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Seizures have infrequently been reported during treatment with carbapenems, including meropenem (see section 4.8). Treatment of patients with bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed above. There was no evidence of mutagenic potential in a conventional test battery and no evidence of reproductive toxicity including teratogenic potential in studies in rats up to 750 mg/kg and in monkeys up to 360 mg/kg. The probabilistic analysis showed that meropenem was the dominant strategy in 94% of the simulations. Each vial contains meropenem trihydrate equivalent to 500 mg anhydrous meropenem. 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. If you are a US Healthcare Professional, click OK to continue. The cost of Carbavance is not yet known. The intravenous formulation was well tolerated in animal studies. There was no evidence of increased sensitivity to meropenem in juveniles compared to adult animals. Meropenem, sold under the brandname Merrem among others, is a broad-spectrum antibiotic used to treat a variety of bacterial infections. 3. Continue typing to refine. 2. There is no experience in children with renal impairment. 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. Bluish lips or skin 2. chills 3. cold, clammy skin 4. confusion 5. dizziness 6. fainting 7. fast heartbeat 8. fast, weak pulse 9. fever 10. itching, skin rash 11. lightheadedness 12. rapid, shallow breathing 13. sweating By Imraan Joosub, Andy Gray, Analyn Crisostomo and Abdul Salam. 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. There are limited safety data available to support the administration of a 2 g dose in adults as an intravenous bolus injection. 9/2020  PP-VAB-US-0184. For the full list of excipients, see section 6.1. Interaction studies have only been performed in adults. Meropenem is cleared by haemodialysis and haemofiltration. Prescribing VABOMERE in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of. Pharmacoeconomic analyses of meropenem from a health payer perspective in the UK, US and Russia predicted that meropenem is a cost-effective therapy relative to other antibacterials, including imipenem/cilastatin or conventional combination antibacterial treatments in the treatment of serious bacterial infections in intensive care units. 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. 1 Meropenem breakpoints for Streptococcus pneumoniae and Haemophilus influenzae in meningitis are 0.25 mg/l (Susceptible) and 1 mg/l (Resistant). Prescribers are advised to take into account the local prevalence of resistance in these bacteria to penems. -- = Susceptibility testing not recommended as the species is a poor target for therapy with the drug. Effects were seen in acute toxicity studies in rodent at doses exceeding 1000 mg/kg. 1. Severe hypersensitivity (e.g. To reduce the development of drug-resistant bacteria and maintain the effectiveness of VABOMERE and other antibacterial drugs, VABOMERE should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. The most commonly reported meropenem-related laboratory adverse events were thrombocytosis (1.6%) and increased hepatic enzymes (1.5-4.3%). As with other antibacterial drugs, prolonged use of VABOMERE may result in overgrowth of nonsusceptible organisms. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). Animal studies indicate that meropenem is well tolerated by the kidney. analysis, which revealed that in 99% of cases meropenem dominated imipenem plus cilastatin. 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. Until there is evidence regarding clinical response for confirmed isolates with MIC values above the current resistant breakpoint they should be reported resistant. The base case also predicts NHS resource savings valued at £6,091 in Year 1, increasing to £15,228 in Year 5. Introduction. Prices are for cash paying customers only and are not valid with insurance plans. Close adherence to the recommended dosage regimens is urged, especially in patients with known factors that predispose to convulsive activity. Additional considerations for dosing are needed when treating patients with renal insufficiency (see further below). Find its price or cost, dose, when to use, how to use, side effects, adverse effects, substitutes. The IV LD50 of meropenem in rodents is greater than 2000 mg/kg. By continuing to browse the site you are agreeing to our policy on the use of cookies. VABOMERE [package insert]: Melinta Therapeutics, Inc. Therefore, it is important to consider this diagnosis in patients who present with diarrhoea during or subsequent to the administration of meropenem (see section 4.8). Meropenem Prices. 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). Meropenem is generally well tolerated by the central nervous system. Meronem is licensed for children over 3 months of age. Meropenem is a carbapenem-type antibiotic that works by stopping the growth of bacteria. For medical inquiries or to report an adverse event, other safety-related information, or product complaints for a company product, please contact Medical Information. Impact on Patients and Carers Reduced mortality/increased length of survival Reduced symptoms or disability Meropenem is usually given by intravenous infusion over approximately 15 to 30 minutes (see sections 6.2, 6.3, and 6.6). The cost of 1 day's treatment with 2 g (2 vials) every 8 hours is £106.68. This information is intended for use by health professionals. 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. If not used immediately in-use storage times and conditions are the responsibility of the user. Resistance rate ≥ 50% in one or more EU countries. EUCAST clinical MIC breakpoints for meropenem (2013-02-11, v 3.1), Haemophilus influenzae1, 2 and Moraxella catarrhalis2, Gram-positive anaerobes except Clostridium difficile. varies across the European Union. Resistance to penems of Enterobacteriaceae, Pseudomonas aeruginosa and Acinetobacter spp. There are no established dose recommendations for patients receiving peritoneal dialysis. 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. Medicinal products that inhibit peristalsis should not be given. anaphylactic reaction, severe skin reaction) to any other type of beta-lactam antibacterial agent (e.g. Caution is required if probenecid is co-administered with meropenem. 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. Symptomatic treatments should be considered. To bookmark a medicine you must sign up and log in. This study compared the cost-effectiveness of meropenem with that of imipenem plus cilastatin in the treatment of severe infections in hospital intensive care in the UK. Pooled analysis from the TANGO 1 and TANGO 2 trials were released by The Medicines Company. These result from reduced cost of adverse events. This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6. There is no target-based cross-resistance between meropenem and agents of the quinolone, aminoglycoside, macrolide and tetracycline classes. A positive direct or indirect Coombs test may develop during treatment with meropenem. Diagn Microbiol Infect Dis. Meropenem is a clinically important antibacterial reserved for treatment of multi-resistant infections. Vabomere® (meropenem and vaborbactam) is available for your patients and our wholesalers remain stocked with all of the products in our portfolio. Any unused product or waste material should be disposed of in accordance with local requirements. There is no evidence of an increased risk of any adverse drug reaction in children based on the limited available data. † For ordering information, please click here. The following table of pathogens listed is derived from clinical experience and therapeutic guidelines. To email a medicine you must sign up and log in. Global Meropenem Trihydrate Market Size, Status And Outlook 2020-2021. Launch of Vaborem™ helps address the need for new products to combat multidrug-resistant Gram-negative bacteria. 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. If signs and symptoms suggestive of these reactions appear, meropenem should be withdrawn immediately and an alternative treatment should be considered. Imipenem and meropenem are useful in cases in which P. aeruginosa is a suspected pathogen. 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. 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 Enterobacter cloacae species complex. When suggestions are available use up and down arrows to review and ENTER to select. In healthy subjects the mean plasma half-life is approximately 1 hour; the mean volume of distribution is approximately 0.25 l/kg (11-27 l) and the mean clearance is 287 ml/min at 250 mg falling to 205 ml/min at 2 g. Doses of 500, 1000 and 2000 mg doses infused over 30 minutes give mean Cmax values of approximately 23, 49 and 115 μg/ml respectively, corresponding AUC values were 39.3, 62.3 and 153 μg.h/ml. Hypersensitivity reactions were reported in patients treated with VABOMERE in the clinical trials. Meronem (1 gm) 1gm - 1 Vial Injection (Meropenem) drug information. Relative overdose may be possible in patients with renal impairment if the dose is not adjusted as described in section 4.2. Alternatively, meropenem doses of up to 20 mg/kg may be given as an intravenous bolus over approximately 5 minutes. Description: Meropenem (SM 7338) is an ultra-broad spectrum injectable antibiotic. Meropenem is a broad-spectrum carbapenem antibiotic with clinical utility in a wide range of multidrug-resistant Gram-negative infections.1 Outpatient parenteral antimicrobial therapy (OPAT) is becoming an increasingly important model for managing infections both in the UK and worldwide. If a severe allergic reaction occurs, the medicinal product should be discontinued and appropriate measures taken. Currently, there is a lack of stability data on meropenem at various concentrations in elastomeric infusion devices for use in outpatient parenteral antimicrobial therapy (OPAT). Concomitant use with valproic acid/sodium valproate/valpromide. The solution should be shaken before use. 2004;49(1):41-46. • Broncho-pulmonary infections in cystic fibrosis, • Complicated skin and soft tissue infections. In individuals with normal renal function, rapid renal elimination will occur. This site uses cookies. BACKGROUND: Treating patients admitted to critical care with severe pneumonia requires timely intervention with an effective antibiotic. The most frequently reported adverse reactions occurring in ≥3% of patients treated with VABOMERE were headache, phlebitis/infusion site reactions, and diarrhea. †In vitro activity does not necessarily correlate with clinical efficacy. Meronem may be used in the management of neutropenic patients with fever that is suspected to be due to a bacterial infection. penicillins or cephalosporins). To view the changes to a medicine you must sign up and log in. 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. The potential effect of meropenem on the protein binding of other medicinal products or metabolism has not been studied. 2 g x 3 daily was taken into consideration for severe infections and in setting the I/R breakpoint. Patients who have a history of hypersensitivity to carbapenems, penicillins or other beta-lactam antibiotics may also be hypersensitive to meropenem. Cost-minimization analysis of imipenem/cilastatin versus meropenem in moderate to severe infections at a tertiary care hospital in Saudi Arabia . The Menarini Group Launches Vaborem™ (meropenem-vaborbactam) in the UK during World Antibiotic Awareness Week 2019. 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. Children from 3 months to 11 years of age and up to 50 kg body weight, Severe pneumonia including hospital and ventilator-associated pneumonia. 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 … Meromac (2g) - 1 Injection (Meropenem) drug information. Treatment with meropenem had an expected cost of £19,026 and QALYs were 4.768. Localised clusters of infections due to carbapenem-resistant bacteria have been reported in the European Union. Severe pneumonia including hospital and ventilator-associated pneumonia. Small amounts of meropenem have been reported to be excreted in human milk. Species for which acquired resistance may be a problem, $ Species that show natural intermediate susceptibility, £ Enterobacteriaceae, Pseudomonas aeruginosa, Acinetobacter spp. The pharmacokinetics of meropenem in neonates requiring anti-infective treatment showed greater clearance in neonates with higher chronological or gestational age with an overall average half-life of 2.9 hours. Haemodialysis will remove meropenem and its metabolite. 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). agranulocytosis, haemolytic anaemia, thrombocytopenia, neutropenia, leukopenia, eosinophilia, anaphylaxis (see sections 4.3 and 4.4), angioedema, diarrhoea, abdominal pain, vomiting, nausea, antibiotic-associated colitis (see section 4.4), transaminases increased, blood alkaline phosphatase increased, blood lactate dehydrogenase increased, toxic epidermal necrolysis, Stevens Johnson syndrome, erythema multiforme (see section 4.4), urticaria, drug reaction with eosinophilia and systemic symptoms, acute generalised exanthematous pustulosis (see section 4.4), blood creatinine increased, blood urea increased, General disorders and administration site conditions, thrombophlebitis, pain at the injection site. Pooled analysis from the two phase III TANGO 1 and TANGO 2 trials for meropenem/vaborbactam showed that mortality at 28 days was 25% in treatment-arm vs. 44% for best available therapy (43.7% reduction).

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