Emtricitabine and Tenofovir Disoproxil Fumarate Tablets 200mg/300mg Technical Specification:

Product Name:Emtricitabine and Tenofovir Disoproxil Fumarate Tablets
Brand Name:Generics
Strength: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 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:

  • Emtricitabine and Tenofovir Disoproxil Fumarate Tablets (200mg/300mg)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Emtricitabine and Tenofovir Disoproxil Fumarate Tablets (200mg/300mg)
    Composition:
    Each film-coated tablet contains:
    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 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.

 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.  

GENERIC NAME OF THE MEDICINAL PRODUCT:

Emtricitabine and Tenofovir Disoproxil Fumarate Tablets (200mg/300mg)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

Emtricitabine and Tenofovir Disoproxil Fumarate Tablets (200mg/300mg)
Composition:
Each film-coated tablet contains:
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 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.
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.