Land: Malta
Sprog: engelsk
Kilde: Malta Medicines Authority
TACROLIMUS
Astellas Pharma Europe B.V.
L04AD02
TACROLIMUS
HARD CAPSULE
TACROLIMUS 5 milligram(s)
POM
IMMUNOSUPPRESSANTS
Authorised
2013-04-05
Page 1 of 10 PACKAGE LEAFLET Page 2 of 10 PACKAGE LEAFLET: INFORMATION FOR THE USER PROGRAF 0.5 MG HARD CAPSULES PROGRAF 1 MG HARD CAPSULES PROGRAF 5 MG 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 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 Prograf is and what it is used for 2. What you need to know before you take Prograf 3. How to take Prograf 4. Possible side effects 5. How to store Prograf 6. Contents of the pack and other information 1. WHAT PROGRAF IS AND WHAT IT IS USED FOR Prograf belongs to a group of medicines called immunosuppressants. Following your organ transplant (e.g. liver, kidney, heart), your body’s immune system will try to reject the new organ. Prograf is used to control your body’s immune response enabling your body to accept the transplanted organ. Prograf is often used in combination with other medicines that also suppress the immune system. You may also be given Prograf 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. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PROGRAF DO NOT TAKE PROGRAF - If you are allergic (hypersensitive) to tacrolimus or any of the other ingredients of Prograf (listed in section 6). - If you are allergic (hypersensitive) to any antibiotic belonging to the subgroup of macrolide antibiotics (e.g. erythromycin, clarithromycin, josamycin). WARNINGS AND PRECAUTIONS Talk to your doctor, pharmacist before taking Prograf - Læs hele dokumentet
Page 1 of 19 SUMMARY OF PRODUCT CHARACTERISTICS Page 2 of 19 1. NAME OF THE MEDICINAL PRODUCT Prograf 0.5 mg hard capsules Prograf 1 mg hard capsules Prograf 5 mg hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Prograf 0.5 mg hard capsules Each capsule contains 0.5 mg of tacrolimus (as monohydrate). Excipient with known effect: 62.85 mg of lactose monohydrate The printing ink used to mark the capsule contains trace amounts of soya lecithin (0.48% of total printing ink composition). Prograf 1 mg hard capsules Each capsule contains 1 mg of tacrolimus (as monohydrate). Excipient with known effect: 61.35 mg of lactose monohydrate The printing ink used to mark the capsule contains trace amounts of soya lecithin (0.48% of total printing ink composition). Prograf 5 mg hard capsules Each capsule contains 5 mg of tacrolimus (as monohydrate). Excipient with known effect: 123.60 mg of lactose monohydrate For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Prograf 0.5 mg hard capsules Capsule, hard Opaque light yellow hard gelatin capsules imprinted in red with "0.5 mg" and "[f] 607", containing white powder. Prograf 1 mg hard capsules Capsule, hard Opaque white hard gelatin capsules imprinted in red with "1 mg" and "[f] 617", containing white powder. Prograf 5 mg hard capsules Capsule, hard Opaque greyish red hard gelatin capsules imprinted in white with "5 mg" and "[f] 657", containing white powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Prophylaxis of transplant rejection in liver, kidney or heart allograft recipients. Page 3 of 19 Treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Prograf therapy requires careful monitoring by adequately qualified and equipped personnel. The medicinal product should only be prescribed, and changes in immunosuppressive therapy initiated, by physicians experienced in immunosuppressive therapy and the management of transplant patients. Inadvertent, unin Læs hele dokumentet