Country: Israel
Bahasa: Inggeris
Sumber: Ministry of Health
EPTACOG ALFA (ACTIVATED)
NOVO NORDISK LTD., ISRAEL
B02BD08
POWDER FOR SOLUTION FOR INJECTION
EPTACOG ALFA (ACTIVATED) 1 MG/VIAL
I.V
Required
NOVO NORDISK A/S, DENMARK
EPTACOG ALFA (ACTIVATED)
EPTACOG ALFA (ACTIVATED)
NovoSeven ® RT is indicated for the treatment of bleeding episodes and for the prevention of bleeding in those undergoing surgery or invasive procedures in the following patient groups: •in patients with congenital haemophilia with inhibitors to coagulation factors VIII or IX > 5 Bethesda Units (BU) •in patients with congenital haemophilia who are expected to have a high anamnestic response to factor VIII or factor IX administration •in patients with acquired haemophilia •in patients with congenital FVII deficiency •in patients with Glanzmann’s thrombasthenia with past or present refractoriness to platelet transfusions, or where platelets are not readily available.Severe postpartum haemorrhageNovoSeven RT is indicated for the treatment of severe postpartum haemorrhage when uterotonics are insufficient to achieve haemostasis
2015-01-31
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS) - 1986 This medicine is dispensed with a doctor’s prescription only NOVOSEVEN ® RT 1 MG (50 KIU) NOVOSEVEN ® RT 2 MG (100 KIU) NOVOSEVEN ® RT 5 MG (250 KIU) POWDER AND SOLVENT FOR SOLUTION FOR INJECTION ACTIVE INGREDIENT: EPTACOG ALFA (ACTIVATED) Inactive ingredients and allergens in this medicine: See section 2 under ‘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 illness is similar to yours. 1. WHAT IS THIS MEDICINE INTENDED FOR? NovoSeven RT is intended to treat bleeding and to prevent excessive bleeding after surgery or other invasive treatments in the following specific groups of patients: • if you were born with hemophilia and do not respond normally to treatment with coagulation factors VIII or IX • if you have acquired hemophilia • if you have Factor VII deficiency • if you have Glanzmann’s thrombasthenia (a bleeding disorder) and your condition cannot be treated effectively with platelet transfusion, or if no platelets are available. THERAPEUTIC GROUP: blood coagulation factors. NovoSeven RT is a blood coagulation factor. It works by making the blood clot at the site of bleeding when the body's own clotting factors are not working. Early treatment with NovoSeven RT reduces how much you bleed and for how long. It works in all types of bleeds, including in bleeding joints. This reduces the need for hospitalization and days absent from work and school. 2. BEFORE USING THIS MEDICINE DO NOT USE THIS MEDICINE IF: • you are sensitive (allergic) to eptacog alfa or any of the other ingredients in this medicine (listed in section Baca dokumen lengkap
NovoSeven RT IL SPC JAN21-Notification Page 1 of 13 1. NAME OF THE MEDICINAL PRODUCT NovoSeven ® RT 1 MG/VIAL NovoSeven ® RT 2 MG/VIAL NovoSeven ® RT 5 MG/VIAL 2. QUALITATIVE AND QUANTITATIVE COMPOSITION NovoSeven RT 1 mg (50 KIU) NovoSeven RT is presented as powder and solvent for solution for injection containing 1 mg eptacog alfa (activated) per vial (corresponds to 50 KIU/vial). NovoSeven RT 2 mg (100 KIU) NovoSeven RT is presented as powder and solvent for solution for injection containing 2 mg eptacog alfa (activated) per vial (corresponds to 100 KIU/vial). NovoSeven RT 5 mg (250 KIU) NovoSeven RT is presented as powder and solvent for solution for injection containing 5 mg eptacog alfa (activated) per vial (corresponds to 250 KIU/vial). 1 KIU equals 1,000 IU (International Units). eptacog alfa (activated) is recombinant coagulation factor VIIa (rFVIIa) with a molecular mass of approximately 50,000 Daltons produced in baby hamster kidney cells (BHK Cells) by recombinant DNA technology. After reconstitution, the product contains 1 mg/ml eptacog alfa (activated) when reconstituted with solvent. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder and solvent for solution for injection. White lyophilised powder. Solvent: clear colourless solution. The reconstituted solution has a pH of approximately 6.0. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS NovoSeven RT is indicated for the treatment of bleeding episodes and for the prevention of bleeding in those undergoing surgery or invasive procedures in the following patient groups: • in patients with congenital haemophilia with inhibitors to coagulation factors VIII or IX > 5 BU • in patients with congenital haemophilia who are expected to have a high anamnestic response to factor VIII or factor IX administration • in patients with acquired haemophilia • in patients with congenital FVII deficiency • in patients with Glanzmann’s thrombasthenia with past or present refractoriness to platelet transfusions, or where pl Baca dokumen lengkap