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Terror campaign in Jaffna: abducted youth tortured and beheaded[TamilNet, Wednesday, 29 December 2010, 21:27 GMT]Mahendran Thiruvarudchelvam, known as Chelvam, abducted 9 days ago was tortured and beheaded as evidenced by his remains reaching Jaffna Teaching Hospital. Even though initial reports said that he had been abducted for a ransom of 8 million, his background and prevailing terror campaign in the SL-military-occupied Jaffna point to deeper motives behind his killing, human rights activists in Jaffna said. Mr. Chelvam, 28-year-old, and father of a child, was living in Vanni to the end of the war, spent some time in the internment camp and was released for resettlement. He returned to his native place Meesaalai North near Kanakan-pu'liyadi and started doing business as a vehicle dealer. The former residents of Vanni, whether they are in captivity or released, are viewed by the occupying military and paramilitary as objects for exploitation and then extermination. Chelvam was abducted from his house located near Kanakan-pu'liyadi in Thenmaraadchi, Jaffna by unidentified men who came to his house. His father confirms that the abductors have demanded ransom. Mr. Chelvams body was recovered from the scrub jungle adjacent to a crematorium, not very far away from Kanakan-puliyadi. The body had several cut wounds and the head was severed. The decomposed state of the body indicated that the slaughter took place 2 or 3 days before its discovery Wednesday by Chaavakachcheari Police. Informed circles say that some recent orders have come from very high circles to a killer squad of the military intelligence to create an atmosphere of terror in various sections of the society in Jaffna. In the month of December alone, more than 6 abductions have been reported, besides the killings of the chief priest of Changkaanai temple and the Valikaamam Deputy Director of Education. Commander of the occupying SL military of Jaffna, Maj. Gen. Hathurusinghe admitted that the T 56 rifle used in the killing of the chief priest belonged to the military. Even though he was accusing former LTTE cadres now conniving with the SL military for such happenings, his partial admittance to military hands and the continuing killings show what message he wants to convey to the people of Jaffna. The released cadres of the LTTE complain that they are systematically and regularly harassed by the occupying military. The harassment has escalated in recent times, pressurising them in many ways and preventing any rehabilitation, they say. Recently they have been ordered to go to the military camps at Oorezhu and Achchezhu every day and sign. These military camps are well known for torture and killings. Besides, they are also asked to sign at the so-called civil offices of the military located in Vadamaraadchi and Thenmaraadchi. In the background of Hathurusinghe and SL minister Douglas Devananda putting the blame on the released LTTE cadres for the happenings in Jaffna, the escalating measures of harassment and entrapment against them cause serious suspicions in the public, about the motives. There are instances where the parents of the abducted in the peninsula were fleeced huge sums of money after giving them some evidence for the existence of their children, but after getting the money either they were not released or killed. People who spoke to SL president Mahinda Rajapaksa tell that he was firm on colonising the conquered land by military and their families by providing them with many incentives, but was negative about releasing the Tamil captives. There are also reports that some powers, who didn't come forward to save the civilians during the war, are now very busy in setting their feet in the 'conquered' Tamil land. At a time when the SL military has to be reduced in number to help peace, reconciliation, and development, some powers helping further increment of it worries all sections of public in the island, who fear the grip of military for many decades to come. What is happening in Jaffna now, is only an initial brunt of the unfolding scenario and it is aimed at silencing whatever civil society remains in the peninsula. Meanwhile, the UN and ICRC offices functioning in Jaffna have been asked to windup many of their operations. ICRC offices in Batticaloa and Mannaar have already been closed. Chronology: 22.01.11 Boy reported missing in Ki'linochchi
Latest 15 Reports
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Think of a child standing outside a school's music room, looking through the small window in the door, watching all of the other kids inside and wishing they too could participate. If only… Too many children don't have the means in their homes to be able to afford even the simplest necessities for participating in their school's music programs.
Our Vision:
One day, all school age children in the Fort Collins Colorado area will have equal access to a quality music education, and the music programs at their schools, or non-profit organizations, will be thriving learning and cultural performance centers. (Video)
Our Mission:
The mission of "The Kayla Foundation" Fund is to provide support to:
- Poudre School District students, with financial needs, helping them to more fully participate in their school's music programs.
- Fort Collins schools, by helping to enhance their music programs.
- Larimer County non-profit organizations, that focus on the needs of children and young adults, with providing musical opportunities.
Grant funding is made through grants to individual schools, or other non-profits, for the purpose of supporting their students / clients and their particular needs. Examples of funding needs are:
For Lower Income Family / Special Needs Students:
- The purchase or rental of uniforms or performance attire.
- Basic musical supplies / maintenance (e.g. sheet music / folders, reeds, replacement strings etc.)
- Large instrument rental fees or the purchase of small instruments and accessories.
- Fees for music retreats, field trips and special opportunity events.
- Sponsorships of private music lessons / accompanists.
- Music therapy programs.
For All Students:
- Purchase of music teaching tools, software, recording media and hardware for the classroom.
- The purchase of sheet music and protective folders.
- The purchase or repair of instruments, cases, stands and tuners for the classroom.
- The purchase of sound system equipment for the school / non-profit.
- Costumes, props, music etc. for school musical productions.
- The sponsorship of visiting teaching or performing professionals.
- Fees associated with musical events benefiting all music student / clients.
We DO NOT Provide Funding for:
- Teacher training
- Lighting equipment
- Videography equipment
- Transportation, lodging or food related expenses to musical events. If these funds are needed we recommend you contact Stacy Poncelow at email@example.com for more information.
Related Links:
Twelve Benefits of Music Education
The Logo…
The Kayla Foundation logo uses her actual signature as its centerpiece. Her signature was copied from the last birthday card she would ever give to her mom, which was just 2 weeks before her death. Her signature is uplifted in the title line representing how she lifted up the lives of others while she was on earth and how her memory continues to lift spirits today. The heart shown was a heart that Kayla always used when signing her name. This particular one was taken from a CD she had made for her sister.
The Kayla Foundation is a component fund of the Community Foundation of Northern Colorado, a 501c3 organization.
To download a copy of our brochure click here.
For further information please contact us at firstname.lastname@example.com.

subset: commoncrawl


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View Poll Results: K-On!! (Second Season) - Total Series Rating | |||
Perfect 10 | 54 | 50.00% | |
9 out of 10 : Excellent | 31 | 28.70% | |
8 out of 10 : Very Good | 10 | 9.26% | |
7 out of 10 : Good | 4 | 3.70% | |
6 out of 10 : Average | 4 | 3.70% | |
5 out of 10 : Below Average | 0 | 0% | |
4 out of 10 : Poor | 1 | 0.93% | |
3 out of 10 : Bad | 2 | 1.85% | |
2 out of 10 : Very Bad | 0 | 0% | |
1 out of 10 : Painful | 2 | 1.85% | |
Voters: 108. You may not vote on this poll |
Thread Tools |
2010-12-30, 16:46 | Link #21 |
Say what?
Join Date: Dec 2010
Age: 17
The second season was just as good, if not better than the first. I really loved it, and it keep me busy for about 2 weeks while I watched it. Now I am slightly depressed it is over, but I cannot wait for the movie. Maybe, if we are lucky, a season 3? Eh, maybe. Season 2 was amazing to me, that's that.
2010-12-31, 19:40 | Link #25 |
Say what?
Join Date: Dec 2010
Age: 17
Woah woah. It's this thing called on opinion. You can watch it, or you can ignore it. I do not care what you do, it's your choice.
[/offtopic] But hey, for most of these people, season 2 was awesome. There was many times they took and did their own things that were not in the manga, and that's good. No need to see the same thing twice. |
2011-01-01, 09:09 | Link #27 | |
Senior Member
Join Date: Sep 2010
Yeah. I just gave mine.
2011-01-01, 19:49 | Link #28 | |
Say what?
Join Date: Dec 2010
Age: 17
EDIT: Sorry for such an offtopic post guys, didn't really mean it to get this far :/ |
2011-01-02, 07:13 | Link #29 | |
Join Date: May 2010
Location: Singapore
And I think the act of milking the cash cow was what Goggen meant when he said that a season 3 of K-ON would not be considered lucky, because frankly it would be a shame for K-ON to have a third season all for the purpose of money. Sure, if there was more material from the manga to animate, then I'll be all up for a third season. But as it is, season 2 has already covered the end of the manga as Goggen pointed out, and it provides a pretty nice closure to the story. I just don't think that focusing on the juniors and their new band is enough for a third season because most of the appeal of K-ON lies in the five main girls and if four of them were to take a lesser role, then the third season would not be as profitable and popular as the first two seasons.
2011-01-10, 21:55 | Link #33 |
Join Date: Jan 2011
Location: In the Milkyway!
Thanks for putting those up but I still like the OP and ED of season one's the best and I still dislike the OP of season two's but the ED songs are nice. I am def. gonna watch it cuz it seems def. as funny and cute as the first season.
2011-01-10, 23:21 | Link #34 | |
Senior Member
Join Date: Feb 2010
Age: 25
As far as the S2 OP's go, the first one annoyed the hell out of me, but it grew on me a bit. I loved the second OP though. Overall though, my favorite is still the season 1 OP.
2011-02-16, 22:54 | Link #35 |
I smartickles. XD
Join Date: Feb 2011
Location: Most Polluted City in America: We won't breath it if we can't see it.
Age: 21
I loved this anime because I'm in my senior year of high school. I was in my school's band (marching band) and made me contimplate who's going to miss me. I also had a senior friend graduate two years ago and made me relive the memory of her leaving. I literally bawled my eyes out for about two hours after I finished it. So, in evoking emotion in me, I give it a 10.
And the music was so awesome, I'm actually beginning to learn the guitar. ^_^ their music is inspirational! so a definate 10 for music. As for editing and all the other animation options, it was a very cute, aesthetically pleasing anime and is much better than most. 10/10 overall, a 10!!!!! And I kinda hope they don't do a third season. just an OVA in which Ui, Azusa, and Jun show how the club will continue and how the original band is doing in college will be enough for me. |
2011-04-12, 09:49 | Link #37 |
Lurking Member
Join Date: Feb 2009
First, I'd like to say that I enjoyed K-On!. It had great art, great animation, great music, and great voice acting. It had some really nice episodes, and it got me attached to some of the characters (especially Azusa). However, good points aside, there were also a few things that I disliked.
When I started watching this anime, I wanted to see the girls actually get involved in their hobby. Instead, I got a ton of slice-of-life scenes where the girls did nothing but eat cakes, do various schoolwork and visit various places (now, I do not mind slice-of-life, but I do mind it when important character development gets sacrificed for such scenes). And in the end, the girls were magically able to play their instruments perfectly and hold out concerts and stuff. Unfortunately, playing in a band doesn't work that way. It takes years for a person to become "pretty good" at playing an instrument (and it takes a while for beginners to get used to playing in a band). The producers got away by playing the "Yui is a genius" card in the first season, which lacked realism and was pretty unfair. However, the situation becomes even more unrealistic if we talk about the songs they played. How did they manage to compose so many of them? Because once again, it takes years for someone to become good enough in music theory, harmony, counterpoint and all that stuff to compose something decent. Did the musical scores appear by magic? Did the girls just play the songs by ear? It seems that not even the producers know the answers to these questions. Maybe that's why they just tossed away the music aspect and focused mostly on the slice-of life scenes (especially in the second season). Oh, well... No, I'm not going to rate this.
2011-04-12, 20:42 | Link #38 | |
Knowledge is the solution
Join Date: Jan 2004
Location: U. of Pittsburgh, Previously in Mexico City.
Age: 30
2011-04-13, 20:31 | Link #40 | |
Obey the Darkly Cute ...
Join Date: Dec 2005
Location: On the whole, I'd rather be in Kyoto ...
Age: 57
Yui is the only "fantastic device" and she's a fortuitous "idiot savant" occurrence - she can't even read music, she just listens. And yes, btw, I've played and written music (mostly in my teenage years). If you really listen, you'll hear in the episodes wrong notes, off-key vocals, poor synchronization INTENTIONALLY put there by Kyo-Ani musicians. The music in the CDs, in the EDs ... that portrays the "future group" as they'd sound when they went pro.
Thread Tools | |


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These marvelous Christmas cookies combine chocolate with spicy gingerbread. "I was tired of basic gingerbread," says Matt Lewis. "And my connection to chocolate is really deep." An added benefit of these cookies: The supple dough is very easy to work with, and the scraps can be rerolled and cut out.
- 3 1/4 cups all-purpose flour, plus more for dusting
- 1/3 cup unsweetened cocoa powder
- 1 tablespoon ground ginger
- 2 teaspoons ground cinnamon
- 1 teaspoon ground cloves
- 1 tablespoon baking soda
- 1/2 teaspoon baking powder
- 1 teaspoon salt
- 5 tablespoons unsalted butter, softened
- 1/3 cup solid vegetable shortening
- 1/2 cup packed dark brown sugar
- 1 large egg at room temperature
- 1/2 cup molasses
- 2 ounces bittersweet chocolate, melted and cooled
- 1 1/4 cups confectioners' sugar
- 1 large egg white
- 1 teaspoon fresh lemon juice
- Mascarpone Filling optional
In a medium bowl, whisk the flour with the cocoa powder, ground ginger, ground cinnamon, ground cloves, baking soda, baking powder and salt. In the bowl of a standing electric mixer fitted with the paddle, beat the softened butter with the shortening at medium speed until the mixture is smooth, about 30 seconds. Add the brown sugar and beat until fluffy, about 2 minutes.
Add the egg to the cookie batter and beat until incorporated. Beat in the molasses and then the melted bittersweet chocolate. Add the flour mixture in 3 batches, beating between additions. Divide the dough into 3 equal parts. Shape each part into a disk, then wrap each one in plastic wrap and refrigerate the cookie dough until chilled, about 2 hours.
Preheat the oven to 350 degrees F. Line 2 large baking sheets with parchment paper. On a lightly floured work surface, roll out 1 disk of dough 1/4 inch thick. Using 4- to 5-inch cookie cutters, cut the dough into shapes and transfer to the prepared baking sheets. Reroll the dough scraps and cut out more cookies.
Bake the cookies for about 7 minutes, rotating the pans halfway through baking until the tops are dry. Let the cookies cool on the pans for 5 minutes, then transfer to wire racks to cool completely. Repeat the process with the remaining dough.
In a medium bowl, combine the confectioners' sugar with the egg white and lemon juice and whisk until the icing is completely smooth.
Scrape the Mascarpone Filling into a piping bag fitted with a medium tip. Turn half of the gingerbread cookies flat-side up and pipe a thin layer of filling over the cookies. Top with the remaining cookies, flat-side down.
Scrape the icing into a piping bag fitted with a very small tip. Decorate the cookies as desired. Let stand until the icing dries, about 30 minutes.
Get more Food & Wine recipes
Recipe reprinted by permission of Publisher. All rights reserved.
RecID 10620
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Book Search
Media Effects
Advances in Theory and Research, 3rd Edition
Series: Routledge Communication Series
With contributions from some of the finest scholars in the discipline, Media Effects serves not only as a comprehensive reference volume for media effects study but also as an exceptional textbook for advanced courses in media effects. Covering the breadth of the media effects arena, this third...
Published December 6th 2013 by Routledge
Selective Exposure To Communication
Series: Routledge Communication Series
First published in 1985. Routledge is an imprint of Taylor & Francis, an informa company....
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Mass Media Effects Research
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This distinctive collection offers a unique set of meta-analyses covering the breadth of media effects research. Editor Raymond W. Preiss and his colleagues bring together an all-star list of contributors. Organized by theories, outcomes, and mass media campaigns, the chapters included here offer...
Published August 29th 2006 by Routledge
Handbook of Sports and Media
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This distinctive Handbook covers the breadth of sports and media scholarship, one of the up-and-coming topics bridging media entertainment, sports management, and popular culture. Organized into historical, institutional, spectator, and critical studies perspectives, this volume brings together the...
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Playing Video Games
Motives, Responses, and Consequences
Series: Routledge Communication Series
From security training simulations to war games to role-playing games, to sports games to gambling, playing video games has become a social phenomena, and the increasing number of players that cross gender, culture, and age is on a dramatic upward trajectory. Playing Video Games: Motives, Responses...
Published March 28th 2006 by Routledge
Psychology of Entertainment
Series: Routledge Communication Series
As entertainment becomes a trillion-dollar-a-year industry worldwide, as our modern era increasingly lives up to its label of the "entertainment age," and as economists begin to recognize that entertainment has become the driving force of the new world economy, it is safe to say that scholars are...
Published February 24th 2006 by Routledge
Communication and Emotion
Essays in Honor of Dolf Zillmann
Series: Routledge Communication Series
This collection serves two important functions: it synthesizes theory and research in the vital and vibrant area of communication and emotion, and it highlights the scholarly work and contributions of Dolf Zillmann, the preeminent contributor to this area of inquiry.As one of the most productive...
Published April 1st 2003 by Routledge
Television and the American Family
2nd Edition
This second edition of a trend-setting volume provides an updated examination of the interaction between families and the most pervasive mass medium: television. Charting the dynamic developments of the American family and television over the past decade, this volume provides a comprehensive...
Published January 1st 2001 by Routledge
Human Communication Theory and Research
Concepts, Contexts, and Challenges, 2nd Edition
Series: Routledge Communication Series
Human Communication Theory and Research introduces students to the growing body of theory and research in communication, demonstrating the integration between the communication efforts of interpersonal, organizational, and mediated settings. This second edition builds from the foundation of the...
Published June 1st 2000 by Routledge
Media, Children, and the Family
Social Scientific, Psychodynamic, and Clinical Perspectives
Series: Routledge Communication Series
This book brings together a group of scholars to share findings and insights on the effects of media on children and family. Their contributions reflect not only widely divergent political orientations and value systems, but also three distinct domains of inquiry into human motivation and behavior...
Published January 1st 1994 by Routledge


text:
As we give thanks for the blessings of family, friends, and a meal to share with them, we must also remember the least fortunate among us this Thanksgiving.
Area soup kitchens and food pantries are always in need of food, volunteers, and monetary support. If you are able to help, please consider contacting a food pantry or soup kitchen in your neighborhood.
Food pantries in Cambridge:
(Please call food pantries before visiting, as their hours vary significantly)
Cambridge Senior Center
806 Massachusetts Avenue
Cambridge, MA 02139
617-349-6060Cambridgeport Baptist Church
Food Pantry/Clothes Closet
459 Putnam Street
Cambridge, MA 02139
617-576-6779CEOC Food Pantry
11 Inman Street
Cambridge, MA 02139
617-868-2900Common Care / St. Peter's Episcopal Church
838 Massachusetts Avenue
Cambridge, MA 02138
617-547-7788East End House
105 Spring Street
Cambridge, MA 02140
Information about the East End House turkey basket giveawayHelping Hand Food Pantry
St. James's Episcopal Church
1991 Massachusetts Avenue
Cambridge, MA 02140
617-876-4381Margaret Fuller House Food Pantry
71 Cherry Street
Cambridge, MA 02139
617-547-4680Project Manna
Massachusetts Avenue Baptist Church
146 Hampshire Street
Cambridge, MA 02139
617-868-4853St. Paul A.M.E. Food Pantry
85 Bishop Allen Drive
Cambridge, MA 02139
617-661-1110Salvation Army
402 Massachusetts Avenue
Cambridge, MA 02139
617-547-3400Western Avenue Baptist Church
299 Western Avenue
Cambridge, MA 02139
617-441-6959Zinberg Clinic Pantry
The Cambridge Hospital
1493 Cambridge Street
Cambridge, MA 02139
Food pantries and soup kitchens in Somerville:
Hearty Meals For All (HMFA)
Somerville Community Baptist Church
31 College AvenueSomerville, Ma 02144
Project Soup:
Saint Benedict's Church
(rear basement)
15 Franklin Street
East Somerville, MA 02145West Pantry
1 Davis Square
Mon – Fri 9:00 – 5:00 PMCommunity Suppers
First Congregational Church of
89 College Avenue, Davis Square
Monday – Beginning at 5:00 PMDollar-A-Bag
Saint Benedict's (rear basement)
15 Franklin Street
East Somerville, MA 02145Somerville Cambridge Elder Services
61 Medford St. Somerville, Ma 02143
All the best,


text:
Living FoodsOrganic Whole Food Bar Variety Pack - 3 bars - Garden of Life
Organic Whole Food Bars Sample Pack
Organic Super Seed Whole Food Fiber Bar APPLE CINNAMON NATURALLY FLAVORED Net Weight per bar 2.4 oz. (64g) Organic Perfect Food Whole Foods Greens Bar RED RASPBERRY NATURALLY FLAVORED Net Weight per bar 2.25 oz. (64g) Organic Fruits of Life Whole Food Antioxidant Matrix Bar SUMMER BERRY NATURALLY FLAVORED *Polyphenols derived from blueberries, cranberries, whole grape extract, and apple powder. Net Weight per bar 2.25 oz. (64g) Benefits At Garden of Life we are dedicated to empowering extraordinary health. Our New Living Foods Bars combine the goodness of nutritious whole foods such as organic fruit, vegetables, nuts and sprouted grains with beneficial LIVE PROBIOTICS, all sweetened with raw honey to create an incredibly satisfying bar that is both delicious and healthy for you. Each bar contains soluble fiber from oat beta glucan, an important ingredient for supporting a healthy heart.
These statements have not been evaluated by the FDA. This product is not intended to diagnose, treat, cure or prevent any disease.


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Shop now and get Free Value Shipping on most orders over $49 to the contiguous 48 states, DC and to all U.S. Military APO/FPO/DPO addresses.
We want to ensure that making a return is as easy and hassle-free as possible! If for any reason you decide that your purchase just isn't for you, simply return the item within 30 days of receipt and we'll cover the cost of return shipping. Learn more about our Return Policy.
If you're shopping for Irwin Strait-Line products, this ought to be your first stop. You can sort through our Irwin Strait-Line products in a number of ways. We don't hold back on the amount of items we carry, so you will no doubt appreciate all the sorting choices available . First, if you know what sort of gear you need, click that category on the left side of this page. Or you can sort by price to find the Irwin Strait-Line products that are in your price range. And looking through our Best Reviewed Pages is a fantastic idea because you can see only those items that people just like you gave their stamp of approval to. If you have questions, make sure to email or call us so we can help you navigate our collection by Irwin Strait-Line. Why buy from OpticsPlanet? Because our team possesses the experience and know-how to make sure you will have the correct tools to do the job.


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You must be in between moving homes or offices and looking for the best provider. Thank you for visiting us and considering us as your option.
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Adobe Flash Player is the client runtime that delivers user experiences across major operating systems, browsers, mobile phones and devices.
VLC media player
2.2.1VLC Media Player is a free software media player for various audio and video formats (MPEG-1, MPEG-2, MPEG-4, DivX, mp3, ogg...) as well as DVDs, VCDs, and various streaming protocols. It is able to stream over networks and to transcode multimedia files and save them into various different formats.
VLC Media Player uses a large number of free decoding and encoding libraries. Many of its codecs are provided by the libavcodec codec library from the FFmpeg project, but it uses mainly its own muxer and demuxers.
Features of VLC Media Player:
- VLC is popular for its ability to play the video content of incomplete, unfinished, or damaged video downloads before the files have been fully downloaded.
- The player also has the ability to use libcdio to access .iso files so that the user can play files on a disk image, even if the user's operating system does not have the capability of working directly with .iso images.
- VLC supports all codecs and all file formats supported by FFmpeg. This means that DVD Video and MPEG-4 playback as well as support for Ogg and Matroska (MKV) file formats work "out of the box".
- VLC media player has some filters that can distort, rotate, split, deinterlace, mirror videos, create display walls, or add a logo overlay.
- VLC media player can play high definition recordings of D-VHS tapes duplicated to a computer using CapDVHS.exe.
- Using a FireWire connection from cable boxes to computers, VLC can stream live, unencrypted content to a monitor or HDTV.
- VLC media player can display the playing video as the desktop wallpaper.
Views / Downloads Today: | 92 / 19 |
Rating / Votes: |
4.76 / 66
Author: | VideoLAN team |
Updated: | |
Operating System: | Windows 2000, XP, 2003, Vista, 7 |
- Download VLC Media Player (27.51 MB)
- Download VLC Media Player (64-bit) 2.2.0 (28.42 MB)
- Download VLC Media Player Portable (ZIP) (45.97 MB)
- Download VLC Media Player Portable (EXE) (25.7 MB)
No comments yet. You can leave your comment on software VLC media player.
KMPlayer is a versatile media player which can cover various types of container formats.
Media Player Classic is a compact media player for Microsoft Windows that uses few system resources.
AIMP is a freeware multimedia player that includes an audio converter, recorder, and tag editor.
iTunes is a free digital media player application for Mac and PC. It plays all your digital music and video.
Windows Media Player is the media player for discovering, playing, and taking your digital entertainment.
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- Adobe AIR SDK 126.96.36.199
- Adobe AIR 188.8.131.52
- Advanced Codecs for Windows 7 and 8 5.2.0
- Standard Codecs for Windows 7 and 8 2.6.0


text:
3 to 6 days
Free delivery when you spend over £75 (GBP).
Will be calculated at checkout
Bandeau dress from VILA FOR NELLY. Elastic to the reverse and tulle skirt. Decorative beads and lace in the top.
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Transfer of manualized CBT for social phobia into clinical practice (SOPHO-PRAX) : a study protocol for a cluster-randomized controlled trial
Background: Cognitive-behavioral therapy (CBT) is generally known to be efficacious in the treatment of social phobia when applied in RCT's, namely when the treatment manual is based on the Clark-Wells approach. However,
Background: Cognitive-behavioral therapy (CBT) is generally known to be efficacious in the treatment of social phobia when applied in RCT's, namely when the treatment manual is based on the Clark-Wells approach. However, little is known about the efficacy of manualized treatments in routine clinical practice (Phase IV of psychotherapy research). The present study (SOPHO-PRAX) is a continuation of a large multi-centre randomized clinical trial (SOPHO-NET) and analyses the extent to which additional training practitioners in manualized procedures enhances treatment effect. Methods: N = 36 private practitioners will be included in three treatment centres and randomly designated to either training in manualized CBT or no specific training. The treatment effects of the therapies conducted by both groups of therapists will be compared. A total of 162 patients (N = 116 completers; N = 58 per condition) will be enrolled. Liebowitz Social Anxiety Scale (LSAS) will serve as primary outcome measure. Remission from social phobia is defined as LSAS total [less than or equal to] 30 points. Data will be collected at treatment begin, after 8, 15, and 25 sessions (50 mins. each), at treatment completion, as well at 6 and 12 months post-treatment. Discussion: The present CBT trial combines elements of randomized-controlled trials and naturalistic studies in an innovative way. It will directly inform about the incremental effects of procedures established in a controlled trial into clinical practice. Study results are relevant to health care decisions and policy. They may serve to improve quality of treatment, and shorten the timeframe between the development and widespread dissemination of effective methods, thereby reducing health cost expenditures. The results of this study will not only inform about the degree to which the new methods lead to an improvement of treatment course and outcome, but also about whether the effects of routine psychotherapeutic treatment are comparable to those of the controlled, strictly manualized treatments of the SOPHO-NET study. Trial Registration: ClinicalTrials.gov identifier: NCT01388231. This study was funded by the German Federal Ministry of Education and Research (SOPHO-NET: BMBF 01GV0607; SOPHO-PRAX: BMBF 01GV1001).…
Author: | Stephen Crawcour, Eric Leibing, Denise Ginzburg, Ulrich Stangier, Jörg Wiltink, Jürgen Hoyer |
URN: | urn:nbn:de:hebis:30:3-249986 |
DOI: | http://dx.doi.org/10.1186/1745-6215-13-70 |
Pubmed Id: | http://www.ncbi.nlm.nih.gov/pubmed?term=22647314 |
Parent Title (English): | Trials |
Publisher: | BioMed Central |
Place of publication: | London |
Document Type: | Article |
Language: | English |
Date of Publication (online): | 2012/05/30 |
Date of first Publication: | 2012/05/30 |
Publishing Institution: | Univ.-Bibliothek Frankfurt am Main |
Release Date: | 2012/11/05 |
Tag: | Cognitive behavioral therapy; Dissemination; Outcome; Phase-IV research; Remission; Social phobia; Training; Treatment |
Volume: | 13 |
Issue: | 70 |
Pagenumber: | 9 |
Note: | © 2012 Crawcour et al.; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. |
HeBIS PPN: | 35734068X |
Institutes: | Medizin |
Dewey Decimal Classification: | 610 Medizin und Gesundheit |
Sammlungen: | Universitätspublikationen |
Licence (German): | Creative Commons - Namensnennung 2.0 |


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2007 NANY CHALLENGE (New Apps For The New Year)
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PesterMeWHAT IT DOES: Allows you to create your own repeating nag message that will popup as frequently as you want. Features Custom nag message, tray icon, customizable timer, sound.


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Vancouverites sweep up, pour out hearts
Vancouver residents on Thursday attempted to scrub clean their tarnished image with garbage bags and handwritten notes expressing their disgust at looters.
View 3 photos
zoomVANCOUVER—From riot to contrition, and mess to clean-up, Vancouver residents attempted to scrub clean their tarnished image with garbage bags and handwritten notes expressing their disgust at thuggish looters.
Facebook pages set up during the riot Wednesday night urged residents to head downtown in the morning to help clean up the city and its damaged reputation following the hooliganism that took place when the Canucks lost the Stanley Cup final.
One page, the Post-Riot Clean-Up, had nearly 10,000 followers as it urged residents to show the world what "Vancouver is really about." Hundreds of people arrived in Vancouver downtown, some as early as 6 a.m. with garbage bags, brooms, mops and gloves and began sweeping damaged glass and broken retail fronts.
"Reading about this last night that people were getting together to do their part was the only thing that made me feel better after watching all the destruction," said Jamie Dechamplain, who was out with her dog Becker before heading off to work.
"It was devastating to realize how much damage a small group of people could do, not just to where we live but to our reputation."
Dechamplain said she's proud of Vancouver's reputation as a livable city and the great hospitality displayed during the Olympics.
On Granville St., optometrist Dr. Brad McDougall arrived early with bucket and broom to clean up the storefront of his store. In the past, rioters have tried to smash in the front window but the addition of an iron gate over the glass has kept eyeglasses and glass windows safe from looters.
"Last night as I watched it on TV, I thought we would have some very serious damage," said McDougall. "But it hasn't been bad at all. Everything is still here and there just a lot of mess like beer bottles and garbage to clean up."
On boards covering smashed-in windows at the Bay and Sears, one of the first notes to appear generated hundreds more.
A handwritten sign was pasted on the board at one of the Bay's windows saying On Behalf of My Team and My City, I'm Sorry!
That note was quickly surrounded by other notes praising Vancouver residents for volunteering to clean up and Vancouver police while criticizing the rioters and looters. "Way to Go Bozos," one note read.
Inside the department store, tinkling sounds of glass was being swept up as Peggy Trendell-Jensen added in her note on the board. Underneath one note that said, "My heart is broken. My city is bleeding," Trendell-Jensen wrote, "Not Any More It's Not."
"It was wonderful to see so many people just decide to come down and do their part," said Trendell-Jensen. "In many places you wouldn't think anything happened because there were so many people helping clean up. There was fighting in a good way because there's not enough garbage now to be picked up."
Mayor Gregor Robertson toured the area early in the morning and said the volunteers have proven that their city cannot be defined by the actions of a few.
"The people who are here are why this is such a great city," Robertson said. "The losers who did what they did don't represent Vancouver at all."
Top News
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- NEW Bad parents on show at sex-ed protests: Mallick
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- NEW Mississauga man annoyed at unsolicited PC membership card
- Updated Ontario school strikes? I'm on it, says Wynne
- NEW A Martian's view of Trudeau's middle-class tax cuts: Walkom


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What Can We Play on Sunday? September & October Services, Book 5
6 Easily Prepared Piano Duet Arrangements
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What Can We Play on Sunday? September & October Services, Book 5 (6 Easily Prepared Piano Duet Arrangements). Arranged by Robert D. Vandall. For Piano. Book; Duet or Duo; Graded Standard Repertoire; Piano Duet (1 Piano, 4 Hands). Sacred Performer Duet Collections. Fall; Hymn; Sacred; Summer. Late Intermediate. 48 pages. Published by Alfred Music (AP.38792).
ISBN 0739084151. Fall; Hymn; Sacred; Summer.
What Can We Play on Sunday? is a series of six books of piano duets (one piano, four hands), each book designed for busy pianists who require accessible arrangements. Book 5 contains selections for holidays and holy days that occur during September and October. It also contains several general hymns. Titles: All Things Bright and Beautiful * Come, Christians, Join to Sing * Holy, Holy, Holy * Oh, How I Love Jesus * Shall We Gather at the River * What a Friend We Have in Jesus.
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Samantha Jones Cover Songs
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"(You Make Me Feel Like) A Natural Woman," from the Aretha Franklin album "Lady Soul", was covered on the Samantha Jones album "Sam Leads the Way: The Penny Farthing Recordings."
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ADAA mourns the loss of Robin Williams and too many others whose lives have ended due to suicide. His tragic death illustrates the great need for increased public awareness of the grave risk that suicide poses.
Drawing on his own long-standing battle with anxiety, Scott Stossel, author of My Age of Anxiety: Fear, Hope, Dread, and the Search for Peace of Mind, presents the history and efforts to understand an affliction that is pervasive yet often misunderstood. Watch his conversation with talk show host Mimi Geerges.
WatchIn his new book, author Scott Stossel reveals his lifelong struggle growing up and living with severe anxiety disorders — and why getting early treatment for children is so important.
Parents will do anything to help their children. Read one man's story of chronic and severe anxiety that began early in his childhood. The editor of The Atlantic magazine, Scott Stossel still struggles with sometimes-disabling symptoms, but he manages his disorders and lives a successful and highly productive life.
Lizabeth Roemer, PhD
Professor of Psychology
College of Liberal Arts
University of Massachusetts Boston
Dr. Roemer explains mindfulness skills and how people can learn to apply them to daily living, and she describes how acceptance-based behavioral therapies are used to treat anxiety disorders and depression.
Dr. Jenny Yip addresses the challenges in diagnosing anxiety disorders in children, identifying the underlying cause of anxiety, and providing appropriate and effective treatment. Listen here.
Jenny C. Yip, PsyD, ABPP
Executive Director, Renewed Freedom Center for Rapid Anxiety Relief
Clinical Assistant Professor of Psychiatry, USC - Keck School of Medicine
Child & Adolescent Psychiatry Residency Program
Dr. Yip addresses the challenges in diagnosing anxiety disorders in children, identifying the underlying cause of anxiety, and providing appropriate and effective treatment.
C. Alec Pollard, PhD
Founder and Director, Saint Louis Behavioral Medicine Institute Anxiety Disorders Center
Professor, Community and Family Medicine, St. Louis University
Author and coauthor of more than 80 publications about anxiety disorders and related topics
Dr. Pollard explains a strategy that teaches family members to shape treatment-seeking behavior in someone with an anxiety disorder.
Diagnostic and Statistical Manual of Mental Disorders (DSM) is the standard classification of mental disorders used by mental health providers in the United States. It contains a listing of diagnostic criteria for every psychiatric disorder recognized by the U.S. health care system.
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STELARA- ustekinumab injection, solution
Janssen Biotech, Inc.
These highlights do not include all the information needed to use STELARA
® safely and effectively. See full prescribing information for STELARA
STELARA ® (ustekinumab) injection, for subcutaneous use Initial U.S. Approval: 2009 RECENT MAJOR CHANGES
INDICATIONS AND USAGESTELARA® is a human interleukin-12 and -23 antagonist indicated for the treatment of adult patients (18 years or older) with DOSAGE AND ADMINISTRATIONSTELARA® is administered by subcutaneous injection. (2) Psoriasis
Psoriatic Arthritis DOSAGE FORMS AND STRENGTHSCONTRAINDICATIONSClinically significant hypersensitivity to ustekinumab or to any of the excipients. (4) WARNINGS AND PRECAUTIONS
ADVERSE REACTIONSMost common adverse reactions (incidence ≥3% and greater than with placebo): Nasopharyngitis, upper respiratory tract infection, headache, and fatigue. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Janssen Biotech, Inc. at 1-800-JANSSEN (1-800-526-7736) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. DRUG INTERACTIONSSee 17 for PATIENT COUNSELING INFORMATION and Medication Guide. Revised: 3/2014 |
STELARA® is administered by subcutaneous injection.
In subjects weighing >100 kg, 45 mg was also shown to be efficacious. However, 90 mg resulted in greater efficacy in these subjects [see Clinical Studies (14)].
STELARA® is for subcutaneous administration. STELARA® is intended for use under the guidance and supervision of a physician. STELARA® should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician.
After proper training in subcutaneous injection technique, a patient may self inject with STELARA® if a physician determines that it is appropriate. Patients should be instructed to follow the directions provided in the Medication Guide (see Medication Guide).
Prior to administration, STELARA® should be visually inspected for particulate matter and discoloration. STELARA® is colorless to light yellow and may contain a few small translucent or white particles. STELARA® should not be used if it is discolored or cloudy, or if other particulate matter is present. STELARA® does not contain preservatives; therefore, any unused product remaining in the vial and/or syringe should be discarded.
The needle cover on the prefilled syringe contains dry natural rubber (a derivative of latex). The needle cover should not be handled by persons sensitive to latex.
It is recommended that each injection be administered at a different anatomic location (such as upper arms, gluteal regions, thighs, or any quadrant of abdomen) than the previous injection, and not into areas where the skin is tender, bruised, erythematous, or indurated. When using the single-use vial, a 27 gauge, ½ inch needle is recommended.
Refer to the diagram below for the provided instructions.
To prevent premature activation of the needle safety guard, do not touch the NEEDLE GUARD ACTIVATION CLIPS at any time during use.
STELARA® solution is colorless to slightly yellow in appearance and contains 90 mg ustekinumab per mL.
Clinically significant hypersensitivity to ustekinumab or to any of the excipients [see Warnings and Precautions (5.5)].
STELARA® may increase the risk of infections and reactivation of latent infections. Serious bacterial, fungal, and viral infections were observed in subjects receiving STELARA® [see Adverse Reactions (6.1)].
STELARA® should not be given to patients with any clinically important active infection. STELARA® should not be administered until the infection resolves or is adequately treated. Instruct patients to seek medical advice if signs or symptoms suggestive of an infection occur. Exercise caution when considering the use of STELARA® in patients with a chronic infection or a history of recurrent infection.
Serious infections requiring hospitalization occurred in the psoriasis and psoriatic arthritis development programs. In the psoriasis program, serious infections included diverticulitis, cellulitis, pneumonia, appendicitis, cholecystitis, sepsis, osteomyelitis, viral infections, gastroenteritis and urinary tract infections. In the psoriatic arthritis program, serious infections included cholecystitis.
Individuals genetically deficient in IL-12/IL-23 are particularly vulnerable to disseminated infections from mycobacteria (including nontuberculous, environmental mycobacteria), salmonella (including nontyphi strains), and Bacillus Calmette-Guerin (BCG) vaccinations. Serious infections and fatal outcomes have been reported in such patients.
It is not known whether patients with pharmacologic blockade of IL-12/IL-23 from treatment with STELARA® will be susceptible to these types of infections. Appropriate diagnostic testing should be considered, e.g., tissue culture, stool culture, as dictated by clinical circumstances.
Evaluate patients for tuberculosis infection prior to initiating treatment with STELARA®.
Do not administer STELARA® to patients with active tuberculosis. Initiate treatment of latent tuberculosis prior to administering STELARA®. Consider anti-tuberculosis therapy prior to initiation of STELARA® in patients with a past history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed. Patients receiving STELARA® should be monitored closely for signs and symptoms of active tuberculosis during and after treatment.
STELARA® is an immunosuppressant and may increase the risk of malignancy. Malignancies were reported among subjects who received STELARA® in clinical studies [see Adverse Reactions (6.1)]. In rodent models, inhibition of IL-12/IL-23p40 increased the risk of malignancy [see Nonclinical Toxicology (13)].
The safety of STELARA® has not been evaluated in patients who have a history of malignancy or who have a known malignancy.
There have been post marketing reports of the rapid appearance of multiple cutaneous squamous cell carcinomas in patients receiving STELARA® who had pre-existing risk factors for developing non-melanoma skin cancer. All patients receiving STELARA® should be monitored for the appearance of non-melanoma skin cancer. Patients greater than 60 years of age, those with a medical history of prolonged immunosuppressant therapy and those with a history of PUVA treatment should be followed closely [see Adverse Reactions (6.1)].
Hypersensitivity reactions, including anaphylaxis and angioedema, have been reported post-marketing. If an anaphylactic or other clinically significant hypersensitivity reaction occurs, institute appropriate therapy and discontinue STELARA® [see Adverse Reactions (6.3)].
One case of reversible posterior leukoencephalopathy syndrome (RPLS) was observed in the clinical trial safety databases for psoriasis and psoriatic arthritis. The subject, who had received 12 doses of STELARA® over approximately two years, presented with headache, seizures and confusion. No additional STELARA® injections were administered and the subject fully recovered with appropriate treatment..
RPLS is a neurological disorder, which is not caused by demyelination or a known infectious agent. RPLS can present with headache, seizures, confusion and visual disturbances. Conditions with which it has been associated include preeclampsia, eclampsia, acute hypertension, cytotoxic agents and immunosuppressive therapy. Fatal outcomes have been reported.
If RPLS is suspected, administer appropriate treatment and discontinue STELARA®.
Prior to initiating therapy with STELARA®, patients should receive all immunizations appropriate for age as recommended by current immunization guidelines. Patients being treated with STELARA® should not receive live vaccines. BCG vaccines should not be given during treatment with STELARA® or for one year prior to initiating treatment or one year following discontinuation of treatment. Caution is advised when administering live vaccines to household contacts of patients receiving STELARA® because of the potential risk for shedding from the household contact and transmission to patient.
Non-live vaccinations received during a course of STELARA® may not elicit an immune response sufficient to prevent disease.
In psoriasis studies the safety of STELARA® in combination with other immunosuppressive agents or phototherapy has not been evaluated. In psoriatic arthritis studies, concomitant MTX use did not appear to influence the safety or efficacy of STELARA® [see Drug Interactions (7.2)]. Ultraviolet-induced skin cancers developed earlier and more frequently in mice genetically manipulated to be deficient in both IL-12 and IL-23 or IL-12 alone [see Nonclinical Toxicology (13)].
The following serious adverse reactions are discussed elsewhere in the label:
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 practice.
Psoriasis Clinical Studies
The safety data reflect exposure to STELARA® in 3117 psoriasis subjects, including 2414 exposed for at least 6 months, 1855 exposed for at least one year, 1653 exposed for at least two years, 1569 exposed for at least three years, 1482 exposed for at least four years and 838 exposed for at least five years.
Table 1 summarizes the adverse reactions that occurred at a rate of at least 1% and at a higher rate in the STELARA® groups than the placebo group during the placebo-controlled period of Ps STUDY 1 and Ps STUDY 2 [see Clinical Studies (14)].
Placebo | 45 mg | 90 mg | |
Subjects treated | 665 | 664 | 666 |
Nasopharyngitis | 51 (8%) | 56 (8%) | 49 (7%) |
Upper respiratory tract infection | 30 (5%) | 36 (5%) | 28 (4%) |
Headache | 23 (3%) | 33 (5%) | 32 (5%) |
Fatigue | 14 (2%) | 18 (3%) | 17 (3%) |
Diarrhea | 12 (2%) | 13 (2%) | 13 (2%) |
Back pain | 8 (1%) | 9 (1%) | 14 (2%) |
Dizziness | 8 (1%) | 8 (1%) | 14 (2%) |
Pharyngolaryngeal pain | 7 (1%) | 9 (1%) | 12 (2%) |
Pruritus | 9 (1%) | 10 (2%) | 9 (1%) |
Injection site erythema | 3 (<1%) | 6 (1%) | 13 (2%) |
Myalgia | 4 (1%) | 7 (1%) | 8 (1%) |
Depression | 3 (<1%) | 8 (1%) | 4 (1%) |
Adverse reactions that occurred at rates less than 1% in the controlled period of Ps STUDIES 1 and 2 through week 12 included: cellulitis, herpes zoster, diverticulitis and certain injection site reactions (pain, swelling, pruritus, induration, hemorrhage, bruising, and irritation).
One case of RPLS occurred during clinical trials [see Warnings and Precautions (5.6)].
In the placebo-controlled period of clinical studies of psoriasis subjects (average follow-up of 12.6 weeks for placebo-treated subjects and 13.4 weeks for STELARA®-treated subjects), 27% of STELARA®-treated subjects reported infections (1.39 per subject-year of follow-up) compared with 24% of placebo-treated subjects (1.21 per subject-year of follow-up). Serious infections occurred in 0.3% of STELARA®-treated subjects (0.01 per subject-year of follow-up) and in 0.4% of placebo-treated subjects (0.02 per subject-year of follow-up) [see Warnings and Precautions (5.1)].
In the controlled and non-controlled portions of psoriasis clinical trials (median follow up of 3.2 years), representing 8998 subject-years of exposure, 72.3% of STELARA®-treated subjects reported infections (0.87 per subject-years of follow-up). Serious infections were reported in 2.8% of subjects (0.01 per subject-years of follow-up).
In the controlled and non-controlled portions of psoriasis clinical trials (median follow up of 3.2 years, representing 8998 subject-years of exposure), 1.7% of STELARA®-treated subjects reported malignancies excluding non-melanoma skin cancers (0.60 per hundred subject-years of follow-up). Non-melanoma skin cancer was reported in 1.5% of STELARA®-treated subjects (0.52 per hundred subject-years of follow-up) [see Warnings and Precautions (5.4)]. The most frequently observed malignancies other than non-melanoma skin cancer during the clinical trials were: prostate, melanoma, colorectal and breast. Malignancies other than non-melanoma skin cancer in STELARA®-treated patients during the controlled and uncontrolled portions of studies were similar in type and number to what would be expected in the general U.S. population according to the SEER database (adjusted for age, gender and race).1
Psoriatic Arthritis Clinical Studies
The safety of STELARA® was assessed in 927 patients in two randomized, double-blind, placebo-controlled studies in adult patients with active psoriatic arthritis (PsA). The overall safety profile of STELARA® in patients with PsA was consistent with the safety profile seen in psoriasis clinical studies. A higher incidence of arthralgia, nausea, and dental infections was observed in STELARA®-treated patients when compared with placebo-treated patients (3% vs. 1% for arthralgia and 3% vs. 1% for nausea; 1% vs. 0.6% for dental infections) in the placebo-controlled portions of the PsA clinical trials.
Approximately 6% of patients treated with STELARA® in psoriasis and psoriatic arthritis clinical studies developed antibodies to ustekinumab, which were generally low-titer. No apparent association between the development of antibodies to ustekinumab and the development of injection site reactions was seen. No ustekinumab-related serious hypersensitivity reactions were observed in psoriasis and psoriatic arthritis clinical trials. In psoriasis studies, the majority of patients who were positive for antibodies to ustekinumab had neutralizing antibodies.
The data above reflect the percentage of subjects whose test results were positive for antibodies to ustekinumab and are highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody positivity in an assay may be influenced by several factors, including sample handling, timing of sample collection, concomitant medications and underlying disease. For these reasons, comparison of the incidence of antibodies to ustekinumab with the incidence of antibodies to other products may be misleading.
Adverse reactions have been reported during post-approval use with STELARA®. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to STELARA® exposure.
Drug interaction studies have not been conducted with STELARA®.
Live vaccines should not be given concurrently with STELARA® [see Warnings and Precautions (5.7)].
In psoriasis studies the safety of STELARA® in combination with immunosuppressive agents or phototherapy has not been evaluated. In psoriatic arthritis studies, concomitant MTX use did not appear to influence the safety or efficacy of STELARA® [see Warnings and Precautions (5.8)].
The formation of CYP450 enzymes can be altered by increased levels of certain cytokines (e.g., IL-1, IL-6, IL-10, TNFα, IFN) during chronic inflammation. Thus, STELARA®, an antagonist of IL-12 and IL-23, could normalize the formation of CYP450 enzymes. Upon initiation of STELARA® in patients who are receiving concomitant CYP450 substrates, particularly those with a narrow therapeutic index, monitoring for therapeutic effect (e.g., for warfarin) or drug concentration (e.g., for cyclosporine) should be considered and the individual dose of the drug adjusted as needed [see Clinical Pharmacology (12.3)].
STELARA® has not been evaluated in patients who have undergone allergy immunotherapy. STELARA® may decrease the protective effect of allergen immunotherapy (decrease tolerance) which may increase the risk of an allergic reaction to a dose of allergen immunotherapy. Therefore, caution should be exercised in patients receiving or who have received allergen immunotherapy, particularly for anaphylaxis.
Pregnancy Category B
Pregnancy Registry
There is a pregnancy registry that monitors pregnancy outcomes in women exposed to STELARA® during pregnancy. Patients should be encouraged to enroll by calling 1-877-311-8972.
There are no adequate and well controlled studies of STELARA® in pregnant women. Developmental toxicity studies conducted with monkeys found no evidence of harm to the fetus due to ustekinumab. STELARA® should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Ustekinumab was tested in two embryo-fetal development toxicity studies with cynomolgus monkeys. No teratogenic effects or other adverse developmental effects were observed in fetuses from pregnant monkeys that were administered ustekinumab during the period of organogenesis either twice weekly via subcutaneous injections or weekly by intravenous injections at doses up to 45 times the maximum recommended human dose (MRHD) (on a mg/kg basis at a maternal dose of 45 mg/kg).
In a combined embryo-fetal development and pre- and post-natal development toxicity study, pregnant cynomolgus monkeys were administered subcutaneous doses of ustekinumab twice weekly up to 45 times the MRHD (on a mg/kg basis at a maternal dose of 45 mg/kg) from the beginning of organogenesis to Day 33 after delivery. Neonatal deaths occurred in the offspring of one monkey administered ustekinumab at 22.5 mg/kg and one monkey dosed at 45 mg/kg. No ustekinumab-related effects on functional, morphological, or immunological development were observed in the neonates from birth through six months of age.
Caution should be exercised when STELARA® is administered to a nursing woman. The unknown risks to the infant from gastrointestinal or systemic exposure to ustekinumab should be weighed against the known benefits of breast-feeding. Ustekinumab is excreted in the milk of lactating monkeys administered ustekinumab. IgG is excreted in human milk, so it is expected that STELARA® will be present in human milk. It is not known if ustekinumab is absorbed systemically after ingestion; however, published data suggest that antibodies in breast milk do not enter the neonatal and infant circulation in substantial amounts.
Safety and effectiveness of STELARA® in pediatric patients have not been evaluated.
Of the 4031 subjects exposed to STELARA®, a total of 248 were 65 years or older (183 patients with psoriasis and 65 patients with psoriatic arthritis), and 29 subjects were 75 years or older. Although no differences in safety or efficacy were observed between older and younger subjects, the number of subjects aged 65 and over is not sufficient to determine whether they respond differently from younger subjects.
Single doses up to 6 mg/kg intravenously have been administered in clinical studies without dose-limiting toxicity. In case of overdosage, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions or effects and appropriate symptomatic treatment be instituted immediately.
STELARA® is a human IgG1κ monoclonal antibody against the p40 subunit of the IL-12 and IL-23 cytokines. Using DNA recombinant technology, STELARA® is produced in a well characterized recombinant cell line and is purified using standard bio-processing technology. The manufacturing process contains steps for the clearance of viruses. STELARA® is comprised of 1326 amino acids and has an estimated molecular mass that ranges from 148,079 to 149,690 Daltons.
STELARA®, for subcutaneous use, is available as: 45 mg of ustekinumab in 0.5 mL and 90 mg of ustekinumab in 1 mL. STELARA® is supplied as a sterile solution in a single-use prefilled syringe with a 27 gauge fixed ½ inch needle, or a single-use 2 mL Type I glass vial with a coated stopper. The syringe is fitted with a passive needle guard and a needle cover that is manufactured using a dry natural rubber (a derivative of latex).
Each 45 mg ustekinumab prefilled syringe also contains: L-histidine and L-histidine monohydrochloride monohydrate (0.5 mg), Polysorbate 80 (0.02 mg), and sucrose (38 mg) to fill to a final volume of 0.5 mL.
Each 90 mg ustekinumab prefilled syringe also contains: L-histidine and L-histidine monohydrochloride monohydrate (1 mg), Polysorbate 80 (0.04 mg), and sucrose (76 mg) to fill to a final volume of 1 mL.
Each 45 mg ustekinumab vial also contains: L-histidine and L-histidine monohydrochloride monohydrate (0.5 mg), Polysorbate 80 (0.02 mg), and sucrose (38 mg) to fill to a final volume of 0.5 mL.
Each 90 mg ustekinumab vial also contains: L-histidine and L-histidine monohydrochloride monohydrate (1 mg), Polysorbate 80 (0.04 mg), and sucrose (76 mg) to fill to a final volume of 1 mL.
The STELARA® solution is colorless to slightly yellow in appearance and has a pH of 5.7–6.3. STELARA® does not contain preservatives.
Ustekinumab is a human IgG1κ monoclonal antibody that binds with specificity to the p40 protein subunit used by both the IL-12 and IL-23 cytokines. IL-12 and IL-23 are naturally occurring cytokines that are involved in inflammatory and immune responses, such as natural killer cell activation and CD4+ T-cell differentiation and activation. In in vitro models, ustekinumab was shown to disrupt IL-12 and IL-23 mediated signaling and cytokine cascades by disrupting the interaction of these cytokines with a shared cell-surface receptor chain, IL-12Rβ1.
In a small exploratory study, a decrease was observed in the expression of mRNA of its molecular targets IL-12 and IL-23 in lesional skin biopsies measured at baseline and up to two weeks post-treatment in subjects with psoriasis.
In subjects with psoriasis, the median time to reach the maximum serum concentration (Tmax) was 13.5 days and 7 days, respectively, after a single subcutaneous administration of 45 mg (N=22) and 90 mg (N=24) of ustekinumab. In healthy subjects (N=30), the median Tmax value (8.5 days) following a single subcutaneous administration of 90 mg of ustekinumab was comparable to that observed in subjects with psoriasis. Following multiple subcutaneous doses of STELARA®, the steady-state serum concentrations of ustekinumab were achieved by Week 28. The mean (±SD) steady-state trough serum concentration ranged from 0.31 ± 0.33 mcg/mL (45 mg) to 0.64 ± 0.64 mcg/mL (90 mg). There was no apparent accumulation in serum ustekinumab concentration over time when given subcutaneously every 12 weeks.
Following subcutaneous administration of 45 mg (N=18) and 90 mg (N=21) of ustekinumab to subjects with psoriasis, the mean (±SD) apparent volume of distribution during the terminal phase (Vz/F) was 161 ± 65 mL/kg and 179 ± 85 mL/kg, respectively. The mean (±SD) volume of distribution during the terminal phase (Vz) following a single intravenous administration to subjects with psoriasis ranged from 56.1 ± 6.5 to 82.1 ± 23.6 mL/kg.
The metabolic pathway of ustekinumab has not been characterized. As a human IgG1κ monoclonal antibody ustekinumab is expected to be degraded into small peptides and amino acids via catabolic pathways in the same manner as endogenous IgG.
The mean (±SD) systemic clearance (CL) following a single intravenous administration of ustekinumab to subjects with psoriasis ranged from 1.90 ± 0.28 to 2.22 ± 0.63 mL/day/kg. The mean (±SD) half-life ranged from 14.9 ± 4.6 to 45.6 ± 80.2 days across all psoriasis studies following intravenous and subcutaneous administration.
When given the same dose, subjects with psoriasis or psoriatic arthritis weighing >100 kg had lower median serum ustekinumab concentrations compared with those subjects weighing ≤100 kg. The median trough serum concentrations of ustekinumab in subjects of higher weight (>100 kg) in the 90 mg group were comparable to those in subjects of lower weight (≤100 kg) in the 45 mg group.
Hepatic and Renal Impairment
No pharmacokinetic data are available in patients with hepatic or renal impairment.
A population pharmacokinetic analysis (N=106/1937 subjects greater than or equal to 65 years old) was performed to evaluate the effect of age on the pharmacokinetics of ustekinumab. There were no apparent changes in pharmacokinetic parameters (clearance and volume of distribution) in subjects older than 65 years old.
Drug-Drug Interactions
The effects of IL-12 or IL-23 on the regulation of CYP450 enzymes were evaluated in an in vitro study using human hepatocytes, which showed that IL-12 and/or IL-23 at levels of 10 ng/mL did not alter human CYP450 enzyme activities (CYP1A2, 2B6, 2C9, 2C19, 2D6, or 3A4). However, the clinical relevance of in vitro data has not been established [see Drug Interactions (7.3)].
Population pharmacokinetic data analyses indicated that the clearance of ustekinumab was not impacted by concomitant MTX, NSAIDs, and oral corticosteroids, or prior exposure to anti-TNFα agents in patients with psoriatic arthritis.
Animal studies have not been conducted to evaluate the carcinogenic or mutagenic potential of STELARA®. Published literature showed that administration of murine IL-12 caused an anti-tumor effect in mice that contained transplanted tumors and IL-12/IL-23p40 knockout mice or mice treated with anti-IL-12/IL-23p40 antibody had decreased host defense to tumors. Mice genetically manipulated to be deficient in both IL-12 and IL-23 or IL-12 alone developed UV-induced skin cancers earlier and more frequently compared to wild-type mice. The relevance of these experimental findings in mouse models for malignancy risk in humans is unknown.
No effects on fertility were observed in male cynomolgus monkeys that were administered ustekinumab at subcutaneous doses up to 45 mg/kg twice weekly (45 times the MRHD on a mg/kg basis) prior to and during the mating period. However, fertility and pregnancy outcomes were not evaluated in mated females.
No effects on fertility were observed in female mice that were administered an analogous IL-12/IL-23p40 antibody by subcutaneous administration at doses up to 50 mg/kg, twice weekly, prior to and during early pregnancy.
Two multicenter, randomized, double-blind, placebo-controlled studies (Ps STUDY 1 and Ps STUDY 2) enrolled a total of 1996 subjects 18 years of age and older with plaque psoriasis who had a minimum body surface area involvement of 10%, and Psoriasis Area and Severity Index (PASI) score ≥12, and who were candidates for phototherapy or systemic therapy. Subjects with guttate, erythrodermic, or pustular psoriasis were excluded from the studies.
Ps STUDY 1 enrolled 766 subjects and Ps STUDY 2 enrolled 1230 subjects. The studies had the same design through Week 28. In both studies, subjects were randomized in equal proportion to placebo, 45 mg or 90 mg of STELARA®. Subjects randomized to STELARA® received 45 mg or 90 mg doses, regardless of weight, at Weeks 0, 4, and 16. Subjects randomized to receive placebo at Weeks 0 and 4 crossed over to receive STELARA® (either 45 mg or 90 mg) at Weeks 12 and 16.
In both studies, the endpoints were the proportion of subjects who achieved at least a 75% reduction in PASI score (PASI 75) from baseline to Week 12 and treatment success (cleared or minimal) on the Physician's Global Assessment (PGA). The PGA is a 6-category scale ranging from 0 (cleared) to 5 (severe) that indicates the physician's overall assessment of psoriasis focusing on plaque thickness/induration, erythema, and scaling.
In both studies, subjects in all treatment groups had a median baseline PASI score ranging from approximately 17 to 18. Baseline PGA score was marked or severe in 44% of subjects in Ps STUDY 1 and 40% of subjects in Ps STUDY 2. Approximately two-thirds of all subjects had received prior phototherapy, 69% had received either prior conventional systemic or biologic therapy for the treatment of psoriasis, with 56% receiving prior conventional systemic therapy and 43% receiving prior biologic therapy. A total of 28% of study subjects had a history of psoriatic arthritis.
Clinical Response
The results of Ps STUDY 1 and Ps STUDY 2 are presented in Table 2 below.
Week 12 | Ps STUDY 1 | Ps STUDY 2 | ||||
Placebo | 45 mg | 90 mg | Placebo | 45 mg | 90 mg | |
Subjects randomized | 255 | 255 | 256 | 410 | 409 | 411 |
PASI 75 response | 8 (3%) | 171 (67%) | 170 (66%) | 15 (4%) | 273 (67%) | 311 (76%) |
PGA of Cleared or Minimal | 10 (4%) | 151 (59%) | 156 (61%) | 18 (4%) | 277 (68%) | 300 (73%) |
Examination of age, gender, and race subgroups did not identify differences in response to STELARA® among these subgroups.
In subjects who weighed ≤100 kg, response rates were similar with both the 45 mg and 90 mg doses; however, in subjects who weighed >100 kg, higher response rates were seen with 90 mg dosing compared with 45 mg dosing (Table 3 below).
Ps STUDY 1 | Ps STUDY 2 | |||||
Placebo | 45 mg | 90 mg | Placebo | 45 mg | 90 mg | |
Subjects randomized | 255 | 255 | 256 | 410 | 409 | 411 |
PASI 75 response at Week 12* | ||||||
≤100 kg | 4% | 74% | 65% | 4% | 73% | 78% |
6/166 | 124/168 | 107/164 | 12/290 | 218/297 | 225/289 | |
>100 kg | 2% | 54% | 68% | 3% | 49% | 71% |
2/89 | 47/87 | 63/92 | 3/120 | 55/112 | 86/121 | |
PGA of Cleared or Minimal at Week 12* | ||||||
≤100 kg | 4% | 64% | 63% | 5% | 74% | 75% |
7/166 | 108/168 | 103/164 | 14/290 | 220/297 | 216/289 | |
>100 kg | 3% | 49% | 58% | 3% | 51% | 69% |
3/89 | 43/87 | 53/92 | 4/120 | 57/112 | 84/121 |
Subjects in Ps STUDY 1 who were PASI 75 responders at both Weeks 28 and 40 were re-randomized at Week 40 to either continued dosing of STELARA® (STELARA® at Week 40) or to withdrawal of therapy (placebo at Week 40). At Week 52, 89% (144/162) of subjects re-randomized to STELARA® treatment were PASI 75 responders compared with 63% (100/159) of subjects re-randomized to placebo (treatment withdrawal after Week 28 dose). The median time to loss of PASI 75 response among the subjects randomized to treatment withdrawal was 16 weeks.
The safety and efficacy of STELARA® was assessed in 927 patients (PsA STUDY 1, n=615; PsA STUDY 2, n=312), in two randomized, double-blind, placebo-controlled studies in adult patients 18 years of age and older with active PsA (≥5 swollen joints and ≥5 tender joints) despite non-steroidal anti-inflammatory (NSAID) or disease modifying antirheumatic (DMARD) therapy. Patients in these studies had a diagnosis of PsA for at least 6 months. Patients with each subtype of PsA were enrolled, including polyarticular arthritis with the absence of rheumatoid nodules (39%), spondylitis with peripheral arthritis (28%), asymmetric peripheral arthritis (21%), distal interphalangeal involvement (12%) and arthritis mutilans (0.5%). Over 70% and 40% of the patients, respectively, had enthesitis and dactylitis at baseline.
Patients were randomized to receive treatment with STELARA® 45 mg, 90 mg, or placebo subcutaneously at Weeks 0 and 4 followed by every 12 weeks (q12w) dosing. Approximately 50% of patients continued on stable doses of MTX (≤25 mg/week). The primary endpoint was the percentage of patients achieving ACR 20 response at Week 24.
In PsA STUDY 1 and PsA STUDY 2, 80% and 86% of the patients, respectively, had been previously treated with DMARDs. In PsA STUDY 1, previous treatment with anti-tumor necrosis factor (TNF)-α agent was not allowed. In PsA STUDY 2, 58% (n=180) of the patients had been previously treated with an anti-TNFα agent, of whom over 70% had discontinued their anti-TNFα treatment for lack of efficacy or intolerance at any time.
Clinical Response
In both studies, a greater proportion of patients achieved ACR 20, ACR 50 and PASI 75 response in the STELARA® 45 mg and 90 mg groups compared to placebo at Week 24 (see Table 4). ACR 70 responses were also higher in the STELARA® 45 mg and 90 mg groups, although the difference was only numerical (p=NS) in Study 2. Responses were similar in patients regardless of prior TNFα exposure.
PsA STUDY 1 | PsA STUDY 2 | |||||
Placebo | 45 mg | 90 mg | Placebo | 45 mg | 90 mg | |
Number of patients randomized | 206 | 205 | 204 | 104 | 103 | 105 |
ACR 20 response, N (%) | 47 (23%) | 87 (42%) | 101 (50%) | 21 (20%) | 45 (44%) | 46 (44%) |
ACR 50 response, N (%) | 18 (9%) | 51 (25%) | 57 (28%) | 7 (7%) | 18 (17%) | 24 (23%) |
ACR 70 response, N (%) | 5 (2%) | 25 (12%) | 29 (14%) | 3 (3%) | 7 (7%) | 9 (9%) |
Number of patients with ≥ 3% BSA* | 146 | 145 | 149 | 80 | 80 | 81 |
PASI 75 response, N (%) | 16 (11%) | 83 (57%) | 93 (62%) | 4 (5%) | 41 (51%) | 45 (56%) |
The percent of patients achieving ACR 20 responses by visit is shown in Figure 1.
Figure 1: Percent of patients achieving ACR 20 response through Week 24
PsA STUDY 1 |
The results of the components of the ACR response criteria are shown in Table 5.
PsA STUDY 1 | |||
Placebo (N=206) |
45 mg (N= 205) |
90 mg (N= 204) |
Number of swollen joints* | |||
Baseline | 15 | 12 | 13 |
Mean Change at Week 24 | -3 | -5 | -6 |
Number of tender joints † | |||
Baseline | 25 | 22 | 23 |
Mean Change at Week 24 | -4 | -8 | -9 |
Patient's assessment of pain‡ | |||
Baseline | 6.1 | 6.2 | 6.6 |
Mean Change at Week 24 | -0.5 | -2.0 | -2.6 |
Patient global assessment‡ | |||
Baseline | 6.1 | 6.3 | 6.4 |
Mean Change at Week 24 | -0.5 | -2.0 | -2.5 |
Physician global assessment‡ | |||
Baseline | 5.8 | 5.7 | 6.1 |
Mean Change at Week 24 | -1.4 | -2.6 | -3.1 |
Disability index (HAQ)§ | |||
Baseline | 1.2 | 1.2 | 1.2 |
Mean Change at Week 24 | -0.1 | -0.3 | -0.4 |
CRP (mg/dL)¶ | |||
Baseline | 1.6 | 1.7 | 1.8 |
Mean Change at Week 24 | 0.01 | -0.5 | -0.8 |
An improvement in enthesitis and dactylitis scores was observed in each STELARA® group compared with placebo at Week 24.
Physical Function
STELARA® treated patients showed improvement in physical function compared to patients treated with placebo as assessed by HAQ-DI at Week 24. In both studies, the proportion of HAQ-DI responders (≥0.3 improvement in HAQ-DI score) was greater in the STELARA® 45 mg and 90 mg groups compared to placebo at Week 24.
STELARA® does not contain preservatives. STELARA® is available in single-use prefilled syringes or single-use vials containing 45 mg or 90 mg of ustekinumab. Each prefilled syringe is equipped with a needle safety guard.
The NDC number for the 45 mg prefilled syringe is 57894-060-03.
The NDC number for the 90 mg prefilled syringe is 57894-061-03.
The NDC number for the 45 mg vial is 57894-060-02.
The NDC number for the 90 mg vial is 57894-061-02.
Storage and Stability
STELARA® vials and prefilled syringes must be refrigerated at 2ºC to 8ºC (36ºF to 46ºF). Store STELARA® vials upright. Keep the product in the original carton to protect from light until the time of use. Do not freeze. Do not shake. STELARA® does not contain a preservative; discard any unused portion.
See FDA-approved patient labeling (Medication Guide and Instructions for Use)
Instruct patients to read the Medication Guide before starting STELARA® therapy and to reread the Medication Guide each time the prescription is renewed.
Inform patients that STELARA® may lower the ability of their immune system to fight infections. Instruct patients of the importance of communicating any history of infections to the doctor, and contacting their doctor if they develop any symptoms of infection.
Allergic Reactions
Advise patients to seek immediate medical attention if they experience any symptoms of serious allergic reactions.
The first self-injection should be performed under the supervision of a qualified healthcare professional. If a patient or caregiver is to administer STELARA®, he/she should be instructed in injection techniques and their ability to inject subcutaneously should be assessed to ensure the proper administration of STELARA® [see Medication Guide and Instructions for Use].
Patients should be instructed to inject the full amount of STELARA® according to the directions provided in the Medication Guide and Instructions for Use. The needle cover on the prefilled syringe contains dry natural rubber (a derivative of latex), which may cause allergic reactions in individuals sensitive to latex.
Needles and syringes should be disposed of in a puncture-resistant container. Patients or caregivers should be instructed in the technique of proper syringe and needle disposal, and be advised not to reuse these items.
Prefilled Syringe Manufactured by: Janssen Biotech, Inc., Horsham, PA 19044, US License No. 1864 at Baxter Pharmaceutical Solutions, Bloomington, IN 47403 and at Cilag AG, Schaffhausen, Switzerland
Vial Manufactured by: Janssen Biotech, Inc., Horsham, PA 19044, US License No. 1864 at Cilag AG, Schaffhausen, Switzerland
© Janssen Biotech, Inc. 2012
STELARA® (stel ar' a)
What is the most important information I should know about STELARA®?
STELARA® is a medicine that affects your immune system. STELARA® can increase your risk of having serious side effects, including:
Serious infections: STELARA® may lower the ability of your immune system to fight infections and may increase your risk of infections. Some people have serious infections while taking STELARA®, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses. Some people have to be hospitalized for treatment of their infection.
You should not start taking STELARA® if you have any kind of infection unless your doctor says it is okay.
Before starting STELARA®, tell your doctor if you think you have an infection or have symptoms of an infection such as:
After starting STELARA®, call your doctor right away if you have any symptoms of an infection (see above).
STELARA® can make you more likely to get infections or make an infection that you have worse.
People who have a genetic problem where the body does not make any of the proteins interleukin 12 (IL-12) and interleukin 23 (IL-23) are at a higher risk for certain serious infections. These infections can spread throughout the body and cause death. It is not known if people who take STELARA® will get any of these infections, because of the effects of STELARA® on these proteins in your body.
STELARA® may decrease the activity of your immune system and increase your risk for certain types of cancers. Tell your doctor if you have ever had any type of cancer. Some people who are receiving STELARA® and have risk factors for skin cancer have developed certain types of skin cancers. During your treatment with STELARA®, tell your doctor if you develop any new skin growths.
Reversible Posterior Leukoencephalopathy Syndrome (RPLS):
RPLS is a rare condition that affects the brain and can cause death. The cause of RPLS is not known. If RPLS is found early and treated, most people recover. Tell your doctor right away if you have any new or worsening medical problems including:
What is STELARA®?
STELARA® is a prescription medicine used to treat adults 18 years and older with:
STELARA® may improve your psoriasis and psoriatic arthritis but may also lower the ability of your immune system to fight infections. This may also increase your risk for certain types of cancer.
It is not known if STELARA® is safe and effective in children.
Who should not take STELARA®?
Do not take STELARA® if you are allergic to ustekinumab or any of the ingredients in STELARA®. See the end of this Medication Guide for a complete list of ingredients in STELARA®.
What should I tell my doctor before receiving STELARA®?
Before you receive STELARA®, tell your doctor if you:
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.
How should I use STELARA®?
What should I avoid while using STELARA®?
You should not receive a live vaccine while taking STELARA®. See "What should I tell my doctor before receiving STELARA®?"
What are the possible side effects of STELARA®?
STELARA® may cause serious side effects, including:
Common side effects of STELARA® include:
These are not all of the possible side effects of STELARA®. Tell your doctor about any side effect that bothers you or that does not go away. For more information, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
You may also report side effects to Janssen Biotech, Inc. at 1-800-JANSSEN (1-800-526-7736).
How do I store STELARA®?
Keep STELARA® and all medicines out of the reach of children.
General information about STELARA®
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use STELARA® for a condition for which it was not prescribed. Do not give STELARA® to other people, even if they have the same symptoms that you have. It may harm them.
If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about STELARA® that was written for health professionals.
What are the ingredients in STELARA®?
Active ingredient: ustekinumab
Inactive ingredients: L-histidine, L-histidine monohydrochloride monohydrate, polysorbate 80, and sucrose.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Prefilled Syringe Manufactured by: Janssen Biotech, Inc., Horsham, PA 19044, US License No. 1864 at Baxter Pharmaceutical Solutions, Bloomington, IN 47403 and at Cilag AG, Schaffhausen, Switzerland
Vial Manufactured by: Janssen Biotech, Inc., Horsham, PA 19044, US License No. 1864 at Cilag AG, Schaffhausen, Switzerland
Revised 03/2014
© Janssen Biotech, Inc. 2012
STELARA® (stel ar' a)
Instructions for injecting STELARA® using a prefilled syringe.
Read this Instructions for Use before you start using STELARA®. Your doctor or nurse should show you how to prepare and give your injection of STELARA® the right way.
If you cannot give yourself the injection:
Do not try to inject STELARA® yourself until you have been shown how to inject STELARA® by your doctor, nurse or health professional.
Important information:
Gather the supplies you will need to prepare and to give your injection. (See Figure A)
You will need:
Step 1: Prepare the injection.
Step 2: Prepare your injection site
*Areas in gray are recommended injection sites.
Step 3: Inject STELARA®
Step 4: Dispose of the syringe.
Keep STELARA® and all medicines out of the reach of children.
Prefilled Syringe Manufactured by:
Janssen Biotech, Inc., Horsham, PA 19044, US License No. 1864 at Baxter Pharmaceutical Solutions, Bloomington, IN 47403
Issued 05/2013
© Janssen Biotech, Inc. 2012
STELARA® (stel ar' a)
Instructions for injecting STELARA® from a vial.
Read this Instructions for Use before you start using STELARA®. Your doctor or nurse should show you how to prepare, measure your dose, and give your injection of STELARA® the right way.
If you cannot give yourself the injection:
Do not try to inject STELARA® yourself until you have been shown how to inject STELARA® by your doctor, nurse or health professional.
Important information:
Gather the supplies you will need to prepare STELARA® and to give your injection. (See Figure A)
You will need:
Step 1: Prepare the injection.
Step 2: Prepare your injection site
*Areas in gray are recommended injection sites.
Step 3: Prepare the vial.
Step4: Prepare the needle
Step 5: Inject STELARA®
If your dose is 90 mg, and you received two 45 mg vials you will need to give a second injection right after the first. Repeat Steps 1–5 using a new syringe. Choose a different site for the second injection.
Step 6: Dispose of the needles and syringes.
Keep STELARA® and all medicines out of the reach of children.
Vial Manufactured by: Janssen Biotech, Inc., Horsham, PA 19044, US License No. 1864 at Cilag AG, Schaffhausen, Switzerland
Issued 05/2013
© Janssen Biotech, Inc. 2012
PRINCIPAL DISPLAY PANEL - 45 mg/0.5 mL Vial Carton
Single use vial–
Discard unused portion
45 mg/0.5 mL
For subcutaneous use
Each vial contains 0.5 mL
Information for use and dosage–
See package insert
Rx only
ATTENTION: Dispense the enclosed
Medication Guide to each patient.
PRINCIPAL DISPLAY PANEL - 90 mg/mL Syringe Carton
90 mg/mL
For subcutaneous use
Contains one 90 mg/mL syringe
Single dose prefilled syringe –
Discard unused portion
See package insert for dosing information
Rx only
ATTENTION: Dispense the enclosed Medication Guide
to each patient.
STELARA ustekinumab injection, solution |
STELARA ustekinumab injection, solution |
Labeler - Janssen Biotech, Inc. (099091753) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
Gallus BioPharmaceuticals, LLC | 965750420 | API MANUFACTURE(57894-060, 57894-061) , ANALYSIS(57894-060, 57894-061) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
Cilag AG | 483237103 | MANUFACTURE(57894-060, 57894-061) , ANALYSIS(57894-060, 57894-061) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
Janssen Biologics, B.V. | 409612918 | ANALYSIS(57894-060, 57894-061) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
Baxter Pharmaceutical Solutions | 604719430 | MANUFACTURE(57894-060, 57894-061) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
Janssen Biologics (Ireland) | 987061921 | API MANUFACTURE(57894-060, 57894-061) , ANALYSIS(57894-060, 57894-061) |