국가: 유럽 연합
언어: 영어
출처: EMA (European Medicines Agency)
tacrolimus
Astellas Pharma Europe BV
L04AD02
tacrolimus
Immunosuppressants
Graft Rejection
Prophylaxis of transplant rejection in adult kidney or liver allograft recipients.Treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products in adult patients.
Revision: 26
Authorised
2007-04-23
48 B. PACKAGE LEAFLET 49 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ADVAGRAF 0.5 MG PROLONGED-RELEASE HARD CAPSULES ADVAGRAF 1 MG PROLONGED-RELEASE HARD CAPSULES ADVAGRAF 3 MG PROLONGED-RELEASE HARD CAPSULES ADVAGRAF 5 MG PROLONGED-RELEASE HARD CAPSULES Tacrolimus 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 and 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 Advagraf is and what it is used for 2. What you need to know before you take Advagraf 3. How to take Advagraf 4. Possible side effects 5. How to store Advagraf 6. Contents of the pack and other information 1. WHAT ADVAGRAF IS AND WHAT IT IS USED FOR Advagraf contains the active substance tacrolimus. It is an immunosuppressant. Following your organ transplant (liver, kidney), your body’s immune system will try to reject the new organ. Advagraf is used to control your body’s immune response, enabling your body to accept the transplanted organ. You may also be given Advagraf for an ongoing rejection of your transplanted liver, kidney, heart or other organ when any previous treatment you were taking was unable to control this immune response after your transplantation. Advagraf is used in adults. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ADVAGRAF DO NOT TAKE ADVAGRAF - if you are allergic (hypersensitive) to tacrolimus or any of the other ingredients of Advagraf (see section 6). - if you are allergic to sirolimus or to any macrolide-antibiotic (e.g., erythromycin, clarithromycin, josamycin). WARNINGS AND PRECAUTIONS Prograf and Advagraf both contain the active substance, tacrolimus. How 전체 문서 읽기
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Advagraf 0.5 mg prolonged-release hard capsules Advagraf 1 mg prolonged-release hard capsules Advagraf 3 mg prolonged-release hard capsules Advagraf 5 mg prolonged-release hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Advagraf 0.5 mg prolonged-release hard capsules Each prolonged-release hard capsule contains 0.5 mg tacrolimus (as monohydrate). Excipients with known effect: Each capsule contains 51.09 mg lactose. The printing ink used to mark the capsule contains trace amounts of soya lecithin (0.48% of total printing ink composition). Advagraf 1 mg prolonged-release hard capsules Each prolonged-release hard capsule contains 1 mg tacrolimus (as monohydrate). Excipients with known effect: Each capsule contains 102.17 mg lactose. The printing ink used to mark the capsule contains trace amounts of soya lecithin (0.48% of total printing ink composition). Advagraf 3 mg prolonged-release hard capsules Each prolonged-release hard capsule contains 3 mg tacrolimus (as monohydrate). Excipients with known effect: Each capsule contains 306.52 mg lactose. The printing ink used to mark the capsule contains trace amounts of soya lecithin (0.48% of total printing ink composition). Advagraf 5 mg prolonged-release hard capsules Each prolonged-release hard capsule contains 5 mg tacrolimus (as monohydrate). Excipients with known effect: Each capsule contains 510.9 mg lactose. The printing ink used to mark the capsule contains trace amounts of soya lecithin (0.48% of total printing ink composition). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Prolonged-release hard capsule. Advagraf 0.5 mg prolonged-release hard capsules G elatin capsules imprinted in red with “0.5 mg” on the light yellow capsule cap and “ 647” on the orange capsule body, containing white powder. Advagraf 1 mg prolonged-release hard capsules Gelatin capsules imprint ed in red with “1 mg” on the white capsule cap and “ 677” o 전체 문서 읽기