البلد: أيرلندا
اللغة: الإنجليزية
المصدر: HPRA (Health Products Regulatory Authority)
OXYGEN
Air Products Ireland Limited
V03AN01
OXYGEN
Min 99.5 %v/v
Inhalation Gas
Product subject to prescription which may not be renewed (A)
Medical gases
Authorised
2004-09-10
PATIENT INFORMATION LEAFLET MEDICAL OXYGEN. INHALATION GAS. MINIMUM PURITY 99.5 % V/V READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. KEEP THIS LEAFLET, YOU MAY NEED TO READ IT AGAIN. ASK YOUR PHARMACIST OR DOCTOR IF YOU NEED MORE INFORMATION. IN THIS LEAFLET PAGE 1 1. What is Medical Oxygen and what it is used for PAGE 2 3. How to use Medical Oxygen 2. Before you use Medical Oxygen 4. Possible side effects 5. How to store Medical Oxygen 6. Further information 1. WHAT IS MEDICAL OXYGEN AND WHAT IT IS USED FOR Medical Oxygen is a breathed in (inhalation) gas. It is colourless, odourless and tasteless. It is supplied under pressure in a cylinder with a valve to control the flow of gas. A variety of cylinders sizes are available. WHAT MEDICAL OXYGEN IS USED FOR? Medical Oxygen is used to increase the levels of oxygen in the body’s tissues. It may be used in the following circumstances: at high concentrations when there is a reduced amount of oxygen being taken into the body through the lungs due to acute or severe asthma or lung diseases such as pulmonary thrombo-embolism (a blockage of one of the arteries in the lung), pneumonia, fibrosing alveolitis (inflammation and scarring of the air sacs of the lungs) and pulmonary oedema (a disease affecting the heart). In low concentrations when there are breathing difficulties due to conditions such as chronic obstructive airways disease (COAD/COPD) (a collection of lung diseases caused by damage to the lungs) in the treatment of acute and severe asthma, sleep apnoea (a sleep disorder in which a person has irregular breathing at night and is excessively sleepy during the day), اقرأ الوثيقة كاملة
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA1075/001/001 Case No: 2062990 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to AIR PRODUCTS IRELAND LIMITED UNIT 950, WESTERN INDUSTRIAL EST, KILLEEN ROAD, DUBLIN 12 an authorisation, subject to the provisions of the said Regulations, in respect of the product MEDICAL OXYGEN. INHALATION GAS. MINIMUM PURITY 99.5%V/V The particulars of which are set out in Part I and Part II of the attached Schedule. The authorisation is also subject to the general conditions as may be specified in the said Regulations as listed on the reverse of this document. This authorisation, unless previously revoked, shall continue in force from 10/09/2009. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 24/09/2009_ _CRN 2062990_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Medical Oxygen. Inhalation Gas. Minimum Purity 99.5 % v/v 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Oxygen. Minimum Purity 99.5% v/v. 3 PHARMACEUTICAL FORM Inhalation Gas A colourless odourless gas. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS o At high concentrations in the treatment of acute severe asthma, pulmonary thrombo-embolism, pneumonia and fibrosing alveolitis. o At low concentrations in the treatment of ventilatory failure due to chronic obstructive airways disease and other causes. o For the treatment of carbon monoxide poisoning. o To reduce the volume of air trapped in اقرأ الوثيقة كاملة