Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
histidine, Quantity: 12.57 mg
Novo Nordisk Pharmaceuticals Pty Ltd
Eptacog alfa (activated),Histidine
Injection, solution
Excipient Ingredients: hydrochloric acid; water for injections; sodium hydroxide
Intravenous
8mg
Not Scheduled after consideration by Committee
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.
Visual Identification: vial with clear liquid; Container Type: Multiple containers; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius
Licence status A
2013-05-01
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_ Read the complete document
_NovoSeven RT pi8.docx _ _ _ _Page 1 of 17_ AUSTRALIAN PRODUCT INFORMATION NOVOSEVEN ® RT (EPTACOG ALFA (ACTIVATED) (BHK)) POWDER AND SOLVENT FOR SOLUTION FOR INJECTION 1 NAME OF THE MEDICINE Eptacog alfa (activated) (bhk) 2 QUALITATIVE AND QUANTITATIVE COMPOSITION NovoSeven RT contains activated recombinant coagulation Factor VII of approximate molecular mass 50K Daltons produced by genetic engineering from baby hamster kidney cells (BHK cells). The recombinant coagulation Factor VIIa (rFVIIa) in NovoSeven RT is structurally very similar to human plasma-derived activated Factor VIIa. After reconstitution with solvent, each vial contains rFVIIa 1.0 mg/mL (50,000 IU/mL), sodium chloride 2.3 mg/mL, calcium chloride dihydrate 1.5 mg/mL, glycylglycine 1.3 mg/mL, polysorbate 80 0.1 mg/mL and mannitol 25 mg/mL, sucrose 10 mg/mL, methionine 0.5 mg/mL and histidine 1.6 mg/mL. The units of rFVIIa are international units measured with reference to the first international standard of FVIIa 89/688. These units should not be mistaken for units of other coagulation factors including FVII. 3 PHARMACEUTICAL FORM NovoSeven RT (eptacog alfa (activated) (bhk)) is supplied as a stable, sterile, freeze-dried white powder in single-use vials, and solvent, for solution for injection. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC 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 D OSE AND METHOD OF ADMINISTRATION NovoSeven RT must be reconstituted with the sterile solvent provided and then administered by intravenous bolus injection over a period of 2-5 minutes. Coagulation parameters should not be used to evaluate NovoSeven RT effectiveness. _DOSING IN CHILDREN _ Current clinical experience does not warrant a general differenti Read the complete document