Cloxacillin Sodium for Injection BP 500mg Technical Specification:

Product Name:Cloxacillin Sodium for Injection BP 500mg
Brand Name:Generics
Strength:500mg, 250mg, 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), SmPC (Summary Product Characteristics)
Regulatory Documents:COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use:β-lactam Antibiotic, Anti-bacterial & Penicillin
Indication: Cloxacillin is used for the treatment of certain bacterial infections. It is most commonly used to treat infections of the skin, bone, heart valve, blood, and lung.
Storage:Store Protected from moisture at a temperature not exceeding 30°C

GENERIC NAME OF MEDICINAL PRODUCT:

  • Cloxacillin Sodium for Injection BP 500mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Cloxacillin Sodium for Injection BP 500mg
    Each vial contains:
    (Sterile) Cloxacillin Sodium BP
    to Cloxacillin…………500mg
    Sterile Water for Injection BP ….…………… 10ml

THERAPEUTIC INDICATION:

Cloxacillin is used for the treatment of certain bacterial infections. It is most commonly used to treat infections of the skin, bone, heart valve, blood, and lung.

DIRECTION OF USE:

The powder is to be reconstituted with 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 & 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: Not to be sold by retail without the prescription of a Registered Medical Practitioner.

STORAGE & DOSAGE:

STORAGE: Store Protected from moisture at a temperature not exceeding 30°C
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.

GENERIC NAME OF THE MEDICINAL PRODUCT:

(A) Cloxacillin Sodium for Injection BP 500mg
(B) Cloxacillin Sodium for Injection BP 250mg
(C) Cloxacillin Sodium for Injection BP 1gm

QUALITATIVE AND QUANTITATIVE COMPOSITION:

1. Cloxacillin Sodium for Injection BP 500mg
A. Each vial contains:
(Sterile) Cloxacillin Sodium BP
Eq. to Cloxacillin…………500mg
B. Sterile Water for Injection BP ….…………… 10ml


2. Cloxacillin Sodium for Injection BP 250mg
A. Each vial contains:
(Sterile) Cloxacillin Sodium BP
Eq. to Cloxacillin…………250mg
B. Sterile Water for Injection BP ….…………… 10ml

3. Cloxacillin Sodium for Injection BP 1gm
A. Each vial contains:
(Sterile) Cloxacillin Sodium BP
Eq. to Cloxacillin…………1000mg
B. Sterile Water for Injection BP ………….… 10ml

THERAPEUTIC INDICATIONS:

Cloxacillin is used for the treatment of certain bacterial infections. It is most commonly used to treat infections of the skin, bone, heart valve, blood, and lung.

DIRECTION OF USE:

The powder to be reconstituted with 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 & 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: Not to be sold by retail without the prescription of Registered Medical Practitioner.

STORAGE & DOSAGE:

STORAGE: Store Protected from moisture at a temperature not exceeding 30°C.
Keep medicine out of reach of children.
Reconstituted solution should be use immediately after preparation.
Any unused reconstitution portion must be discarded.
Read enclosed leaflet before use.
DOSAGE: As directed by Physician.