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

מדינה: אירלנד

שפה: אנגלית

מקור: HPRA (Health Products Regulatory Authority)

מרכיב פעיל:

LEUPRORELIN ACETATE

זמין מ:

Mercury Pharmaceuticals Ltd

קוד ATC:

L02AE; L02AE02

INN (שם בינלאומי):

LEUPRORELIN ACETATE

כמות:

22.5 milligram(s)

טופס פרצבטיות:

Powder and solvent for suspension for injection

מסלול נתינה (של תרופות):

intravenous route

יחידות באריזה:

One (1) type I glass vial containing 22.5 mg

סוג מרשם:

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

תוצרת:

GP-Pharm S.A.

קבוצה תרפויטית:

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

איזור תרפויטי:

Gonadotropin releasing hormone analogues; leuprorelin

סממני תרפויטית:

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

מצב אישור:

Not marketed

תאריך אישור:

2015-07-17

מאפייני מוצר

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