País: Unión Europea
Idioma: inglés
Fuente: EMA (European Medicines Agency)
tacrolimus
Astellas Pharma Europe B.V.
L04AD02
tacrolimus
Immunosuppressants
Graft Rejection
Prophylaxis of transplant rejection in adult and paediatric, kidney, liver or heart allograft recipients.Treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products in adult and paediatric patients.
Revision: 19
Authorised
2009-05-15
33 B. PACKAGE LEAFLET 34 PACKAGE LEAFLET: INFORMATION FOR THE USER MODIGRAF 0.2 MG, GRANULES FOR ORAL SUSPENSION MODIGRAF 1 MG, GRANULES FOR ORAL SUSPENSION 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 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 Modigraf is and what it is used for 2. What you need to know before you take Modigraf 3. How to take Modigraf 4. Possible side effects 5. How to store Modigraf 6. Contents of the pack and other information 1. WHAT MODIGRAF IS AND WHAT IT IS USED FOR Modigraf contains the active substance tacrolimus. It is an immunosuppressant. Following your organ transplant (e.g., liver, kidney, heart), your body’s immune system will try to reject the new organ. Modigraf is used to control your body’s immune response enabling your body to accept the transplanted organ. You may also be given Modigraf for an ongoing rejection of your transplanted liver, kidney, heart or other organ or if any previous treatment you were taking was unable to control this immune response after your transplantation. Modigraf is used in adults and children. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MODIGRAF DO NOT TAKE MODIGRAF - If you are allergic to tacrolimus or any of the other ingredients of this medicine (listed in section 6). - If you are allergic to sirolimus (another substance used to prevent rejection of your transplanted organ) or to any macrolide antibiotic (e.g., erythromycin, clarithromycin, josamycin). WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Modigraf - if you have or have Leer el documento completo
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Modigraf 0.2 mg granules for oral suspension Modigraf 1 mg granules for oral suspension 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Modigraf 0.2 mg granules for oral suspension Each sachet contains 0.2 mg tacrolimus (as monohydrate). Excipient with known effect: Each sachet contains 94.7 mg lactose (as monohydrate). Modigraf 1 mg granules for oral suspension Each sachet contains 1 mg tacrolimus (as monohydrate). Excipient with known effect: Each sachet contains 473 mg lactose (as monohydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Granules for oral suspension. White granules. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Prophylaxis of transplant rejection in adult and paediatric, kidney, liver or heart allograft recipients. Treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products in adult and paediatric patients. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION This medicinal product should only be prescribed, and changes in immunosuppressive therapy initiated, by physicians experienced in immunosuppressive therapy and the management of transplant patients. Modigraf is a granular formulation of tacrolimus, for twice-a-day administration. Modigraf therapy requires careful monitoring by adequately qualified and equipped personnel. Posology The recommended initial doses presented below are intended to act solely as a guideline. Modigraf is routinely administered in conjunction with other immunosuppressive agents in the initial post-operative period. The dose may vary depending upon the immunosuppressive regimen chosen. Modigraf dosing should primarily be based on clinical assessments of rejection and tolerability in each patient individually aided by blood level monitoring (see below under “Therapeutic drug monitoring”). If clinical signs of rejection are apparent, alteration of the immunosuppressive regimen should be considered. Careful and frequent mo Leer el documento completo