Always take ReFacto AF exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are not sure.
Your doctor will decide the dose of ReFacto AF you will receive. This dose and duration will depend upon your individual needs for replacement factor VIII therapy.
During your treatment, your doctor may decide to change the dose of ReFacto AF you receive. Consult with your health care provider before you travel. You should bring enough of your factor VIII product for anticipated treatment when travelling.
It is recommended that every time you use ReFacto AF, you record the name on the carton and batch number of the product. You can use one of the peel-off labels found on the vial to document the batch number in your diary or for reporting any side effects.
Reconstitution and administration
The procedures below are provided as guidelines for the reconstitution and administration of ReFacto AF. Patients should follow the specific reconstitution and administration procedures provided by their doctors.
Use only the pre-filled syringe provided in the box for reconstitution. Other sterile disposable syringes may be used for administration.
ReFacto AF is administered by intravenous (IV) injection after reconstitution of the lyophilised powder for injection with the supplied solvent [sodium chloride 9 mg/ml (0.9%) solution] syringe. ReFacto AF should not be mixed with other infusion solutions.
Always wash your hands before performing the following reconstitution and administration procedures. Aseptic technique (meaning clean and germ-free) should be used during the reconstitution procedure.
Reconstitution:
1. Allow the vial of lyophilised ReFacto AF and the pre-filled solvent syringe to reach room temperature.
2. Remove the plastic flip-top cap from the ReFacto AF vial to expose the central portion of the rubber stopper.
3. Wipe the top of the vial with the alcohol swab provided, or use another antiseptic solution and allow to dry. After cleaning, do not touch the rubber stopper with your hand or allow it to touch any surface.
4. Peel back the lid from the clear plastic vial adapter package. Do not remove the adapter from the package.
5. Place the vial on a flat surface. While holding the adapter package, place the vial adapter over the vial. Press down firmly on the package until the adapter snaps into place on top of the vial, with the adapter spike penetrating the vial stopper.
6. Lift the package away from the adapter and discard the package.
7. Attach the plunger rod to the solvent syringe by inserting the rod into the opening in the syringe stopper and pushing and turning the rod firmly until it is securely seated in the stopper.
8. Break off the tamper-resistant plastic tip cap from the solvent syringe by snapping the perforation of the cap. This is done by bending the cap up and down until the perforation is broken. Do not touch the inside of the cap or the syringe tip. The cap may need to be replaced (if not administering reconstituted ReFacto AF immediately), so set it aside by placing it on its top.
9. Place the vial on a flat surface. Connect the solvent syringe to the vial adapter by inserting the tip of the syringe into the adapter opening while firmly pushing and turning the syringe clockwise until the connection is secured.
10. Slowly depress the plunger rod to inject all the solvent into the ReFacto AF vial.
11. With the syringe still connected to the adapter, gently rotate the vial until the powder is dissolved.
12. The final solution must be inspected visually for particulate matter before administration. The solution will appear clear to slightly opalescent and colourless.
Note: If you use more than one vial of ReFacto AF per infusion, each vial should be reconstituted as per the previous instructions. The solvent syringe should be removed, leaving the vial adapter in place, and a single large luer lock syringe may be used to draw back the reconstituted contents of each of the individual vials.
13. Ensuring that the syringe plunger rod is still fully depressed, invert the vial. Slowly draw back all the solution through the vial adapter into the syringe.
14. Detach the syringe from the vial adapter by gently pulling and turning the syringe counter-clockwise. Discard the vial with the adapter attached.
Note: If the solution is not to be used immediately, the syringe cap is to be carefully replaced. Do not touch the syringe tip or the inside of the cap.
ReFacto AF must be used within 3 hours of reconstitution. The reconstituted solution may be stored at room temperature prior to administration.
Administration (Intravenous Injection):
ReFacto AF should be administered using the infusion set provided in this kit and the pre-filled solvent syringe provided or a single sterile disposable plastic luer lock syringe.
1. Attach the syringe to the luer end of the infusion set tubing.
2. Apply a tourniquet and prepare the injection site by wiping the skin well with an alcohol swab provided in the kit.
3. Insert the needle on the infusion set tubing into the vein as instructed by your doctor, and remove the tourniquet. Remove any air in the infusion set tubing by drawing back on the syringe. The reconstituted product is to be injected intravenously over several minutes. Your doctor may change your recommended infusion rate to make the infusion more comfortable.
Please dispose of all unused solution, the empty vial(s) and the used needles and syringes in an appropriate container for throwing away of medical waste as these materials may hurt others if not disposed of properly.
If you take more ReFacto AF than you should
Check with your doctor or pharmacist.
If you stop taking ReFacto AF
Do not stop using ReFacto AF without consulting your doctor.
If you have any further questions regarding this product, ask your doctor or pharmacist.
