Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
oxygen, Quantity: 100 % v/v
BOC Limited
Gas, medicinal
Excipient Ingredients:
Inhalation
53370 L (size F9 manifold pack, 9 x size G), 124400 L (size MAN 15 manifold pack, 15 x size G), 51300 L (size F8 manifold pack,
Not scheduled. Not considered by committee
For respiratory delivery where there is a requirement for medical oxygen to treat or prevent hypoxemia
Visual Identification: Colourless gas; Container Type: Gas Cylinder
Registered
1992-01-02
1 MEDICAL OXYGEN 99.5% CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET? This leaflet answers some common questions about Medical Oxygen. It contains only some information, and does not take the place of talking to your doctor or appropriatehealthcare professional. All medicines may assist you, but sometimes there are risks. Your doctor or healthcare professional has weighed up the risks of you using Medical Oxygen against the benefits they expect it will have for you. If you have any questions about using Medical Oxygen, ask your doctor. Keep this leaflet with you as you may want to read it again. WHAT MEDICAL OXYGEN IS USED FOR? Medical Oxygen is used for breathing, to treat or prevent oxygen deficiency. It is usually given by a doctor, anaesthetist, dentist, ambulance officer or nurse via a mask or nasal prongs. When directed by a doctor, Medical Oxygen can be used in your home. Medical Oxygen works by increasing uptake and concentrating oxygen in your tissues. Your doctor may prescribe Medical Oxygen for another purpose. Ask your doctor if you have any questions about why Medical Oxygen has been prescribed for you. This medicine is available only with a doctor's prescription. BEFORE YOU USE MEDICAL OXYGEN _WHEN YOU MUST NOT USE IT_ WARNING: MEDICAL OXYGEN BOOSTS BURNING AND MAY INCREASE THE CHANCE OF FIRE. DO NOT USE MEDICAL OXYGEN IF: A. YOU ARE SMOKING. B. YOU ARE NEAR OPEN FLAMES. C. YOU ARE COOKING. Do not use Medical Oxygen if the cylinder is damaged or has the tamper evident plastic seal removed. _BEFORE YOU START TO USE IT_ _ _ YOU MUST TELL YOUR DOCTOR IF: 1. YOU ARE A SMOKER. 2. YOU HAVE HAD ANY REACTION TO MEDICAL OXYGEN THERAPY. 3. YOU HAVE OR HAVE HAD ANY OTHER HEALTH PROBLEMS OR MEDICAL CONDITIONS, INCLUDING: • Severe lung disease such as chronic bronchitis or emphysema. 4. YOU ARE PREGNANT OR INTEND TO BECOME PREGNANT. 5. YOU ARE BREASTFEEDING OR WISH TO BREASTFEED. 6. CARE SHOULD BE TAKEN WHEN USING MEDICAL OXYGEN BECAUSE IT IS STORED AT HIGH PRESSURE IN THE GAS CYLINDER. MEDICAL OXYGEN Read the complete document
Page 1 of 10 AUSTRALIAN PRODUCT INFORMATION – BOC GASES OXYGEN 99.5% MEDICAL EP GRADE WARNING: OXYGEN AIDS AND INCREASES COMBUSTION. OXYGEN STRONGLY SUPPORTS COMBUSTION (INCLUDING SOME MATERIALS, WHICH DO NOT NORMALLY BURN IN AIR). SMOKING IS PROHIBITED WHEN MEDICAL OXYGEN IS IN USE, AND NO NAKED FLAME IS ALLOWED. THERE IS A HIGH RISK OF SPONTANEOUS COMBUSTION IF OXYGEN COMES INTO CONTACT WITH OILS, GREASES AND TARRY SUBSTANCES. SEE _SPECIAL WARNINGS AND PRECAUTIONS FOR USE_ AND _SPECIAL PRECAUTIONS FOR STORAGE_ . 1 NAME OF THE MEDICINE Oxygen 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Contains 99.5% v/v oxygen. Complies with current British Pharmacopoeial specifications, purity not less than 99.5%. Purity Not less than 99.5% v/v Carbon dioxide Not more than 300 ppm v/v Carbon monoxide Not more than 5 ppm v/v Water Not more than 67 ppm v/v There are no excipients. 3 PHARMACEUTICAL FORM Compressed medical gas for medicinal use. Odourless, colourless gas. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS For respiratory delivery where there is a requirement for medical oxygen to treat or prevent hypoxemia. 4.2 D OSE AND METHOD OF ADMINISTRATION Medical oxygen is administered by inhalation through the lungs. The major exception is when a metered supply is fed into the oxygenator of an extracorporeal circulation of a cardio-pulmonary bypass system. Inhaled Medical Oxygen must be administered using an appropriate pressure reduction device and equipment such as mask or nasal prongs to deliver the required inspired concentration of oxygen, between 21% and 100%, as determined by the prescriber after full clinical assessment. Most delivery systems for adults result in an inspired oxygen concentration of 60% or less. Inhaled oxygen may require humidification when treatment duration is longer than an hour. Page 2 of 10 Standard texts and clinical protocols should be consulted for the oxygen requirements specific to the underlying condition and the clinical status of the individual patient. It is essential to monitor ven Read the complete document