Eligard 4 Month

国: ニュージーランド

言語: 英語

ソース: Medsafe (Medicines Safety Authority)

有効成分:

Leuprorelin acetate 30mg (includes 35.8mg leuprorelin acetate to deliver 30mg leuprorelin);  ;  ; Leuprorelin acetate 30mg (includes 37.2mg leuprorelin acetate to deliver 30mg leuprorelin)

から入手可能:

Mundipharma New Zealand Ltd

INN（国際名）:

Leuprorelin acetate 30 mg (includes 35.8mg leuprorelin acetate to deliver 30mg leuprorelin)

投薬量:

30 mg

医薬品形態:

Injection with diluent

構図:

Active: Leuprorelin acetate 30mg (includes 35.8mg leuprorelin acetate to deliver 30mg leuprorelin)     Excipient: N-Methyl-2-pyrrolidone Polyglactin Active: Leuprorelin acetate 30mg (includes 37.2mg leuprorelin acetate to deliver 30mg leuprorelin) Excipient: N-Methyl-2-pyrrolidone Polyglactin

パッケージ内のユニット:

Syringe, Kit (Syringe A & B, replacement plunger+needle), 1 dose unit

クラス:

Prescription

処方タイプ:

Prescription

製:

Hemmo Pharmaceuticals Pvt. Ltd.

適応症:

indicated for the palliative treatment of advanced prostate cancer.

製品概要:

Package - Contents - Shelf Life: Syringe, Kit (Syringe A & B, replacement plunger+needle) - 1 dose units - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 8 weeks not refrigerated stored at or below 25°C 30 minutes reconstituted stored at or below 25°C - Syringe, PP syringe A - 1 dose units -   - Syringe, PP syringe B - 1 dose units -  

承認日:

2003-10-22

製品の特徴

Data Sheet
Version 9.0
1
ELIGARD
®
NAME OF THE MEDICINE
Leuprorelin
acetate
CAS: 74381-53-6
DESCRIPTION
Eligard
®
is a sterile polymeric matrix formulation of leuprorelin acetate for
subcutaneous injection. It
is designed to deliver leuprorelin acetate at a controlled rate over a
therapeutic period.
Leuprorelin acetate is a synthetic nonapeptide analogue of naturally
occurring gonadotropin releasing
hormone (GnRH or LH-RH) that, when given continuously, inhibits
pituitary gonadotropin secretion
and suppresses testicular steroidogenesis.
The analogue possesses greater potency than the natural
hormone. The chemical name is
5-oxo-L-prolyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-D-leucyl-
L-leucyl-L-arginyl-N-ethyl-L-prolinamide acetate (salt).
COMPOSITION
Eligard
®
is available in a single use kit. The kit consists of a two-syringe
mixing system, a 20-gauge
5/8 inch needle (for Eligard
®
1 month and Eligard
®
3 month and Eligard® 4 month) or a or a 18-gauge
5/8-inch needle (for Eligard
®
6 month), 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
leuprorelin acetate.
Eligard
®
is prefilled and supplied in two separate, sterile syringes whose
contents are mixed
immediately prior to administration. The two syringes are joined and
the single dose product is
mixed
until it is homogenous. Eligard
®
is administered subcutaneously where it forms a solid drug
delivery
depot.
The Atrigel
®
Delivery System is a polymeric (non-gelatin containing) delivery
system consisting of a
biodegradable polyglactin. The
polymer
is dissolved
in
a
biocompatible solvent,
_N_
-methyl-2-
pyrrolidone. The polyglactin mixture and volume differ with each
presentation of Eligard
®
.
Data Sheet
Version 9.0
2
Eligard
®
contains no anti-microbial agent Eligard
®
does not contain: lactose, sucrose, gluten, tartrazine, or
any other azo dyes.
Eligard
®
1 month co