Saizen Caution For Usage

Incompatibilities: Solution for injection/Powder for injection 8 mg click.easy vial: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Powder for injection 3.33 mg vial: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products except those mentioned in Instructions for use/handling as previously mentioned.
Special precautions for disposal and other handling: Solution for injection: The cartridge containing the solution of Saizen Liquid is for use only with the easypod auto-injector or the aluetta pen injector. For storage of injectors containing a cartridge, see Storage.
The aluetta pen injectors and Saizen cartridges are available in several presentations. Each aluetta pen injector is colour coded and must only be used with the matching colour coded Saizen cartridge to give the correct dose. The aluetta pen injector 6 (blue) must be used with the cartridge containing 6 mg somatropin (blue). The aluetta pen injector 12 (red) must be used with the cartridge containing 12 mg somatropin (red). The aluetta pen injector 20 (yellow) must be used with the cartridge containing 20 mg somatropin (yellow). The solution for injection should be clear to slightly opalescent with no particles and without visible signs of deterioration. If the solution contains particles, it must not be injected.
Any unused product or waste material should be disposed of in accordance with local requirements.
Powder for injection 3.33 mg vial: To reconstitute Saizen, inject 5 ml of the bacteriostatic solvent into the vial of Saizen 3.33 mg aiming the liquid against the glass wall. Swirl the vial with a gentle rotary motion until the content is dissolved completely. Avoid vigorous shaking. Discard any unused solvent.
Benzyl alcohol as a preservative in bacteriostatic sodium chloride solution may cause toxic reactions and anaphylactoid reactions in infants and children up to 3 years old and must not be given to premature babies or neonates. Saizen may be reconstituted with Sodium Chloride Injection BP or Sterile Water for Injections for immediate use when administering to children under 3 years of age.
Any unused product or waste material should be disposed of in accordance with local requirements.
Powder for injection 8 mg click.easy vial: The cartridge containing the reconstituted solution of Saizen 8 mg click.easy is for use only with the one. click auto-injector, the cool.click needle-free autoinjectors, or the easypod auto-injector.
For storage of the auto-injectors containing the cartridge, see Storage. The reconstituted solution for injection should be clear with no particles. If the solution contains particles, it must not be injected.
Any unused product or waste material should be disposed of in accordance with local requirements.
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 mg click.easy please read the following instructions carefully.
When the medicine is injected into the same place every time for a long time, it can cause damage. It is important to keep changing the place where the patient has the injection. The doctor or pharmacist can speak about which part of the body the patient should use. Do not use any areas in which the patient feels lumps, firm knots, depressions, or pain; talk to the doctor or pharmacist about anything the patient finds. Clean the skin at the injection site with soap and water.
A separate leaflet gives the patient detailed instructions in pictures about how to use this reconstituted kits.
Please consult the doctor or pharmacist, if the patient has any questions concerning the reconstitution process.
How to prepare the solution of Saizen 8 mg click.easy: Make sure the click.easy is complete by checking that the Saizen vial, the sterile transfer cannula and the solvent cartridge are present.
Check that the tamper evident seals on the click.easy housing and on the cap are not broken. If either of the tamper evident seals are broken return it to the pharmacist or doctor.
Place all elements needed for the preparation of the solution on a clean surface.
Wash the hands with soap and water.
1. Place the click.easy reconstitution device vertically on a flat surface with the vial at the bottom and the cap facing upward.
2. Push the cap down until it will go no further. (Note: The tamper evident seal on the click.easy housing is now broken).
3. Turn slightly the cap clockwise until the green button is positioned in the vertical opening.
4. Continue pushing the cap down very slowly until it will go no 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.
5. Dissolve the powder with the solvent by gently swirling the click.easy (Please note that the patient should not shake the solution strongly or the solution will foam). Avoid vigorous shaking to prevent creation of foam. Let the solution stand until the powder is completely dissolved. If the solution contains particles, it must not be injected. Push the cap back down until it will go no further and keep it in position.
6. Turn the click.easy so that the vial is at the top and 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.
7. 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).
8. 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.
9. 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 the local requirements.
The cartridge containing the reconstituted solution of Saizen is now ready to be used for administration with the one.click auto-injector, Easypod auto-injector or cool.click needle-free auto-injector.
The reconstituted solution for injection should be clear with no particles. If the solution contains particles, it must not be injected.
How to perform the daily self-administration of Saizen: For instructions on how to load the cartridge into the one.click auto-injector, Easypod auto-injector or how to use the cool.click needle-free auto-injector and inject the reconstituted solution of Saizen, please carefully read the corresponding instruction manual with each auto-injector. Use of the devices by children should always be made under adult's supervision.