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.

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).
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.
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.
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.

HOW SUPPLIED

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

Manufactured for:
EMD Serono Inc., Rockland, MA 02370
Rx Only BX Rated

June 2010

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SAIZEN 
somatropin   kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 44087-1005
 
Packaging
# NDC Package Description Multilevel Packaging
1 44087-1005-2 1 KIT In 1 CARTON None
 
QUANTITY OF PARTS
Part # Package Quantity Total Product Quantity
Part 1 1 VIAL, GLASS    1 mL
Part 2 1 VIAL, GLASS    10 mL
 
Part 1 of 2
SAIZEN 
somatropin   injection, powder, lyophilized, for solution
 
Product Information

Route of Administration SUBCUTANEOUS, INTRAMUSCULAR DEA Schedule      
 
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SOMATROPIN (SOMATROPIN)  SOMATROPIN 5 mg  in 1 mL
 
Inactive Ingredients
Ingredient Name Strength
SUCROSE 34.2 mg  in 1 mL
PHOSPHORIC ACID 1.16 mg  in 1 mL
 
Product Characteristics
Color &nb