| Product Name: | Kanamycin Injection USP |
| Brand Name: | Generic |
| Strength: | 1000mg |
| 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: | Antibiotic (aminoglycoside), Anti-bacterial |
| Indication: | Kanamycin is indicated in the short-term treatment of serious infections caused by susceptible strains of the designated microorganisms below. Bacteriological studies to identify the causative organisms and to determine their susceptibility to kanamycin should be performed. |
| Storage: | Store in a cool & dry place. Protect from light. |
GENERIC NAME OF MEDICINAL PRODUCT:
Kanamycin Injection USP (1000mg)
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Kanamycin Injection USP (1000mg)
Composition:
Each vial contains:
Kanamycin acid
Sulphate USP (Sterile)
Equivalent to
Kanamycin ………………………1000mg
Sterile Water for Injection USP…………15ml
DIRECTION OF USE:
Dissolve the contents of vials in 3ml of Sterile Water for Injection USP.
The reconstituted solution should be used immediately after preparation.
Discard remaining Water for Injection.
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: Not to be sold by retail without the prescription of a Registered Medical Practitioner only.
STORAGE & DOSAGE:
Storage: Store in a cool & dry place. Protect from light.
Keep all medicines out of reach of children.
Dosage: As directed by Physician.