Capreomycin for Injection USP 500mg Technical Specification:
| Product Name: | Capreomycin for Injection USP 500mg |
| Brand Name: | Capretaj |
| Strength: | 500mg, 750mg, 1000mg |
| Dosage Form: | Dry Powder Injection (Sterile) *Preservative Free |
| Packing: | 1 Vial + 1 Ampule + WFI Tray (Single use only) |
| Route of Administration: | For Intravenous Infusion 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: | Antibiotic, Antitubercular, Anti Tuberculosis (TB) |
| Indication: | Capreomycin is an injectable broad-spectrum antibiotic used in the therapy of drug resistant tuberculosis as a second line agent, always in combination with other antituberculosis drugs. Capreomycin has not been linked to cases of clinically apparent liver disease. |
| Storage: | Store at 20°C to 25°C; excursion permitted to 15°C to 30°C. [See USP Controlled Room Temperature]. |
GENERIC NAME OF MEDICINAL PRODUCT:
- Capreomycin for Injection USP (500mg) (Capretaj)
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Capreomycin for Injection USP (500mg)
Composition:
Each vial contains:
Sterile Capreomycin Sulphate USP
Equivalent to
Capreomycin………………………500mg
Sterile Water for Injection BP…………5ml
THERAPEUTIC INDICATIONS:
Capreomycin is an injectable broad-spectrum antibiotic used in the therapy of drug resistant tuberculosis as a second line agent, always in combination with other antituberculosis drugs. Capreomycin has not been linked to cases of clinically apparent liver disease.
DIRECTION OF USE:
Withdraw 2ml of sterile water for injection* BP from the supplied pack and dissolved the contents of pack and dissolved the contents of vial immediately before use.
Discard remaining WFI
The reconstituted solution may be stored for 48 hours at room temperature and up to 14 days under refrigeration.
CAUTION & WARNING:
CAUTION: If any foreign particle is visible in the vial after reconstitution, please do not use the solution.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE
WARNING: Capreomycin can harm your kidneys or damage the nerve that controls your hearing. Before you use capreomycin, tell your doctor about all your medical conditions and any medicines you are using.
STORAGE & DOSAGE:
Storage: Store at 20°C to 25°C; excursion permitted to 15°C to 30°C. [See USP Controlled Room Temperature].
Keep out of the reach of children.
Dosage: As directed by Physician.
GENERIC NAME OF THE MEDICINAL PRODUCT:
A. Capreomycin for Injection USP (500mg)
B. Capreomycin for Injection USP (750mg)
C. Capreomycin for Injection USP (1000mg)
B. Capreomycin for Injection USP (750mg)
C. Capreomycin for Injection USP (1000mg)
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A. Capreomycin for Injection USP (500mg)
Composition:
a) Each vial contains:
Sterile Capreomycin Sulphate USP
Equivalent to
Capreomycin………………………500mg
b) Sterile Water for Injection BP…………5ml
B. Capreomycin for Injection USP (750mg)
Composition:
a) Each vial contains:
Sterile Capreomycin Sulphate USP
Equivalent to
Capreomycin………………………750mg
b) Sterile Water for Injection BP…………5ml
C. Capreomycin for Injection USP (1000mg)
Composition:
a) Each vial contains:
Sterile Capreomycin Sulphate USP
Equivalent to
Capreomycin………………………1000mg
b) Sterile Water for Injection BP…………5ml
Composition:
a) Each vial contains:
Sterile Capreomycin Sulphate USP
Equivalent to
Capreomycin………………………500mg
b) Sterile Water for Injection BP…………5ml
B. Capreomycin for Injection USP (750mg)
Composition:
a) Each vial contains:
Sterile Capreomycin Sulphate USP
Equivalent to
Capreomycin………………………750mg
b) Sterile Water for Injection BP…………5ml
C. Capreomycin for Injection USP (1000mg)
Composition:
a) Each vial contains:
Sterile Capreomycin Sulphate USP
Equivalent to
Capreomycin………………………1000mg
b) Sterile Water for Injection BP…………5ml
THERAPEUTIC INDICATIONS:
Capreomycin is an injectable broad-spectrum antibiotic used in the therapy of drug resistant tuberculosis as a second line agent, always in combination with other antituberculosis drugs. Capreomycin has not been linked to cases of clinically apparent liver disease.
DIRECTION OF USE:
Withdraw 2ml of sterile water for injection* BP from the supplied pack and dissolved the contents of pack and dissolved the contents of vial immediately before use.
Discard remaining WFI
The reconstituted solution may be stored for 48 hours at room temperature and up to 14 days under refrigeration.
Discard remaining WFI
The reconstituted solution may be stored for 48 hours at room temperature and up to 14 days under refrigeration.
CAUTION & WARNING:
CAUTION: If any foreign particle is visible in the vial after reconstitution, please do not use the solution.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE
WARNING: Capreomycin can harm your kidneys or damage the nerve that controls your hearing. Before you use capreomycin, tell your doctor about all your medical conditions and any medicines you are using.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE
WARNING: Capreomycin can harm your kidneys or damage the nerve that controls your hearing. Before you use capreomycin, tell your doctor about all your medical conditions and any medicines you are using.
STORAGE & DOSAGE:
Storage: Store at 20°C to 25°C; excursion permitted to 15°C to 30°C. [See USP Controlled Room Temperature].
Keep out of the reach of children.
Dosage: As directed by Physician.
Keep out of the reach of children.
Dosage: As directed by Physician.
