מדינה: דרום אפריקה
שפה: אנגלית
מקור: South African Health Products Regulatory Authority (SAHPRA)
Janssen Pharmaceutica (Pty) Ltd
Not Indicated
TABLET
None
Registered
2013-05-12
_APPLICANT: _ JANSSEN PHARMACEUTICA (PTY) LTD_ _ _ _ _PRODUCT PROPRIETARY NAME_:_ _ EDURANT _DOSAGE FORM: _ FILM COATED TABLETS _STRENGTH(S): _ RILPIVIRINE 25 MG PER TABLET _ _ _ _ _Page 1 of 12 _ PATIENT INFORMATION LEAFLET SCHEDULING STATUS: EDURANT Film-coated tablet contains 25 mg of rilpivirine as rilpivirine hydrochloride Contains sugar: Each film-coated tablet contains 56,113 mg lactose monohydrate. READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN EDURANT FILM-COATED TABLET • Keep this leaflet. You may need to read it again. • EDURANT has been prescribed for you personally and you should not share your medicine with other people. It may harm them, even if their symptoms are the same as yours. • Ask your health care provider or pharmacist if you need more information or advice. WHAT IS IN THIS LEAFLET 1. What EDURANT is and what it is used for 2. What you need to know before you take EDURANT 3. How to take EDURANT 4. Possible side effects Schedule 4 _APPLICANT: _ JANSSEN PHARMACEUTICA (PTY) LTD_ _ _ _ _PRODUCT PROPRIETARY NAME_:_ _ EDURANT _DOSAGE FORM: _ FILM COATED TABLETS _STRENGTH(S): _ RILPIVIRINE 25 MG PER TABLET _ _ _ _ _Page 2 of 12 _ 5. How to store EDURANT 6. Contents of the pack and other information 1. WHAT EDURANT IS AND WHAT IT IS USED FOR EDURANT is a medicine used for the treatment of Human Immunodeficiency Virus (HIV) infection. It belongs to a group of HIV medicines called non-nucleoside reverse transcriptase inhibitors (NNRTIs). EDURANT works by reducing the amount of HIV in your body. This will improve your immune system and reduces the risk of developing illnesses linked to HIV infection. EDURANT is always used in combination with other HIV medicines to treat patients 12 years of age and older who are infected by HIV and who have never been treated before with HIV medicines. Your doctor will discuss with you which combination of medicines is best for you. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE EDURANT DO NOT TAKE EDURANT • If you are ALLERGIC (hypersensitive) to rilpivi קרא את המסמך השלם
_APPLICANT: _ JANSSEN PHARMACEUTICA (PTY) LTD_ _ _ _ _PRODUCT PROPRIETARY NAME_:_ _ EDURANT _DOSAGE FORM: _ FILM COATED TABLETS _STRENGTH(S): _ RILPIVIRINE 25 MG PER TABLET _ _ _Page 1 of 35 _ PROFESSIONAL INFORMATION INSERT SCHEDULING STATUS Schedule 4 1. NAME OF THE MEDICINE EDURANT 25 MG (film-coated tablet) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet of EDURANT contains 25 mg rilpivirine as rilpivirine hydrochloride. Contains sugar: Each film-coated tablet contains 56,113 mg lactose monohydrate. For a full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM White to off-white, film-coated, round, biconvex tablet, debossed with “TMC” on one side and “25” on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ADULT PATIENTS EDURANT, in combination with other antiretroviral medicines, is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-naïve adult patients. Schedule 4 _APPLICANT: _ JANSSEN PHARMACEUTICA (PTY) LTD_ _ _ _ _PRODUCT PROPRIETARY NAME_:_ _ EDURANT _DOSAGE FORM: _ FILM COATED TABLETS _STRENGTH(S): _ RILPIVIRINE 25 MG PER TABLET _ _ _Page 2 of 35 _ PAEDIATRIC PATIENTS (12 TO LESS THAN 18 YEARS OF AGE) EDURANT, in combination with other antiretroviral medicinal products, is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-naïve paediatric patients 12 to less than 18 years of age with a viral load of ≤ 100000 HIV-1 RNA copies/mL. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION EDURANT must always be given in combination with other antiretroviral medicinal products. ADULTS AND PAEDIATRIC PATIENTS (12 TO LESS THAN 18 YEARS OF AGE) The recommended dose of EDURANT is 25 mg once-daily taken orally with a meal. _Dose adjustment with rifabutin coadministration _ For patients concomitantly receiving rifabutin, the EDURANT dose should be increased to 50 mg (two tablets of 25 mg each) once daily, taken with a meal. When rifabutin co admi קרא את המסמך השלם