Quốc gia: Israel
Ngôn ngữ: Tiếng Anh
Nguồn: Ministry of Health
SIROLIMUS
PFIZER PHARMACEUTICALS ISRAEL LTD
L04AA10
COATED TABLETS
SIROLIMUS 1 MG
PER OS
Required
PFIZER IRELAND PHARMACEUTICALS
SIROLIMUS
Rapamune is indicated for the prophylaxis of organ rejection in adult patients at low to moderate immunological risk receiving a renal transplant. It is recommended that Rapamune be used initially in combination with cyclosporine microemulsion and corticosteroids for 2 to 3 months. Rapamune may be continued as maintenance therapy with corticosteroids only if cyclosporine can be progressively discontinued.
2014-10-31
Rapamune 1mg coated tablets PIL CC technical change 22 March 2022 English 1 2022-0076905 PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS) - 1986 This medicine is dispensed with a doctor’s prescription only RAPAMUNE ® 1 MG TABLETS COATED TABLETS Each tablet contains: sirolimus 1 mg Inactive ingredients and allergens: See section 2 under ‘Important information about some of this medicine’s ingredients’ and section 6 ‘Further information’. READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE. This leaflet contains concise information about this medicine. If you have any further questions, consult your doctor or 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 to yours. 1. WHAT IS THIS MEDICINE INTENDED FOR? Rapamune ® is intended to suppress the immune system. This medicine is intended for prevention of transplant rejection in patients receiving a kidney transplant. THERAPEUTIC GROUP: selective immunosuppressant. 2. BEFORE USING THIS MEDICINE DO NOT USE THIS MEDICINE IF: • You are sensitive (allergic) to the active ingredient or to any of the other ingredients in this medicine (see section 6). SPECIAL WARNINGS REGARDING USE OF THE MEDICINE BEFORE TREATMENT WITH RAPAMUNE ® , TELL YOUR DOCTOR IF: • you are pregnant – see the section ‘Pregnancy, breastfeeding, and fertility’. • you have impaired liver function or have had a disease which may have affected your liver. Your dose may need to change and you may need additional blood tests. • you have problems with your immune system. Rapamune ® , like other immunosuppressive medicines, may decrease your body’s immune resistance, and may increase your risk of developing cancer of the lymphoid tissues and skin. • you have a body mass index (BMI) greater than 30 (weight[kg]/height 2 [m 2 ]). You may be at increased risk of abnormal wound knitting and scabbing. • you are at high risk for t Đọc toàn bộ tài liệu
Rapamune coated tablets 1 mg LPD 12 Feb 2019 2016-0016968, 2016-0018383, 2015-0014015, 20190048434 1 1. NAME OF THE MEDICINAL PRODUCT RAPAMUNE 1 MG COATED TABLETS 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each coated tablet contains 1 mg sirolimus. Excipients with known effect: Each tablet contains 86.4 mg of lactose monohydrate and 215.8 mg of sucrose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Coated tablet (tablet). White-coloured, triangular-shaped coated tablet marked “RAPAMUNE 1 mg” on one side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Rapamune is indicated for the prophylaxis of organ rejection in adult patients at low to moderate immunological risk receiving a renal transplant. It is recommended that Rapamune be used initially in combination with ciclosporin microemulsion and corticosteroids for 2 to 3 months. Rapamune may be continued as maintenance therapy with corticosteroids only if ciclosporin microemulsion can be progressively discontinued (see sections 4.2 and 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment should be initiated by and remain under the guidance of an appropriately qualified specialist in transplantation. Posology _ _ _Initial therapy (2 to 3 months post-transplantation) _ The usual dose regimen for Rapamune is a 6 mg single oral loading dose, administered as soon as possible after transplantation, followed by 2 mg once daily until results of therapeutic monitoring of the medicinal product are available (see _Therapeutic monitoring of the _ _medicinal product and dose adjustment_ ). The Rapamune dose should then be individualised to obtain whole blood trough levels of 4 to 12 ng/mL (chromatographic assay). Rapamune therapy should be optimised with a tapering regimen of steroids and ciclosporin microemulsion. Suggested ciclosporin trough concentration ranges for the first 2-3 months after transplantation are 150-400 ng/mL (monoclonal assay or equivalent technique) (see section 4.5 _)_ . To minimise variability, Rapamune should be Đọc toàn bộ tài liệu