Држава: Ирска
Језик: Енглески
Извор: HPRA (Health Products Regulatory Authority)
Helium
BOC Gases Ireland Ltd
V03AN; V03AN03
Helium
99.5 percent volume/volume
Medicinal gas, compressed
Product subject to prescription which may not be renewed (A)
Medical gases; helium
Marketed
1980-04-01
PACKAGE LEAFLET: INFORMATION FOR THE USER MEDICAL HELIUM HELIUM 99.95 %, MEDICINAL GAS. COMPRESSED READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. - Keep this leaflet as you may need to read it again. - If you have further questions, ask your healthcare professional (doctor, nurse or pharmacist). - This medicine has been prescribed for you. - Do not pass it on to others as it may harm them, even if their symptoms are the same as yours. - If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your heathcare professional immediately. THIS LEAFLET GIVES YOU INFORMATION ABOUT: 1. What is Medical Helium and what is it used for 2. Things to consider before use 3. How to use Medical Helium 4. Possible side effects 5. How to store Medical Helium cylinders 6. Further Information _ _ 1. WHAT IS MEDICAL HELIUM AND WHAT IS IT USED FOR Medical Helium is a medicinal gas, supplied in cylinders filled to a high pressure. Medical Helium is a very light gas and flows through openings in the lungs with obstructions much more easily than other medical gases. Medical Helium will always be given to you with Medical Oxygen. Medical Helium is used: • to help the flow of Oxygen into the lungs if you are suffering from breathing diseases such as bronchitis • to assist you to breathe if part of the lung fails to expand • with other medical gases for lung function testing • to prevent the collapse of lung tissue in certain conditions. 2. THINGS TO CONSIDER BEFORE USE Medical Helium is only given to you in a hospital or clinic under the supervision of a healthcare professional. Ensure that your healthcare professional is aware of any medical conditions that you may have. PREGNANCY AND BREAST-FEEDING Medical Helium will not affect you or your baby if used during pregnancy or whilst breast-feeding. DRIVING AND USING MACHINES You may drive and use machines after using Medical Helium providing that your healthcare professional considers that you are bo Прочитајте комплетан документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Medical Helium 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Medical Helium Cylinders are supplied to the following specification: Helium 99.5% The Medical Helium cylinder specification complies with the current European Pharmacopoeia monograph (2155). 3 PHARMACEUTICAL FORM Medicinal gas, compressed. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Because of its low density helium flows through an orifice much more easily then other medical gases. Helium is used with a least 21% oxygen in the following circumstances: To assist the flow of oxygen into the alveoli of patients with severe respiratory obstruction. To prevent atelectasis In various concentrations, in conjunctions with air or oxygen, for gas transfer lung function tests. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION There is no distinction generally between the use of helium in age groups. In its role as a carrier for oxygen, helium is administered through the lungs by inhalation with 21% or higher concentrations of oxygen by mask or endotracheal tube. Cylinders should only be used in conjunction with medical helium gas pressure regulators, although medical oxygen gas pressure regulators may be used on the F-size helium cylinders. 4.3 CONTRAINDICATIONS Not applicable. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Helium should never be used with less than 21% oxygen. Helium will diffuse through rubber tubing. Care is needed in the handling and use of medical helium gas cylinders. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ Прочитајте комплетан документ