GENERIC NAME OF THE MEDICINAL PRODUCT:

(A) Benzyl Penicillin Injection BP 1 MIU
(B) Benzyl Penicillin Injection BP 1.2 MIU
(C) Benzyl Penicillin Injection BP 5 MIU

QUALITATIVE AND QUANTITATIVE COMPOSITION:

1. Benzyl Penicillin for Injection BP 1 MIU
a) Each vial contains:
Benzyl Penicillin Sodium BP
(as sodium) …………………….1,000,000 Units
b) Sterilized Water for Injection BP…….10ml

2. Benzyl Penicillin for Injection BP 1.2 MIU
a) Each vial contains:
Benzylpenicillin Sodium BP
(as sodium) …………………….1,200,000 Units
b) sterilized Water for Injection BP…….10ml


3. Benzyl Penicillin for Injection BP 5 MIU
a) Each vial contains:
Benzylpenicillin Sodium BP
(as sodium) …………………….5,000,000 Units
b) sterilized Water for Injection BP…….10ml

THERAPEUTIC INDICATIONS:

Benzylpenicillin is indicated for most wound infections, pyogenic infections of the skin, soft tissue infections and infections of the nose, throat, nasal sinuses, respiratory tract and middle ear, etc.

DIRECTION OF USE:

For I.M./I.V. use only.
The prepared solution should be used immediately.
For dosage, administration and detailed direction for use see pack insert.

CAUTION & WARNING:

CAUTION: Do not use the injection if the contents are not clear or contains visible particulate matter after reconstitution.
Not to be Infuse directly: Dilute the preparation with compatible Intravenous solution prior to administration.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
Any unused portion must be Discarded properly.
WARNING: To be sold by the retail on the prescription of a registered medical practitioner only.
If any particle is visible in the vial after dissolving the contents, please do not use & return for replacement.

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 Injection BP 1.2 MIU Technical Specification:

Product Name:Benzyl Penicillin Injection BP 1.2MIU
Brand Name:Generics
Strength:1 MIU (600mg) (10,00,000 IU),
1.2MIU (900mg) (12,00,000 IU),
5 MIU (3000mg) (50,00,000 IU)
Dosage Form:Dry Powder for Injection (Sterile)
Packing:1 Vial + WFI in a Tray
Route of Administration:For I.M./I.V. use only
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: Benzylpenicillin is indicated for most wound infections, pyogenic infections of the body parts.
Storage:Store Below 25°C.  Protect from light. Do not freeze.

GENERIC NAME OF MEDICINAL PRODUCT:

  • Benzyl Penicillin Injection BP 1.2 MIU

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Benzyl Penicillin for Injection BP 1.2 MIU
    Each vial contains:
    Benzyl Penicillin Sodium BP
    (as sodium) …………………….1,200,000 Units
    Sterilized Water for Injection BP…….10ml

THERAPEUTIC INDICATION:

Benzylpenicillin is indicated for most wound infections, pyogenic infections of the skin, soft tissue infections and infections of the nose, throat, nasal sinuses, respiratory tract and middle ear, etc.

DIRECTION OF USE:

For I.M./I.V. use only.

The prepared solution should be used immediately.

For dosage, administration and detailed direction for use see pack insert.

CAUTION & Warning:

CAUTION: Do not use the injection if the contents are not clear or contains visible particulate matter after reconstitution.

Not to be Infuse directly: Dilute the preparation with compatible Intravenous solution prior to administration.

FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.

Any unused portion must be Discarded properly.

WARNING: To be sold by the retail on the prescription of a registered medical practitioner only.

If any particle is visible in the vial after dissolving the contents, please do not use & return for replacement.

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.