देश: आयरलैंड
भाषा: अंग्रेज़ी
स्रोत: HPRA (Health Products Regulatory Authority)
Tacrolimus
Rowex Ltd
L04AD; L04AD02
Tacrolimus
1 milligram(s)
Prolonged-release capsule, hard
Calcineurin inhibitors; tacrolimus
Not marketed
2020-01-17
PACKAGE LEAFLET PACKAGE LEAFLET: INFORMATION FOR THE PATIENT DAILIPORT 0.5 MG PROLONGED-RELEASE HARD CAPSULES DAILIPORT 1 MG PROLONGED-RELEASE HARD CAPSULES DAILIPORT 2 MG PROLONGED-RELEASE HARD CAPSULES DAILIPORT 3 MG PROLONGED-RELEASE HARD CAPSULES DAILIPORT 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 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 Dailiport is and what it is used for 2. What you need to know before you take Dailiport 3. How to take Dailiport 4. Possible side effects 5. How to store Dailiport 6. Contents of the pack and other information 1. WHAT DAILIPORT IS AND WHAT IT IS USED FOR Dailiport 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. Dailiport is used to control your body’s immune response, enabling your body to accept the transplanted organ. You may also be given Dailiport 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. Dailiport is used in adults. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DAILIPORT _ _ DO NOT TAKE DAILIPORT: _ _ 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) if you are allergic to peanut or पूरा दस्तावेज़ पढ़ें
Health Products Regulatory Authority 07 July 2021 CRN00C6NP Page 1 of 15 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Dailiport 1 mg Prolonged-release hard capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each prolonged-release hard capsule contains 1 mg of tacrolimus (as monohydrate). Excipient(s) with known effect Each prolonged-release hard capsule contains 102 mg of lactose (as monohydrate). Each prolonged-release hard capsule contains 7.4 microgram of Sunset yellow FCF (E 110). Each prolonged-release hard capsule contains 0.6 microgram of Allura red AC (E 129). The printing ink used to mark the capsule contains trace amounts of: Allura Red AC Aluminium Lake (E129) (14 %w/w of total printing ink composition); Sunset Yellow FCF Aluminium Lake (E110) (3%w/w of total printing ink composition); lecithin (soya) (0.99%w/w of total printing ink composition). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Prolonged-release hard capsule. _ _ Gelatin capsule size 4 with a light brown body and a white cap, imprinted in black with "1 mg", containing white to yellowish powder or compacted powder (length 14.0 – 14.6 mm). 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 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. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Dailiport is a once-a-day oral formulation of tacrolimus. Dailiport therapy requires careful monitoring by adequately qualified and equipped personnel. 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. Different oral formulations of tacrolimus should not be substituted without clinical supervision. Inadvertent, unintentional or unsupervised switching between different oral formulation of tacrolimus with पूरा दस्तावेज़ पढ़ें