Goserelin UAB Boston Biopharma LT 10.8 mg implant, in a pre-filled syringe

País: Malta

Idioma: inglés

Fuente: Medicines Authority

Ingredientes activos:

GOSERELIN ACETATE

Disponible desde:

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

Código ATC:

L02AE03

Designación común internacional (DCI):

GOSERELIN ACETATE 10.8 mg

formulario farmacéutico:

IMPLANT

Composición:

GOSERELIN ACETATE 10.8 mg

tipo de receta:

POM

Área terapéutica:

ENDOCRINE THERAPY

Estado de Autorización:

Withdrawn

Fecha de autorización:

2019-04-03

Información para el usuario

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PACKAGE LEAFLET
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PACKAGE LEAFLET: INFORMATION FOR THE USER
GOSERELIN UAB BOSTON BIOPHARMA LT10.8 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 LT10.8 mg is and what it is used
for
2.
What you need to know before you use Goserelin UAB Boston Biopharma
LT10.8 mg
3.
How to use Goserelin UAB Boston Biopharma LT10.8 mg
4.
Possible side effects
5.
How to store Goserelin UAB Boston Biopharma LT10.8 mg
6.
Contents of the pack and other information
1.
WHAT GOSERELIN UAB BOSTON BIOPHARMA LT10.8 MG IS AND WHAT IT IS USED
FOR
Goserelin UAB Boston Biopharma LT10.8 mg contains a medicine called
goserelin. This belongs
to a group of medicines called ‘LHRH analogues’. Goserelin UAB
Boston Biopharma LT10.8 mg
is a long-acting form of Goserelin UAB Boston Biopharma LT3.6mg and it
is given every 12
weeks
Goserelin UAB Boston Biopharma LT10.8 mg is used to treat prostate
cancer. It works by reducing
the amount of ‘testosterone’ (a hormone) that is produced by your
body. .
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN GOSERELIN UAB BOSTON
BIOPHARMA
LT10.8 MG DO NOT USE GOSERELIN UAB BOSTON BIOPHARMA LT10.8 MG:
•
if you are allergic to goserelin or any of the other ingredients of
this medicine (listed in
section 6).
•
you are a woman.
Do not have Goserelin UAB Boston Biopharma LT10.8 mg if

Ficha técnica

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SUMMARY OF PRODUCT CHARACTERISTICS
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1.
NAME OF THE MEDICINAL PRODUCT
Goserelin UAB Boston Biopharma LT 10.8 mg implant, in a pre-filled
syringe
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One implant contains 10.8 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
1.5 mm, length 13 mm, mass
44 mg), embedded in biodegradable polymer matrix.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Goserelin UAB Boston Biopharma LT is indicated (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).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adult males _
One depot of Goserelin UAB Boston Biopharma LT injected subcutaneously
into the anterior
abdominal wall every 3 months (see section 5.1 Pharmacodynamic
properties).
_Elderly _
No dosage adjustment is necessary in the elderly.
_Renal impairmen