GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Acyclovir Sodium Injection 500mg/10ml
B. Acyclovir Sodium Injection 1000mg/20ml
C. Acyclovir Sodium Injection 25mg/ml

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Acyclovir Sodium Injection 500mg/10ml
Each ml contains:
Acyclovir Sodium
Eq to Acyclovir……………………50mg
Excipients………………………….q.s
Water for Injections USP…….q.s

B. Acyclovir Sodium Injection 1000mg/20ml
Each ml contains:
Acyclovir Sodium
Eq to Acyclovir …………………50mg
Excipients……………..…………..q.s
Water for Injections USP…….q.s

C. Acyclovir Sodium Injection 25mg/ml
Each ml contains:
Acyclovir Sodium
Eq to Acyclovir……………………25mg
Excipients………………………….q.s
Water for Injections USP…….q.s


THERAPEUTIC INDICATIONS:

Acyclovir injection is used to treat first-time or repeat outbreaks of herpes simplex (a herpes virus infection of the skin and mucus membranes) and to treat herpes zoster (shingles; a rash that can occur in people who have had chickenpox in the past) in people with weak immune systems.

DIRECTION OF USE:

For Intravenous Infusion use.
Dilute to 7mg/ml or lower prior to infusion.
See insert for additional dilution instructions.

CAUTION & WARNING:

CAUTION: Do not use if any foreign particulate matter is visible.
MUST BE FURTHER DILUTED PRIOR TO USE.
Discard unused portion.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
Warning: Not to be sold by retail without the prescription of a Registered Medical Practitioner.

STORAGE & DOSAGE:

Storage: Store at 20°C to 25°C (68°F TO 77°F).
Keep all medicines out of reach of children.
Dosage: As directed by the Physician.

Acyclovir Sodium Injection 25mg/ml Technical Specification:

Product Name:Acyclovir Sodium Injection
Brand Name:Generic
Strength:500mg/10ml,  1000mg/20ml, 25mg/ml
Dosage Form:Liquid Injection (Sterile and Nonpyrogenic)
Packing:50mg/ml- 10ml Single Dose Vials/Ampoules
50mg/ml- 20ml Single Dose Vials/Ampoules
25mg/ml- 10ml Single Dose Vials/Ampoules
Route of Administration:For I.V. 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:Antiviral, Anti-Infective
Indication: Acyclovir injection is used to treat first-time or repeat outbreaks of herpes simplex (a herpes virus infection of the skin and mucus membranes) and to treat herpes zoster (shingles; a rash that can occur in people who have had chickenpox in the past) in people with weak immune systems.
Storage:Store at 20°C to 25°C (68°F TO 77°F).

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Acyclovir Sodium Injection 25mg/ml

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Acyclovir Sodium Injection 25mg/ml
    Each ml contains:
    Acyclovir Sodium
    Eq to Acyclovir……………………25mg
    Excipients………………………….q.s
    Water for Injections USP…………q.s

THERAPEUTIC INDICATIONS:

Acyclovir injection is used to treat first-time or repeat outbreaks of herpes simplex (a herpes virus infection of the skin and mucus membranes) and to treat herpes zoster (shingles; a rash that can occur in people who have had chickenpox in the past) in people with weak immune systems.

DIRECTION OF USE:

For Intravenous Infusion use.
Dilute to 7mg/ml or lower prior to infusion.
See insert for additional dilution instructions.

CAUTION & Warning:

CAUTION: Do not use if any foreign particulate matter is visible.
MUST BE FURTHER DILUTED PRIOR TO USE.
Discard unused portion.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.

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

STORAGE & DOSAGE:

Storage: Store at 20°C to 25°C (68°F TO 77°F).
Keep all medicines out of reach of children.

Dosage: As directed by the Physician.