Country: Եվրոպական Միություն
language: անգլերեն
source: EMA (European Medicines Agency)
Sirolimus
Pfizer Europe MA EEIG
L04AA10
sirolimus
Immunosuppressants
Graft Rejection; Kidney Transplantation
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. Rapamune is indicated for the treatment of patients with sporadic lymphangioleiomyomatosis with moderate lung disease or declining lung function.,
Revision: 46
Authorised
2001-03-13
64 B. PACKAGE LEAFLET 65 PACKAGE LEAFLET: INFORMATION FOR THE USER RAPAMUNE 1 MG/ML ORAL SOLUTION sirolimus READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Rapamune is and what it is used for 2. What you need to know before you take Rapamune 3. How to take Rapamune 4. Possible side effects 5. How to store Rapamune 6. Contents of the pack and other information 1. WHAT RAPAMUNE IS AND WHAT IT IS USED FOR Rapamune contains the active substance sirolimus, which belongs to a group of medicines called immunosuppressants. It helps to control your body’s immune system after you have received a kidney transplant. Rapamune is used in adults to prevent your body from rejecting transplanted kidneys and is normally used with other immunosuppressant medicines called corticosteroids and initially (the first 2 to 3 months) with ciclosporin. Rapamune is also used for the treatment of patients with sporadic lymphangioleiomyomatosis (S-LAM) with moderate lung disease or declining lung function. S-LAM is a rare progressive lung disease that affects predominantly women of childbearing age. The most common symptom of S-LAM is shortness of breath. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE RAPAMUNE DO NOT TAKE RAPAMUNE if you are allergic to sirolimus or any of the other ingredients of this medicine (listed in section 6). if you are allergic to peanut or soya. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Rapamune If you have any liver problems or have had a disease which read_full_document
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Rapamune 1 mg/mL oral solution 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL contains 1 mg sirolimus. Each 60 mL bottle contains 60 mg sirolimus. Excipients with known effect Each mL contains up to 25 mg of ethanol, approximately 350 mg of propylene glycol (E1520), and 20 mg of soya oil. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Oral solution. Pale yellow to yellow solution. 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). Rapamune is indicated for the treatment of patients with sporadic lymphangioleiomyomatosis with moderate lung disease or declining lung function (see sections 4.2 and 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Prophylaxis of organ rejection_ Treatment should be initiated by and remain under the guidance of an appropriately qualified specialist in transplantation. _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 mo read_full_document