Cefoperazone & Sulbactam for Injection 1.5gm Technical Specification:

Product Name:Cefoperazone & Sulbactam for Injection 1.5gm
Brand Name:(CEFOZONE FORTE)
Strength:1.5gm, 3gm, 2gm, 1gm
Dosage Form:Dry Powder Injection (Sterile)
Packing:Vial + WFI in Tray
Route of Administration:For I.M./I.V. use
Pack Insert/Leaflet:PIL (Patient Information Leaflet)
Documents:COA, MOA, Product Permission, Stability Studies, GMP
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 Below 30°C.Protect from light and moisture. Do not freeze

GENERIC NAME OF MEDICINAL PRODUCT:

  • Cefoperazone & Sulbactam for Injection 1.5gm

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Cefoperazone & Sulbactam for Injection 1.5gm
    Each vial contains:
    Cefoperazone Sodium IP (Sterile)
    Equivalent to Anhydrous Cefoperazone …………. 1000mg
    Sulbactam Sodium IP (Sterile)
    Equivalent to Anhydrous Sulbactam………………….. 500mg
    Sterile Water for Injection IP…….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 IP included in this pack. Reconstitution is to be carried out as per the instruction in the package. Use a reconstituted solution if it is clear and devoid of particulate matter.

CAUTION AND SCHEDULE:

CAUTION: If any foreign particle is visible in the vial after dissolving the contents, please do not use the solution.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.

SCHEDULE: SCHEDULE ‘H1’ DRUG; It is dangerous to take this preparation except in accordance with medical advice.
Not to be sold by retail without the prescription of a Registered Medical Practitioner.

STORAGE AND DOSAGE:

STORAGE: Store Below 30°C.Protect from light and moisture. Do not freeze.

The reconstituted solution should be used immediately after preparation.

KEEP OUT OF REACH OF CHILDREN
DOSAGE: As directed by the Physician

GENERIC NAME OF MEDICINAL PRODUCT:

(A) Cefoperazone & Sulbactam for Injection 1.5gm (Cefozone Forte)
(B) Cefoperazone & Sulbactam for Injection 3gm (Cefozone Forte)
(C) Cefoperazone & Sulbactam for Injection 2gm (Cefozone Forte)
(D) Cefoperazone & Sulbactam for Injection 1gm (Cefozone Forte)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

1. Cefoperazone & Sulbactam for Injection 1.5gm (Cefozone Forte)
A. Each vial contains:
Cefoperazone Sodium IP (Sterile)
eq. to Anhydrous Cefoperazone ............. 1000mg
Sulbactam Sodium IP (Sterile)
eq. to Anhydrous Sulbactam....................... 500mg
B. Sterile Water for Injection IP…….10ml


2. Cefoperazone & Sulbactam for Injection 3gm (Cefozone Forte)
A. Each vial contains:
Cefoperazone Sodium IP (Sterile) eq. to Anhydrous Cefoperazone.............. 2000mg
Sulbactam Sodium IP (Sterile)
eq. to Anhydrous Sulbactam....................... 1000mg
B. Sterile water for Injection IP……….……… 20ml

3. Cefoperazone & Sulbactam for Injection 2gm (Cefozone Forte)
A. Each vial contains:
Cefoperazone Sodium IP (Sterile)
eq. to Anhydrous Cefoperazone ............. 1000mg
Sulbactam Sodium IP (Sterile)
eq. to Anhydrous Sulbactam....................... 1000mg
B. Sterile water for Injection IP ……….…… 20ml

4. Cefoperazone & Sulbactam for Injection 1gm (Cefozone Forte)
A. Each vial contains:
Cefoperazone Sodium IP (Sterile)
eq. to Anhydrous Cefoperazone ............. 500mg
Sulbactam Sodium IP (Sterile)
eq. to Anhydrous Sulbactam....................... 500mg
B. Sterile Water for Injection IP…….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 vial in Sterile Water for Injection IP included in this pack. Reconstitution to be carried out as per the instruction in the package.
Use reconstituted solution if it is clear and devoid of particulate matter.

CAUTION AND SCHEDULE:

CAUTION: If any foreign particle is visible in the vial after dissolving the contents, please do not use the solution.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
SCHEDULE: SCHEDULE 'H1' DRUG: It is dangerous to take this preparation except in accordance with the medical advice.
Not to be sold by retail without the prescription of Registered Medical Practitioner.

STORAGE AND DOSAGE:

STORAGE: Store Below 30°C.Protect from light and moisture. Do not freeze.
Reconstituted solution should be use immediately after preparation.
KEEP OUT OF REACH OF CHILDREN
DOSAGE: As directed by Physician