Ifem

INSTRUCTIONS for medical use of the medicinal product IFEEM

Composition:

Active substance: meropenem;

1 vial contains meropenem trihydrate equivalent to anhydrous meropenem 1 g;

Excipient: anhydrous sodium carbonate.

Pharmaceutical form. Powder for solution for injection.

Main physicochemical properties: crystalline powder of white or pale yellow color.

Pharmacotherapeutic group. Antimicrobial agents for systemic use.

Carbapenems. ATC code J01DH02.

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, time above the minimum inhibitory concentration (MIC) (T > MIC) has been shown to correlate highly with efficacy. In preclinical models, meropenem demonstrated activity when plasma concentrations exceeded the MIC for the infecting microorganisms for approximately 40% of the dosing interval. This target value has not been clinically established.

Bacterial resistance to meropenem may arise due to: (1) reduced permeability of the outer membrane of Gram-negative bacteria (due to decreased porin production), (2) reduced 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 drugs belonging to the classes of quinolones, aminoglycosides, macrolides, and tetracyclines is absent with regard to target microorganisms. However, bacteria may exhibit resistance to more than one class of antibacterial agents when the mechanism involved includes reduced membrane permeability and/or 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-mic-breakpoints_en.xlsx

The prevalence of acquired resistance may vary geographically and over time for individual species; therefore, local information on microbial resistance should be consulted, 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 lists pathogenic microorganisms based on clinical experience and therapeutic treatment guidelines.

Generally susceptible species

Gram-positive aerobes

Enterococcus faecalis $

Staphylococcus aureus (methicillin-sensitive) £

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 faecium $,†

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

$ Species exhibiting inherent intermediate susceptibility.

£ All methicillin-resistant staphylococci are resistant to meropenem.

† 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 available data on human use. Physicians should refer to national and/or international consensus documents regarding the treatment of glanders and melioidosis.

Pharmacokinetics.

In healthy volunteers, the mean plasma elimination half-life (t½) is approximately 1 hour; the mean volume of distribution is approximately 0.25 L/kg (11–27 L); mean clearance is 287 mL/min following a 250 mg dose, decreasing to 205 mL/min with a 2 g dose. Following administration as a 30-minute infusion at doses of 500, 1000, and 2000 mg, mean Cmax values are approximately 23, 49, and 115 µg/mL, respectively; corresponding AUC values are 39.3, 62.3, and 153 µg×h/mL. After a 5-minute infusion, Cmax values are 52 and 112 µg/mL following 500 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 receiving 1000 mg meropenem every 8 hours after surgery for intra-abdominal infections, Cmax and t½ values were similar to those in healthy subjects, but a larger volume of distribution (27 L) was observed.

Distribution.

The mean plasma protein binding of meropenem is approximately 2% and is independent of drug concentration. After rapid administration (5 minutes or less), the 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 tract 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-1) compared to imipenem, thus eliminating the need for concomitant administration of a DHP-1 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. Fecal excretion accounts for only about 2% of the dose. Measured renal clearance and the effect of probenecid indicate that meropenem undergoes both glomerular filtration and tubular secretion.

Renal impairment.

Impaired renal function leads to higher plasma AUC values and a prolonged elimination half-life for meropenem. AUC values increase by a factor of 2.4 in patients with moderate renal impairment (creatinine clearance (CrCl) 33–74 mL/min), by 5 times in patients with severe renal impairment (CrCl 4–23 mL/min), and by 10 times in patients on hemodialysis (CrCl < 2 mL/min), compared to healthy volunteers (CrCl > 80 mL/min). AUC values of the microbiologically inactive open-ring metabolite are also 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.

Studies in patients with alcoholic cirrhosis show no effect of liver disease on the pharmacokinetics of meropenem 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: following doses of 10, 20, and 40 mg/kg, Cmax values approach those observed in adults after 500, 1000, and 2000 mg doses, respectively. Comparison revealed consistent pharmacokinetic characteristics between doses and elimination half-lives similar to those observed in adults, except in the youngest patients (< 6 months, t½ 1.6 hours). Mean clearance values of meropenem are 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 within 12 hours as meropenem and an additional 12% as metabolite. Meropenem concentrations in cerebrospinal fluid in children with meningitis are approximately 20% of simultaneously measured plasma levels, 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 a mean elimination half-life of 2.9 hours. Monte Carlo simulations based on the population pharmacokinetic model indicated that with a dosing regimen of 20 mg/kg every 8 hours, 60% T > MIC for 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 unless moderate or severe renal impairment is present.

Clinical characteristics.

Indications.

Iphem 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;
• infections during childbirth and postpartum infections;
• complicated skin and soft tissue infections;
• acute bacterial meningitis.

Iphem may be used for the treatment of patients with neutropenia and fever suspected of having a bacterial infection.

Treatment of patients with bacteremia associated or potentially associated with any of the infections listed above.

Official recommendations regarding the appropriate use of antibacterial agents should be taken into account.

Contraindications.

Hypersensitivity to the active substance or to any of the excipients of the medicinal product.

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.

Studies on the interaction of the drug with other medicinal products, except probenecid, have not been conducted.

Probenecid competes with meropenem for active tubular secretion and thus 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 the protein binding of other drugs or metabolism has not been studied. However, since protein binding is so minimal, interactions with other compounds based on this mechanism are not expected.

Decreased serum levels of valproic acid have been reported 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 interaction, concomitant administration of valproic acid/sodium valproate/valpromide with carbapenems is considered non-adjustable; therefore, such combination should 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 effect of oral anticoagulants, including warfarin, in patients receiving antibiotics concomitantly. The risk may vary depending on the 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 only in adults.

Special precautions for use.

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 European Union, resistance to penems among Enterobacteriaceae, Pseudomonas aeruginosa, and Acinetobacter varies. When prescribing the drug, local resistance patterns of these bacteria to penems should be taken into account.

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 thorough patient history regarding prior hypersensitivity reactions to beta-lactam antibiotics should be obtained before initiating meropenem therapy.

If a severe allergic reaction occurs, administration of the drug should be discontinued immediately and appropriate measures initiated.

Severe skin adverse reactions have been reported in patients receiving meropenem treatment, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), erythema multiforme, and acute generalized exanthematous pustulosis (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 use.

If signs or symptoms of rhabdomyolysis occur, meropenem should be discontinued and appropriate therapy 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"). Consideration should be given to discontinuing meropenem and initiating specific therapy directed against Clostridium difficile. Medicinal products that inhibit intestinal peristalsis should not be prescribed.

Seizures

Seizures have been rarely reported 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, discontinuation of treatment should be considered if clinically appropriate. Re-administration of meropenem should only be considered if its use is deemed clearly necessary.

Use in patients with hepatic disease: Liver function should be closely monitored in patients with pre-existing liver disease during meropenem therapy. Dose adjustment is not required (see section "Dosage and administration").

Seroconversion in the direct antiglobulin test (Coombs' test)

Meropenem therapy may result in a positive direct/indirect Coombs' test.

Concomitant use of meropenem and valproic acid/sodium valproate/valpromide is not recommended (see section "Interaction with other medicinal products and other forms of interaction").

Ipham contains approximately 90.2 mg of sodium per 1 g dose, which should be considered when prescribing the drug 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 number.

Animal studies have not shown direct or indirect harmful effects on reproductive toxicity. As a precautionary measure, it is advisable to avoid using meropenem during pregnancy.

Breastfeeding

It has been reported that small amounts of meropenem pass 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 drug on the ability to drive vehicles or operate machinery have not been conducted.

When driving or operating machinery, caution should be exercised due to the possibility of developing headache, paresthesia, or seizures, which have been reported during meropenem use.

Dosage and Administration

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 a dose of 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 patients with febrile neutropenia	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 the 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 the doses of the medicinal product indicated in Table 2, adjusted to the 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 dosage regimens for patients undergoing peritoneal dialysis.

Hepatic impairment

Dosage adjustment is not required in patients with hepatic impairment (see section "Special warnings and precautions for use").

Dosage for elderly patients

Dosage 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, and 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 up to 50 kg

Infection	Single dose to be 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 children with impaired renal function.

Method of administration

Meropenem is usually administered as an intravenous infusion over 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 meropenem at a dose of 40 mg/kg as an intravenous bolus injection 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 solution for bolus injection has been demonstrated for 3 hours at temperatures up to 25°C or for 12 hours when stored in a refrigerator (2–8°C).

From a microbiological standpoint, if the method of opening/reconstitution/dilution does not exclude the risk of microbiological 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 carefully controlled.

Preparation for intravenous infusion

The infusion solution should be prepared by dissolving the medicinal product in 0.9% sodium chloride infusion solution or 5% glucose (dextrose) infusion solution to achieve 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 when stored 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 carefully controlled.

The solution prepared with 5% glucose (dextrose) should be used immediately.

Do not freeze the prepared solutions.

Children

The drug is 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 "Dosage and administration". Limited post-marketing experience with the drug suggests that adverse reactions following overdose are consistent with the profile of the adverse reactions listed in the section "Adverse reactions", and 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 via the kidneys.

Meropenem and its metabolites are removed from the body during hemodialysis.

Adverse reactions

In the review of data from 4872 out of 5026 patients regarding the impact of meropenem treatment, the most common adverse reactions associated with the use of meropenem were diarrhea (2.3%), rash (1.4%), nausea/vomiting (1.4%), and injection site phlebitis (1.1%). The most commonly reported laboratory-related adverse events associated with meropenem use were thrombocytosis (1.6%) and elevated liver enzymes (1.5–4.3%).

The adverse reactions listed in the table below are categorized by organ system 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.

Table 4

System organ class	Frequency	Adverse reactions
Infections and infestations	uncommon	Oropharyngeal and vaginal candidiasis.
Blood and lymphatic system disorders	common uncommon	Thrombocytosis. Eosinophilia, thrombocytopenia, leukopenia, neutropenia, agranulocytosis, hemolytic anemia.
Immune system disorders	uncommon	Angioedema, anaphylactic reaction. (see sections "Contraindications" and "Special warnings and precautions for use")
Nervous system disorders	common uncommon rare	Headache. Paraesthesia. Seizures. (see section "Special warnings and precautions for use").
Gastrointestinal disorders	common uncommon	Diarrhea, vomiting, nausea, abdominal pain. Antibiotic-associated colitis. (see section "Special warnings and precautions for use").
Metabolism and nutrition disorders	uncommon	Hypokalemia.
Hepatobiliary disorders	common uncommon	Elevated transaminase levels, elevated alkaline phosphatase levels in blood, elevated lactate dehydrogenase levels in blood. Elevated bilirubin levels in blood. Drug-induced liver injury (DILI) (DILI includes hepatitis and hepatic failure).
Skin and subcutaneous tissue disorders	common uncommon frequency not known	Rash, pruritus. Urticaria. Toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme (see section "Special warnings and precautions for use"). Drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), acute generalized exanthematous pustulosis (see section "Special warnings and precautions for use").
Musculoskeletal and connective tissue disorders		Rhabdomyolysis
Renal and urinary disorders	uncommon	Elevated creatinine levels in blood, elevated blood urea levels.
General disorders and administration site conditions	common uncommon	Inflammation, pain. Thrombophlebitis, injection site pain.
Psychiatric disorders	rare	Delirium

Description of individual adverse reactions

Kounis syndrome

Acute coronary syndrome associated with an allergic reaction (Kounis syndrome) has been reported with the use of other beta-lactam antibiotics (see section "Special precautions for use").

Children

Iphem is approved for use in children over 3 months of age. The limited available data do not indicate an increased risk of adverse events in children. All reported cases correspond to adverse reactions observed in adult patients.

Reporting of adverse reactions

Reporting of adverse reactions after drug registration is of great importance. It allows continuous monitoring of the benefit-risk balance of the use of this medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, should report all suspected adverse reactions and lack of efficacy via the Automated Pharmacovigilance Information System at the following link: https://aisf.dec.gov.ua.

Shelf life. 3 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 used during reconstitution and administration.

Shake the solution well before use.

Any unused product or waste material must be disposed of in accordance with local requirements.

Incompatibilities.

Meropenem must not be mixed or combined with other medicinal products.

Meropenem intended for intravenous bolus injection should be reconstituted with sterile water for injections.

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 vial. One vial per cardboard box.

Prescription status. Prescription only.

Manufacturer.

Auronext Pharma Pvt. Ltd.

Manufacturer's address.

A-1128, RIICO Industrial Area Phase III, Bhivadi District - Alwar, Rajasthan, 301 019, India.

Marketing Authorisation Holder.

Ananta Medicare Ltd.

Address of the Marketing Authorisation Holder.

Suite 1, 2 Station Court, Imperial Wharf, Townmead Road, Fulham, London, United Kingdom.