Χώρα: Αυστραλία
Γλώσσα: Αγγλικά
Πηγή: Department of Health (Therapeutic Goods Administration)
propofol, Quantity: 200 mg
Baxter Healthcare Pty Ltd
Propofol
Injection, emulsion
Excipient Ingredients: medium chain triglycerides; sodium oleate; glycerol; sodium hydroxide; water for injections; egg lecithin; Soya Oil
Intravenous
5 vials
(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 MCT-LCT 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 MCT-LCT 1% may also be used in adults for sedation of ventilated patients receiving intensive care. PROVIVE MCT-LCT 1% may also be used in adults for monitored conscious sedation for surgical and diagnostic procedures.
Visual Identification: White, oil in water emulsion, in clear glass vial.; Container Type: Vial; Container Material: Glass; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius
Licence status A
2010-03-05
Consumer Medicine Information - Provive MCT-LCT CMI – 20190104 Page 1 of 4 PROVIVE MCT-LCT 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 MCT-LCT 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 MCT-LCT 1% IS USED FOR AND HOW IT WORKS _General anaesthesia _ Provive MCT-LCT 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 MCT-LCT 1% can be used for very short operations when only one injection is needed. Provive MCT-LCT 1% can be used throughout longer operations if more is given as repeated doses. Provive MCT-LCT 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 MCT-LCT 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 MCT-LCT 1% can also be used in intensive care wards for adults and adolescents o Διαβάστε το πλήρες έγγραφο
Version .3.0 1 of 17 AUSTRALIAN PRODUCT INFORMATION – PROVIVE MCT-LCT 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 (50 mg/mL) and 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 MCT-LCT 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 of general anaesthesia in adults and in children aged one month and older. Provive MCT-LCT 1% has no analgesic properties. Short acting anaesthetic agent suitable for maintenance of general anaesthesia in adults and children aged 3 years or older. Provive MCT-LCT 1% may also be used for maintenance of general anaesthesia in children aged from 1 month to 3 years for procedures not exceeding 60 minutes unless alternative anaesthetic agents should be avoided. Provive MCT-LCT 1% may also be used in adults for sedation of ventilated patients receiving intensive care. Provive MCT-LCT 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 MCT-LCT 1%. Provive MCT-LCT 1% is for single use in one patient only. Provive MCT-LCT 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 Version .3.0 2 Διαβάστε το πλήρες έγγραφο