Pharmaceutical particulars : מידע רוקחי

6.     PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Powder:
Lactose monohydrate, polysorbate 20, sodium phosphate dibasic heptahydrate (for pH adjustment), phosphoric acid (concentrated) (for pH adjustment).
Solvent:
Metacresol, water for injection.
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, the solution may be stored for a maximum of 28 days at not more than-25°C. Do not freeze.
6.4 Special precautions for storage
Store in a refrigerator (2°C – 8°C). Do not freeze. Store in the original package in order to protect from light.
For storage condition of the reconstituted medicinal product, see section 6.3 6.5 Nature and contents of container
MENOPUR 600 IU:
Powder: 2 ml colourless glass (type I glass) vial with rubber stopper closed with a cap.
Solvent: 1 ml pre-filled syringe (type I glass) with rubber (type I) tip cap and plunger rubber stopper .
Each pack contains 1 vial of powder, 1 pre-filled syringe with solvent for reconstitution, 1 needle for reconstitution and 9 disposable syringes for administration graduated in FSH/LH units with pre-fixed needles.
MENOPUR 1200 IU:
Powder: 2 ml colourless glass (type I glass) vial with rubber stopper closed with a cap.
Solvent: 1 ml pre-filled syringe (type I glass) with rubber (type I) tip cap and plunger rubber stopper.
Each pack contains 1 vial of powder, 2 pre-filled syringes with solvent for reconstitution, 1 needle for reconstitution, 18 disposable syringes for administration graduated in FSH/LH units with pre-fixed needles.
6.6 Special precautions for disposal
The powder should only be reconstituted with the solvent provided in the package.
Attach the reconstitution needle to the prefilled syringe. Inject the total contents of solvent into the vial containing the powder.
MENOPUR 600 IU must be reconstituted with one pre-filled syringe with solvent before use.
MENOPUR 1200 IU must be reconstituted with two pre-filled syringes with solvent before use. The powder should dissolve quickly to a clear solution. If not, roll the vial gently between the hands until the solution is clear. Vigorous shaking should be avoided.
The reconstituted solution should not be administered if it contains particles or is not clear.
The single use administration syringes are graduated in FSH/LH units from 37.5 – 600 IU.
Draw up the exact prescribed dose of reconstituted solution from the vial using one of the disposable syringes provided for injection and administer the dose immediately.. Each ml of reconstituted solution contains 600 IU FSH and LH.
Discard the syringe after use.
Each reconstituted MENOPUR 600 IU or 1200 IU vial should be for individual patient use only.
Any unused product or waste material should be disposed in accordance with local requirements.