APO-go® PFS 5mg/ml Solution for Infusion in Pre-filled Syringe*Abbreviated to APO-go in the text
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
17-02-2018
Summary of Product characteristics
(SPC)
27-11-2018
Active ingredient:
Apomorphine hydrochloride
Available from:
Britannia Pharmaceuticals Ltd
ATC code:
N04BC; N04BC07
INN (International Name):
Apomorphine hydrochloride
Dosage:
5 milligram(s)/millilitre
Pharmaceutical form:
Solution for infusion in pre-filled syringe
Prescription type:
Product subject to prescription which may not be renewed (A)
Therapeutic area:
Dopamine agonists; apomorphine
Authorization status:
Marketed
Authorization date:
2008-02-29
Patient Information leaflet
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
Read the complete document
Summary of Product characteristics
Health Products Regulatory Authority
23 November 2018
CRN008L59
Page 1 of 12
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 10 ml pre-filled syringe contains 50 mg 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
Health Products Regulatory Authority
23 November 2018
CRN008L59
Page 2 of 12
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 ago
Read the complete document
