Eligard 3 Month

Land: Nieuw-Zeeland

Taal: Engels

Bron: Medsafe (Medicines Safety Authority)

Werkstoffen:

Leuprorelin acetate 22.5mg (includes 28.2mg leuprorelin acetate to deliver 22.5mg leuprorelin);  ;  ; Leuprorelin acetate 22.5mg (includes 29.2mg leuprorelin acetate to deliver 22.5mg leuprorelin)

Beschikbaar vanaf:

Mundipharma New Zealand Ltd

INN (Algemene Internationale Benaming):

Leuprorelin acetate 22.5 mg (includes 28.2mg leuprorelin acetate to deliver 22.5mg leuprorelin)

Dosering:

22.5 mg

farmaceutische vorm:

Injection with diluent

Samenstelling:

Active: Leuprorelin acetate 22.5mg (includes 28.2mg leuprorelin acetate to deliver 22.5mg leuprorelin)     Excipient: N-Methyl-2-pyrrolidone Polyglactin Active: Leuprorelin acetate 22.5mg (includes 29.2mg leuprorelin acetate to deliver 22.5mg leuprorelin) Excipient: N-Methyl-2-pyrrolidone Polyglactin

Eenheden in pakket:

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

klasse:

Prescription

Prescription-type:

Prescription

Geproduceerd door:

Hemmo Pharmaceuticals Pvt. Ltd.

therapeutische indicaties:

indicated for the palliative treatment of advanced prostate cancer.

Product samenvatting:

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 -  

Autorisatie datum:

2003-10-22

Productkenmerken

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