Goserelin Boston Biopharma 3.6mg implant in a Pre-filled Syringe

Država: Malta

Jezik: engleski

Izvor: Medicines Authority

Aktivni sastojci:

GOSERELIN ACETATE

Dostupno od:

Boston Biopharma Limited Malta Life Sciences Park, Building 2, Level 0, San Gwann SGN 3000, Malta

ATC koda:

L02AE03

INN (International ime):

GOSERELIN ACETATE

Farmaceutski oblik:

IMPLANT

Sastav:

GOSERELIN ACETATE 3.6 milligram(s)

Tip recepta:

POM

Područje terapije:

ENDOCRINE THERAPY

Status autorizacije:

Authorised

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 BOSTON BIOPHARMA 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 Boston Biopharma is and what it is used for
2.
What you need to know before you use Goserelin Boston Biopharma
3.
How to use Goserelin Boston Biopharma
4.
Possible side effects
5.
How to store Goserelin Boston Biopharma
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 BOSTON BIOPHARMA IS AND WHAT IT IS USED FOR
Goserelin Boston Biopharma contains a medicine called goserelin. This
belongs to a group of
medicines called ‘LHRH analogues’.
USE OF GOSERELIN BOSTON BIOPHARMA BY MEN
In men, Goserelin Boston Biopharma 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 BOSTON BIOPHARMA BY WOMEN
In women, Goserelin Boston Biopharma is used to:
-
Treat breast cancer.
-
Treat a condition called ‘endometriosis’. This is where cells
normally only found in the lining
of the womb (uterus) are f

Svojstava lijeka

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SUMMARY OF PRODUCT CHARACTERISTICS
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1.
NAME OF THE MEDICINAL PRODUCT
Goserelin Boston Biopharma 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).
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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).
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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 Boston Biopharma 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