Pays: Irlande
Langue: anglais
Source: HPRA (Health Products Regulatory Authority)
Methacholine Chloride
Acic Europe Limited
V04CX; V04CX03
Methacholine Chloride
100 milligram(s)
Powder for nebuliser solution
Other diagnostic agents; methacholine
Marketed
2020-06-12
Page 1 of 4 PACKAGE LEAFLET: INFORMATION FOR THE USER METHACHOLINE CHLORIDE 100 MG POWDER FOR NEBULISER SOLUTION methacholine chloride READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 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 or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Methacholine chloride is and what it is used for 2. What you need to know before you take Methacholine chloride 3. How to take Methacholine chloride 4. Possible side effects 5. How to store Methacholine chloride 6. Contents of the pack and other information 1. WHAT METHACHOLINE CHLORIDE IS AND WHAT IT IS USED FOR WHAT METHACHOLINE CHLORIDE IS Methacholine chloride contains a medicine called ‘methacholine chloride’. It works on the airways causing them to tighten and become narrower or retract. The product is for diagnostic use only. WHAT IS METHACHOLINE CHLORIDE USED FOR Methacholine chloride is used in adults and children (5 years or older). It is used as part of a breathing test called a 'methacholine challenge test’. Your doctor or nurse will do this test to help: • decide if you have asthma • check how severe your asthma is • decide if you have ‘occupational asthma’. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE METHACHOLINE CHLORIDE DO NOT TAKE METHACHOLINE CHLORIDE IF: • you are allergic to methacholine chloride or other cholinergic drugs, such as those used to treat conditions such as myasthenia gravis, glaucoma, and urinary retention • you are a child under 5 years of age • you have asthma or difficulty breathing • you are taking medicines that are beta-blockers • you have already done a Lire le document complet
Health Products Regulatory Authority 15 June 2020 CRN008K6W Page 1 of 10 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Methacholine chloride 100 mg Powder for nebuliser solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 20 mL vial contains 100 mg methacholine chloride 3 PHARMACEUTICAL FORM Powder for nebuliser solution White or off-white powder 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS This medicinal product is for diagnostic use only. Methacholine chloride is indicated in adults and children (5 years old and above) able to perform reproducible spirometry for the diagnosis of non-specific bronchial airway hyper-reactivity who do not have clinically apparent asthma but with a clinical history suggestive of the condition and with normal spirometry (see section 4.2 and section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Medicinal product subject to restricted medical prescription. POSOLOGY ADULTS AND CHILDREN (AGED 5 YEARS AND ABOVE): Methacholine chloride is administered only in solution for inhalation. Before starting a Methacholine chloride challenge test, baseline spirometry must be performed. For a patient to be able to undergo the test, he or she must present with baseline FEV 1 (Forced Expiratory Volume in 1 second) greater than or equal to 60% of the predicted value (in adults and children) and greater than or equal to 1.5 L (in adults). At commencement of the Methacholine chloride challenge test and prior to nebulisation with Methacholine chloride, FEV 1 should be measured following exposure to nebulised diluent (post-diluent FEV 1 ). The methacholine challenge test is considered positive if there is a reduction in FEV 1 of 20% or more from FEV 1 with the recommended diluent. The test should be stopped at this point. The reduction value must be calculated and recorded before starting the test with Methacholine chloride. PAEDIATRIC POPULATION The safety and efficacy of Methacholine chloride in children under 5 years of age has not been established. No data are availabl Lire le document complet