Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Propofol
Claris Lifesciences Australia Pty Ltd
Medicine Registered
PROVIVE 1% [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 Provive 1% 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 PROVIVE 1% IS USED FOR GENERAL ANAESTHESIA Provive 1% 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. Provive 1% 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. Provive 1% can be used for very short operations when only one injection is needed. Provive 1% can be used throughout longer operations if more is given as repeated doses. Provive 1% 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 Provive 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. This type of sedation may be required during certain tests or procedures. Provive 1% can also be used in intensive care wards for adults and adolescents over 16 years of age who are being ventilated (on a breat Read the complete document
PRODUCT INFORMATION PROVIVE 1% NAME OF THE DRUG Provive 1% is composed of:- _Active: _ Propofol (10 mg/mL). _Excipients: _Soya oil (100 mg/mL), glycerol (22.5 mg/mL), egg lecithin (12 mg/mL), sodium oleate (0.3 mg/mL). DESCRIPTION Chemical name: 2,6-diisopropylphenol. Chemical structure: CAS: 2078-54-8. Molecular formula: C 12 H 18 O Molecular Weight: 178 Provive 1% is a white, oil in water emulsion in a clear glass vial. PHARMACOLOGY _Pharmacodynamics: _Propofol is a short acting general anaesthetic agent with a rapid onset of action of approximately 30 seconds. Recovery from anaesthesia is usually rapid. The mechanism of action, as for other general anaesthetics, is poorly understood. The majority of pharmacodynamic properties exhibited by propofol are proportional to the dose or concentration in the blood. These dose or dose rate dependent properties include the desired therapeutic effects of mild sedation through to anaesthesia, but also include the increasing incidence of cardiac and respiratory depression seen with increasing dose. The cardiovascular effects of propofol range from a minimal reduction in blood pressure through to arterial hypotension, and a decrease in heart rate. However, the haemodynamic parameters normally remain relatively stable during maintenance and the incidence of untoward haemodynamic changes is low. Although ventilatory depression can occur following administration of propofol, any effects are qualitatively similar to those of other intravenous anaesthetic agents and are readily manageable in clinical practice. It has been reported that in patients with normal intraocular pressure that propofol anaesthesia produces a decrease in intraocular pressure, which may be associated with a conc Read the complete document