País: Austrália
Língua: inglês
Origem: Department of Health (Therapeutic Goods Administration)
propofol
Sandoz Pty Ltd
Propofol
Registered
PROPOFOL SANDOZ _Propofol_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about this medicine. 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 Sandoz 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 AFTER YOUR OPERATION OR HOSPITAL STAY. You may need to read it again. WHAT PROPOFOL SANDOZ IS USED FOR _GENERAL ANAESTHESIA_ Propofol Sandoz contains propofol, which 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. Propofol Sandoz is short-acting, which means that patients go to sleep quickly, usually within 30 seconds of receiving the medication, but then wake up quickly as it wears off. Propofol Sandoz can be used for very short operations when only one injection is needed. Propofol Sandoz can be used throughout longer operations if more is given as repeated doses (maintenance anaesthesia). Propofol Sandoz can also be used to start off an anaesthetic (induction anaesthesia). This means the anaesthetist may change over to a gas anaesthetic once sleep is induced. _SEDATION_ Propofol Sandoz 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. This type of sedation may be required during certain tests or procedures. Propofol Sandoz can also be given in intensive care wards for adults and adolescents over 16 years of age who are being ventilated (on a breathing machine) to keep them sedated. 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 Leia o documento completo
200205-Propofol Sandoz-pi Page 1 of 15 AUSTRALIAN PRODUCT INFORMATION PROPOFOL SANDOZ ® (PROPOFOL) 1. NAME OF THE MEDICINE Propofol 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 mL of Propofol Sandoz contains 10 mg of propofol. List of excipients with known effect: egg lecithin, soya oil. For the full list of excipients, see Section 6.1 List of excipients. 3. PHARMACEUTICAL FORM Injection, emulsion for (intravenous infusion). Propofol Sandoz is a white, oil in water emulsion in a clear glass vial. 4. CLINICAL PARTICULARS 4.1. T HERAPEUTIC INDICATIONS Propofol Sandoz is a short acting intravenous anaesthetic agent suitable for induction and maintenance of general anaesthesia in adults and in children aged three years and older. Propofol Sandoz has no analgesic properties. Although the safety and efficacy of propofol in paediatric day surgery have not been demonstrated, it may be a useful agent in this setting and its use should not be precluded. Propofol Sandoz may also be used in adults for sedation of ventilated patients receiving intensive care. Propofol Sandoz may also be used in adults for monitored conscious sedation for surgical and diagnostic procedures. 4.2. D OSE AND METHOD OF ADMINISTRATION DOSAGE _ADULTS _ _INDUCTION OF GENERAL ANAESTHESIA _ Propofol Sandoz may be used to induce anaesthesia by slow bolus injection or infusion. In unpremedicated and in premedicated patients, it is recommended that Propofol Sandoz should be titrated (approximately 4 mL (40 mg) every ten seconds in an average healthy adult) against the response of the patient until the clinical signs show the onset of anaesthesia. Most adult patients aged less than 55 years are likely to require Propofol Sandoz at 2.0 to 2.5 mg/kg. In elderly patients, requirements will be generally less (see Elderly patients, below). In general, slower rates of infusion at induction results in a lower induction dose requirement and greater haemodynamic stability. In patients of ASA grades III and IV, lower rates of administration should be used (approxi Leia o documento completo