Riik: Iirimaa
keel: inglise
Allikas: HPRA (Health Products Regulatory Authority)
Apomorphine hydrochloride hemihydrate
Pharmaceuticals Sales & Development Sweden AB (PharmSwed)
N04BC; N04BC07
Apomorphine hydrochloride hemihydrate
5 milligram(s)/millilitre
Solution for infusion
Product subject to prescription which may not be renewed (A)
Dopamine agonists; apomorphine
Not marketed
2012-10-26
1 PACKAGE LEAFLET: INFORMATION FOR THE USER APOMORPHINE HYDROCHLORIDE 5 MG/ML, SOLUTION FOR INFUSION apomorphine hydrochloride hemihydrate 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 or pharmacist. - 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Apomorphine hydrochloride is and what it is used for 2. What you need to know before you use Apomorphine hydrochloride 3. How to use Apomorphine hydrochloride 4. Possible side effects 5. How to store Apomorphine hydrochloride 6. Contents of the pack and other information 1. WHAT APOMORPHINE HYDROCHLORIDE 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. WHAT YOU NEED TO KNOW BEFORE YOU USE APOMORPHINE HYDROCHLORIDE DO NOT USE APOMORPHINE HYDROCHLORIDE: - if you are allergic to apomorphine or any of the other ingredients of this medicine (listed in section 6) - 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 overmobility, so called dyskinesia (involuntary movements), or abnormal muscle tension (so called dystonia) Lugege kogu dokumenti
Health Products Regulatory Authority 13 March 2020 CRN009DYX Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Apomorphine hydrochloride 5mg/ml solution for infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml contains 5 mg apomorphine hydrochloride hemihydrate. One 20 ml vial contains 100 mg apomorphine hydrochloride hemihydrate. Excipient with known effect: Sodium metabisulfite 1 mg per ml. Contains sodium 3.3mg per ml. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for infusion Clear and practically colourless solution pH 2.6 – 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 Posology Patients Suitable for Apomorfin PharmSwed Patients selected for treatment with Apomorfin PharmSwed be capable of inserting the needle s.c. themselves or else have a responsible carer able to insert the needle s.c. 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 treatment should be initiated in a controlled environment of a specialist clinic. The treatment should be managed 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 Apomorfin PharmSwed treatment. _Establishment of treatment_ Alterations in dosage may be made according to the patient’s response. The optima Lugege kogu dokumenti