Navigation Links
CSL Behring Announces FDA Approval of Berinert(R), First and Only Therapy Approved for the Treatment of Acute Abdominal and Facial Attacks of Hereditary Angioedema in U.S.
Date:10/12/2009

in. Without C1-INH, patients with HAE suffer from recurrent episodes of rapid swelling of areas of the skin and underlying tissues including the face, mouth and abdomen. Berinert( )is a unique HAE therapy because of its reliable record of proven efficacy and safety in international clinical use in over 400,000 treatments in Germany, Austria, Switzerland, and several other countries where it is manufactured and sold by CSL Behring under the trade name Berinert® P.

Important Safety Information

Berinert is a plasma derived concentrate of C1 Esterase Inhibitor (Human), indicated for the treatment of acute abdominal or facial attacks of hereditary angioedema (HAE) in adult and adolescent patients.

The safety and efficacy of Berinert for prophylactic therapy have not been established. Berinert is contraindicated in individuals who have had an anaphylactic or severe systemic reaction to C1-INH preparations. Monitor patients for early signs of allergic or hypersensitivity reactions (including hives, generalized urticaria, chest tightness, wheezing, hypotension, and anaphylaxis). If hypersensitivity is suspected, immediately discontinue administration and initiate appropriate treatment. Epinephrine should be immediately available for treatment of acute severe hypersensitivity reactions.

Thrombotic events have occurred in patients receiving off-label high doses of Berinert. Monitor patients with known risk factors for thrombotic events.

Berinert is derived from human plasma. The risk of transmission of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent, cannot be completely eliminated.

The most serious adverse reaction reported in subjects in clinical studies who received Berinert is an increase in the severity of pain associated with HAE. The most common adverse reactions observed in more than 4 percent of subjects after Berinert treatment wer
'/>"/>

SOURCE CSL Behring
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3 4 5

Related medicine technology :

1. CSL Behring Receives Orphan-Drug Exclusivity for RiaSTAP(TM), First and Only Approved Treatment of Acute Bleeding Episodes in Patients with Congenital Fibrinogen Deficiency
2. Over $10 Million of CSL Behrings Privigen Was Sold in the U.S. During the Third Quarter of 2008
3. CSL Behring Submits BLA Requesting Approval of C1-Esterase Inhibitor for the Treatment of Hereditary Angioedema
4. CSL Behring Study in Animal Models Shows Feasibility of Developing a Half-Life Extended Recombinant FVIIa that Retains Biologic Activity
5. CSL Behring Reaches Primary Endpoint in Clinical Study of C1-INH for Treatment of Hereditary Angioedema
6. Child Neurology Foundation Announces the Launch of Infantilespasmsinfo.org
7. Elbit Imaging Ltd. Announces Sale of Plaza Centers Shares
8. Onyx Pharmaceuticals Announces Investor Teleconference and Webcast
9. Kensey Nash Corporation Announces Its First Quarter Fiscal Year 2010 Earnings Release Date and Teleconference
10. ADVENTRX Pharmaceuticals Announces Closing of Financing
11. Stereotaxis Announces Pricing of $26 Million Common Stock Offering
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/27/2015)... , August 27, 2015 According to ... (Transfer, Hammock, Toilet, Seating, Universal, Standing, Bariatric ), Material (Nylon, Padded, ... Forecast to 2020", published by MarketsandMarkets, the Medical Lifting Sling Market ... 411.5 Million in 2015, at a CAGR of 11.4 % from ... ma rket data T ables and ...
(Date:8/27/2015)... Ga. , Aug. 27, 2015  MiMedx Group, ... medicine company utilizing human amniotic tissue and patent-protected ... therapies for the Wound Care, Surgical, Orthopedic, Spine, ... responded today and corrected the multiple inaccuracies in ... Foundation ("MTF") regarding the recent rulings from the ...
(Date:8/27/2015)... August 27, 2015 According to ... by Type (Integrated, Standalone), by Deployment Mode (Web based, ... Emergency Healthcare Service Providers), by Component - Global Trends ... Market is estimated at $501.1 Million 2014, and is ... CAGR of 7.6% from 2014 to 2019. ...
Breaking Medicine Technology:Medical Lifting Sling Market Worth USD 706.0 Million by 2020 2Medical Lifting Sling Market Worth USD 706.0 Million by 2020 3Medical Lifting Sling Market Worth USD 706.0 Million by 2020 4MiMedx Corrects Inaccuracies In MTF Press Release Regarding The Recent Rulings From The Patent Trial And Appeal Board 2MiMedx Corrects Inaccuracies In MTF Press Release Regarding The Recent Rulings From The Patent Trial And Appeal Board 3MiMedx Corrects Inaccuracies In MTF Press Release Regarding The Recent Rulings From The Patent Trial And Appeal Board 4Radiology Information Systems Market Worth $722.7 Million by 2019 2Radiology Information Systems Market Worth $722.7 Million by 2019 3Radiology Information Systems Market Worth $722.7 Million by 2019 4
... PRXL ) announced today it will be presenting ... von Rickenbach, Chairman and Chief Executive Officer will be making ... January 13, 2011. A live webcast of this ... of PAREXEL,s website at www.PAREXEL.com in the Upcoming ...
... Pharmaceuticals, Inc. (Nasdaq: AMLN ) will be presenting ... Francisco on Monday, January 10, 2011 at 4:30 p.m. ET ... and chief executive officer of Amylin Pharmaceuticals, will provide a ... be webcast through the "Investors" section of Amylin,s corporate website ...
Cached Medicine Technology:PAREXEL International to Present at J.P. Morgan Healthcare Conference 2
(Date:8/27/2015)... (PRWEB) , ... August 27, ... ... Black Swan Analysis signed a partnership agreement for quality market research promotion ... reports elaborated by Black Swan Analysis. , Commenting on the partnership agreement, ...
(Date:8/27/2015)... (PRWEB) , ... August 27, 2015 , ... Susan ... edge procedure to relieve vaginal discomfort due to pre- and post-menopause, chemotherapy, and child ... a CO2 laser, which delivers controlled energy to the vaginal tissue, revitalizing cells so ...
(Date:8/27/2015)... (PRWEB) , ... August 27, 2015 , ... Sunbelt® Bakery, ... high fructose corn syrup, is changing the expectation of how protein bars should taste ... indulgent taste unlike any other protein bar on the market today. , The ...
(Date:8/27/2015)... CT (PRWEB) , ... August 27, 2015 , ... ... List. , “The companies selected have the platforms required not only to effectively deliver, ... Ken Taylor, President of Training Industry, Inc. , For six consecutive years, NetDimensions ...
(Date:8/27/2015)... ... 27, 2015 , ... Healthpointe clinics are now offering Executive ... Orange County. , Designed to accommodate the busy lifestyles and work schedules ... its locations. Executive Physicals are scheduled so that busy professionals wait very ...
Breaking Medicine News(10 mins):Health News:Market Publishers Ltd and Black Swan Analysis Sign Partnership Agreement 2Health News:Market Publishers Ltd and Black Swan Analysis Sign Partnership Agreement 3Health News:LifeStream Health Centre & MedSpa Announces New Treatment for Vaginal Discomfort 2Health News:LifeStream Health Centre & MedSpa Announces New Treatment for Vaginal Discomfort 3Health News:Sunbelt® Bakery Changes the Expectations of How Protein Bars Should Taste with the Introduction of Its New Protein Delights 2Health News:Sunbelt® Bakery Changes the Expectations of How Protein Bars Should Taste with the Introduction of Its New Protein Delights 3Health News:NetDimensions Named Among Top 20 Learning Portal Companies of 2015 2Health News:NetDimensions Named Among Top 20 Learning Portal Companies of 2015 3Health News:Healthpointe Now Offering Executive Physicals 2
... As controversy swirls about proper clinical use of opioids and ... Society annual meeting shows that, contrary to widespread beliefs, less ... abuse who are prescribed opioids for chronic pain will show ... , In his plenary session address, Srinivasa Raja, MD, ...
... $20,000 Nationwide Scholarship, Competition with Celebrity Spokesperson Megyn Price of the ... ... YORK, May 9 The Tea Council of the USA,Inc. announced ... competition awarding one creative student $20,000,towards their education, in an effort ...
... Emilio and Gloria Estefan at the event to ... benefit ... Valeria Gastaldi, MIAMI, May 9 St. Jude Children,s Research Hospital(R),the ... Jude Angels & Stars Gala on Saturday,May 17, at the Adrienne Arsht ...
... Oceana, an international,ocean conservation group based in Washington, D.C., ... Consuming big fish high on,the food chain is the ... heavy,metal that can cause neurological and other health problems., ... Amber Valletta,offers a few tips for keeping your family ...
... JOSE, Calif., May 9 VNUS(R) Medical,Technologies, Inc. today ... to allow a second continuation patent application related to,the ... of,endovenous laser products. This comes on the heels of ... separate patent application, also filed,as a continuation of one ...
... the lives of 30% of infected patients in U.K., ... British research into Steno, one the most recent ... an incredible ability to resist antibiotics and other drugs, ... Stenotrophomonas maltophilia , thrives in moist environments, such ...
Cached Medicine News:Health News:Risks for painkiller abuse do not outweigh benefits in chronic pain 2Health News:Drink Tea. Win $20,000. Experience the 'Calm-A-Sutra of Tea' 2Health News:Drink Tea. Win $20,000. Experience the 'Calm-A-Sutra of Tea' 3Health News:Miami Rolls Out the Red Carpet for Latin Star Studded FedEx/St. Jude Gala 2Health News:Miami Rolls Out the Red Carpet for Latin Star Studded FedEx/St. Jude Gala 3Health News:Amber Valletta on Preventing Mercury Exposure 2Health News:Amber Valletta on Preventing Mercury Exposure 3Health News:U.S. Patent Office Allows Another Significant VNUS Patent 2Health News:U.S. Patent Office Allows Another Significant VNUS Patent 3Health News:Steno 'Superbug' Genome Shows Extreme Drug Resistance 2
The balloon catheter is designed to pass over a previously placed .015 inch diameter wire guide included. Supplied sterile in peel-open packages. Intended for one-time use....
Radiopaque markers are placed at the proximal and distal ends of the balloon. A special pin vise handle is included to stabilize the wire guide during introduction. Supplied sterile in peel-open pack...
Radiopaque markers are placed at the proximal and distal ends of the balloon. A special pin vise handle is included to stabilize the wire guide during introduction. Supplied sterile in peel-open pack...
... Technologies, The UroMax Ultra ia designed ... high pressure and low profile., Refolding ... a remarkably strong material that is ... materials., Non-Compliant Balloons, A compliant balloon ...
Medicine Products: