Land: Israel
Språk: engelsk
Kilde: Ministry of Health
MEROPENEM AS ANHYDROUS
NEOPHARM (ISRAEL) 1996 LTD
J01DH02
POWDER FOR SOLUTION FOR INJ/INF
MEROPENEM AS ANHYDROUS 500 MG/VIAL
I.V
Required
ACS DOBFAR S.P. A, ITALY
MEROPENEM
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.
2021-12-31
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.), Les hele dokumentet