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SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
APO-go PEN 10 mg/ml Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1ml contains 10mg apomorphine hydrochloride
Excipients: Also contains sodium bisulphite 0.93 mg per ml.
For a full list of excipients see section 6.1
3 PHARMACEUTICAL FORM
Solution for injection.
Solution is clear and colourless.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
The treatment of disabling motor fluctuations (‘on-off’ phenomena) in patients with Parkinson’s disease which persist
despite individually titrated treatment with levodopa (with a peripheral decarboxylase inhibitor) and/or other dopamine
agonists.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
APO-go Pen 10 mg/ml Solution for Injection is for subcutaneous use by intermittent bolus injection. See section 4.4
_Dosage_
Adults
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 20 mg 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 treatment 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.
IRISH MEDICINES BOARD
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_Date Printed 13/03/2012_
_CRN 2105137_
_page number: 1
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