What NovoSeven contains
- The active substance is recombinant coagulation factor VIIa (activated eptacog alfa).
- The other ingredients in the powder are sodium chloride, calcium chloride dihydrate, glycylglycine, polysorbate 80, mannitol, hydrochloric acid and sodium hydroxide. The solvent is water for injections.
The powder for solution for injection contains: 1.2 mg/vial (corresponding to 60 KIU/vial), 2.4 mg/vial (corresponding to 120 KIU/vial) or 4.8 mg/vial (corresponding to 240 KIU/vial). After reconstitution 1 ml of the solution contains 0.6 mg eptacog alfa (activated).
1 KIU equals 1000 IU (International Units).
What NovoSeven looks like and contents of the pack
The powder vial contains white powder and the water vial contains a clear colourless solution. The reconstituted solution for injection is colourless. Do not use the reconstituted solution if particle formation or discolouration is noticed.
Each NovoSeven pack contains:
- 1 vial with white powder (NovoSeven) for solution for injection
- 1 vial with water (Water for injections) for reconstitution
- 1 sterile vial adapter for reconstitution
- 1 sterile disposable syringe for reconstitution and administration
- 1 sterile infusion set
- 2 alcohol swabs.
Pack sizes: 1.2 mg (60 KIU), 2.4 mg (120 KIU) and 4.8 mg (240 KIU).
Please refer to outer packaging for present pack size.
Marketing authorisation holder and manufacturer
Novo Nordisk A/S
DK-2880 Bagsværd, Denmark
This leaflet was last approved in
NOVOSEVEN USER INSTRUCTIONS
Water vial Powder vial Infusion set Alcohol swabsPlastic cap Plastic cap Rubber stopper Rubber stopper NeedleCap SheathSyringe Vial adapterPlungerTip Spik
Preparing the solution
Wash your hands. Bring the NovoSeven powder and water vials to room temperature (but not above 37°C). You can do this by holding them in your hands. Remove the plastic caps from the two vials. If the caps are loose or missing, do not use the vials. Clean the rubber stoppers on the vials with the alcohol swabs and allow them to dry before use.
Remove the protective paper from the vial adapter without taking the vial adapter out of the protective cap. Attach the vial adapter to the water vial. Take care not to touch the spike on the vial adapter.
Once attached, remove the protective cap from the vial adapter.
Pull the plunger to draw in a volume of air that is equal to the amount of water in the water vial (ml equals cc on the syringe).
Screw the syringe tightly onto the vial adapter on the water vial. Inject air into the vial by pushing the plunger until you feel a clear resistance.
Hold the syringe with the water vial upside down and pull the plunger to draw the water into the syringe.
Remove the empty water vial by tipping the syringe with the vial adapter.
Click the vial adapter, still attached to the syringe, onto the powder vial. Hold the syringe slightly tilted with the vial facing downwards. Push the plunger slowly to inject the water into the powder vial. Make sure not to aim the stream of water directly at the NovoSeven powder as this will cause foaming.
Gently swirl the vial until all the powder is dissolved. Do not shake the vial as this will cause foaming. Check the solution for visible particles and discolouration. If you notice either, do not use it.
Although NovoSeven will be stable for 24 hours after it has been mixed, you should use it at once to avoid infection. If you do not use it immediately after mixing, you should store the vial with the syringe still attached in a refrigerator at 2°C to 8°C for no longer than 24 hours. Do not store the solution without your doctor?s advice.
Injecting the solution
Ensure that the plunger is pushed all the way in before turning the syringe upside down (it may have been pushed out by the pressure in the syringe). Hold the syringe with the vial upside down and pull the plunger to draw all the solution into the syringe.
Unscrew the vial adapter with the empty vial.
NovoSeven is now ready for injection. Follow the injection procedure as instructed by your health care professional.
Safely dispose of the syringe, vial adapter, vials, infusion set and any unused product as instructed by your health care professional.