APO-go AMPOULES 10 mg/ml Solution for Injection or Infusion *Abbreviated to APO-go in the text

Država: Irska

Jezik: engleski

Izvor: HPRA (Health Products Regulatory Authority)

Aktivni sastojci:

Apomorphine hydrochloride

Dostupno od:

Britannia Pharmaceuticals Ltd

ATC koda:

N04BC; N04BC07

INN (International ime):

Apomorphine hydrochloride

Doziranje:

10 milligram(s)/millilitre

Farmaceutski oblik:

Solution for injection/infusion

Tip recepta:

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

Područje terapije:

Dopamine agonists; apomorphine

Status autorizacije:

Not marketed

Datum autorizacije:

2003-03-07

Uputa o lijeku

Page 1 of 8
PACKAGE LEAFLET: INFORMATION FOR THE USER
APO-GO
® AMPOULES 10 MG/ML SOLUTION FOR INJECTION OR INFUSION*
Apomorphine hydrochloride
* _Abbreviated to_ APO-go Ampoules_ in the text_
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 Ampoules is and what it is used for
2.
What you need to know before you use APO-go Ampoules
3.
How to use APO-go Ampoules
4.
Possible side effects
5.
How to store APO-go Ampoules
6.
Contents of the pack and other information
1.
WHAT APO-GO AMPOULES IS AND WHAT IT IS USED FOR
APO-go Ampoules contains apomorphine solution for injection. It is
injected into the area under the
skin (subcutaneously). The active ingredient in APO-go Ampoules is
apomorphine hydrochloride.
There is 10 mg of apomorphine in each millilitre of solution.
Apomorphine hydrochloride belongs to a group of medicines known as
dopamine agonists. APO-go
Ampoules is used to treat Parkinson's disease. Apomorphine helps
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 (another treatment for Parkinson’s disease) 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 AMPOULES
Before you use APO-go Ampoules, your doctor will obtain an ECG
(electrocardiogram) and will ask
for a list of all other med

Svojstava lijeka

Health Products Regulatory Authority
23 November 2018
CRN008L59
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
APO-go AMPOULES 10 mg/ml Solution for Injection or Infusion
*Abbreviated to
APO-go in the text
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1ml contains 10mg apomorphine hydrochloride
2ml contains 20mg apomorphine hydrochloride
5ml contains 50mg apomorphine hydrochloride
Excipient(s) with known effect:
Sodium metabisulphite (E223) 1mg per ml
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Solution for Injection or Infusion
Clear, colourless or almost colourless, 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 agonists,