For storage conditions after reconstitution of the medicinal product, see section 6.3. This information is intended for use by health professionals. Children from 3 months to 11 years of age and up to 50 kg body weight, Severe pneumonia including hospital and ventilator-associated pneumonia. Alert patients receiving VABOMERE on an outpatient basis regarding adverse reactions such as seizures, delirium, headaches and/or paresthesias that could interfere with mental alertness and/or cause motor impairment. Discontinuation of therapy with meropenem and the administration of specific treatment for Clostridium difficile should be considered. All methicillin-resistant staphylococci are resistant to meropenem. The identification and antimicrobial susceptibility tests on any such isolate must be repeated and if the result is confirmed the isolate sent to a reference laboratory. Histological evidence of renal tubular damage was seen in mice and dogs only at doses of 2000 mg/kg and above after a single administration and above and in monkeys at 500 mg/kg in a 7-day study. Alternatively, meropenem doses of up to 20 mg/kg may be given as an intravenous bolus over approximately 5 minutes. Vaborbactam is an enzyme inhibitor (beta-lactamase inhibitor) that helps meropenem work better. 2. Prescribers are advised to take into account the local prevalence of resistance in these bacteria to penems. Date of first authorisation/renewal of the authorisation. Use in patients with liver disease: patients with pre-existing liver disorders should have liver function monitored during treatment with meropenem. Hypersensitivity reactions were reported in patients treated with VABOMERE in the clinical trials. London (UK). There are limited safety data available to support the administration of a 40 mg/kg dose in children as an intravenous bolus injection. Symptomatic treatments should be considered. 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. Severe cutaneous adverse reactions (SCAR), such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), erythema multiforme (EM) and acute generalised exanthematous pustulosis (AGEP) have been reported in patients receiving meropenem (see section 4.8). IMPACT - SPECULATIVE . 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. Prices are for cash paying customers only and are not valid with insurance plans. Each 500 mg vial contains 104 mg sodium carbonate which equates to approximately 2 mEq of sodium (approximately 45 mg). Get PDF (494 KB) Cite . Thus, meropenem was the dominant strategy as it was both less expensive and more effective. Diagn Microbiol Infect Dis. 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. Haemodialysis will remove meropenem and its metabolite. Bloodstream Infections. After infusion over 5 minutes Cmax values are 52 and 112 μg/ml after 500 and 1000 mg doses respectively. Further, prolonged storage of reconstituted meropenem in elastomeric infusion devices may be required in rural or remote administration sites where several days’ supply may be needed. No studies on the effect on the ability to drive and use machines have been performed. In individuals with normal renal function, rapid renal elimination will occur. Small amounts of meropenem have been reported to be excreted in human milk. If a severe allergic reaction occurs, the medicinal product should be discontinued and appropriate measures taken. Tuesday, November 19th 2019, London 07:30. Alternatively, meropenem doses of up to 20 mg/kg may be given as an intravenous bolus over approximately 5 minutes. They are for use only for organisms that do not have specific breakpoints. Some of these include meningitis, intra-abdominal infection, pneumonia, sepsis, and anthrax. Impact on Patients and Carers Reduced mortality/increased length of survival Reduced symptoms or disability Chemical and physical in-use stability for a prepared solution for bolus injection has been demonstrated for 3 hours at up to 25°C or 12 hours under refrigerated conditions (2-8°C). Meropenem-vaborbactam (Vabomere) Meropenem is a carbapenem antibiotic and vaborbactam is a beta-lactamase inhibitor. Therefore, this study aimed to … The most commonly reported meropenem-related laboratory adverse events were thrombocytosis (1.6%) and increased hepatic enzymes (1.5-4.3%). Global Meropenem Trihydrate Market Size, Status And Outlook 2020-2021. Meropenem is generally well tolerated by the central nervous system. There is no evidence of an increased risk of any adverse drug reaction in children based on the limited available data. The potential effect of meropenem on the protein binding of other medicinal products or metabolism has not been studied. Pooled analysis from the TANGO 1 and TANGO 2 trials were released by The Medicines Company. 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). The acquisition cost of meropenem alone is £17.78 (excluding VAT) for 1 vial containing 1 g of powder for solution for injection (Drug Tariff, October 2019). resistance. In repeat dose studies of up to 6 months duration only minor effects were seen including a decrease in red cell parameters in dogs. Average Wholesale Prices (AWP) for Commonly-Used Intravenous Antibiotics, by dose, per day (source: Bartlett, J. et al, Johns Hopkins Antibiotic Guide, 2005) As necessary, expert advice should be sought when the local prevalence of resistance is such that the utility of the agent in at least some types of infections is questionable. Localised clusters of infections due to carbapenem-resistant bacteria have been reported in the European Union. There are no established dose recommendations for patients receiving peritoneal dialysis. Find its price or cost, dose, when to use, how to use, side effects, adverse effects, substitutes. Cost-minimization analysis of imipenem/cilastatin versus meropenem in moderate to severe infections at a tertiary care hospital in Saudi Arabia . The most frequently reported adverse reactions occurring in â¥3% of patients treated with VABOMERE were headache, phlebitis/infusion site reactions, and diarrhea. Monte Carlo simulation based on a population PK model showed that a dose regimen of 20 mg/kg 8 hourly achieved 60%T>MIC for P. aeruginosa in 95% of pre-term and 91% of full term neonates. Seizures and other adverse Central Nervous System (CNS) experiences have been reported during treatment with meropenem, which is a component of VABOMERE. Do not freeze the reconstituted solution. A 2015 meta analysis concluded that the anti-pseudomonal penicillin-beta lactamase inhibitor combination piperacillin-tazobactam gives results equivalent to treatment with a carbapenem in patients with sepsis. However, bacteria may exhibit resistance to more than one class of antibacterial agents when the mechanism involved include impermeability and/or an efflux pump(s). 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. 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. As with all beta-lactam antibiotics, serious and occasionally fatal hypersensitivity reactions have been reported (see sections 4.3 and 4.8). This site is intended for US Healthcare Professionals. Meronem 500 mg: This medicinal product contains 45 mg sodium per 500 mg vial, equivalent to 2.25% of the WHO recommended maximum daily intake of 2 g sodium for an adult. anaphylactic reaction, severe skin reaction) to any other type of beta-lactam antibacterial agent (e.g. Burgess OS, Hall RG II. Resistance rate ≥ 50% in one or more EU countries. Continue, 2. For medical inquiries or to report an adverse event, other safety-related information, or product complaints for a company product, please contact Medical Information. 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. To email a medicine you must sign up and log in. Meropenem is usually given by intravenous infusion over approximately 15 to 30 minutes (see sections 6.2, 6.3, and 6.6). Launch of Vaborem™ helps address the need for new products to combat multidrug-resistant Gram-negative bacteria. 14. Case reports in the literature have shown that. Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. The medicinal product is supplied in pack sizes of 1 or 10 vials. Pharmacotherapeutic group: antibacterials for systemic use, carbapenems, ATC code: J01DH02, Pharmacokinetic/Pharmacodynamic (PK/PD) relationship. Patients who have a history of hypersensitivity to carbapenems, penicillins or other beta-lactam antibiotics may also be hypersensitive to meropenem. If not used immediately in-use storage times and conditions are the responsibility of the user. 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. Author information: (1)Kellogg College, University of Oxford, Oxford, UK. A positive direct or indirect Coombs test may develop during treatment with meropenem. VabomereÂ® (meropenem and vaborbactam) is available for your patients and our wholesalers remain stocked with all of the products in our portfolio. There are limited safety data available to support the administration of a 2 g dose in adults as an intravenous bolus injection. The IV LD50 of meropenem in rodents is greater than 2000 mg/kg. Continue typing to refine. Until there is evidence regarding clinical response for confirmed isolates with MIC values above the current resistant breakpoint they should be reported resistant. Treatment with meropenem had an expected cost of £19,026 and QALYs were 4.768. Direct antiglobulin test (Coombs test) seroconversion. Any unused product or waste material should be disposed of in accordance with local requirements. The sole metabolite of meropenem had a similar profile of toxicity in animal studies. Author information: (1)AstraZeneca UK Ltd, Luton, UK. Alternatively, doses up to 1 g can be given as an intravenous bolus injection over approximately 5 minutes. Chemical and physical in-use stability for a prepared solution for infusion using 0.9% sodium chloride solution has been demonstrated for 3 hours at up to 25°C or 24 hours under refrigerated conditions (2-8°C). 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. penicillins or cephalosporins). meropenem: [ mer″o-pen´em ] a broad-spectrum β-lactam antibiotic effective against a wide variety of gram-positive and gram-negative organisms; used in treatment of … Broncho-pulmonary infections in cystic fibrosis, Complicated skin and soft tissue infections, Management of febrile neutropenic patients. Enterobacteriaceae, Pseudomonas aeruginosa and Acinetobacter spp. 9/2020 PP-VAB-US-0184. All reports received were consistent with events observed in the adult population. Severe pneumonia including hospital and ventilator-associated pneumonia. Decreases in blood levels of valproic acid have been reported when it is co-administered with carbapenem agents resulting in a 60-100 % decrease in valproic acid levels in about two days. The solution should be shaken before use. Animal studies indicate that meropenem is well tolerated by the kidney. 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. Close adherence to the recommended dosage regimens is urged, especially in patients with known factors that predispose to convulsive activity. VABOMERE ® (meropenem and vaborbactam) is indicated for the treatment of patients 18 years of age and older with complicated urinary tract infections (cUTI) including pyelonephritis caused by the following susceptible microorganisms: Escherichia coli, Klebsiella pneumoniae, and … EUCAST clinical MIC breakpoints for meropenem (2013-02-11, v 3.1), Haemophilus influenzae1, 2 and Moraxella catarrhalis2, Gram-positive anaerobes except Clostridium difficile. The Meropenem Trihydrate Market report is a collection of useful information, quantitative and qualitative estimation by industry experts, the contribution from industry connoisseurs and industry accomplices across the value chain. 2010 vabomere-meropenem-vaborbactam-1000130 Drugs Drugs meropenem/vaborbactam 2002 966919-overview Diseases & Conditions Dose (based on “unit” dose range of 500 mg or 1 g or 2 g, see table above). 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. Before initiating therapy with meropenem, careful inquiry should be made concerning previous hypersensitivity reactions to beta-lactam antibiotics. However, the protein binding is so low that no interactions with other compounds would be expected on the basis of this mechanism. 2 Isolates with MIC values above the susceptible breakpoint are very rare or not yet reported. Meropenem, sold under the brandname Merrem among others, is a broad-spectrum antibiotic used to treat a variety of bacterial infections. Due to the rapid onset and the extent of the decrease, co-administration of valproic acid/sodium valproate/valpromide with carbapenem agents is not considered to be manageable and therefore should be avoided (see section 4.4). The use of OPAT to deliver meropenem as a continuous infusion in the “hospital in the home” setting has many advantages.
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