Meropenem meropenem this product information is intended only for residents of the united states. Meropenem astrazeneca class carbapenem betalactam o meropenem merrem 500 mg q8 iv o imipenem primaxin imipenemcilastin 500mg q8 iv imipenem rapidly degraded by renal enzyme dehydropeptidase1 when administered alone, so coadministered with cilastin inhibits o ertapenem invanz 1g q24 iv moa. Em individuos com funcao normal dos rins ocorrera rapida eliminacao renal. Meropenem is a broad spectrum injectable antibiotic for a wide variety of. It showed clinical activity in the treatment of obstetric and gynecological infections, skin and soft tissue infections, communityacquired pneumonia, urinary tract infections, and in intra. Astrazeneca to change the territories of the business of meropenem, a carbapenem antibiotic. Meropenem in the treatment of complicated skin and soft. The agencys committee for medicinal products for human use chmp has concluded that there is a need to harmonise the prescribing information for meronem and associated names in the. See full prescribing information for merrem iv merrem iv meropenem for injection, for intravenous use initial u. Jun 24, 2019 in the meropenem for injection, usp treated group, 1215 patients with seizures had late onset seizures defined as occurring on day 3 or later versus 720 in the comparator arm. Meropenem is approved for use in complicated intraabdominal infection ciai. Astrazeneca announces positive topline results from the phase iii programme of cazavi in patients with complicated intraabdominal infections ciai astrazeneca announces positive topline results from the phase iii programme of cazavi in patients with complicated intraabdominal infections ciai. Aug 19, 2014 astrazeneca today announced positive topline results from reclaim1 and reclaim2, the pivotal phase iii studies investigating the potential of the antibiotic ceftazidimeavibactam cazavi as a treatment for hospitalised adult patients with complicated intraabdominal infections. Meropenem monotherapy for the treatment of hospitalacquired.
Astrazeneca is a global, scienceled biopharmaceutical business and our innovative medicines are used by millions of patients worldwide. Astrazenecas environmental risk summaries as part of. Meronem is manufactured by astrazeneca uk however, some patients, parents and carers are trained to give meronem at home. Pdf meropenem monotherapy as an empirical treatment of. To report suspected adverse reactions, contact astrazeneca. Meropenem is metabolised by hydrolysis of the betalactam ring generating a microbiologically inactive metabolite.
Astrazeneca announces positive topline results from the. Merrem iv meropenem injection astrazeneca pharmaceuticals lphighlights of prescribing information these highlights do not include all the information needed to use merrem iv safely and effectively. Unlike conventional carbapenems such as imipenem, meropenem is stable against meropenem pfizersumitomo dainippon pharma. May 17, 2019 meropenem for injection is a penem antibacterial indicated for the treatment of. Sumitomo dainippon pharma to conduct meropenem business in. Find patient medical information for meropenem intravenous on webmd including its uses, side effects and safety, interactions, pictures, warnings and user ratings. Meronem from astrazeneca, meropenem aeropen to esblanem meropenem, an antibiotic is prescribed for the treatment of intraabdominal infections including appendicitis, peritonitis, bacterial meningitis, nosocomial pneumonia hospitalacquired, skin and soft tissue infections in adults and children. Astrazeneca holds the global rights to commercialize zavicefta, with the exception of north america, where the rights are held by allergan. Nov 09, 2018 meropenem is an antibiotic that fights bacteria. The meropenem group had a statistically higher number of patients with transient elevation of liver enzymes. Meronem iv 500mg summary of product characteristics smpc. Prescribing information az medical information astrazeneca.
When there are changes to the label, the pdf version will show the updates sooner than the web version. Astrazeneca s pipeline, and patent cliff, was the subject of much speculation in april 2007 leading to. Meropenem administered intravenously to pregnant cynomolgus monkeys during organogenesis from day 20 to 50 after mating at doses of 120, 240, and 360 mgkgday did not produce maternal or fetal toxicity at the noael dose of 360 mgkgday approximately 2. The efficacy and tolerability of meropenem as empirical treatment in patients with hospitalacquired pneumonia was determined in a prospective, openlabel, nonrandomized trial. Find out what health conditions may be a health risk when taken with meropenem intravenous. This drug is widely used for various types of moderate to severe infectious diseases caused by grampositive gramnegative bacteria. Astrazenecas environmental risk summaries as part of astrazeneca s ongoing commitment to environmental data transparency, this website provides environmental risk summaries for the active pharmaceutical ingredients api found in our core brands. The efficacy of meropenem as monotherapy in the treatment of meningitis caused by penicillin nonsusceptible isolates of streptococcus pneumoniaehas not been established. Merrem iv meropenem dosing, indications, interactions.
Meronem from astrazeneca, meropenem aeropen to esblanem. Environmental risk assessment data meropenem astrazeneca. A link to download a pdf version of the drug profile will be included in your email receipt. Search medical information this website was created by astrazeneca healthcare professionals for healthcare professionals. Optimization of meropenem minimum concentration mic ratio. Highlights of prescribing information these highlights do not include all the information needed to use vabomere safely and effectively.
Meronem iv 500mg powder for solution for injection or. Pdf meropenem monotherapy is as effective as and safer than. Recommended merrem iv dosage schedule for pediatric patients 3. It is designed to provide selfservice access to medical information about astrazeneca drugs and disease education. Meropenem is a carbapenem antibiotic created by sumitomo dainippon pharma and developed as an antibiotic preparation for injection, which was launched in japan in 1995. Questions and answers on the referral for meronem and. Dec 23, 2019 meropenem has been shown to penetrate well into several body fluids and tissues. Pdf widespread emergence of resistance to antimicrobial agents is a serious problem. Meropenem trihydrate a derivative of meropenem is reported as an ingredient of meropenem pfizer in the following countries.
Meropenem, sold under the brandname merrem among others, is a broadspectrum antibiotic used to treat a variety of bacterial infections. In addition, an altered 2 side chain enhances its antipseudomonal activity. Identification of the substancemixture and of the companyundertaking product identifier meronem details of the supplier of the safety data sheet. Sin embargo, meropenem es intrinsecamente mas potente contra pseudomonas aeruginosa y puede ser activo in vitro contra cepas resistentes a imipenem. The agencys committee for medicinal products for human use chmp has concluded that there is a need to harmonise the prescribing information for meronem and associated names in the european union eu. Meropenem indicaciones, dosificacion, presentacion, efectos. Patients from 28 centers in the usa received meropenem 1 g every 8 h intravenously. The web version of each document is easier to navigate. Below is a complete list of astrazeneca products and associated prescribing information. Ertapenem is a bacterial cell wall biosynthesis inhibitor with activity against a wide range of gramnegative and grampositive bacteria and resistance to a broad and extended spectrum of. Meropenem is a broad spectrum injectable antibiotic for a wide variety of serious. Ends notes to editors about astrazeneca s small molecule antiinfective business medicine indication merremmeronem meropenem merremmeronem is a carbapenem antibacterial used for the treatment of serious infections in hospitalised patients. Sumitomo dainippon pharma announces partnership with.
Nov 18, 2012 meropenem is a recently developed carbapenem antibiotic, similar to imipenem, with a wide spectrum of activity against grampositive and gramnegative bacteria. For intravenous use only food and drug administration. Mar 27, 2019 bula meropenem pdf meronem meropenem triidratado. Meropenem is used to treat severe infections of the skin or stomach. Data sources include ibm watson micromedex updated 28 feb 2020, cerner multum updated 2 mar 2020, wolters kluwer updated. It is given by injection into a vein common side effects include nausea, diarrhea, constipation, headache, rash, and pain at the site of injection. Vabomere meropenem and vaborbactam for injection, for intravenous use initial u. Indications and usage, intraabdominal infections, pediatric patients less than 3 months of age 1. Compare prices, print coupons and get savings tips for meropenem generic merrem and other skin infection, bacterial infection, meningitis, and gastrointestinal infection drugs at cvs, walgreens, and other pharmacies. Astrazeneca pharmaceuticals lp merrem iv meropenem.
Meropenem pfizer may be available in the countries listed below. It was initially marketed by astrazeneca under the trade name merrem, the spectrum of action includes many grampositive and gramnegative bacteria and anaerobic. Meropenem is a broadspectrum, injectable carbapenem antibacterial. Webmd provides common contraindications for meropenem intravenous. On this page about meropenem ranbaxy you will find information relating to side effects, age restrictions, food interactions, whether the medicine is available at a government subsidised price on the pharmaceutical benefits scheme pbs as well as other useful information. Meropenem has been shown to penetrate well into several body fluids and tissues. Highlights of prescribing information see full prescribing. Meropenem is a new carbapenem antibiotic which differs chemically from imipenemcilastatin by having a 1betamethyl substitution, providing it with excellent intrinsic stability to human renal dehydropeptidasei. In comparison with imipenem, meropenem is relatively stable to hydrolysis by the enzyme dehydropeptidase i dhpi, thus precluding the need for coadministration with an inhibitor of dhpi, such as cilastatin. Meropenem appears to be widely distributed in various body tissues and fluids hutchison et al 1995. Esta bula foi atualizada conforme bula padrao aprovada pela anvisa em. Meropenem monotherapy as empirical t reatment of febrile neutropenia in childhood cancer patients stay was detected to be significantly longer in patients 5 years old and younger table 2. Meropenem pfizersumitomo dainippon pharma adisinsight. Page 1 of 39 product monograph merrem meropenem for injection, 500 mg, 1 g per vial as meropenem trihydrate for intravenous use antibiotic astrazeneca canada inc.
It is hoped that the pharmacodynamics of meropenem t mic and the minimum concentration c minmic ratio can be optimized by this innovative and practical dosing strategy. In order to monitor the safety of astrazeneca products, we encourage reporting any side effects experienced while taking an astrazeneca product to the az information center at 18002369933. Use of meronem from astrazeneca, pregnancy, lactation in childrens and special precautions. Meropenem es activo in vitro contra muchas cepas resistentes a otros antibioticos. Meropenem side effects, dosage, interactions drugs. Indications and usage merrem iv is a penem antibacterial indicated for the treatment of. Complicated skin and skin structure infections adult patients and pediatric patients 3 months of age and older only. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Alternatively, you can report any side effects of prescription drugs directly to the fda. As bulas disponibilizadas neste site nao substituem a relacao entre medico e paciente. The pdf version is available to download and print. Meropenem 1g powder for solution for injection or infusion polonia meropenem noridem 1g proszek do sporz. Sep 17, 2012 meropenem merrem, meronem is a broadspectrum antibacterial agent of the carbapenem family, indicated as empirical therapy prior to the identification of causative organisms, or for disease caused by single or multiple susceptible bacteria in both adults and children with a broad range of serious infections. The prolonged infusion of meropenem is being investigated clinically in a multicenter trial of nosocomial pneumonia g.
142 1392 1565 910 145 1637 1128 57 1224 835 1001 505 660 874 1216 1447 790 814 1254 197 1598 1580 1648 1551 174 1387 1078 745 443 1296 667 509 134 1276 1107 130 268 1356 1127 1008 1196