Страна: Израел
Език: английски
Източник: Ministry of Health
COAGULATION FACTOR IX RECOMBINANT-RFIX
PFIZER PHARMACEUTICALS ISRAEL LTD
B02BD04
LYOPHILIZED POWDER FOR INJECTION
COAGULATION FACTOR IX RECOMBINANT-RFIX 2000 IU
I.V
Required
WYETH FARMA S.A, SPAIN
COAGULATION FACTOR IX
COAGULATION FACTOR IX
Benefix is indicated for the control and prevention of hemorrhagic episodes in patients with hemophilia B (congenital factor IX deficiency or christmas disease), including control and prevention of bleeding in surgical settings, in previously treated patients (PTP) and previously untreated patients (PUP). Benefix is not indicated for the treatment of other factor deficiencies (e.g. factors II,VII, and X)' nor for the treatment of hemophilia A patients with inhibitors to factor VIII, nor for the reversal of coumarin-induced anticoagulation, nor for the treatment of bleeding due to low levels of liver-dependent coagulation factors.
2020-11-30
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS )PREPARATIONS( - 1986 This medicine is dispensed with a doctor’s prescription only BENEFIX ® 250 IU BENEFIX ® 500 IU BENEFIX ® 1000 IU BENEFIX ® 2000 IU POWDER AND DILUENT FOR SOLUTION FOR INTRAVENOUS )IV( INJECTION EACH VIAL CONTAINS: RECOMBINANT COAGULATION FACTOR IX 250IU, 500IU, 1000IU, 2000IU For a list of inactive ingredients and allergens, see section 6 “Further information”. READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE. This leaflet contains concise information about this medicine. If you have any further questions, consult your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if it seems to you that their medical condition is similar to yours. 1. WHAT IS THIS MEDICINE INTENDED FOR? Benefix ® is indicated for prevention and reduction of the rate of bleeding episodes in patients with hemophilia B (congenital factor IX deficiency or Christmas disease), including control of bleeding in surgical settings, in previously treated patients and previously untreated patients. Benefix ® is not indicated for the treatment of other factor deficiencies (factors II, VII, X), not for treatment of hemophilia A patients with inhibitors to factor VIII, not for reversal of coumarin (Warfarin)-induced anticoagulation and not for treatment of bleeding due to low levels of liver-dependent coagulation factors. THERAPEUTIC GROUP: coagulation factor. 2. BEFORE USING THIS MEDICINE Do not use this medicine if: you had a life-threatening, immediate hypersensitivity, including anaphylaxis, to the active ingredient or to any of the other ingredients in this medicine, listed in section 6, including sensitivity to hamster protein. SPECIAL WARNINGS REGARDING USE OF THE MEDICINE CALL YOUR DOCTOR RIGHT AWAY IF BLEEDING IS NOT CONTROLLED AFTER INJECTING THE MEDICINE. BEFORE TREATMENT WITH BENEFIX ® , TELL YOUR DOCTOR IF: • you have any allergies, including allergies to hamsters. Прочетете целия документ
Benefix LPD CC 12 Dec 2022 1 2022-0079930 BENEFIX ® - NAME OF THE MEDICINAL PRODUCT BeneFIX 250 IU BeneFIX 500 IU BeneFIX 1000 IU BeneFIX 2000 IU QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial of Benefix 250 IU contains nominally 250 IU nonacog alfa (recombinant coagulation factor IX). Each vial of Benefix 500 IU contains nominally 500 IU nonacog alfa (recombinant coagulation factor IX). Each vial of Benefix 1000 IU contains nominally 1000 IU nonacog alfa (recombinant coagulation factor IX). Each vial of Benefix 20000 IU contains nominally 2000 IU nonacog alfa (recombinant coagulation factor IX). For the full list of excipients, see section 11. PHARMACEUTICAL FORM BeneFIX 250 IU, 500 IU, 1000 IU, 2000 IU powder and solvent for solution for injection White powder and clear and colorless solvent. 1 INDICATIONS AND USAGE 1.1 CONTROL AND PREVENTION OF BLEEDING EPISODES IN HEMOPHILIA B BeneFIX ® , Coagulation Factor IX (Recombinant), is indicated for the control and prevention of bleeding episodes in adult and pediatric patients with hemophilia B (congenital factor IX deficiency or Christmas disease). 1.2 PERI -OPERATIVE MANAGEMENT IN PATIENTS WITH HEMOPHILIA B BeneFIX, Coagulation Factor IX (Recombinant), is indicated for peri-operative management in adult and pediatric patients with hemophilia B. BeneFIX, Coagulation Factor IX (Recombinant), is NOT indicated for: a. treatment of other factor deficiencies (e.g., factors II, VII, VIII, and X), b. treatment of hemophilia A patients with inhibitors to factor VIII, c. reversal of coumarin-induced anticoagulation, d. treatment of bleeding due to low levels of liver-dependent coagulation factors. 2.DOSAGE AND ADMINISTRATION Benefix LPD CC 12 Dec 2022 2 2022-0079930 2.1GENERAL CONSIDERATIONS FOR ADMINISTRATION FOR INTRAVENOUS USE AFTER RECONSTITUTION • TREATMENT WITH BENEFIX, COAGULATION FACTOR IX (RECOMBINANT), SHOULD BE INITIATED UNDER THE SUPERVISION OF A PHYSICIAN EXPERIENCED IN THE TREATMENT OF HEMOPHILIA B. • EACH VIAL OF BENEFIX HAS THE RFIX POTENCY IN THE Прочетете целия документ