Country: Israel
Bahasa: Inggeris
Sumber: Ministry of Health
RILPIVIRINE AS HYDROCHLORIDE
J-C HEALTH CARE LTD
J05AG05
TABLETS
RILPIVIRINE AS HYDROCHLORIDE 25 MG
PER OS
Required
JANSSEN CILAG S.P.A., ITALY
RILPIVIRINE
RILPIVIRINE
EDURANT™, in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-naïve adult patients with HIV-1 RNA less than or equal to 100,000 copies/mL at the start of therapy.
2017-08-31
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS )PREPARATIONS( – 1986 The medicine is dispensed with a doctor’s prescription only EDURANT ® , FILM-COATED TABLETS, 25 MG Active ingredient and its quantity per dosage unit: RILPIVIRINE )AS HYDROCHLORIDE( 25 MG PER TABLET Inactive and allergenic ingredients in the medicine – see section 6 “Further information”. READ THE LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have further questions, refer to the doctor or pharmacist. This medicine has been prescribed for the treatment of your ailment. Do not pass it on to others. It may harm them even if it seems to you that their ailment is similar. The medicine is intended for adults )above the age of 18 years(. 1. WHAT IS THE MEDICINE INTENDED FOR? Edurant is a medicine intended for the treatment of HIV infection in adults. Edurant works by reducing the amount of HIV in your body. This reduction will lead to an improved immune system and to a reduction in the risk of developing diseases that are associated with HIV. Edurant is intended for adults who were not treated in the past with other HIV medicines and whose viral load does not exceed 100,000 copies per ml. The doctor will measure your viral load. Edurant is always given in combination with other HIV medicines. Your doctor will explain to you which combination of medicines is best for you. THERAPEUTIC GROUP: HIV treatment from the non-nucleoside reverse transcriptase inhibitors )NNRTIs( group. 2. BEFORE USING THE MEDICINE: DO NOT USE THE MEDICINE IF: • You are sensitive )allergic( to the active ingredient rilpivirine or to any of the other ingredients contained in Edurant. For a list of the additional ingredients, see section 6 “Further information”. • DO NOT TAKE EDURANT IN COMBINATION WITH ANY OF THE FOLLOWING MEDICINES, as they may affect the activity of Edurant or alternatively, Edurant may affect the activity of the medicines: ∘ carbamaz Baca dokumen lengkap
1 1. NAME OF THE MEDICINAL PRODUCT EDURANT 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains rilpivirine hydrochloride equivalent to 25 mg rilpivirine. Excipient with known effect Each film-coated tablet contains 56 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet White to off-white, round, biconvex tablet debossed with “TMC” on one side and “25” on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS EDURANT™, in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-naïve adult patients with HIV-1 RNA less than or equal to 100,000 copies/mL at the start of therapy. EDURANT is not recommended for patients less than 18 years of age. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The recommended dose of EDURANT is one 25 mg tablet once daily. EDURANT MUST BE taken orally with a meal [ _see section 5.2 Pharmacokinetic properties_ ]. _Dose adjustment_ For patients concomitantly receiving rifabutin, the EDURANT dose should be increased to 50 mg (two tablets of 25 mg each) taken once daily, taken with a meal. When rifabutin co-administration is stopped, the EDURANT dose should be decreased to 25 mg once daily, taken with a meal _[see section 4.5 _ _Interaction with other medicinal products and other forms of interaction ]. _ _ _ _Missed dose_ If the patient misses a dose of EDURANT within 12 hours of the time it is usually taken, the patient must take the medicine with a meal as soon as possible and resume the normal dosing schedule. If a patient misses a dose of EDURANT by more than 12 hours, the patient should not take the missed dose, but resume the usual dosing schedule. If a patient vomits within 4 hours of taking the medicine, another EDURANT tablet should be taken with a meal. If a patient vomits more than 4 hours after taking the medicine, the patient does not need to take another dose of EDU Baca dokumen lengkap