País: Irlanda
Idioma: inglés
Fuente: HPRA (Health Products Regulatory Authority)
APOMORPHINE HYDROCHLORIDE
Genus Pharmaceuticals Limited
10 Mg/Ml
Solution for Inj/Inf
2010-10-08
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 Solution is clear and colourless pH 3.0-4.0 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 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 subcutaneous infusion by minipump and/or syringe-driver (see section 6.6). APOMORPHINE MUST NOT BE USED VIA THE INTRAVENOUS ROUTE. _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 20mg three times daily, for at least two days prior to initiation of therapy. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 13/03/2012_ _CRN 2105137_ _page n Leer el documento completo