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MIXING AND PREPARING SANDOSTATIN® LAR®

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Sandostatin® LAR® should only be administered by a trained healthcare professional and may only be administered by deep intramuscular injection. For more information on mixing and preparation instructions, contact your local Novartis affiliate.

The formulation kit comes with both a vial adapter and safety needle.

The kit includes:

formulation kit

  1. One vial containing Sandostatin® LAR® powder
  2. One prefilled syringe containing the vehicle solution for reconstitution
  3. One vial adapter for drug product reconstitution
  4. One safety injection needle

Preparing and mixing Sandostatin® LAR®

Guaranteed administration by a healthcare professional: Helps ensure control of patients' therapy
• Helps a patient receive the right dose at the right time, using the right technique 

Preparation:

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

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 (20°-25°C). 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

Step 2: Sandostatin® LAR® Preparation

  • Remove the plastic cap from the vial and clean the rubber stopper of the vial with an alcohol wipe.

Step 2: Sandostatin® LAR® Preparation

  • 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

Step 3: Sandostatin® LAR® Preparation

  • 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

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.

 

Mixing

Step 5

Step 5: Sandostatin® LAR® Mixing

  • 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

Step 6: Sandostatin® LAR® Mixing

  • 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

Step 7: Sandostatin® LAR® Mixing

  • Screw the safety injection needle onto the syringe.
  • If immediate administration is delayed, gently re-shake the syringe to ensure a milky uniform suspension.
  • Prepare injection site with an alcohol wipe.
  • Pull the protective cover straight off the needle.
  • Gently tap the syringe to remove any visible bubbles and expel them from the syringe.
  • Proceed immediately to administration. Any delay may result in sedimentation.