STEP 2 – APPLY MIXJECT VIAL ADAPTER

Peel the cover away from the blister pack containing the vial adapter. Do not remove the vial adapter from the blister pack.

On a level surface, place the blister pack containing the vial adapter firmly on the vial top. Ensure the spike is centered and vertical when piercing the vial. Push down gently until you feel it snap into place.

Remove the blister pack from the vial adapter.

Ensure luer lock for needle connection is tight.

STEP 3 – PREPARE SYRINGE BARREL

(a) Screw the plunger rod into the gray stopper in the barrel end of the syringe.

Grasp the plastic ‘spin lock’ collar on the syringe barrel with index finger and thumb, unscrew and discard the gray rubber cap from the syringe barrel.

(b) Maintain your grip on the spin lock, ensuring that you have clear visibility of the connection. Attach the syringe to the vial adapter by screwing the spin lock clockwise into the opening on the side of the vial adapter. Gently twist the syringe until it stops turning to ensure a tight connection. (Overtightening can result in a poor connection and leakage)

STEP 4 – TRANSFER DILUENT TO VIAL

While keeping the syringe and vial securely coupled in an upright position, slowly push the plunger to transfer all of the diluent into the vial. Ensure that diluent rinses the sides of the vial.

Keep the plunger rod depressed and do not release the plunger rod.

STEP 5 – MIX TRELSTAR SUSPENSION

Keep the plunger rod depressed, grip the vial and vial adapter firmly and shake vigorously for 30 seconds to mix the contents thoroughly. This will ensure complete mixing of TRELSTAR and the sterile water diluent.

The suspension should appear homogeneous and milky. In order to avoid separation of the suspension, proceed to the next steps without delay. The product must be injected within less than 2 minutes from reconstitution.

Note: If there is sedimentation in the vial, shake again.

STEP 6 – LOAD THE SYRINGE WITH TRELSTAR

(a) Invert the MIXJECT system so that the vial is at the top.

Hold the MIXJECT system firmly by the luer lock connection and syringe barrel and pull back the plunger rod slowly to draw the reconstituted TRELSTAR into the syringe while maintaining pressure on the plunger.

(b) Rotate MIXJECT system so syringe is vertical. Remove air bubbles by expelling air into the vial but do not propel the suspension beyond the luer lock.

STEP 7 – DISCONNECT VIAL ADAPTER

Return the vial to its upright position.

Hold the barrel and luer lock firmly.

With your other hand, disconnect the vial adapter and vial from the MIXJECT syringe by grasping the plastic cap of the vial adapter and turning it clockwise.

Grasp only the vial adapter cap when removing.

STEP 8 – PREPARE NEEDLE FOR INJECTION

Make sure that the patient is ready for the administration.

Just prior to administration, perform at least 5 inversions with the syringe to resuspend the particles.

Lift up the safety cover and remove the clear plastic needle shield by pulling it from the assembly. The safety cover should be perpendicular to the needle, with the needle facing away from you. Do not prime the needle.

The syringe containing the TRELSTAR suspension is now ready for administration. The suspension should be administered immediately (less than 2 minutes) after reconstitution to avoid excessive thickening of the suspension.