Quốc gia: Ai-len
Ngôn ngữ: Tiếng Anh
Nguồn: HPRA (Health Products Regulatory Authority)
Meptazinol
Almirall, S.A.
N02AX; N02AX05
Meptazinol
100 milligram(s)/millilitre
Solution for injection
Product subject to prescription which may not be renewed (A)
Other opioids; meptazinol
Not marketed
1983-10-10
1 PACKAGE LEAFLET: INFORMATION FOR THE USER MEPTID 100 MG/ML SOLUTION FOR INJECTION Meptazinol 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 phamacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Meptid Injection is and what it is used for 2. What you need to know before you use Meptid Injection 3. How to use Meptid Injection 4. Possible side effects 5. How to store Meptid Injection 6. Contents of the pack and other information THIS MEDICINE CONTAINS MEPTAZINOL WHICH IS AN OPIOID, WHICH CAN CAUSE ADDICTION. YOU CAN GET WITHDRAWAL SYMPTOMS IF YOU STOP USING IT SUDDENLY. 1. WHAT MEPTID INJECTION IS AND WHAT IT IS USED FOR This medicine has been prescribed for you for the treatment of moderate to severe pain, including post- operative pain and the pain of renal colic. It contains meptazinol which belongs to a class of medicines called opioids, which are ‘pain relievers’. This medicine has been prescribed to you and should not be given to anyone else. Opioids can cause addiction and you may get withdrawal symptoms if you stop using it suddenly. Your prescriber should have explained how long you will be using it for and when it is appropriate to stop, how to do this safely. The name of this medicine is Meptid 100 mg/ml Solution for Injection but will be referred to as Meptid Injection throughout the remainder of the leaflet. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE MEPTID INJECTION DO NOT USE MEPTID INJECTION IF YOU - are allergic to Meptazinol or any of the other ingredients of this medicine (listed in Section 6) - have any alcohol-related problems - Đọc toàn bộ tài liệu
Health Products Regulatory Authority 28 January 2022 CRN00CS57 Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Meptid 100 mg/ml Solution for Injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1 ml of solution contains 100 mg of meptazinol (as hydrochloride). For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for Injection. A clear colourless solution free from particulate matter. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the treatment of moderate to severe pain, including post-operative pain, obstetric pain and the pain of renal colic. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Prior to starting treatment with opioids, a discussion should be held with patients to put in place a strategy for ending treatment with meptazinol in order to minimise the risk of addiction and drug withdrawal syndrome (see section 4.4). Posology ADULTS Intramuscular dosage: 75 to 100 mg meptazinol. This injection may be repeated 2 to 4 hourly as required. For obstetric pain a dose of 100 to 150 mg should be used according to weight. This dose should approximate 2 mg/kg. Intravenous dosage: 50 to 100 mg meptazinol by slow intravenous injection. The injection may be repeated 2 to 4 hourly as required. If vomiting occurs, a suitable antiemetic should be given. Epidural/intrathecal use: this formulation is not suitable for these routes. ELDERLY The adult dosage schedule can be used in the elderly. PAEDIATRIC POPULATION No data are available 4.3 CONTRAINDICATIONS - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. - Patients with the following conditions: ● acute alcoholism and where there is a risk of paralytic ileus ● raised intracranial pressure or head injury (in addition to interfering with respiration, affects pupillary responses vital for neurological assessment) Health Products Regulatory Authority 28 January 2022 CRN00CS57 Page 2 of 6 ● phaeochromocytoma (risk of pressor response to histamine release) ● acut Đọc toàn bộ tài liệu