Pays: Irlande
Langue: anglais
Source: HPRA (Health Products Regulatory Authority)
APOMORPHINE HYDROCHLORIDE
Genus Pharmaceuticals Limited
APOMORPHINE HYDROCHLORIDE
10 Mg/Ml
Solution for Injection
Product subject to prescription which may be renewed (B)
Authorised
0000-00-00
PIL Apomorphin UK342 Pen, ICD+ Neuer Pen Text+ Neue Bilder (sudd. sleep onset ist enthalten), Formatiert 2013-02-26/AR PACKAGE LEAFLET: INFORMATION FOR THE USER APO-GO ® PEN 10 MG/ML SOLUTION FOR INJECTION * Apomorphine hydrochloride * Abbreviated to APO-go ® Pen in the text READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor, nurse or pharmacist. - This medicine has been prescribed for you. Do not give it to others. It may harm them, even if their symptoms are the same as yours. - If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, nurse or pharmacist. IN THIS LEAFLET: 1. What APO-go Pen is and what it is used for 2. Before you use APO-go Pen 3. How to use APO-go Pen 4. Possible side effects 5. How to store APO-go Pen 6. Further information 1. WHAT APO-GO PEN IS AND WHAT IT IS USED FOR APO-go Pen contains apomorphine solution for injection. It is injected into the area under the skin (subcutaneously). The active ingredient in APO-go Pen is apomorphine hydrochloride. There is 10 mg of apomorphine in each milliliter of solution. Apomorphine hydrochloride belongs to a group of medicines known as dopamine agonists. APO-go Pen is used to treat Parkinson’s disease. Apomorphine helps to reduce the amount of time spent in an “off” or immobile state in people who have been previously treated for Parkinson’s disease with levodopa and/or other dopamine agonists. Your doctor or nurse will help you to recognise the signs of when to use your medicine. Despite the name, apomorphine does not contain morphine. 2. BEFORE YOU US Lire le document complet
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. The solution is clear, practically colourless, odourless and free from visible particles. pH = 3.0 to 4.0 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS The 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 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 23/06/2014_ _CRN 2148576_ _page number: 1_ Dete Lire le document complet