देश: इसराइल
भाषा: अंग्रेज़ी
स्रोत: Ministry of Health
NONACOG BETA PEGOL
NOVO NORDISK LTD., ISRAEL
B02BD04
POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
NONACOG BETA PEGOL 1000 IU/VIAL
I.V
Required
NOVO NORDISK A/S, DENMARK
COAGULATION FACTOR IX
Treatment and prophylaxis of bleeding in pretreated patients with haemophilia B (congenital factor IX deficiency).
2023-03-15
1 1986 - REGULATIONS (PREPARATIONS) PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' This medicine is dispensed with a doctor’s prescription only REFIXIA 1000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION ACTIVE INGREDIENT: nonacog beta pegol Pegylated human coagulation factor IX (rDNA). Each vial of Refixia contains nominally 1000 IU nonacog beta pegol, corresponding to approximately 250 IU/ml after reconstitution with histidine solvent. Inactive ingredients and allergens: See section 2 ‘Important information about some of this medicine’s ingredients’, and section 6 ‘Additional information'. READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START 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? Refixia is indicated for treatment and prophylaxis of bleeding in pretreated patients with haemophilia B (congenital factor IX deficiency). THERAPEUTIC GROUP: antihaemorrhagics, coagulation factor IX. Refixia contains the active substance nonacog beta pegol. It is a long-acting version of factor IX. Factor IX is a protein naturally found in the blood, which helps to stop bleeding. In patients with haemophilia B, factor IX is missing or does not work properly. Refixia replaces the faulty or missing factor IX and helps to form blood clots at the site of bleeding. 2. BEFORE USING THIS MEDICINE DO NOT USE THIS MEDICINE IF: • You are sensitive (allergic) to the active substance or to any of the other ingredients in this medicine (see section 6). • You are allergic to hamster proteins. SPECIAL WARNINGS ABOUT USING THIS MEDICINE TALK TO YOUR DOCTOR BEFORE USING REFIXIA. ALLERGIC REACTIONS AND DEVELOPMENT OF INHIBITORS There is a rare risk that you may experience a sudden and severe allergic reaction (e.g. anaphy पूरा दस्तावेज़ पढ़ें
1 1. NAME OF THE MEDICINAL PRODUCT Refixia 1000 IU powder and solvent for solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Refixia 1000 IU powder and solvent for solution for injection Each vial contains nominally 1000 IU nonacog beta pegol*. After reconstitution, 1 ml of Refixia contains approximately 250 IU nonacog beta pegol. *recombinant human factor IX, produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology, covalently conjugated to a 40 kDa polyethylene-glycol (PEG). The potency (IU) is determined using the European Pharmacopoeia one-stage clotting test. The specific activity of Refixia is approximately 144 IU/mg protein. Refixia is a purified recombinant human factor IX (rFIX) with a 40 kDa polyethylene-glycol (PEG) selectively attached to specific N-linked glycans in the rFIX activation peptide. Upon activation of Refixia, the activation peptide including the 40 kDa polyethylene-glycol moiety is cleaved off, leaving the native activated factor IX molecule. The primary amino acid sequence of the rFIX in Refixia is identical to the Ala148 allelic form of human plasma-derived factor IX. No additives of human or animal origin are used in the cell culture, purification, conjugation, or formulation of Refixia. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder and solvent for solution for injection. The powder is white to off-white. The solvent is clear and colourless. pH: 6.4. Osmolality: 272 mOsmol/kg. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment and prophylaxis of bleeding in pretreated patients with haemophilia B (congenital factor IX deficiency). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment should be under the supervision of a physician experienced in the treatment of haemophilia. Previously untreated patients The safety and efficacy of Refixia in previously untreated patients have not yet been established. 2 Treatment monitoring Routine monitoring of factor IX activity levels for the purpose of dose adjustment is n पूरा दस्तावेज़ पढ़ें