Acyclovir for Injection USP 1GM

GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Acyclovir for Injection USP 250mg
B. Acyclovir for Injection USP 500mg
C. Acyclovir for Injection USP 1gm

QUALITATIVE AND QUANTITATIVE COMPOSITION:

1. Acyclovir for Injection USP 250mg
a) Each vial contains:
Acyclovir Sodium USP
Equivalent to
Acyclovir…………………………250mg
Excipients………………………q.s
b) This pack is also contains:
One FFS ampule of Sterile Water for Injection USP…….5ml

2. Acyclovir for Injection USP 500mg
c) Each vial contains:
Acyclovir Sodium USP
Equivalent to
Acyclovir………………………500mg
Excipients………………………q.s
d) This pack is also contains:
One FFS ampule of Sterile Water for Injection USP…….10ml

3. Acyclovir for Injection USP 1gm
a) Each vial contains:
Acyclovir sodium USP
Equivalent to
Acyclovir…………………………1g
Excipients………………………q.s
b) This pack is also contains:
One FFS ampule of Sterile Water for Injection USP…….20ml

THERAPEUTIC INDICATIONS:

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:

For Intravenous Infusion use.
Inject 5ml of Sterile Water for Injection in Acyclovir for Injection USP 250mg into vial. Shake until clear solution is achieved and use within 12 hours.
Inject 10ml of Sterile Water for Injection in Acyclovir for Injection USP 500mg into vial. Shake until clear solution is achieved and use within 12 hours.
Inject 20ml of Sterile Water for Injection in Acyclovir for Injection USP 1g into vial. Shake until clear solution is achieved and use within 12 hours.
Dilute to 7mg/ml or lower prior to infusion.
See enclosed leaflet for further information.

CAUTION & WARNING:

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.
Warning: Not to be sold by retail without the prescription of a Registered Medical Practitioner.

STORAGE & DOSAGE:

Storage: Store between 15°C to 25°C (59°F to 77°F).
Protect from moisture.
Keep all medicines out of reach of children.
Dosage: See package insert for usual dosage, direction for use and administration.

Acyclovir for Injection USP 1gm Technical Specification:

Product Name:Acyclovir for Injection USP
Brand Name:Generic
Strength:250mg, 500mg,  1gm
Dosage Form:Lyophilized Powder for Injection
Packing:1 Single Dose Vial + WFI Tray
Route of Administration:For IV Infusion use only
Pack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents:COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use:Antivirals, 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 between 15°C to 25°C (59°F to 77°F). Protect from moisture.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Acyclovir for Injection USP 1gm

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Acyclovir for Injection USP 1gm
    a. Each vial contains:
    Acyclovir Sodium USP
    Equivalent to
    Acyclovir……………………………..1gm
    Excipients………………………q.s
    b. This pack is also contains:
    One FFS ampule of Sterile Water for Injection USP…….20ml

THERAPEUTIC INDICATIONS:

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:

For Intravenous Infusion use.
Inject 20ml of Sterile Water for Injection in Acyclovir for Injection USP 1g into vial. Shake until clear solution is achieved and use within 12 hours.
Dilute to 7mg/ml or lower prior to infusion.
See package insert for usual dosage, reconstitution and dilution instruction.

CAUTION & Warning:

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.

Warning: Not to be sold by retail without the prescription of a Registered Medical Practitioner.

STORAGE & DOSAGE:

Storage: Store between 15°C to 25°C (59°F to 77°F).
Protect from moisture.
Keep all medicines out of reach of children.

Dosage: As directed by the Physician.