Cefoperazone & Sulbactam for Injection 2gm Technical Specification:

Product Name:Cefoperazone and Sulbactam for Injection 2gm
Brand Name:TAJCEF FORTE
Strength:1.5gm, 3gm, 2gm, 1gm
Dosage Form:Sterile Dry Powder Injection
Packing:1 Vial + WFI in Tray
Route of Administration:For I.M/I.V. use
Pack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents:COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use:β-lactam Antibiotic, Anti-bacterial & Cephalosporins.
Indication: Cefoperazone +Sulbactam is used in the treatment of bacterial infections. It works by preventing the formation of the bacterial protective covering which is essential for the survival of bacteria.
Storage:Store at a temperature not exceeding 25°C. Do not freeze. Protect from light & moisture.

GENERIC NAME OF MEDICINAL PRODUCT:

  • Cefoperazone & Sulbactam for Injection 2gm

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Cefoperazone & Sulbactam for Injection 2gm
    Each vial contains
    Cefoperazone Sodium (Sterile) USP
    equivalent to Anhydrous Cefoperazone…………….1000mg
    Sulbactam Sodium (Sterile) USP
    equivalent to Anhydrous Sulbactam………1000mg
    Sterile Water for Injection USP………20ml

THERAPEUTIC INDICATION:

Cefoperazone +Sulbactam is used in the treatment of bacterial infections. It works by preventing the formation of the bacterial protective covering which is essential for the survival of bacteria.

DIRECTION OF USE:

Dissolve the content of the vial in Sterile Water for Injection USP included in this pack. Reconstitute solution should be used immediately after preparation. Reconstitution is to be carried out as per the instruction in the package.

CAUTION AND WARNING:

CAUTION:  It is dangerous to take this preparation except in accordance with medical advice.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.

WARNING: To be sold by retail on the prescribed of a registered medical partitioner only.

STORAGE AND DOSAGE:

Storage:  Store at a temperature not exceeding 25°C, do not freeze, and protect from light & moisture.
The reconstituted solution should be used immediately after preparation.
Keep all medicines out of reach of children.

Dosage: As directed by the Physician.

GENERIC NAME OF MEDICINAL PRODUCT:

A. Cefoperazone and Sulbactam for Injection 1.5gm (TAJCEF FORTE)
B. Cefoperazone and Sulbactam for Injection 3gm (TAJCEF FORTE)
C. Cefoperazone and Sulbactam for Injection 2gm (TAJCEF FORTE)
D. Cefoperazone and Sulbactam for Injection 1gm (TAJCEF FORTE)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Cefoperazone and Sulbactam for Injection 1.5gm (TAJCEF FORTE)
a. Each vial contains:
Cefoperazone Sodium (Sterile) USP
equivalent to Anhydrous Cefoperazone…………….1000mg
Sulbactam Sodium (Sterile) USP
equivalent to Anhydrous Sulbactam………500mg
b. Sterile Water for Injection USP………10ml

B. Cefoperazone and Sulbactam for Injection 3gm (TAJCEF FORTE)
a. Each vial contains:
Cefoperazone Sodium (Sterile) USP
equivalent to Anhydrous Cefoperazone…………….2000 mg
Sulbactam Sodium (Sterile) USP
equivalent to Anhydrous Sulbactam………1000 mg
b. Sterile Water for Injection USP……….20ml

C. Cefoperazone and Sulbactam for Injection 2gm (TAJCEF FORTE)
a. Each vial contains:
Cefoperazone Sodium (Sterile) USP
equivalent to Anhydrous Cefoperazone…………….1000 mg
Sulbactam Sodium (Sterile) USP
equivalent to Anhydrous Sulbactam………1000 mg
b. Sterile Water for Injection USP………20ml


D. Cefoperazone and Sulbactam for Injection 1gm (TAJCEF FORTE)
a. Each vial contains:
Cefoperazone Sodium (Sterile) USP
equivalent to Anhydrous Cefoperazone…………….500mg
Sulbactam Sodium (Sterile) USP
equivalent to Anhydrous Sulbactam………500mg
b. Sterile Water for Injection USP………10ml

THERAPEUTIC INDICATION:

Cefoperazone & Sulbactam is used in the treatment of bacterial infections.
It works by preventing the formation of the bacterial protective covering which is essential for the survival of bacteria.

DIRECTION OF USE:

Dissolve the content of the vial in Sterile Water for Injection USP included in this pack. Reconstitute solution should be used immediately after preparation.
Reconstitution is to be carried out as per the instruction in the package.

CAUTION AND WARNING:

CAUTION: It is dangerous to take this preparation except in accordance with the medical advice.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
WARNING: To be sold by retail on the prescribed of a registered medical partitioner only.

STORAGE AND DOSAGE:

Storage: Store at a temperature not exceeding 25°C, do not freeze, protect from light & moisture.
Reconstituted solution should be used immediately after preparation.
Keep all medicines out of reach of children.
Dosage: As directed by Physician.