Nazione: Singapore
Lingua: inglese
Fonte: HSA (Health Sciences Authority)
Darunavir Ethanolate 867.28mg eqv Darunavir
JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE LTD
J05AE10
800 mg
TABLET, FILM COATED
Darunavir Ethanolate 867.28mg eqv Darunavir 800 mg
ORAL
Prescription Only
JANSSEN-ORTHO LLC
ACTIVE
2014-08-28
PRODUCT NAME PREZISTA® 75 mg film‑coated tablets. PREZISTA® 150 mg film‑coated tablets. PREZISTA® 400 mg film‑coated tablets. PREZISTA® 600 mg film‑coated tablets. PREZISTA® 800mg film-coated tablets. PHARMACEUTICAL FORM Film‑coated tablet. * 75mg white caplet-shaped tablet, debossed with 75 on one side and TMC on the other side; contains 75 mg of darunavir (corresponding to 81.31 mg of darunavir ethanolate). * 150mg white oval-shaped tablet, debossed with 150 on one side and TMC on the other side; contains 150 mg of darunavir (corresponding to 162.62 mg of darunavir ethanolate). * 400mg light orange oval-shaped tablet, debossed with 400MG on one side and TMC on the other side; contains 400 mg of darunavir (corresponding to 433.64 mg of darunavir ethanolate). The film‑coating of the light orange tablet contains sunset yellow FCF (E110). * 600mg orange oval-shaped tablet, debossed with 600MG on one side and TMC on the other side; contains 600 mg of darunavir (corresponding to 650.46 mg of darunavir ethanolate). The film‑coating of the orange tablet contains sunset yellow FCF (E110). * 800mg dark red oval-shaped tablet, debossed with 800 on one side and T on the other side; contains 800mg of darunavir (corresponding to 867.28mg of darunavir ethanolate). The film coating of the dark red tablet contains Iron Oxide Red. For excipients, see _List of Excipients_. CLINICAL INFORMATION INDICATIONS ADULT PATIENTS PREZISTA, in combination with 100 mg low dose ritonavir (PREZISTA/rtv) and with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (HIV) infection. PAEDIATRIC PATIENTS PREZISTA, in combination with low dose ritonavir (PREZISTA/rtv) and with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (HIV) infection in treatment‑experienced paediatric patients of 6 years and above and at least 20kg body weight. In treatment-experienced adult and paediatric patients, the following points should be considered Leggi il documento completo
- 1 - PRODUCT NAME PREZISTA ® 75 mg film-coated tablets. PREZISTA ® 150 mg film-coated tablets. PREZISTA ® 400 mg film-coated tablets. PREZISTA ® 600 mg film-coated tablets. PREZISTA ® 800mg film-coated tablets. DOSAGE FORMS AND STRENGTHS Film-coated tablet - 75mg white caplet-shaped tablet, debossed with 75 on one side and TMC on the other side; contains 75 mg of darunavir (corresponding to 81.31 mg of darunavir ethanolate). - 150mg white oval-shaped tablet, debossed with 150 on one side and TMC on the other side; contains 150 mg of darunavir (corresponding to 162.62 mg of darunavir ethanolate). - 400mg light orange oval-shaped tablet, debossed with 400MG on one side and TMC on the other side; contains 400 mg of darunavir (corresponding to 433.64 mg of darunavir ethanolate). The film-coating of the light orange tablet contains sunset yellow FCF (E110). - 600mg orange oval-shaped tablet, debossed with 600MG on one side and TMC on the other side; contains 600 mg of darunavir (corresponding to 650.46 mg of darunavir ethanolate). The film-coating of the orange tablet contains sunset yellow FCF (E110). - 800mg dark red oval-shaped tablet, debossed with 800 on one side and T on the other side; contains 800mg of darunavir (corresponding to 867.28mg of darunavir ethanolate). The film coating of the dark red tablet contains Iron Oxide Red. For excipients, see _List of Excipients_ . CLINICAL INFORMATION INDICATIONS ADULT PATIENTS PREZISTA ® , in combination with 100 mg low dose ritonavir (PREZISTA ® /rtv) and with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (HIV) infection. PEDIATRIC PATIENTS PREZISTA ® , in combination with low dose ritonavir (PREZISTA ® /rtv) and with other antiretroviral agents, is indicated for the treatment of HIV infection in treatment-experienced pediatric patients of 6 years and above and at least 20kg body weight. In treatment-experienced adult and pediatric patients, the following points should be considered when initiating therapy with PR Leggi il documento completo