Cefepime & Tazobactam for Injection 1.125gm

GENERIC NAME OF MEDICINAL PRODUCT:

(A) Cefepime & Tazobactam for Injection 1.125gm
(B) Cefepime & Tazobactam for Injection 2.25gm
(C) Cefepime & Tazobactam for Injection 562.5mg
(D) Cefepime & Tazobactam for Injection 281.25mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

1. Cefepime & Tazobactam for Injection 1.125gm
A. Each vial contains:
(Sterile) Cefepime Hydrochloride USP
Eq. to cefepime………….1000mg
(Sterile Mixture of Cefepime Hydrochloride & L-Arginine)
(Sterile) Tazobactam Sodium
Eq. to Tazobactam USP……….125mg
B. Sterile Water for Injection BP….…………… 10ml

2. Cefepime & Tazobactam for Injection 2.25gm
A. Each vial contains:
(Sterile) Cefepime Hydrochloride USP
Eq. to cefepime………….2000mg
(Sterile Mixture of Cefepime Hydrochloride & L-Arginine)
(Sterile) Tazobactam Sodium
Eq. to Tazobactam USP……….250mg
B. Sterile Water for Injection BP….……………20 ml

3. Cefepime & Tazobactam for Injection 562.5mg
A. Each vial contains:
(Sterile) Cefepime Hydrochloride USP
Eq. to cefepime………….500mg
(Sterile Mixture of Cefepime Hydrochloride & L-Arginine)
(Sterile) Tazobactam Sodium
Eq. to Tazobactam USP……….62.5mg
B. Sterile Water for Injection BP….…………… 5ml

4. Cefepime & Tazobactam for Injection 281.25mg
A. Each vial contains:
(Sterile) Cefepime Hydrochloride USP
Eq. to cefepime………….250mg
(Sterile Mixture of Cefepime Hydrochloride & L-Arginine)
(Sterile) Tazobactam Sodium
Eq. to Tazobactam USP……….31.25mg
B. Sterile Water for Injection BP….…………… 5ml

THERAPEUTIC INDICATION:

Cefepime + Tazobactam is a combination of two medicines: Cefepime and Tazobactam. Cefepime is an antibiotic. It works by preventing the formation of the bacterial protective covering which is essential for the survival of bacteria in the human body.

DIRECTION OF USE:

The powder to be reconstituted with 20ml or 10ml of Sterile Water for Injections BP.
The reconstituted solution should be use immediately after preparation. The prepared solution should be used only, if it is clear.

CAUTION AND WARNING:

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.
WARNING: 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 25°C. Protect from light & moisture.
Keep medicine out of reach of children.
Any unused reconstitution portion must be discarded.
Read enclosed leaflet before use.
DOSAGE: As directed by Physician. See the package insert for more information.

Cefepime & Tazobactam for Injection 1.125gm Technical Specification:

Product Name:Cefepime & Tazobactam for Injection 1.125gm
Brand Name:Generic
Strength:1.125gm, 2.25gm, 562.5mg, 281.25mg
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), SmPC (Summary Product Characteristics)
Regulatory Documents:COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use:β-lactam Antibiotic, Anti-bacterial & Cephalosporin.
Indication: Cefepime & Tazobactam is used in the treatment of bacterial infections.
Storage:Store below 25°C. Protect from light & moisture.

GENERIC NAME OF MEDICINAL PRODUCT:

  • Cefepime & Tazobactam for Injection 1.125gm

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Cefepime & Tazobactam for Injection 1.125gm
    Each vial contains:
    (Sterile) Cefepime Hydrochloride USP
    Eq. to Cefepime……….1000mg
    (Sterile Mixture of Cefepime Hydrochloride & L-Arginine)
    (Sterile) Tazobactam Sodium
    Eq. to Tazobactam USP……….125mg
    Sterile Water for Injection BP….…………… 10ml

THERAPEUTIC INDICATION:

Cefepime + Tazobactam is a combination of two medicines: Cefepime and Tazobactam. Cefepime is an antibiotic. It works by preventing the formation of the bacterial protective covering which is essential for the survival of bacteria in the human body.

DIRECTION OF USE:

The powder is to be reconstituted with 20ml or 10ml of Sterile Water for Injection BP.
The reconstituted solution should be used immediately after preparation. The prepared solution should be used only if it is clear.

CAUTION AND WARNING:

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.

WARNING: 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 25°C. Protect from light and moisture.
Keep the medicine out of reach of children.
The reconstituted solution should be used immediately after preparation.
Any unused reconstitution portion must be discarded.
Read the enclosed leaflet before use. 

Dosage:  As directed by the Physician. See the package insert for more information.