Country: Malasía
Tungumál: enska
Heimild: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
EMTRICITABINE; Tenofovir alafenamide fumarate
Gilead Sciences Malaysia Sdn. Bhd.
EMTRICITABINE; Tenofovir alafenamide fumarate
30 Tablets
PATHEON INC
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ DESCOVY ® 200MG/10MG AND 200MG/25MG FILM-COATED TABLETS _EMTRICITABINE (200MG) AND TENOFOVIR ALAFENAMIDE (10MG), _ _EMTRICITABINE (200MG) AND TENOFOVIR ALAFENAMIDE (25MG) _ 1 WHAT IS IN THIS LEAFLET? 1. What Descovy is used for 2. How Descovy works 3. Before you take descovy 4. How to use Descovy 5. While you are using Descovy 6. Side effects 7. Storage and disposal of Descovy 8. Product description 9. Manufacturer 10. Product RegistrationHolder WHAT DESCOVY IS USED FOR Descovy in combination with other medicines is for the TREATMENT OF HUMAN IMMUNODEFICIENCY VIRUS 1 (HIV-1) INFECTION in adults and adolescents 12 years of age and older, who weigh at least 35 kg. HOW DESCOVY WORKS Descovy contains two active substances: • EMTRICITABINE, an antiretroviral medicine of a type known as a nucleoside reverse transcriptase inhibitor (NRTI) • TENOFOVIR ALAFENAMIDE, an antiretroviral medicine of a type known as a nucleotide reverse transcriptase inhibitor (NtRTI) Descovy blocks the action of the reverse transcriptase enzyme, which is essential for the virus to multiply. Descovy therefore reduces the amount of HIV in your body. BEFORE YOU TAKE DESCOVY _-When you must not use it _ DO NOT TAKE DESCOVY: • IF YOU ARE ALLERGIC TO EMTRICITABINE, TENOFOVIR ALAFENAMIDE or any of the other ingredients of this medicine (listed in section 6 of this leaflet). CHILDREN AND ADOLESCENTS Do not give this medicine to children aged 11 years or under, or weighing less than 35 kg. The use of Descovy in children aged 11 years or under has not yet been studied. _-Before you start to use it _ WARNINGS AND PRECAUTIONS You must remain under the care of your doctor while taking Descovy. TALK TO YOUR DOCTOR BEFORE TAKING DESCOVY: • IF YOU HAVE LIVER PROBLEMS OR HAVE SUFFERED LIVER DISEASE, INCLUDING HEPATITIS. Patients with liver disease including chronic hepatitis B or C, who are treated with antiretrovirals, have a higher risk of severe and potentially fatal liver complications. If you have Lestu allt skjalið
1 DESCOVY ® (200 mg/10 mg film -coated tablets emtricitabine/tenofovir alafenamide ) for oral use (200 mg/25 mg film -coated tablets emtricitabine/tenofovir alafenamide) for oral use FULL PRESCRIBING INFORMATION 1. NAME OF THE MEDICINAL PRODUCT Descovy ® 200 mg /10 mg film -coated tablets Descovy ® 200 mg/25 mg film -coated tablets. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Descovy 200 mg/10 mg film -coated tablets Each tablet contains 200 mg of emtricitabine and tenofovir alafenamide fumarate equivalent to 10 mg of tenofovir alafenamide . Descovy 200 mg/25 mg film -coated tablets. Each tablet contains 200 mg of emtricitabine and tenofovir alafenamide fumarate equivalent to 25 mg of tenof ovir alafenamide. 3. PHARMACEUTICAL FORM Film -coated tablet. Descovy 200 mg/10 mg film -coated tablets Grey, rectangular -shaped, film -coated tablet debossed with “GSI” on one side and “210” on the other side of the tablet . Descovy 200 mg/25 mg film -coated tablets. Blue, rectangular -shaped, film -coated tablet debossed with “ GSI” on one side and “225” on the other side of the tablet. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Descovy is indicated in combination with other antiretroviral agents for the treatment of adults and adolescents ( aged 12 years and older wi th body weight at least 35 kg) infected with human immunodeficiency virus type 1 ( HIV -1) (see section s 4.2 and 5.1). 4.2 Posology and method of administration Therapy should be initiated by a physician experienced in the management of HIV infection. Pos ology Adults and adolescents aged 12 years and older, weighing at least 35 kg Descovy should be administered as shown in Table 1. Lestu allt skjalið