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, sucrose, methionine, hydrochloric acid, sodium hydroxide. The ingredients in the solvent are histidine, hydrochloric acid, sodium hydroxide, water for injections.
The powder for solution for injection contains: 1 mg/vial (corresponding to 50 KIU/vial), 2 mg/vial (corresponding to 100 KIU/vial), 5 mg/vial (corresponding to 250 KIU/vial) or 8 mg/vial (corresponding to 400 KIU/vial).
After reconstitution 1 ml of the solution contains 1 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 solvent 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 for solution for injection
- 1 vial with solvent for reconstitution
Pack sizes: 1 mg (50 KIU), 2 mg (100 KIU), 5 mg (250 KIU) and 8 mg (400 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
Solvent vial Powder vial Plastic cap Plastic cap Rubber stopper Rubber stopper
Preparing the solution
Wash your hands. NovoSeven powder and solvent vials should be at room temperature at reconstitution. 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 alcohol swabs and allow them to dry before use. Use a disposable syringe of an appropriate size and a vial adapter, transfer needle (20 - 26G) or other suitable device.
Remove the protective paper from the vial adapter without taking it out of the protective cap. Attach the vial adapter to the solvent vial. Once attached, remove the protective cap. Take care not to touch the spike on the vial adapter. If using a transfer needle, remove transfer needle from the packaging without taking it out of the protective cap. Screw the transfer needle tightly onto the syringe.
Pull the plunger to draw in a volume of air that is equal to the amount of solvent in the solvent vial (ml equals cc on the syringe).
Screw the syringe tightly onto the vial adapter on the solvent vial. If using a transfer needle, remove the protective cap and insert the transfer needle into the rubber stopper of the solvent vial. Take care not to touch the end of the transfer needle. Inject air into the vial by pushing the plunger until you feel a clear resistance.
Hold the syringe with the solvent vial upside down. If you are using a transfer needle, make sure that the transfer needle tip is in the solvent. Pull the plunger to draw the solvent into the syringe.
Remove the empty solvent vial. If you use a vial adapter, tip the syringe to remove it from the vial.
Attach the syringe with vial adapter or transfer needle to the powder vial. If you use a transfer needle, make sure to penetrate the centre of the rubber stopper. Hold the syringe slightly tilted with the vial facing downwards. Push the plunger slowly to inject the solvent into the powder vial. Make sure not to aim the stream of solvent 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. NovoSeven reconstituted product is a clear, colourless solution. Keep the vial adapter or transfer needle attached to the vial.
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). If you use a transfer needle, make sure that the transfer needle tip is in the solution. Hold the syringe with the vial upside down and pull the plunger to draw all the solution into the syringe.
If you use a vial adapter, unscrew the vial adapter with the empty vial. If you use a transfer needle, remove the transfer needle from the vial, replace the transfer needle cap, and twist the transfer needle off the syringe.
NovoSeven is now ready for injection. Follow the injection procedure as instructed by your health care professional.
Safely dispose of the syringe, vials, any unused product and other waste materials as instructed by your health care professional.