ZOLADEX LA

Land: Israel

Sprog: engelsk

Kilde: Ministry of Health

Aktiv bestanddel:

GOSERELIN AS ACETATE

Tilgængelig fra:

ASTRAZENECA (ISRAEL) LTD

ATC-kode:

L02AE03

Lægemiddelform:

IMPLANT FOR INJECTION

Sammensætning:

GOSERELIN AS ACETATE 10.8 MG/UNIT

Indgivelsesvej:

S.C

Recept type:

Required

Fremstillet af:

ASTRA ZENECA UK LIMITED

Terapeutisk gruppe:

GOSERELIN

Terapeutisk område:

GOSERELIN

Terapeutiske indikationer:

Prostate cancer suitable for hormonal manipulation.

Autorisation dato:

2022-04-30

Indlægsseddel

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS'
REGULATIONS (PREPARATIONS) - 1986
The dispensing of this medicine requires a doctor's prescription.
ZOLADEX
®
LA
Implant for subcutaneous injection in a pre-filled syringe
COMPOSITION
Each syringe contains:
goserelin (as acetate) 10.8 mg
For inactive ingredients, please see section 6 – Further
information.
Read the package insert carefully in its entirety before using this
medicine.
Keep this leaflet; you may need it again.
This leaflet contains concise information about the medicine. If you
have further
questions, refer to the doctor or pharmacist.
This medicine has been prescribed for the treatment of your ailment.
Do not pass it
on to others. It may harm them, even if it seems to you that their
ailment is similar.
If you have any of the side effects, or if you experience a side
effect that is not
mentioned in this leaflet, please contact your doctor immediately.
This medicine is not intended for women and children.
1.
WHAT IS THE MEDICINE INTENDED FOR?
For the treatment of prostate cancer.
Therapeutic group
Zoladex LA contains a medicine called goserelin. This belongs to a
group of
medicines called ‘LHRH analogues’.
Zoladex LA is used to treat prostate cancer. It works by reducing the
amount of
‘testosterone’ (a hormone) that is produced by your body. Zoladex
LA is a long-acting
form of Zoladex and it is given every 12 weeks.
2.
BEFORE USING THE MEDICINE
X Do not use this medicine if:
You are allergic to goserelin or to any of the other ingredients in
this
product (see section 6).
Not to be used by women.
This medicine should not be given to children.
Do not use Zoladex LA if any of the above apply to you. If you are not
sure,
talk to your doctor, pharmacist or nurse before using Zoladex LA.
Special warnings regarding use of Zoladex
If you go into hospital, tell the medical staff that you are having
Zoladex LA.
! Before treatment with Zoladex inform the doctor, or pharmacist or
nurse if:
•
You suffer from high blood pressure.
•
You have

Produktets egenskaber

1. NAME OF THE MEDICINAL PRODUCT
ZOLADEX
®
LA
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Goserelin acetate (equivalent to 10.8 mg goserelin).
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Implant for injection, in pre-filled syringe.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
ZOLADEX LA is indicated for prostate cancer suitable for hormonal
manipulation.
4.2 Posology and method of administration
Adult
males
(including
the
elderly)
-
one
depot
of
ZOLADEX
LA
injected
subcutaneously into the anterior abdominal wall every 12 weeks.
Children - ZOLADEX LA is not indicated for use in children.
Renal Impairment - no dosage adjustment is necessary for patients with
renal
impairment.
Hepatic Impairment - no dosage adjustment for patients with hepatic
impairment.
Method of administration
For correct administration of Zoladex LA, see instructions on the
instruction card.
The instruction card has to be read prior to administration.
Caution is needed when administering Zoladex LA into anterior
abdominal wall due to
the proximity of underlying inferior epigastric artery and its
branches.
Extra care to be given to patients with a low BMI or who are receiving
anticoagulation
medication (see section 4.4).
Care should be taken to ensure injection is given subcutaneously,
using the
technique described in the instruction card. Do not penetrate into a
blood vessel,
muscle or peritoneum.
_ _
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2
In the event of the need to surgically remove a Zoladex LA implant, it
may be
localised by ultrasound.
For special precautions for disposal and other handling see section
6.6.
4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
4.4 Special warnings and precautions for use
There is no data on removal or dissolution of the implant.
There is an increased risk of incident depression (which may be
severe) in patients
undergoing treatment with GnRH agonists, such as Goserelin.
Patients should be informed accordingly and treated as appropriat