Benzathine Penicillin Injection BP 0.6MIU
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Benzathine Penicillin Injection BP 0.6MIU  Technical Specification:

Product Name:Benzathine Penicillin Injection BP 0.6MIU
Brand Name:Generic
Strength:0.6MIU, 1.2MIU, 2.4MIU
Dosage Form:Dry Powder Injection (Sterile)
Packing:Vial + WFI in Tray
Route of Administration:For deep Intramuscular Injection 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:Penicillin, β-lactam Antibiotic & Anti-bacterial
Indication: Benzathine benzylpenicillin, also known as benzathine penicillin G, is an antibiotic useful for the treatment of a number of bacterial infections. Specifically, it is to treat strep throat, diphtheria, syphilis, and yaws.
Storage:Store below 25°C. Protect from light & moisture. Do not freeze.

GENERIC NAME OF MEDICINAL PRODUCT:

  •  Benzathine Penicillin Injection BP 0.6MIU

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Benzathine Penicillin Injection 0.6MIU
    Each vial contains:
    Benzathine Benzylpenicillin BP………. 6,00,000 units.
    Buffering Agent:
    Sodium Citrate BP
    Dispersing Agent:
    Sodium Carboxymethyl Cellulose USP
    Sterile Water for Injection BP……….10ml

 THERAPEUTIC INDICATION:

Benzathine benzylpenicillin, also known as benzathine penicillin G, is an antibiotic useful for the treatment of a number of bacterial infections. Specifically, it is to treat strep throat, diphtheria, syphilis, and yaws. It is also used to prevent rheumatic fever. It is given by injection into a muscle.

DIRECTION OF USE:

Add 3-4 ml water for Injection before use.
The prepared solution should be used immediately.
Any unused reconstitution portion must be discarded.
For dosage, administration, and detailed direction of use, see package insert.

CAUTION & Warning:

CAUTION: Do not use the injection if the contents are not clear or contain visible particulate matter after reconstitution.
 “Penicillin Sensitivity Test Essential”
Not to be infused directly: Dilute the preparation with a compatible intravenous solution prior to administration.
For deep intramuscular injection only
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE

Warning: To be sold by the retail on the prescription of a Registered Medical Practitioner only.
Warning: If any particle is visible after dissolving the contents do not use & return for a replacement.

STORAGE & DOSAGE:

Storage: Store below 25°C.
Protect from light & moisture.
Do not freeze.

KEEP OUT OF REACH OF CHILDREN

Dosage: As directed by the Physician.

GENERIC NAME OF THE MEDICINAL PRODUCT:

(A) Benzathine Penicillin Injection BP 2.4MIU
(B) Benzathine Penicillin Injection BP 1.2MIU
(C) Benzathine Penicillin Injection BP 0.6 MIU

QUALITATIVE AND QUANTITATIVE COMPOSITION:

1. Benzathine Penicillin Injection 2.4MIU
a) Each vial contains:
Benzathine Benzylpenicillin BP………. 24,00,000 units.
Buffering Agent:
Sodium Citrate BP
Dispersing Agent:
Sodium Carboxymethyl Cellulose USP
b) Sterile Water for Injection BP……….10ml

2. Benzathine Penicillin Injection 1.2MIU
a) Each vial contains:
Benzathine Benzylpenicillin BP………. 1,200,000 units.
Buffering Agent:
Sodium Citrate BP
Dispersing Agent:
Sodium Carboxymethyl Cellulose USP
b) Sterile Water for Injection BP……….10ml

3. Benzathine Penicillin Injection 0.6MIU
a) Each vial contains:
Benzathine Benzylpenicillin BP………. 6,00,000 units.
Buffering Agent:
Sodium Citrate BP
Dispersing Agent:
Sodium Carboxymethyl Cellulose USP
b) Sterile Water for Injection BP……….10ml

THERAPEUTIC INDICATIONS:

Benzathine benzylpenicillin, also known as benzathine penicillin G, is an antibiotic useful for the treatment of a number of bacterial infections. Specifically, it is to treat strep throat, diphtheria, syphilis, and yaws. It is also used to prevent rheumatic fever. It is given by injection into a muscle.

DIRECTION OF USE:

Add 3-4 ml water for Injection before use.
The prepared solution should be used immediately.
Any unused reconstitution portion must be discarded.
For dosage, administration and detailed direction of 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.
"Penicillin Sensitivity Test Essential"
Not to be infuse directly: Dilute the preparation with compatible intravenous solution prior to administration.
For deep intramuscular injection only
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE
WARNING: To be sold by the retail on the prescription of a Registered Medical Practitioner only.
WARNING: If any particle is visible after dissolving the contents do not use & return for replacement.

STORAGE & DOSAGE:

Storage: Store below 25°C.
Protect from light & moisture.
Do not freeze.
KEEP OUT OF REACH OF CHILDREN
Dosage: As directed by Physician