Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Propofol
Phebra Pty Ltd
Medicine Registered
Propofol CMI Page 1 DBL ® PROPOFOL INJECTION Propofol _(pro-po-fole) _ CONSUMER MEDICINE INFORMATION _Date of dispensing _ _Consumer name _ _pharmacy name _ _Consumer address _ _pharmacy address _ WHAT IS IN THIS LEAFLET This leaflet answers some common questions about DBL ® Propofol Injection. It does not contain all the available information. It does not take the place of talking to your doctor or anaesthetist. All medicines have risks and benefits. Your doctor or anaesthetist has weighed the risks of you being given propofol against the benefits it is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT BEING GIVEN THIS MEDICINE, ASK YOUR DOCTOR OR ANAESTHETIST. KEEP THIS LEAFLET. You may need to read it again. WHAT DBL ® PROPOFOL INJECTION IS USED FOR _GENERAL ANAESTHESIA _ DBL ® Propofol Injection is used as a short-acting general anaesthetic in adults, and children aged 3 years or older. A general anaesthetic is a medicine which produces general anaesthesia. This is the condition of heavy sleep needed during surgery. Propofol is short-acting, which means that patients go to sleep quickly, usually within 30 seconds of receiving propofol, but then wake up quickly as it wears off. Propofol can be used for very short operations when only one injection is needed. Propofol can be used throughout longer operations if more is given as repeated doses. Propofol can also be used to start off anaesthesia (induction anaesthesia). This means the anaesthetist may change over to another anaesthetic once sleep is induced. _SEDATION _ Propofol can be given to adults and adolescents over 16 years of age in lower doses if they need to be sedated (calm) or sleepy, but do not need the heavy sleep of anaesthesia. This type of sedation may be required during certain tests or procedures. Propofol can also be us Read the complete document
Page 1 of 12 Propofol (propofol) 200mg/20mL, 1000mg/100mL, 500mg/50mL injection vial, 200mg/20mL injection ampoule 06.03.08 Version 08 PRODUCT INFORMATION PROPOFOL INJECTION NAME OF THE MEDICINE PROPOFOL The chemical name of propofol is 2,6-diisopropylphenol. Propofol has the following structural formula: The molecular weight of propofol is 178.27. CAS Number: 2078-54-8 DESCRIPTION Propofol Injection is a white, aqueous, isotonic emulsion of pH 6 to 8.5. Propofol Injection contains as the active ingredient 10mg of propofol per 1mL. It also contains the inactive ingredients glycerol, soya oil, sodium hydroxide, egg lecithin and water for injections. PHARMACOLOGY PHARMACOKINETICS Propofol is distributed rapidly with a half-life between 1.8 and 8.3 minutes. It is about 98% bound to plasma proteins. Propofol is metabolised by conjugation, probably in the liver (half-life between 34 and 64 minutes). Inactive metabolites are excreted by the kidney. Under the usual maintenance regimens, significant accumulation of propofol does not occur. Propofol has a terminal half-life of elimination of between 184 and 502 minutes which may be attributable to redistribution from poorly perfused fatty tissue. From prolonged observations, it appears that the elimination half-life of propofol may be prolonged by an extended period of sampling (ranging from 200 to 1,353 minutes). However, the blood propofol concentration during this phase is considerably lower than that likely to induce sedation and therefore prolongation of the terminal phase is not considered of clinical significance. Page 2 of 12 Propofol (propofol) 200mg/20mL, 1000mg/100mL, 500mg/50mL injection vial, 200mg/20mL injection ampoule 06.03.08 Version 08 INDICATIONS Short acting intravenous anaesthetic agent Read the complete document