Country: ইস্রায়েল
ভাষা: ইংরেজি
সূত্র: Ministry of Health
AMBRISENTAN
GLAXO SMITH KLINE (ISRAEL) LTD
C02KX02
FILM COATED TABLETS
AMBRISENTAN 10 MG
PER OS
Required
PATHEON INC., CANADA
AMBRISENTAN
Volibris is indicated for treatment of pulmonary arterial hypertension (PAH) in adult patients of WHO Functional Class (FC) II to III, including use in combination treatment with tadalafil.Efficacy has been shown in idiopathic PAH (IPAH) and in PAH associated with connective tissue disease.
2024-01-31
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986 The medicine is dispensed according to a physician’s prescription only VOLIBRIS 5 MG FILM-COATED TABLETS EACH TABLET CONTAINS: AMBRISENTAN 5 MG VOLIBRIS 10 MG FILM-COATED TABLETS EACH TABLET CONTAINS: AMBRISENTAN 10 MG For a list of inactive and allergenic ingredients in the medicine, see section 2 – “Important information about some of the ingredients of the medicine” and section 6 – “Additional information”. READ THE LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have any other questions, refer to the physician or the pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them even if it seems to you that their medical condition is similar. Volibris patient safety information card IN ADDITION TO THE LEAFLET, VOLIBRIS HAS A PATIENT SAFETY INFORMATION CARD REGARDING POTENTIAL HARM TO THE FETUS AND POTENTIAL LIVER INJURY. THIS CARD CONTAINS IMPORTANT SAFETY INFORMATION THAT YOU MUST KNOW AND ACT UPON BEFORE STARTING AND DURING TREATMENT WITH VOLIBRIS. READ THE PATIENT SAFETY INFORMATION CARD AND THE PATIENT LEAFLET BEFORE STARTING TO USE THE PREPARATION. KEEP THE CARD AND THE LEAFLET FOR FURTHER READING IF NECESSARY. Do not take Volibris if you are pregnant since the use of this medicine may harm the fetus )see section 2 “Do not use the medicine”, section 2 “Pregnancy” and “Breast-feeding”). If you are a woman of child-bearing age who may become pregnant, a pregnancy test should be performed before starting treatment with Volibris and routinely each month while you are taking this medicine, and a month after stopping the treatment. Ensure a negative result at each pregnancy test. You must use a reliable form of birth control )contraception) during the treatment with Volibris, and for an additional one month after stopping the treatment )see section 2 “Pregnancy”). 1. WHAT IS সম্পূর্ণ নথি পড়ুন
Page 1 of 18 VOLIBRIS 5 MG VOLIBRIS 10 MG 1. NAME OF THE MEDICINAL PRODUCT Volibris 5 mg Volibris 10 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION VOLIBRIS 5 MG: Each tablet contains 5 mg of ambrisentan. Excipient(s) with known effect: Each tablet contains approximately 90.3 mg of lactose (as monohydrate), approximately 0.25 mg of lecithin (soya) (E322) and approximately 0.11 mg of allura red AC aluminium lake (E129). VOLIBRIS 10 MG Each tablet contains 10 mg of ambrisentan. Excipient(s) with known effect: Each tablet contains approximately 85.5mg lactose (as monohydrate), approximately 0.25 mg of lecithin (soya) (E322) and approximately 0.45 mg of allura red AC aluminium lake (E129). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet Volibris 5 mg : Pale-pink, 6.6 mm square, convex, film-coated tablet with “GS” debossed on one side and “K2C” on the other side. Volibris 10 mg: Deep-pink, 9.8 mm × 4.9 mm oval, convex, film-coated tablet with “GS” debossed on one side and “KE3” on the other side. Page 2 of 18 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Volibris is indicated for treatment of pulmonary arterial hypertension (PAH) in adult patients of WHO Functional Class (FC) II to III, including use in combination treatment with tadalafil . Efficacy has been shown in idiopathic PAH (IPAH) and in PAH associated with connective tissue disease. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment must be initiated by a physician experienced in the treatment of PAH. Posology _Ambrisentan monotherapy _ Volibris is to be taken orally to begin at a dose of 5 mg once daily and may be increased to 10 mg daily depending upon clinical response and tolerability. _ _ _Ambrisentan in combination with tadalafil _ When used in combination with tadalafil, Volibris should be titrated to 10 mg once daily. In the AMBITION study, patients received 5 mg ambrisentan daily for the first 8 weeks before up titrating to 10 mg, dependent on tolerability (see section 5.1). When u সম্পূর্ণ নথি পড়ুন