Name of the product: IMIPENEM + CILASTATINA DOSA IV

Active ingredient: Imipenem 500 mg + cilastatine 500 mg

Dosage form: powder for injection

Name of the product: IMIPENEM + CILASTATINA DOSA IM

Active ingredient: Imipenem 500 mg + cilastatine 500 mg

Dosage form: powder for injection

Dispensing requirements: Rx only

Argentine Industry

Composition:

IMIPENEM + CILASTATINA DOSA IV (endovenous use):

Each glass bottle with powder for injection contains imipenem 500 mg (as imipenem monohydrate), cilastatine 500 mg (as sodium cilastatine), and sodium bicarbonate.

IMIPENEM + CILASTATINA DOSA IM (intramuscular use):

Each glass bottle with powder for injection contains imipenem 500 mg (as imipenem monohydrate) and cilastatine 500 mg (as sodium cilastatine).

Each glass bottle with dissolving solution contains lidocaine hydrochloride, sodium chloride, sodium hydroxide, and water for injection.

Indications:

IMIPENEM + CILASTATINA DOSA IV is indicated for the treatment of severe infections caused by strains susceptible to the microorganisms designated in the following conditions: lower respiratory tract infections; urinary infections; intra abdominal infections; gynaecologic infections; bone and joint infections; skin and skin structure infections; endocarditis; and poly microbial infections.

IMIPENEM + CILASTATINA DOSA IM is indicated for the treatment of poly microbial infections caused by an exceptionally wide bacterial range; for the treatment of mix infections caused by aerobic and anaerobic microorganisms; and as initial treatment before indentifying the causing microorganisms. It is indicated for the treatment of the following infections caused by microorganisms susceptible to its action: intra abdominal infections; lower respiratory tract infections, gynaecologic infections; septicaemia; urinary infections; bone and joint infections; skin and soft tissue infections; and endocarditis.

Therapeutic action:

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Storage:

IMIPENEM + CILASTATINA DOSA IV:

Keep at temperature between 15° and 25º C in the marketed packing.

IMIPENEM + CILASTATINA DOSA IM:

Keep at temperature between below 25º C in the marketed packing.

Marketed presentations:

IMIPENEM + CILASTATINA DOSA IV:

Packs containing 1 glass bottle with powder for injection.

IMIPENEM + CILASTATINA DOSA IM:

Packs containing 1 glass bottle with powder for injection + 1 glass bottle with dissolving solution.

Medicinal speciality authorised by the Ministry of Health.

Certificate Nº 54684

Laboratorio DOSA S.A.

Girardot 1369, (C1427AKC) Buenos Aires, Argentine

Pharmaceutical Director: María C. Terzo, Pharmacist