Negara: Irlandia
Bahasa: Inggris
Sumber: HPRA (Health Products Regulatory Authority)
APOMORPHINE HYDROCHLORIDE
Genus Pharmaceuticals Limited
5 Mg/Ml
Solution for Infusion
2009-12-04
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT APO-go PFS 5mg/ml Solution for Infusion in Pre-filled Syringe 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1ml contains 5mg apomorphine hydrochloride. Each 10ml pre-filled syringe contains 50mg apomorphine hydrochloride. Excipient: Sodium metabisulphite (E223) 0.5 mg per ml For a full list of excipients, see Section 6.1 3 PHARMACEUTICAL FORM Solution for Infusion, pre-filled syringe Solution is clear and colourless 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-g 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 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. Administration APO-go PFS 5mg/ml Solution for Infusion in Pre-filled Syringe is a pre-diluted pre-filled syringe intended for use without dilution as a continuous subcutaneous infusion by minipump and / or syringe-driver. It is not intended to be used for intermittent injection. APOMORPHINE MUST NOT BE USED VIA Baca dokumen lengkapnya