Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS
6.1   List of excipients

Powder
Mannitol (E421)

Solvent
Water for injections
6.2   Incompatibilities


In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

6.3   Shelf life

The expiry date of the product is indicated on the packaging materials.
After reconstitution
Chemical and physical in-use stability has been demonstrated for 2 hours at 25ºC. From a microbiological point of view, unless the method of reconstitution precludes the risk of microbial contamination, the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user.
6.4 Special precautions for storage
Do not store above 25°C
For storage conditions of the reconstituted medicinal product, see section 6.3.
6.5 Nature and contents of container
Firmagon 120 mg
2 glass (type I ) vials with bromobutyl rubber stopper and aluminium flip-off seal containing 120 mg powder for solution for injection
2 Pre-filled glass (type I) syringes with elastomer plunger stopper, tip cap and line-marking at 3 ml containing 3ml solvent
2 plunger rods
2 vial adaptors
2 injection needles (25G 0.5 x 25mm)

Firmagon 80 mg.
1 glass (type I ) vial with bromobutyl rubber stopper and aluminium flip-off seal containing 80 mg powder for solution for injection
1 Pre-filled glass (type I) syringe with elastomer plunger stopper, tip cap and line-marking at 4 ml containing 4.2 ml solvent
Plunger rod
1 vial adapter
1 injection needle (25G 0.5 x 25mm)


6.6   Special precautions for disposal and other handling
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.



NOTE:
•  THE VIALS SHOULD NOT BE SHAKEN

The pack contains one vial of powder and one pre-filled syringe with solvent that must be prepared for subcutaneous injection.



1. Remove the cover from the vial adapter pack. Attach the adapter to the powder vial by pressing the adapter down until the spike pushes through the rubber stopper and the adapter snaps in place.



2. Prepare the pre-filled syringe by attaching the plunger rod.
3. Remove the cap of the pre-filled syringe. Attach the syringe to the powder vial by screwing it on to the adapter. Transfer all solvent to the powder vial.



4. With the syringe still attached to the adapter, swirl gently until the liquid looks clear and without undissolved powder or particles. If the powder adheres to the side of the vial above 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 usually takes a few minutes, but may take up to 15 minutes in some cases.



5. Turn the vial upside down and draw up to the line mark on the syringe for injection.
Always make sure to withdraw the precise volume and adjust for any air bubbles.
Firmagon 80 mg powder and solvent for solution for injection: withdrawn until the line marking at 4 ml.


Firmagon 120 mg powder and solvent for solution for injection: withdrawn until the line marking at 3 ml.


6. Detach the syringe from the vial adapter and attach the needle for deep subcutaneous injection to the syringe.



7. Perform a deep subcutaneous injection. To do so: grasp the skin of the abdomen, elevate the subcutaneous tissue and insert the needle deeply at an angle of not less than 45 degrees.
Firmagon 80 mg powder and solvent for solution for injection: Inject 4 ml of FIRMAGON 80 mg slowly,
immediately after reconstitution.

Firmagon 120 mg powder and solvent for solution for injection: Inject 3 ml of FIRMAGON 120 mg slowly,
immediately after reconstitution

8. No injections should be given in areas where the patient will be exposed to pressure, e.g. around the belt or waistband or close to the ribs.
Do not inject directly into a vein. Gently pull back the plunger to check if blood is aspirated. If blood appears in the syringe, the medicinal product can no longer be used. Discontinue the procedure and discard the syringe and the needle (reconstitute a new dose for the patient).

9. Firmagon 120 mg powder and solvent for solution for injection: Repeat the reconstitution procedure for the second dose. Choose a different site and inject 3 ml.
No special requirements for disposal.

7. MANUFACTURER:              Ferring GmbH Germany