Страна: Ирландия
Език: английски
Източник: HPRA (Health Products Regulatory Authority)
APOMORPHINE HYDROCHLORIDE
Genus Pharmaceuticals Limited
APOMORPHINE HYDROCHLORIDE
5 Mg/Ml
Solution for Infusion
Product subject to prescription which may be renewed (B)
Authorised
0000-00-00
APO-GO ® PFS 5MG/ML SOLUTION FOR INFUSION IN PRE-FILLED SYRINGE APOMORPHINE HYDROCHLORIDE 50MG/10ML FOR USE IN ADULTS PACKAGE LEAFLET: INFORMATION FOR THE USER 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 or pharmacist. This medicine has been prescribed for you. Do not pass it on 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 or pharmacist. IN THIS LEAFLET: 1. What APO-go PFS is and what it is used for 2. Before you use APO-go PFS 3. How to use APO-go PFS 4. Possible side effects 5. How to store APO-go PFS 6. Further information 1. WHAT APO-GO PFS IS AND WHAT IT IS USED FOR Apomorphine hydrochloride belongs to a group of medicines known as dopamine agonists which are used to treat Parkinson‟s disease. It helps to reduce the amount of time spent in an “off” or immobile state in people who have previously been 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. 2. BEFORE YOU USE APO-GO PFS DO NOT USE APO-GO PFS if you are under 18 years of age if you have breathing difficulties or suffer from asthma if you have dementia or Alzheimer‟s disease if you suffer from confusion, hallucinations or any other similar problems if you have liver problems if you have severe dyskinesia (involuntary movements) or severe dystonia (inability to move) on account of the treatment with levodopa if you are allergic to apomorphine or any of the other ingredients of APO-g Прочетете целия документ
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 Clear solution, practically colourless, odourless and practically free from visible particles 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-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 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. _ADULTS_ 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 int Прочетете целия документ