Navigation Links
Janssen Research & Development Submits Application to U.S. FDA for XARELTO® (rivaroxaban) to Reduce Secondary Cardiovascular Events in Patients with Acute Coronary Syndrome
Date:12/29/2011

efficacy of XARELTO® in the elderly (65 years or older) was similar to that seen in patients younger than 65 years. Both thrombotic and bleeding event rates were higher in these older patients, but the risk-benefit profile was favorable in all age groups.
  • Renal Impairment
    • Patients with renal impairment taking P-gp and weak to moderate CYP3A4 inhibitors may have significant increases in exposure, which may increase bleeding risk.
    • Nonvalvular Atrial Fibrillation: For patients with CrCl 15 mL/min to 50 mL/min, the recommended dose of XARELTO® is 15 mg once daily with the evening meal. Avoid use in patients with CrCl <15 mL/min. Periodically assess renal function as clinically indicated (ie, more frequently in situations in which renal function may decline) and adjust therapy accordingly. Discontinue XARELTO® in patients who develop acute renal failure while on XARELTO®.
    • Prophylaxis of Deep Vein Thrombosis: Avoid use in severe renal impairment
      (CrCl <30 mL/min) due to an expected increase in rivaroxaban exposure and pharmacodynamic effects in this patient population. Observe closely and promptly evaluate any signs or symptoms of blood loss in patients with moderate renal impairment (CrCl 30 mL/min to 50 mL/min). Patients who develop acute renal failure while on XARELTO® should discontinue treatment.
  • Hepatic Impairment: No clinical data are available for patients with severe hepatic impairment. Avoid the use of XARELTO® in patients with moderate (Child-Pugh B) and severe (Child-Pugh C) hepatic impairment or with any hepatic disease associated with coagulopathy.
  • OVERDOSAGE

    • Overdose of XARELTO® may lead to hemorrhage. A specific antidote for rivaroxaban is no
      '/>"/>

    SOURCE Janssen Research & Development, LLC
    Copyright©2010 PR Newswire.
    All rights reserved

    Page: 1 2 3 4 5 6 7 8 9 10 11

    Related medicine technology :

    1. Record Breaking $327 Million Verdict Upheld in Janssen Case and Request for New Trial Denied
    2. Dr. Paul Janssen Award for Biomedical Research Issues Call for Nominations
    3. Pharmacyclics Forms Pact to Develop and Commercialize PCI-32765 for Hematologic Cancers with Janssen Biotech, Inc.
    4. Janssen Pharmaceuticals, Inc. Launches Online Tools on PrescribeResponsibly.com
    5. Janssen Pharmaceuticals, Inc. Announces Definitive Agreement to Divest Ortho Dermatologics Division
    6. Dr. Napoleone Ferrara Wins 2011 Dr. Paul Janssen Award for Biomedical Research
    7. Janssen Products, LP Modifies Prescribing Information for PROCRIT® (Epoetin alfa) in Chronic Kidney Disease
    8. Ortho-McNeil-Janssen Pharmaceuticals, Inc. Voluntarily Recalls One Lot of RISPERDAL® Tablets and One Lot of Risperidone Tablets
    9. Record Breaking $327 Million Verdict Announced in Janssen Case
    10. MHPA Center for Best Practices Receives Sponsorship from Ortho-McNeil Janssen Pharmaceuticals, Inc. to Improve Medicaid Quality, Care Coordination for Serious Mental Illness
    11. Lilly Makes an Irrevocable Offer to Acquire Janssen Animal Health
    Post Your Comments:
    *Name:
    *Comment:
    *Email:
    (Date:9/23/2014)... , Sept. 23, 2014  Medela announced today ... Biomedical Company (ABC), assigning Medela as the exclusive distributor ... known as the Medela Enteral Feeding Pump. Through this ... help NICU parents and healthcare professionals by offering a ... Medela Enteral Feeding Pump is integral to the delivery ...
    (Date:9/23/2014)... Sept. 23, 2014 A case report and ... SynCardia temporary Total Artificial Heart into a patient with ... were reversed, along with other abnormalities. ... the SynCardia Total Artificial Heart to treat a patient ... and video in the Journal of Visualized Experiments show ...
    (Date:9/23/2014)... September 23, 2014 BerGenBio ... company, today announces it has been granted a ... Award from the UK,s Wellcome Trust to develop ... novel cancer target. The Wellcome Trust ... fund especially promising, innovative new therapeutic concepts through ...
    Breaking Medicine Technology:Medela Enters Exclusive Enteral Feeding Pump Agreement with Atlanta Biomedical Company 21st Use of the SynCardia Total Artificial Heart in a 17-Year-Old Congenital Heart Disease Patient at Pediatric Hospital 21st Use of the SynCardia Total Artificial Heart in a 17-Year-Old Congenital Heart Disease Patient at Pediatric Hospital 31st Use of the SynCardia Total Artificial Heart in a 17-Year-Old Congenital Heart Disease Patient at Pediatric Hospital 4BerGenBio Granted a Prestigious Wellcome Trust Seeding Drug Discovery Award 2BerGenBio Granted a Prestigious Wellcome Trust Seeding Drug Discovery Award 3
    (Date:9/23/2014)... a driving force behind many chronic diseases, especially ... inflammation caused by conditions such as viral hepatitis ... options. Now, scientists at Virginia Commonwealth University Massey ... in preclinical studies that blocking the expression of ... halts the development and progression of liver cancer ...
    (Date:9/23/2014)... Becker's Hospital Review has published the ... and Health Systems With Great Orthopedic Programs." , ... list have orthopedic surgery departments, programs or dedicated ... sources. Exceptional orthopedic departments include physicians who provide ... treat professional athletes. , This is the fifth ...
    (Date:9/23/2014)... under the curve of oxygen desaturation" (AUC Desat ) ... oxygen levels during procedures using sedation, according to a ... The AUC Desat provides information not only whether ... depth, duration, and rate of episodes of oxygen desaturation. ... University of Cincinnati and colleagues reports on the development ...
    (Date:9/23/2014)... Ind. -- Contrary to what is often assumed about ... new study from The Kinsey Institute has found that ... are sexually active as often as singles without children ... children. , The study, "Dating and Sexual Behavior Among ... was published online in the Journal of Sex ...
    (Date:9/23/2014)... (PRWEB) September 23, 2014 Kenall ... has expanded its MedMaster™ M4 product line with ... extends the M4 product line – currently available ... options – providing more flexibility when designing lighting ... MedMaster M4 Series include:, •Three sizes ...
    Breaking Medicine News(10 mins):Health News:Study uncovers genetic driver of inflammation, uses it to prevent and treat liver cancer 2Health News:125 Hospitals With Great Orthopedic Programs 2Health News:125 Hospitals With Great Orthopedic Programs 3Health News:125 Hospitals With Great Orthopedic Programs 4Health News:125 Hospitals With Great Orthopedic Programs 5Health News:New measure provides more data on oxygen levels during sedation 2Health News:Kinsey study of single parents' dating, sexual activity contradicts assumptions 2Health News:Kenall Expands MedMaster™ M4 Surgical Suite Product Portfolio with New 1'×4' Option 2Health News:Kenall Expands MedMaster™ M4 Surgical Suite Product Portfolio with New 1'×4' Option 3
    ... Ill., Jan. 6 Baxter International,(NYSE: BAX ), ... 2008 financial results on Thursday, January 22, 2009, at 8:30 ... call, please dial,866-238-0637 (domestic) or 703-639-1156 (international). Please dial ... of the call for the operator to,connect you. , ...
    ... Jan. 6, 2009 AMERIGROUP Corporation (NYSE: AGP ... Annual J.P. Morgan Healthcare Conference on January 14 in San ... January 14 at 6:30 p.m. Eastern Time, can be accessed ... page. A replay will be available for 30 days, and ...
    ... of life improved , , TUESDAY, Jan. 6 (HealthDay News) -- ... stimulation improves both physical function and quality of life after ... stimulation (DBS) performed better than currently available drug treatments, but ... a study in the Jan. 7 issue of the ...
    ... Surf Sweets today announced,the introduction of its organic, natural ... country. Surf Sweets provides a natural, organic candy,option ... children. , Surf Sweets gummy ... ingredients without artificial flavors and colors. Surf Sweets ...
    ... 6 Karen Ignagni, President and CEO of America,s Health ... CMS today showing that health spending in the United States ... percent in 2007. According to the CMS report, private ... rate as in 2006, but much lower than the recent ...
    ... , ... Fla. (Vocus) January 6, 2009 -- Whether you commit to your new ... this year by bringing them in for regular check ups. Regular check ... to a loved one,s life saved and less costly medical bills for pet ...
    Cached Medicine News:Health News:Deep Brain Stimulation Helps Those With Advanced Parkinson's 2Health News:Deep Brain Stimulation Helps Those With Advanced Parkinson's 3Health News:AHIP Statement on National Health Expenditure Data 2Health News:Early Detection Saves Pets 2Health News:Early Detection Saves Pets 3
    ... ORTHOSET Radiopaque Bone Cement ... system: a sterile,ampule containing bone ... pack, and a sterile polyethylene ... a peelable pouch. The interiors ...
    Antibiotics (Gentamicin) loaded, low viscosity bone cement for syringe use with an average setting time of approx. 7-9 Min., 41.6g of powder and 16.4g of liquid....
    ... Featuring new technology, such as a recessed ... and lens housings, this arthroscope has superior ... by EO, Steris and steam autoclaving or ... Light post/adapters to fit ACMI, Wolf, Dyonics ...
    ... Passport II delivery device is the second ... C11UB. Its simple-to-use syringe technology allows one-handed ... small incision. The blue colored plunger allows ... protect the haptics during insertion. The modified ...
    Medicine Products: