Patients with a known sensitivity to any of the above active substances or excipients should avoid using this product.

PHARMACEUTICAL FORM

Powder and diluent for solution for injection: Powder and diluent (0.3% (w/v) metacresol in water for injection) for parenteral use.

METHOD AND ROUTE OF ADMINISTRATION

The product (powder in vials) must be reconstituted with the enclosed diluent (0.3% (w/v) metacresol in water for injection) using the click.easy® reconstitution device.

The reconstituted solution is intended for subcutaneous administration (under the skin) and should be clear with no particles. If the solution contains particles, it must not be injected.

IMPORTANT INFORMATION

Patients should be thoroughly instructed in the reconstitution procedure.

For young children, the reconstitution process should be supervised by an adult.

For administration of Saizen® 8.8 mg contained in the click.easy® device, please read the following instructions carefully. Please consult your doctor, nurse or pharmacist if you have any questions concerning the reconstitution process.

Check that the click.easy® reconstitution device contains an unused Saizen® vial (a) and an unused diluent cartridge (c).

Do NOT use the device if the vial or cartridge appear empty or used and return it to your pharmacist or doctor.

Wash your hands with soap and water.

HOW TO PREPARE YOUR SOLUTION OF SAIZEN®

Place the click.easy® device vertically on a clean flat surface with the Saizen® vial on the bottom and the diluent cartridge outer housing cap (g) on top facing upward.
Push on the top diluent cartridge outer housing cap (g) firmly until the Saizen® vial outer housing (h) is completely inside the main body. This step breaks the tamper evident seal on the vial.
Turn the diluent cartridge outer housing cap (g) clockwise until the green square (f) is visible at the lower end of the narrow rectangular opening.  Push the diluent cartridge outer housing cap down very slowly until it will go no further and the green colored square appears at the upper end of the narrow rectangular opening.
Check that all the diluent has been transferred into the vial. Dissolve the Saizen® powder with the diluent by gently swirling the click.easy® device (Note: Do not transfer the diluent forcefully or shake the click.easy® device. A fast transfer of the diluent or shaking of the click.easy® device will create more foam). Let the solution stand for 2-5 minutes until the Saizen® powder is completely dissolved.
Turn the click.easy® device upside down so the Saizen® vial is now on top and pull the diluent cartridge outer housing cap slowly downwards until the solution is completely drawn back into the cartridge. Check that no more than one or two drops of solution remain in the vial.
If there are more than one or two drops of solution remaining in the vial, slowly push the diluent cartridge outer housing cap up until some of the solution is back in the vial and gently tap the click.easy® device. Then draw the solution slowly again back into the cartridge.
Remove any excess air that has been drawn into the cartridge by slowly pushing the cap up until no air bubble is visible in the cartridge. There should be no air bubble in the cartridge (Note: Avoid pulling the cap down too fast, as this will draw air into the cartridge).
Turn the click.easy® device so that the cap is a