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meropenem cost uk

There are limited safety data available to support the administration of a 2 g dose in adults as an intravenous bolus injection. Treatment of patients with bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed above. 1. 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). Powder for solution for injection or infusion. Meronem is licensed for children over 3 months of age. 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). Interaction studies have only been performed in adults. 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. Use in patients with liver disease: patients with pre-existing liver disorders should have liver function monitored during treatment with meropenem. References: Until there is evidence regarding clinical response for confirmed isolates with MIC values above the current resistant breakpoint they should be reported resistant. Meropenem is usually given by intravenous infusion over approximately 15 to 30 minutes (see sections 6.2, 6.3, and 6.6). There is no dose adjustment necessary (see section 4.2). These result from reduced cost of adverse events. 1 Meropenem breakpoints for Streptococcus pneumoniae and Haemophilus influenzae in meningitis are 0.25 mg/l (Susceptible) and 1 mg/l (Resistant). Furthermore, the report also provides the qualitative results of diverse market … Alternatively, doses up to 1 g can be given as an intravenous bolus injection over approximately 5 minutes. Standard aseptic techniques should be used for solution preparation and administration. The concomitant use of meropenem and valproic acid/sodium valproate/valpromide is not recommended (see section 4.5). Seizures have infrequently been reported during treatment with carbapenems, including meropenem (see section 4.8). IMPACT - SPECULATIVE . The following table of pathogens listed is derived from clinical experience and therapeutic guidelines. 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). 9/2020  PP-VAB-US-0184. † 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 required dose should be administered after completion of the haemodialysis cycle. steven.edwards@kellogg.ox.ac.uk BACKGROUND: Treating patients admitted to critical care with severe pneumonia requires timely intervention with an effective antibiotic. 2004;49(1):41-46. 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%). Species for which acquired resistance may be a problem, $ Species that show natural intermediate susceptibility, £ The medicinal product is supplied in pack sizes of 1 or 10 vials. Concomitant use with valproic acid/sodium valproate/valpromide. The cost of 1 day's treatment with 2 g (2 vials) every 8 hours is £106.68. 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. Do not freeze the reconstituted solution. 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 was provided by Molekula (Gillingham, Dorset, UK), whereas amoxicillin and clavulanate were bought from Sigma-Aldrich (Poole, Dorset, UK). Meromac (2g) - 1 Injection (Meropenem) drug information. Case reports in the literature have shown that. Localised clusters of infections due to carbapenem-resistant bacteria have been reported in the European Union. 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. For ordering information, please click here. However, when driving or operating machines, it should be taken into account that headache, paraesthesia and convulsions have been reported for meropenem. After infusion over 5 minutes Cmax values are 52 and 112 μg/ml after 500 and 1000 mg doses respectively. 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 bookmark a medicine you must sign up and log in. Each 500 mg vial contains 104 mg sodium carbonate which equates to approximately 2 mEq of sodium (approximately 45 mg). To email a medicine you must sign up and log in. 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 … 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. In vitro killing of parenteral beta-lactams against standard and high inocula of extended-spectrum beta-lactamase and non-ESBL producing Klebsiella pneumoniae. By continuing to browse the site you are agreeing to our policy on the use of cookies. 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 is usually given by intravenous infusion over approximately 15 to 30 minutes (see sections 6.2, 6.3 and 6.6). 2 g x 3 daily was taken into consideration for severe infections and in setting the I/R breakpoint. Therefore, this study aimed to … London (UK). 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. Meropenem is cleared by haemodialysis and haemofiltration. If signs and symptoms suggestive of these reactions appear, meropenem should be withdrawn immediately and an alternative treatment should be considered. Resistance rate ≥ 50% in one or more EU countries. Author information: (1)AstraZeneca UK Ltd, Luton, UK. steven.j.edwards@astrazeneca.com 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. Dose (based on “unit” dose range of 500 mg or 1 g or 2 g, see table above). The intravenous formulation was well tolerated in animal studies. Alternatively, meropenem doses of up to 20 mg/kg may be given as an intravenous bolus over approximately 5 minutes. 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. 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. 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. When multiple doses are administered 8-hourly to subjects with normal renal function, accumulation of meropenem does not occur. Symptomatic treatments should be considered. Average Wholesale Prices (AWP) for Commonly-Used Intravenous Antibiotics, by dose, per day (source: Bartlett, J. et al, Johns Hopkins Antibiotic Guide, 2005) Impact on Patients and Carers Reduced mortality/increased length of survival Reduced symptoms or disability This information is intended for use by health professionals. Find its price or cost, dose, when to use, how to use, side effects, adverse effects, substitutes. The constituted solutions should not be frozen. They are for use only for organisms that do not have specific breakpoints. Each vial contains meropenem trihydrate equivalent to 500 mg anhydrous meropenem. Meropenem is usually given by intravenous infusion over approximately 15 to 30 minutes (see sections 6.2, 6.3, and 6.6). 14. Children from 3 months to 11 years of age and up to 50 kg body weight, Severe pneumonia including hospital and ventilator-associated pneumonia. 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. This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6. Broncho-pulmonary infections in cystic fibrosis, Complicated skin and soft tissue infections, Management of febrile neutropenic patients. 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. For medical inquiries or to report an adverse event, other safety-related information, or product complaints for a company product, please contact Medical Information. 6 The beta-lactam susceptibility of streptococcus groups A, B, C and G is inferred from the penicillin susceptibility. Tuesday, November 19th 2019, London 07:30. The most commonly reported meropenem-related laboratory adverse events were thrombocytosis (1.6%) and increased hepatic enzymes (1.5-4.3%). Hypersensitivity reactions were reported in patients treated with VABOMERE in the clinical trials. Enterobacteriaceae, Pseudomonas aeruginosa, Acinetobacter spp. 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 A positive direct or indirect Coombs test may develop during treatment with meropenem. There was no evidence of increased sensitivity to meropenem in juveniles compared to adult animals. This site uses cookies. ), or very severe infections. 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). Data on file: Melinta Therapeutics, Inc. 2. Patients who have a history of hypersensitivity to carbapenems, penicillins or other beta-lactam antibiotics may also be hypersensitive to meropenem. Small amounts of meropenem have been reported to be excreted in human milk. 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. The sole metabolite of meropenem had a similar profile of toxicity in animal studies. Meropenem is already marketed in the UK; a 10 vial pack of 500mg powder for solution for injection costs £77. In repeat dose studies of up to 6 months duration only minor effects were seen including a decrease in red cell parameters in dogs. Diagn Microbiol Infect Dis. 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. 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 storage conditions after reconstitution of the medicinal product, see section 6.3. Caution is required if probenecid is co-administered with meropenem. Resistance to penems of Enterobacteriaceae, Pseudomonas aeruginosa and Acinetobacter spp. Severe hypersensitivity (e.g. The base case also predicts NHS resource savings valued at £6,091 in Year 1, increasing to £15,228 in Year 5. Description: Meropenem (SM 7338) is an ultra-broad spectrum injectable antibiotic. 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. 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). 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. If you are a US Healthcare Professional, click OK to continue. The Menarini Group Launches Vaborem™ (meropenem-vaborbactam) in the UK during World Antibiotic Awareness Week 2019. analysis, which revealed that in 99% of cases meropenem dominated imipenem plus cilastatin. 3. Author information: (1)Kellogg College, University of Oxford, Oxford, UK. Meropenem, sold under the brandname Merrem among others, is a broad-spectrum antibiotic used to treat a variety of bacterial infections. varies across the European Union. The potential effect of meropenem on the protein binding of other medicinal products or metabolism has not been studied. Discontinuation of therapy with meropenem and the administration of specific treatment for Clostridium difficile should be considered. Pooled analysis from the TANGO 1 and TANGO 2 trials were released by The Medicines Company. 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. Animal studies indicate that meropenem is well tolerated by the kidney. Additional considerations for dosing are needed when treating patients with renal insufficiency (see further below). Burgess OS, Hall RG II. 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. resistance. • Broncho-pulmonary infections in cystic fibrosis, • Complicated skin and soft tissue infections. 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. Intravenous bolus injection administration. 2 Isolates with MIC values above the susceptible breakpoint are very rare or not yet reported. The cost of Carbavance is not yet known. Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Relative overdose may be possible in patients with renal impairment if the dose is not adjusted as described in section 4.2. Some of these include meningitis, intra-abdominal infection, pneumonia, sepsis, and anthrax. 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. 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. Prescribers are advised to take into account the local prevalence of resistance in these bacteria to penems. Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. Use normal dose every 12 hours if estimated glomerular filtration rate 26–50 mL/minute/1.73 m 2.. Use half normal dose every 12 hours if estimated glomerular filtration rate 10–25 mL/minute/1.73 m 2.. Use half normal dose every 24 hours if estimated glomerular filtration rate less than 10 mL/minute/1.73 m 2. No studies on the effect on the ability to drive and use machines have been performed. Tel 1-844-MED-MLNT (1-844-633-6568)1-844-MED-MLNT (1-844-633-6568), ©2020 Melinta Therapeutics, Inc.  All rights reserved. For the full list of excipients, see section 6.1. Any unused product or waste material should be disposed of in accordance with local requirements. Isolates may be reported as R without prior testing. As with other antibacterial drugs, prolonged use of VABOMERE may result in overgrowth of nonsusceptible organisms. Treating physicians should refer to national and/or international consensus documents regarding the treatment of glanders and melioidosis. In patients with renal impairment, thrombocytopenia has been observed in patients treated with meropenem, but no clinical bleeding has been reported. Get PDF (494 KB) Cite . There are limited safety data available to support the administration of a 40 mg/kg dose in children as an intravenous bolus injection. Meropenem should not be used in breast-feeding women unless the potential benefit for the mother justifies the potential risk to the baby. Find its price or cost, dose, when to use, how to use, side effects, adverse effects, substitutes. As with all beta-lactam antibiotics, serious and occasionally fatal hypersensitivity reactions have been reported (see sections 4.3 and 4.8). Start typing to retrieve search suggestions. 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. penicillins or cephalosporins). 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. The most frequently reported adverse reactions occurring in ≥3% of patients treated with VABOMERE were headache, phlebitis/infusion site reactions, and diarrhea. Meronem may be used in the management of neutropenic patients with fever that is suspected to be due to a bacterial infection. 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. A solution for bolus injection is prepared by dissolving the drug product in water for injection to a final concentration of 50 mg/ml. When suggestions are available use up and down arrows to review and ENTER to select. Launch of Vaborem™ helps address the need for new products to combat multidrug-resistant Gram-negative bacteria. 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. As a precautionary measure, it is preferable to avoid the use of meropenem during pregnancy. Effects were seen in acute toxicity studies in rodent at doses exceeding 1000 mg/kg. There is no evidence of an increased risk of any adverse drug reaction in children based on the limited available data. There are no established dose recommendations for patients receiving peritoneal dialysis. Imipenem and meropenem are useful in cases in which P. aeruginosa is a suspected pathogen. 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). VABOMERE [package insert]: Melinta Therapeutics, Inc. 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. Vaborbactam is an enzyme inhibitor (beta-lactamase inhibitor) that helps meropenem work better. Serious and occasionally fatal hypersensitivity (anaphylactic) reactions and serious skin reactions have been reported in patients receiving therapy with. 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. 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. Hypersensitivity to any other carbapenem antibacterial agent. 5 Non-species related breakpoints have been determined using PK/PD data and are independent of MIC distributions of specific species. 2010 vabomere-meropenem-vaborbactam-1000130 Drugs Drugs meropenem/vaborbactam 2002 966919-overview Diseases & Conditions Bloodstream Infections. This site is intended for US Healthcare Professionals. The concomitant use of VABOMERE and valproic acid or divalproex sodium is generally not recommended. Alternatively, meropenem doses of up to 20 mg/kg may be given as an intravenous bolus over approximately 5 minutes. The probabilistic analysis showed that meropenem was the dominant strategy in 94% of the simulations. 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. Thus, meropenem was the dominant strategy as it was both less expensive and more effective. Continue typing to refine. If not used immediately in-use storage times and conditions are the responsibility of the user. Meronem (1 gm) 1gm - 1 Vial Injection (Meropenem) drug information. The IV LD50 of meropenem in rodents is greater than 2000 mg/kg. Prices are for cash paying customers only and are not valid with insurance plans. 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. Meropenem-vaborbactam (Vabomere) Meropenem is a carbapenem antibiotic and vaborbactam is a beta-lactamase inhibitor. 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 … 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). Close adherence to the recommended dosage regimens is urged, especially in patients with known factors that predispose to convulsive activity. 3 Susceptibility of staphylococci to carbapenems is inferred from the cefoxitin susceptibility. anaphylactic reaction, severe skin reaction) to any other type of beta-lactam antibacterial agent (e.g. 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. Enterobacteriaceae, Pseudomonas aeruginosa and Acinetobacter spp. Date of first authorisation/renewal of the authorisation. Meropenem is generally well tolerated by the central nervous system. 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). 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. Vabomere® (meropenem and vaborbactam) is available for your patients and our wholesalers remain stocked with all of the products in our portfolio. This medication is given by injection into a vein as directed by your doctor, usually every 8 hours. †In vitro activity does not necessarily correlate with clinical efficacy. Introduction. 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). Meropenem Prices. To view the changes to a medicine you must sign up and log in. No specific medicinal product interaction studies other than probenecid were conducted. All methicillin-resistant staphylococci are resistant to meropenem. 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.

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