GENERIC NAME OF MEDICINAL PRODUCT:

A. Acyclovir Intravenous Infusion IP 250mg
B. Acyclovir Intravenous Infusion IP 500mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Acyclovir Intravenous Infusion IP 250mg
(a) Each vial contains:
Acyclovir Sodium (Sterile) IP
Equivalent to Acyclovir…..250mg
Excipients………………………q.s
(b) This pack is also contains:
One FFS ampule of Sterile Water for Injection IP…..5ML


B. Acyclovir Intravenous Infusion IP 500mg
(a) Each vial contains:
Acyclovir Sodium (Sterile) IP
Equivalent to Acyclovir…..500mg
Excipients………………………q.s
(b) This pack is also contains:
One FFS ampule of Sterile Water for Injection IP…..10ML

THERAPEUTIC INDICATION:

Acyclovir for infusion is indicated for the treatment of Herpes simplex infections in immunocompromised patients and severe initial genital herpes in the non-immunocompromised. Acyclovir for infusion is indicated for the prophylaxis of Herpes simplex infections in immunocompromised patients.

DIRECTION OF USE:

Constitute the content with Sterile Water for Injection IP supplied with this pack.
Prick the ampoule of Sterile Water for Injection IP only once and discard the ampoule.
The constituted solution should be used immediately and should not be stored.
See package insert for usual dosage, direction for use and administration.

CAUTION AND SCHEDULE:

CAUTION:
• The injection should not be used It contains visible particulate matter after reconstitution.
• Reconstituted solution should be use immediately after preparation.
• DO NOT ACCEPT IF VIAL SEAL IS BROKEN.
• RAPID OR BOLUS INTRAVENOUS INJECTION MUST BE AVOIDED.
• DO NOT USE BACTERIOSTATIC WATER FOR INJECTION CONTAINING BENZYL ALCOHOL AND PARABENS.
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°C.
Protect from moisture.
DOSAGE: As directed by the Physician.

Acyclovir Intravenous Infusion IP 250mg Technical Specification:

Product Name:Acyclovir Intravenous Infusion IP
Brand Name:Generic
Strength:250mg, 500mg
Dosage Form:Lyophilized Powder for Injection (Sterile)
Packing:1 Single Dose Vial + WFI Tray
Route of Administration:For I.V. Infusion use only
Pack Insert/Leaflet:PIL (Patient Information Leaflet)
Documents:COA, MOA, Product Permission, Stability Studies, GMP
Therapeutic use:Antiviral, Anti-Infective
Indication: Acyclovir for infusion is indicated for the treatment of Herpes simplex infections in immunocompromised patients and severe initial genital herpes in the non-immunocompromised. Acyclovir for infusion is indicated for the prophylaxis of Herpes simplex infections in immunocompromised patients.
Storage:Store below 25°C. Protect from moisture.

GENERIC NAME OF MEDICINAL PRODUCT:

  • Acyclovir Intravenous Infusion IP 250mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Acyclovir Intravenous Infusion IP 250mg
    a. Each vial contains:
    Acyclovir Sodium (Sterile) IP
    Equivalent to Acyclovir…..250mg
    Excipients…………………….q.s
    b. This pack is also contains:
    One FFS ampule of Sterile Water for Injection IP…..q.s

THERAPEUTIC INDICATION:

Acyclovir for infusion is indicated for the treatment of Herpes simplex infections in immunocompromised patients and severe initial genital herpes in the non-immunocompromised. Acyclovir for infusion is indicated for the prophylaxis of Herpes simplex infections in immunocompromised patients.

DIRECTION OF USE:

Constitute the content with Sterile Water for Injection IP supplied with this pack.
Prick the ampoule of Sterile Water for Injection IP only once and discard the ampoule.
The constituted solution should be used immediately and should not be stored.
See package insert for usual dosage, direction for use and administration. 

CAUTION AND SCHEDULE:

CAUTION:

  • The injection should not be used It contains visible particulate matter after reconstitution.
  • Reconstituted solution should be use immediately after preparation.
  • DO NOT ACCEPT IF VIAL SEAL IS BROKEN.
  • RAPID OR BOLUS INTRAVENOUS INJECTION MUST BE AVOIDED.
  • DO NOT USE BACTERIOSTATIC WATER FOR INJECTION CONTAINING BENZYL ALCOHOL AND PARABENS.

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°C.
Protect from moisture.

DOSAGE: As directed by the Physician.