Šalis: Australija
kalba: anglų
Šaltinis: Department of Health (Therapeutic Goods Administration)
oxygen, Quantity: 0.5 L/L; nitrous oxide, Quantity: 0.5 L/L
BOC Limited
Nitrous oxide,Oxygen
Gas, medicinal
Excipient Ingredients:
Inhalation
various
(S4) Prescription Only Medicine
INDICATIONS AS AT 1 NOVEMBER 2001: "Nitrous oxide with oxygen (Entonox) is indicated in adults and children for analgesia." This approval is based on the evaluation of the information and data provided with the original letter of application and with any subsequent correspondence and submissions relating to the application.
Visual Identification: Colourless gas; Container Type: Gas Cylinder
Registered
1992-01-02
D:\My Documents\Regulatory Affairs Files\Medical Gases\CMI's TGA Approved\CMI - 27.03.08.doc 1 ENTONOX 50% v/v Nitrous oxide, N 2 O and 50% v/v Oxygen, O 2 CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Entonox. It does not contain all the available information. It does not take the place of talking to your doctor,, anaesthetist or appropriate healthcare professional. All medicines have risks and benefits. Your doctor or healthcare professional has weighed the risks of you using Entonox against the benefits they expect it will have for you. If you have any concerns about using Entonox, ask your doctor. Keep this leaflet with you, you may want to read it again. WHAT ENTONOX IS USED FOR Entonox is a nominal gas mixture of 50% nitrous oxide and 50% oxygen used for pain relief. It is usually given by a doctor, anaesthetist, dentist, ambulance officer or nurse via a mask or mouthpiece in which you breathe in the gas. Entonox works by relieving pain for certain procedures. Your doctor may prescribe Entonox for another purpose. Ask your doctor if you have any questions about why Entonox has been prescribed for you. This medicine is available only with a doctor's prescription. BEFORE YOU USE ENTONOX _WHEN YOU MUST NOT USE IT_ DO NOT USE ENTONOX IF: 1. YOU HAVE AN ALLERGY TO ENTONOX OR NITROUS OXIDE OR ANY OTHER GAS COMPONENT OR HAVE HAD AN ALLERGIC REACTION IN THE PAST. 2. YOU HAVE EMPHYSEMA, CHRONIC BRONCHITIS OR IF IT IS FOR A PREMATURE INFANT. 3. YOU HAVE A CONDITION WHERE AIR IS ENTRAPPED WITHIN YOUR BODY AND IT MIGHT EXPAND WHEN GIVEN NITROUS OXIDE (EG BOWEL OBSTRUCTION, BLOCKED MIDDLE EAR, FOLLOWING A RECENT DIVE). ASK YOUR DOCTOR FOR FULL DETAILS OF THESE CONDITIONS. 4. YOU HAVE BEEN USING IT FOR A PROLONGED PERIOD WITHOUT PROPER MONITORING OF YOUR BLOOD. Do not use Entonox if the cylinder is damaged or shows signs of tampering or it has degraded. 5. YOU ARE SMOKING OR THERE ARE NAKED FLAMES NEARBY. YOU MUST NOT SMOKE OR LIGHT ANY FLAMES WHILST Perskaitykite visą dokumentą
1 AUSTRALIAN PRODUCT INFORMATION – ENTONOX (NITROUS OXIDE / OXYGEN) 1. NAME OF THE MEDICINE Nitrous oxide and Oxygen 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Nitrous oxide 50% v/v Oxygen 50% v/v Entonox is a homogenous gas mixture of oxygen and nitrous oxide in equal volumetric proportions. Nitrous oxide is the active ingredient. There are no excipients. 3. PHARMACEUTICAL FORM Compressed medical gas mixture (for medicinal use only). Nitrous oxide is a sweet smelling colourless non-irritating gas. Oxygen is a colourless, odourless and tasteless gas. Nitrous oxide is not very soluble in water and has a low solubility in blood and tissues. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Nitrous oxide with oxygen (Entonox) is indicated in adults and children for analgesia. 4.2 DOSE AND METHOD OF ADMINISTRATION Entonox should only be administered by medical personnel trained in the appropriate techniques and in an adequate environment with access to adequate resuscitation equipment. Cylinders should only be used in conjunction with special Entonox gas pressure regulators and demand valves. Entonox is self-administered and inhaled via a demand valve through a face mask or mouthpiece. The gas is breathed in by the patient on demand and absorbed through the lungs. In dentistry, the use of a double mask is recommended, alternatively, a mask with adequate scavenging/ventilation should be used. 4.3 CONTRAINDICATIONS Hypersensitivity to nitrous oxide or any other component in the gas is a contraindication. Nitrous oxide should not be used with any condition where air is entrapped within a body and where its expansion might be dangerous, such as: the presence of intracranial air; artificial, traumatic or spontaneous pneumothorax; pneumopericardium; air (or gas) embolism; severe head trauma; decompression sickness; following a recent dive; severe bullous emphysema; during myringoplasty; occluded middle ear; cysts; gross abdominal distension; maxillofacial injuries, following cardiopulmonary bypass or air encephalograp Perskaitykite visą dokumentą