Adynovate Caution For Usage

Incompatibilities: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Special precautions for disposal and other handling: The reconstituted medicinal product should be inspected visually for particulate matter and discoloration prior to administration. The solution should be clear or slightly opalescent. Solutions that are cloudy or have deposits should not be used.
After reconstitution, the solution has a pH of 6.7 to 7.3. The osmolality is ≥ 380 mOsmol/kg.
Preparation and reconstitution using the BAXJECT II Hi-Flow device: For reconstitution use only the solvent vial and the reconstitution device provided in the pack.
1. Use antiseptic technique (clean and low-germ conditions) and a flat work surface during the reconstitution procedure.
2. Allow the vials of powder and solvent to reach room temperature (between 15°C and 25°C) before use.
3. Remove plastic caps from the powder and solvent vials.
4. Clean rubber stoppers with an alcohol wipe and allow to dry prior to use.
5. Open the BAXJECT II Hi-Flow device package by peeling away the lid, without touching the inside. Do not remove the device from the package.
6. Turn the package over. Press straight down to fully insert the clear plastic spike through the solvent vial stopper.
7. Grip the BAXJECT II Hi-Flow package at its edge and pull the package off the device. Do not remove the blue cap from the BAXJECT II Hi-Flow device. Do not touch the exposed purple plastic spike.
8. Turn the system over so that the solvent vial is on top. Quickly insert the purple plastic spike fully into the powder vial stopper by pushing straight down. The vacuum will draw the solvent into the powder vial.
9. Swirl gently until the powder is completely dissolved. Do not refrigerate after reconstitution.
Administration: Visually inspect the reconstituted solution for particulate matter and discoloration prior to administration.
The appearance of the reconstituted solution is clear and colourless.
Do not use if particulate matter or discoloration is observed.
Administer as soon as possible, but no later than 3 hours after reconstitution.
Administration Steps: 1. Remove the blue cap from the BAXJECT II Hi-Flow device. Do not draw air into the syringe. Connect the syringe to the BAXJECT II Hi-Flow. Use of a Luer-lock syringe is recommended.
2. Turn the system upside down (powder vial now on top). Draw the reconstituted solution into the syringe by pulling the plunger back slowly.
3. Disconnect the syringe; attach a suitable needle and inject intravenously. If a patient is to receive more than one vial of ADYNOVATE, the contents of multiple vials may be drawn into the same syringe.
A separate BAXJECT II Hi-Flow device is required to reconstitute each vial of ADYNOVATE with the solvent.
4. Administer over a period of up to 5 minutes (maximum infusion rate 10 ml per min).
It is strongly recommended that every time ADYNOVATE is administered, the name and batch number of the product are recorded. Peel-off labels are provided on the powder vial.
Reconstitution with the BAXJECT III system: Do not use if the lid is not completely sealed on the blister.
1. If the product is still stored in a refrigerator, take the sealed blister (contains powder and solvent vials preassembled with the system for reconstitution) from the refrigerator and let it reach room temperature (between 15°C and 25°C).
2. Wash hands thoroughly using soap and warm water.
3. Open the ADYNOVATE blister by peeling away the lid. Remove the BAXJECT III system from the blister.
4. Place the powder vial on a flat surface with the solvent vial on top. The solvent vial has a blue stripe. Do not remove the blue cap until instructed in a later step.
5. With one hand holding the powder vial in the BAXJECT III system, press down firmly on the solvent vial with the other hand until the system is fully collapsed and the solvent flows down into the powder vial. Do not tilt the system until the transfer is complete.
6. Verify that the solvent transfer is complete. Swirl gently until all material is dissolved. Be sure that the powder is completely dissolved, otherwise not all reconstituted solution will pass through the device filter. The product dissolves rapidly (usually in less than 1 minute). After reconstitution the solution should be clear, colourless and free from particles.
Administration: Visually inspect the reconstituted solution for particulate matter and discoloration prior to administration.
The appearance of the reconstituted solution is clear and colourless.
Do not use if particulate matter or discoloration is observed.
Administer as soon as possible, but no later than 3 hours after reconstitution.
Administration Steps: 1. Remove the blue cap from the BAXJECT III device. Do not draw air into the syringe.
Connect the syringe to the BAXJECT III device. Use of a Luer-lock syringe is recommended.
2. Turn the system upside down (powder vial now on top). Draw the reconstituted solution into the syringe by pulling the plunger back slowly.
3. Disconnect the syringe; attach a suitable needle and inject intravenously. If a patient is to receive more than one vial of ADYNOVATE, the contents of multiple vials may be drawn into the same syringe.
4. Administer over a period of up to 5 minutes (maximum infusion rate 10 ml per min).
It is strongly recommended that every time ADYNOVATE is administered, the name and batch number of the product are recorded. Peel-off labels are provided on the blister.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.