Instructions for Use: The instructions for reconstitution must be followed carefully.
Administration of other concentrations is not recommended because the gel depot formation is influenced by the concentration. The reconstituted solution should be a clear liquid, free of undissolved matter.
The vials should not be shaken.
Firmagon 80 mg: The pack contains 1 set of powder and solvent that must be prepared for SC inj. Firmagon 120 mg: The pack contains 2 sets of powder and solvent that must be prepared for SC inj. Hence, the instructions as follows need to be repeated for a 2nd time.
1. Remove the cover from the vial adapter pack. Attach the adapters to both the solvent and powder vial by pressing the adapter down until the spike pushes through the rubber stopper and the adapter snap in place.
2. Remove the cover from the syringe pack. Attach the syringe to the solvent vial by screwing it on to the adapter.
3. Turn the vial upside down and draw 4.2 mL solvent of Firmagon 80 mg or 3 mL solvent of Firmagon 120 mg into the syringe. Always make sure to withdraw the precise volume, as the amount of solvent affects the reconstitution. Detach the syringe from the adapter and discard the vial with the remaining solvent.
4. Attach the syringe to the powder vial by screwing it on to the adapter. Transfer the solvent to the powder vial. With the syringe still attached to the adapter, swirl very gently until the liquid looks clear and without undissolved powder or particles. In case the powder adheres to the vial over the liquid surface, the vial can be tilted slightly. Avoid shaking to prevent foam formation.
A ring of small air bubbles on the surface of the liquid is acceptable. The reconstitution procedure may take, in some cases, up to 15 min, but usually takes a few minutes.
5. Turn the vial upside down and, holding it vertically, draw 4 mL of Firmagon 80 mg or 3 mL of Firmagon 120 mg solution into the syringe for injection. Always make sure to withdraw the precise volume. It can be necessary to tilt the vial slightly.
6. Detach the syringe from the vial adapter and attach the needle for deep SC inj to the syringe. Carefully remove any air bubbles.
7. Grasp the skin of the abdomen, elevate the subcutaneous tissue. Perform a profound SC inj. To do so, insert the needle deeply at an angle of not less than 45 degrees.
8. Inject 4 mL of Firmagon 80 mg or 3 mL of Firmagon 120 mg immediately after reconstitution.
9. Do not inject directly into a vein. Gently pull back the plunger to check if blood is aspirated. If blood appears in the syringe, Firmagon can no longer be used. Discontinue the procedure and discard the syringe and the needle (reconstitute a new dose for the patient).
10. Firmagon 120 mg: Repeat the reconstitution procedure for the 2nd dose. Choose a different injection site and inject 3 mL.
No injections should be given in areas where the patient will be exposed to pressure eg, around the belt or waistband or close to the ribs.
After Reconstitution: Chemical and physical in-use stability has been demonstrated for 2 hrs at 25ºC. From a microbiological point of view, unless the method of reconstitution precludes the risk of microbial contamination, Firmagon should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user.