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 Saizen Click Easy ® Pen - Manufacturer's Insert

Saizen Click Easy ® PEN

Click Easy replaces the One Click pen

Click here for diagrams illustrating the usage procedure.

  One vial of SAIZEN and cartridge of solvent pre-assembled in a reconstitution device, click easy®: using a one click® auto-injector or cool click® needle-free auto injector

 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 mg click.easy® please read the following instructions carefully.

 • Make sure the click.easy is complete by checking that the Saizen vial (a), the sterile transfer cannula (b) and the solvent cartridge (c) are present.

• Check that the tamper evident seals on the click.easy housing (d) and on the cap (e) are not broken. If either of the tamper evident seals are broken return it to your pharmacist or doctor.

• Place all elements needed for the preparation of the solution on a clean surface.

• Wash your hands with soap and water.

 

How to prepare your solution of Saizen 8 mg click.easy:

5. Place the click.easy reconstitution device vertically on a flat surface with the vial at the bottom and the cap (g) facing upward.

6. Push the cap down until it will go no further. (Note: The tamper evident seal on the click.easy housing is now broken).

7. Turn slightly the cap clockwise until the green button (f) is positioned in the vertical opening.

8. Continue pushing the cap down very slowly until it will go not further to transfer the solvent from the cartridge into the vial (Note: The tamper evident seal on the cap is now broken). It is important to push slowly to prevent foam to appear in the vial. Check that all the solvent has been transferred into the vial.

9. Dissolve the powder with the solvent by gently swirling the click.easy (Note: Avoid vigorous shaking to prevent creation of foam). Let the solution stand until the powder is completely dissolved.

10. Turn the click.easy upside down (vial on top). Push the cap up until it will go no further and subsequently pull the 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 cap up until some of the solution is back in the vial and gently tap the click.easy. Then draw the solution slowly again back into the cartridge. Remove any excess air that has been drawn into the cartridge by pushing slowly the cap up until no air is visible in the cartridge. (Note: Avoid pulling the cap down too fast, as this will draw air into the cartridge).

11. Keeping the click.easy in this position (vial on the top) unscrew the cap and remove it. Still keeping the same position (vial on the top) remove the cartridge containing the reconstituted solution for injection from the click.easy.

12. Carefully peel off the outer label using the tab provided. Write the reconstitution date on the transparent inner label on the cartridge.

Discard the click.easy safely in accordance with your local requirements.

The cartridge containing the reconstituted solution of Saizen is now ready to be used for administration with your one.click auto-injector or cool.click needle-free auto-injector.

Please refer to the one.click® or cool.click® Instruction Manuals on how to use the one.click® or cool.click® device.

The above information is the translation of the manufacturer's insert. It is provided under the supplying company's terms and conditions and should not replace the advice of your personal physician.
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