Dolutegravir, Lamivudine and Tenofovir Disoproxil Fumarate Tablets Technical Specification:
| Product Name: | Dolutegravir, Lamivudine and Tenofovir Disoproxil Fumarate Tablets |
| Brand Name: | Generic |
| Strength: | 50mg/300mg/300mg |
| Dosage Form: | Tablets (film-coated tablet) |
| Route of Administration: | Via Oral Route |
| Packing: | 30s,90s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet),SmPC (Summary Product Characteristics) |
| Documents: | COA, MOA, Stability Studies, GMP |
| Therapeutic use: | HIV / AIDS, Antivirals |
| Indication: | Dolutegravir+Lamivudine+Tenofovir disoproxil fumarate is a combination of antiretrovirals medicines. It is prescribed to treat HIV (human immunodeficiency virus) infection. It boosts up the immunity to fight against HIV to manage or treat AIDS (acquired immunodeficiency syndrome). |
| Storage: | Store at a temperature not exceeding 30°C. Protect from light & Moisture. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
Dolutegravir, Lamivudine and Tenofovir Disoproxil Fumarate Tablets
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Dolutegravir, Lamivudine and Tenofovir Disoproxil Fumarate IP Tablets
Each film-coated tablet contains:
Dolutegravir Sodium IP equivalent to Dolutegravir ……………50mg
Tenofovir Disoproxil Fumarate IP
equivalent to Tenofovir Disoproxil 245mg …………………..300mg
Lamivudine IP ………………………………………………..………… 300mg
Excipients ………………………..q.s.
Colour: Titanium Dioxide IP
THERAPEUTIC INDICATIONS:
Dolutegravir+Lamivudine+Tenofovir disoproxil fumarate is a combination of antiretrovirals medicines. It is prescribed to treat HIV (human immunodeficiency virus) infection. It boosts up the immunity to fight against HIV to manage or treat AIDS (acquired immunodeficiency syndrome).
CAUTION & SCHEDULE:
Read the enclosed leaflet before use.
Keep stored in a tightly closed container.
Dispense in original container.
Keep the medicine out of reach of children.
Do not use if seal over bottle opening is broken or missing.
SCHEDULE: SCHEDULE H PRESCRIPTION: To be sold by retail on the prescription of a “Hepatologist Only”.
WARNING: Formulation contain lactose
STORAGE & DOSAGE:
Storage: Store at a temperature not exceeding 30°C. Protect from light & Moisture.
Dosage: As directed by the Physician.