MEROPENEM FRESENIUS 500 MG

Land: Israel

Språk: engelsk

Kilde: Ministry of Health

Aktiv ingrediens:

MEROPENEM AS ANHYDROUS

Tilgjengelig fra:

NEOPHARM (ISRAEL) 1996 LTD

ATC-kode:

J01DH02

Legemiddelform:

POWDER FOR SOLUTION FOR INJ/INF

Sammensetning:

MEROPENEM AS ANHYDROUS 500 MG/VIAL

Administreringsrute:

I.V

Resept typen:

Required

Produsert av:

ACS DOBFAR S.P. A, ITALY

Terapeutisk område:

MEROPENEM

Indikasjoner:

For treatment in adults and children of the following severe infections caused by single or multiple susceptible bacteria sensitive to Meropenem: - Pneumonias and nosocomial pneumonias. - Pulmonary infections in patients with cystic fibrosis. - Urinary tract infections. - Intra-abdominal infections. - Gynecological infections such as endometritis and pelvic inflammatory disease. - Skin and skin structure infections. - Meningitis. - Septicemia. Meropenem has proved efficacious alone or in combination with other antimicrobial agents in the treatment of polymicrobial infections. There is no experience in pediatric patients with neutropenia or primary or secondary immunodeficiency.

Autorisasjon dato:

2021-12-31

Preparatomtale

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
MEROPENEM FRESENIUS 500 mg
MEROPENEM FRESENIUS 1000 MG
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Meropenem Fresenius 500 mg
Each vial contains 570 mg meropenem trihydrate equivalent to 500 mg
anhydrous meropenem.
Meropenem Fresenius 1000mg
Each vial contains 1140 mg meropenem trihydrate equivalent to 1000 mg
anhydrous meropenem.
Excipients with known effect:
Each 500 mg vial contains 1.96 mmol (45.13 mg) of sodium.
Each 1000 mg vial contains 3.92 mmol (90.25 mg) of sodium.
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Powder for solution for injection or infusion.
A white to light yellow powder.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For treatment, in adults and children, of the following severe
infections caused by single or multiple susceptible bacteria
sensitive to Meropenem:
- Pneumonias and nosocomial pneumonias.
- Pulmonary infections in patients with cystic fibrosis.
- Urinary tract infections.
- Intra-abdominal infections.
- Gynecological infections, such as endometritis and pelvic
inflammatory disease.
- Skin and skin structure infections.
- Meningitis.
- Septicemia.
Meropenem has proved efficacious alone or in combination with other
antimicrobial agents in the treatment of
polymicrobial infections.
There is no experience in pediatric patients with neutropenia or
primary or secondary immunodeficiency.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The tables below provide general recommendations for dosing.
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.),