μg/mL) (see Description [11]). Patients with antibodies to IgA have a greater risk of developing potentially severe hypersensitivity and anaphylactic reactions. Flebogamma 5% DIF is contraindicated in patients with antibodies against IgA and a history of hypersensitivity reaction. (See Contraindications [4])
Acute renal dysfunction/failure, acute tubular necrosis, proximal tubular nephropathy, osmotic nephrosis and death have been reported in patients receiving IGIV, particularly those products containing sucrose (2). Flebogamma 5% DIF does not contain sucrose.
Ensure that patients are not volume-depleted before administering Flebogamma 5% DIF. For patients judged to be at risk for developing renal dysfunction, including patients with any degree of pre-existing renal insufficiency, diabetes mellitus, age greater than 65, volume depletion, sepsis, paraproteinemia, or patients receiving known nephrotoxic drugs, administer Flebogamma 5% DIF at the minimum rate of infusion practicable (3). (See Boxed Warning) (See Dosing 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 (1). Assess renal function, including measurement of blood urea nitrogen (BUN) and serum creatinine, before the initial infusion of Flebogamma 5% DIF and at appropriate intervals thereafter. If renal function deteriorates, consider discontinuation of the product.
Hyperproteinemia, increased serum viscosity and hyponatremia may occur in patients receiving Flebogamma 5% DIF therapy. It is clinically critical to distinguish true hyponatremia from a pseudohyponatremia that is temporally or causally related to hyperproteinemia with concomitant decreased calculated serum osmolarity 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 higher risk of thrombosis.
Thrombosis may occur following treatment with immune globulin products, including FLEBOGAMMA 5% DIF. 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. (see Warnings and Precautions [5.10]) For patients at risk of thrombosis, administer FLEBOGAMMA 5% DIF 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] and Patient Counseling Information [17]).
AMS has been reported to occur following IGIV treatment. Discontinuation of IGIV treatment has resulted in remission of AMS within several days without sequelae (7-10). The symptoms of AMS usually begin within several hours to 2 days following IGIV treatment.
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 with elevated protein levels up to several hundred mg/dL, but negative culture results. Conduct a thorough neurological examination to patients exhibiting such signs and symptoms, including CSF studies, to rule out other causes of meningitis.
AMS may occur more frequently following high-dose (e.g. > 1.0 g/kg body weight) and/or rapid-infusion of IGIV.
Hemolytic anemia can develop subsequent to IGIV therapy, including Flebogamma 5% DIF. Flebogamma 5% DIF contains blood group antibodies which may act as hemolysins and induce in vivo coating of red blood cells (RBCs) with immunoglobulin, causing a positive direct antiglobulin reaction and hemolysis (11-13). Acute intravascular hemolysis has been reported, and delayed hemolytic anemia can develop subsequent to IGIV therapy due to enhanced RBC sequestration (14).
Monitor patients for clinical signs and symptoms of hemolysis. If signs and/or symptoms of hemolysis are present after Flebogamma 5% DIF infusion, perform appropriate confirmatory laboratory testing. (See Patient Counseling Information [17])
Non-cardiogenic pulmonary edema has been reported in patients following IGIV treatment (15). TRALI is characterized by severe respiratory distress, pulmonary edema, hypoxemia, normal left ventricular function and fever. Symptoms typically appear within 1 to 6 hours after transfusion.
Monitor patients for pulmonary adverse reactions (see Patient Counseling Information [17]). If TRALI is suspected, perform appropriate tests for the presence of antineutrophil antibodies and anti-HLA antibodies in both the product and patient serum. TRALI may be managed by using oxygen therapy with adequate ventilatory support.
Individuals receiving Flebogamma 5% DIF for the first time or being restarted on the product after a treatment hiatus of more than 8 weeks, may be at a higher risk for the development of fever, chills, nausea, and vomiting. Careful monitoring of recipients and adherence to recommendations regarding dosage and administration may reduce the risk of these types of events (see Dosage and Administration [2.3]).
Because Flebogamma 5% DIF is made from human plasma, it may carry a risk of transmitting infectious agents, e.g. viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent. This also applies to unknown or emerging viruses and other pathogens. No cases of transmission of viral diseases or CJD have been associated with the use of Flebogamma 5% DIF. All infections suspected by a physician possibly to have been transmitted by this product should be reported by the physician or other healthcare provider to Grifols Biologicals at 1-888-474-3657.
Before prescribing or administering Flebogamma 5% DIF, the physician should discuss the risks and benefits of its use with the patient (see Patient Counseling Information [17]).
After infusion of IgG, 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.
The most common adverse reactions (reported in ≥ 5% of clinical trial subjects) were: headache, pyrexia/fever, pain, infusion site reactions, diarrhea, rigors or chills, urticaria and infusion site inflammation.
To report SUSPECTED ADVERSE REACTIONS, contact Grifols Biologicals at 1- 888-GRIFOLS (1-888-474-3657) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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.
Adverse reactions were reported in a study of 46 individuals with PI receiving infusions every 3 to 4 weeks of 300 to 600 mg/kg body weight. Thirty-one subjects (67.4%) had at least an adverse reaction at some time during the study that was considered product-related. None of the 46 subjects who participated in this study discontinued the study prematurely due to an adverse drug reaction.
Adverse reactions that occurred with an incidence of ≥ 5% on a per subject basis are summarized in Table 1.
a = includes combined reported terms of pyrexia and body temperature increase. |
b = include combined reported terms of pain such as pain (not otherwise specified), injection site pain, back pain, abdominal pain (not otherwise specified) and abdominal pain upper. |
c = include combined reported terms of infusion site inflammation and others such as injection site oedema and injection site swelling. |
Adverse Reaction | Subjects (%) N=46 | Number of Events |
Headache | 10 (21.7) | 24 |
Pyrexiaa | 9 (19.6) | 12 |
Painb | 7 (15.2) | 11 |
Injection site reaction | 6 (13.0) | 10 |
Diarrhoea | 4 (8.7) | 5 |
Rigors | 4 (8.7) | 7 |
Urticaria | 3 (6.5) | 3 |
Infusion site inflammationc | 3 (6.6) | 3 |
The most common other adverse drug reactions reported in fewer than 5% of the subjects included hypertension, sinusitis, nausea/vomiting, positive Coombs test, arthralgia, myalgia, dizziness, bronchitis and hypotension.
The total number of adverse reactions reported whose onset were within 72 hours after the end of an infusion of Flebogamma 5% DIF was 107. There were a total of 709 infusions, resulting in a rate of 0.15 temporally associated adverse reactions per infusion (the upper bound of the 1-sided 95% confidence interval = 0.18). There were 70 infusions (9.7%, 1-sided 95% upper bound CI = 12.4%) associated with 1 or more adverse reaction that began within 72 hours after the completion of an infusion.
In 58 infusions the patients reported mild adverse reactions; 25 infusions were recorded with moderate adverse reactions and in 1 infusion the patient reported a severe adverse reaction. The percentages of infusions with a mild, moderate or severe adverse reaction were 8.2% (upper bound 95% CI=10.5%), 3.5 % (upper bound 95% CI=5.2%) and 0.1% (upper bound 95% CI=0.8%), respectively.
Three subjects (6.5%) experienced a treatment-emergent rise in AST (> 3x the upper-limit of normal), and 1 subject (2.2%) experienced a treatment-emergent rise in ALT (> 3x the upper-limit of normal). None of these abnormal lab values were long-lasting (i.e. they occurred at 1 or 2 infusions), and none of these subjects had a concomitant treatment-emergent rise in total bilirubin.
Because adverse reactions are reported voluntarily 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.
The following adverse reactions have been identified during the post-approval use of IGIV products (16-17), including Flebogamma 5% DIF.
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), Transfusion-Related Acute Lung Injury (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 multiformae, dermatitis (e.g. bullous dermatitis) |
Hematologic | Pancytopenia, leukopenia, hemolysis, positive direct antiglobulin (Coombs) test |
Musculoskeletal | Back pain |
Gastrointestinal | Hepatic dysfunction, abdominal pain |
General/Body as a Whole | Pyrexia, rigors |
Passive transfer of antibodies may transiently impair the immune response to live attenuated virus vaccines, such as measles, mumps and rubella. Inform the immunizing physician of recent therapy with Flebogamma 5% DIF so that appropriate measures can be taken (see Patient Counseling Information [17]).
Pregnancy Category C. Animal reproduction studies have not been performed with Flebogamma 5% DIF. It is also not known whether Flebogamma 5% DIF can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Immunoglobulins cross the placenta from maternal circulation increasingly after 30 weeks of gestation. Flebogamma 5% DIF should be given to a pregnant woman only if clearly needed.
Clinical studies of Flebogamma 5% DIF for the treatment of PI did not include sufficient numbers of subjects aged 16 and younger to determine whether they respond differently from adults. Efficacy and safety in pediatric patients have not been established (see Clinical Studies [14]).
Limited information is available for the geriatric use of Flebogamma 5% DIF. Clinical studies of Flebogamma 5% DIF did not include sufficient numbers of subjects over the age of 65 to determine whether they respond differently from younger subjects. Use caution when administering Flebogamma 5% DIF to patients age 65 and over who are judged to be at increased risk for developing thrombosis or renal insufficiency. Do not exceed recommended dose, and administer Flebogamma 5% DIF at the minimum infusion rate practicable and less than 0.06 mL/kg/min (3 mg/kg/minute). (See Boxed Warning, Warning and Precautions [5.2, 5.4]; Dosage and Administration [2.3]).
Overdose may lead to fluid overload and hyperviscosity. Patients at particular risk of complications of fluid overload and hyperviscosity include elderly patients and patients with cardiac or renal impairment.
Flebogamma 5% DIF is a ready to use, sterile, clear or slightly opalescent and colorless to pale yellow, liquid preparation of purified immunoglobulin (IgG) obtained from human plasma pools. The purification process includes cold ethanol fractionation, polyethylene glycol precipitation, ion exchange chromatography, low pH treatment, pasteurization, solvent detergent treatment and Planova nanofiltration using 20 nanometer (nm) filters.
Flebogamma 5% DIF is a purified (≥ 97% IgG), unmodified, human IgG. The distribution of the four IgG subclasses is approximately 66.6% IgG1, 28.5% IgG2, 2.7% IgG3, and 2.2% IgG4. Flebogamma 5% DIF contains trace amounts of IgA (typically < 50 μg/mL) and trace amounts of sodium and IgM.
Flebogamma 5% DIF contains 5 g human normal immunoglobulin and 5 g D-sorbitol (as stabilizer) in 100 mL of water for injection, and ≤ 3 mg/mL polyethylene glycol. There is no preservative in the formulation. The pH of the solution ranges from 5 to 6 and the osmolality from 240 to 370 mOsm/L, which is within the normal physiological range.
Screening against potentially infectious agents begins with the donor selection process and continues throughout plasma collections and plasma preparation. Each individual plasma donation used in the manufacture of Flebogamma 5% DIF is collected only at FDA approved blood establishments and is tested by FDA licensed serological test for Hepatitis B Surface Antigen (HBsAg), for antibodies to Human Immunodeficiency Virus (HIV-1/HIV-2) and Hepatitis C Virus (HCV) in accordance with U.S. regulatory requirements. As an additional safety measure, mini-pools of plasma are tested for the presence of HBV, HIV-1 and HCV by FDA licensed Nucleic Acid Testing (NAT) and found to be negative. In addition, plasma is tested by in-process NAT testing for Hepatitis A virus (HAV) and parvovirus B19 (B19) on mini-pools and the viral load limit for B19 in the manufacturing pool is set not to exceed 104 IU/mL. NAT testing for the presence of HCV and HIV in the manufacturing plasma pool is also performed and found to be negative.
To further improve the margin of safety, three dedicated, independent and effective virus inactivation/removal steps have been integrated into the manufacturing and formulation processes, namely pasteurization at 60 ºC, 10 hours, solvent-detergent treatment for 6 hours and nanofiltration down to 20 nm Planova filters.
In vitro virus spiking studies have been used to validate the capability of the manufacturing process to inactivate and remove viruses. To establish the minimum applicable virus clearance capacity of the manufacturing process, these virus clearance studies were performed on 7 steps of the production process (pasteurization, solvent-detergent treatment, nanofiltration, Fraction I precipitation, Fraction II+III precipitation, 4% PEG precipitation and pH treatment for 4 hours at 37 ºC).
The viral reduction data (in log10) from these experiments are summarized in Table 2.
* When the RF is < 1 log10, it is not taken into account for the calculation of the overall reduction capacity. |
≥: No residual infectivity detected / nd: not done / na: non-applicable, since the virus is theoretically resistant to this treatment. |
Abbreviations: HIV; Human Immunodeficiency Virus, PRV; Pseudorabies Virus, IBR; Infectious Bovine Rhinotracheitis Virus, BVDV; Bovine Viral Diarrhoea Virus, SINDBIS; Sindbis Virus, WNV; West Nile Virus, EMC; Encephalomyocarditis Virus, PPV; Porcine Parvovirus. |
Target virus | HIV-1, HIV-2
(env. RNA) | HBV Herpesvirus
(env. DNA) | HCV
(env. RNA) | WNV
(env. RNA) | HAV
(non-env. RNA) | Virus B19
(non-env. DNA) |
Model virus | HIV-1 | PRV | IBR | BVDV | SINDBIS | WNV | EMC | PPV |
Fraction I precipitation | < 1.00* | nd | nd | nd | nd | 2.78 | nd | < 1.00* |
Ethanol incubation (Fraction II+III) | 1.48 | nd | nd | nd | nd | < 1.00* | nd | nd |
PEG precipitation | ≥ 6.10 | ≥ 5.92 | nd | ≥ 5.78 | nd | nd | ≥ 6.41 | 6.35 |
Acid pH treatment | 2.47 | ≥ 5.32 | nd | < 1.00* | nd | nd | 1.36 | na |
Pasteurization | ≥ 5.64 | ≥ 4.96 | ≥ 6.33 | ≥ 4.69 | ≥ 6.49 | ≥ 5.42 | ≥ 5.56 | 4.08 |
Solvent Detergent | ≥ 4.61 | ≥ 6.95 | nd | ≥ 6.14 | nd | ≥ 5.59 | na | na |
20 nanometer | ≥ 4.81 | ≥ 4.63 | nd | ≥ 4.67 | nd | ≥ 3.63 | ≥ 5.92 | 4.61 |
Overall Reduction Capacity | ≥25.11 | ≥ 27.78 | ≥ 6.33 | ≥ 21.28 | ≥ 6.49 | ≥ 17.42 | ≥ 19.25 | 15.04 |
Additionally, the manufacturing process was investigated for its capacity to decrease infectivity of an experimental agent of transmissible spongiform encephalopathy (TSE), considered as a model for the vCJD and CJD agents.
Several individual production steps in the Flebogamma 5% DIF manufacturing process have been shown to decrease TSE infectivity of an experimental model agent. TSE reduction steps include: 4% Polyethylene glycol precipitation [≥ 6.19 log10] and Planova nanofiltration using a 20 nanometer filter [≥ 5.45 log10]. These studies provide reasonable assurance that low levels of CJD/vCJD agent infectivity, if present in the starting material, would be removed.
Immune Globulin Intravenous (Human), Flebogamma 5% DIF is a replacement therapy for PI. It supplies a broad spectrum of opsonizing and neutralizing IgG antibodies against a wide variety of bacterial and viral agents. Flebogamma 5% DIF also contains a spectrum of antibodies capable of reacting with cells such as erythrocytes. The role of these antibodies and the mechanisms of action of IgG in Flebogamma 5% DIF have not been fully elucidated.
In the clinical study assessing safety and efficacy in PI, Flebogamma 5% DIF was administered as an IV infusion (300 to 600 mg/kg) to subjects every 3 (n = 8) or 4 (n = 12) weeks for 12 months. The pharmacokinetics of total IgG was determined after the 7th infusion for the 3-week dosing interval and after the 5th infusion for the 4-week dosing interval (Table 3).
a. This half-life is an apparent value derived from a period of measurement of 28 days |
b. For subjects on the 3-week schedule, the average of the trough levels from Infusion 7 to the end of the study was calculated; for those on a 4-week schedule, the average of the trough levels from Infusion 5 to the end of the study was calculated. The means of the subject means are presented in this table. |
Variable | 3-Week Dosing Interval (n=8) | 4-Week Dosing Interval (n=12) | ||
Mean [Range] | SD | Mean [Range] | SD | |
Cmax (mg/mL) | 193 [130-242] | 44 | 207 [159-280] | 34 |
AUC0 - last (day·mg/mL) | 3,116 [2,046-4,010] | 657 | 3,289 [2,765-4,181] | 389 |
Clearance (mL/day) | 139 [81-243] | 57 | 109 [59-161] | 33 |
Half-life (days)a | 30 [19-41] | 9 | 32 [25-39] | 5 |
Trough IgG level (mg/mL)b | 95.1 [77.3-114.3] | 13.2 | 90.0 [77.7-113.7] | 9.2 |
There were 3 adolescent (≤ 16 years of age) subjects who underwent pharmacokinetic testing, all of whom were on the 3-week infusion schedule. There were no clinically relevant differences among the adults and adolescents that were tested.
No animal studies were conducted to evaluate the carcinogenic or mutagenic effect of Flebogamma 5% DIF or its effects on fertility.
Acute toxicity studies were performed in mice and rats at doses up to 2.5 g/kg body weight with infusion rates 6 to 37 times higher than the maximum rates recommended for humans. The most common clinical observations in mice studies were piloerection, ptosis, ataxia and increase in respiration all lasting 90 minutes or less. No relevant adverse effects could be confirmed affecting respiratory, circulatory, renal, autonomic and central nervous systems, somatomotor activity, and behavior of the treated mice and rats.
Five out of the 25 rats treated with the highest dose at approximately 8 times the maximum infusion rate recommended for humans, showed a transient "reddish urine" sign which was not confirmed as a relevant toxicity causing phenomenon after renal macro and microscopic analysis. This phenomenon was ascribed to hemolysis when serum was analyzed, suggesting a possible relation to cross reactivity of rodent red cells with human antibodies. No "reddish urine" was detected in any mouse, a much smaller animal where the rate of infusion was comparatively much higher than in rats. The macroscopic inspection of all treated mice did not show any renal alteration.
A multicenter, open-label, historically controlled study was conducted in the United States to assess the efficacy, safety and pharmacokinetics of Flebogamma 5% DIF in adult and pediatric subjects with PI. A total of 46 subjects aged 15-75 years (63% male, 37% female) were enrolled, and were treated with Flebogamma 5% DIF at a dose of 300-600 mg/kg per infusion every 3 or 4 weeks for 12-months.
Since the subjects in the clinical study were assigned to 2 different treatment intervals (3-week vs. 4-week infusion schedules), the dosage had to be adjusted to ensure that the subjects received approximately the same dosage on an annualized basis. Therefore, subjects in the 3-week schedule received 75% of the monthly (4-week) dosage per infusion. This resulted in a mean annualized dosage of 451 mg/kg/month for subjects in the 3-week schedule (n=13, range 288-588 mg/kg/month) and 448 mg/kg/month for subjects in the 4-week schedule (n=33, range 298-591 mg/kg/month).
During the study period, the annual rate of acute serious bacterial infection, defined as bacterial pneumonia, bacteremia or sepsis, osteomyelitis/septic arthritis, visceral abscesses and bacterial meningitis per subject per year, was 0.021 (with an upper 1-sided 98% confidence interval of 0.001 to 0.112). One subject had one episode of bacterial pneumonia and there were no other episodes of serious bacterial infections reported (Table 4).
[1] Estimate = Total episodes/Total patient years. |
[2] The confidence interval is obtained by using a generalized linear model procedure for Poisson distribution. |
Infections | Patients (N=46)
N (%) | Episodes | Estimates [1] | 98% CI [2] |
Bacterial pneumonia | 1 (2.2) | 1 | ||
Bacteremia or sepsis | 0 (0.0) | 0 | ||
Osteomyelitis/septic arthritis | 0 (0.0) | 0 | ||
Bacterial meningitis | 0 (0.0) | 0 | ||
Total patients | 1 (2.2) | 1 | 0.021 | (0.001-0.112) |
The number of days of work/school missed, hospitalizations and days of each hospitalization, the number of visits to physicians or emergency rooms, other infections documented by positive radiographic findings and fever, and days on therapeutic and prophylactic oral/parenteral antibiotic use were also evaluated. These variables were annualized by using the subject-years exposure data of those subjects experiencing the events, but not the entire study cohort. With regard to the number of other validated infections, the mean rate was less than 2 days/subject/year (the calculation used all subjects, including those who had no infections, see Table 5).
[1] Days of work/school missed per patient year are derived as total days of work/school missed divided by total days in study multiplied by 365. If data are missing for a period (e.g. between Infusion 2 and Infusion 3), then number of days in this period is not counted in the denominator. All other endpoints are derived similarly. |
Variable |
Subjects | Mean number of events, days or visits/subject/year[1] | |
Work/school days missed | 23 | 50.0 | 12.95 |
Days of normal activities missed | 18 | 39.1 | 7.28 |
Days in hospital | 4 | 8.7 | 0.77 |
Visits to physician/ER | 29 | 63.0 | 4.31 |
Number of other documented infectious episodes | 33 | 71.7 | 1.96 |
Days of therapeutic oral antibiotic use | 35 | 76.1 | 55.52 |
Days of therapeutic parenteral antibiotic use | 2 | 4.3 | 0.14 |
Days of other therapeutic antibiotic use | 16 | 34.8 | 44.30 |
Days of prophylactic oral antibiotic use | 19 | 41.3 | 81.08 |
Days of prophylactic parenteral antibiotic use | 1 | 2.3 | 0.02 |
Days of other prophylactic antibiotic use | 0 | 0.0 | 0.00 |
Flebogamma 5% DIF is supplied in single-use, individually laser etched vials containing the labeled amount of functionally active IgG. The following presentations of Flebogamma 5% DIF are available:
NDC Number | Size | Grams Protein |
61953-0004-1 | 10 mL | 0.5 g |
61953-0004-2 | 50 mL | 2.5 g |
61953-0004-3 | 100 mL | 5.0 g |
61953-0004-4 | 200 mL | 10.0 g |
61953-0004-5 | 400 mL | 20.0 g |
Each vial has an integral suspension band and a label with two peel-off strips showing the product name and lot number.
Flebogamma 5% DIF may be stored at room temperature at 2 to 25 ºC (36 to 77 ºF) for 24 months, as indicated by the expiration date printed on the outer carton and container label. Discard after expiration date. Do not freeze.
Keep Flebogamma 5% DIF in its original carton to protect it from light.
Instruct patients to immediately report the following signs and symptoms to their physician:
Inform patients that Flebogamma 5% DIF is made from human plasma and may contain infectious agents that can cause disease (e.g. viruses and, theoretically, the vCJD agent). The risk of Flebogamma 5% DIF transmitting an infectious agent has been reduced by screening plasma donors for prior exposure, testing the donated plasma, and inactivating and/or removing certain viruses during manufacturing (see Warnings and Precautions [5.8]). Instruct patients to report any symptoms that concern them might be caused by infections.
Inform patients that Flebogamma 5% DIF may interfere with their immune response to live viral vaccines such as measles, mumps and rubella. Inform patients to notify their health care professional of this potential interaction when they are receiving vaccinations (see Drug Interactions [7]).
Manufactured by:
U.S. License No. 1181
Principal Display Panel - Vial Label
Immune Globulin
Intravenous (Human)
Flebogamma® 5% DIF
0.5 g in 10 mL
Rx only.
Store at 2 - 25 °C (36 - 77 °F).
Manufactured by Instituto Grifols, S.A.
Barcelona - SPAIN
U.S. License No. 1181
Principal Display Panel - Carton Label
Immune Globulin
Flebogamma® 5% DIF
Solution for infusion
0.5 g in 10 mL
Nanofiltered (20 nm)
Principal Display Panel - Vial Label
Immune Globulin Intravenous (Human)
Flebogamma® 5% DIF
2.5 g in 50 mL Rx only.
Dosage and directions for administration, see package insert.
Store at 2 - 25 °C (36 - 77 °F). DO NOT USE IF TURBID, ONCE THE
Manufactured by Instituto Grifols, S.A. Barcelona - SPAIN
U.S. License No. 1181
Principal Display Panel - Carton Label
Immune Globulin
Intravenous (Human)
Flebogamma® 5% DIF
Solution for infusion
2.5 g in 50 mL
Nanofiltered (20 nm)
Principal Display Panel - Vial Label
Immune Globulin Intravenous (Human)
Flebogamma® 5% DIF
5 g in 100 mL Rx only.
Dosage and directions for administration, see package insert.
Store at 2 - 25 °C (36 - 77 °F). DO NOT USE IF TURBID, ONCE THE
Manufactured by Instituto Grifols, S.A. Barcelona - SPAIN
U.S. License No. 1181
Principal Display Panel - Carton Label
Immune Globulin
Intravenous (Human)
Flebogamma® 5% DIF
Solution for infusion
5 g in 100 mL
Nanofiltered (20 nm)
Principal Display Panel - Vial Label
Immune Globulin Intravenous (Human)
Flebogamma® 5% DIF
10 g in 200 mL Rx only.
Dosage and directions for administration, see package insert.
Store at 2 - 25 °C (36 - 77 °F). DO NOT USE IF TURBID, ONCE THE
Manufactured by Instituto Grifols, S.A. Barcelona - SPAIN
U.S. License No. 1181
Principal Display Panel - Carton Label
Immune Globulin
Intravenous (Human)
Flebogamma® 5% DIF
Solution for infusion
10 g in 200 mL
Nanofiltered (20 nm)
Principal Display Panel - Vial Label
Immune Globulin Intravenous (Human)
Flebogamma® 5% DIF
20 g in 400 mL Rx only.
Dosage and directions for administration, see package insert.
Store at 2 - 25 °C (36 - 77 °F). DO NOT USE IF TURBID, ONCE THE
Manufactured by Instituto Grifols, S.A. Barcelona - SPAIN
U.S. License No. 1181
human immunoglobulin g injection, solution |
Labeler - GRIFOLS USA, LLC (048987452) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
Instituto Grifols, S.A. | 465562213 | MANUFACTURE(61953-0004) |


text:
IOGEAR Advances HD and 3D Wireless Streaming with new Digital A/V Kit
The latest A/V streaming kit wirelessly transmits 1080p HD / 3D video content and 5.1 digital audio up to 100 feet, through standard walls.
Foothill Ranch, Calif. â November 9, 2011 â IOGEAR, a leader in convergence through connectivity products, announces the Wireless 3D Digital Kit (GW3DHDKIT), which reduces cable clutter and provides flexible and reliable 1080p HD and 3D wireless streaming for up to two rooms. Relying on the 5GHz wireless spectrum, the Wireless 3D Digital Kit does not require a line-of-sight placement, and delivers uncompressed full 1080p, 3D content and 5.1 digital audio up to 100 feet (figure assumes ideal wireless conditions).
The IOGEAR Wireless 3D Digital Kit consists of a transmitter and receiver with connections that allow it to stream standard, HD or 3D resolution content from up to two HDMI® enabled devices. Included with the kit are an IR blast cable, a remote control, and two power adapters. To add a second room, one HDTV can connect directly to the transmitterâs loop-through (local) port, while a second HDTV simultaneously receives content via the wireless receiver. A âFloating HDTVâ can be set up by connecting two HD or 3D media sources to the wireless transmitter while a wall-mounted TV receives content from the connected wireless receiver.
The Wireless 3D Digital Kit is housed in a sleek black casing with rounded edges, giving it a modern but understated appearance. The unobtrusive transmitter, receiver, IR blast cable and remote control underscore just what a powerful device the Wireless 3D Digital Kit really is. Streaming high-bandwidth 3D and 1080p content up to 100 feet is made possible by the use of 5GHz technology, which is generally less susceptible to network interference and can carry more data than its 2.4 GHz relative.
By supporting devices such as 3D Blu-ray and DVD players, DVR/set-top boxes and game consoles, the Wireless 3D Digital Kit allows users to keep their components neatly out-of-sight and keep the focus on their celebrated HD or 3D TVs. Perfect as a DIY retrofit solution, the built-in Infrared (IR) pass-though allows user control over source devices that are hidden away in a different location. Additionally, the GW3DHDKIT is HDCP 2.0 Compliant and requires no software or driver installation.
âOur Wireless 3D Digital Kit advances the technology of streaming A/V content and is a perfect fit for those who already have a 3D display or are planning to get one,â said Bill Nguyen, Senior Marketing Manager for IOGEAR. âThe GW3DHDKIT offers an easy, affordable way to stream both HD and 3D entertainment discretely with multiple retrofit and installation options.â
For its initial launch, the Wireless 3D Digital Kit will be available online at Costco.com. A nationwide roll-out that includes shopIOGEAR.com, brick and mortar retailers and online resellers will happen in later in Q4 2011. MSRP of the Wireless 3D Digital Kit is $379.95.
For more information on IOGEAR and its connectivity solutions, please visit: www.iogear.com. Follow IOGEAR on Twitter, the company blog, and become a fan on Facebook for additional industry, company and product details.
About IOGEAR
IOGEAR, headquartered in Foothill Ranch, Calif., manufactures innovative Home Electronics and Information Technology solutions that enable convergence through connectivity. Founded in 1999, the company develops products that help integrate technologies, share resources, decrease clutter and energy consumption, and reduce electronic waste. IOGEAR distributes throughout North and South America, Europe and Asia.
The company emphasizes the conservation of natural resources to both employees and customers through its GREEN initiatives program and âRoad to a Million Treesâ campaign. In partnership with Trees for the Future, one tree is planted for every product purchased on the IOGEAR site or through an IOGEAR GREEN initiative partner.
(c)2011 IOGEAR. All rights reserved. IOGEAR and the IOGEAR logo are registered trademarks or trademarks of IOGEAR. Other company and product names may be trademarks of their respective owners.
Related Topics: Connected Home, Infrastructure, New Products, Video
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subset: commoncrawl


text:
ATO digs in on private equity
PUBLISHED: 12 Jan 2011 00:01:18 | UPDATED: 12 Jan 2011 07:52:02PUBLISHED: 12 Jan 2011 PRINT EDITION: 12 Jan 2011Tax commissioner Michael D'Ascenzo says the ATO would have been "derelict" in its duty if it hadn't targeted two private equity funds with legal action over tax bills.
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Companies | Myer Holdings Ltd |
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Greenpeace is campaigning for safe, ecological agriculture that's good for the planet and good for people.
The introduction of genetically engineered (GE) organisms into the complex ecosystems of our environment is a dangerous global experiment with nature and evolution.
Greenpeace has invited Professor Wen Tiejun and his team from the Renmin University's School of Agriculture and Rural Area Development to present an analysis of China's chemical fertilizer industry, nitrogen fertilizer use, its impacts, and...
With your help, Greenpeace has not only reached around the globe to push policy and take direct action, but we have engaged the imagination of a world - a world which is not happy with business as usual and demands a sustainable future. From...
China's overall food production may plunge by up to 23% by 2050 from 2000 levels because of land loss, water shortages and temperature rise.
Eco-farming, such as raising ducks in rice fields, is the best strategy to adapting to climate change.
1 - 7 of 7 results.
The Greenpeace Google Search will also return results form http://archive.greenpeace.org - Greenpeace's archive of web content dating back to 1994, along with content from those few Greenpeace websites not shared on this.


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At Harmony Auto Works, we have a highly trained and qualified repair staff that are dedicated to Subaru repair in Lynden, WA. We first opened our doors in 1979 and quickly gained a loyal clientele. Because of the dedication and skill of certified technicians and staff, we were able to expand from our original shop in 1993 and move into a convenient Bellingham location where we can now service the entire regions repair needs.
It is hard to imagine someone would look forward to visiting an auto mechanic, the wait can be long, the bill high and then to top it off you really don't know what the mechanic did to your vehicle.
We have a large, modern 6,500 ft shop with 12 service bays which are just waiting to help you with your Subaru repair in Ferndale, WA. More service bays means that we can get to your vehicle sooner, we also don't need to take your vehicle off of the rack in the middle of a service to deal with an emergency. Come visit us for all of your Subaru repair needs, we cover standard maintenance, exhaust repair and we will even deal with your wheel issues. We have a special tire alignment setup which will allow us to fix your alignment quickly and easily. You can get in and out in no time. The fact that we have a separate alignment setup allows us to serve even more customers and minimize their waiting time.
At Harmony Motorworks we do everything we can to make sure that you understand what repairs have been done on your vehicle and why. We also provide you with detailed billing that matches our estimates, we don't want you be surprised. We want you to return to us for your next Subaru repair in Lynden, WA.
If you need Subaru service in Ferndale, WA come see us. We offer great customer service and we try to make your auto repair experience positive. There's no reason for mechanics to have the greasy and gruff reputation that they do. All of our staff is friendly, courteous and knowledgeable.
When looking for repair or maintenance on your Subaru, give us a call at (360)671-2420. We will be more than happy to schedule you and your vehicle in. We are conveniently located at 1922 Grant Street in Bellingham.


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Our online tools make booking, managing your schedule and paying for lessons easy and hassle-free.
Access and compare detailed information about teaching style, experience, education, and more.
If you're not 100% satisfied, we'll help you find another teacher or give your money back, no questions asked.
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Students will be required to learn various pedaling etudes as well as proper non-legato touch. Other aspects of organ technique will be investigated.
Benjamin Z. began his musical journey when he was 9 with classical piano lessons in Chicago. He earned a Bachelor of Music degree (Piano; Jazz Emphasis) at Portland State University in 2011. Benjamin has studied and performed straight ahead Jazz, Western Classical, Soul, Rhythm and Blues, Funk, Experimental and electronic genres. He has composed and arranged for many types of ensembles including jazz vocal groups, jazz chamber groups (trios, quartets, etc), vocal ensembles and Big-bands. Benjamin has experience working with students ranging from preschool to senior citizens in all skill levels. He has worked with adult group-piano classes at the collegiate level, coaching elementary students in after school music programs, group children's classes, and individual instruction. Benjamin
Chuck recently moved to Portland, Oregon from Gainesville, Florida, where he was a staple of the music teaching and performing community for more than 25 years. Originally from Chicago, Chuck completed his BA in Music History and Masters of Music (MM) at the University of Florida. Chuck became obsessed with The Beatles when he began piano lessons at age 12. His first attempt at composing was actually improvising melodies over the ending chords to "Hey Jude". Along with playing Beatles tunes Chuck learned classic standards from a set of Reader's Digest Songbooks inherited from his grandmother. Chuck has performed with classic rock, top 40, funk, R&B, and jazz groups, and has served as an opening act for Bela Fleck and the Flecktones, and legendary Texas bluesman Clarence ...
Hello! I am a 35 year old music teacher. My studio is a large space with lots of seating and is at a professional commercial location, (Main St. in downtown Hillsboro, OR). I have been playing music since 3 years old. At that age I started my first piano lessons at St. Marks Church in St. Charles, IL. My teacher, Sharon, was the first of many piano teachers I had over the next 12 years to come. At age 14 I started on guitar. I still play keyboard and guitar often and this makes up the majority of my students. I also have ukulele students as well as people who just want theory lessons. I started teaching music full time as an independent contractor at Watz Up Hillsboro Music in 2010. I taught at that location for almost 4 years before they closed. The owners retired and I still keep
"Steven is very professional and extremely helpful. He always has a smile on and is serious about helping you phrase the music. I would highly recommend him to anyone."
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"My daughter's wedding was weeks away and I had never been able to dance a step. With Jenny's help, I came further than ever before in such short time in any subject."


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We are a clean, safe, affordable hostel with both private and dorm-style accommodations. Our historic hostel was completely renovated in 2009, retaining an old-world feel while adding modern amenities.
Enjoy these great amenities during your stay with us:
- library
- TV room
- free wi-fi
- dining room
- guest lounge
- internet cafe
- storage lockers
- free daily breakfast
- 24 hour in/out privilege
- free towel and bed linens
- 24 hour large, modern kitchen
- coin-operated laundry facilities
We also offer these fun extras:
- free, weekly pancake dinner
- discounted tours of Safeco Field
- free walking tours
- happy hour every Thursday
- tours of the International District
- discounted kayaking tours
- pub crawl on Fridays
Uwajimaya Asian Grocery Store is one block away so guests can bring their own food back to the American Hotel. Or guests may eat at the many inexpensive restaurants in the area, including a bakery, noodle restaurant, creperie, the sandwich shop in our very own building--and much more!


text: Bret Michaels, lead singer of rock band Poison, is back looking for love, and this time he means it! Twenty more beautiful babes vie for his love and affection. Some bare more than their souls in an attempt to grab Bret's attention. Only fifteen will stay after an elimination ceremony with two... Read Full Summary »


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Effects Of Hiv Aids
Here's a taste of what TheBody.com has to offer on this topic:
Ask the Experts
emotional effects of hiv aidshow is the person infected affected emotionally by this desease and what causes them to be affected in this way?Response from Ewald Horwath, M.D.
University of Miami School of Medicine
...The emotional effects of HIV vary from person to person. Anxiety, anger, sadness and fear are very common reactions, but some people are very adaptive and
Read more »
Emotional effects of HIV/AIDSHi, although I am not suffering from AIDS/HIV, I am currently undertaking my VCE and am in need of... Read more »side effects? (HIV versus AIDS, 2010)my boyfriend and I were infected around the same time 3 years ago. I am still healthy and my doctor... Read more »
NIAID Director Fauci Discusses Effect of HIV/AIDS on Women, Microbicide Research...statement released on Saturday in recognition of International Women's Day discussed microbicide research and the effects of HIV/AIDS on women, CQ HealthBeat reports. Fauci in the statement said that in the U.S., the percentage of adults and... Read more »WHO Director-General Chan Discusses Effect of HIV/AIDS on Women on International Women's Day... statement released in recognition of International Women's Day, which is scheduled for Thursday, discussed the effects of HIV/AIDS on women in sub-Saharan Africa, Xinhua News Agency reports. Chan in the statement said that in 2006, 74% of... Read more »Government, Businesses Should Cooperate to Mitigate Effects of HIV/AIDS in Papua New Guinea, Conference Delegate Says... The government and businesses in Papua New Guinea should work together to alleviate the effects of HIV/AIDS and avoid a "catastrophic health burden," Australian Parliamentary Secretary for Pacific Island Affairs Duncan Kerr said Read more »Guardian Publishes Several Articles on Poverty, Its Effect on HIV/AIDS Pandemic... London's Guardian on Wednesday published several articles on poverty, including its effect on HIV/AIDS and malaria. Summaries appear below. " We're at a Chronic Stage ": Although the HIV/AIDS pandemic appears to be leveling off, Read more »
Connect With Others
Safe, Natural & Effective HIV/AIDS Treatment
Posted by MICA_INC, 1 Reply
... SEEKING CLINICAL TRIALS SPONSORSHIP & VOLUNTEERS We are trying to get HIV Groups & Organizations, Medical and Pharmaceutical Institutions, and Universities and the Medical & Scientific Communities aware,
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Feeling effects of stigmatization towards HIV/AIDS
Posted by HIVstigmastudy
...Coping with HIV/AIDS: How the Perception of Stigmatization Affects Adherence to Medical Treatment and Disease Prognosis http://hivstigmastudy.webs.com/
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Long-term HIV and Aids survivors' health worrying
Posted by ScotCharles
...From KaiserNet January 8, 2008 Some experts and doctors recently have voiced concerns that people who were diagnosed with HIV and Aids in the early years of the epidemic are experiencing "premature[e]" or "disproportionate numbers" of ailments...
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Is Pancreatitis a symptom/effect of HIV Infection?
Posted by Anonymous, 2 Replies
...Is Pancreatitis a symptom/effect of HIV Infection?
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The literature of architecture: the evolution of architectural theory and practice in nineteenth-century America |
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Review: My Teacher For President
User Review - Sara Graham - GoodreadsMy Teacher For President, is a good book to read during election time. It allows children to get a simple understanding of a presidents job. The child thinks a teachers role is somewhat like the role of the president, and that their teacher would make a good president. Read full review
Review: My Teacher For President
User Review - Shakeema Gabriel - GoodreadsThis book shows a good comparison between a teacher and a president. I thought it as cute how he wrote his letter. This could be a great book to use for an activity on comparing and contrast and using a venom diagram. Read full review
List of Illustrations | 10 |
The Confluence of Ideas 18201865 | 63 |
Robert Mills | 80 |
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UPDATE SUNDAY evening: Prairie Pioneer Days 2009 was picture perfect
The Marv Meyer Walk-Run at the Regional Fitness Center got the 25th annual Prairie Pioneer Days off on the right foot Saturday morning. Chokio native Andy Schuster and his rock band Electric Allmighty ensured the day wouldn't lose momentum when the sun started to set.
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What features contribute to the Postcolonialism within Things Fall Apart?
1 Answer | Add Yours
One distinct Post-colonial feature in Achebe's work is placing focus from the Ibo point of view. In Post-colonial works, the point of view feature helps to emphasize a different reality than the Eurocentric one. For Achebe, this exists in the reference point from the traditional indigenous people of the Ibo. Another feature of Post-colonial writing present in Achebe's work is its critique of Colonial reality. Achebe does not present Colonialism in a traditionally affirming manner. A distinctly Post-colonial feature of the work is how it represents a sense of honesty in the work as it shows Colonialism to be a force of control and oppression. Additionally, the sense of loss and the forlorn condition is another feature of Okonkwo's narrative that is a Post-colonial feature. Postcolonalism discusses the reality of alienation that individuals feel in the wake of a Colonial reality imposed on a particular region. This feature is evident in Achebe's work. Upon his return to the village, Okonkwo cannot recognize it as European control has been effective in transforming it. His forlorn condition is brought about in part due to Colonization, a Postcolonial reflection of realty.
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Winds: North 11
A pedestrian died late Wednesday night after being struck by a tractor trailer on Ga. Highway 85 south near Whitewater Middle School, according to the Fayette County Sheriff's Office.
The pedestrian's identity is being withheld pending notification of next of kin, officials said.
The incident occurred around 11:30 p.m. as the tractor trailer was heading south on the highway, according to Fayette County Sheriff Barry Babb. No charges have been filed against the driver. As with all serious motor vehicle crashes, drug and alcohol samples were taken from the driver, Babb confirmed.
Piedmont Fayette Hospital celebrated national EMS Week, May 19-25, with a barbeque lunch to show appreciation to all local EMS workers for all the life-saving work they do each and every day. Andy Steele, Piedmont Fayette's senior director of emergency services (second from right) is shown with Fayette County Emergency Management Services workers who were among the many EMS providers from Fayette and Coweta counties who came out for the event. Photo/Special.
Peachtree City food bank sends water to Oklahoma storm victims
The Georgia Division of Midwest Food Bank located in Peachtree City is helping the tornado victims in Oklahoma by sending bottled water.
Within two days of the tornado, Bracken Stubbs, Midwest Food Bank truck driver, picked up a semi load of bottled water in Savannah and on Memorial Day he will leave for Springfield, Mo., to drop it off with Convoy of Hope for distribution to Oklahoma. Read More»
Local residents will have to detour around a section of Redwine Road Friday to make way for the filming of scenes in a new movie version of "Endless Love."
The road is slated to be closed from 2 a.m. in the morning of May 24 through midnight. Vehicles will be detoured onto Harris and Harp roads to navigate around the closed area, officials said.
Also, on the following Tuesday, May 28, there will be intermittent traffic delays on Redwine between Harris and Harp roads that motorists should be prepared for. Those delays will be ongoing all day from 7 a.m. to 7:30 p.m. Read More»
The Peachtree City Police Department is working with the Magnolia Disaster Relief and will be taking donations to be delivered to the Oklahoma City area this Sunday, May 26. Read More»
A bolt of lightning struck and damaged the steeple at First Baptist Church of Fayetteville Sunday as strong thunderstorms moved through the area. But worshippers gathered at the church afterwards and continued to use the building Sunday evening, according to John Munford, reporter for The Citizen. "We're lucky it didn't strike the courthouse where the art show was, or the county parking lot where they were doing Taste of Fayette at the time.," Munford wrote. Photo/John Munford.
A 22-year-old Fayetteville woman died early Friday morning after her vehicle ran off Lees Mill Road, according to Fayette County Sheriff Barry Babb. Read More»
A Starr's Mill sophomore suffered a serious head injury Thursday, May 9, when the golf cart she was riding on wrecked in the Kedron Village area.
Janice Dominguez was riding on the rear of the cart when it careened off the path, according to her mother, Marlene Dominguez. Janice was flown by air ambulance to Atlanta Medical Center where she was admitted to the intensive care unit for treatment. Read More»
The Fayette County Commission on May 9 cast a unanimous vote to begin the process that will eliminate eight of the 11 positions at the Fayette County Marshal's Office beginning in July. Read More»
In the wake of several brazen daylight armed robberies and carjackings at the county's largest shopping center, interim Fayetteville Police Chief Scott Pitts in a May 2 report to the Fayetteville City Council announced his plans to beef up the police presence at the Fayette Pavilion.
Those plans include increased security patrols and the possibility of installing license plate readers and cameras on Pavilion Parkway. Read More»


text:
Temper tantrums, acting up in school — our expert tells us that Suri may face a host of issues now that she's a child of divorce.
After Tom Cruise, 49, and Katie Holmes, 33, made headlines of their divorce how will the shocking news affect Suri Cruise's mental state?
Psychotherapist Dr. Gilda Carle, the 30-second therapist on Today.com, said "It's not unlike a child to act up in school. To do things that that child would not [normally] do."
Throwing a temper-tantrum would also be very typical for the 6-year old.
"When she's crying or having an issue, she's got to be able to express herself in a safe way," said Dr. Gilda, of drgilda.com. "It has to be looked upon as a way of grabbing her parents attention so they will come back in unison."
"Kids are very manipulative and they will pull anything to get parents to come back together again," she concluded.
HollyMoms, are you worried for Suri?
– Written by Lorraine Chow, reporting by Emily Morgan
More on Tom and Katie:
- Tom Cruise & Katie Holmes Are Divorcing — It's Official
- Tom Cruise & Katie Holmes Divorce: How They Should Break The News To Suri — Expert
- Tom Cruise & Katie Holmes — Their Marriage In Photos
View Comment
Nina Levin
Posted at 3:12 PM on July 8, 2012
weight loss
Posted at 9:28 PM on July 6, 2012
ارائه سرویس های هاست ، پرداخت آنلاین ، تبلیغ ، ویزاکارت ، سرور مجازی، دومین،سروراختصاصی ولایسنس ها معتبر
Posted at 10:26 PM on July 5, 2012
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Posted at 3:34 PM on July 2, 2012
I have been browsing online greater than three hours lately, yet I by no means discovered any fascinating article like yours. It's pretty worth sufficient for me. In my opinion, if all webmasters and bloggers made just right content material as you did, the web can be much more helpful than ever before.
Posted at 1:24 AM on July 2, 2012
Posted at 10:31 PM on July 1, 2012
By the way, by not mentioning Scientology at all as a reason for the divorce, this website does make itself a bit suspicious, I got to say. Are we a bit of a Scientology apologist by any chance (or even a member), Lorraine? Just saying…if you want to be a decent journalist, don't report only half the story.
Posted at 10:27 PM on July 1, 2012
Well, the worst that could happen to the poor child is to stay in the hands of evil, fascist Scientology bastards. So divorce is the best Katie could do and I applaud her! You go girl! Don't let their Gestapo frighten you! Save your daughter's mind and soul. All my best wishes for Katie and Suri!!!
Posted at 7:09 PM on June 29, 2012


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Muzzleloaders hold annual North Dakota convention
It looked a bit like the people and wares from an early 1800s fur trading post, plus a few Civil War soldiers, were transported to a modern metal-framed building on a cold January Saturday in 2011.
The North Dakota Muzzleloaders is holding its annual convention and trade fair this weekend at the Red River Valley Fairgrounds.
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What does NUF mean in Non-Profit Organizations?
This page is about the meanings of the acronym/abbreviation/shorthand NUF in the Community field in general and in the Non-Profit Organizations terminology in particular.
Find a translation for NUF in other languages:
Select another language:
Discuss this NUF abbreviation with the community:
Use the citation below to add this abbreviation to your bibliography:
"NUF." Abbreviations.com. STANDS4 LLC, 2015. Web. 4 Mar. 2015. <http://www.abbreviations.com/term/209447>.
NUF also stands for:
- Enough
- Message for New Users on their First call ( Procomm Plus)
- National Undergrduate Fellowship
- Network Underground Facility
- No-Flow Underfill Reliability
... and 6 more »
Nearby & related abbreviations:
Alternative search:
- Search National Urban Fellows on Amazon
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text:
The accounts of losing yourself were as follows:
i. The voices of the people around you started to sound like a cassette tape in fast forward. You couldn't understand why they were talking that way.
ii. When you saw your reflection in the looking glass, you began to see someone else.
You couldn't recognize the face in the mirror. you reached out to touch who you thought you were, and your hand slipped through the surface like a hand submerging into water. And that was the last you saw of your face (or at least, what you thought was your face)
iii. So now, you became a faceless creature. You saw without eyes, hearing only static and white noise. You walked on abandoned sidewalks, tripping over broken glass and getting tangled up in withered weeds. It is there where you completely lost yourself. And no one saw you slip through the cracks into the crevices of shattered dreams and empty promises. No one saw you fall through paved over lies and stomped out wishes.
Somewhere along the way, you misplaced what it was to be human.
You became something else entirely.
You became a writer.


text:
We stayed at Pension Zimmermann for 8 nights and loved our stay. The owners are very friendly, helpful and speak good English. The double room was spacious, clean and beds were very comfortable. The breakfast was excellent in continental style and a few basics cooked to order if they were wanted. It was our first visit to Austria, the owners... More
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Delaware Student Bar Association Sponsors Health Week
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- Published: February 5, 2010
From Monday, February 8th through Friday, February 12th, the Delaware Student Bar Association is sponsoring Health Week. Each day during the week will see various events related to improving both mental and physical health.
The Schedule of Events for the Week
Monday, February 8th
Women's Law Caucus Health Week Table
Information about homeopathic remedies to treat common everyday things like colds, sore throats, cuts, burns, etc., and a list of local businesses that specialize in alternative medicines
Healthy eating tips, advice, and FREE healthy snacks!
Tuesday, February 9th
Massage Therapist from Salon 926
FREE Massages from 11-1 in Arsht Conference room (L238). No appointment needed. Light refreshments will be served
Dr Amy Gulino
Amy Gulino, the school psychologist, will be in the Arsht Conference Center from 11:00 a.m.-1:00 p.m. with information about anxiety and depression as well as relaxation techniques.
Wednesday, February 10th
Wii in the Student Lounge
Wii will be setup in the Student Lounge from 4:30-6:30. All are welcome.
Campus First Aid Awareness
Stop by our table to get information about first aid and safety around campus.
Taste Tester and Healthy Recipe Cards
Stop by our table on Main Street to test out some of our healthy dishes and grab a few recipe cards to try the meals at home.
Health Law Society
The Health Law Society will have a table set-up in the Student Lounge with blood drive sign-ups sheets and information about their writing competition and Medical/Legal clinic.
Thursday, February 11th
Health Week Panel
Dr. Lauren Schofield and Dr. Denise Butler of Advanced Chiropractic Wellness Center, Inc. will be in the Student Lounge from 12:00-1:00 p.m. for an informal discussion on nutrition and chiropractic care. Light refreshments will be served.
Wii in the Student Lounge
Wii will be setup in the Student Lounge from 4:30-6:30. All are welcome.
Friday, February 12th
No Smoking Table
Need help quitting smoking? Stop by our table on Main Street to get some information and support!


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This is a potential security issue, you are being redirected to http://nvd.nist.gov
Last updated: 3/5/2015 9:45:30 AM
CVE Publication rate: 15.93
NVD provides four mailing lists to the public. For information and subscription instructions please visit NVD Mailing Lists
Memory leak in the on_dtp_close function in ftpserver.py in pyftpdlib before 0.5.2 allows remote authenticated users to cause a denial of service (memory consumption) by sending a QUIT command during a data transfer.
By selecting these links, you will be leaving NIST webspace. We have provided these links to other web sites because they may have information that would be of interest to you. No inferences should be drawn on account of other sites being referenced, or not, from this page. There may be other web sites that are more appropriate for your purpose. NIST does not necessarily endorse the views expressed, or concur with the facts presented on these sites. Further, NIST does not endorse any commercial products that may be mentioned on these sites. Please address comments about this page to firstname.lastname@example.com.


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I'm putting out a world wide web bulletin to get everyone's help.
You see, I've lost my smile. I'm not really myself without it. I
have a couple leads that give me hope that it may have been found,
including a vague description. She appears to be between 21 and 28
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(I am 5' 10"), not a bbw, but doesn't live at the gym either. She
has high-maintenance looks with a down-to-earth attitude, values,
and personality. She likes Rock & Roll and may be found at
concerts. I have conflicting reports that she's either a blonde or
a brunette. She's intelligent with her own career and not dependent
on someone to support her. If this person can be found, I can offer
a reward of lifetime devotion, long, slow kisses that last for
days, midnight massages, a partner that loves to cook and doesn't
mind sharing in the household chores, someone to wash your back, a
shoulder to lean on, and someone who will hold you at night. If you
think you may have found my smile, please e-mail me as I really
need it to be myself. Thanks.
Join OkCupid
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What I'm doing with my life
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talking to people.
The first things people usually notice about me
I'm an empty essay… fill me out!
My eyes and my tattoos.
Favorite books, movies, shows, music, and food
Help your potential matches find common interests.
Favorite movies- Don't be a menace to the south central while
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Grey's Anatomy
Thursdays 8:00 PM on ABCFollow Grey's Anatomy
Grey's Anatomy Season 9 Episode 12
Walking on a Dream
- Meredith works with Bailey and Ross on a liver transplant which requires her flying.
- Derek operates again.
- Arizona deals with Phantom Limb Syndrome but gets through with Owen's help.
- A financial advisor named Alana comes to SGH to help find ways to cut costs. She wants to cut the ER. She is a former student of Richards.
- Show:
- Grey's Anatomy
- Season:
- Grey's Anatomy Season 9
- Episode Number:
- 12
Thanks a bunch for the answer!!!! I was driving me and my mom nuts.
the pregnant liver transplant's partner us Navi Rawat from the OC and Numb3rs... YOU'RE WELCOME!
Who played the pregnant liver transplant's partner?
is a matt hires song going to be played on tonights episode. if so, which song.. thank you
I totally am not liking the 'hints' for next week's episode. Meredith's worst fear isn't flying. Her worst fear is getting Early Onset Alzheimer's. I ...will stop watching the show entirely if that's what it is.
I think Dr. Cahill Will be the new Chief of Surgery. Owen will go back to his old job. Mer is affraid to fly so I think that's her worst fear she will have to for some reason or something happens with Zola. The dr.'s may not get their money if an appeal is filed. I know I had a large case and as soon as the judgement was made the other side stood up and appealed. So they will most likely take a lot lower settlement.
This is the episode where Constance Zimmer as Dr Cahill will make her first appearance but we will hear her and not see her. I am sure she will be doing something to help Arizona. There is definitely some connection there.
Around the Web
Grey's Anatomy Season 9 Episode 12 Quotes
Put on your big girl pants, you're about to learn how to run the pit.
- Permalink: Put on your big girl pants, you're about to learn how to run the...
- Added:
It's these stupid pregnancy hormones. They make me want to have sex all the time.
- Permalink: It's these stupid pregnancy hormones. They make me want to have ...
- Added:
Grey's Anatomy Season 9 Episode 12 Music
Song | Artist | ||
Time To Run | Lord Huron | iTunes | |
Someone | Future Of Forestry | iTunes | |
Forever | Matt Hires |


text:
Glass Half Full: Novell Begins Year with Wins and Losses
Novell is reporting a current quarter revenue loss, but some wins at the same time.
Novell's first quarter of 2009 results, which ended January 31, showed revenues of $215 million, compared with $231 million for the first quarter a year ago. This in light of $245 million results for the last quarter of 2008. The company holds the foreign currency exchange rate responsible for the loss, although it did benefit operating costs by $11 million. Another monetary exchange benefit came from operations income, which rose by $6 million from $8 million the first quarter of 2008 to $14 million so far this year.
Considering the financial base, Novell recognized a renewed upswing in their Linux product revenue. In the first three months of their fiscal year, the Open Platform Solutions revenue came to $37 million, $35 million (95%) involving Linux products, a 24% increase over the same period last year. This nevertheless shows a declining revenue rate compared to the increase in 2008 over the previous year of 38%.
The revenue for identity and security management products of $28 million was down 8% from the same period last year, with workgroup products similarly down 9% to $81 million. A cash inflow from Microsoft contributed $25 million in the first quarter.
Novell CEO Ron Hovsepian is disappointed and holds the economy responsible. Nevertheless, Novell management "reiterates its target of no less than 10% non-GAAP operating margin in the full fiscal year 2009." Hovsepian emphasizes in the press release that "We are confident about our long-term growth opportunities and remain committed to maintaining our target profitability levels."
Novell is currently pursuing some cost savings through some staff layoffs. They also cancelled their annual BrainShare conference and limited their participation in CeBIT 2009.
Issue 172/2015
Buy this issue as a PDF
Old Vulnerabilities Are Kept Alive Through Bad Configuration
HP's annual Cyber Risk report offers a bleak look at the state of IT.
Linus Torvalds Announces Linux 4.0
But what do the big numbers really mean?
Microsoft Frees CoreCLR
.NET Core execution engine is the basis for cross-platform .NET implementations.
New Trojan Attacks Linux Servers
The Xnote trojan hides itself on the target system and will launch a variety of attacks on command.
Cisco Releases Annual Security Report
Spammers go low-volume, and 90% of IE browsers are unpatched.
Zero Day Exploits Target Flash
Adobe scrambles to release patches for vulnerable Flash Player.
Intel Unveils Compute Stick
Four-inch-long computer on a stick lets you boot a full Linux system from any HDMI display device.
Obama Proposes Personal Data Notification Law
New statute would require companies to report break-ins to consumers.
TGXf Project Warns of File Transfer through Screen Pixels
Weird data transfer technique avoids all standard security measures.
Industry Giants Announce a Fix for the Password Mess
FIDO alliance declares the beginning of the end for old-style login authentication.


text:
What does CFACC stand for?
What does CFACC mean? This page is about the various possible meanings of the acronym, abbreviation, shorthand or slang term: CFACC.
We've found a total of 1 definition for CFACC:
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CFACC | Combined Force Air Component Commander |
Still can't find the acronym definition you were looking for? Use our Power Search technology to look for more unique definitions from across the web!
"CFACC." Abbreviations.com. STANDS4 LLC, 2015. Web. 26 Feb. 2015. <http://www.abbreviations.com/CFACC>.


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The cast is set for A Broadway Cabaret -- the next production of the North Platte Community Playhouse.
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text:
Will This Price Target Increase Help Texas Instruments (TXN) Today?
Story updated at 9:40 a.m. to reflect market activity.
NEW YORK (TheStreet) -- Jefferies raised its price target for Texas Instruments (TXN - Get Report) to $52 from $50 Friday.
Shares of Texas Instruments gained 0.2% to $45.12 in morning trading.
The analyst firm reiterated its "buy" rating for the company. The raised target is due to Texas Instruments reiterating its commitment to generate FCF growth and return much of FCF to shareholders.
Must read: Warren Buffett's 10 Favorite Stocks STOCKS TO BUY: TheStreet Quant Ratings has identified a handful of stocks that can potentially TRIPLE in the next 12 months. Learn more. ----------- Separately, TheStreet Ratings team rates TEXAS INSTRUMENTS INC as a Buy with a ratings score of A-. TheStreet Ratings Team has this to say about their recommendation: "We rate TEXAS INSTRUMENTS INC (TXN) a BUY. This is based on the convergence of positive investment measures, which should help this stock outperform the majority of stocks that we rate. The company's strengths can be seen in multiple areas, such as its solid stock price performance, impressive record of earnings per share growth, compelling growth in net income, revenue growth and notable return on equity. Although the company may harbor some minor weaknesses, we feel they are unlikely to have a significant impact on results." Highlights from the analysis by TheStreet Ratings Team goes as follows:- Powered by its strong earnings growth of 100.00% and other important driving factors, this stock has surged by 29.99% over the past year, outperforming the rise in the S&P 500 Index during the same period. Regarding the stock's future course, although almost any stock can fall in a broad market decline, TXN should continue to move higher despite the fact that it has already enjoyed a very nice gain in the past year.
- TEXAS INSTRUMENTS INC reported significant earnings per share improvement in the most recent quarter compared to the same quarter a year ago. The company has demonstrated a pattern of positive earnings per share growth over the past two years. We feel that this trend should continue. During the past fiscal year, TEXAS INSTRUMENTS INC increased its bottom line by earning $1.92 versus $1.50 in the prior year. This year, the market expects an improvement in earnings ($2.10 versus $1.92).
- The net income growth from the same quarter one year ago has significantly exceeded that of the S&P 500 and the Semiconductors & Semiconductor Equipment industry. The net income increased by 93.6% when compared to the same quarter one year prior, rising from $264.00 million to $511.00 million.
- Despite its growing revenue, the company underperformed as compared with the industry average of 5.3%. Since the same quarter one year prior, revenues slightly increased by 1.7%. Growth in the company's revenue appears to have helped boost the earnings per share.
- The return on equity has improved slightly when compared to the same quarter one year prior. This can be construed as a modest strength in the organization. Compared to other companies in the Semiconductors & Semiconductor Equipment industry and the overall market, TEXAS INSTRUMENTS INC's return on equity exceeds that of both the industry average and the S&P 500.
- You can view the full analysis from the report here: TXN Ratings Report
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text:
Home → Maine Resources → Maine Writers Search → Maine Writers List → A Maine Writer
Healy, Jeremiah (1948 - 2014)
Genre: Mystery
Mystery writer Jeremiah Healy lives in Maine in Summer, Florida in Winter, and Boston the rest of the time. He is a graduate of Rutgers College and Harvard Law School and taught as a professor at the New England School of Law for eighteen years, after which he turned to writing full time. He has written eighteen novels and over sixty short stories and has been nominated numerous times for the Shamus Award.
Selected Bibliography
John Francis Cuddy Novels
- The Staked Goat (1987)
- Act of God (1994)
- Foursome: A John Cuddy Novel (1994)
- Rescue (1995)
- Invasion of Privacy (1997)
- Spiral: A John Francis Cuddy Mystery (1999)
- The Only Good Lawyer: A John Francis Cuddy Mystery (1999)


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So the stars of the Harry Potter film series are all grown-up. Emma Watson has ditched her education to enjoy her fame. But it's not all fun. David Letterman this week asked her intrusive questions about the "drink problem" of her co-star Daniel Radcliffe. What a nasty ambush. The worst thing about the end of childhood is the ongoing discovery that so many adults continue to behave like playground bullies, and that far too often, behaving like a playground bully pays.
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Given who started this thread I trust that information was made available and is accurate and if I was him I wouldn't say how either.
Given who started this thread I trust that information was made available and is accurate and if I was him I wouldn't say how either.
Playing Fantasy Football does not qualify you to be the in the front office or on the coaching staff of the Pittsburgh Steelers. They are professionals and you are not!
LaCanfora was saying last night or this morning that the competition is now between Clements, Hailey, and Fichtner.
Even if Bill Belichick was getting an atomic wedgie, his face would look exactly the same.
I wouldn't mind any of them. Wonder if Haley would take a QB coaching job if it was down to Fichtner or Clements
SKL's been on target before with these scoops.Originally Posted by Mister Pittsburgh
Clements is at the top of my list. As others have noticed, he's done good things here before. And when you look at Matt Flynn & Aaron Rogers it's hard not to be excited about the chance of landing him.
Crossing my fingers for this one...
so we are excited about a guy who coached the bills offense in the early 2000's? where they only sent a punter and 1 OL to the probowl in 2 seasons?
In his coaching career from 1992 to the present with Notre Dame, the Saints, Chiefs, Steelers, Bills, and Packers, he spent a grand total of 2 seasons with the Bills.Originally Posted by Doogie36
Trade #22 (780 points) to JAX for #36 + #67 (795 points)
2.4 TE Maxx Williams, Minnesota 6'4" 250 lbs.
2.24 OLB Nate Orchard, Utah 6'3" 252 lbs.
3.3 OG Laken Tomlinson, Duke 6'4" 323 lbs.
3.23 SS Jaquiski Tartt, Samford 6'1" 220 lbs.
4.22 CB Ronald Darby, Florida State 5'11" 195 lbs.
5.24 FS Kurtis Drummond, Michigan State 6'1" 205 lbs.
6.23 CB Cam Thomas, Western Kentucky 6'0" 195 lbs.
7.22 RB Malcolm Brown, Texas 6'0" 223 lbs.
Originally Posted by Oviedo
Molon labe
People sleep peaceably in their beds at night only because rough men stand ready to do violence on their behalf. George Orwell
American metal pimped by asiansteel
Only two defining forces have ever offered to die for you 1. Jesus Christ, 2.The American G.I., One died for your soul, the other for your freedom.
You are clueless.Originally Posted by Doogie36
In 2004 Clements coached the Buffalo Bill offense to 7th in points scored in the NFL. As you pointed out, the team had very little talent.
In 2011 Arians coached the Steelers offense to 21st in points scored.
Hmmm, seems that Clements CAN coach offense after all.
Here comes the BOOM!


text:
Nov. 9, 2012 at 8:08 AM ET
You saw them all on TODAY this week (wait, you didn't? Get watching!). Now, decide which one made you cringe, clap and just plain LOL the most.
Two weeks ago you liked the elevator prank that left riders terrified. Can it beat three new challengers for the title of TODAY's Top Click?
1. Baby Kung-Fu! Tot takes on dragon
Indie filmmaker and dad Patrick Boivin has set the bar pretty high for parents creating videos of their kids! He shot his adorable son taking on a dragon toy. Read more about the video.
2. Obama 'raps' MC Hammer in viral mashup
Mashup artist Barackdubs edited together words from President Obama's speeches and set them to MC Hammer's song "Can't Touch This," for a hilarious remix that shows how the president may have celebrated last night. Read more about the video.
3. 'I do' cam catches intimate wedding moments
An Internet video documents a San Diego couple's wedding day from a small camera placed inside the bride's bouquet.
**Previous winner**"
4. Ad's elevator prank leaves riders terrified
The bottom of an elevator was replaced with screens playing a video that simulated the floor falling away, and a hidden camera captured riders' terrified reactions.
This poll is now closed. The results are listed below:
Baby takes on stuffed dragon – 51 percent
Obama 'raps' MC – 17 percent
"I do" cam captures wedding – 3 percent
Elevator prank terrifies riders – 29 percent
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