CEFOBID 1GM PARENTERAL

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

CEFOPERAZONE SODIUM

Available from:

PFIZER (MALAYSIA) SDN. BHD.

INN (International Name):

CEFOPERAZONE SODIUM

Units in package:

1gm mcg/mL; 1 gm mcg/mL

Manufactured by:

Haupt Pharma Latina S.r.l.

Patient Information leaflet

NOT APPLICABLE

Summary of Product characteristics

Pfizer Confidential
1. NAME OF THE MEDICINAL PRODUCT
CEFOBID
2. QUALITATIVE AND QUANTITA TIVE COMPOSITION
Cefoperazone sodium is a semisynthetic broad -spectrum cepha losporin antibiotic for
parenteral use only. Cefoperazone contains 34 mg sodium (1.5 mEq) per gram.
Cefoperazone is a white crystalline powder which is fr eely soluble in water. Th e pH of a
25% aqueous solution is 5.0 to 6.5 and the solution is colorless to straw -yellow, depending
on the concentration. The empirical formula is C 25H26N9NaO 8S2.
3. PHARMACEUTICAL FORM
Cefoperazone sodium is available in vials containing 1 and 2 grams .
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Monother apy
Cefoperazone is indicated for the treatment of the following infections when caused by
susceptible organisms:
Respiratory Tract Infections (Upper an d Lower)
Urinary Tract In fections (Upper and Lower)
Peritonitis, Cholecystitis, Cholangitis, and Other Intra -Abdominal Infections
Septicemia
Meningitis
Skin and Soft Tissue Infections
Infections of Bones and Joints
Pelvic Inflammatory Disease, Endometritis , Gonorrhea, and Other In fections of the Genital
Tract
Prophylaxis
Cefoperazone sodium may be indica ted in the prophylaxis of post -operative infection in
patients undergoing abdominal and gynecological surgery, cardiovascular and orthopedic
surgery.
Com bination Therapy