Land: Irland
Sprache: Englisch
Quelle: HPRA (Health Products Regulatory Authority)
APOMORPHINE HYDROCHLORIDE
Genus Pharmaceuticals Limited
10 Mg/Ml
Solution for Injection
2010-01-25
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 ________________________________________________________________________________________________________________________ _Date Printed 13/03/2012_ _CRN 2105137_ _page number: 1 Lesen Sie das vollständige Dokument