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MIXING AND PREPARING SANDOSTATIN® LAR®

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A convenient formulation of Sandostatin® LAR® created to simplify preparation and administration is available in some countries. Please select mixing and preparation instructions applicable to your area. If you are unsure, contact your local Novartis affiliate to find out which formulation is available in your area.

 

Updated formulation kit

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

The kit includes:

Updated 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 the updated formulation of 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:

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

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.

Original formulation kit

The original kit may come with a safety needle and comes without a vial adapter.

Kits with a safety needle contain:

Original formulation kit with a safety needle

  1. 5-mL glass vial containing Sandostatin® LAR®
  2. Prefilled glass syringe containing diluent
  3. One needle (40 mm [1.5 inch], 19 gauge)
  4. One safety injection needle (40 mm [1.5 inch], 19 gauge)

Kits without a safety needle contain:

Original formulation kit without a safety needle

  1. 5-mL glass vial containing Sandostatin® LAR®
  2. Prefilled glass syringe containing diluent
  3. Two needles (40 mm [1.5 inch], 19 gauge)

Mixing and preparing the original formulation of 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 

Step 1

Step 1: Sandostatin® LAR® Mixing and preparing the original formulation

  1. Allow Sandostatin® LAR® vial and vehicle syringe to reach room temperature
  2. Remove cap from vial and assure that powder is settled at bottom of vial by lightly tapping vial

Note: Failure to tap vial before injecting vehicle increases risk of clogging.

Step 2

Step 2: Sandostatin® LAR® Mixing and preparing the original formulation

  1. Remove cap from vehicle syringe and attach one of the supplied
    needles—use only 1.1-mm diameter, 19-gauge needles

Note: Do not directly inject vehicle without preparing vial.

Step 3

Step 3: Sandostatin® LAR® Mixing and preparing the original formulation

  1. Disinfect vial's rubber stopper with alcohol swab and insert needle through center
  2. Without disturbing powder, gently inject vehicle into vial by running vehicle down inside wall of vial

Note: Do not inject vehicle directly into powder.

Step 4

Step 4: Sandostatin® LAR® Mixing and preparing the original formulation

  1. Do not disturb vial until vehicle has totally wetted powder (at least 2 to 5 minutes)
  2. Without inverting vial, check sides and bottom of vial for dry spots
  3. If dry spots exist, allow undisturbed wetting to continue

Note: Powder must be completely wetted before proceeding.

Step 5

Step 5: Sandostatin® LAR® Mixing and preparing the original formulation

  1. Once complete wetting has occurred, vial should be moderately swirled for 30 to 60 seconds until a milky, uniform suspension is achieved

Note: Do not invert or shake vial vigorously, as this can cause lumps to form.

Step 6

Step 6: Sandostatin® LAR® Mixing and preparing the original formulation

  1. Immediately reinsert needle through rubber stopper and then—with bevel down and vial tipped at a 45° angle (as shown in diagram)—slowly draw contents of vial into syringe
  2. Some residual suspension will remain—vial contains a calculated overfill

Note: Never invert vial, as this can affect the dose.

Step 7

Step 7: Sandostatin<sup>®</sup> LAR<sup>®</sup> Mixing and preparing the original formulation

  1. Discard first needle and attach second supplied needle and administer immediately after suspension preparation

These preparation instructions may be more detailed than those approved in your country.