Afstyla Caution For Usage

Incompatibilities: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products, diluents or solvents except those mentioned in Description and Presentation.
Precautions for disposal and other handling: General instructions: The solution should be almost colourless, clear or slightly opalescent. After filtering/withdrawal (see as follows) the reconstituted product should be inspected visually for particulate matter and discoloration prior to administration.
Do not use visibly cloudy solutions or solutions still containing flakes or particles.
Reconstitution and withdrawal must be carried out under aseptic conditions.
Reconstitution: Bring the solvent to room temperature. Ensure product and solvent vial flip caps are removed and the stoppers are treated with an antiseptic solution and allowed to dry prior to opening the Mix2Vial package.
1. Open the Mix2Vial package by peeling off the lid. Do not remove the Mix2Vial from the blister package.
2. Place the solvent vial on an even, clean surface and hold the vial tight. Take the Mix2Vial together with the blister package and push the spike of the blue adapter end straight down through the solvent vial stopper.
3. Carefully remove the blister package from the Mix2Vial set by holding at the rim, and pulling vertically upwards. Make sure to only pull away the blister package and not the Mix2Vial set.
4. Place the product vial on an even and firm surface. Invert the solvent vial with the Mix2Vial set attached and push the spike of the transparent adapter end straight down through the product vial stopper. The solvent will automatically flow into the product vial.
5. With one hand grasp the product-side of the Mix2Vial set and with the other hand grasp the solvent-side and unscrew the set carefully counterclockwise into two pieces.
Discard the solvent vial with the blue Mix2Vial adapter attached.
6. Gently swirl the product vial with the transparent adapter attached until the substance is fully dissolved. Do not shake.
7. Draw air into an empty, sterile syringe. While the product vial is upright, connect the syringe to the Mix2Vial's Luer Lock fitting by screwing clockwise. Inject air into the product vial.
Withdrawal and application: 8. While keeping the syringe plunger pressed, turn the system upside down and draw the solution into the syringe by pulling the plunger back slowly.
9. Now that the solution has been transferred into the syringe, firmly hold on to the barrel of the syringe (keeping the syringe plunger facing down) and disconnect the transparent Mix2Vial adapter from the syringe by unscrewing counterclockwise.
For injection of AFSTYLA the provided administration sets are recommended to be used because treatment failure can occur as a consequence of factor VIII adsorption to the internal surface of some injection equipment.
Care should be taken that no blood enters the syringe filled with product, as there is a risk that the blood could coagulate in the syringe and fibrin clots could therefore be administered to the patient.
The AFSTYLA solution must not be diluted.
The reconstituted solution should be administered by a separate injection/infusion line by slow intravenous injection, at a rate comfortable to the patient, up to a maximum of 10 ml/min.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.