A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Eligard Indications, Dosage, Storage, Stability - Leuprolide acetate
Eligard Indications, Dosage, Storage, Stability - Leuprolide acetate
INDICATIONS
AND USAGE
ELIGARD™ 7.5 mg is indicated for the palliative treatment
of advanced prostate cancer.
DOSAGE AND ADMINISTRATION
The recommended dose of ELIGARD™ 7.5 mg is one injection
every month. The injection delivers 7.5 mg of leuprolide acetate, incorporated
in a polymer formulation. It is administered subcutaneously and provides continuous
release of leuprolide for one month.
Once mixed, ELIGARD™ 7.5 mg should be discarded if not
administered within 30 minutes.
As with other drugs administered by subcutaneous injection,
the injection site should vary periodically.
Mixing Procedure
IMPORTANT: Allow the product to reach room temperature
before using. Once mixed, the product must be administered within 30 minutes.
Follow the instructions as directed to ensure proper preparation
of ELIGARD™ 7.5 mg prior to administration:
ELIGARD™ 7.5 mg is packaged in a pouch that contains
two smaller pouches (Figure 3), a needle cartridge and a desiccant pack (Figure
4). Syringe A pouch contains the sterile Syringe A pre-filled with the ATRIGEL®
polymer system and a long white replacement plunger rod (Figure 5). Syringe
B pouch contains the sterile Syringe B pre-filled with leuprolide acetate powder
(Figure 6).
HOW SUPPLIED
ELIGARD™ 7.5 mg is available in a single use kit. The
kit consists of a two-syringe mixing system, a 20-gauge half-inch needle, a
silicone desiccant pouch to control moisture uptake, and 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™ 7.5 mg is administered as a single
dose.
(NDC xxxxx-xxx-xx)
Store at 2 - 8 °C (36 – 46 °F)
Atrix Laboratories, Inc. Fort Collins, CO 80521
04XXXX, Rev 0 1/02
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