Riik: Suurbritannia
keel: inglise
Allikas: MHRA (Medicines & Healthcare Products Regulatory Agency)
Efmoroctocog alfa
Swedish Orphan Biovitrum Ltd
Efmoroctocog alfa
2000unit
Powder and solvent for solution for injection
Intravenous
No Controlled Drug Status
Valid as a prescribable product
BNF: ; GTIN: 7350031440768
PACKAGE LEAFLET: INFORMATION FOR THE USER ELOCTA 250 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION ELOCTA 500 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION ELOCTA 750 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION ELOCTA 1000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION ELOCTA 1500 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION ELOCTA 2000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION ELOCTA 3000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION efmoroctocog alfa (recombinant coagulation factor VIII) This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects. READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor, pharmacist or nurse. • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. • If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What ELOCTA is and what it is used for 2. What you need to know before you use ELOCTA 3. How to use ELOCTA 4. Possible side effects 5. How to store ELOCTA 6. Contents of the pack and other information 7. Instructions for preparation and administration 1. WHAT ELOCTA IS AND WHAT IT IS USED FOR ELOCTA contains the active substance efmoroctocog alfa, a recombinant coagulation factor VIII, Fc fusion protein. Factor VIII is a protein produced naturally in the body and is necessary for the blood to form clots and stop bleeding. ELOCTA is a medicine used for the treatment and prevention of bleeding in all age groups of patients with haemophilia A (inherited bleeding disorder caused by factor VIII deficie Lugege kogu dokumenti
OBJECT 1 ELOCTA POWDER AND SOLVENT FOR SOLUTION FOR INJECTION Summary of Product Characteristics Updated 05-Dec-2017 | Swedish Orphan Biovitrum Ltd This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1. Name of the medicinal product ELOCTA 250 IU powder and solvent for solution for injection ELOCTA 500 IU powder and solvent for solution for injection ELOCTA 750 IU powder and solvent for solution for injection ELOCTA 1000 IU powder and solvent for solution for injection ELOCTA 1500 IU powder and solvent for solution for injection ELOCTA 2000 IU powder and solvent for solution for injection ELOCTA 3000 IU powder and solvent for solution for injection 2. Qualitative and quantitative composition ELOCTA 250 IU powder and solvent for solution for injection Each vial contains nominally 250 IU efmoroctocog alfa. After reconstitution, each mL of solution for injection contains approximately 83 IU efmoroctocog alfa. ELOCTA 500 IU powder and solvent for solution for injection Each vial contains nominally 500 IU efmoroctocog alfa. After reconstitution, each mL of solution for injection contains approximately 167 IU efmoroctocog alfa. ELOCTA 750 IU powder and solvent for solution for injection Each vial contains nominally 750 IU efmoroctocog alfa. After reconstitution, each mL of solution for injection contains approximately 250 IU efmoroctocog alfa. ELOCTA 1000 IU powder and solvent for solution for injection Each vial contains nominally 1000 IU efmoroctocog alfa. After reconstitution, each mL of solution for injection contains approximately 333 IU efmoroctocog alfa. ELOCTA 1500 IU powder and solvent for solution for injection Each vial contains nominally 1500 IU efmoroctocog alfa. After reconstitution, each mL of solution for injection contains approximately 500 IU efmoroctocog alfa. ELOCTA 2000 IU powder and solvent for sol Lugege kogu dokumenti