Lutrate 3 month Depot 22.5 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:

22.5 milligram(s)

pharmaceutical_form:

Powder and solvent for suspension for injection

administration_route:

intravenous route

units_in_package:

One (1) type I glass vial containing 22.5 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 t is indicated for palliative treatment of hormone dependent advanced prostate cancer

authorization_status:

Not marketed

authorization_date:

2015-07-17

SPC

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lutrate 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
(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.
Lutrate 3 month Depot must be administered under direction of
healthcare professional having the appropriate expertise
for monitoring the response to treatment.
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 De