Ország: Új-Zéland
Nyelv: angol
Forrás: Medsafe (Medicines Safety Authority)
Emtricitabine 200mg; ; ; ; Rilpivirine hydrochloride 27.5mg equivalent to rilpivirine free base 25 mg; ; Tenofovir disoproxil fumarate 300mg; ; ;
Gilead Sciences (NZ)
Emtricitabine 200 mg
Film coated tablet
Active: Emtricitabine 200mg Rilpivirine hydrochloride 27.5mg equivalent to rilpivirine free base 25 mg Tenofovir disoproxil fumarate 300mg Excipient: Croscarmellose sodium Lactose monohydrate Magnesium stearate Microcrystalline cellulose Opadry Polysorbate 20 Povidone Pregelatinised maize starch Purified water
Bottle, plastic, HDPE with PP cap and desiccant, 30 tablets
Prescription
Prescription
Union Quimico Farmaceutica SA (Uquifa SA)
EVIPLERA is indicated for the treatment of HIV infection in treatment-na?ve adult patients with plasma HIV-1 RNA less than or equal to 100,000 copies/mL at the start of therapy. EVIPLERA is also indicated in certain virologically-suppressed (HIV-1 RNA <50 copies/mL) adult patients on a stable antiretroviral regimen at start of therapy in order to replace their current antiretroviral treatment regimen (see CLINICAL TRIALS). Patients must not have a history of resistance to any of the components of EVIPLERA (tenofovir DF, emtricitabine or rilpivirine).
Package - Contents - Shelf Life: Bottle, plastic, HDPE with PP cap and desiccant - 30 tablets - 36 months from date of manufacture stored at or below 30°C
2012-02-29
EVIPLERA Consumer Medicine Information v13.0 – (06 November 2020) Page 1 EVIPLERA ® TABLETS _300_ _ _ _mg tenofovir disoproxil fumarate / 200 mg emtricitabine/ 25 mg rilpivirine _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET Read all of this leaflet carefully before you start taking this medicine. This leaflet answers some of the common questions about EVIPLERA tablets. It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist about your medical condition or treatment. If you have further questions, please ask your doctor or your pharmacist. Keep this leaflet with your EVIPLERA medicine. You may need to read it again. This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours. WHAT IS EVIPLERA EVIPLERA is used to treat Human Immunodeficiency Virus (HIV-1) infection in adults. EVIPLERA consists of three medicines: • tenofovir disoproxil fumarate, also called tenofovir DF • emtricitabine or FTC • rilpivirine These are combined in one tablet to help control Human Immunodeficiency Virus (HIV-1) infection. Tenofovir disoproxil fumarate and emtricitabine belong to a group of antiviral medicines known as nucleoside and nucleotide reverse transcriptase inhibitors (NRTI). Rilpivirine belongs to a group of antiviral medicines known as non- nucleoside reverse transcriptase inhibitors (NNRTI). _HOW EVIPLERA WORKS _ HIV-1 infection destroys CD4 T cells, which are important to the immune system. The immune system helps fight infection. After a large number of T cells are destroyed, acquired immune deficiency syndrome (AIDS) may develop. EVIPLERA helps block HIV-1 reverse transcriptase, a viral chemical in your body (enzyme) that is needed for HIV-1 to multiply. EVIPLERA lowers the amount of HIV-1 in the blood (viral load). EVIPLERA may also help to increase the number of T cells (CD4 + cells), allowing your immune system to improve. Lowering the amoun Olvassa el a teljes dokumentumot
EVIPLERA Data Sheet v11.0 – (06 November 2020) Page 1 DATA SHEET 1. EVIPLERA ® (TENOFOVIR DISOPROXIL FUMARATE, EMTRICITABINE AND RILPIVIRINE) TABLETS 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 300 mg tenofovir disoproxil fumarate/200 mg emtricitabine/25 mg rilpivirine For full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. EVIPLERA tablets are capsule shaped, film-coated and purplish-pink in colour. Each tablet is debossed with ‘GSI’ on one side and plain on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS EVIPLERA is indicated for the treatment of HIV infection in treatment-naïve adult patients with plasma HIV-1 RNA ≤ 100,000 copies/mL at the start of therapy. EVIPLERA is also indicated in certain virologically-suppressed (HIV-1 RNA <50 copies/mL) adult patients on a stable antiretroviral regimen at start of therapy in order to replace their current antiretroviral treatment regimen (see section 5.1 Pharmacodynamic properties, Clinical trials). Patients must not have a history of resistance to any of the components of EVIPLERA (tenofovir DF, emtricitabine or rilpivirine). 4.2 DOSE AND METHOD OF ADMINISTRATION _Adults:_ The recommended dose of EVIPLERA is one tablet once daily taken orally with food. When discontinuation of EVIPLERA is necessary due to one of the components, or where dose modification is necessary, separate preparations of tenofovir DF, emtricitabine and rilpivirine should be used. Please refer to the product information for these products (see section 4.5 Interactions with other medicines and other forms of interactions). _ _ _Paediatric population: _ EVIPLERA is not recommended for use in children below 18 years of age due to insufficient data on safety and efficacy. _SPECIAL POPULATIONS _ _RENAL IMPAIRMENT:_ EVIPLERA is not recommended for use in patients with moderate or severe renal impairment (Creatinine Clearance (CrCl) < 50 mL/min). Patients with moderate or severe renal impairment require dose interval adjustments of tenofovir Olvassa el a teljes dokumentumot