Страна: Австралія
мова: англійська
Джерело: Department of Health (Therapeutic Goods Administration)
propofol, Quantity: 500 mg
Baxter Healthcare Pty Ltd
Propofol
Injection, emulsion
Excipient Ingredients: Soya Oil; water for injections; egg lecithin; sodium oleate; glycerol; sodium hydroxide
Intravenous
1 vial
(S4) Prescription Only Medicine
Short acting intravenous anaesthetic agent suitable for induction and maintenance of general anaesthesia in adults and children aged three years and older. Provive 1% has no analgesic properties. Although the safety and efficacy of propofol in paediatric day surgery have not been demonstrated, it may also be a useful agent in this setting and its use should not be precluded. Provive 1% may also be used in adults for sedation of ventilated patients receiving intensive care. Provive 1% may also be used in adults for monitored conscious sedation and diagnostic procedures.
Visual Identification: White oil-in-water emulsion in a clear glass vial.; Container Type: Vial; Container Material: Glass; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius
Licence status A
2005-05-06
Consumer Medicine Information – Provive 1% CMI – 20190107 Page 1 of 4 PROVIVE 1 % Propofol Emulsion for Intravenous Injection or Infusion 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. IF YOU HAVE ANY CONCERNS ABOUT BEING_ _ADMINISTERED THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET. You may need to read it again. WHAT PROVIVE 1% IS USED FOR AND HOW IT WORKS _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 MCT- LCT 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 breathing machine) to ke Прочитайте повний документ
Version 3.0 1 of 17 AUSTRALIAN PRODUCT INFORMATION – PROVIVE 1% (PROPOFOL) EMULSION FOR INTRAVENOUS INJECTION, OR INFUSION 1 NAME OF THE MEDICINE Propofol 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Active Ingredient: Propofol (10 mg/mL). List of excipients with known effect: Soya oil (100 mg/mL), Egg lecithin (12 mg/mL). For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Emulsion for intravenous injection, or infusion. Provive 1% is a white, oil in water emulsion in a clear glass vial. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Short acting intravenous anaesthetic agent suitable for induction and maintenance of general anaesthesia in adults and in children aged three years and older. Provive 1% 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. Provive 1% may also be used in adults for sedation of ventilated patients receiving intensive care. Provive 1% may also be used in adults for monitored conscious sedation for surgical and diagnostic procedures. 4.2 DOSE AND METHOD OF ADMINISTRATION Aseptic technique (see Section 4.4 Special warnings and precautions for use): Strict aseptic technique must always be maintained during the handling of Provive 1%. Provive 1% is for single use in one patient only. Provive 1% can support the growth of microorganisms as it is not an antimicrobially preserved product. 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). There have been reports in which failure to use aseptic technique when handling propofol products was Version 3.0 2 of 17 associated with microbial contamination of the product and with fever, infection/ sepsis, other life-threatening illness, and/or death. ADULTS _Induction of general a Прочитайте повний документ