Страна: Ізраїль
мова: англійська
Джерело: Ministry of Health
COBICISTATE; DARUNAVIR AS ETHANOLATE
J-C HEALTH CARE LTD
J05AE10
FILM COATED TABLETS
COBICISTATE 150 MG; DARUNAVIR AS ETHANOLATE 800 MG
PER OS
Required
JANSSEN CILAG S.P.A., ITALY
DARUNAVIR
REZOLSTA is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV 1) infection in treatment-naïve and treatment-experienced adults with no darunavir resistance-associated substitutions (V11i, V32i, L33F, i47V, i50V, i54L, i54M, T74P, L76V, i84V, L89V).שינוי משטר מינון 2/4/2019Pregnancy and postpartumTreatment with REZOLSTA during pregnancy results in low darunavir exposure (see sections 4.4 and 5.2). Therefore, therapy with REZOLSTA should not be initiated during pregnancy, and women who become pregnant during therapy with REZOLSTA should be switched to an alternative regimen, see section 4.4 and 4.6. Darunavir/ritonavir may be considered as an alternative.
2020-09-30
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986 The medicine is dispensed with a doctor’s prescription only NAME AND FORM OF THE PREPARATION: REZOLSTA ® FILM-COATED TABLETS ACTIVE INGREDIENTS AND THEIR QUANTITY: darunavir 800 mg (as ethanolate), cobicistat 150 mg. Inactive and allergenic ingredients: See “Further Information” in section 6 and “Important information about some of the ingredients of the medicine” in section 2. READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THIS MEDICINE. The leaflet contains concise information about the medicine. If you have further questions, refer to the doctor or pharmacist. This medicine has been prescribed to treat your ailment. Do not pass it on to others. It may harm them even if it seems to you that their ailment is similar. 1. WHAT IS THE MEDICINE INTENDED FOR? Rezolsta is an antiretroviral medicine used to treat infection caused by the human immunodeficiency virus (HIV), in combination with other antiretroviral medicines, in adult patients who have not received treatment or who received treatment in the past, on the condition that they did not develop resistance to darunavir. THERAPEUTIC GROUP: Darunavir is an anti-HIV agent of the protease inhibitor group. Cobicistat is a cytochrome P450 inhibitor. The medicine contains the active ingredients: darunavir, which acts by reducing the level of HIV in the blood to a very low level, and cobicistat, which increases the amount of the active ingredient darunavir in the blood. Treatment with Rezolsta will improve your immune system (your body’s natural defence) and will reduce the risk of developing illnesses linked to HIV infection; however, Rezolsta does not cure HIV infection. 2. BEFORE USING THE MEDICINE DO NOT USE THE MEDICINE IF: • You are sensitive (allergic) to any of the active ingredients or to any of the other ingredients contained in the medicine (listed in section 6). • You are suffering from SEVERE LIVER PROBLEMS. Ask the doctor if you are u Прочитайте повний документ
Page 1 of 33 REZOLSTA_800_150-TABLETS_SPC_02_2023 1. NAME OF THE MEDICINAL PRODUCT REZOLSTA 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 800 mg of darunavir (as ethanolate) and 150 mg of cobicistat. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). Pink oval shaped tablet of 23 mm x 11.5 mm, debossed with “800” on one side and “TG” on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS REZOLSTA is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV 1) infection in treatment-naïve and treatment-experienced adults with no darunavir resistance-associated substitutions (V11I, V32I, L33F, I47V, I50V, I54L, I54M, T74P, L76V, I84V, L89V). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Therapy should be initiated by a healthcare provider experienced in the management of HIV infection. Posology After therapy with REZOLSTA has been initiated, patients should not alter the dosage or discontinue therapy without the instruction of their healthcare provider. _ART-naïve patients _ The recommended dose regimen is one film-coated tablet of REZOLSTA once daily taken with food. _ _ _ART-experienced patients _ One film-coated tablet of REZOLSTA once daily taken with food may be used in patients with prior exposure to antiretroviral medicinal products but without darunavir resistance associated mutations (DRV-RAMs)* and who have plasma HIV-1 RNA < 100,000 copies/mL and CD4+ cell count ≥ 100 cells x 10 6 /l (see section 4.1). * DRV-RAMs: V11I, V32I, L33F, I47V, I50V, I54M, I54L, T74P, L76V, I84V, L89V. In all other ART-experienced patients or if HIV-1 genotype testing is not available, the use of REZOLSTA is not appropriate and another antiretroviral regimen should be used. Refer to the Summary of Product Characteristics of other antiretroviral medicinal products for dosing information. _Advice on missed doses _ If REZOLSTA is missed within 12 hours of the time it is us Прочитайте повний документ