Lutrate 3 month Depot 22.5 mg powder and solvent for prolonged-release suspension for injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Leuprorelin acetate

Available from:

GP-PHARM, S.A.

ATC code:

L02AE; L02AE02

INN (International Name):

Leuprorelin acetate

Dosage:

22.5 milligram(s)

Pharmaceutical form:

Powder and solvent for prolonged-release suspension for injection

Therapeutic area:

Gonadotropin releasing hormone analogues; leuprorelin

Authorization status:

Not marketed

Authorization date:

2015-07-17

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LUTRATE 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 ARE GIVEN 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 nurse.
-
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 nurse. This
includes any possible side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Lutrate 3 month Depot
is and what it is used for
2.
What you need to know before you are given Lutrate 3 month Depot
3.
How Lutrate 3 month Depot will be given to you
4.
Possible side effects
5.
How to store Lutrate 3 month Depot
6.
Contents of the pack and other information
1.
WHAT LUTRATE 3 MONTH DEPOT IS AND WHAT IT IS USED FOR
_ _
Lutrate 3 month Depot
contains the active ingredient leuprorelin acetate (also called
LEUPROLIDE
),
which belongs to a group of medicines called luteinizing hormone
releasing hormone (LHRH)
agonists (medicines that reduce testosterone – a sex hormone).
Lutrate 3 month Depot
is a vial
containing a white powder, which is made into a suspension for
injection into a muscle.
Your doctor has prescribed Lutrate 3 month Depot
for
_ _
the treatment of prostate cancer.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN LUTRATE 3 MONTH DEPOT
YOU SHOULD NOT BE GIVEN LUTRATE 3 MONTH DEPOT:
-
if you are allergic to leuprorelin acetate, LHRH agonists or any of
the other ingredients of this
medicine (listed in section 6). An allergic reaction may include rash,
itching, difficulty in
breathing or swelling of the face, lips, throat or tongue
-
if you have had an orchiectomy (removal of the testicles)
-
if you are female or a child
-
Lutrate 3 month Depot
must not be used alone for the treatmen

Summary of Product characteristics

Health Products Regulatory Authority
28 September 2022
CRN00D5WP
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lutrate 3 month Depot 22.5 mg 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.
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
(i) Metastatic prostate cancer.
(ii) Locally advanced prostate cancer, as an alternative to surgical
castration.
(iii) As an adjuvant treatment to radiotherapy in patients with
high-risk localised or locally advanced prostate cancer.
(iv) As an adjuvant treatment to radical prostatectomy in patients
with locally advanced prostate cancer at high risk of disease
progression.
(v) As neo-adjuvant treatment prior to radiotherapy in patients with
high-risk localised or locally advanced prostate cancer.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The usual recommended dose of Lutrate 3 month Depot is 22.5 mg
presented as a three months depot injection and
administered as a single intramuscular injection every three months.
The dose of Lutrate 3 month Depot 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
intramuscular injection every three months. Intraarterial or
intravenous administration must be avoided. The vial of Lutrate 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