Navigation Links
FDA Approves Elitek(R) (rasburicase) for Management of Plasma Uric Acid Levels in Adults with Leukemia, Lymphoma, and Solid Tumors Receiving Anti-Cancer Therapy
Date:10/16/2009

eparin and immediately immerse and maintain sample in an ice water bath. Assay plasma samples within 4 hours of collection.

Among the 347 (265 pediatric; 82 adult) patients for whom all adverse reactions regardless of severity were assessed in Studies 1, 2 and 3, as well as an uncontrolled safety trial, the most frequently observed adverse reactions (incidence greater than or equal to 10%) were vomiting (50%), fever (46%), nausea (27%), headache (26%), abdominal pain (20%), constipation (20%), diarrhea (20%), mucositis (15%), and rash (13%).

Among the 275 adult patients in Study 4, hypersensitivity reactions occurred in 4.3% of patients treated with ELITEK alone and 1.1% of patients treated with the ELITEK/oral allopurinol combination. Hypersensitivity reactions included arthralgia, injection site irritation, peripheral edema, and rash. The most common Grade 3 or 4 adverse reactions regardless of relationship to study drug in the 3 arms of Study 4 (ELITEK alone; ELITEK combined with oral allopurinol; oral allopurinol alone) were sepsis (5.4%; 6.5%; 4.4%), hypophosphatemia (4.3%; 6.5%; 6.6%), anxiety (3.3%; 0%; 0%), abdominal pain (3.3%; 4.3%; 2.2%), hyperbilirubinemia (3.3%; 2.2%; 4.4%), and increased alanine aminotransferase (3.3%; 4.3%; 2.2%), respectively.

The following serious adverse reactions occurred with a difference in incidence of greater than or equal to 2% in patients receiving ELITEK compared to patients receiving oral allopurinol in randomized studies (Study 1 and Study 4): pulmonary hemorrhage, respiratory failure, supraventricular arrhythmias, ischemic coronary artery disorders, and abdominal and gastrointestinal infections.

For full prescribing information, including boxed WARNING, please visit http://products.sanofi-aventis.us/elitek/elitek.html.

About Tumor Lysis Syndrome

Tumor lysis synd
'/>"/>

SOURCE sanofi-aventis
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7

Related medicine technology :

1. FDA Approves Cervarix, GlaxoSmithKlines Cervical Cancer Vaccine
2. U.S. Food and Drug Administration Approves CRESTOR(R) for Use in Pediatric Patients With Heterozygous Familial Hypercholesterolemia
3. Chinese Food and Drug Administration Approves Gabexate Mesylate as Pharmaceutical Raw Material
4. FDA Approves New Indication For Mirena(R) to Treat Heavy Menstrual Bleeding in IUD Users
5. US FDA Approves Extavia(R) - the First in a New Portfolio of Planned MS Therapies from Novartis to Help Patients with this Devastating Disease
6. Video: FDA Approves INVEGA(R) SUSTENNA(TM) for the Acute and Maintenance Treatment of Schizophrenia
7. FDA Approves Tekturna HCT(R) as Initial Treatment in Patients Unlikely to Achieve Their Blood Pressure Goals With a Single Agent
8. FDA Approves ADCIRCA(TM) (Tadalafil) Tablets for the Treatment of Pulmonary Arterial Hypertension
9. FDA Approves Vanda Pharmaceuticals Fanapt(TM) for the Treatment of Schizophrenia
10. FDA Approves an Expanded Indication for Peginterferon-Based Combination Therapy for Patients With Chronic Hepatitis C
11. FDA Approves LUSEDRA(TM) (fospropofol disodium) Injection for Monitored Anesthesia Care (MAC) Sedation
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/15/2014)... wearable injector slightly larger than an Oreo cookie may soon ... drugs in the large doses required to treat a wide ... genetic disorders.  An emerging biologic drugs market ... analysts.   Many of these drugs will require a new type ...
(Date:1/14/2014)... 14, 2014 InformEx, North America,s ... chemistry, will hold the 30 th edition of its ... Convention Center from January 21-24. (Logo: http://photos.prnewswire.com/prnh/20131028/NY05330LOGO-a ... pharmaceutical, fine chemical and specialty chemical companies will take part ...
(Date:1/14/2014)... 2014 /PRNewswire-iReach/ -- Acumed,s new SLIC Screw System - ... instrumentation to place and insert the screw accurately - ... (e.g. ligament) repair or reconstruction as it holds the ... (Photo: http://photos.prnewswire.com/prnh/20140114/MN45636 ) The SLIC ...
Breaking Medicine Technology:Enable Injections Presents A New Class of Injectors for Drug Delivery at PEPTalk, Drug Delivery Partnership Meetings 2Media Advisory: InformEx 2014 Events & Speaker Lineup for 30th Edition Conference in Miami Beach 2Acumed introduces the Scapho-Lunate Inter Carpal (SLIC) Screw System 2Acumed introduces the Scapho-Lunate Inter Carpal (SLIC) Screw System 3
... DALLAS, September 6, 2010 ... ... var ... by longUrl, so we need to grab the first one. for (var r in data.results) { first_result ...
... Sept. 3 The editors of Inc. Magazine have ... 2010 "Inc. 5000" List , which acknowledges the ... States.  Qosina is being recognized for the second consecutive ... four times including the "Inc. 500" in 1989 and ...
Cached Medicine Technology:Diagnostic Imaging Market to 2016 - Nuclear Imaging Systems and Ultrasound Systems to be the key Revenue Generators now Available at ReportsandReports 2Diagnostic Imaging Market to 2016 - Nuclear Imaging Systems and Ultrasound Systems to be the key Revenue Generators now Available at ReportsandReports 3Diagnostic Imaging Market to 2016 - Nuclear Imaging Systems and Ultrasound Systems to be the key Revenue Generators now Available at ReportsandReports 4Diagnostic Imaging Market to 2016 - Nuclear Imaging Systems and Ultrasound Systems to be the key Revenue Generators now Available at ReportsandReports 5Diagnostic Imaging Market to 2016 - Nuclear Imaging Systems and Ultrasound Systems to be the key Revenue Generators now Available at ReportsandReports 6Diagnostic Imaging Market to 2016 - Nuclear Imaging Systems and Ultrasound Systems to be the key Revenue Generators now Available at ReportsandReports 7Diagnostic Imaging Market to 2016 - Nuclear Imaging Systems and Ultrasound Systems to be the key Revenue Generators now Available at ReportsandReports 8Qosina Recognized for Second Consecutive Year on the 'Inc. 5000' List 2
(Date:4/18/2014)... turns 160 years of neuroanatomy on its head. , ... essential for the fast transmission of impulses along the ... thought, according to a new work lead by Professor ... and the University,s Department of Stem Cell and Regenerative ... Department of Molecular and Cellular Biology. , "Myelin is ...
(Date:4/18/2014)... Two Simon Fraser University psychologists have made a ... treatment of attention-deficit disorders. , This discovery opens ... may hinder or suppress a specific brain activity ... prevent distraction. , The Journal of Neuroscience ... discovery by John McDonald, an associate professor of ...
(Date:4/17/2014)... PHILADELPHIA The presence of chronic inflammation in ... aggressive, prostate cancer, and this association was found ... levels, according to a study published in ... of the American Association for Cancer Research. , ... some participants of the placebo arm of the ...
(Date:4/17/2014)... Ill. One of the most popular vaccine brands ... And doctors may be overlooking some cost factors when ... a more expensive option, according to a new study ... vaccines to administer can be driven by numerous factors," ... and a professor of computer science and of mathematics ...
(Date:4/17/2014)... Two recent papers by a University of ... help scientists develop treatments or vaccines for Dengue ... and other disease-causing flaviviruses. , Jeffrey S. Kieft, ... at the School of Medicine and an early ... and colleagues recently published articles in the scholarly ...
Breaking Medicine News(10 mins):Health News:Finding turns neuroanatomy on its head 2Health News:Finding turns neuroanatomy on its head 3Health News:Scientists discover brain's anti-distraction system 2Health News:Chronic inflammation may be linked to aggressive prostate cancer 2Health News:Chronic inflammation may be linked to aggressive prostate cancer 3Health News:Study recalculates costs of combination vaccines 2Health News:CU researchers discover target for treating dengue fever 2
... statement of CEO Nancy Brown on the Senate passage of ... today by the American Heart Association: , , The ... ensure a healthier future for our children with passage of ... legislation will allow us to protect them from a dirty ...
... Senators Vote for Historic Bill to Regulate Tobacco Products ... for Tobacco-Free Kids applauds U.S. Senator Richard Durbin for leading ... that gives the U.S. Food and Drug Administration (FDA) authority ... on tobacco marketing and sales to kids. , , ...
... June 11 The Campaign for Tobacco-Free Kids ... in the U.S. Senate to pass historic legislation that gives ... tobacco products, including the authority to crack down on tobacco ... the bipartisan bill 79 to 17. The House has ...
... Scheduled for Friday, June 12, 2009 , , LANCASTER, ... ) today reported financial results for the third quarter ended May ... the thirteen weeks ended May 3, 2009 were approximately $41.8 million, ... ended May 4, 2008. , , Income from continuing operations ...
... DALLAS, June 11 Zix Corporation (ZixCorp(R)), ... encryption services and payor sponsored e-Prescribing services, announced today ... assist ZixCorp,s Board of Directors in investigating strategic alternatives ... This strategic review may result in a partnership, ...
... Calif., June 11 Bionovo, Inc. (Nasdaq: BNVI ... 10, 2009 has denied all claims against the company and ... , The decision was in reference to a suit ... fraud, negligent misrepresentation and breach of oral contract stemming from ...
Cached Medicine News:Health News:Senator Durbin Leads Fight to Protect America's Kids from Tobacco 2Health News:Senator Durbin Leads Fight to Protect America's Kids from Tobacco 3Health News:Senator Reid Leads Fight to Protect America's Kids From Tobacco 2Health News:Herley Industries, Inc. Reports Third Quarter Earnings 2Health News:Herley Industries, Inc. Reports Third Quarter Earnings 3Health News:Herley Industries, Inc. Reports Third Quarter Earnings 4Health News:Herley Industries, Inc. Reports Third Quarter Earnings 5Health News:Herley Industries, Inc. Reports Third Quarter Earnings 6Health News:Herley Industries, Inc. Reports Third Quarter Earnings 7Health News:Herley Industries, Inc. Reports Third Quarter Earnings 8Health News:Herley Industries, Inc. Reports Third Quarter Earnings 9Health News:Herley Industries, Inc. Reports Third Quarter Earnings 10Health News:Herley Industries, Inc. Reports Third Quarter Earnings 11Health News:Herley Industries, Inc. Reports Third Quarter Earnings 12Health News:Zix Corporation Announces Review of Strategic Alternatives for e-Prescribing Business 2Health News:Bionovo Announces Arbitration Decision in Lawsuit Filed by Former Officer - All Claims Denied 2
Stab incision blades color coded for simple and accurate identification...
Smooth, round edges allow for safe manipulation within the eye. 1.1mm wide gradually tapers to .50 mm wide. 45, 1.1mm wide, gradually tapers to .50mm wide....
... has two perforations which enable ... various single or bilateral configurations ... drape has two perforations which ... to various single or bilateral ...
30, 6.0mm from end...
Medicine Products: