GENERIC NAME OF THE MEDICINAL PRODUCT:
A. Azithromycin for Injection USP 500mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
(A) Azithromycin for Injection USP 500mg
Each Combipack Contains:
a) Azithromycin for injection USP 500mg
Each vial contains:
Azithromycin Dihydrate USP
Eq. to Azithromycin (Anhydrous)………..500mg
Excipients……………………………………………q.s
b) Sterile water For injection USP 5ML FFS Plastic Ampoule
Each Ampoule contains:
Sterile water for injection USP
Each ml of reconstituted injection contains:
Azithromycin Dihydrate USP
Eq. to Azithromycin (Anhydrous)………100mg
Use within 24hours after reconstitution and store at room temperature.
Each Combipack Contains:
a) Azithromycin for injection USP 500mg
Each vial contains:
Azithromycin Dihydrate USP
Eq. to Azithromycin (Anhydrous)………..500mg
Excipients……………………………………………q.s
b) Sterile water For injection USP 5ML FFS Plastic Ampoule
Each Ampoule contains:
Sterile water for injection USP
Each ml of reconstituted injection contains:
Azithromycin Dihydrate USP
Eq. to Azithromycin (Anhydrous)………100mg
Use within 24hours after reconstitution and store at room temperature.
THERAPEUTIC INDICATIONS:
Azithromycin injection is used to treat bacterial infections in many different parts of the body. It is also used to prevent Mycobacterium avium complex (MAC) disease in patients infected with the human immunodeficiency virus (HIV). Azithromycin belongs to the class of drugs known as macrolide antibiotics.
DIRECTION OF USE:
Prepare the solution of azithromycin for injection by adding 5ml of sterile water for injection to the 500mg vial and shaking the vial until all of the dissolved.
Reconstituted solution is stable for 24 hours when stored below 30℃, To be diluted with diluents and given as IV infusion over a period of not less than 60 minites.
Reconstituted solution is stable for 24 hours when stored below 30℃, To be diluted with diluents and given as IV infusion over a period of not less than 60 minites.
CAUTION & WARNING:
CAUTION:
• If any particles are visible in the vial after dissolving the contents, please do not use the solution and ask for replacement.
• Even visible damage to vial caused during transit, storage or handling may result into contamination.
• Reconstituted solution should be use immediately after preparation.
• KEEP OUT OF REACH AND SIGHT OF CHILDREN.
• FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
• Must be further diluted before use.
Warning:
To be sold by retail with the prescription of a Registered Medical Practitioner.
• If any particles are visible in the vial after dissolving the contents, please do not use the solution and ask for replacement.
• Even visible damage to vial caused during transit, storage or handling may result into contamination.
• Reconstituted solution should be use immediately after preparation.
• KEEP OUT OF REACH AND SIGHT OF CHILDREN.
• FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
• Must be further diluted before use.
Warning:
To be sold by retail with the prescription of a Registered Medical Practitioner.
STORAGE & DOSAGE:
Storage: Store below 25℃.
Store in a cool, dry and dark place.
Protect from light and moisture.
Keep all medicines out of reach of children.
Dosage: As directed by the Physician.
Store in a cool, dry and dark place.
Protect from light and moisture.
Keep all medicines out of reach of children.
Dosage: As directed by the Physician.
Azithromycin for Injection USP 500mg Technical Specification:
| Product Name: | Azithromycin for Injection USP |
| Brand Name: | Generic |
| Strength: | 500mg |
| Dosage Form: | Lyophilized Powder for Injection (Sterile, Nonpyrogenic) |
| Packing: | 1 Single Dose Vial + WFI Tray |
| Route of Administration: | For IV Infusion use |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
| Regulatory Documents: | COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier |
| Therapeutic use: | Antibacterials, Anti-Infectives, Antibiotic(macrolide) |
| Indication: | Azithromycin injection is used to treat bacterial infections in many different parts of the body. It is also used to prevent Mycobacterium avium complex (MAC) disease in patients infected with the human immunodeficiency virus (HIV). Azithromycin belongs to the class of drugs known as macrolide antibiotics. |
| Storage: | Store below 25℃. Store in a cool, dry and dark place. Protect from light and moisture. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Azithromycin for Injection USP 500mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Azithromycin for Injection USP 500mg
Each Combipack Contains:
a) Azithromycin for injection USP 500mg
Each vial contains:
Azithromycin Dihydrate USP
Eq. to Azithromycin (Anhydrous)………..500mg
Excipients……………………………………………q.s
b) Sterile water For injection USP 5ML FFS Plastic Ampoule
Each Ampoule contains:
Sterile water for injection USP - Each ml of reconstituted injection contains:
Azithromycin Dihydrate USP
Eq. to Azithromycin (Anhydrous)………100mg
Use within 24hours after reconstitution and store at room temperature.
THERAPEUTIC INDICATIONS:
Azithromycin injection is used to treat bacterial infections in many different parts of the body. It is also used to prevent Mycobacterium avium complex (MAC) disease in patients infected with the human immunodeficiency virus (HIV). Azithromycin belongs to the class of drugs known as macrolide antibiotics.
DIRECTION OF USE:
Prepare the solution of azithromycin for injection by adding 5ml of sterile water for injection to the 500mg vial and shaking the vial until all of the dissolved. Reconstituted solution is stable for 24 hours when stored below 30℃, To be diluted with diluents and given as IV infusion over a period of not less than 60 minutes.
CAUTION & WARNING:
CAUTION:
- If any particles are visible in the vial after dissolving the contents, please do not use the solution and ask for replacement.
- Even visible damage to vial caused during transit, storage or handling may result into contamination.
- Reconstituted solution should be use immediately after preparation.
- KEEP OUT OF REACH AND SIGHT OF CHILDREN.
- FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
- Must be further diluted before use.
Warning: To be sold by retail with the prescription of a Registered Medical Practitioner.
STORAGE & DOSAGE:
Storage: Store below 25℃.
Store in a cool, dry and dark place.
Protect from light and moisture.
Keep all medicines out of reach of children.
Dosage: As directed by the Physician.
