ly after reconstitution. DO NOT INJECT Saizen® if the reconstituted product is cloudy immediately after reconstitution or refrigeration. Occasionally, after refrigeration, small colorless particles may be present in the Saizen® solution. This is not unusual for proteins like Saizen®.
Drug Preparation Instructions - click.easy cartridges
For drug preparation instructions for Saizen® click.easy® cartridges, please refer to the instructions for use provided with click.easy® reconstitution device.
STABILITY AND STORAGE
Before Reconstitution - Saizen® [somatropin (rDNA origin) for injection] should be stored at room temperature (15°-30°C/59°-86°F). Expiration dates are stated on the labels.
After Reconstitution - Saizen® 5 mg and 8.8 mg vials reconstituted with the Bacteriostatic Water for Injection, USP (0.9% Benzyl Alcohol) provided should be stored under refrigeration (2°–8°C/36°–46°F) for up to 14 days.
Saizen® 8.8 mg click.easy® cartridge reconstituted with the Sterile Water for Injection, (0.3% (w/v) metacresol) provided should be stored under refrigeration (2°–8°C/36°–46°F) for up to 21 days.
Avoid freezing reconstituted vials or cartridges of Saizen®.
HOW SUPPLIED
Saizen® can be administered using (1) a standard sterile disposable syringe and needle, (2) a compatible Saizen® needle-free injection device or (3) a compatible Saizen® needle injection device. For proper use, refer to the Instructions for Use provided with the administration device.
Saizen® [somatropin (rDNA origin) for injection] is a sterile, non pyrogenic, white, lyophilized powder supplied in packages containing:
1 vial of 5 mg Saizen® and 1 vial of 10 mL Bacteriostatic Water for Injection, USP (0.9% Benzyl Alcohol) NDC 44087-1005-2
1 vial of 8.8 mg Saizen® and 1 vial of 10 mL Bacteriostatic Water for Injection, USP (0.9% Benzyl Alcohol) NDC 44087-1088-1
1 click.easy® cartridge of 8.8 mg Saizen® and 1.51 mL Sterile Water for Injection 0.3% (w/v) metacresol in WFI NDC 44087-1080-1
Rx Only
June 2010
Manufactured for: EMD Serono, Inc., Rockland, MA 02370 USA
® - Registered trademark of EMD Serono, Inc., Rockland, MA 02370
N12Z0101F
click.easy® Reconstitution Device
Saizen® 8.8 mg
[somatropin (rDNA origin) for injection]
INSTRUCTIONS FOR USE
For complete dosing and safety information, please refer to the Saizen® [somatropin (rDNA origin) for injection] Package Insert.
COMPOSITION
Each vial of Saizen® 8.8 mg contained in 5.83 mg/mL the 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
