Valganciclovir Tablet USP 450mg (Valcytaj) Technical Specification:

Product Name:Valganciclovir Tablets USP 450mg
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.

Attach dispensing label as per end country.

GENERIC NAME OF THE MEDICINAL PRODUCT:

A) Valganciclovir Tablet USP 450mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Valganciclovir Tablet USP 450mg
Each film-coated tablet contains:
Valganciclovir Hydrochloride USP
Eq. to Valganciclovir ……….450mg
Excipients…………………….…………q.s.
Colour: Titanium Dioxide IP

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 (eg, heart, kidney, or kidney-pancreas transplant. This indicated is for the induction and maintenance treatment of cytomegalovirus (CMV) retinitis in adult patients with acquired immunodeficiency syndrome (AIDS).

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: Keep in cool & Dry place.
Protect from Light & moisture.
Temperature not exceeding 30°C.
Preserve in tight container.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
Read enclosed leaflet before use.
DOSAGE: AS Directed by The Physician.