Land: Israel
Språk: engelsk
Kilde: Ministry of Health
DARUNAVIR AS ETHANOLATE
J-C HEALTH CARE LTD
J05AE10
FILM COATED TABLETS
DARUNAVIR AS ETHANOLATE 600 MG
PER OS
Required
JANSSEN CILAG S.P.A., ITALY
DARUNAVIR
DARUNAVIR
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.
2014-11-30
Prezista 600mg SPC 03-2022 SUB 1. NAME OF THE MEDICINAL PRODUCT PREZISTA 600 MG 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 600 mg of darunavir (as ethanolate). Excipient with known effect: Each tablet contains a maximum of 1.375 mg sunset yellow FCF. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Orange oval shaped tablet, debossed with “600MG” 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 patients 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-Experienced Adult Patients _ Treatment-Experienced Adult Patients With at least one darunavir resistance associated substitution* 600 mg PREZISTA twice daily taken with ritonavir 100 mg twice daily and with food * V11I, V32I, L33F, I47V, I50V, I54L, I54M, T74P, L76V, I84V and L89V For antiretroviral treatment-experienced patients genotypic testing is recommended. However, when genotypic testing is not feasible, PREZISTA/ritonavir 600/100 mg twice daily dosing is recommended. Prezista 600mg SPC 03-2022 SUB _Advice on missed doses _ in case a dose of PREZISTA and/or ritonavir is missed within 6 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 6 hours after the time it is usually taken, the missed dose should not be taken and the patient should resume the usual dosing schedule. This guidance is based on the 15 hour ha Les hele dokumentet
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 Les hele dokumentet