Lutrate 1 month Depot 3.75 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:

3.75 milligram(s)

טופס פרצבטיות:

Powder and solvent for suspension for injection

מסלול נתינה (של תרופות):

intramuscular route

יחידות באריזה:

One (1) type I glass vial containing 3.75 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 is indicated for palliative treatment of locally advanced or metastatic prostate cancer

מצב אישור:

Not marketed

תאריך אישור:

2015-07-17

מאפייני מוצר

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