Krajina: Malta
Jazyk: angličtina
Zdroj: Medicines Authority
APOMORPHINE HYDROCHLORIDE
Britannia Pharmaceuticals Limited
N04BC07
APOMORPHINE HYDROCHLORIDE
SOLUTION FOR INFUSION
APOMORPHINE HYDROCHLORIDE 5 mg/ml
POM
ANTI-PARKINSON DRUGS
Authorised
2011-11-29
PACKAGE LEAFLET: INFORMATION FOR THE USER APO-GO ® PFS 5 MG/ML SOLUTION FOR INFUSION IN PRE-FILLED SYRINGE* Apomorphine hydrochloride * _Abbreviated to_ APO-go PFS _ in the text_ 50 MG/10 ML For use in adults READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor, pharmacist or nurse. This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What APO-go PFS is and what it is used for 2. What you need to know 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. Contents of the pack and other information 1. WHAT APO-GO PFS IS AND WHAT IT IS USED FOR APO-go PFS contains apomorphine hydrochloride. 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. Despite the name, apomorphine does not contain morphine. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE APO-GO PFS Before you use APO-go PFS your doctor will obtain an ECG (electrocardiogram) and will ask for a list of all other medicines you take. This ECG will be repeated in the first days of your treatment and at any point if your doctor thinks this is needed. He or she will also ask you about other diseases you may have, in particular concerning your heart. Some of the questions and investigations may be repeated at each medical Prečítajte si celý dokument
Page 1 of 11 SUMMARY OF PRODUCT CHARACTERISTICS (SMPC) 1 NAME OF THE MEDICINAL PRODUCT APO-go ® PFS 5 mg/ml Solution for Infusion in Pre-filled Syringe* _*ABBREVIATED TO APO-GO IN THE TEXT _ 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml contains 5 mg apomorphine hydrochloride. Each 10 ml pre-filled syringe contains 50 mg apomorphine hydrochloride. Excipient(s) with known effect 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. Patients treated with apomorphine will usually need to start domperidone at least two days prior to initiation of therapy. The domperidone dose should be titrated to the lowest effective dose and discontinued as soon as possible. Before the decision to initiate domperidone and apomorphine treatment, risk factors for QT interval prolongation in the individual patient should be carefully assessed to ensure that the benefit outweighs the risk (see section 4.4). 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. _ _ Page 2 of 11 Posology _ _ _Continuous Infusion _ Patients who h Prečítajte si celý dokument