GENERIC NAME OF MEDICINAL PRODUCT:

(A) Benzyl Penicillin Sodium for Injection B.P. 0.8 MIU

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Benzyl Penicillin Sodium for Injection B.P. 0.8 MIU
a) Each vial contains:
Benzyl Penicillin Sodium BP
(As sodium) ………………………800,000IU
b) Sterile Water for Injection BP ….…………… 20ml

THERAPEUTIC INDICATION:

Benzyl Penicillin is a local anaesthetic and antibiotic combination for intramuscular injection to treat a variety of bacterial infections while reducing pain from a deep intramuscular injection. Benzylpenicillin is an injectable antibiotic.

DIRECTION OF USE:

The powder to be reconstituted with 20ml of Sterile Water for Injections BP.
FOR IM USE ONLY
The prepared 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.
Reconstituted solution should be use immediately after preparation.
Any unused reconstitution portion must be discarded.
Read enclosed leaflet before use.
Not to be infuse directly:
Dilute the preparation with compatible intravenous solution prior to administration.
WARNING: Not to be sold by retail without the prescription of Registered Medical Practitioner.
“Penicillin Sensitivity Test Essentail”

STORAGE & DOSAGE:

STORAGE: Store below 25°C. Protect from Light. Do not freeze.
Keep medicine out of reach of children.
DOSAGE: As directed by Physician.

Benzyl Penicillin Sodium for Injection B.P. 0.8 MIU Technical Specification:

Product Name:Benzyl Penicillin Sodium for Injection B.P.
jBrand Name:Generics
Strength:0.8 MIU
Dosage Form:Dry Powder Injection (Sterile)
Packing:Vial + WFI in Tray
Route of Administration:For I.M. 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: Procaine benzylpenicillin is a local anaesthetic and antibiotic combination for intramuscular injection to treat a variety of bacterial infections while reducing pain from a deep intramuscular injection. Benzylpenicillin is an injectable antibiotic.
Storage:Store below 25°C. Protect from Light. Do not freeze.

GENERIC NAME OF MEDICINAL PRODUCT:

  • Benzyl Penicillin Sodium for Injection B.P. 0.8 MIU

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  1. Benzyl Penicillin Sodium for Injection B.P. 0.8 MIU
    a) Each vial contains:
    Benzyl Penicillin Sodium BP
    (As sodium) ………………………800,000IU
    b) Sterile Water for Injection BP ….…………… 20ml

THERAPEUTIC INDICATION:

Benzyl Penicillin is a local anesthetic and antibiotic combination for intramuscular injection to treat a variety of bacterial infections while reducing pain from a deep intramuscular injection. Benzylpenicillin is an injectable antibiotic.

DIRECTION OF USE:

The powder to be reconstituted with 20ml of Sterile Water for Injections BP.

FOR IM USE ONLY

The prepared 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.

Reconstituted solution should be use immediately after preparation.

Any unused reconstitution portion must be discarded.

Read enclosed leaflet before use.

Not to be infuse directly:
Dilute the preparation with compatible intravenous solution prior to administration.

WARNING: Not to be sold by retail without the prescription of Registered Medical Practitioner.
“Penicillin Sensitivity Test Essential”

STORAGE & DOSAGE:

STORAGE:  Store below 25°C. Protect from Light. Do not freeze.

Keep medicine out of reach of children.

DOSAGE:  As directed by Physician.