APO-go® PFS 5mg/ml Solution for Infusion in Pre-filled Syringe*Abbreviated to APO-go in the text

Država: Irska

Jezik: engleski

Izvor: HPRA (Health Products Regulatory Authority)

Aktivni sastojci:

Apomorphine hydrochloride

Dostupno od:

Stada Arzneimittel AG

ATC koda:

N04BC; N04BC07

INN (International ime):

Apomorphine hydrochloride

Doziranje:

5 milligram(s)/millilitre

Farmaceutski oblik:

Solution for infusion in pre-filled syringe

Tip recepta:

Product subject to prescription which may not be renewed (A)

Područje terapije:

Dopamine agonists; apomorphine

Status autorizacije:

Marketed

Datum autorizacije:

2014-11-28

Uputa o lijeku

PACKAGE LEAFLET: INFORMATION FOR THE USER
APO-GO
® PFS 5 MG/ML SOLUTION FOR INFUSION IN PRE-FILLED SYRINGE*
Apomorphine hydrochloride
*
_Abbreviated to_
APO-go PFS
_ in the text_
50 MG/10 ML
For use in adults
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 side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What APO-go PFS is and what it is used for
2.
What you need to know before you use APO-go PFS
3.
How to use APO-go PFS
4.
Possible side effects
5.
How to store APO-go PFS
6.
Contents of the pack and other information
1.
WHAT APO-GO PFS IS AND WHAT IT IS USED FOR
APO-go PFS contains apomorphine hydrochloride. Apomorphine
hydrochloride belongs to a group of
medicines known as dopamine agonists which are used to treat
Parkinson’s disease. It helps to reduce
the amount of time spent in an “off” or immobile state in people
who have previously been treated for
Parkinson’s disease with levodopa and/or other dopamine agonists.
Your doctor or nurse will help you
to recognise the signs of when to use your medicine.
Despite the name, apomorphine does not contain morphine.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE APO-GO PFS
Before you use APO-go PFS your doctor will obtain an ECG
(electrocardiogram) and will ask for a
list of all other medicines you take. This ECG will be repeated in the
first days of your treatment and
at any point if your doctor thinks this is needed. He or she will also
ask you about other diseases you
may have, in particular concerning your heart. Some of the questions
and investigations may be
repeated at each medical

Svojstava lijeka

Health Products Regulatory Authority
18 December 2023
CRN00DXYY
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
APO-go® PFS 5mg/ml Solution for Infusion in Pre-filled
Syringe*Abbreviated to APO-go in the text
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1ml contains 5mg apomorphine hydrochloride.
Each 10ml pre-filled syringe contains 50mg apomorphine hydrochloride.
Excipient(s) with known effect
Sodium metabisulphite (E223), 0.5 mg per ml
For the full list of excipients, see Section 6.1
3 PHARMACEUTICAL FORM
Solution for Infusion, pre-filled syringe
Clear solution, practically colourless, odourless and practically free
from visible particles
pH = 3.0 to 4.0
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of motor fluctuations ('on-off' phenomena) in patients with
Parkinson’s disease which are not sufficiently controlled
by oral anti-Parkinson medication
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Selection of Patients Suitable for APO-go injections:
Patients selected for treatment with APO-go should be able to
recognise the onset of their ‘off’ symptoms and be capable of
injecting themselves or else have a responsible carer able to inject
for them when required.
Patients treated with apomorphine will usually need to start
domperidone at least two days prior to initiation of therapy. The
domperidone dose should be titrated to the lowest effective dose and
discontinued as soon as possible. Before the decision to
initiate domperidone and apomorphine treatment, risk factors for QT
interval prolongation in the individual patient should be
carefully assessed to ensure that the benefit outweighs the risk (see
section 4.4).
Apomorphine should be initiated in the controlled environment of a
specialist clinic. The patient should be supervised by a
physician experienced in the treatment of Parkinson’s disease (e.g.
neurologist). The patient’s treatment with levodopa, with or
without dopamine agonists, should be optimised before starting APO-go
treatment.
Posology
_Continuou