Lutrate 1 month Depot 3.75 mg powder and solvent for prolonged-release suspension for injection

Country: Իռլանդիա

language: անգլերեն

source: HPRA (Health Products Regulatory Authority)

active_ingredient:

LEUPRORELIN ACETATE

MAH:

Mercury Pharmaceuticals Ltd

ATC_code:

L02AE; L02AE02

INN:

LEUPRORELIN ACETATE

dosage:

3.75 milligram(s)

pharmaceutical_form:

Powder and solvent for suspension for injection

administration_route:

intramuscular route

units_in_package:

One (1) type I glass vial containing 3.75 mg

prescription_type:

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

manufactured_by:

GP-Pharm S.A.

therapeutic_group:

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

therapeutic_area:

Gonadotropin releasing hormone analogues; leuprorelin

therapeutic_indication:

It is indicated for palliative treatment of locally advanced or metastatic prostate cancer

authorization_status:

Not marketed

authorization_date:

2015-07-17

SPC

Health Products Regulatory Authority
16 April 2019
CRN008YR9
Page 1 of 11
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.
Excipients with known effect:
Each vial contains from 1.3 to 2.2 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 transparent 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 1 month Depot is 3.75 mg
presented as a one month depot injection and
administered as a single intramuscular injection every month.
Lutrate 1 month Depot must be administered under the supervision of a
physician or a qualified health practitioner.
The dose of Lutrate 1 month Depot allowing the continuous release of
leuprorelin acetate during one month is incorporated in
a depot formulation. The lyophilized powder should be reconstituted
and administered as a single intramuscular injection at
monthly intervals. Intra-arterial or intravenous administration must
be avoided. The vial of Lutrate 1 month Depot mi