Pharmaceutical particulars : מידע רוקחי

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients
Powder: lactose monohydrate
Solvent: sodium chloride and water for injections

6.2 Incompatibilities

In the absence of compatibility studies, this 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, immediate use is recommended.
6.4 Special precautions for storage
Do not store above 25°C. Keep the vial and the ampoule in the outer carton, in order to protect from light.

6.5 Nature and contents of container

Powder in a vial (type I glass) with a stopper (bromobutyl rubber) with a seal (aluminium) and a flip-off cap (plastic) + 1 ml of solvent in an ampoule (type I glass); Pack size of 1, and 10 sets.
Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling

The solution must be prepared just before injection.
One vial is for single use only. The medicinal product must be reconstituted under aseptic conditions.

FOSTIMON must only be reconstituted with the solvent provided in the package.

A clean surface should be prepared and hands should first be washed before the solution is reconstituted.

Set out all the following items on the clean surface:

-     two cotton-wool alcohol swabs (not provided)
-     one vial containing FOSTIMON powder
-     one solvent ampoule
-     one syringe (not provided)
-     one needle for reconstitution of the solution for injection (not provided) -     one fine needle for subcutaneous injection (not provided)

Both intramuscular and subcutaneous routes of administration are possible. If the intramuscular route is preferred appropriate needles will have to be prescribed.

Reconstitution of the solution for injection using 1 vial of powder
Open the solvent ampoule containing the clear liquid.
A coloured mark is indicated on the tip of the solvent ampoule:
At this mark the ampoule neck is specifically designed to break more easily. Gently tap the top of the ampoule to dislodge any liquid which may remain in the tip. Firmly press the ampoule above the neck and break it while levering up at the coloured mark. Carefully place the opened ampoule onto the preparation area.

Withdraw the solvent:
Attach the reconstitution needle (long needle) to the syringe. With the syringe in one hand, hold the previously opened solvent ampoule, place the needle into it and withdraw all the solvent. Place the syringe very carefully on the preparation area and avoid touching the needle.
Prepare the solution for injection:

1 - Remove the coloured plastic cap from the powder vial by gently pushing it upwards. Disinfect the top of the rubber stopper by wiping it with an alcohol swab and allow to dry.
2 - Pick up the syringe and slowly inject the solvent into the powder vial through the middle of the top of the rubber stopper. Press the plunger down firmly to squirt all the solution onto the powder.
3 – Do not shake, but gently roll the vial between the hands until the powder is completely dissolved, taking care to avoid creating foam.
4 - Once the powder is dissolved (which, in general, occurs immediately), slowly draw the solution into the syringe.
Gently push the plunger to draw all the solution up into the syringe. Check that the reconstituted solution is clear and colourless.

Preparation of higher doses, using more than 1 vial of powder
When reconstituting more than 1 vial of FOSTIMON, at the end of step 4 above, draw the reconstituted contents of the first vial back into the syringe, and slowly inject into a second vial.
Repeat steps 2 to 4 for the second and subsequent vials and until the contents of the required number of vials equivalent to the prescribed dosage are dissolved (within the limit of the maximum total dosage of 450 IU, corresponding to a maximum of 6 vials of FOSTIMON 75 IU or 3 vials of FOSTIMON 150 IU).

The solution must be clear and colourless.

Dispose of all used items:
Any unused product or waste material should be disposed of in accordance with local requirements (once the injection is ended, all the needles and empty ampoules should be disposed of in an appropriate container).


7. MARKETING AUTHORIZATION HOLDER
Tzamal Bio-Pharma, 20 Hamagshimim St., Kiryat Matalon, Petah Tikva.