London (UK). A dose of up to 2 g three times daily in adults and adolescents and a dose of up to 40 mg/kg three times daily in children may be particularly appropriate when treating some types of infections, such as infections due to less susceptible bacterial species (e.g. From a microbiological point of view, unless the method of opening/reconstitution/dilution precludes the risk of microbiological contamination, the product should be used immediately. Dose (based on “unit” dose range of 500 mg or 1 g or 2 g, see table above). Meropenem is generally well tolerated by the central nervous system. Start typing to retrieve search suggestions. This site is intended for US Healthcare Professionals. analysis, which revealed that in 99% of cases meropenem dominated imipenem plus cilastatin. The cost of 1 day's treatment with 2 g (2 vials) every 8 hours is £106.68. -- = Susceptibility testing not recommended as the species is a poor target for therapy with the drug. Pooled analysis from the TANGO 1 and TANGO 2 trials were released by The Medicines Company. The probabilistic analysis showed that meropenem was the dominant strategy in 94% of the simulations. resistance. penicillins or cephalosporins). Isolates may be reported as R without prior testing. The medicinal product is supplied in pack sizes of 1 or 10 vials. The prevalence of acquired resistance may vary geographically and with time for selected species and local information on resistance is desirable, particularly when treating severe infections. Vaborbactam is an enzyme inhibitor (beta-lactamase inhibitor) that helps meropenem work better. 2 Isolates with MIC values above the susceptible breakpoint are very rare or not yet reported. The selection of meropenem to treat an individual patient should take into account the appropriateness of using a carbapenem antibacterial agent based on factors such as severity of the infection, the prevalence of resistance to other suitable antibacterial agents and the risk of selecting for carbapenem-resistant bacteria. Until there is evidence regarding clinical response for confirmed isolates with MIC values above the current resistant breakpoint they should be reported resistant. 2. Broncho-pulmonary infections in cystic fibrosis, Complicated skin and soft tissue infections, Management of febrile neutropenic patients. There are no established dose recommendations for patients receiving peritoneal dialysis. If signs and symptoms suggestive of these reactions appear, meropenem should be withdrawn immediately and an alternative treatment should be considered. 2004;49(1):41-46. VABOMERE is contraindicated in patients with known hypersensitivity to any components of VABOMERE (meropenem and vaborbactam), or to other drugs in the same class or in patients who have demonstrated anaphylactic reactions to beta-lactam antibacterial drugs. Meropenem, sold under the brandname Merrem among others, is a broad-spectrum antibiotic used to treat a variety of bacterial infections. Tel 1-844-MED-MLNT (1-844-633-6568)1-844-MED-MLNT (1-844-633-6568), ©2020 Melinta Therapeutics, Inc.  All rights reserved. The threshold analysis showed that meropenem would be the dominant strategy until the cost of imipenem plus cilastatin was reduced to 4.08 or less (72 in the base-case), or until its daily cost was increased to 158.25 or more (85.25 in the base-case). Glanders and melioidosis: Use of meropenem in humans is based on in vitro B.mallei and B. pseudomallei susceptibility data and on limited human data. If you are a US Healthcare Professional, click OK to continue. The rising incidence of resistance to currently available antibiotics among pathogens, particularly Gram-negative pathogens, in complicated intra-abdominal infections (cIAIs) has become a challenge for clinicians. Effects were seen in acute toxicity studies in rodent at doses exceeding 1000 mg/kg. 4.7 Effects on ability to drive and use machines No studies on the effect on the ability to drive and use machines have been performed. Meropenem is already marketed in the UK; a 10 vial pack of 500mg powder for solution for injection costs £77. In meropenem-resistant bacteria of the family Enterobacteriales, NDM-1 is considerably more common than IMP-1, despite both metallo-β-lactamases (MBLs) hydrolysing meropenem with almost identical kinetics. Seizures and other adverse Central Nervous System (CNS) experiences have been reported during treatment with meropenem, which is a component of VABOMERE. Hepatic function should be closely monitored during treatment with meropenem due to the risk of hepatic toxicity (hepatic dysfunction with cholestasis and cytolysis) (see section 4.8). For medical inquiries or to report an adverse event, other safety-related information, or product complaints for a company product, please contact Medical Information. When suggestions are available use up and down arrows to review and ENTER to select. This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6. If not used immediately in-use storage times and conditions are the responsibility of the user. Alternatively, doses up to 1 g can be given as an intravenous bolus injection over approximately 5 minutes. Qualitative and quantitative composition, 4.2 Posology and method of administration, 4.4 Special warnings and precautions for use, 4.5 Interaction with other medicinal products and other forms of interaction, 4.7 Effects on ability to drive and use machines, 6.6 Special precautions for disposal and other handling, 9. 6 The beta-lactam susceptibility of streptococcus groups A, B, C and G is inferred from the penicillin susceptibility. Antibiotic-associated colitis and pseudomembranous colitis have been reported with nearly all anti-bacterial agents, including meropenem, and may range in severity from mild to life threatening. † Meropenem-vaborbactam (Vabomere) Meropenem is a carbapenem antibiotic and vaborbactam is a beta-lactamase inhibitor. Continue typing to refine. In vitro killing of parenteral beta-lactams against standard and high inocula of extended-spectrum beta-lactamase and non-ESBL producing Klebsiella pneumoniae. Furthermore, the report also provides the qualitative results of diverse market … Direct antiglobulin test (Coombs test) seroconversion. Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. In patients with renal impairment, thrombocytopenia has been observed in patients treated with meropenem, but no clinical bleeding has been reported. The constituted solutions should not be frozen. 9/2020  PP-VAB-US-0184. Background: The rising incidence of resistance to currently available antibiotics among pathogens, particularly Gram-negative pathogens, in complicated intra-abdominal infections (cIAIs) has become a challenge for clinicians. Probenecid competes with meropenem for active tubular secretion and thus inhibits the renal excretion of meropenem with the effect of increasing the elimination half-life and plasma concentration of meropenem. They are for use only for organisms that do not have specific breakpoints. Hypersensitivity reactions were reported in patients treated with VABOMERE in the clinical trials. Animal studies indicate that meropenem is well tolerated by the kidney. Resistance rate ≥ 50% in one or more EU countries. Prescribers are advised to take into account the local prevalence of resistance in these bacteria to penems. 5 Non-species related breakpoints have been determined using PK/PD data and are independent of MIC distributions of specific species. Treatment with meropenem had an expected cost of £19,026 and QALYs were 4.768. Diagn Microbiol Infect Dis. Tuesday, November 19th 2019, London 07:30. As with all beta-lactam antibiotics, serious and occasionally fatal hypersensitivity reactions have been reported (see sections 4.3 and 4.8). Launch of Vaborem™ helps address the need for new products to combat multidrug-resistant Gram-negative bacteria. In the table below all adverse reactions are listed by system organ class and frequency: very common (≥ 1/10); common (≥ 1/100 to <1/10); uncommon (≥ 1/1,000 to <1/100); rare (≥ 1/10,000 to <1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data). Standard aseptic techniques should be used for solution preparation and administration. In individuals with normal renal function, rapid renal elimination will occur. Review appropriate cUTI patients for VABOMERE treatment, VABOMERE® has 32-fold more in vitro activity than meropenem alone1*, Meropenem and vaborbactam weredesigned to work together2,3. Get PDF (494 KB) Cite . ), or very severe infections. Reconstituted solution of the product in 5% dextrose solution should be used immediately. Meropenem should not be used in breast-feeding women unless the potential benefit for the mother justifies the potential risk to the baby. Use normal dose every 12 hours if eGFR 26–50 mL/minute/1.73 m 2.. Use half normal dose every 12 hours if eGFR 10–25 mL/minute/1.73 m 2.. Use half normal dose every 24 hours if eGFR less than 10 mL/minute/1.73 m 2. The required dose should be administered after completion of the haemodialysis cycle. For the full list of excipients, see section 6.1. To email a medicine you must sign up and log in. A solution for infusion is prepared by dissolving the drug product in either 0.9% sodium chloride solution for infusion or 5% dextrose solution for infusion to a final concentration of 1 to 20 mg/ml. BACKGROUND: Treating patients admitted to critical care with severe pneumonia requires timely intervention with an effective antibiotic. Close adherence to the recommended dosage regimens is urged, especially in patients with known factors that predispose to convulsive activity. Before initiating therapy with meropenem, careful inquiry should be made concerning previous hypersensitivity reactions to beta-lactam antibiotics.
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