APO-GO AMPOULES 10 Mg/Ml Solution for Inj/Inf
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
23-04-2024
Summary of Product characteristics
(SPC)
23-04-2024
Active ingredient:
APOMORPHINE HYDROCHLORIDE
Available from:
Genus Pharmaceuticals Limited
INN (International Name):
APOMORPHINE HYDROCHLORIDE
Dosage:
10 Mg/Ml
Pharmaceutical form:
Solution for Inj/Inf
Prescription type:
Product subject to prescription which may be renewed (B)
Authorization status:
Authorised
Authorization date:
0000-00-00
Patient Information leaflet
Page 1 of 10
APO-GO
®
AMPOULES 10MG/ML SOLUTION FOR INJECTION*
APOMORPHINE HYDROCHLORIDE
For use in adults
PACKAGE LEAFLET: INFORMATION FOR THE USER
* _Abbreviated to_ APO-go Ampoules_ in the text_
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING
THIS MEDICINE.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor,
nurse or pharmacist.
This medicine has been prescribed for you. Do not give it to
others. It may harm them, even
if their symptoms are the same as yours.
If any of the side effects gets serious, or if you notice
any side effects not listed in this
leaflet, please tell your doctor, nurse or pharmacist.
IN THIS LEAFLET:
1.
What APO-go Ampoules is and what it is used for
2.
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.
Further 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.
BEFORE YOU USE APO-GO AMPO
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Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
APO-go AMPOULES 10 mg/ml Solution for Injection or Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1ml contains 10mg apomorphine hydrochloride
2ml contains 20mg apomorphine hydrochloride
5ml contains 50mg apomorphine hydrochloride
Excipient: Sodium metabisulphite (E223) 1mg per ml
For a 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 3.0-4.0
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.
It is essential that the patient is established on domperidone, usually 20mg three times daily, for at least two days prior
to initiation of therapy.
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.
ADULTS
_Administration_
APO-go Ampoules 10 mg/ml Solution for Injection or Infusion is for subcutaneous use by intermittent bolus injection.
APO-go Ampoules 10 mg/ml Solution for Injection or Infusion may also be administered as a continuous subc
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