click.easy® Reconstitution Device
Saizen® 8.8 mg
[somatropin (rDNA origin) for injection]
INSTRUCTIONS FOR USE
- Patient Information:
Details with Side Effects
For complete dosing and safety information, please refer to the Saizen® [somatropin (rDNA origin) for injection] Package Insert.
Each vial of Saizen® 8.8 mg contained in the 5.83 mg/mL click.easy® device contains the following ingredients:
- Active substance: Somatropin (Recombinant Human Growth Hormone) 8.8 mg.
- Excipients: Sucrose, Phosphoric acid, Sodium Hydroxide; 1 mL of the reconstituted Saizen® solution contains 5.83 mg of somatropin when reconstituted with the contents of the diluent cartridge.
COMPOSITION OF DILUENT
Each cartridge of diluent contained in the click.easy® reconstitution device contains the following ingredients:
5.83 mg/mL click.easy®
Active substance: Metacresol USP (4.52 mg),
Excipients: Phosphoric acid 85% to adjust pH, Water for Injection, USP (1.51 mL)
Patients with a known sensitivity to any of the above active substances or excipients should avoid using this product.
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.
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®
1. 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.
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.
7. 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).
8. Turn the click.easy® device so that the cap is again on the top. Unscrew the cap and remove it.
9. Remove the cartridge containing the reconstituted Saizen® solution from the click.easy® device by grasping the end of the cartridge and pulling straight out of the outer housing.
10. Carefully peel off the outer white label on the cartridge using the tab provided by slowly pulling in the direction of the black arrow
11. Write the reconstitution date on the transparent inner label on the cartridge. This cartridge now contains the reconstituted Saizen® solution that will be used for your treatment.
12. The cartridge containing the reconstituted Saizen® solution is now ready to be used (Note: Please read the instruction manual provided with the injection device for instruction on how to inject the reconstituted Saizen® solution from the cartridge).
13. The Saizen® reconstituted solution should be stored in a refrigerator (2°-8°C / 36°-46°F) and should be used within 21 days after reconstitution. Do not freeze.
14. Discard the click.easy® device containing the empty Saizen® vial safely in accordance with your local requirements. It is not necessary to remove the empty Saizen® vial from the click.easy® device prior to disposal.
15. Injections should be given in different parts of your body. Do not use any areas in which you feel lumps, firm knots, depressions, or pain; talk to your doctor or healthcare professional about anything you find. Clean the skin at the injection site with soap and water.
STABILITY AND STORAGE
Vials of Saizen® 8.8 mg pre-assembled in the click.easy® reconstitution device should be stored in the original package at room temperature (15°-30°C / 59°-86°F).
Saizen® 8.8 mg reconstituted solution should be stored in a refrigerator (2°-8°C / 36°-46°F) and should be used within 21 days after reconstitution.
Do not freeze.
Saizen® 8.8 mg contained in the click.easy® device is available in the following pack sizes:
1 vial of Saizen® 8.8 mg product and 1 cartridge of 1.51 mL diluent pre-assembled in 1 reconstitution device (click.easy®) comprising 1 device housing and 1 sterile transfer cannula NDC 44087-1080-1.
Last reviewed on RxList: 4/16/2012
This monograph has been modified to include the generic and brand name in many instances.
Additional Saizen Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.