meropenem cost uk

Meronem may be used in the management of neutropenic patients with fever that is suspected to be due to a bacterial infection. Pharmacotherapeutic group: antibacterials for systemic use, carbapenems, ATC code: J01DH02, Pharmacokinetic/Pharmacodynamic (PK/PD) relationship. 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). Seizures and other adverse Central Nervous System (CNS) experiences have been reported during treatment with meropenem, which is a component of VABOMERE. 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. Each 500 mg vial contains 104 mg sodium carbonate which equates to approximately 2 mEq of sodium (approximately 45 mg). Some of these include meningitis, intra-abdominal infection, pneumonia, sepsis, and anthrax. For storage conditions after reconstitution of the medicinal product, see section 6.3. Close adherence to the recommended dosage regimens is urged, especially in patients with known factors that predispose to convulsive activity. Treatment with meropenem had an expected cost of £19,026 and QALYs were 4.768. Enterobacteriaceae, Pseudomonas aeruginosa, Acinetobacter spp. 2. Reconstituted solution of the product in 5% dextrose solution should be used immediately. For the full list of excipients, see section 6.1. Tuesday, November 19th 2019, London 07:30. Treating physicians should refer to national and/or international consensus documents regarding the treatment of glanders and melioidosis. Alternatively, doses up to 1 g can be given as an intravenous bolus injection over approximately 5 minutes. No specific medicinal product interaction studies other than probenecid were conducted. Meropenem is usually given by intravenous infusion over approximately 15 to 30 minutes (see sections 6.2, 6.3, and 6.6). 3. Meropenem is usually given by intravenous infusion over approximately 15 to 30 minutes (see sections 6.2, 6.3 and 6.6). anaphylactic reaction, severe skin reaction) to any other type of beta-lactam antibacterial agent (e.g. London (UK). There is no experience in children with renal impairment. Any unused product or waste material should be disposed of in accordance with local requirements. Meropenem is a carbapenem-type antibiotic that works by stopping the growth of bacteria. Furthermore, the report also provides the qualitative results of diverse market … Meropenem, sold under the brandname Merrem among others, is a broad-spectrum antibiotic used to treat a variety of bacterial infections. Meromac (2g) - 1 Injection (Meropenem) drug information. 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. Limited post-marketing experience indicates that if adverse reactions occur following overdose, they are consistent with the adverse reaction profile described in section 4.8, are generally mild in severity and resolve on withdrawal or dose reduction. Alternatively, meropenem doses of up to 20 mg/kg may be given as an intravenous bolus over approximately 5 minutes. The Menarini Group Launches Vaborem™ (meropenem-vaborbactam) in the UK during World Antibiotic Awareness Week 2019. 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. 2 g x 3 daily was taken into consideration for severe infections and in setting the I/R breakpoint. Serious and occasionally fatal hypersensitivity (anaphylactic) reactions and serious skin reactions have been reported in patients receiving therapy with. Prices are for cash paying customers only and are not valid with insurance plans. In a review of 4,872 patients with 5,026 meropenem treatment exposures, meropenem-related adverse reactions most frequently reported were diarrhoea (2.3%), rash (1.4%), nausea/vomiting (1.4%) and injection site inflammation (1.1%). The probabilistic analysis showed that meropenem was the dominant strategy in 94% of the simulations. varies across the European Union. Imipenem and meropenem are useful in cases in which P. aeruginosa is a suspected pathogen. 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. ), or very severe infections. The cost of Carbavance is not yet known. Author information: (1)AstraZeneca UK Ltd, Luton, UK. Concomitant use with valproic acid/sodium valproate/valpromide. † There is no dose adjustment necessary (see section 4.2). The most frequently reported adverse reactions occurring in ≥3% of patients treated with VABOMERE were headache, phlebitis/infusion site reactions, and diarrhea. However, when driving or operating machines, it should be taken into account that headache, paraesthesia and convulsions have been reported for meropenem. Diagn Microbiol Infect Dis. 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 … To bookmark a medicine you must sign up and log in. As a precautionary measure, it is preferable to avoid the use of meropenem during pregnancy. They are for use only for organisms that do not have specific breakpoints. 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. As with other antibacterial drugs, prolonged use of VABOMERE may result in overgrowth of nonsusceptible organisms. This medication is given by injection into a vein as directed by your doctor, usually every 8 hours. All methicillin-resistant staphylococci are resistant to meropenem. Meropenem Prices. No studies on the effect on the ability to drive and use machines have been performed. 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). In vitro: Meropenem has an antibacterial spectrum which is broadly similar to that of imipenem but, whilst slightly less active against staphylococci and enterococci, it is more active against Pseudomonas aeruginosa, all Enterobacteriaceae and Haemophilus influenzae. Medicinal products that inhibit peristalsis should not be given. Animal studies indicate that meropenem is well tolerated by the kidney. 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. 2004;49(1):41-46. Localised clusters of infections due to carbapenem-resistant bacteria have been reported in the European Union. 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. 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. When suggestions are available use up and down arrows to review and ENTER to select. For ordering information, please click here. 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. Meropenem was provided by Molekula (Gillingham, Dorset, UK), whereas amoxicillin and clavulanate were bought from Sigma-Aldrich (Poole, Dorset, UK). 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. Children from 3 months to 11 years of age and up to 50 kg body weight, Severe pneumonia including hospital and ventilator-associated pneumonia. Meronem is indicated for the treatment of the following infections in adults and children aged 3 months and older (see sections 4.4 and 5.1): • Severe pneumonia, including hospital and ventilator-associated pneumonia. Do not freeze the reconstituted solution. Launch of Vaborem™ helps address the need for new products to combat multidrug-resistant Gram-negative bacteria. 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). Species for which acquired resistance may be a problem, $ Species that show natural intermediate susceptibility, £ 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. The dose of meropenem administered and the duration of treatment should take into account the type of infection to be treated, including its severity, and the clinical response. As with all beta-lactam antibiotics, serious and occasionally fatal hypersensitivity reactions have been reported (see sections 4.3 and 4.8). Until there is evidence regarding clinical response for confirmed isolates with MIC values above the current resistant breakpoint they should be reported resistant. Caution is required if probenecid is co-administered with meropenem. Continue typing to refine. meropenem/vaborbactam would lead to an overall cost of [commercial in confidence figure removed] in Year 1, increasing to [commercial in confidence figure removed] in Year 5. Each vial contains meropenem trihydrate equivalent to 500 mg anhydrous 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. penicillins or cephalosporins). The concomitant use of VABOMERE and valproic acid or divalproex sodium is generally not recommended. Hypersensitivity reactions were reported in patients treated with VABOMERE in the clinical trials. In individuals with normal renal function, rapid renal elimination will occur. In vitro killing of parenteral beta-lactams against standard and high inocula of extended-spectrum beta-lactamase and non-ESBL producing Klebsiella pneumoniae. Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Broncho-pulmonary infections in cystic fibrosis, Complicated skin and soft tissue infections, Management of febrile neutropenic patients. 6 The beta-lactam susceptibility of streptococcus groups A, B, C and G is inferred from the penicillin susceptibility. 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 … 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). If signs and symptoms suggestive of these reactions appear, meropenem should be withdrawn immediately and an alternative treatment should be considered. The cost of 1 day's treatment with 2 g (2 vials) every 8 hours is £106.68. Hypersensitivity to any other carbapenem antibacterial agent. Enterobacteriaceae, Pseudomonas aeruginosa and Acinetobacter spp. Severe hypersensitivity (e.g. -- = Susceptibility testing not recommended as the species is a poor target for therapy with the drug. Case reports in the literature have shown that. 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. The concomitant use of meropenem and valproic acid/sodium valproate/valpromide is not recommended (see section 4.5). Meronem (1 gm) 1gm - 1 Vial Injection (Meropenem) drug information. Therefore, this study aimed to … 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. 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. Powder for solution for injection or infusion. Meropenem is already marketed in the UK; a 10 vial pack of 500mg powder for solution for injection costs £77. Meropenem was FDA-approved in the United States in July of 1996 and is used today for a variety of infections including pneumonia, bacteremia, osteomyelitis, urinary tract infection, and meningitis. Start typing to retrieve search suggestions. †In vitro activity does not necessarily correlate with clinical efficacy. 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. Interaction studies have only been performed in adults. However, the protein binding is so low that no interactions with other compounds would be expected on the basis of this mechanism. 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. 1. Bloodstream Infections. Non species related breakpoints are based on the following dosages: EUCAST breakpoints apply to meropenem 1000 mg x 3 daily administered intravenously over 30 minutes as the lowest dose. Meropenem is usually given by intravenous infusion over approximately 15 to 30 minutes (see sections 6.2, 6.3, and 6.6). 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 Resistance rate ≥ 50% in one or more EU countries. 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. Thus, meropenem was the dominant strategy as it was both less expensive and more effective. Pooled analysis from the TANGO 1 and TANGO 2 trials were released by The Medicines Company. EUCAST clinical MIC breakpoints for meropenem (2013-02-11, v 3.1), Haemophilus influenzae1, 2 and Moraxella catarrhalis2, Gram-positive anaerobes except Clostridium difficile. 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). A positive direct or indirect Coombs test may develop during treatment with meropenem. 2 Isolates with MIC values above the susceptible breakpoint are very rare or not yet reported. This site uses cookies. Intravenous bolus injection administration. Additional considerations for dosing are needed when treating patients with renal insufficiency (see further below). Introduction. If not used immediately in-use storage times and conditions are the responsibility of the user. Find its price or cost, dose, when to use, how to use, side effects, adverse effects, substitutes. Burgess OS, Hall RG II. Vabomere® (meropenem and vaborbactam) is available for your patients and our wholesalers remain stocked with all of the products in our portfolio. Meronem is licensed for children over 3 months of age. A study of 12 patients administered meropenem 1000 mg 8 hourly post-surgically for intra-abdominal infections showed a comparable Cmax and half-life to normal subjects but a greater volume of distribution 27 l. Meropenem is cleared by haemodialysis with clearance during haemodialysis being approximately 4 times higher than in anuric patients. Standard aseptic techniques should be used for solution preparation and administration. 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. 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. 5 Non-species related breakpoints have been determined using PK/PD data and are independent of MIC distributions of specific species. Relative overdose may be possible in patients with renal impairment if the dose is not adjusted as described in section 4.2. Date of first authorisation/renewal of the authorisation. Author information: (1)Kellogg College, University of Oxford, Oxford, UK. All reports received were consistent with events observed in the adult population. The constituted solutions should not be frozen. Meropenem is generally well tolerated by the central nervous system. Meropenem is cleared by haemodialysis and haemofiltration. resistance. Average Wholesale Prices (AWP) for Commonly-Used Intravenous Antibiotics, by dose, per day (source: Bartlett, J. et al, Johns Hopkins Antibiotic Guide, 2005) The cost for meropenem intravenous powder for injection 500 mg is around $41 for a supply of 10 powder for injection, depending on the pharmacy you visit. 2010 vabomere-meropenem-vaborbactam-1000130 Drugs Drugs meropenem/vaborbactam 2002 966919-overview Diseases & Conditions 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 following table of pathogens listed is derived from clinical experience and therapeutic guidelines. 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. Prescribers are advised to take into account the local prevalence of resistance in these bacteria to penems. Use in patients with liver disease: patients with pre-existing liver disorders should have liver function monitored during treatment with meropenem. Alternatively, meropenem doses of up to 20 mg/kg may be given as an intravenous bolus over approximately 5 minutes. Continue, 2. In patients with renal impairment, thrombocytopenia has been observed in patients treated with meropenem, but no clinical bleeding has been reported. Global Meropenem Trihydrate Market Size, Status And Outlook 2020-2021. 1 Meropenem breakpoints for Streptococcus pneumoniae and Haemophilus influenzae in meningitis are 0.25 mg/l (Susceptible) and 1 mg/l (Resistant). References: Patients who have a history of hypersensitivity to carbapenems, penicillins or other beta-lactam antibiotics may also be hypersensitive to meropenem. It is given by injection into a vein.. Common side effects include nausea, diarrhea, constipation, headache, rash, and pain at the site of injection. For instructions on reconstitution of the medicinal product before administration, see section 6.6. 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. 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 potential effect of meropenem on the protein binding of other medicinal products or metabolism has not been studied. 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. BACKGROUND: Treating patients admitted to critical care with severe pneumonia requires timely intervention with an effective antibiotic. Small amounts of meropenem have been reported to be excreted in human milk. A solution for bolus injection is prepared by dissolving the drug product in water for injection to a final concentration of 50 mg/ml. 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). There are limited safety data available to support the administration of a 2 g dose in adults as an intravenous bolus injection. There are no established dose recommendations for patients receiving peritoneal dialysis. 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. Data on file: Melinta Therapeutics, Inc. 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. In repeat dose studies of up to 6 months duration only minor effects were seen including a decrease in red cell parameters in dogs. After infusion over 5 minutes Cmax values are 52 and 112 μg/ml after 500 and 1000 mg doses respectively. When multiple doses are administered 8-hourly to subjects with normal renal function, accumulation of meropenem does not occur. If you are a US Healthcare Professional, click OK to continue. Cost-minimization analysis of imipenem/cilastatin versus meropenem in moderate to severe infections at a tertiary care hospital in Saudi Arabia . 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. Isolates may be reported as R without prior testing. Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6. The use of OPAT to deliver meropenem as a continuous infusion in the “hospital in the home” setting has many advantages. Tel 1-844-MED-MLNT (1-844-633-6568)1-844-MED-MLNT (1-844-633-6568), ©2020 Melinta Therapeutics, Inc.  All rights reserved. Discontinuation of therapy with meropenem and the administration of specific treatment for Clostridium difficile should be considered. Before initiating therapy with meropenem, careful inquiry should be made concerning previous hypersensitivity reactions to beta-lactam antibiotics. Vaborbactam is an enzyme inhibitor (beta-lactamase inhibitor) that helps meropenem work better. Consideration should be given to official guidance on the appropriate use of antibacterial agents. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). IMPACT - SPECULATIVE . The sole metabolite of meropenem had a similar profile of toxicity in animal studies. 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. The medicinal product is supplied in pack sizes of 1 or 10 vials. The most commonly reported meropenem-related laboratory adverse events were thrombocytosis (1.6%) and increased hepatic enzymes (1.5-4.3%). There is no evidence of an increased risk of any adverse drug reaction in children based on the limited available data. 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. Symptomatic treatments should be considered. 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. Find its price or cost, dose, when to use, how to use, side effects, adverse effects, substitutes. These result from reduced cost of adverse events. By continuing to browse the site you are agreeing to our policy on the use of cookies. The solution should be shaken before use. 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). By Imraan Joosub, Andy Gray, Analyn Crisostomo and Abdul Salam. Dose (based on “unit” dose range of 500 mg or 1 g or 2 g, see table above). VABOMERE [package insert]: Melinta Therapeutics, Inc.

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