GENERIC NAME OF THE MEDICINAL PRODUCT:
QUALITATIVE AND QUANTITATIVE COMPOSITION:
a) Each vial contains:
Azithromycin IP
Eq to Azithromycin (Anhydrous)……500mg
Excipients………………………………………q.s
b) This pack is also contains:
Sterile Water for Injection IP…….5ml
THERAPEUTIC INDICATIONS:
DIRECTION OF USE:
For details of sterile water for Injection I.P. refer ampule label.
CAUTION AND SCHEDULE:
Even visible damage to vial caused during transit, storage or handling may result into contamination.
SCHEDULE: SCHEDULE 'H PRESCRIPTION DRUG-CAUTION: Not to be sold by retail without the prescription of a Registered Medical Practitioner.
STORAGE & DOSAGE:
Reconstituted solution should be use immediately after preparation.
KEEP OUT OF REACH AND SIGHT OF CHILDREN.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
DOSAGE: As directed by the Physician.
Refer the enclosed package insert.
Azithromycin for Injection 500mg Technical Specification:
Product Name: | Azithromycin for Injection |
Brand Name: | Generic |
Strength: | 500mg/Vial |
Dosage Form: | Lyophilized Powder for Injection |
Packing: | 1Vial + WFI Tray |
Route of Administration: | For I.V. Infusion only |
Pack Insert/Leaflet: | PIL (Patient Information Leaflet) |
Documents: | COA, MOA, Product Permission, Stability Studies, GMP |
Therapeutic use: | Antibacterial, 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 30°C in dry form. |
GENERIC NAME OF MEDICINAL PRODUCT:
- Azithromycin for Injection 500mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Azithromycin for Injection 500mg
a)Each vial contains:
Azithromycin IP
Eq to Azithromycin (Anhydrous)……500mg
Excipients………………………………………q.sb) This pack also contains:
Sterile Water for Injection IP…….5ml
THERAPEUTIC 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.
DIRECTION OF USE:
Reconstitute with 4.8ml of Sterile Water for Injection IP. Reconstituted the contents with prior diluent and reconstituted solution should be used immediately. Not to be stored.
For details of sterile water for Injection I.P. refer ampule label.
CAUTION AND SCHEDULE:
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.
SCHEDULE: SCHEDULE ‘H PRESCRIPTION DRUG-CAUTION: Not to be sold by retail without the prescription of a Registered Medical Practitioner.
STORAGE AND DOSAGE:
STORAGE: Store in a cool, dry and dark place.
Reconstituted solution should be use immediately after preparation.
KEEP OUT OF REACH AND SIGHT OF CHILDREN.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
DOSAGE: As directed by the Physician.
Refer the enclosed package insert.