GENERIC NAME OF MEDICINAL PRODUCT:
B. Streptomycin for Injection USP (1g)
QUALITATIVE AND QUANTITATIVE COMPOSITION:
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:
DIRECTION OF USE:
The reconstituted solution should be used within 4 days when stored in a cool place.
CAUTION & WARNING:
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:
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.