A. Acyclovir for Injection USP 250mg
B. Acyclovir for Injection USP 500mg
C. Acyclovir for Injection USP 1gm
GENERIC NAME OF THE MEDICINAL PRODUCT:
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A. Acyclovir for Injection USP 250mg
a) Each vial contains:
Acyclovir Sodium USP
Equivalent to Acyclovir……250mg
Sodium Hydroxide USP………24.5mg
b) This pack is also contains:
One FFS ampule of Sterile Water for Injection USP……5ml
B. Acyclovir for Injection USP 500mg
a) Each vial contains:
Acyclovir Sodium USP
Equivalent to Acyclovir……500mg
Sodium Hydroxide USP………49mg
b) This pack is also contains:
One FFS ampule of Sterile Water for Injection USP……10ml
C. Acyclovir for Injection USP 1gm
a) Each vial contains:
Acyclovir sodium USP
Equivalent to Acyclovir……1g
Sodium Hydroxide USP………98mg
b) This pack is also contains:
One FFS ampule of Sterile Water for Injection USP……20ml
a) Each vial contains:
Acyclovir Sodium USP
Equivalent to Acyclovir……250mg
Sodium Hydroxide USP………24.5mg
b) This pack is also contains:
One FFS ampule of Sterile Water for Injection USP……5ml
B. Acyclovir for Injection USP 500mg
a) Each vial contains:
Acyclovir Sodium USP
Equivalent to Acyclovir……500mg
Sodium Hydroxide USP………49mg
b) This pack is also contains:
One FFS ampule of Sterile Water for Injection USP……10ml
C. Acyclovir for Injection USP 1gm
a) Each vial contains:
Acyclovir sodium USP
Equivalent to Acyclovir……1g
Sodium Hydroxide USP………98mg
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.
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.
CAUTION & WARNING:
CAUTION: The injection should not be used It contains visible particulate matter after reconstitution.
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.
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)
Keep all medicines out of reach of children.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE
Dosage: As directed by the Physician.
See package insert for usual dosage, direction for use and administration.
Keep all medicines out of reach of children.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE
Dosage: As directed by the Physician.
See package insert for usual dosage, direction for use and administration.
Acyclovir for Injection USP 250mg Technical Specification:
| Product Name: | Acyclovir for Injection USP 250mg |
| 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. Aciclovir 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) |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Acyclovir for Injection USP 250mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Acyclovir for Injection USP 250mg
Each vial contains:
Acyclovir Sodium USP
Equivalent to Acyclovir……250mg
Sodium Hydroxide USP………24.5mg
This pack is also contains:
One FFS ampule of Sterile Water for Injection USP……5ml
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.
Dilute to 7mg/ml or lower prior to infusion.
CAUTION & Warning:
CAUTION: The injection should not be used It contains visible particulate matter after reconstitution.
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)
Keep all medicines out of reach of children.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE
Dosage: As directed by the Physician.
See package insert for usual dosage, direction for use and administration.
