国: アイルランド
言語: 英語
ソース: HPRA (Health Products Regulatory Authority)
Tacrolimus
Astellas Pharma Co. Limited
L04AD; L04AD02
Tacrolimus
5 milligram(s)/millilitre
Concentrate for solution for infusion
Product subject to prescription which may not be renewed (A)
Calcineurin inhibitors; tacrolimus
Marketed
1996-02-16
1 PACKAGE LEAFLET: INFORMATION FOR THE USER PROGRAF 5 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION Tacrolimus READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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, pharmacist or nurse. - 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, pharmacist or nurse. 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 use Prograf 3. How to use 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 USE PROGRAF DO NOT USE PROGRAF - If you are allergic (hypersensitive) to tacrolimus or to any antibiotic belonging to the subgroup of macrolide antibiotics (e.g. erythromycin, clarithromycin, josamycin). - If you are allergic (hypersensitive) to any of the other ingredients of Prograf (listed in section 6) - in particular polyoxyethylene hydrogenated castor oil or similar substances. WARNINGS AND PRECAUTIONS Talk to your doctor, pharmacist or nu 完全なドキュメントを読む
Health Products Regulatory Authority 15 May 2023 CRN00DKQF Page 1 of 18 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Prograf 5 mg/ml concentrate for solution for infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml concentrate for solution for infusion contains 5 mg of tacrolimus. Excipients with known effect : 200 mg of polyoxyethylene hydrogenated castor oil and 638 mg of dehydrated alcohol. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Concentrate for solution for infusion The concentrate is a clear colourless solution. 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 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. General considerations The recommended initial dosages presented below are intended to act solely as a guideline. Prograf dosing should primarily be based on clinical assessments of rejection and tolerability in each patient individually aided by blood level monitoring (see below for recommended target whole blood trough concentrations). If clinical signs of rejection are apparent, alteration of the immunosuppressive regimen should be considered. Prograf can be administered intravenously or orally. In general, dosing may commence orally; if necessary, by administering the capsule contents suspended in water, via nasogastric tubing. Prograf is routinely administered in conjunction with other immunosuppressive agents in the initial post-operative period. The Prograf dose may vary depending upon the immunosuppressive regimen chosen. Posology Dosage recommendations – Liver transplant 完全なドキュメントを読む