GENERIC NAME OF THE MEDICINAL PRODUCT:
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Composition:
Each film-coated tablet contains:
Efavirenz …………………….….600mg
Emtricitabine ……………………200mg
Tenofovir Disoproxil………….245mg
(Equivalent to 300mg of Tenofovir Disoproxil Fumarate or 136mg of Tenofovir).
Excipients…………………………. 76mg
Lactose (as monohydrate)
Colours: Titanium Dioxide USP
THERAPEUTIC INDICATIONS:
Treat and prevent HIV/AIDS Immunodeficiency Virus (HIV).
Nucleoside and Nucleotide reverse transcriptase inhibitors.
CAUTION & WARNING:
Swallow whole do not chew or crush.
Keep the container tightly closed.
WARNING: Do not skip/discontinue the dose for effective treatment.
Do not stop taking your medicine or change your dosage without consulting your doctor.
***Suitable for Vegetarians & Vegans.
Efavirenz, Emtricitabine and Tenofovir should not be used to treat hepatitis B virus infection (HBV; an ongoing liver infection).
Keep out of the reach and sight of children.
STORAGE & DOSAGE:
Dosage: As directed by the Physician.
Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate Tablets (600mg/200mg/300mg) Technical Specification:
Product Name: | Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate Tablets |
Brand Name: | Generics |
Strength: | 600mg/200mg/300mg |
Dosage Form: | Film-coated tablets |
Packing: | 120 Tab Bottle |
Route of Administration: | For Oral 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 |
Indication: | The indication applied is for the use of Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva in the treatment of Human immunodeficiency virus-1 (HIV-1) infection in adults aged 18 years and over with virologic suppression to HIV-1 RNA levels of < 50 copies/ml on their current combination antiretroviral therapy. |
Storage: | Store protected from moisture at a temperature not exceeding 30°C. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate Tablets (600mg/200mg/300mg)
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate Tablets (600mg/200mg/300mg)
Composition:
Each film-coated tablet contains:
Efavirenz …………………….….600mg
Emtricitabine ……………………200mg
Tenofovir Disoproxil………….245mg
(Equivalent to 300mg of Tenofovir Disoproxil Fumarate or 136mg of Tenofovir).
Excipients…………………………. 76mg
Lactose (as monohydrate)
Colours: Titanium Dioxide USP
THERAPEUTIC INDICATIONS:
The indication applied is for the use of Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva in the treatment of Human immunodeficiency virus-1 (HIV-1) infection in adults aged 18 years and over with virologic suppression to HIV-1 RNA levels of < 50 copies/ml on their current combination antiretroviral therapy.
Treat and prevent HIV/AIDS Immunodeficiency Virus (HIV).
Nucleoside and Nucleotide reverse transcriptase inhibitors.
CAUTION & WARNING:
CAUTION: Do not throw away consumer package insert.
Swallow whole do not chew or crush.
Keep the container tightly closed.
WARNING: Do not skip/discontinue the dose for effective treatment.
Do not stop taking your medicine or change your dosage without consulting your doctor.
***Suitable for Vegetarians & Vegans.
Efavirenz, Emtricitabine and Tenofovir should not be used to treat hepatitis B virus infection (HBV; an ongoing liver infection).
Keep out of the reach and sight of children.
STORAGE & DOSAGE:
Storage: Store protected from moisture at a temperature not exceeding 30°C.
Dosage: As directed by the Physician.