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It is an antibacterial injection that can be given to children aged 3 months and older, as well as to adults. It is indicated for the treatment of surgical infections, intra abdominal infections, bacterial meningitis, gynaecological infections, pelvic inflammatory disease, bacterial septicaemia, acute pneumonia and ventilator-associated pneumonia, pulmonary bronchial infections in cystic fibrosis, omplicated urinary tract infections intrapartum and postpartum infections, complex infections of the skin and soft tissues and acute bacterial meningitis. Meropenem may be used in the treatment of patients with bacteremia that occurs with or is suspected to be associated with any of the infections listed above.

This medicine contains meropenem which helps treat bacterial infections by killing the bacteria. It prevents the formation of the bacterial protective cell wall, which is required for bacteria to survive and helps in effectively treating bacterial infection. It is advised to take meropenem as long as the doctor has prescribed it for depending on the patient’s condition. In some cases, the patient may experience nausea, vomiting, diarrohea, constipation, headache, pain, redness, swelling on the injection side, insomnia, sores in the mouth or throat. It is given in an hospital by an expert, and must never be self-administered. Regualr monitoring of kidney function and blood cell count is required during Meropenem intake.

Meropenem is a broad spectrum antibiotic containing Meropenem which is known to fight against a variety of bacterial infections.

Official guidance on the appropriate use of antibacterial agents must be observed.

Adults and Teens: The infection dose is given every 8 hours

Severe pneumonia including hospital- and ventilator-associated pneumonia: 500 mg or 1 g

Pulmonary bronchial infections in cystic fibrosis: 2 g

Complicated urinary tract infections: 500 mg or 1 g

Complex intra-abdominal infections: 500 mg or 1 g

Infections during and after childbirth: 500 mg or 1 g

Complex infections of the skin and soft tissues: 500 mg or 1 g

Acute bacterial meningitis: 2 g

Management of febrile neutropenia patients: 1 g

Meropenem is usually given by intravenous infusion over a period of approximately 15 to 30 minutes

Alternatively, doses up to 1 g may be given as an intravenous bolus over the course of approximately 5 minutes. Limited safety data are available to support administration of the 2 g dose to adults as an intravenous bolus.

Renal failure

The dose for adults and adolescents should be adjusted when creatinine clearance is less than 51 mL/min, as described below. There is limited data to support giving these dose adjustments for a dose unit of 2 g.

Creatinine clearance (ml/min) Dose

(based on 'unit' dose range 500 mg, 1 g or 2 g, see table above)

Frequency

26-50 doses every 12 hours

10-25 doses of one half unit every 12 hours

<10 One half dose every 24 hours

Meropenem is cleared by hemodialysis and hemofiltration. The required dose should be given after completion of the dialysis cycle.

There are no specific dosage recommendations for patients receiving peritoneal dialysis.

Hepatic impairment

No dose adjustment is necessary in patients with hepatic impairment (see section 4.4).

Dosage in elderly patients

No dose adjustment is required for the elderly with normal renal function or creatinine clearance values ​​greater than 50 mL/min.

Children's population

Children under 3 months old

The safety and efficacy of meropenem in children under 3 months of age has not been established and the optimal dosing regimen has not been established. However, limited pharmacokinetic data suggest that 20 mg/kg every 8 hours may be an appropriate regimen.

Children from 3 months to 11 years old and weighing 50 kg

The recommended dosing regimens are shown in the table below:

The infection dose is given every 8 hours

Severe pneumonia including hospital- and ventilator-associated pneumonia: 10 or 20 mg/kg

Pulmonary bronchitis in cystic fibrosis: 40 mg/kg

Complicated urinary tract infections: 10 or 20 mg/kg

Complex intra-abdominal infections: 10 or 20 mg/kg

Complex infections of the skin and soft tissues: 10 or 20 mg/kg

Acute bacterial meningitis: 40 mg/kg

Treatment of febrile neutropenia: 20 mg/kg

Children weighing more than: 50 kg

Special warnings and precautions for use

Selection of meropenem for patient treatment should consider the appropriateness of using a carbapenem antibacterial agent based on factors such as the severity of the infection, prevalence of resistance to other appropriate antibacterial agents and the risk of selection of carbapenem-resistant bacteria.

Pregnancy

There are no data or a limited amount of use of meropenem in pregnant women.

Studies in animals do not indicate direct or indirect adverse effects with respect to reproductive toxicity (see section 5.3).

As a precaution, it is best to avoid the use of meropenem during pregnancy.

Breastfeeding

Small amounts of meropenem have been reported to be excreted in human milk. Meropenem should not be used in breastfeeding women unless the potential benefit to the mother justifies the potential risk to the baby.

Effects on ability to drive and use machines

No studies have been conducted on the effect on the ability to drive and use machines. However, when driving or operating machinery, it should be borne in mind that headache, sedation and convulsions have been reported due to meropenem.