Land: Israël
Taal: Engels
Bron: Ministry of Health
MEROPENEM AS TRIHYDRATE
K.S.KIM INTERNATIONAL (SK- PHARMA) LTD., ISRAEL
J01DH02
POWDER FOR SOLUTION FOR INJ/INF
MEROPENEM AS TRIHYDRATE 1000 MG/VIAL
I.V
Required
ANFARM HELLAS S.A., GREECE
MEROPENEM
MEROPENEM
Meropenem is indicated 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
2018-07-31
Page 1 of 16 MEROPENEM / ANFARM 500 MG MEROPENEM / ANFARM 1G 1. NAME OF THE MEDICINAL PRODUCT Meropenem/ANFARM 500mg Meropenem/ANFARM 1g 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Meropenem/ANFARM 500mg Each vial contains meropenem trihydrate equivalent to 500 mg anhydrous meropenem. Excipients with known effect: Each 500 mg vial contains 104 mg sodium carbonate which equates to approximately 2 mEq of sodium (approximately 45 mg). Meropenem/ANFARM 1 g Each vial contains meropenem trihydrate equivalent to 1 g anhydrous meropenem. Excipients with known effect: Each 1 g vial contains 208 mg sodium carbonate which equates to approximately 4 mEq of sodium (approximately 90 mg). For the 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 Meropenem/ANFARM IV is indicated for treatment, in adults and children, of the following infections caused by single or multiple bacteria sensitive to meropenem. Page 2 of 16 • Pneumonias and Nosocomial Pneumonias • Pulmonary infections in patients with cystic fibrosis • Urinary Tract Infections • Intra-abdominal Infections • Gynaecological Infections, such as endometritis and pelvic inflammatory disease • Skin and Skin Structure Infections • Meningitis • Septicemia Meropenem/ANFARM 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 ADULTS The dosage and duration of therapy shall be established depending on type and severity of infection and the condition of the patient. The recommended daily dosage is as follows: 500 mg IV every 8 hours in the treatment of pneumonia, UTI, gynaecological infections such as endometritis, pelvic inflammatory disease, skin and skin structure infections. 1 g IV every 8 hours in the Lees het volledige document