Navigation Links
U.S. FDA Approves Bayer's Gadavist™ (Gadobutrol) Injection for MRI of the Central Nervous System
Date:3/14/2011

njury.
  • Screen patients for acute kidney injury and other conditions that may reduce renal function. For patients at risk for chronically reduced renal function (for example, age >60 years, hypertension or diabetes), estimate the glomerular filtration rate (GFR) through laboratory testing.
  • For patients at highest risk for NSF, do not exceed the recommended Gadavist dose and allow a sufficient period of time for elimination of the drug from the body prior to any re-administration [see Warnings and Precautions].
  • The possibility of serious or life-threatening hypersensitivity, anaphylactic or anaphylactoid reactions associated with cardiovascular, respiratory, or cutaneous manifestations, including death, should always be considered.
  • The most frequent adverse reactions associated with Gadavist in clinical studies were headache, nausea, injection site reaction, dysgeusia and feeling hot.

  • Please see full prescribing information at http://BayerImaging.com.

    About the U.S. Phase III TrialsPatients referred for MRI of the central nervous system with contrast were enrolled in two clinical trials (Study A and Study B) that evaluated the visualization characteristics of lesions. In both studies, patients underwent a baseline, pre-contrast MRI prior to administration of Gadavist at a dose of 0.1 mmol/kg, followed by a post-contrast MRI. In Study A, patients also underwent an MRI before and after the administration of gadoteridol. The studies were designed to demonstrate superiority of Gadavist MRI to non-contrast MRI for lesion visualization. For both studies, pre-contrast and pre-plus-post contrast images (paired images) were independently evaluated by three readers for contrast enhancement and border delineation using a scale of 0 to 4, and for internal morphology using a scale of 0 to 3.  Lesion counting was also performed to
    '/>"/>

    SOURCE Bayer HealthCare Pharmaceuticals
    Copyright©2010 PR Newswire.
    All rights reserved

    Page: 1 2 3 4

    Related medicine technology :

    1. FDA Approves Lillys Osteoporosis Drug EVISTA(R) (raloxifene HCl) to Reduce The Risk of Invasive Breast Cancer in Two Populations of Postmenopausal Women
    2. Health Canada Approves ATRIPLA(R) (efavirenz 600 mg/emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg), the First Once-Daily Single Tablet Regimen for HIV
    3. FDA Approves Cymbalta(R) for Maintenance Treatment of Major Depressive Disorder
    4. European Commission Approves ATRIPLA(R) (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg), the First Once-Daily Single Tablet Regimen for Virologically Suppressed Adults With HIV-1 Infection
    5. FDA Approves MiddleBrooks Amoxicillin PULSYS for Pharyngitis/Tonsillitis in Adolescents and Adults
    6. FDA Approves XYZAL(R) (levocetirizine dihydrochloride) Oral Solution for the Relief of Seasonal and Year Round Allergies and Chronic Idiopathic Urticaria
    7. UM Maryland Industrial Partnerships Program Approves 18 Collaborative Research Projects, Worth $4.4 Million, Between University Faculty, State Technology Companies
    8. U.S. Food and Drug Administration Approves ABILIFY(R) (aripiprazole) for the Acute Treatment of Manic and Mixed Episodes Associated With Bipolar I Disorder in Pediatric Patients (10 to 17 Years of Age)
    9. U.S. Food and Drug Administration Approves ORENCIA(R) (abatacept) for the Treatment of Moderate-to-Severe Polyarticular Juvenile Idiopathic Arthritis (JIA) in Patients Six Years and Older
    10. FDA Approves HIFU Clinical Trial for Recurrent Prostate Cancer
    11. EPA Approves XDS-CALUX(R) as Alternate Dioxin Test Method 4435
    Post Your Comments:
    *Name:
    *Comment:
    *Email:
    (Date:8/28/2015)... and PITTSBURGH , Aug. 28, ... today announced that its shareholders have approved Mylan,s ... PRGO ; TASE) and the related issuance of ... extraordinary general meeting of shareholders held today. The ... at the extraordinary general meeting. In addition, the ...
    (Date:8/28/2015)... y LONDRES, 28 de agosto de 2015 /PRNewswire/ ... hoy su participación en el  Congreso de la ... cardiológicas más recientes y novedosas, entre ellas HeartModel ... a las personas y la tecnología con los ... diagnosticar, guiar los tratamientos y permitir atención en ...
    (Date:8/27/2015)... , Aug. 27, 2015  The Academy of ... and Drug Administration,s (FDA,s) draft guidance and proposed ... and biosimilars, to bear a nonproprietary name with ... been seeking a decision from the FDA on ... health care stakeholders urging the agency to use ...
    Breaking Medicine Technology:Mylan Shareholders Overwhelmingly Approve Proposed Acquisition of Perrigo 2Mylan Shareholders Overwhelmingly Approve Proposed Acquisition of Perrigo 3Mylan Shareholders Overwhelmingly Approve Proposed Acquisition of Perrigo 4Mylan Shareholders Overwhelmingly Approve Proposed Acquisition of Perrigo 5Mylan Shareholders Overwhelmingly Approve Proposed Acquisition of Perrigo 6Mylan Shareholders Overwhelmingly Approve Proposed Acquisition of Perrigo 7Mylan Shareholders Overwhelmingly Approve Proposed Acquisition of Perrigo 8Mylan Shareholders Overwhelmingly Approve Proposed Acquisition of Perrigo 9Philips presenta nuevas soluciones cardiológicas integradas para desarrollar procedimientos menos invasivos 2Philips presenta nuevas soluciones cardiológicas integradas para desarrollar procedimientos menos invasivos 3Philips presenta nuevas soluciones cardiológicas integradas para desarrollar procedimientos menos invasivos 4Philips presenta nuevas soluciones cardiológicas integradas para desarrollar procedimientos menos invasivos 5AMCP Is Disappointed in FDA's Draft Guidance and Proposed Rule Calling for Suffix on Nonproprietary Names of Biological Products 2
    ... Cornerstone Therapeutics Inc. (Nasdaq: CRTX ), a specialty ... primarily for the respiratory and related markets, today announced that ... ET on Tuesday, May 4, 2010 , to ... 31, 2010 .  Management will also provide an update on ...
    ... International Merchant Advisors, Inc. (Pink Sheets: IMAI) www.imaiinc.com ... Science, Inc., intends to launch a national line of medical marijuana ... in the new CNBC article "Marijuana and Money" www.cnbc.com , ... $109 billion per year. , ...
    Cached Medicine Technology:Cornerstone Therapeutics to Host First Quarter 2010 Conference Call 2Cornerstone Therapeutics to Host First Quarter 2010 Conference Call 3International Merchant Advisors to Develop Organic Science Branded Medical Marijuana Product Line 2International Merchant Advisors to Develop Organic Science Branded Medical Marijuana Product Line 3
    (Date:8/28/2015)... ... August 28, 2015 , ... ... high grade protein with zero fat, carbs, sugar, gluten, lactose or caffeine in ... finalist for the 2015 SupplySide CPG Editor’s Choice Awards. , Five consumer packaged ...
    (Date:8/28/2015)... Neb. (PRWEB) , ... August 28, 2015 , ... Medical ... the 2015 Best Places to Work in Healthcare by Modern Healthcare and ... , Now in its eighth year, the Best Places to Work in ...
    (Date:8/28/2015)... ... August 28, 2015 , ... SmartPractice Calendars ... Personalized with practice contact information and logos, Calendars stand alone as functional brand-building ... Calendars into seasonal mailings, thank you and welcome communications, and to complement statements ...
    (Date:8/28/2015)... (PRWEB) , ... August 28, 2015 , ... ... to announce its collaboration with coffee connoisseur and Emmy-nominated actress, Sofia Vergara, and ... It features revolutionary Thermal Flavor Extraction™ technology, which delivers a variety of sizes ...
    (Date:8/28/2015)... (PRWEB) , ... August 28, ... ... Services, Inc.’s (AIS) Medicare-Medicaid Dual Eligibles Database have added comprehensive information on ... alignment demonstration approved for a December 2015 launch; and Idaho’s partnership to ...
    Breaking Medicine News(10 mins):Health News:Pocket Protein™ Named 2015 CPG Editor’s Choice Award Finalist by Informa’s SupplySide 2Health News:Pocket Protein™ Named 2015 CPG Editor’s Choice Award Finalist by Informa’s SupplySide 3Health News:Medical Solutions Recognized as One of 2015 Best Places to Work in Healthcare 2Health News:Medical Solutions Recognized as One of 2015 Best Places to Work in Healthcare 3Health News:SmartPractice® Introduces 2016 Calendars for Dental Practice Giveaways 2Health News:Sofia Vergara Partners With SharkNinja® To Launch The Ninja Coffee Bar™ 2Health News:Sofia Vergara Partners With SharkNinja® To Launch The Ninja Coffee Bar™ 3Health News:AIS Duals Database: August Update Finds Two New Duals Programs in Rhode Island and Idaho 2
    ... The Centers for Disease Control and Prevention ( ... leading cause of death. In 2009, an estimated ... attack, and about 470,000 will have a recurrent ... of people nationwide focus on education and provide ...
    ... brings extensive experience in neuroscience and oncology to ... therapeutic categories , , ROCKVILLE, Md. ... Pharmaceutical, Inc. (OAPI), a fast-growing health care company ... North America, has announced the appointment of Mark ...
    ... Pharmaceutical Services, Inc. (NYSE: WST ) announced ... results before the market opens on Thursday, February 19, ... discuss the results and business expectations at 9:00 a.m. ... (888)790-3758 or (210)839-8398. The passcode is WST.A live broadcast ...
    ... Additional $2.5 MillionCRANBURY, N.J., Feb. 12 Palatin ... it has received $4.1 million from AstraZeneca relating ... and license agreement to discover, develop and commercialize ... trial sponsored research agreement. Palatin also announced that ...
    ... discuss fourth quarter financial results -LAVAL, QC, Feb. 12 ... DDSS ) today announced that it will host a ... (ET) to discuss its fourth quarter 2008 financial results. ... via news release at approximately 7:00 a.m. the same ...
    ... Inc. (OTC Bulletin Board: DORB) (DOR or the Company) ... million partnering agreement with Sigma - Tau Pharmaceuticals, Inc. ... North America of orBec(R) (oral beclomethasone dipropionate or Oral ... make a $6 million upfront investment in DOR, inclusive ...
    Cached Medicine News:Health News:The ISSA Offers 8 Tips for American Heart Month 2Health News:Otsuka America Pharmaceutical, Inc. Announces the Appointment of Mark Altmeyer as President and Chief Executive Officer 2Health News:Otsuka America Pharmaceutical, Inc. Announces the Appointment of Mark Altmeyer as President and Chief Executive Officer 3Health News:Otsuka America Pharmaceutical, Inc. Announces the Appointment of Mark Altmeyer as President and Chief Executive Officer 4Health News:Otsuka America Pharmaceutical, Inc. Announces the Appointment of Mark Altmeyer as President and Chief Executive Officer 5Health News:Otsuka America Pharmaceutical, Inc. Announces the Appointment of Mark Altmeyer as President and Chief Executive Officer 6Health News:West to Host 2008 Fourth Quarter Conference Call 2Health News:Palatin Technologies Announces Receipt of $4.1 Million from AstraZeneca 2Health News:Labopharm to host conference call Thursday, February 26, 2009 at 8:30 a.m. (ET) 2Health News:DOR BioPharma Announces Potential $30 Million North American Partnership Agreement with Sigma-Tau Pharmaceuticals for orBec(R) in the Treatment of Graft-versus-Host Disease 2Health News:DOR BioPharma Announces Potential $30 Million North American Partnership Agreement with Sigma-Tau Pharmaceuticals for orBec(R) in the Treatment of Graft-versus-Host Disease 3Health News:DOR BioPharma Announces Potential $30 Million North American Partnership Agreement with Sigma-Tau Pharmaceuticals for orBec(R) in the Treatment of Graft-versus-Host Disease 4Health News:DOR BioPharma Announces Potential $30 Million North American Partnership Agreement with Sigma-Tau Pharmaceuticals for orBec(R) in the Treatment of Graft-versus-Host Disease 5Health News:DOR BioPharma Announces Potential $30 Million North American Partnership Agreement with Sigma-Tau Pharmaceuticals for orBec(R) in the Treatment of Graft-versus-Host Disease 6Health News:DOR BioPharma Announces Potential $30 Million North American Partnership Agreement with Sigma-Tau Pharmaceuticals for orBec(R) in the Treatment of Graft-versus-Host Disease 7
    Soft PVC. Available in sizes 12-36F, Interior striations for smooth suction catheter insertion. Bevel tip. Single use. Sterile....
    Soft Guedel Oral Airways...
    ... airways., ,When a difficult airway must ... Now you can be assured of rapid ... Esophageal/Tracheal double-Lumen Airway from Nellcor. Unlike traditional ... to establish a nonsurgical patient airway when ...
    All oral and nasal airways are manufactured with smooth, rounded edges for increased patient comfort and safety., ,Portex® offers a broad selection of airways for a variety of clinical applicati...
    Medicine Products: