Pharmaceutical particulars : מידע רוקחי

6.     PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Powder
Poly(D,L-lactide-co-glycolide) (50-60:40-50)
Poly(D,L-lactide-co-glycolide) (50:50)

Solvent

Mannitol
Carmellose sodium / carboxymethylcellulose sodium
Poloxamer 188
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.
6. 4   Special precautions for storage

Store in a refrigerator (2°C – 8°C). Do not freeze.

The product must be used immediately after reconstitution.
6.5    Nature and contents of container

Powder: brownish vial (glass) with rubber stopper (chlorobutyl rubber), containing the active substance (pasireotide).
Solvent: colourless pre-filled syringe (glass) with front and plunger stopper (chlorobutyl rubber), containing 2 ml solvent.

Unit packs (all strengths): each unit pack contains a blister tray with one injection kit (one vial and, in a separate sealed section, one pre-filled syring, one vial adapter and one safety-engineered needle for injection).

6.6   Special precautions for disposal and other handling

There are two critical steps in the reconstitution of Signifor LAR. Not following them could result in failure to deliver the injection appropriately.
•     The injection kit must reach room temperature. Remove the injection kit from the fridge and let the kit stand at room temperature for a minimum of 30 minutes before reconstitution, but do not exceed 24 hours.
•     After adding the solvent, shake the vial moderately for a minimum of 30 seconds until a uniform suspension is formed.

Included in the injection kit: a     One vial containing the powder b     One pre-filled syringe containing the solvent c     One vial adapter for medicinal product reconstitution d     One safety injection needle (20G x 1.5″)

Follow the instructions below carefully to ensure proper reconstitution of Signifor LAR powder and solvent for suspension for injection before deep intramuscular injection.

Signifor LAR suspension must only be prepared immediately before administration.

Signifor LAR should only be administered by a trained healthcare professional.
To prepare Signifor LAR for deep intramuscular injection, please adhere to the following instructions: 
1.     Remove the Signifor LAR injection kit from refrigerated storage. ATTENTION: It is essential to start the reconstitution process only after the injection kit reaches room temperature. Let the kit stand at room temperature for a minimum of 30 minutes before reconstitution, but do not exceed 24 hours. If not used within 24 hours, the injection kit can be returned to the fridge.
2.     Remove the plastic cap from the vial and clean the rubber stopper of the vial with an alcohol wipe.
3.     Remove the lid film of the vial adapter packaging, but do NOT remove the vial adapter from its packaging.
4.     Holding the vial adapter packaging, position the vial adapter on top of the vial and push it fully down so that it snaps in place, confirmed by a “click”.
5.     Remove the packaging from the vial adapter by lifting it straight up.
6.     Remove the cap from the syringe pre-filled with solvent and screw the syringe onto the vial adapter.
7.     Slowly push the plunger all the way down to transfer all the solvent in the vial.
8.     ATTENTION: Keep the plunger pressed and shake the vial moderately for a minimum of 30 seconds so that the powder is completely suspended. Repeat moderate shaking for another 30 seconds if the powder is not completely suspended.
9.     Turn syringe and vial upside down, slowly pull the plunger back and draw the entire content from the vial into the syringe.
10.    Unscrew the syringe from the vial adapter.
11.    Screw the safety injection needle onto the syringe.
12.    Pull the protective cover straight off the needle. To avoid sedimentation, you may gently shake the syringe to maintain a uniform suspension. Gently tap the syringe to remove any 


visible bubbles and expel them from the syringe. The reconstituted Signifor LAR is now ready for immediate administration.
13.   Signifor LAR must be given only by deep intramuscular injection. Prepare the injection site with an alcohol wipe. Insert the needle fully into the left or right gluteus at a 90° angle to the skin. Slowly pull back the plunger to check that no blood vessel has been penetrated (reposition if a blood vessel has been penetrated). Slowly depress the plunger until the syringe is empty. Withdraw the needle from the injection site and activate the safety guard.
14.   Activate the safety guard over the needle, in one of the two methods shown: -      either press the hinged section of the safety guard down onto a hard surface -      or push the hinge forward with your finger
An audible “click” confirms proper activation. Dispose of syringe immediately in a sharps container.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.