Meropenem ananta
Ukraine
Table of Contents
INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT MEROPEM ANANTA (MEROPENEMANANTA)
Composition:
active substance: meropenem;
1 vial contains meropenem trihydrate equivalent to anhydrous meropenem 1000 mg;
excipient: anhydrous sodium carbonate.
Pharmaceutical form. Powder for solution for injection or infusion.
Main physicochemical characteristics: white to yellowish powder.
Pharmacotherapeutic group. Antimicrobial agents for systemic use. Carbapenems. ATC code J01D H02.
Pharmacological properties.
Pharmacodynamics.
Meropenem exerts a bactericidal effect by inhibiting the synthesis of bacterial cell walls in Gram-positive and Gram-negative bacteria through binding to penicillin-binding proteins (PBPs).
As with other beta-lactam antibacterial agents, the duration of time during which meropenem concentrations exceed the minimum inhibitory concentrations (MICs) (T> MIC) correlates highly with efficacy. In preclinical models, meropenem demonstrated activity at plasma concentrations exceeding the MIC for infecting microorganisms for approximately 40% of the dosing interval. This target value has not been established clinically.
Bacterial resistance to meropenem may occur due to: (1) decreased permeability of the outer membrane of Gram-negative bacteria (due to reduced porin production), (2) decreased affinity for target PBPs, (3) increased expression of efflux pump components, and (4) production of beta-lactamases capable of hydrolyzing carbapenems.
In the European Union (EU), outbreaks of infection caused by carbapenem-resistant bacteria have been reported.
Cross-resistance between meropenem and medicinal products belonging to the classes of quinolones, aminoglycosides, macrolides, and tetracyclines is absent with respect to the target microorganisms. However, bacteria may exhibit resistance to more than one class of antibacterial agents when the mechanism of action involves reduced membrane permeability and/or the presence of efflux pump(s).
The MIC breakpoints established during clinical studies by the European Committee on Antimicrobial Susceptibility Testing (EUCAST) are available at https://www.ema.europa.eu/documents/other/minimum-inhibitory-concentration-micbreakpoints_en.xlsx
The prevalence of acquired resistance may vary geographically and over time for individual species; therefore, local information on microbial resistance should be taken into account, especially when treating severe infections. If necessary, when the local prevalence of microbial resistance is such that the benefit of using the medicinal product, at least for certain types of infections, is questionable, expert consultation should be sought.
The following pathogenic microorganisms are listed based on clinical experience and therapeutic treatment guidelines.
Typically susceptible species
Gram-positive aerobes
Enterococcus faecalis7
Staphylococcus aureus (methicillin-sensitive)8
Staphylococcus species (methicillin-sensitive), including Staphylococcus epidermidis
Streptococcus agalactiae (Group B)
Streptococcus milleri group (S. anginosus, S. constellatus, and S. intermedius)
Streptococcus pneumoniae
Streptococcus pyogenes (Group A)
Gram-negative aerobes
Citrobacter freundii
Citrobacter koseri
Enterobacter aerogenes
Enterobacter cloacae
Escherichia coli
Haemophilus influenzae
Klebsiella oxytoca
Klebsiella pneumoniae
Morganella morganii
Neisseria meningitidis
Proteus mirabilis
Proteus vulgaris
Serratia marcescens
Gram-positive anaerobes
Clostridium perfringens
Peptoniphilus asaccharolyticus
Peptostreptococcus species (including P. micros, P. anaerobius, P. magnus)
Gram-negative anaerobes
Bacteroides caccae
Bacteroides fragilis group
Prevotella bivia
Prevotella disiens
Species for which acquired resistance may be a problem
Gram-positive aerobes
Enterococcus faecium7,9
Gram-negative aerobes
Acinetobacter species, Burkholderia cepacia
Pseudomonas aeruginosa
Inherently resistant microorganisms
Gram-negative aerobes
Stenotrophomonas maltophilia
Legionella species
Other microorganisms
Chlamydophila pneumoniae
Chlamydophila psittaci
Coxiella burnetii
Mycoplasma pneumoniae
7 Species showing natural intermediate susceptibility.
8 All methicillin-resistant staphylococci are resistant to meropenem.
9 Resistance rate > 50% in one or more EU countries.
Glanders and melioidosis: the use of meropenem in humans is based on in vitro susceptibility data for B. mallei and B. pseudomallei and limited human data. Physicians should refer to national and/or international consensus documents regarding the treatment of glanders and melioidosis.
Pharmacokinetics.
In healthy volunteers, 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 following a 250 mg dose, decreasing to 205 mL/min with a 2 g dose. After administration of doses of 500 mg, 1000 mg, and 2000 mg as a 30-minute infusion, mean maximum concentration (Cmax) values are approximately 23 µg/mL, 49 µg/mL, and 115 µg/mL, respectively; corresponding area under the concentration-time curve (AUC) values are 39.3 µg×h/mL, 62.3 µg×h/mL, and 153 µg×h/mL. After a 5-minute infusion, Cmax is 52 µg/mL and 112 µg/mL following 500 mg and 1000 mg doses, respectively. With multiple dosing every 8 hours in patients with normal renal function, accumulation of meropenem is not observed.
In a study involving 12 patients who received meropenem 1000 mg every 8 hours after surgery for intra-abdominal infections, Cmax and half-life (t1/2) values were consistent with those in healthy individuals, but with a larger volume of distribution (27 L).
Distribution
The mean extent of meropenem binding to plasma proteins is approximately 2% and is independent of drug concentration. After rapid administration (5 minutes or less), pharmacokinetics are biexponential, but this is much less evident after a 30-minute infusion. Meropenem has been shown to penetrate well into certain body fluids and tissues, including lungs, bronchial secretions, bile, cerebrospinal fluid, female genital tissues, skin, fascia, muscle, and peritoneal exudates.
Metabolism
Meropenem is metabolized by hydrolysis of the beta-lactam ring, forming a microbiologically inactive metabolite. In vitro, meropenem shows reduced susceptibility to hydrolysis by human dehydropeptidase-I (DHP-I) compared to imipenem, thus eliminating the need for co-administration of a DHP-I inhibitor.
Excretion
Meropenem is primarily excreted unchanged by the kidneys; approximately 70% (50–75%) of the dose is excreted unchanged within 12 hours, with an additional 28% excreted as the microbiologically inactive metabolite. Only about 2% of the dose is excreted in feces. Measured renal clearance and the effect of probenecid indicate that meropenem undergoes both glomerular filtration and tubular secretion.
Renal impairment
Renal dysfunction results in higher plasma AUC values and a prolonged half-life for meropenem. AUC increased 2.4-fold in patients with moderate renal impairment (creatinine clearance (CrCl) 33–74 mL/min), 5-fold in patients with severe renal impairment (CrCl 4–23 mL/min), and 10-fold in patients undergoing hemodialysis (CrCl < 2 mL/min), compared to healthy volunteers (CrCl > 80 mL/min). AUC values for the microbiologically inactive open-ring metabolite were also significantly increased in patients with renal impairment. Dose adjustment is recommended for patients with moderate and severe renal impairment (see section "Dosage and administration").
Meropenem is removed by hemodialysis, with a clearance during hemodialysis approximately 4 times higher than in anuric patients.
Hepatic impairment
A study in patients with alcoholic cirrhosis showed no effect of liver disease on meropenem pharmacokinetics after repeated dosing.
Adult patients
Pharmacokinetic studies in patients have not revealed significant pharmacokinetic differences compared to healthy volunteers with similar renal function. A population model developed from data in 79 patients with intra-abdominal infection or pneumonia showed dependence of key parameters on body weight, creatinine clearance, and age.
Children
Pharmacokinetic studies in infants and children with infection, administered doses of 10 mg/kg, 20 mg/kg, and 40 mg/kg, demonstrated Cmax values approaching those observed in adults after 500 mg, 1000 mg, and 2000 mg doses, respectively. Comparison revealed pharmacokinetic characteristics between doses and t1/2 similar to those observed in adults, except in the youngest patients (< 6 months, t1/2 1.6 hours). Mean meropenem clearance values were 5.8 mL/min/kg (6–12 years), 6.2 mL/min/kg (2–5 years), 5.3 mL/min/kg (6–23 months), and 4.3 mL/min/kg (2–5 months). Approximately 60% of the dose is excreted in urine as meropenem and an additional 12% as metabolite within 12 hours. Meropenem concentration in cerebrospinal fluid in children with meningitis is approximately 20% of the simultaneously measured plasma concentration, although there is considerable inter-individual variability.
Pharmacokinetics of meropenem in neonates receiving antibacterial treatment showed higher clearance in neonates with greater chronological or gestational age, with an overall mean half-life of 2.9 hours. Monte Carlo simulation based on the population pharmacokinetic model indicated that with a dosing regimen of 20 mg/kg every 8 hours, T > MIC of 60% against P. aeruginosa was achieved in 95% of preterm neonates and 91% of term neonates.
Elderly patients
Pharmacokinetic studies in healthy elderly volunteers (65–80 years) showed reduced plasma clearance, correlating with age-related reduction in creatinine clearance, as well as a slight reduction in non-renal clearance. Dose adjustment is not required in elderly patients, except in cases of moderate to severe renal impairment.
Clinical characteristics.
Indications.
The drug is indicated for the treatment of the following infections in adults and children aged 3 months and older:
- severe pneumonia, including hospital-acquired and ventilator-associated pneumonia;
- bronchopulmonary infections in cystic fibrosis;
- complicated urinary tract infections;
- complicated intra-abdominal infections;
- obstetrical and postpartum infections;
- complicated skin and soft tissue infections;
- acute bacterial meningitis.
Meropenem may be used for the treatment of patients with neutropenia and fever suspected to be caused by a bacterial infection.
Treatment of patients with bacteremia associated or potentially associated with any of the above-mentioned infections.
Official recommendations regarding appropriate use of antibacterial agents should be taken into account.
Contraindications.
Hypersensitivity to the active substance or to any of the excipients of the drug.
Hypersensitivity to any other antibacterial agent of the carbapenem group.
Severe hypersensitivity (e.g., anaphylactic reactions, severe skin reactions) to any other type of beta-lactam antibacterial agent (e.g., penicillins or cephalosporins).
Interaction with other medicinal products and other types of interactions.
Interaction studies with other medicinal products, except probenecid, have not been conducted.
Probenecid competes with meropenem for active tubular secretion and thereby inhibits renal excretion of meropenem, resulting in an increased elimination half-life and elevated plasma concentrations of meropenem. Caution should be exercised when probenecid is administered concomitantly with meropenem.
The potential effect of meropenem on protein binding or metabolism of other drugs has not been studied. However, since protein binding is so low, interactions based on this mechanism are not expected.
Decreased plasma levels of valproic acid have been observed when co-administered with carbapenems, resulting in a 60–100% reduction in valproic acid levels within approximately 2 days. Due to the rapid onset and extent of this reduction, concomitant administration of valproic acid/sodium valproate/valpromide and carbapenems is considered non-adjustable and should therefore be avoided (see section "Special precautions for use").
Oral anticoagulants
Concomitant use of antibiotics with warfarin may enhance its anticoagulant effect. Numerous reports have documented increased anticoagulant effects of oral anticoagulants, including warfarin, in patients receiving antibiotics concomitantly. The risk may vary depending on the type of underlying infection, age, and general condition of the patient, making it difficult to assess the exact contribution of antibacterial agents to the increase in INR (International Normalized Ratio). Frequent monitoring of INR levels is recommended during and immediately after concomitant use of antibiotics with oral anticoagulants.
Children
All drug interaction studies have been conducted in adults only.
Special precautions.
When selecting meropenem as a treatment option, consideration should be given to the appropriateness of using a carbapenem-class antibacterial agent, taking into account factors such as the severity of infection, prevalence of resistance to other suitable antibacterial agents, and the risk of selecting for carbapenem-resistant bacteria.
Resistance in Enterobacteriaceae, Pseudomonas aeruginosa, and Acinetobacter
In the EU, resistance to penems among Enterobacteriaceae, Pseudomonas aeruginosa, and Acinetobacter varies. Local resistance patterns of these bacteria to penems should be considered when prescribing the drug.
Hypersensitivity reactions
As with other beta-lactam antibiotics, serious, and sometimes fatal, hypersensitivity reactions have been reported (see sections "Contraindications" and "Adverse reactions").
Patients with a history of hypersensitivity to carbapenems, penicillins, or other beta-lactam antibiotics may also be at increased risk of hypersensitivity to meropenem. A careful patient history regarding previous hypersensitivity reactions to beta-lactam antibiotics should be obtained prior to initiating meropenem therapy.
If a severe allergic reaction occurs, administration of the drug must be discontinued immediately and appropriate measures initiated.
Severe skin reactions have been reported, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), erythema multiforme, and acute generalized exanthematous pustulosis in patients receiving meropenem (see section "Adverse reactions"). If signs or symptoms suggestive of these reactions occur, meropenem should be discontinued immediately and alternative therapy considered.
Hypersensitivity reactions progressing to Kounis syndrome (acute allergic coronary artery spasm that may lead to myocardial infarction) have been reported with other beta-lactam antibiotics (see section "Adverse reactions").
Rhabdomyolysis
Cases of rhabdomyolysis have been reported during meropenem therapy.
If signs or symptoms of rhabdomyolysis occur, meropenem should be discontinued and appropriate treatment initiated (see section "Adverse reactions").
Antibiotic-associated colitis
Cases of antibiotic-associated colitis, including pseudomembranous colitis, have been reported with nearly all antibacterial agents, including meropenem, with severity ranging from mild to life-threatening. Therefore, this diagnosis should be considered in patients who develop diarrhea during or after meropenem therapy (see section "Adverse reactions"). Discontinuation of meropenem and initiation of specific therapy directed against Clostridium difficile should be considered. Medicinal products that inhibit intestinal peristalsis should not be administered.
Seizures
Seizures have been reported rarely during treatment with carbapenems, including meropenem (see section "Adverse reactions").
Drug-induced liver injury (DILI)
Due to the risk of drug-induced liver injury (DILI) during meropenem therapy, liver function should be closely monitored (see section "Adverse reactions"). If severe DILI develops, treatment discontinuation should be considered if clinically appropriate. Re-administration of meropenem should only be considered if its use is deemed clinically necessary.
Use in patients with hepatic disease: liver function should be closely monitored during meropenem therapy in patients with pre-existing liver disease. Dose adjustment is not required (see section "Dosage and administration").
Seroconversion of the direct antiglobulin test (Coombs test)
Meropenem therapy may result in a positive direct or indirect Coombs test.
Concomitant administration of meropenem and valproic acid/sodium valproate/valpromide is not recommended (see section "Interaction with other medicinal products and other forms of interaction").
This medicinal product contains 90.2 mg of sodium per dose. Caution is advised when administering this product to patients on a sodium-restricted diet.
Use during pregnancy or breastfeeding
Pregnancy
Data on the use of meropenem in pregnant women are lacking or limited in quantity.
Animal studies have not shown direct or indirect effects on reproductive toxicity. As a precautionary measure, it is advisable to avoid the use of meropenem during pregnancy.
Breastfeeding period
It has been reported that small amounts of meropenem are excreted into human breast milk. Meropenem may be used during lactation only if the expected benefit to the mother outweighs the potential risk to the infant.
Ability to affect reaction speed when driving or operating machinery
Studies on the effect of the medicinal product on the ability to drive vehicles or operate machinery have not been conducted.
When driving vehicles or operating machinery, particular caution is recommended due to the possibility of developing headache, paresthesia, or seizures, which have been reported during meropenem therapy.
Administration and Dosage.
Dosage
The tables below provide general recommendations for dosage of the medicinal product.
The dose of meropenem and duration of treatment depend on the causative pathogen, severity of the infection, and the patient's response to therapy.
Meropenem administered at doses up to 2 g three times daily in adults and children with body weight over 50 kg, and up to 40 mg/kg three times daily in children, may be particularly appropriate for the treatment of certain infections caused by less susceptible bacterial species (e.g., Enterobacteriaceae, Pseudomonas aeruginosa, Acinetobacter), or in cases of severe infections.
Additional dosage recommendations must be followed when treating patients with renal impairment (see below).
Table 1
Recommended doses for adults and children with body weight over 50 kg
| Infection |
Single dose administered every 8 hours |
| Severe pneumonia, including hospital-acquired and ventilator-associated |
500 mg or 1 g |
| Respiratory tract infections in cystic fibrosis |
2 g |
| Complicated urinary tract infections |
500 mg or 1 g |
| Complicated intra-abdominal infections |
500 mg or 1 g |
| Infections during childbirth and postpartum infections |
500 mg or 1 g |
| Complicated skin and soft tissue infections |
500 mg or 1 g |
| Acute bacterial meningitis |
2 g |
| Treatment of febrile neutropenic patients |
1 g |
Meropenem should be administered as an intravenous infusion over 15 to 30 minutes.
Additionally, doses of up to 1 g may be given as an intravenous bolus injection over approximately 5 minutes. Safety data supporting administration of a 2 g dose as an intravenous bolus injection in adults are limited.
Renal impairment
Table 2
Recommended doses of the drug for adults and children with body weight over 50 kg when the patient's creatinine clearance is less than 51 mL/min
| Creatinine clearance (ml/min) |
Single dose (see Table 1) |
Frequency |
| 26–50 |
full single dose |
every 12 hours |
| 10–25 |
half the single dose |
every 12 hours |
| < 10 |
half the single dose |
every 24 hours |
Data supporting the use of doses of the medicinal product indicated in Table 2, adjusted per 2 g dose unit, are limited.
Meropenem is eliminated by hemodialysis and hemofiltration; therefore, the required dose of the medicinal product should be administered after completion of the hemodialysis procedure.
There are no recommendations regarding established dosing of the medicinal product for patients undergoing peritoneal dialysis.
Hepatic impairment
Dose adjustment of the medicinal product is not required in patients with hepatic impairment (see section "Special warnings and precautions for use").
Dosing in elderly patients
Dose adjustment is not required in elderly patients with normal renal function or with creatinine clearance values above 50 ml/min.
Children under 3 months of age
There are no data on the safety and efficacy of meropenem in children under 3 months of age; the optimal dosing regimen has not been established. There are limited pharmacokinetic data supporting the use of a meropenem dose of 20 mg/kg every 8 hours (see section "Pharmacokinetics").
Table 3
Recommended doses of the medicinal product for children aged from 3 months to 11 years and with body weight below 50 kg
| Infection |
Single dose administered every 8 hours |
| Severe pneumonia, including hospital-acquired and ventilator-associated |
10 or 20 mg/kg body weight |
| Respiratory tract infections in cystic fibrosis |
40 mg/kg body weight |
| Complicated urinary tract infections |
10 or 20 mg/kg body weight |
| Complicated intra-abdominal infections |
10 or 20 mg/kg body weight |
| Complicated skin and soft tissue infections |
10 or 20 mg/kg body weight |
| Acute bacterial meningitis |
40 mg/kg body weight |
| Treatment of patients with febrile neutropenia |
20 mg/kg body weight |
Children with body weight more than 50 kg
The dose should be the same as for adult patients.
There is no experience with the use of the drug in pediatric patients with impaired renal function.
Method of administration
Meropenem should be administered as an intravenous infusion lasting from 15 to 30 minutes. Additionally, meropenem doses up to 20 mg/kg may be administered as an intravenous bolus injection over approximately 5 minutes. Safety data supporting administration of the drug as an intravenous bolus injection at a dose of 40 mg/kg in children are limited.
Preparation for intravenous bolus injection
The solution for bolus injection should be prepared by dissolving the medicinal product in water for injections to obtain a concentration of 50 mg/mL.
Chemical and physical stability of the prepared bolus injection solution has been demonstrated for 3 hours at temperatures up to 25 °C or for 12 hours in a refrigerator (2–8 °C).
From a microbiological standpoint, if the method of opening/reconstitution/dilution does not exclude the risk of microbial contamination, the medicinal product should be used immediately.
If the medicinal product is not used immediately, the storage duration and conditions of the prepared solution should be strictly controlled.
Preparation for intravenous infusion
The infusion solution should be prepared by dissolving the medicinal product in 0.9% sodium chloride infusion solution or in 5% glucose (dextrose) infusion solution to obtain a concentration of 1–20 mg/mL.
Chemical and physical stability of the prepared infusion solution using 0.9% sodium chloride solution has been demonstrated for 3 hours at 25 °C or for 24 hours in a refrigerator (2–8 °C). From a microbiological standpoint, the medicinal product should be used immediately. If the medicinal product is not used immediately, the storage duration and conditions of the prepared solution should be strictly controlled.
The solution prepared with 5% glucose (dextrose) should be used immediately.
Do not freeze prepared solutions.
Children
The drug may be administered to children aged 3 months and older.
Overdose
Relative overdose is possible in patients with impaired renal function if the dose of the drug is not adjusted as described in the section "Method of administration and dosage".
Limited post-marketing experience indicates that if adverse reactions occur after overdose, they are consistent with the profile of the specified adverse reactions described in the section "Adverse reactions", are generally mild in severity, and resolve after discontinuation of the drug or dose reduction. Symptomatic treatment should be considered as necessary.
In individuals with normal renal function, the drug is rapidly eliminated by the kidneys.
During hemodialysis, meropenem and its metabolites are removed from the body.
Adverse Reactions
In the course of reviewing data from 4872 out of 5026 patients regarding the impact of meropenem treatment, the most frequently reported adverse reactions associated with meropenem use were diarrhea (2.3%), rash (1.4%), nausea/vomiting (1.4%), and injection site inflammation (1.1%). The most commonly reported laboratory abnormalities associated with meropenem use were thrombocytosis (1.6%) and elevated liver enzymes (1.5–4.3%).
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 (≥ 1/1000 to < 1/100); rare (≥ 1/10000 to < 1/1000); very rare (< 1/10000); frequency not known (cannot be estimated based on available data). Within each frequency group, adverse reactions are listed in decreasing order of severity.
Infections and infestations: uncommon – oral and vaginal candidiasis.
Blood and lymphatic system disorders: common – thrombocytosis; uncommon – agranulocytosis, hemolytic anemia, eosinophilia, thrombocytopenia, leukopenia, neutropenia.
Immune system disorders: uncommon – anaphylactic reaction (see sections "Contraindications" and "Special precautions"); angioedema.
Psychiatric disorders: rare – delirium.
Nervous system disorders: common – headache; uncommon – paresthesia; rare – seizures (see section "Special precautions").
Gastrointestinal disorders: common – diarrhea, vomiting, nausea, abdominal pain; uncommon – colitis associated with antibiotic use (see section "Special precautions").
Metabolism and nutrition disorders: uncommon – hypokalemia.
Hepatobiliary disorders: common – increased transaminases, increased alkaline phosphatase in blood, increased lactate dehydrogenase in blood; uncommon – increased blood bilirubin, drug-induced liver injury (DILI) (DILI includes hepatitis and liver failure).
Skin and subcutaneous tissue disorders: common – rash, pruritus; uncommon – urticaria, toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme (see section "Special precautions"); frequency not known – drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), acute generalized exanthematous pustulosis (see section "Special precautions").
Musculoskeletal and connective tissue disorders: rhabdomyolysis.
Renal and urinary disorders: uncommon – increased blood creatinine, increased blood urea.
General disorders and administration site conditions: common – inflammation, pain; uncommon – thrombophlebitis, injection site pain.
Description of selected adverse reactions
Kounis syndrome
Cases of acute coronary syndrome associated with allergic reaction (Kounis syndrome) have been reported with the use of other beta-lactam antibiotics (see section "Special precautions").
Pediatric population
Meropenem Ananta is approved for use in children aged 3 months and older. The limited available data do not indicate an increased risk of adverse events in children. All reported events correspond to adverse reactions observed in adult patients.
Reporting of adverse reactions
Reporting of adverse reactions after marketing authorization of a medicinal product is important. It allows continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals, pharmacists, patients, and their legal representatives are encouraged to report all suspected adverse reactions and lack of efficacy via the Automated Pharmacovigilance Information System at: https://aisf.dec.gov.ua.
Shelf life. 2 years.
Storage conditions.
Store in the original packaging at a temperature not exceeding 30 °C. Keep out of reach of children. Do not freeze.
Each vial is for single use only.
Standard aseptic techniques should be followed during reconstitution and administration.
Shake the solution well before use.
Any unused product or waste material should be disposed of in accordance with local requirements.
Incompatibilities.
Meropenem must not be mixed or added to other medicinal products.
Meropenem intended for intravenous bolus injection should be reconstituted with sterile water for injection.
Meropenem in vials intended for intravenous infusion may be directly reconstituted with 0.9% sodium chloride solution or 5% glucose solution for infusion.
Packaging. Powder in a glass vial stoppered with a rubber plug and sealed with an aluminum cap with a "flip-off" component, one vial per carton.
Prescription status. Prescription only.
Manufacturer.
Venus Remedies Limited.
Manufacturer's address and place of business.
Hill Top Industrial Estate, Jharmajari ERIPR Phase 1 Extension Batoli Kalan, Solan, Baddi, 173205, India.
Marketing Authorization Holder.
Ananta Medikare Ltd.
Address of the Marketing Authorization Holder and/or its representative.
Suite 1, 2 Station Court, Imperial Wharf, Townmead Road, Fulham, London, United Kingdom.