Țară: Israel
Limbă: engleză
Sursă: Ministry of Health
DARUNAVIR AS ETHANOLATE
J-C HEALTH CARE LTD
J05AE10
FILM COATED TABLETS
DARUNAVIR AS ETHANOLATE 75 MG
PER OS
Required
JANSSEN CILAG S.P.A., ITALY
DARUNAVIR
DARUNAVIR
Adult Patients:Prezista, co-administered with ritonavir (Prezista/rtv), and with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (HIV -1) infection. This indication is based on analyses of plasma HIV-1 RNA levels and CD4+ cell counts from 2 controlled phase 3 trials of 48 weeks duration in antiretroviral treatment - naive and treatment-experienced patients and 2 controlled phase 2 trials of 96 weeks duration in clinically advanced, treatment-experienced adult patients .Pediatric patients:Prezista, co-administered with ritonavir (Prezista/rtv), and with other antiretroviral agents, is indicated for the treatment of HIV-1 infection in treatment-experienced pediatric patients 6 years of age and older .This indication is based on 24 Week analyses of plasma HIV-1 RNA levels and CD4+ cell counts from an open-label phase 2 trial in antiretroviral treatment-experienced pediatric patients 6 to < 18 years of age. In treatment-experienced adult and pediatric patients, the following points should be considered when initiating therapy with Prezista/rtv: - Treatment history and, when available, genotypic or phenotypic testing, should guide the use of Prezista/rtv. - The use of other active agents with Prezista/rtv is associated with a greater likelihood of treatment response.
2015-07-31
העדוה העדוה לע לע הרמחה הרמחה ( ( עדימ עדימ ןולעב )תוחיטב ןולעב )תוחיטב ל ל אפור אפור ןכדועמ( ןכדועמ( 05.2013 05.2013 ) ) ךיראת _ 4.8.15 _ םש רישכת תילגנאב רפסמו םושירה 75MG PREZISTA םושיר רפסמ 144-22-32957-00 PREZISTA 150MG םושיר רפסמ 144-32-32992-00 PREZISTA 400MG םושיר רפסמ 142-12-31999-00 PREZISTA 600MG םושיר רפסמ 142-13-32000-00 PREZISTA 800MG םושיר רפסמ 151-64-34005-00 םש לעב םושירה _ J-C HEALTH CARE LTD . ספוט הז דעוימ טורפל תורמחהה דבלב ! תורמחהה תושקובמה קרפ ןולעב טסקט יחכונ טסקט שדח Interactions 7.3 ESTABLISHED AND OTHER POTENTIALLY SIGNIFICANT DRUG INTERACTIONS Darunavir and ritonavir are both inhibitors of the CYP3A isoform. Co-administration of darunavir and ritonavir and medicinal products primarily metabolised by CYP3A may result in increased systemic exposure to such medicinal products, which could increase or prolong their therapeutic effect and adverse reactions . PREZISTA co-administered with low dose ritonavir must not be combined with medicinal products that are highly dependent on CYP3A for clearance and for which increased systemic exposure is associated with serious and/or life-threatening events (narrow therapeutic index). These medicinal products include amiodarone, bepridil, quinidine, systemic lidocaine, astemizole, alfuzosin, terfenadine, sildenafil (when used for the treatment of pulmonary arterial hypertension), 7.3 ESTABLISHED AND OTHER POTENTIALLY SIGNIFICANT DRUG INTERACTIONS Darunavir and ritonavir are both inhibitors of the CYP3A isoform. Co-administration of darunavir and ritonavir and medicinal products primarily metabolised by CYP3A may result in increased systemic exposure to such medicinal products, which could increase or prolong their therapeutic effect and adverse reactions . PREZISTA co-administered with low dose ritonavir must not be combined w Citiți documentul complet
Prezista 400mg_SPC_03-2022_ SUB 1. NAME OF THE MEDICINAL PRODUCT PREZISTA 400 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 400 mg of darunavir (as ethanolate). Excipient with known effect: Each tablet contains 0.834 mg sunset yellow FCF (E110). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Light orange oval shaped tablet, debossed with “400MG” on one side and “TMC” on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Prezista, co-administered with 100 mg ritonavir (Prezista/rtv), and with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (HIV -1) infection for over 18 years of age. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION PREZISTA must be co-administered with ritonavir to exert its therapeutic effect. Failure to correctly co-administer PREZISTA with ritonavir will result in plasma levels of darunavir that will be insufficient to achieve the desired antiviral effect and will alter some drug interactions. _Treatment-Naïve Adult Patients _ The recommended oral dose of PREZISTA tablets is 800 mg taken with ritonavir 100 mg once daily and with food. _Treatment-Experienced Adult Patients _ Treatment-Experienced Adult Patients With no darunavir resistance associated substitutions* 800 mg PREZISTA once daily with ritonavir 100 mg once daily and with food Prezista 400mg_SPC_03-2022_ SUB * V11I, V32I, L33F, I47V, I50V, I54L, I54M, T74P, L76V, I84V and L89V For antiretroviral treatment-experienced patients genotypic testing is recommended. _Advice on missed doses _ If once daily dose of PREZISTA and/or ritonavir is missed within 12 hours of the time it is usually taken, patients should be instructed to take the prescribed dose of PREZISTA and ritonavir with food as soon as possible. If this is noticed later than 12 hours after the time it is usually taken, the missed dose should not be taken and the patient should resume the usual dosing schedule. If a patient vomits within Citiți documentul complet