Eligard Caution For Usage

Incompatibilities: The leuprorelin present in syringe B must only be mixed with the solvent in syringe A and must not be mixed with other medicinal products.
Special precautions for disposal and other handling: Allow the product to come to room temperature by removing from the refrigerator approximately 30 minutes prior to use.
Prepare the patient for injection first, followed by the preparation of the product, using the instructions as follows. If the product is not prepared using the proper technique, it should not be administered, as lack of clinical efficacy may occur due to incorrect reconstitution of the product.
Step 1: Open both trays (tear off the foil from the corner which can be recognized by a small bubble) and empty the contents onto a clean field (two trays containing Syringe A and Syringe B). Discard the desiccant pouches.
Step 2: Pull out and do not unscrew the blue coloured short plunger rod together with the attached grey stopper from Syringe B and discard. Do not attempt to mix the product with two stoppers in place.
Step 3: Gently screw the Syringe B white plunger rod to the remaining grey stopper in Syringe B.
Step 4: Remove the grey rubber plug from Syringe B and put down the Syringe.
Step 5: Hold Syringe A in a vertical position to ensure no liquid leaks out and unscrew the clear cap from Syringe A.
Step 6: Join the two syringes together by pushing in and twisting Syringe B onto Syringe A until secure. Do not over tighten.
Step 7: Flip the connected unit over and continue to hold the syringes vertically with Syringe B on the bottom while injecting the liquid contents of Syringe A into Syringe B containing the powder (leuproreline acetate).
Step 8: Thoroughly mix the product by gently pushing the contents of both syringes back and forth between syringes (60 times in total, which takes approximately 60 seconds) in a horizontal position to obtain a homogenous, viscous solution. Do not bend the syringe system (note that this may cause leakage as it may partially unscrew the syringes).
When thoroughly mixed, the viscous solution will appear with a colour in the range of colourless to white to pale yellow (which could include shades of white to pale yellow).
Important: After mixing proceed with the next step immediately as the product gets more viscous over time. Do not refrigerate the mixed product.
Note: Product must be mixed as described; shaking WILL NOT provide adequate mixing of the product.
Step 9: Hold the syringes vertically with Syringe B on the bottom. The syringes should remain securely coupled. Draw the entire mixed product into Syringe B (wide syringe) by pushing down the Syringe A plunger and slightly withdrawing the Syringe B plunger.
Step 10: Twist off Syringe A while continuing to push down on the Syringe A plunger. Ensure that no product leaks out as the needle will then not secure properly when attached.
Note: one large or a few small air bubbles may remain in the formulation - this is acceptable. Do not purge the air bubbles from Syringe B at this stage as product may be lost.
Step 11: Hold Syringe B upright and hold back the white plunger to prevent loss of the product.
Open pack of the safety needle by peeling back paper tab and take out safety needle. Do not remove the hinged safety shield.
Secure the safety needle to Syringe B by holding the syringe and gently turning the needle clockwise with approximately a three-quarter turn until the needle is secure.
Do not over tighten as this may cause cracking of the needle hub resulting in leakage of the product during injection.
Should the needle hub crack, appear to be damaged, or have any leakage, the product should not be used. The damaged needle should not be substituted/replaced and the product should not be injected.
The entire product should be disposed of securely.
In the event of damage to the needle hub, a new replacement product should be used.
Step 12: Move the safety shield away from the needle and pull off the protective needle cap prior to administration.
Important: Do not operate the safety needle mechanism before administration.
Step 13: Prior to administration, purge any large air bubbles from Syringe B. Administer the product subcutaneously whilst keeping the safety shield away from the needle. Ensure that the full amount of the product in Syringe B is injected.
Step 14: After injection, lock the safety shield using any of the activation methods listed as follows.
1. Closure on a flat surface: Press the safety shield, lever side down, onto a flat surface to cover the needle and lock the shield.
Verify locked position through audible and tactile "click". Locked position will completely cover needle tip.
2. Closure with the thumb: Placing the thumb on safety shield, cover the needle tip and lock the shield.
Verify locked position through audible and tactile "click". Locked position will completely cover needle tip.
Step 15: Once safety shield is locked, immediately dispose of the needle and syringe in an approved sharps container.