MEROPENEM FOR INJECTION 1G/20ML

Indications:

Meronem is indicated for the treatment of the following infections in adults and children aged 3 months and older:

• Severe pneumonia, including hospital and ventilator-associated pneumonia.

• Broncho-pulmonary infections in cystic fibrosis

• Complicated urinary tract infections

• Complicated intra-abdominal infections

• Intra- and post-partum infections

• Complicated skin and soft tissue infections

• Acute bacterial meningitis

Meronem may be used in the management of neutropenic patients with fever that is suspected to be due to a bacterial infection.

Treatment of patients with bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed above.

Dosage and Administration:

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.

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. Enterobacteriaceae, Pseudomonas aeruginosa, Acinetobacter spp.), or very severe infections.

Additional considerations for dosing are needed when treating patients with renal insufficiency .

Method of administration
Infusion
Meropenem is usually given by intravenous infusion over approximately 15 to 30 minutes. For intravenous infusion meropenem vials may be directly constituted with 0.9% sodium chloride or 5% dextrose solutions for infusion.
Injection
Meropenem to be used for bolus intravenous injection should be constituted with sterile water for injection.

Precautions & Warning:

l Enterobacteriaceae, Pseudomonas aeruginosa and Acinetobacter spp. resistance

l Hypersensitivity reactions

l Antibiotic-associated colitis

l Seizures

l Hepatic function monitoring

l Concomitant use with valproic acid/sodium valproate/valpromide

Contra-indications:

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

Hypersensitivity to any other carbapenem antibacterial agent.

Severe hypersensitivity (e.g. anaphylactic reaction, severe skin reaction) to any other type of beta-lactam antibacterial agent (e.g. penicillins or cephalosporins).

Drug interactions:

No specific medicinal product interaction studies other than probenecid were conducted.

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. Caution is required if probenecid is co-administered with meropenem.

The potential effect of meropenem on the protein binding of other medicinal products or metabolism has not been studied. However, the protein binding is so low that no interactions with other compounds would be expected on the basis of this mechanism.

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. 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.

Oral anti-coagulants

Simultaneous administration of antibiotics with warfarin may augment its anti-coagulant effects. There have been many reports of increases in the anti-coagulant effects of orally administered anti-coagulant agents, including warfarin in patients who are concomitantly receiving antibacterial agents.

Storage instructions:

Do not store above 30°C.

Do not freeze the reconstituted solution.

From a microbiological point of view, the product should be used immediately.