| Product Name: | Valganciclovir Tablets USP |
| Brand Name: | Generic |
| Strength: | 450mg |
| Dosage Form: | Tablets (film-coated) |
| Route of Administration: | Via Oral Route |
| Packing: | 10s, 30s, 100s, 500s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
| Regulatory Documents: | COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier |
| Therapeutic use: | Antiretrovirals, HIV, AIDS. |
| Indication: | Valganciclovir is an antiviral. It is used to treat infections caused by viruses. This medicine is also used to prevent CMV disease in patients who have received an organ transplant (e.g., heart, kidney, or kidney-pancreas transplant). |
| Storage: | Store at 20° to 25°C (68° to 77°F). See USP controlled room temperature. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Valganciclovir Tablets USP 450mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Valganciclovir Tablets USP 450mg
Each film-coated tablet contains:
Valganciclovir USP
Equivalent to Valganciclovir hydrochloride …………….450mg
Excipients………………………………. q. s
Color: Sunset yellow FCF
THERAPEUTIC INDICATIONS:
Valganciclovir is an antiviral. It is used to treat infections caused by viruses. This medicine is also used to prevent CMV disease in patients who have received an organ transplant (e.g., heart, kidney, or kidney-pancreas transplant).
CAUTION & WARNING:
CAUTION:
Read enclosed leaflet before use.
Do not use if seal over bottle opening is broken or missing.
Dispense in a tight, light-resistance, container.
Keep store in tightly closed container.
Dispense in original container.
Keep medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.
STORAGE & DOSAGE:
STORAGE: Store at 20° to 25°C (68° to 77°F). See USP controlled room temperature.
Store in dry place protected from light and moisture.
DOSAGE: As directed by the Physician.