Navigation Links
Talecris Biotherapeutics Receives FDA Approval for Gamunex®-C
Date:10/14/2010

er infusion of IgG, the transitory rise of the various passively transferred antibodies in the patient's blood may yield positive serological testing results, with the potential for misleading interpretation.

In clinical studies, the most common adverse reactions with Gamunex-C were headache, fever, chills, hypertension, rash, nausea, and asthenia (in CIDP); headache, cough, injection site reaction, nausea, pharyngitis, and urticaria with intravenous use (in PI) and infusion site reactions, headache, fatigue, arthralgia and pyrexia with subcutaneous use (in PI); and headache, vomiting, fever, nausea, back pain, and rash (in ITP).  

The most serious adverse reactions in clinical studies were pulmonary embolism (PE) in one subject with a history of PE (in CIDP), an exacerbation of autoimmune pure red cell aplasia in one subject (in PI), and myocarditis in one subject that occurred 50 days post-study drug infusion and was not considered drug related (in ITP).

Due to a potential risk of hematoma formation, Gamunex-C should not be administered subcutaneously in patients with ITP.  Subcutaneous administration of Gamunex-C in patients with ITP has not been studied.

You are encouraged to report negative side effects of prescription drugs to the FDA.  Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

For additional information about Gamunex, please see www.gamunex.com for Full Prescribing Information.  The package insert is currently being revised to incorporate information regarding subcutaneous administration for treatment of primary immunodeficiency.

Cautionary statement regarding forward-looking statements

This press release contains forward-looking statements within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements include, but are no
'/>"/>

SOURCE Talecris Biotherapeutics, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4 5

Related medicine technology :

1. Talecris Biotherapeutics to Report Third Quarter 2010 Financial Results
2. Talecris Biotherapeutics CEO Accepts 2010 Ernst & Young Entrepreneur Of The Year Award on Behalf of Employees and Patients
3. Talecris Forms Partnership to Co-Promote Life-Saving Rabies Products
4. Talecris Biotherapeutics Receives FDA Approval for PROLASTIN(R)-C
5. Garnet BioTherapeutics Announces First Patient Treated in Trial of New Therapy for Improvement in Scar Appearance
6. NASDAQ Trading for Oxygen Biotherapeutics, Inc. Shares to Begin January 15, 2010
7. Oxygen Biotherapeutics, Inc. Announces Approval for NASDAQ Listing
8. Oxygen Biotherapeutics, Inc. Expands Board of Directors
9. Oxygen Biotherapeutics, Inc. Enrolls First Patient in Traumatic Brain Injury Clinical Trial in Switzerland
10. Northwest Biotherapeutics Receives Approval of US Patent for Cost Saving Automation of High-Concentration DCVax(R) Manufacturing
11. Oxygen Biotherapeutics, Inc. Begins Shipping Cosmetic Product to Customers
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/4/2015)... Aug. 4, 2015  Eli Lilly and Company (NYSE: ... San Diego (UCSD) of its intent to end its ... Anti-amyloid Treatment in Asymptomatic Alzheimer,s disease (A4) study. The ... in the preclinical stage of Alzheimer,s disease in older ... on a PET scan, but do not show symptoms ...
(Date:8/4/2015)... , Aug. 4, 2015  Rigel Pharmaceuticals, Inc. (Nasdaq: ... second quarter and six months ended June 30, 2015. ... in ITP are progressing and we continue to expect ... Rodriguez , president and chief executive officer of Rigel. ... other clinical programs, including evaluating fostamatinib for new treatment ...
(Date:8/4/2015)... 04, 2015 Research ... addition of the "MRI Systems Market to ... Efficiency, with Growth Driven by Developing Economies" ... Market to 2020 - Focus on Patient Comfort ... Economies" discusses the market, competitive landscape, and trends ...
Breaking Medicine Technology:Lilly to End Contract with the University of California, San Diego for A4 Alzheimer's Study 2Lilly to End Contract with the University of California, San Diego for A4 Alzheimer's Study 3Rigel Announces Second Quarter 2015 Financial Results 2Rigel Announces Second Quarter 2015 Financial Results 3Rigel Announces Second Quarter 2015 Financial Results 4Rigel Announces Second Quarter 2015 Financial Results 5Rigel Announces Second Quarter 2015 Financial Results 6Global MRI Systems Market Outlook to 2020 - Focus on Patient Comfort and Operational Efficiency, with Growth Driven by Developing Economies 2
... announced that Brian Catlett has joined the company in ... will be a key member of Within3,s executive team ... the leading provider of online community solutions for life ... Within3 with more than 25 years of financial and ...
... YORK, May 26, 2011 Reportlinker.com announces that ... its catalogue: The Drug-Eluting Stent ... http://www.reportlinker.com/p0483600/The-Drug-Eluting-Stent-Market-Outlook-to-2016.html?utm_source=prnewswire&utm_medium=pr&utm_campaign=Drug_Delivery_Technology Introduction ... since the introduction of DES in 2003, but ...
Cached Medicine Technology:Within3 Adds Chief Financial Officer 2Reportlinker Adds The Drug-Eluting Stent Market Outlook to 2016 2Reportlinker Adds The Drug-Eluting Stent Market Outlook to 2016 3Reportlinker Adds The Drug-Eluting Stent Market Outlook to 2016 4Reportlinker Adds The Drug-Eluting Stent Market Outlook to 2016 5
(Date:8/4/2015)... ... 2015 , ... Renowned review site BestMillionaireDatingSites.com recently refreshed its list of the ... ranked as the best dating service in the segment. , A representative from the ... essential that people find the right dating platform so that they can make the ...
(Date:8/4/2015)... ... August 04, 2015 , ... Statement by Paul Gionfriddo, President and CEO, ... Mental Health Reform Act of 2015 by Senators Bill Cassidy and Christopher ... reality in America. , “This legislation and H.R. 2646 [The Helping ...
(Date:8/4/2015)... , ... August 04, 2015 , ... ... has joined the American Association of Tissue Banks (AATB) as an Affiliate Member. ... mission “to honor donors, and to save and improve lives by promoting the ...
(Date:8/4/2015)... RI (PRWEB) , ... August 04, 2015 , ... Rhode ... imaging center in the George Washington Medical Building on Wake Robin Road in Lincoln, ... the Wake Robin office will offer the most extensive out-patient x-ray hours in the ...
(Date:8/4/2015)... ... August 04, 2015 , ... ... Angeles commercial customers. Finding reliable hardware can be difficult and troublesome for ... putting an office together or designing a new facility, it is imperative to ...
Breaking Medicine News(10 mins):Health News:BestMillionaireDatingSites.com Publishes Reviews of the Best Dating Sites for Wealthy Singles 2Health News:MHA Applauds Introduction of Mental Health Reform Act of 2015 2Health News:MHA Applauds Introduction of Mental Health Reform Act of 2015 3Health News:Exsurco Medical Joins AATB as Affiliate Member 2Health News:Rhode Island Medical Imaging Opens Satellite Imaging Center on Wake Robin Road in Lincoln 2Health News:Ryadon, Inc. is Now Offering their Ball Bearing Drawer Slides to Los Angeles, CA Commercial Customers 2Health News:Ryadon, Inc. is Now Offering their Ball Bearing Drawer Slides to Los Angeles, CA Commercial Customers 3Health News:Ryadon, Inc. is Now Offering their Ball Bearing Drawer Slides to Los Angeles, CA Commercial Customers 4
... (NYSE: PER ) and ChinaSoft International (HK8216) ... mutually,beneficial opportunities in the Chinese Healthcare market., ... take our broad,Healthcare IT expertise into the international ... with ChinaSoft in order to evaluate and,pursue opportunities ...
... Neuroethics, in March 2008. Appearing three times a year, it ... related issues in the sciences of the mind. Springer ... all articles during 2008 and 2009. , Neuroethics will be ... the neuroscience of ethics. The journal will be highly ...
... A study appearing in the March 2008 issue of ... a natural family planning method developed by researchers from ... new women to family planning. More than half the ... previously used family planning and on average, contraceptive use ...
... Duane Quinlan, mother of Karen Ann Quinlan, whose legal ... the use of life-support for the dying, will present ... Dr. John Gregory from Overlook Hospital, Summit, N.J., and ... Coloney from the Center for Hope Hospice, Scotch Plains, ...
... launch of a new $5 million initiative to enhance ... called the Program for Adult Care Excellence (PACE), will ... with cystic fibrosis. , The number of adults with ... the disease continues to rise. To meet the growing ...
... Have Household Incomes,Over $100,000 a Year, WASHINGTON, ... plans increased in 2007, but,still makes up a ... the third EBRI/Commonwealth Fund Consumerism in Health Care ... tax-advantaged,account was 2 percent of the privately insured ...
Cached Medicine News:Health News:Perot Systems and ChinaSoft to Pursue Chinese Healthcare Opportunities 2Health News:Springer to publish new journal focusing on ethical issues in neuroscience 2Health News:New choices bring wider range of women to family planning 2Health News:Julia Quinlan to present awards at a conference hosted by Rutgers College of Nursing 2Health News:Cystic Fibrosis Foundation announces $5 million initiative to enhance care for adults with CF 2Health News:New EBRI/Commonwealth Fund Research: Enrollment in Consumer-Driven Plans Remains Low, Survey Shows 2Health News:New EBRI/Commonwealth Fund Research: Enrollment in Consumer-Driven Plans Remains Low, Survey Shows 3Health News:New EBRI/Commonwealth Fund Research: Enrollment in Consumer-Driven Plans Remains Low, Survey Shows 4
The Perkins has been established for well over 20 years as a "world standard" for hand held applanation tonometers....
... Topcon, leader in the ... the most advanced technology ... conveniences and totally reliable ... Refractometry and Auto Kerato-Refractometry. ...
... measurement combined with short examination time and ease ... professional and quick. The advanced touch-screen display ... automatically with one simple movement. Capture one ... do both eyes automatically. With the new ...
... First Combination Unit, the M3,Marco introduces 3 ... Non-Contact Tonometer. By combining automatic refraction, keratometry, ... save time while providing the accurate measurements ... The M3 not only saves you valuable ...
Medicine Products: