Страна: Ірландія
мова: англійська
Джерело: HPRA (Health Products Regulatory Authority)
Human coagulation factor viii
Instituto Grifols S.A.
B02BD; B02BD02
Human coagulation factor viii
250 international unit(s)
Powder and solvent for solution for injection
Product subject to prescription which may not be renewed (A)
Blood coagulation factors; coagulation factor VIII
Not marketed
2000-07-07
Fanhdi\2016 PRAC Fanhdi\IE Fanhdi PIL_clean.doc 1 PACKAGE LEAFLET: INFORMATION FOR THE USER FANHDI 250, 500 AND 1000 IU, POWDER AND SOLVENT FOR SOLUTION FOR INJECTION Human coagulation factor VIII, Ph.Eur. PLEASE READ 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 Fanhdi is and what it is used for 2. What you need to know before you use Fanhdi 3. How to use Fanhdi 4. Possible side effects 5. How to store Fanhdi 6. Contents of the pack and other information 1. WHAT FANHDI IS AND WHAT IT IS USED FOR Fanhdi is supplied as a powder for solution for injection containing 250, 500 or 1000 IU of human coagulation factor VIII per vial. (Note IU stands for international unit, a standard measure of activity). Once reconstituted with the appropriate amount of solvent (water for injections), each vial contains 25, 50 or 100 IU of FVIII/ml. Fanhdi is one of the group of medicines called clotting factors. Fanhdi is used for the treatment and prevention of bleeding in patients with haemophilia A (congenital factor VIII deficiency). This product may be used in the management of acquired factor VIII deficiency. No data is available to recommend the use of Fanhdi in von Willebrand disease. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE FANHDI DO NOT USE FANHDI If you are allergic to human coagulation factor VIII or to any of the other ingredients of this medicine (listed in section 6). If you have not been fully trained how to inject yourself by your doctor or haemophilia nurse. If you want more detailed infor Прочитайте повний документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Fanhdi 250 IU powder and solvent for solution for injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Human coagulation factor VIII. Fanhdi is presented as a lyophilised powder for solution for injection containing nominally 250 IU human coagulation FVIII per vial. The product contains approximately 25 IU/ml of human coagulation factor VIII when reconstituted with 10 ml of water for injections. The FVIII:C potency (IU) is determined using the European Pharmacopoeia chromogenic assay. The specific activity of Fanhdi is at least of 2.5 IU FVIII:C/mg protein. Produced from the plasma of human donors. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder and solvent for solution for injection. Vial containing white or pale yellow powder and syringe with Water for Injections (solvent). 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Fanhdi is indicated for the treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency). No data is available to recommend the use of Fanhdi in von Willebrand disease. This product may be used in the management of acquired factor VIII deficiency. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment should be initiated under the supervision of a physician experienced in the treatment of haemophilia. _Posology_ The dosage and duration of the substitution therapy depend on the severity of the factor VIII deficiency, on the location and extent of the bleeding and on the patient’s clinical condition. The number of units of factor VIII administered is expressed in International Units (IU), which are related to the current WHO standard for factor VIII products. Factor VIII activity in plasma is expressed either as a percentage (relative to normal human plasma) or in International Units (relative to an International Standard for factor VIII in plasma). H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _ Прочитайте повний документ