Страна: Армения
Язык: английский
Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
human blood coagulation factor VIII/Von Willebrand Factor(VWF:RCo)
Baxter AG
B02BD06
human blood coagulation factor VIII/Von Willebrand Factor(VWF:RCo)
1000IU/750IU
powder and solvent for solution for injection
(1) glass vial, (1) vial with solvent 10ml, (1) transfer/filter set, (1) disposable syringe 10ml, (1) disposable needle, (1) winged infusion set
Prescription
Registered
2020-07-17
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, please 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 Immunate is and what it is used for 2. What you need to know before you use Immunate 3. How to use Immunate 4. Possible side effects 5. How to store Immunate 6. Contents of the pack and other information 1. What Immunate is and what it is used for What Immunate is Immunate is a coagulation factor VIII / von Willebrand factor complex made from human plasma. The coagulation factor VIII in Immunate replaces the factor VIII which is lacking or is not functioning properly in haemophilia A. Haemophilia A is a sex-linked, hereditary blood coagulation defect due to reduced factor VIII levels. This results in severe bleeding in joints, muscles and inner organs, either spontaneously or as a consequence of accidental or surgical traumata. The administration of Immunate temporarily corrects the factor VIII deficiency and reduces the bleeding tendency. In addition to its role as a Factor VIII protecting protein, von Willebrand Factor (VWF) mediates platelet adhesion to sites of vascular injury and plays a role in platelet aggregation. What Immunate is used for Immunate is used for the treatment and prevention of bleeding in congenital (haemophilia A) or acquired factor VIII deficiency. Immunate is also used for the treatment of bleeding in patients with von Willebrand’s disease with factor VIII deficiency, if no specific preparation effective against von Willebrand’s disease is available, and when desmopressin (DDAVP) treatment alone is ineffe Прочитать полный документ
SPC IMMUNATE 1000 IU November 2017 1/11 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Immunate 1000 IU FVIII/750 IU VWF powder and solvent for solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active Substances: Human coagulation Factor VIII/ Human von Willebrand Factor Each vial contains nominally 1000 IU human coagulation factor VIII 1 and 750 IU human von Willebrand factor 2 (VWF:RCo). Immunate 1000 IU FVIII/750 IU VWF contains approximately 100 IU/ml of human coagulation factor VIII and 75 IU/ml human von Willebrand factor after reconstitution. The potency of factor VIII (IU) is determined using the European Pharmacopoeia chromogenic assay. The specific activity of Immunate is 70 ± 30 IU FVIII/mg protein 3 . The potency of VWF (IU) is determined using the European Pharmacopoeia ristocetin co-factor assay (VWF:RCo). Produced from the plasma of human donors. Excipients with known effect: 1 vial contains approx. 19.6 mg sodium. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder and solvent for solution for injection. White or pale yellow powder or friable solid. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment and prophylaxis of bleeding in patients with congenital (haemophilia A) or acquired factor VIII deficiency. Treatment of bleeding in patients with von Willebrand's disease with factor VIII deficiency, if no specific preparation effective against von Willebrand’s disease is available, and when desmopressin (DDAVP) treatment alone is ineffective or contra- indicated. 1 The FVIII potency was determined against the WHO International Standard for FVIII Concentrates. 2 The ristocetin cofactor activity of human von Willebrand factor was determined against the WHO International Standard for von Willebrand Factor, Concentrate. 3 without stabilizer (albumin); The maximum specific activity at a 1:1 ratio of factor VIII activity to von Willebrand factor-antigen is 100 IU factor VIII per mg protein. SPC IMMUNATE 1000 IU November 2017 2/ Прочитать полный документ