ixing of the product.
6.Hold the syringes vertically with Syringe B on the bottom. The syringes should remain securely coupled. Draw the entire mixed product into Syringe B (short, wide syringe) by depressing the Syringe A plunger and slightly withdrawing the Syringe B plunger. Uncouple Syringe A while continuing to push down on the Syringe A plunger (Figure 15). Note: Small air bubbles will remain in the formulation – this is acceptable.
7.Hold Syringe B upright. Remove the cap on the bottom of the sterile needle cartridge by twisting it (Figure 16). Attach the needle cartridge to the end of Syringe B (Figure 17) by pushing in and turning the needle until it is firmly seated. Do not twist the needle onto the syringe until it is stripped. Pull off the clear needle cartridge cover prior to administration (Figure 18).
Administration Procedure
IMPORTANT: Allow the product to reach room temperature before using. Once mixed, the product must be administered within 30 minutes.
Choose an injection site on the abdomen, upper buttocks, or anywhere with adequate amounts of subcutaneous tissue that does not have excessive pigment, nodules, lesions, or hair. Since you can vary the injection site with a subcutaneous injection, choose an area that hasn't recently been used.
Cleanse the injection-site area with an alcohol swab.
Using the thumb and forefinger of your nondominant hand, grab and bunch the area of skin around the injection site.
Using your dominant hand, insert the needle quickly at a 90° angle. The approximate angle you use will depend on the amount and fullness of the subcutaneous tissue and the length of the needle. After the needle is inserted, release the skin with your nondominant hand.
Inject the drug using a slow, steady push. Press down on the plunger until the syringe is empty.
Withdraw the needle quickly at the same angle used for insertion.
Discard all components safely in an appropriate biohazard container.
HOW SUPPLIED
ELIGARD® is available in a single use kit. The kit consists of a two-syringe mixing system, a sterile needle (Table 9), a silicone desiccant pouch to control moisture uptake, and a package insert for constitution and administration procedures. Each syringe is individually packaged. One contains the ATRIGEL® Delivery System and the other contains leuprolide acetate. When constituted, ELIGARD® is administered as a single dose.
Table 9. ELIGARD® Needle specifications ELIGARD® formulation Gauge Length
7.5 mg 20-gauge ½-inch
22.5 mg 20-gauge ½-inch
30 mg 20-gauge 5/8-inch
45 mg 18-gauge 5/8-inch
ELIGARD® 7.5 mg – NDC 0024-0793-75
ELIGARD® 22.5 mg – NDC 0024-0222-05
ELIGARD® 30 mg – NDC 0024-0610-30
ELIGARD® 45 mg – NDC 0024-0605-45
Store at 2 – 8 °C (35.6 – 46.4 °F)
Manufactured by: TOLMAR, Inc.
Fort Collins, CO 80526
for: TOLMAR Therapeutics, Inc.
Fort Collins, CO 80526
Distributed by: sanofi-aventis U.S. LLC
Bridgewater, NJ 08807
44380, Rev 1 11/09 Revised 11/2009
PRINCIPAL DISPLAY PANEL - 7.5 mg Carton
E-907
NDC 0024-0793-75
Eligard® 7.5 mg
leuprolide acetate for
injectable suspension
7.5 mg Every month
Sterile
For subcutaneous injection
Must be constituted before use
Store refrigerated 2 to 8°C
(36 to 46°F)
Rx Only
sanofi aventis
PRINCIPAL DISPLAY PANEL - 7
