Lutrate 1 month Depot 3.75 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:

3.75 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 1 MONTH DEPOT 3.75 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 1 month Depot is and what it is used for
2.
What you need to know before you are given Lutrate 1 month Depot
3.
How Lutrate 1 month Depot will be given to you
4.
Possible side effects
5.
How to store Lutrate 1 month Depot
6.
Contents of the pack and other information
1.
WHAT LUTRATE 1 MONTH DEPOT IS AND WHAT IT IS USED FOR
_ _
Lutrate 1 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 and estradiol – sex
hormones). Lutrate 1 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 1 month Depot for:
•
Treatment of prostate cancer in men
•
Treatment of early-stage breast cancer in pre and perimenopausal women
at higher risk of
recurrence.
•
Treatment of hormone responsive advanced breast cancer in pre and
perimenopausal women.
•
Treatment of endometriosis and uterine fibroids.
•
Preservation of ovarian function in pre-menopausal women with cancer
who are having
chemotherapy.
USE IN CHILDREN:
Lutrate 1 month Depot is a synthetic hormone which can be used to
reduce the levels of testosterone
and estrogen circulating in

Summary of Product characteristics

Health Products Regulatory Authority
28 September 2022
CRN00D5WP
Page 1 of 22
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lutrate 1 month Depot 3.75 mg powder and solvent for prolonged-release
suspension for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 3.75 mg of leuprorelin acetate (equivalent to 3.57
mg leuprorelin free base).
1 ml of reconstituted suspension contains 1.875 mg of leuprorelin
acetate.
For the full list of excipients, see SECTION 6.1.
3 PHARMACEUTICAL FORM
Each vial contains 3.75 mg of leuprorelin acetate (equivalent to 3.57
mg leuprorelin free base).
1 ml of reconstituted suspension contains 1.875 mg of leuprorelin
acetate.
For the full list of excipients, see SECTION 6.1.
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.
(vi) Management of estrogen dependant gynaecological disorders
including the management of pain and lesions associated
with endometriosis.
(vii) Preoperative management of uterine fibroids to reduce their size
and associated bleeding.
(viii) As treatment in pre- and perimenopausal women with advanced
breast cancer suitable for hormonal manipulation.
(ix) As adjuvant treatment in combination with tamoxifen or an
aromatase inhibitor, of endocrine responsive early stage breast
cancer in pre- and perimenopausal women at higher risk of disease
recurrence (young age, high grade tumour, lymph node
involvement). In women who have received chemotherapy, premenopausal
status must be confirmed after completion of
chemotherapy.
(x) Preservation of