Instructions for intramuscular injection of Sandostatin LAR without vial adapter/safety needle:
Follow the instructions carefully to ensure complete saturation of the powder and its uniform suspension before intramuscular (IM) injection.
Sandostatin LAR suspension must only be prepared immediately before administration. Sandostatin LAR should only be administered by a trained health professional.
Allow the Sandostatin LAR vial and the vehicle syringe to reach room temperature.
Remove the cap from vial containing Sandostatin LAR. Assure that the powder is settled at the bottom of the vial by lightly tapping the vial.
Remove the cap from the vehicle syringe.
Attach one of the supplied needles to the vehicle syringe.
Disinfect the rubber stopper of the vial with an alcohol swab. Insert the needle through the centre of the rubber stopper of the Sandostatin LAR vial.
Without disturbing the Sandostatin LAR powder, gently inject all the vehicle into the vial by running the vehicle down the inside wall of the vial. Do not inject the vehicle directly into the powder. Withdraw the needle from the vial.
Do not disturb the vial until the vehicle has totally wetted the Sandostatin LAR powder (between 2-5 min). Without inverting the vial check the powder on the walls and bottom of the vial. If dry spots exist, allow undisturbed wetting to continue. At this stage, prepare the patient for injection.
Once complete wetting has occurred, the vial should be moderately swirled for about 30-60 seconds until a uniform milky suspension is achieved. Do not vigorously shake the vial as this may cause the suspension to flocculate, making it unusable.
Immediately re-insert the needle through the rubber stopper and then, with the bevel down and the vial tipped at approximately 45 degree angle, slowly draw the contents of the vial into the syringe. Do not invert the vial when filling the syringe as this may affect the amount withdrawn.
It is normal for a small amount of suspension to remain on the walls and bottom of the vial. This is a calculated overfill.
Immediately change the needle (supplied).
Administration must occur immediately after the suspension has been prepared. Gently invert the syringe as needed to maintain a uniform suspension. Eliminate air from syringe.
Disinfect the injection site with an alcohol swab.
Insert needle into right or left gluteus and draw back to ensure that no blood vessel has been penetrated. Inject slowly IM by deep intragluteal injection with steady pressure. If the needle blocks, attach a new needle of the same diameter (1.1 mm, 19 gauge).
Sandostatin LAR must be given only by deep intragluteal injection, never intravenously If a blood vessel has been penetrated, attach a new needle and select another injection site.
Instructions for Intramuscular Injection of Sandostatin LAR with Vial Adapter/Safety Needle:
Step 1. Take the Sandostatin LAR injection kit out of the refrigerated storage in order to ensure it reaches room temperature. Plan approximately 30-60 min for acclimatization but do not exceed 24 hrs.
Wash your hands with soap and hot water. Place the package on a clean and flat surface. Peel off the lid film from the blister tray containing the injection kit.
Take the vial containing the Sandostatin LAR powder and detach the flip off cap.
Step 2. Clean the rubber stopper of the vial with an alcohol swab.
Note: Do not touch the rubber stopper after it has been cleaned.
Peel off the lid film of the blister tray containing the vial adapter. Do not remove the vial adapter from the blister tray.
Holding the blister tray, position the vial adapter on top of the vial and push it fully down so that it snaps in place onto the vial, confirmed by an audible “click”.
Hold the blister tray by the top and with a vertical movement lift the blister tray off the vial adapter.
Step 3. Pull-off the cap from the prefilled syringe containing the vehicle solution and screw the syringe onto the vial adapter.
Slowly push the plunger all the way down to transfer all the vehicle solution in the vial.
Step 4. Let the vial stand until the vehicle has wetted the powder (between 2-5 min). At this stage, prepare the patient for injection.
Note: It is normal if the plunger rod moves up as there might be a slight overpressure in the vial.
Step 5. After the wetting period, press the plunger all the way back in the syringe.
Keep the plunger pressed and shake the vial moderately in a horizontal direction for about 30 seconds.
Check visually that the powder is completely suspended in the vehicle (uniform milky suspension). Repeat shaking for further 30 seconds if the powder is not completely suspended.
Step 6. Turn syringe and vial upside down, slowly pull the plunger out and draw the entire content from the vial into the syringe.
Unscrew the syringe from the vial adapter.
Administration must occur immediately after reconstitution.
Step 7. Screw the safety injection needle onto the syringe.
Pull the protective cover straight off the needle.
Gently invert the syringe to maintain a uniform suspension.
Gently tap the syringe to remove any visible bubbles and expel them from the syringe.
The reconstituted Sandostatin LAR is now ready for immediate administration.
Step 8. Sandostatin LAR must be given only by deep intragluteal injection, never IV.
Clean the injection site with an alcohol swab.
Insert the needle fully into the right or left gluteus.
Slowly draw back the plunger rod to check that no blood vessel has been penetrated, otherwise change the needle position.
Using a steady pressure, slowly depress the plunger rod to inject the entire dose. After completing the injection, 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, using a single handed technique:
Either by pressing the hinged section of the safety guard down onto a rigid surface; eg, table or by pushing the hinge forward with your forefinger making sure always to keep all fingers behind the needle tip.
An audible "click" confirms the proper activation of the safety mechanism.
Dispose of the vial and the syringe with needle immediately in a sharps container or other rigid closed disposal container.
Special precautions for disposal: Any unused product or waste material should be disposed of in accordance with local requirements.
Note: Sandostatin LAR must be kept out of the reach and sight of children.