Quốc gia: Vương quốc Anh
Ngôn ngữ: Tiếng Anh
Nguồn: MHRA (Medicines & Healthcare Products Regulatory Agency)
Sirolimus
Pfizer Ltd
S01XA23
Sirolimus
1mg/1ml
Oral solution
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 08020200; GTIN: 5010981001724
Page 1 of 9 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. 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 may have affected your liver, please tell your doctor as this may affect the dose of Rapamune that you receive and may result in your having additional blood tests._ _ Rapamune, like other immunosuppressive medicines, may decrease your body’s ability to fight infection, and may increase the risk of developi Đọc toàn bộ tài liệu
OBJECT 1 RAPAMUNE 0.5MG, 1MG AND 2MG COATED TABLETS Summary of Product Characteristics Updated 29-Mar-2017 | Pfizer Limited 1. Name of the medicinal product Rapamune 0.5 mg coated tablets Rapamune 1 mg coated tablets Rapamune 2 mg coated tablets Rapamune 1 mg/mL oral solution 2. Qualitative and quantitative composition Rapamune 0.5mg coated tablets Each coated tablet contains 0.5 mg sirolimus. Rapamune 1 mg coated tablets Each coated tablet contains 1 mg sirolimus. Rapamune 2 mg coated tablets Each coated tablet contains 2 mg sirolimus. Rapamune 1 mg/mL oral solution Each mL contains 1 mg sirolimus. Each 60 mL bottle contains 60 mg sirolimus. Excipients with known effect Rapamune 0.5 mg coated tablets Each tablet contains 86.4 mg of lactose monohydrate and 215.7 mg of sucrose. Rapamune 1 mg coated tablets Each tablet contains 86.4 mg of lactose monohydrate and 215.8 mg of sucrose. Rapamune 2 mg coated tablets Each tablet contains 86.4 mg of lactose monohydrate and 214.4 mg of sucrose. Oral Solution Each mL contains 20 mg of ethanol and 20 mg of soya oil. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Coated tablet (tablet). Rapamune 0.5 mg coated tablets Tan-coloured, triangular-shaped, coated tablet marked “RAPAMUNE 0.5 mg” on one side. Rapamune 1 mg coated tablets White-coloured, triangular-shaped, coated tablet marked “RAPAMUNE 1 mg” on one side. Rapamune 2 mg coated tablets Yellow to beige-coloured, triangular-shaped, coated tablet marked “RAPAMUNE 2 mg” on one side. 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 disconti Đọc toàn bộ tài liệu