MERONEM 1 G.

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

MEROPENEM AS TRIHYDRATE

Available from:

PFIZER PFE PHARMACEUTICALS ISRAEL LTD

ATC code:

J01DH02

Pharmaceutical form:

POWDER FOR SOLUTION FOR INJ/INF

Composition:

MEROPENEM AS TRIHYDRATE 1000 MG/VIAL

Administration route:

I.V

Prescription type:

Required

Manufactured by:

PFIZER INC, USA

Therapeutic area:

MEROPENEM

Therapeutic indications:

Meronem 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. Meronem 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.

Authorization date:

2022-01-31

Summary of Product characteristics

Meronem LPD CC 160223 Technical change
Page 1 of 16
2023-0084125
MERONEM 500MG
MERONEM 1G
1.
NAME OF THE MEDICINAL PRODUCT
Meronem 500mg
Meronem 1g
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Meronem 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).
Meronem 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
Meronem IV is indicated for treatment, in adults and children, of the
following infections
caused by single or multiple bacteria sensitive to meropenem.
•
Pneumonias and Nosocomial Pneumonias
Meronem LPD CC 160223 Technical change
Page 2 of 16
2023-0084125
•
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
•
Septicaemia
Meronem has proved efficacious alone or in combination with other
antimicrobial agents in
the treatment of polymicrobial infections.
There is no experience in paediatric 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.