Special precautions for disposal and other handling: ADVATE is to be administered intravenously after reconstitution of the product.
The reconstituted solution should be inspected visually for any foreign particulate matter and/or discoloration.
After reconstitution the solution should be clear, colourless and free from foreign particles.
Do not use solutions that are cloudy or have deposits.
For administration the use of a luer-lock syringe is required.
Use within three hours after reconstitution.
Do not refrigerate the preparation after reconstitution.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Reconstitution: For reconstitution use only the sterilised water for injections and the reconstitution device provided in the pack.
Do not use if the BAXJECT II device, its sterile barrier system or its packaging is damaged or shows any sign of deterioration.
Aseptic Technique should be used.
1. If the product is still stored in a refrigerator, take both the ADVATE powder and solvent vials from the refrigerator and let them reach room temperature (between 15 °C and 25 °C).
2. Wash hands thoroughly using soap and warm water.
3. Remove caps from powder and solvent vials.
4. Cleanse stoppers with alcohol swabs. Place the vials on a flat clean surface.
5. Open the package of BAXJECT II device by peeling away the paper lid without touching the inside. Do not remove the device from the package. Do not use if the BAXJECT II device, its sterile barrier system or its packaging is damaged or shows any sign of deterioration.
6. Turn the package over and insert the clear plastic spike through the solvent stopper. Grip the package at its edge and pull the package off BAXJECT II. Do not remove the blue cap from the BAXJECT II device.
7. For reconstitution only the sterilised water for injections and the reconstitution device provided in the pack should be used. With BAXJECT II attached to the solvent vial, invert the system so that the solvent vial is on top of the device. Insert the white plastic spike through the ADVATE powder stopper. The vacuum will draw the solvent into the ADVATE powder vial.
8. Swirl gently until all material is dissolved. Be sure that the ADVATE 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 foreign particles.
Administration: Use Aseptic Technique.
Parenteral medicinal products should be inspected for particulate matter prior to administration, whenever solution and container permit. Only a clear and colourless solution should be used.
1. Remove the blue cap from BAXJECT II. Do not draw air into the syringe. Connect the syringe to BAXJECT II.
2. Invert the system (the vial with the reconstituted solution has to be on top). Draw the reconstituted solution into the syringe by pulling the plunger back slowly.
3. Disconnect the syringe.
4. Attach a butterfly needle to the syringe. Inject intravenously. The solution should be administered slowly, at a rate as determined by the patient's comfort level, not to exceed 10 ml per minute. The pulse rate should be determined before and during administration of ADVATE. Should a significant increase occur, reducing the rate of administration or temporarily interrupting the injection usually allows the symptoms to disappear promptly (see Precautions and Adverse Reactions).
Incompatibilities: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products or solvents.