Pharmaceutical particulars : מידע רוקחי

6.     PHARMACEUTICAL PARTICULARS
6.1.   List of excipients

Powder (Vial):
Poly (DL-lactide-co-glycolide)
Sterilized Mannitol

Solvent (Prefilled syringe):
Carmellose sodium
Mannitol
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.
The product must not be stored after reconstitution (must be used immediately).

6.4.    Special precautions for storage
Store in the original package in order to protect from light.
Store in a refrigerator (2°C to 8°C). Do not freeze.
Sandostatin LAR may be stored below 25°C on the day of the injection.
For storage conditions after reconstitution, refer to section 6.3.

6.5.    Nature and contents of container

Unit packs containing one 6 mL glass vial with rubber stopper (bromobutyl rubber), sealed with an aluminium flip-off seal, containing powder for suspension for injection and one 3 mL colourless pre-filled glass syringe with front and plunger stopper (chlorobutyl rubber) with 2 mL solvent, co-packaged in a sealed rigid plastic tray with one vial adapter and one safety injection needle.


6.6.    Special precautions for disposal and other handling
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.


Instructions for preparation and intramuscular injection for Sandostatin LAR 
FOR DEEP INTRAMUSCULAR INJECTION ONLY

Included in the injection kit:

 a.   One vial containing Sandostatin LAR powder,
b.   One prefilled syringe containing the vehicle solution for reconstitution, c.   One vial adapter for drug product reconstitution,
d.   One safety injection needle.


Follow the instructions below carefully to ensure proper reconstitution of Sandostatin LAR before deep intramuscular injection.

There are 3 critical actions in the reconstitution of Sandostatin LAR. Not following them could result in failure to deliver the drug 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 diluent solution, ensure that the powder is fully saturated by letting the vial stand for 5 minutes.
• After saturation, shake the vial moderately in a horizontal direction for a minimum of 30 seconds until a uniform suspension is formed. The Sandostatin LAR suspension must only be prepared immediately before administration.

Sandostatin LAR should only be administered by a trained healthcare professional.



Step 1
•   Remove the Sandostatin 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.
Note: The injection kit can be re-refrigerated if needed.

Step 2
•   Remove the plastic cap from the vial and clean the rubber stopper of the vial with an alcohol wipe.
•   Remove the lid film of the vial adapter packaging, but do
NOT remove the vial adapter from its packaging.
•   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 an audible “click.”
•   Lift the packaging off the vial adapter with a vertical movement.



Step 3
•   Remove the cap from the syringe prefilled with diluent solution and screw the syringe onto the vial adapter.
•   Slowly push the plunger all the way down to transfer all the diluent solution in the vial.


Step 4
ATTENTION: It is essential to let the vial stand for 5 minutes to ensure that the diluent has fully saturated the powder.
Note: It is normal if the plunger rod moves up as there might be a slight overpressure in the vial.
•   At this stage prepare the patient for injection.


Step 5
•   After the saturation period, make sure that the plunger is pushed all the way down in the syringe.
ATTENTION: Keep the plunger pressed and shake the vial moderately in a horizontal direction for a minimum of
30 seconds so that the powder is completely suspended
(milky uniform suspension). Repeat moderate shaking for another 30 seconds if the powder is not completely suspended.
Step 6
•   Prepare injection site with an alcohol wipe.
•   Turn syringe and vial upside down, slowly pull the plunger back and draw the entire contents from the vial into the syringe.
•   Unscrew the syringe from the vial adapter.



Step 7
•   Screw the safety injection needle onto the syringe.
•   Gently re-shake the syringe to ensure a milky uniform suspension
•   Pull the protective cover straight off the needle.
•   Gently tap the syringe to remove any visible bubbles and expel them from the syringe. Verify that injection site has not been contaminated.
•   Proceed immediately to Step 8 for administration to the patient. Any delay may result in sedimentation.



Step 8
•   Sandostatin LAR must be given only by deep intramuscular injection, NEVER intravenously.
•   Insert the needle fully into the left or right gluteus at a 90º 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).
•   Depress the plunger with steady pressure until the syringe is empty. Withdraw the needle from the injection site and activate the safety guard (as shown in Step 9).


Step 9
•   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 (figure A)
- or push the hinge forward with your finger (figure B).
•   An audible “click” confirms the proper activation.
•   Dispose of syringe immediately (in a sharps container).


7.    REGISTRATION HOLDER AND IMPORTER:

Novartis Israel Ltd.,
P.O.B 7126, Tel Aviv, Israel