Leuprorelin 3-month Depot 22.5mg Powder and Solvent for Prolonged-release Suspension for Injection

Land: Ierland

Taal: Engels

Bron: HPRA (Health Products Regulatory Authority)

Werkstoffen:

LEUPRORELIN ACETATE

Beschikbaar vanaf:

GP-PHARM, S.A.

ATC-code:

L02AE; L02AE02

INN (Algemene Internationale Benaming):

LEUPRORELIN ACETATE

Dosering:

22.5 milligram(s)

farmaceutische vorm:

Pdr+Solv for PR for Susp for Inj

Toedieningsweg:

Intramuscular injection

Eenheden in pakket:

Kit including: 1 vial, 1 prefilled syringe, 1 sterile needle

Prescription-type:

Product subject to prescription which may not be renewed (A)

Geproduceerd door:

GP-PHARM, S.A.

Therapeutische categorie:

Endocrine therapy. Hormones and related agents. Gonadotropin-releasing hormones

Therapeutisch gebied:

Gonadotropin releasing hormone analogues; leuprorelin

therapeutische indicaties:

It is indicated for palliative treatment of hormone dependent advanced prostate cancer.

Autorisatie-status:

Not marketed

Autorisatie datum:

2015-06-19

Bijsluiter

LUTRATE DEPOT 22.5 MG
MODULE 1
SECTION 1.3.1
PAGE 1/11
Lut(3m)-ie-pl-v03-Var PRAC-clean-Ago2018
PACKAGE LEAFLET: INFORMATION FOR THE USER
LEUPRORELIN 3-MONTH DEPOT 22.5 MG POWDER AND SOLVENT FOR
PROLONGED-RELEASE
SUSPENSION FOR INJECTION
leuprorelin acetate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm
them, even if their signs of illness are the same as yours.
-
If you get any side effects talk to your doctor or pharmacist. This
includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Leuprorelin 3-month Depot is and what it is used for
2.
What you need to know before you use Leuprorelin 3-month Depot
3.
How to use Leuprorelin 3-month Depot
4.
Possible side effects
5.
How to store Leuprorelin 3-month Depot
6.
Contents of the pack and other information
1.
WHAT LEUPRORELIN 3-MONTH DEPOT IS AND WHAT IT IS USED FOR
_ _
Leuprorelin 3-month Depot is a vial containing a white powder, which
is made into a
suspension for injection into a muscle. Leuprorelin 3-month Depot
contains the active
ingredient leuprorelin (also called LEUPROLIDE), which belongs to a
group of medicines called
luteinizing hormone releasing hormone (LHRH) agonists (medicines that
reduce testosterone
– a sex hormone).
Your doctor has prescribed Leuprorelin 3-month Depot for_ _palliative
treatment of advanced
prostate cancer.
LUTRATE DEPOT 22.5 MG
MODULE 1
SECTION 1.3.1
PAGE 2/11
Lut(3m)-ie-pl-v03-Var PRAC-clean-Ago2018
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE LEUPRORELIN 3-MONTH DEPOT
DO NOT USE LEUPRORELIN 3-MONTH DEPOT:
-
if
you
are
allergic
(hypersensitive)
to
LHRH,
LHRH
agonists
or
any
of
the
other
ingredients of this medicine (listed in section 6). An allergic
reaction may include rash,
itching, difficulty of

Productkenmerken

Health Products Regulatory Authority
24 January 2019
CRN008VHS
Page 1 of 17
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Leuprorelin 3-month Depot 22.5mg Powder and Solvent for
Prolonged-release
Suspension for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 22.5 mg of leuprorelin acetate (equivalent to 21.42
mg leuprorelin
free base).
1 mL of reconstituted suspension contains 11.25 mg of leuprorelin
acetate.
_Excipients with known effect:_
Each vial contains from 1.6 to 2.7 mg (<1 mmol) of sodium (as
carmellose sodium).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder and solvent for prolonged-release suspension for injection.
Powder: white to off-white powder.
Solvent: clear, colorless and particle free solution (pH 5.0 – 7.0).
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Leuprorelin 3-month Depot is indicated for palliative treatment of
hormone
dependent advanced prostate cancer.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The usual recommended dose of Leuprorelin 3-month Depot is 22.5 mg
presented as
a three months depot injection and administered as a single
intramuscular injection
every three months.
Leuprorelin 3-month Depot must be administered under direction of
healthcare
professional having the appropriate expertise for monitoring the
response to
treatment.
The dose of Leuprorelin 3-month Depot 22.5 mg allowing the continuous
release of
leuprorelin acetate over a three month period is incorporated in a
depot formulation.
The lyophilized powder should be reconstituted and administered as a
single
Health Products Regulatory Authority
24 January 2019
CRN008VHS
Page 2 of 17
intramuscular injection every three months. Intraarterial or
intravenous
administration must be avoided. The vial of Leuprorelin 3-month Depot
microsphere
powder should be reconstituted immediately prior to administration by
intramuscular injection. As with other drugs administered regularly by
injection, the
injection site should be varied periodi