Šalis: Izraelis
kalba: anglų
Šaltinis: Ministry of Health
TACROLIMUS
ASTELLAS PHARMA INTERNATIONAL B.V., ISRAEL
L04AA05
CAPSULES
TACROLIMUS 0.5 MG
PER OS
Required
ASTELLAS IRELAND CO. LTD, IRELAND
TACROLIMUS
TACROLIMUS
Prophylaxis of transplant rejection in liver kidney or heart allograft recipients. Treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products.
2011-03-31
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986 The medicine is dispensed with a doctor’s prescription only PROGRAF ® CAPSULES PROGRAF ® 0.5 MG PROGRAF ® 1 MG PROGRAF ® 5 MG CAPSULES CAPSULES CAPSULES COMPOSITION Each capsule contains: Tacrolimus 0.5 mg Tacrolimus 1 mg Tacrolimus 5 mg For information regarding inactive ingredients and allergens, see section 2 - “Important information about some ingredients of the medicine” and section 6 - “Additional information”. READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have additional questions, refer to the doctor or the pharmacist. This medicine has been prescribed for your treatment. Do not pass it on to others. It may harm them even if it seems to you that their medical condition is similar. 1. WHAT IS THE MEDICINE INTENDED FOR? Prophylaxis of transplant rejection in liver, kidney or heart allograft recipients. Treatment of allograft rejection resistant to treatment with other immunosuppressive drugs. Prograf belongs to a group of medicines that suppress the immune system. Following organ transplant (such as liver, kidney and heart) your body’s immune system will try to reject the new organ. Prograf is used for modulation of your body’s immune reaction and allows your body to accept the transplanted organ. THERAPEUTIC CLASS: immunosuppressive agents. 2. BEFORE USING THE MEDICINE DO NOT REPLACE WITH ANOTHER TACROLIMUS PREPARATION, UNLESS THE DOCTOR FROM THE TRANSPLANT CLINIC YOU ARE TREATED IN APPROVES THAT. DO NOT USE THIS MEDICINE IF: • You are sensitive (allergic) to tacrolimus or to any of the other ingredients this medicine contains (see section 6 – “Additional information”). • You are sensitive (allergic) to any antibiotic of the macrolide group (e.g. erythromycin, clarithromycin, josamycin). SPECIAL WARNINGS REGARDING THE USE OF THE MEDICINE FOR YOUR ATTENTION, IT IS IMPORTANT TO ASCERTAIN THAT YOU ALWAYS RECEIV Perskaitykite visą dokumentą
Prograf Capsules MF 11/2022 Notification SUMMARY OF PRODUCT CHARACTERISTICS PROGRAF ® 0.5 MG PROGRAF ® 1 MG PROGRAF ® 5 MG IMPORTANT! In order to ensure the continuity of different products of tacrolimus in individual patients it should be emphasized that if patients are changed from one tacrolimus product to another it should be done only with specific counselling and tight monitoring from their transplantation specialist. 1. NAME OF THE MEDICINAL PRODUCT Prograf 0.5 mg Prograf 1 mg Prograf 5 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Prograf 0.5 mg capsules Each capsule contains 0.5 mg of tacrolimus. 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 capsules Each capsule contains 1 mg of tacrolimus. 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 capsules Each capsule contains 5 mg of tacrolimus. 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 capsules Capsule, hard Light yellow hard gelatin capsules imprinted in red with “0.5 mg” and “[f] 607”, containing white powder. Prograf 1 mg capsules Capsule, hard Opaque white hard gelatin capsules imprinted in red with “1 mg” and “[f] 617”, containing white powder. Prograf 5 mg capsules Capsule, hard Opaque greyish red hard gelatin capsules imprinted in white with “5 mg” and “[f] 657”, containing white powder. Prograf Capsules MF 11/2022 Notification 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Prophylaxis of transplant rejection in liver, kidney or heart allograft recipients. Treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Prograf thera Perskaitykite visą dokumentą