Pajjiż: Irlanda
Lingwa: Ingliż
Sors: HPRA (Health Products Regulatory Authority)
SALBUTAMOL SULFATE
B & S Healthcare
R03AC02
SALBUTAMOL SULFATE
100 Microgram
Pressurised Inhalation Suspension
Product subject to prescription which may be renewed (B)
Selective beta-2-adrenoreceptor agonists
Authorised
2006-08-18
PACKAGE LEAFLET: INFORMATION FOR THE USER VENTOLIN ® EVOHALER ® 100MICROGRAM PRESSURISED INHALATION, SUSPENSION salbutamol (as sulphate) 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, nurse 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, nurse or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. The name of your medicine is Ventolin ® Evohaler ® 100microgram Pressurised Inhalation, Suspension but it will be referred to as Ventolin Evohaler throughout this leaflet. WHAT IS IN THIS LEAFLET: 1 What Ventolin Evohaler is and what it is used for 2 What you need to know before you use Ventolin Evohaler 3 How to use Ventolin Evohaler 4 Possible side effects 5 How to store Ventolin Evohaler 6 Contents of the pack and other information 1. WHAT VENTOLIN EVOHALER IS AND WHAT IT IS USED FOR Ventolin Evohaler contains a medicine called salbutamol. This belongs to a group of medicines called fast-acting bronchodilators. Bronchodilators help the airways in your lungs to stay open. This makes it easier for air to get in and out. They help to relieve chest tightness, wheezing and cough. Ventolin Evohaler is for use in adults, adolescents and children. For babies and children under 4 years of age, see Section 3. Ventolin Evohaler is used to help prevent and treat breathing problems in people with asthma and chronic obstructive Aqra d-dokument sħiħ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ventolin Evohaler 100 micrograms Pressurised Inhalation, Suspension 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each metered dose contains 100 micrograms of Salbutamol (as sulphate). For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Pressurised inhalation, suspension _Product imported from the UK:_ Pressurised inhalation suspension supplied in an aluminium can with metering valve and a blue actuator. 4 CLINICAL PARTICULARS As per PA1077/049/010 5 PHARMACOLOGICAL PROPERTIES As per PA1077/049/010 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Norflurane (Hydrofluoralkane (HFA) 134a) 6.2 INCOMPATIBILITIES Not applicable. 6.3 SHELF LIFE The shelf-life expiry date of this product shall be the date shown on the container and outer package of the product on the market in the country of origin. 6.4 SPECIAL PRECAUTIONS FOR STORAGE Store below 30°C. Do not refrigerate or freeze. The canister contains a pressurised liquid. Do not expose to temperatures higher than 50°C. Do not pierce the canister even when apparently empty. 6.5 NATURE AND CONTENTS OF CONTAINER The suspension is contained in an aluminium alloy can, internally coated with fluoropolymer and sealed with a metering valve. Each canister is fitted into a plastic actuator incorporating an atomising nozzle and fitted with a dustcap. Each canister contains at least 200 metered doses. HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 30/11/2015_ _CRN 2170543_ _page number: 1_ 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCT AND OTHER HANDLING OF THE PRODUCT Patients should be carefull Aqra d-dokument sħiħ