Country: Ավստրալիա
language: անգլերեն
source: Department of Health (Therapeutic Goods Administration)
emtricitabine, Quantity: 200 mg; tenofovir disoproxil fumarate, Quantity: 300 mg; rilpivirine hydrochloride, Quantity: 27.5 mg (Equivalent: rilpivirine, Qty 25 mg)
Gilead Sciences Pty Ltd
Emtricitabine,rilpivirine hydrochloride,Tenofovir disoproxil fumarate
Tablet, film coated
Excipient Ingredients: pregelatinised maize starch; microcrystalline cellulose; croscarmellose sodium; polysorbate 20; povidone; lactose monohydrate; magnesium stearate; titanium dioxide; hypromellose; sunset yellow FCF aluminium lake; triacetin; iron oxide red; macrogol 3350; indigo carmine aluminium lake
Oral
30 tablets/bottle
(S4) Prescription Only Medicine
EVIPLERA is indicated for the treatment of HIV infection in treatment-na?ve 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 CLINICAL TRIALS). Patients must not have a history of resistance to any of the components of EVIPLERA (tenofovir DF, emtricitabine or rilpivirine).
Visual Identification: Purplish-pink, capsule-shaped film-coated tablet; debossed with 'GSI' on one side, and plain faced on the other side; Container Type: Bottle; Container Material: HDPE; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure
Licence status A
2012-01-30
EVIPLERA Consumer Medicine Information v12.0 – (15 July 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 amount of read_full_document
EVIPLERA Product Information v17.0 – (15 July 2020) Page 1 AUSTRALIAN PRODUCT INFORMATION - EVIPLERA ® (TENOFOVIR DISOPROXIL FUMARATE, EMTRICITABINE AND RILPIVIRINE) TABLETS 1 NAME OF THE MEDICINE EVIPLERA (tenofovir disoproxil fumarate/emtricitabine/rilpivirine). 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 300 mg tenofovir disoproxil fumarate (tenofovir DF) which is equivalent to 245 mg of tenofovir disoproxil, 200 mg emtricitabine (FTC), and 27.5 mg rilpivirine hydrochloride which is equivalent to 25 mg rilpivirine (RPV). Tenofovir DF is a white to off-white crystalline powder. Emtricitabine is a white to off-white crystalline powder. Rilpivirine hydrochloride is a white to almost white powder. For the full list of excipients, see section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Each EVIPLERA tablet is capsule-shaped, film-coated and purplish-pink in colour. Each tablet is debossed with ‘GSI’ on one side and plain on the other side. The tablets are supplied in bottles with child resistant closures. 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, FTC or RPV). EVIPLERA Product Information v17.0 – (15 July 2020) Page 2 4.2 DOSE AND METHOD OF ADMINISTRATION DOSAGE _Adults:_ The recommended dose of EVIPLERA is one tablet once daily taken orally with food. DOSAGE ADJUSTMENT _Renal impairment:_ EVIPLERA is not recommended for use in patients with moderate or severe renal impairment (creatinine clearance (CrCl) < 50 mL/min). Patient read_full_document