Country: Իսրայել
language: անգլերեն
source: Ministry of Health
FACTOR VIII INHIBITOR BYPASSING FRACTION
TAKEDA ISRAEL LTD
B02BD03
POWDER AND SOLVENT FOR SOLUTION FOR INJECTION/INFUSION
FACTOR VIII INHIBITOR BYPASSING FRACTION 500 U/VIAL
I.V
Required
BAXTER AG, AUSTRIA
FACTOR VIII INHIBITOR BYPASSING ACTIVITY
FACTOR VIII INHIBITOR BYPASSING ACTIVITY
Control of bleeding episodes in haemophilia A patients with Factor VIII Inhibitors and also in patients with acquired Factor VIII Inhibitors.Control of bleeding in hemophilia B patients with inhibitors, if no other specific treatment is available.
2012-07-31
העדוה העדוה לע לע הרמחה הרמחה ( ( עדימ עדימ ןולעב )תוחיטב ןולעב )תוחיטב ל ל אפור אפור ןכדועמ( ןכדועמ( 05.2013 05.2013 ) ) ךיראת ________ APRIL 19, 2015 ___ םש רישכת תילגנאב רפסמו םושירה _ FEIBA NF 500 U, 1000 U POWDER FOR SOLUTION FOR INJECTION REG NO: 500 U: 026 14 25389 00; 1000U: 0261525390 00 _ םש לעב םושירה TEVA MEDICAL (MARKETING) LTD., HAORGIM ST 8, ASHDOD 77100 ספוט הז דעוימ טורפל תורמחהה דבלב ! תורמחהה תושקובמה קרפ ןולעב טסקט יחכונ טסקט שדח INDICATION FEIBA NF is indicated for the control of bleeding episodes in haemophilia A patients with Factor VIII inhibitors and also in patients with acquired Factor VIII inhibitors. - Control of bleeding episodes in haemophilia A patients with Factor VIII inhibitors and also in patients with acquired Factor VIII inhibitors. - Control of bleeding in hemophilia B patients with inhibitors, if no other specific treatment is available. CONTRAINDICATIONS POSOLOGY, DOSAGE & ADMINISTRATION SURGERY 50-100 U/kg bw should be given at intervals of up to 6 hours, a maximum daily dose of 200 U/kg bw should not be exceeded. SURGERY In surgical interventions, an initial dose of 100 U/kg body weight may be administered preoperatively, and a further dose of 50 – 100 U/kg body weight may be administered after 6 – 12 hours. As a postoperative maintenance dose, 50 – 100 U/kg body weight may be administered at 6 – 12-hour intervals; dosage, dosage intervals and duration of the peri- and postoperative therapy are guided by the surgical intervention, the patient’s general condition and the clinical efficacy in each individual case. (The maximum daily dose of 200 U/kg body weight must not be exceeded!) SURGERY 50-100 U/kg bw should be given at intervals of up to 6 hours, a maximum daily dose of 200 U/kg bw should not be exceeded. USE OF FEIBA NF IN SPECIAL PATIENT GROUPS See Section 5.1 for information read_full_document
FEIBA 1000U with BAXJECT II Hi-Flow Device_ SPC_ update_ 2023 - 01 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT FEIBA 1000U Powder and solvent for solution for infusion or injection. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION (a) Powder: each glass vial contains: FEIBA - 1000 U* Active ingredient: Human Plasma Protein with a Factor Eight Inhibitor Bypassing Activity of 400-1200 mg 1000 units Other ingredients: Sodium Chloride 160 mg Sodium Citrate dihydrate 80 mg 1 ml of Feiba 1000U contains 50 U* factor VIII inhibitor bypassing activity *) A solution containing 1 U of FEIBA shortens the activated partial thromboplastin time (aPTT) of a factor VIII inhibitor plasma to 50% of the buffer value (blank value). FEIBA also contains the factors II, IX and X mainly in non-activated form as well as activated factor VII; factor VIII coagulant antigen (F VIII C:Ag) is present in a concentration of up to 0.1 U/1 U FEIBA. The factors of the kallikrein-kinin system are present in trace amounts only, if at all. (b) Solvent: each glass vial contains 20 ml sterile water for injections. Excipients with known effect: FEIBA 1000U contains approximately 80 mg sodium per vial. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder and solvent for solution for injection or infusion. White, off-white or pale green powder. The pH value of the ready-to-use solution is between 6.8 and 7.6. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS • Control of bleeding episodes in hemophilia A patients with Factor VIII inhibitors and also in patients with acquired Factor VIII inhibitors. • Control of bleeding in hemophilia B patients with inhibitors, if no other specific treatment is available. FEIBA 1000U with BAXJECT II Hi-Flow Device_ SPC_ update_02-2023 2 4.2. POSOLOGY AND METHOD OF ADMINISTRATION The treatment is to be initiated and monitored by a physician experienced in the management of coagulation disorders. _Posology _ Dosage and duration of the treatment depend on the severity of the h read_full_document