Navigation Links
FDA Requires Additional Information on DORIBAX for Treatment of Hospital-Acquired Pneumonia
Date:8/21/2008

process that is used to identify the specific type of bacteria.

DORIBAX was approved in the U.S. in October 2007 for the treatment of complicated intra-abdominal infections (cIAI) and complicated urinary tract infections (cUTI), including pyelonephritis, due to susceptible bacteria, and is marketed by Ortho-McNeil, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. DORIBAX also is approved in Europe and Russia for cIAI, cUTI and NP, including VAP. Doripenem is licensed from Shionogi & Co., Ltd.

INDICATIONS

DORIBAX is indicated as a single agent for the treatment of: complicated intra-abdominal infections caused by susceptible strains of E. coli, K. pneumoniae, P. aeruginosa, B. caccae, B. fragilis, B. thetaiotaomicron, B. uniformis, B. vulgatus, S. intermedius, S. constellatus or P. micros, and for the treatment of complicated urinary tract infections, including pyelonephritis, caused by susceptible strains of E. coli, including cases with concurrent bacteremia, K. pneumoniae, P. mirabilis, P. aeruginosa, or A. baumannii.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of DORIBAX and other antibacterial drugs, DORIBAX should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting and modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

IMPORTANT SAFETY INFORMATION

DORIBAX is contraindicated in patients with known serious hypersensitivity to doripenem or other carbapenems or in patients who have demonstrated anaphylactic reactions to beta-lactams.

Serious and occasionally fatal hypersensitivity (anaphylactic) and serious skin reactions have been reported in patients receiving beta-lactam antibiotics. These reactions are more
'/>"/>

SOURCE Johnson & Johnson Pharmaceutical Research & Development,L.L.C.
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3 4 5

Related medicine technology :

1. ESBATech Raises Additional CHF 23M (USD 22M), Extending Series B Venture Financing
2. Biodel Inc. Announces the Completion of Its Two Pivotal Trials and the Release of EASD Abstracts Containing Additional Interim Data From Its VIAject(TM) Program
3. AlphaDetail AlphaPulse(TM): Most Practicing Physicians React Positively to FDA Panels Recommendation for Additional Cardiovascular Safety Trials for New Diabetes Medications.
4. Journal of Antimicrobial Chemotherapy Paper Supports Additional Role for Cethromycin as Potential Treatment for Infections Caused by Community- Associated Methicillin Resistant Staphylococcus Aureus (CA-MRSA)
5. Ardea Biosciences Reports Additional Positive Phase 2a Results for Lead HIV Candidate, RDEA806, Demonstrating Up to 1.9 Log Reduction in Plasma Viral Load with Once-Daily Dosing
6. PTC Therapeutics Announces Data from Additional Clinical Studies of PTC124 in Cystic Fibrosis Confirming Activity
7. Genaera Corporation Presents Additional Promising Preclinical Type 2 Diabetes Data for Trodusquemine (MSI-1436) at American Diabetes Association
8. BioElectronics Announces Profitability Breakeven and Additional Clinical Trials
9. QRxPharma Releases Additional Phase 3 Data for Q8003IR Dual Opioid Pain Therapy
10. Nventa Announces Additional Positive Immunological Data From HspE7 Phase 1 Cervical Dysplasia Trial
11. Go Healthy Initiates Additional Clinical Tests on Cholesterade
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/14/2014)... 14, 2014  Luminex Corporation (Nasdaq: LMNX ) today ... quarter of 2013 on Monday, February 3, 2014. A press ... close of trading. (Logo: http://photos.prnewswire.com/prnh/20100104/LUMINEXLOGO ) ... the operating highlights and financial results for the fourth quarter ...
(Date:1/14/2014)... Brandeis Medical Center, led by Dr. Emmanuel Brandeis , offers ... tattoo removal experience with the advanced Astanza Duality laser and a ... cosmetic services with cutting edge medical technology and offering expert medical ... has seen a dramatic increase in the presence of tattoo ...
(Date:1/14/2014)... -- Acumed,s new SLIC Screw System - a jointed ... place and insert the screw accurately - offers surgeons ... repair or reconstruction as it holds the bones reduced ... http://photos.prnewswire.com/prnh/20140114/MN45636 ) The SLIC Screw is ...
Breaking Medicine Technology:Luminex Corporation Fourth Quarter Earnings Release Scheduled for February 3, 2014 2Luminex Corporation Fourth Quarter Earnings Release Scheduled for February 3, 2014 3Beverly Hills Physician Features Tattoo Removal with the Astanza Duality Laser, Offers $99 Special 2Acumed introduces the Scapho-Lunate Inter Carpal (SLIC) Screw System 2Acumed introduces the Scapho-Lunate Inter Carpal (SLIC) Screw System 3
... WIRE)--May 23, 2007 -,ProtoKinetix Inc. (OTCBB:PKTX) has just ... Inc. at the University of Finland.,These outstanding results ... demonstrate the vital importance of this,molecule in the ... series of tests using AAGP(TM) on human embryonic ...
... Therapeutics,(OTCBB:MIVT) (FWB:MIV), a leading developer of next ... for,Cardiovascular stents and other implantable medical devices, ... animal trial comparing its,proprietary polymer free Hydroxyapatite-coated ... be presented at,this weeks EuroPCR 2007 conference ...
Cached Medicine Technology:ProtoKinetix's AAGP Dramatically Increases Recovery Rate of,Cryopreserved Stem Cells 2MIV Therapeutics Announces Renowned Researcher to Detail Milestone,Pre-Clinical Results at Prominent International Conference EuroPCR,2007 2MIV Therapeutics Announces Renowned Researcher to Detail Milestone,Pre-Clinical Results at Prominent International Conference EuroPCR,2007 3MIV Therapeutics Announces Renowned Researcher to Detail Milestone,Pre-Clinical Results at Prominent International Conference EuroPCR,2007 4
(Date:7/9/2014)... a reputation for being highly toxic, but when used in ... found to offer potential health benefits in a range of ... new compound (AP39), designed and made at the University of ... delivery of very small amounts of the substance to the ... Exeter have already found that the compound protects mitochondria ...
(Date:7/9/2014)... liver is one of the most important organs in ... we utilize our food properly this is its ... from our organism this is its detoxification function. ... unhealthy food all damage the liver. The resulting diseased ... cirrhoses, and life-threatening liver failure. According to the German ...
(Date:7/9/2014)... labels handed out by pharmacists may be misread ... according to new research by the University of ... Blind)., The study, published recently in the ... prescription medications dispensed by pharmacies do not consistently ... simply following recommended guidelines for font size, use ...
(Date:7/9/2014)... , , , , , ... , , , , ... assault rifle and the microphone is 50m downrange from the firer and approximately 30cm from the bullet... , ... , , , , , ... , , , , , , ...
(Date:7/9/2014)... The occurrence of allergic diseases has risen dramatically in ... are less exposed to microorganisms and have fewer infections ... system. , A study by researchers at Sahlgrenska Academy, ... three to examine maturation of the immune system in ... in rural areas of the Vstra Gtaland Region, half ...
Breaking Medicine News(10 mins):Health News:Rotten egg gas holds key to healthcare therapies 2Health News:Telemedicine for patients with chronic liver diseases 2Health News:Telemedicine for patients with chronic liver diseases 3Health News:Most prescription labels fail to meet guidelines, risking dosage errors 2Health News:Fit for the frontline? New study identifies the hearing requirements of British soldiers 2Health News:Fit for the frontline? New study identifies the hearing requirements of British soldiers 3Health News:Fit for the frontline? New study identifies the hearing requirements of British soldiers 4Health News:Fit for the frontline? New study identifies the hearing requirements of British soldiers 5Health News:Fit for the frontline? New study identifies the hearing requirements of British soldiers 6Health News:Fit for the frontline? New study identifies the hearing requirements of British soldiers 7
... Many hospitals in India are opting for high-tech scanners ... comparatively costlier. These high-tech scanners are capable of capturing ... // ,In less than 15 months of ... Healthcare, three leading Indian hospitals have invested in the ...
... drug for breast cancer victims is denied by the NHS ... but the private medical insurers have saved their day by ... already made available this drug to almost 100 women, who ... has made the drug available in 30 such cases. ...
... biggest supermarket, TESCO, was in public glare for the wrong reasons, ... land and for not being party to a movement that promotes ... Agency got after Tesco, soon after the latter rejected the proposition ... made profits of over ?2 billion last year and a turnover ...
... in the forefront, monitoring the Herculean task of culling of ... of the dealers. // This is being done to ascertain ... in safe custody. 20 teams comprising of officials and animal ... civic officials. ,The teams will be checking the ...
... pledged to donate his body for the "advancement of ... Roy said that, "The chief minister has always been ... with which Bhattacharya signed his formal pledge on March ... Basu, Somnath Chatterjee, Anil Biswas and Biman Bose who ...
... Glasgow and discussing on the issue of how to ... programmes and rehabilitation// services. This is the fourth annual ... by day in UK. It was very disturbing when ... Neil Hunter, Glasgow Addiction Services Partnership, said that there ...
Cached Medicine News:Health News:Hospitals In India Opt For High-tech Scanners 2
Ballard trach care HMES and filters, tv1000, HME...
Ballard trach care HMES and filters, tv 1500, HME with built-in flex tube...
Indications For Usage: , ,Single patient use on anesthetized patients and respiratory care patients who require a breathing circuit. The product is intended to be replaced at least once every 24 hou...
Indications For Usage:, ,Single use on tracheostomy patients who can breathe spontaneously. The product is intended to be replaced at least once every 24 hours....
Medicine Products: