Country: Kesatuan Eropah
Bahasa: Inggeris
Sumber: EMA (European Medicines Agency)
tacrolimus
Chiesi Farmaceutici S.p.A.
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: 12
Authorised
2014-07-18
41 B. PACKAGE LEAFLET 42 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ENVARSUS 0.75 MG PROLONGED-RELEASE TABLETS ENVARSUS 1 MG PROLONGED-RELEASE TABLETS ENVARSUS 4 MG PROLONGED-RELEASE TABLETS 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 Envarsus is and what it is used for 2. What you need to know before you take Envarsus 3. How to take Envarsus 4. Possible side effects 5. How to store Envarsus 6. Contents of the pack and other information 1. WHAT ENVARSUS IS AND WHAT IT IS USED FOR Envarsus contains the active substance tacrolimus. It is an immunosuppressant. Following your kidney or liver transplant, your body’s immune system will try to reject the new organ. Envarsus is used to control your body’s immune response, enabling your body to accept the transplanted organ. You may also be given Envarsus 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. Envarsus is used in adults. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ENVARSUS DO NOT TAKE ENVARSUS - 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 or to any macrolide-antibiotic (e.g., erythromycin, clarithromycin, josamycin). WARNINGS AND PRECAUTIONS Envarsus contains the active substance tacrolimus presented in a prolonged release formulation. Envarsus is taken once daily and is NOT interchange Baca dokumen lengkap
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Envarsus 0.75 mg prolonged-release tablets Envarsus 1 mg prolonged-release tablets Envarsus 4 mg prolonged-release tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Envarsus 0.75 mg prolonged-release tablets Each prolonged-release tablet contains 0.75 mg tacrolimus (as monohydrate). _Excipient with known effect _ Each tablet contains 41.7 mg lactose monohydrate. Envarsus 1 mg prolonged-release tablets Each prolonged-release tablet contains 1 mg tacrolimus (as monohydrate). _Excipient with known effect _ Each tablet contains 41.7 mg lactose monohydrate. Envarsus 4 mg prolonged-release tablets Each prolonged-release tablet contains 4 mg tacrolimus (as monohydrate). _ _ _Excipient with known effect _ Each tablet contains 104 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Prolonged-release tablet. Envarsus 0.75 mg prolonged-release tablets Oval, white to off-white uncoated tablet, debossed with “0.75” on one side and “TCS” on the other side. Envarsus 1 mg prolonged-release tablets Oval, white to off-white uncoated tablet, debossed with “1” on one side and “TCS” on the other side. Envarsus 4 mg prolonged-release tablets Oval, white to off-white uncoated tablet, debossed with “4” on one side and “TCS” on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Prophylaxis of transplant rejection in adult kidney or liver allograft recipients. 3 Treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products in adult patients. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Envarsus is a once-a-day oral formulation of tacrolimus. Tacrolimus therapy requires careful monitoring by adequately qualified and equipped personnel. This medicinal product should only be prescribed, and changes in immunosuppressive therapy be initiated, by physicians experienced in immunosuppressive therapy and the management of transplant patients. I Baca dokumen lengkap