GENERIC NAME OF MEDICINAL PRODUCT:

A. Streptomycin for Injection USP (0.75g)
B. Streptomycin for Injection USP (1g)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Streptomycin for Injection USP (0.75g)
 Composition:
a) Each vial contains:
Streptomycin Sulphate USP (Sterile)
Equivalent to Streptomycin…………………0.75gm
b) Sterile Water for Injection USP…………2mL or more

B. Streptomycin for Injection USP (1g)
 Composition:
a) Each vial contains:
Streptomycin Sulphate USP (Sterile)
Equivalent to Streptomycin …………………1gm
b) Sterile Water for Injection USP…………2mL or more


THERAPEUTIC INDICATIONS:

Moderate to severe susceptible infections, including plague, tularemia, endocarditis. Second-line therapy for gram-negative bacillary bacteremia, meningitis, pneumonia, brucellosis, granuloma inguinale, chancroid, UTIs.

DIRECTION OF USE:

Add 2ml or more Sterile Water for Injection USP for reconstitution.
The reconstituted solution should be used within 4 days when stored in a cool place.

CAUTION & WARNING:

CAUTION: The reconstituted solution should not be used if it contains any visible particulate matter.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE
WARNING: Not to be sold by retail without the prescription of a Registered Medical Practitioner only.

STORAGE & DOSAGE:

Storage: Store dry powder at controlled room temperature 20° to 25°C.
Sterile reconstituted solutions should be protected from light & may be stored at controlled room temperature up to 7 days.
Retain in carton until the time of use.
Keep all medicines out of reach of children.
Dosage: As directed by Physician.

Streptomycin for Injection USP 1g Technical Specification:

Product Name:Streptomycin for Injection USP
Brand Name:Generic
Strength:0.75g, 1g
Dosage Form:Lyophilized
Dry Powder Injection (Sterile) *Preservative Free
Packing:1 Vial + 1 Ampule + WFI Tray
Route of Administration:For IM 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:Antibiotics (aminoglycoside)
Indication: Moderate to severe susceptible infections, including plague, tularemia, and endocarditis. Second-line therapy for gram-negative bacillary bacteremia, meningitis, pneumonia, brucellosis, granuloma inguinale, chancroid, and UTIs.
Storage:Store dry powder at a controlled room temperature of 20° to 25° C.
Sterile reconstituted solutions should be protected from light & may be stored at controlled room temperature for up to 7 days.

GENERIC NAME OF MEDICINAL PRODUCT:

  • Streptomycin for Injection USP (1g)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Streptomycin for Injection USP (1g)
    Composition:
    Each vial contains:
    Streptomycin Sulphate USP (Sterile)
    Equivalent to Streptomycin…………………1g
    Sterile Water for Injection USP…………2mL or more

THERAPEUTIC INDICATIONS:

Moderate to severe susceptible infections, including plague, tularemia, and endocarditis. Second-line therapy for gram-negative bacillary bacteremia, meningitis, pneumonia, brucellosis, granuloma inguinale, chancroid, and UTIs.

DIRECTION OF USE:

Add 2ml or more Sterile Water for Injection USP for reconstitution.
The reconstituted solution should be used within 4 days when stored in a cool place.

CAUTION & WARNING:

CAUTION: The reconstituted solution should not be used if it contains any visible particulate matter.

FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE

WARNING:  Not to be sold by retail without the prescription of a Registered Medical Practitioner only.

STORAGE & DOSAGE:

Storage: Store dry powder at a controlled room temperature of 20° to 25° C.
Sterile reconstituted solutions should be protected from light & may be stored at controlled room temperature for up to 7 days.
Retain in a carton until the time of use.

Keep all medicines out of reach of children.

Dosage: As directed by the Physician.