Pharmaceutical particulars : מידע רוקחי

6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
1 vial of powder for injection contains: poly(d,l-lactide-co-glycolide), mannitol, carmellose sodium, polysorbate 80
1 ampoule of 2 ml solvent contains: Water for injection

6.2.     Incompatibilities
Decapeptyl depot powder for injection should only be mixed in the pack for the solvent.
6.3.     Shelf life
The expiry date of the product is indicated on the packaging materials.
Use immediately after reconstitution.
6.4.     Special precautions for storage
Store bellow 25oC.
For storage conditions of the reconstituted medicinal product see section 6.3.
6.5.     Nature and contents of container
1 vial with powder containing 3.75mg triptorelin
1 ampoule with solvent containing 2 ml water for injection.
1 syringe and 2 needles .
6.6.     Special precautions for disposal and other handling
The powder must be reconstituted aseptically and only using the ampoule of dilution liquid provided.
The instructions for dilution below and which are provided in the package leaflet must be followed exactly. Draw up the dilution liquid into the syringe provided by using the reconstitution needle and then transferring the liquid to the injection vial containing the powder Reconstitute the powder by carefully shaking the injection vial from side to side in an oscillating movement until a homogeneous, milk-like suspension forms. Do not turn the injection vial upside down. It is important to check there is no unsuspended powder in the vial.
Draw the suspension that has formed back into the syringe, without turning the injection vial upside down. Then replace the needle with the injection needle that does have a prick guard (20 G) and will be used for administration later on. Since the product is a suspension, it must be injected immediately after reconstitution to avoid deposits forming.

Intended for single use only.

Used injections, used needles, any unused suspension or other waste material should be disposed of in accordance with local requirements.

The suspension for injection should be prepared immediatelly before use.
Preparation for injection.
Two needles are provided in the box:
• The reconstitution needle
• The injection needle
     Tap any solution that may be present in the tip of the ampoule back into the main reservoir of the solvent ampoule.
     Screw the reconstitution needle onto the syringe (do not remove the needle guard at this point!)
     Break open the solvent ampoule (breakpoint facing your body).
     Remove the needle guard from the reconstitution needle and draw up all the solvent into the syringe (Fig.A).



    Put aside the syringe containing the solvent.
    Take out the vial containing the powder. Tap any powder which has accumalated at the top of the vial back to the bottom of the vial.
    Remove the plastic cap from the top of the vial.
    Pick up the syringe containing the solvent again and insert the needle thorogh the rubber stopper of the vial and slowly inject the solvent so that it flows down the edge of the vial over a wide area (Fig.B).



    Pull up the needle to above the level of the liquid and gently swirl the vial to produce a homogeneous, milky suspension for injection (Fig.C). Make sure there is no powder left in the vial, and if nessesary, continue swirling the vial until the powder has completely disappeared.


N.B.: Do not mix the suspension by repeatedly filling and emptying the syringe! 


Then draw up all of the suspension for injection into the syringe (Fig.D).

As the product is a suspension, the injection should be administered immediately after reconstitution to prevent precipitation.




    Remove the reconstitution needle. Firmly screw the injection needle onto the syringe (screw it on tightly). Only touch the colored hub.
    .
    Remove the needle guard from the injection needle.
    Expel any air from the syringe (Fig.E2).



Injection
Inject the suspension for injection relatively rapidly and in a steady and uninterrupted manner into the muscles.

After use
•    Dispose the needle in a designated sharps container.
For single use only. Any unused suspension must be discared

7. Name of manufacturer:
DEBIOPHARM RESEARCH & MANUFACTURING S.A, SWITZERLAND
8. Name of registration holder: Ferring pharmaceuticals LTD, 8 Hashita Street, Industrial Park, Caesarea 3088900, Israel.