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

Quốc gia: Ai-len

Ngôn ngữ: Tiếng Anh

Nguồn: HPRA (Health Products Regulatory Authority)

Thành phần hoạt chất:

LEUPRORELIN ACETATE

Sẵn có từ:

Mercury Pharmaceuticals Ltd

Mã ATC:

L02AE; L02AE02

INN (Tên quốc tế):

LEUPRORELIN ACETATE

Liều dùng:

22.5 milligram(s)

Dạng dược phẩm:

Powder and solvent for suspension for injection

Tuyến hành chính:

intravenous route

Các đơn vị trong gói:

One (1) type I glass vial containing 22.5 mg

Loại thuốc theo toa:

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

Sản xuất bởi:

GP-Pharm S.A.

Nhóm trị liệu:

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

Khu trị liệu:

Gonadotropin releasing hormone analogues; leuprorelin

Chỉ dẫn điều trị:

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

Tình trạng ủy quyền:

Not marketed

Ngày ủy quyền:

2015-07-17

Đặc tính sản phẩm

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