NovoSeven Caution For Usage

Incompatibilities: NovoSeven must not be mixed with infusion solutions or be given in a drip.
Special precautions for disposal and other handling: Procedure for pooling of vials for hospital use only: During in vitro studies, the chemical and physical in-use stability has been demonstrated for 24 hours at 25°C in a 50 ml syringe (polypropylene). Compatibility with the product was demonstrated for the system consisting of a 50 ml syringe (polypropylene), a 2 m infusion tube (polyethylene) and an in-line filter with a 5 micrometer pore size.
Pooling of vials (hospital use only): All steps should be completed under controlled and validated aseptic conditions by adequately trained staff.
If not reconstituted, pooled or used as recommended the in-use times and conditions prior to use are the responsibility of the user.
Ensure that a vial adapter is used irrespective of presentation.
Reconstitute the product as described in the Instructions on how to use NovoSeven. Unscrew the empty syringe from the vial adapter and for both presentation ensure that a vial adapter is attached to the vial containing reconstituted product.
Repeat the procedure with the appropriate number of additional vials, solvent vials/pre-filled syringes and vial adapters.
Draw approximately 5 ml of sterile air into the 50 ml syringe (polypropylene). Screw the syringe securely onto the vial adapter until resistance is felt. Hold the syringe slightly tilted with the vial pointing downwards. Push the plunger rod gently to inject a little air into the vial. Turn the syringe with the vial upside down and withdraw the contents of the vial into the syringe.
Repeat the previously mentioned procedure with the remaining vials with reconstituted product, to obtain the desired volume in the syringe.
An in-line filter with a 5 micrometer pore size must be ensured for administration. Ensure that the syringe, the infusion tube and the in-line filter are primed and free of air before administration.
The syringe with adequately reconstituted product is now ready for administration in a CE-marked infusion pump (accepting a 50 ml syringe).
The infusion pump must only be operated by trained hospital personnel.