देश: आयरलैंड
भाषा: अंग्रेज़ी
स्रोत: HPRA (Health Products Regulatory Authority)
APOMORPHINE HYDROCHLORIDE
Archimedes Pharma UK Limited
APOMORPHINE HYDROCHLORIDE
10 Mg/Ml
Solution for Inj/Inf
Product subject to prescription which may not be renewed (A)
Withdrawn
2012-03-30
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Apomorphine hydrochloride 10mg/ml solution for injection/infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains 10mg apomorphine hydrochloride 2ml contains 20mg apomorphine hydrochloride 5ml contains 50mg apomorphine hydrochloride Sodium metabisulphite 1 mg/ml Sodium 0.3 mg/ml (maximum) For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Solution for injection/ infusion A clear, colourless to pale yellow solution. pH 3 – 4 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 Apomorphine 10mg/ml solution for injection is for subcutaneous use by intermittent bolus injection. Apomorphine 10mg/ml solution for injection may also be administered as a continuous subcutaneous infusion by minipump and/or syringe driver. Apomorphine 10mg/ml solution for injection may be diluted with sodium chloride 9mg/ml (0.9%) solution for injection or Water for Injections. APOMORPHINE MUST NOT BE USED VIA THE INTRAVENOUS ROUTE. Dosage ADULTS Administration _SELECTION OF PATIENTS SUITABLE FOR APOMORPHINE 10MG/ML SOLUTION FOR INJECTION_ Patients selected for treatment with Apomorphine 10mg/ml solution for injection 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. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 07/03/2012_ _CRN 2 पूरा दस्तावेज़ पढ़ें