GENERIC NAME OF MEDICINAL PRODUCT:

A. Azithromycin for Injection 500mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Azithromycin for Injection 500mg
a) Each vial contains:
Azithromycin IP
Eq to Anhydroyus Azithromycin ……..500mg
Excipients………………………………………q.s
b) This pack is 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.
• Must be further diluted before use.
• 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.
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 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.

Azithromycin for Injection 500mg Technical Specification:

Product Name:Azithromycin for Injection
Brand Name:Generic
Strength:500mg/Vial
Dosage Form:Lyophilized Powder for Injection
Packing:1 Sterile Single Dose Vial + 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: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 MEDICINAL PRODUCT:

  • Azithromycin for Injection 500mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Azithromycin for Injection 500mg
    a. Each vial contains:
    Azithromycin IP
    Eq to Anhydroyus Azithromycin ……..500mg
    Excipients………………………………………q.s
    b. This pack is 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.
  • Must be further diluted before use.
  • 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.

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 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.