Goserelin UAB Boston Biopharma LT 3.6 mg implant, in a pre-filled syringe

Država: Malta

Jezik: engleski

Izvor: Medicines Authority

Aktivni sastojci:

GOSERELIN ACETATE

Dostupno od:

UAB Boston Biopharma LT V.A. Graiciuno g. 6-2 Vilniaus m. sav. LT-02241, Lithuania

ATC koda:

L02AE03

INN (International ime):

GOSERELIN ACETATE 3.6 mg

Farmaceutski oblik:

IMPLANT

Sastav:

GOSERELIN ACETATE 3.6 mg

Tip recepta:

POM

Područje terapije:

ENDOCRINE THERAPY

Status autorizacije:

Withdrawn

Datum autorizacije:

2019-04-03

Uputa o lijeku

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PACKAGE LEAFLET
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PACKAGE LEAFLET: INFORMATION FOR THE USER
GOSERELIN UAB BOSTON BIOPHARMA LT 3.6 MG IMPLANT, IN A PRE-
FILLED SYRINGE
Goserelin
Read all of this leaflet carefully before you start using this
medicine because it contains important
information for you.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor, pharmacist or
nurse.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
•
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Goserelin UAB Boston Biopharma LT is and what it is used for
2.
What you need to know before you use Goserelin UAB Boston Biopharma LT
3.
How to use Goserelin UAB Boston Biopharma LT
4.
Possible side effects
5.
How to store Goserelin UAB Boston Biopharma LT
6.
Contents of the pack and other information
Most of the information in this leaflet applies to both men and women.
-
Where information only applies to men, it is shown by the heading
Information for men.
-
Where information only applies to women, it is shown by the heading
Information for women.
1.
WHAT GOSERELIN UAB BOSTON BIOPHARMA LT IS AND WHAT IT IS USED FOR
Goserelin UAB Boston Biopharma LT contains a medicine called
goserelin. This belongs to
a group of medicines called ‘LHRH analogues’.
USE OF GOSERELIN UAB BOSTON BIOPHARMA LT BY MEN
In men, Goserelin UAB Boston Biopharma LT is used to treat prostate
cancer. It works by reducing
the amount of ‘testosterone’ (a hormone) that is produced by your
body.
USE OF GOSERELIN UAB BOSTON BIOPHARMA LT BY WOMEN
In women, Goserelin UAB Boston Biopharma LT is used to:
-
Treat breast cancer.
-
Treat a condition called ‘endometriosis’. This is where cells
normally o

Svojstava lijeka

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SUMMARY OF PRODUCT CHARACTERISTICS
Page 2 of 11
1.
NAME OF THE MEDICINAL PRODUCT
Goserelin UAB Boston Biopharma LT 3.6 mg implant, in a pre-filled
syringe
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One implant contains 3.6 mg goserelin (as goserelin acetate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Implant, in a pre-filled syringe
White to off-white cylindrical rods (approximate dimensions: diameter
1.2 mm, length 13 mm, mass
18 mg), embedded in biodegradable polymer matrix.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
(i)
Treatment of prostate cancer in the following settings (see also
section 5.1):
-
In the treatment of metastatic prostate cancer where goserelin has
demonstrated
comparable
survival benefits to surgical castrations (see section 5.1).
-
In the treatment of locally advanced prostate cancer, as an
alternative to surgical
castration
where goserelin has demonstrated comparable survival benefits to an
anti-
androgen (see
section 5.1).
-
As adjuvant treatment to radiotherapy in patients with high-risk
localised or locally advanced
prostate cancer where goserelin has demonstrated improved disease-free
survival and overall
survival (see section 5.1).
-
As neo-adjuvant treatment prior to radiotherapy in patients with
high-risk localised or locally
advanced prostate cancer where goserelin has demonstrated improved
disease-free survival
(see
section 5.1).
-
As adjuvant treatment to radical prostatectomy in patients with
locally advanced prostate
cancer at high risk of disease progression where goserelin has
demonstrated improved
disease-
free survival (see section 5.1).
(ii)
Advanced breast cancer in pre and perimenopausal women suitable for
hormonal manipulation.
(iii)
Goserelin UAB Boston Biopharma LT 3.6 mg is indicated as an
alternative to chemotherapy in
the standard of care for pre/perimenopausal women with oestrogen
receptor (ER) positive early
breast c