Země: Austrálie
Jazyk: angličtina
Zdroj: Department of Health (Therapeutic Goods Administration)
propofol, Quantity: 10 mg/mL
Fresenius Kabi Australia Pty Ltd
Injection, emulsion
Excipient Ingredients: Soya Oil; water for injections; egg lecithin; sodium hydroxide; oleic acid; glycerol
Intravenous
1 vial
(S4) Prescription Only Medicine
FRESOFOL 1% is a short-acting intravenous anaesthetic agent suitable for the induction and maintenance of general anaesthesia in adults and children aged three years and older. FRESOFOL 1% has no analgesic properties. Although the safety and efficacy of FRESOFOL 1% in paediatric day surgery have not been demonstrated, it may be a useful agent in this setting and its use should not be precluded. FRESOFOL 1% may also be used in adults for the sedation of ventilated patients receiving intensive care, and for monitored conscious sedation for surgical and diagnostic procedures.
Visual Identification: white, homogenous emulsion; Container Type: Vial; Container Material: Glass Type II Clear; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius
Licence status A
2004-11-24
Mar, 2016 CMI FOR FRESOFOL Filename: FreCMI160316-clean Page 1 of 3 Change: Address change FRESOFOL 1% Propofol 1% w/v CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Fresofol 1%. 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 Fresofol 1% against the benefits it is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR ANAESTHETIST. KEEP THIS LEAFLET. YOU MAY NEED TO READ IT AGAIN. WHAT IS FRESOFOL 1% USED FOR GENERAL ANAESTHESIA Fresofol 1% contains propofol, which is used as a short-acting general anaesthetic in adults and children aged 3 years or older. Fresofol 1% is a general anaesthetic agent that puts you in heavy sleep which is needed during surgery. Fresofol 1% is short-acting which means that once you are given Fresofol 1% it will put you to sleep quickly, usually within 30 seconds. You will wake up quickly as the effect wears off. If you are undergoing surgery, Fresofol 1% can be used to put you to sleep, and then your anaesthetist may give you more Fresofol 1% or he/she may change over to a gas anaesthetic to keep you asleep during surgery. SEDATION Fresofol 1% can be given to adults and adolescents over 16 years of age in lower doses if they need to be sedated or sleepy, but do not need the heavy sleep of anaesthesia. Fresofol 1% can also be given slowly (by a special pump) if you need to be sedated. This may be necessary during special tests or procedures or after an operation. Your anaesthetist or doctor may need to give you a pain-relieving or relaxing medicine as well. Ask your doctor or anaesthetist if you have any questions about why this medicine has been prescribed for you. Your doctor or anaesthetist may have prescribed it for another reason. Fresofol 1% is not addictive. Fresofol 1% is available only with a doctor Přečtěte si celý dokument
Page 1 of 17 AUSTRALIAN PRODUCT INFORMATION FRESOFOL ® 1 % (PROPOFOL) 1 NAME OF MEDICINE Propofol 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 mL of Fresofol 1% injection contains propofol 10 mg. It also contains; soya oil and egg lecithin. For the full list of excipients see section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM Propofol is a clear colourless to straw yellow liquid with a typical odour. Fresofol 1% injection is a white, isotonic (oil-in water) emulsion and is designed for intravenous injection. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Fresofol 1% is a short-acting intravenous anaesthetic agent suitable for the induction of general anaesthesia in adults and children aged three years and older. Fresofol 1% has no analgesic properties. Although safety and efficacy of Fresofol 1% in paediatric day surgery have not been demonstrated, it may be a useful agent in this setting and its use should not be precluded. Fresofol 1% may also be used in adults for the sedation of ventilated patients receiving intensive care. Fresofol 1% may also be used in adults for monitored conscious sedation for surgical and diagnostic procedures. 4.2 DOSE AND METHOD OF ADMINISTRATION Dosage and Administration (see also Aseptic Technique) Strict aseptic technique must always be maintained during handling. Fresofol 1% injection is a single patient use only parenteral product which does not contain any antimicrobial preservative. Accordingly, strict aseptic technique must still be adhered to. Do not use if contamination is suspected. Discard unused portions as directed within the required time limits (see section 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE- Aseptic Technique and 6.3 SHELF LIFE). There have been reports in which failure to use aseptic technique when handling Fresofol 1% injection was associated with microbial contamination of the product and with fever, infection/sepsis, other life-threatening illness, and/or death. ADULTS a) Induction of general anaesthesia Page 2 of 17 Fresofol 1% may be used to in Přečtěte si celý dokument