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Azithromycin for Injection USP 500mg Technical Specification:

Product Name:Azithromycin for Injection USP
Brand Name:Zithromin
Strength:500mg
Dosage Form:Lyophilized Powder for Injection (Sterile, Nonpyrogenic)
Packing:1 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: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 at 20°C to 25°C (68°F to 77°F)

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GENERIC NAME OF MEDICINAL PRODUCT:

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.