MEROPENEM ANFARM 500 MG

Pays: Israël

Langue: anglais

Source: Ministry of Health

Ingrédients actifs:

MEROPENEM AS TRIHYDRATE

Disponible depuis:

K.S.KIM INTERNATIONAL (SK- PHARMA) LTD., ISRAEL

Code ATC:

J01DH02

forme pharmaceutique:

POWDER FOR SOLUTION FOR INJ/INF

Composition:

MEROPENEM AS TRIHYDRATE 500 MG/VIAL

Mode d'administration:

I.V

Type d'ordonnance:

Required

Fabriqué par:

ANFARM HELLAS S.A., GREECE

Groupe thérapeutique:

MEROPENEM

Domaine thérapeutique:

MEROPENEM

indications thérapeutiques:

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

Date de l'autorisation:

2018-07-31

Résumé des caractéristiques du produit

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