国家: 澳大利亚
语言: 英文
来源: Department of Health (Therapeutic Goods Administration)
propofol, Quantity: 10 mg/mL
B Braun Australia Pty Ltd
Propofol
Injection, intravenous infusion
Excipient Ingredients: glycerol; medium chain triglycerides; Soya Oil; egg lecithin; sodium oleate; water for injections
Intravenous
5 x 20 mL
(S4) Prescription Only Medicine
Induction of General Anaesthesia in Children and Adults Propofol-Lipuro 1% is a short-acting intravenous anaesthetic agent suitable for induction of general anaesthesia in adults and children aged one month and older. Maintenance of General Anaesthesia in Children and Adults Propofol-Lipuro 1% is a short-acting intravenous anaesthetic agent suitable for maintenance of general anaesthesia in adults and children aged 3 years and older. Propofol-Lipuro 1% may also be used for maintenance of general anaesthesia in children aged from one month to 3 years for procedures not exceeding 60 minutes, unless alternative anaesthetic agents should be avoided. Propofol-Lipuro has no analgesic properties. Sedation during Intensive Care in Adults Propofol-Lipuro 1% may be used in adults for sedation of ventilated patients receiving intensive care. Conscious Sedation for Surgical and Diagnostic Procedures in Adults Propofol-Lipuro 1% may also be used in adults for monitored conscious sedation for surgical and diagnostic procedures.
Visual Identification: white, milky oil in water emulsion; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius
Registered
2009-11-20
B.Braun Australia Pty Ltd Page 1 CONSUMER MEDICINE INFORMATION PROPOFOL-LIPURO 1% AND 2% 1. What is in this leaflet This leaflet contains some common questions about Propofol-Lipuro. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist All medicines have risks and benefits. Your doctor or pharmacist has weighed the risk of you taking this medicine against the benefits they expect it will have for you. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. 2. What is Propofol-Lipuro used for? It is a short-acting sleep inducing medicinal product used to start and sustain a general anaesthesia. It is used to induce sleep or lower your level of consciousness (as a sedative) during intensive care or during diagnostic or surgical procedures. 3. Before you are given Propofol-Lipuro _WHEN YOU MUST NOT BE GIVEN PROPOFOL-LIPURO _ _ _ Do not use Propofol-Lipuro: if you are allergic (hypersensitive) to Propofol or any of the other ingredients of Propofol-Lipuro if you are allergic (hypersensitive) to soya or peanut _TAKE SPECIAL CARE WITH PROPOFOL-LIPURO IF: _ you have a disorder in which your body does not handle fat properly you have any other health problems which require much caution in the use of fat emulsions you are very overweight your blood volume is too low (hypovolaemia) you are very weak or have heart, circulatory, kidney or liver problems you have high pressure within in the skull and low blood pressure in the arteries you have problems with your breathing you have epilepsy you are undergoing some procedures where spontaneous movements are particularly, undesirable. Please tell your doctor if you have one of these diseases or conditions. Do not give Propofol-Lipuro in children of one month of age or younger as a general anaesthetic. B.Braun Australia Pty Ltd Page 2 Do not give Propofol-Lipuro 2% in children under 3 years of age. Do not give Pro 阅读完整的文件
Version 2.1 Supersedes: Version 2.0 Page 1 of 20 AUSTRALIAN PRODUCT INFORMATION PROPOFOL-LIPURO 1% AND 2% (PROPOFOL) 1. NAME OF MEDICINE Propofol 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Propofol-Lipuro contains: _per 1 mL_ _per 20 mL ampoule or vial_ _per 50 mL bottle_ _per 100 mL bottle_ _Propofol- _ _Lipuro 1%_ _10 mg _ _propofol_ _200 mg propofol_ _500 mg propofol_ _1000 mg propofol_ _Propofol- _ _Lipuro 2%_ _20 mg _ _propofol_ _ _ _ _ _-_ _1000 mg propofol_ _-_ Contains egg lecithin and soya oil. For the full list of excipients, see section 6.1 List of excipients. 3. PHARMACEUTICAL FORM Sterile, milky white, isotonic, oil in water emulsion for intravenous infusion or injection containing 10 mg propofol per 1 mL (Propofol-Lipuro 1%) or 20 mg propofol per 1 mL (Propofol-Lipuro 2%). 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Because of the difficulty in titrating small volumes, Propofol-Lipuro 2% should not be used in children aged from one month to 3 years. INDUCTION OF GENERAL ANAESTHESIA IN CHILDREN AND ADULTS Propofol-Lipuro is a short-acting intravenous anaesthetic agent suitable for induction of general anaesthesia in adults and children aged one month and older. MAINTENANCE OF GENERAL ANAESTHESIA IN CHILDREN AND ADULTS Propofol-Lipuro is a short acting intravenous anaesthetic agent suitable for maintenance of general anaesthesia in adults and children aged 3 years and older. Propofol-Lipuro 1% may also be used for maintenance of general anaesthesia in children aged from one month to 3 years for procedures not exceeding 60 minutes, unless alternative anaesthetic agents should be avoided. Propofol has no analgesic properties. Version 2.1 Supersedes: Version 2.0 Page 2 of 20 SEDATION DURING INTENSIVE CARE IN ADULTS Propofol-Lipuro may also be used in patients >16 years for sedation of ventilated patients receiving intensive care. CONSCIOUS SEDATION FOR SURGICAL AND DIAGNOSTIC PROCEDURES Propofol-Lipuro may also be used for monitored conscious sedation for surgical and diagnostic procedures in 阅读完整的文件