País: Nueva Zelanda
Idioma: inglés
Fuente: Medsafe (Medicines Safety Authority)
Eptacog alfa (activated) 5mg
Novo Nordisk Pharmaceuticals Ltd
Eptacog alfa (activated) 5 mg
5 mg
Powder for injection with diluent
Active: Eptacog alfa (activated) 5mg Excipient: Calcium chloride dihydrate Glycylglycine Mannitol Methionine Nitrogen Polysorbate 80 Sodium chloride Sucrose Histidine Water for injection
Combination pack, 1x(active+diluent), 5 mg
General sale
General sale
Novo Nordisk A/S
indicated for the control of bleeding and surgical prophylaxis in patients: · with inhibitors to coagulation Factors VIII or IX · with congenital FVII deficiency · with Glanzmann's Thrombasthenia, who have antibodies to GPIIb-IIIa and/or HLA, and with past or present refractoriness to platelet transfusions
Package - Contents - Shelf Life: Combination pack, 1x(active+diluent) - 5 mg - 36 months from date of manufacture stored at or below 25°C protect from light 5 hours reconstituted stored at or below 25°C protect from light 24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) protect from light. Stored in vial 24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) protect from light. Prepared in aseptic conditions and stored in a polypropylene syringe - Syringe, glass, diluent, Type 1 glass - 5.2 mL - 48 months from date of manufacture stored at or below 25°C 36 months from date of manufacture stored at or below 30°C - Vial, glass, active - 5 mg - - Vial, glass, diluent - 5.2 mL -
2008-01-03
NovoSeven ® RT page 1 of 8 NovoSeven RT-cmi7.docx NOVOSEVEN ® RT 1.0MG, 2.0MG, 5.0MG AND 8.0MG eptacog alfa (activated) (bhk) Recombinant coagulation factor VIIa _CONSUMER MEDICINE INFORMATION _ WHAT IS IN THIS LEAFLET WHAT IS IN THIS LEAFLET .......................... 1 WHAT NOVOSEVEN ® RT IS USED FOR ..... 1 BEFORE YOU USE NOVOSEVEN ® RT ........ 1 USING NOVOSEVEN ® RT ........................ 2 WHILE YOU ARE USING NOVOSEVEN ® RT .............................................................. 2 SIDE EFFECTS ........................................... 2 STORAGE ................................................. 2 PRODUCT DESCRIPTION ........................... 3 INSTRUCTIONS FOR USE ........................... 4 This leaflet answers some common questions about NovoSeven® RT. It does not contain all the available information. It does not take the place of talking to your doctor or healthcare professional. All medicines have risks and benefits. Your doctor has weighed the risks of you using NovoSeven® RT against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR HEALTHCARE PROFESSIONAL. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT NOVOSEVEN ® RT IS USED FOR NovoSeven ® RT is a medicine that works by activating the blood clotting system at the site of bleeding. It is similar to the activated factor VII (7) in human blood. NovoSeven ® RT is made by genetic engineering. NovoSeven ® RT is used to control bleeding episodes and to prevent excessive bleeding connected with surgery in people who have: inhibitors to clotting factors VIII (8) or IX (9), or congenital FVII deficiency, Glanzmann’s Thrombasthenia which cannot be treated effectively with platelet transfusions. Your doctor may want to give you NovoSeven ® RT for another reason. ASK YOUR DOCTOR OR HEALTHCARE PROFESSIONAL IF YOU HAVE ANY QUESTIONS ABOUT WHY NOVOSEVEN ® RT HAS BEEN GIVEN TO YOU. BEFORE YOU USE NOVOSEVEN ® RT _WHEN _ _NOVOSEVEN_ Leer el documento completo
- 1 - NEW ZEALAND DATASHEET 1 PRODUCT NAME NOVOSEVEN ® RT 1.0 mg, 2.0 mg, 5.0 mg, 8.0 mg powder and solvent for solution for injection. 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 RTis 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). NovoSeven RT 8 mg (400 KIU) NovoSeven RT is presented as powder and solvent for solution for injection containing 8 mg eptacog alfa (activated) per vial (corresponds to 400 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. The reconstituted solution is colourless. 4 CLINICAL PARTICULARS 4.1 Therapeutic indications NOVOSEVEN RT is indicated for the control of bleeding and surgical prophylaxis in patients: with inhibitors to coagulation Factors VIII or IX; with congenital FVII deficiency; with Glanzmann's Thrombasthenia, who have antibodies to GPIIb-IIIa and/or HLA, and with past or present refractoriness to platelet transfusions. 4.2 Dose and method of administration NOVOSEVEN RT must be reconstituted with the sterile solvent provided a Leer el documento completo