| Product Name: | Valganciclovir Tablet USP |
| Brand Name: | Generics |
| Strength: | 450mg |
| Dosage Form: | Tablet (Film-coated) |
| Route of Administration: | Via oral Route |
| Packing: | 10s, 30s, 100s |
| 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, Antiretrovirals |
| Indication: | Valganciclovir is used to treat cytomegalovirus (CMV) retinitis (eye infection that can cause blindness) in people who have acquired immunodeficiency syndrome (AIDS). |
| Storage: | Protect form moisture at a temperature not exceeding 30˚C.Do not freeze. Keep the container tightly closed in order to protect from moisture. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
Valganciclovir Tablet USP 450mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Valganciclovir Tablet USP 450mg
Each Film coated tablet contains:
Valganciclovir Hydrochloride USP
Equivalent to Valganciclovir …………………………….450mg
Excipients…………………………………. q.s.
Colours: Sunset Yellow FCF
THERAPEUTIC INDICATIONS:
Valganciclovir is used to treat cytomegalovirus (CMV) retinitis (eye infection that can cause blindness) in people who have acquired immunodeficiency syndrome (AIDS).
CAUTION & WARNING:
CAUTION: Read enclosed leaflet before use.
Keep medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
Warning: Not to be sold by retail without the prescription of a Registered Medical Prescriber.
STORAGE & DOSAGE:
Storage: Protect form moisture at a temperature not exceeding 30˚C.Do not freeze. Keep the container tightly closed in order to protect from moisture.
Dosage: As directed by the Physician.