Zoladex LA 10.8 mg Implant

البلد: أيرلندا

اللغة: الإنجليزية

المصدر: HPRA (Health Products Regulatory Authority)

العنصر النشط:

Goserelin

متاح من:

Originalis B.V.

ATC رمز:

L02AE; L02AE03

INN (الاسم الدولي):

Goserelin

الشكل الصيدلاني:

Implant

المجال العلاجي:

Gonadotropin releasing hormone analogues; goserelin

تاريخ الترخيص:

2023-06-23

نشرة المعلومات

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 Zoladex LA is and what it is used for
2.
What you need to know before you use Zoladex LA
3.
How to use Zoladex LA
4.
Possible side effects
5.
How to store Zoladex LA
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 Zoladex LA is and what it is used for
Zoladex LA contains a medicine called goserelin. This belongs to a
group
of medicines called ‘LHRH analogues’. Zoladex LA is a long-acting
form
of Zoladex and it is given every 12 weeks.
Use of Zoladex LA by men
In men, Zoladex LA is used to treat prostate cancer. It works by
reducing
the amount of ‘testosterone’ (a hormone) that is produced by your
body.
Use of Zoladex LA by women
In women, Zoladex LA is used to:
•
Treat a condition called ‘endometriosis’. This is where cells
normally only
found in the lining of the womb (uterus) are found elsewhere in your
body
(normally on other structures near the womb).
•
Treat benign growths in the womb called ‘uterine fibroids’.
In women, Zoladex LA works by reducing the amount of ‘oestrogen’
(a hormone)
that is produced by your body.
2.
What you need to know before you use Zoladex LA
Do not use Zoladex LA:
•
if you are allergic to goserelin or any of the

خصائص المنتج

Health Products Regulatory Authority
26 June 2023
CRN00D4QW
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zoladex LA 10.8 mg Implant
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each implant contains goserelin acetate equivalent to 10.8 mg
goserelin.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Implant.
_Product imported from Romania and Greece._
Cylindrical implant in a pre-filled syringe
4 CLINICAL PARTICULARS
As per PA1019/027/002
5 PHARMACOLOGICAL PROPERTIES
As per PA1019/027/002
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
lactide/glycolide copolymers.
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf-life expiry date of this product is the date shown on the
container and outer package of the product on the market in
the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
To be stored at a temperature lower than 25°C. Do not freeze. To be
stored in the original packaging.
6.5 NATURE AND CONTENTS OF CONTAINER
Zoladex LA comes in the form of an implant in a ready-to-use
pre-filled syringe. It is supplied as a single dose Safe System™
syringe applicator with a protective sleeve in a sealed pouch which
contains a desiccant
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL
Use as directed by the prescriber.
Use only if pouch is undamaged.
Use immediately after opening pouch.
Health Products Regulatory Authority
26 June 2023
CRN00D4QW
Page 2 of 2
7 PARALLEL PRODUCT AUTHORISATION HOLDER
Originalis B.V.,
Joop Geesinkweg 901,
1114 AB Amsterdam-Duivendrecht,
Netherlands
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA2306/027/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 23
rd
June 2023
10 DATE OF REVISION OF THE TEXT