מדינה: אוסטרליה
שפה: אנגלית
מקור: Department of Health (Therapeutic Goods Administration)
propofol, Quantity: 10 g/L
Fresenius Kabi Australia Pty Ltd
Propofol
Injection, emulsion
Excipient Ingredients: medium chain triglycerides; water for injections; glycerol; sodium hydroxide; Soya Oil; egg lecithin; oleic acid
Intravenous
10 x 100mL bottles
Medicine Registered
(S4) Prescription Only Medicine
Induction of General Anaesthesia in Children and Adults,Fresofol (1 percent) MCT / LCT 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,Fresofol (1 percent) MCT / LCT is a short acting intravenous anaesthetic agent suitable for maintenance of general anaesthesia in adults and children aged 3 years and older.,Fresofol (1 percent) MCT / LCT 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.,Fresofol (1 percent) MCT / LCT has no analgesic properties. ,Sedation During Intensive Care in Adults,Fresofol (1 percent) MCT / LCT may also be used in adults for sedation of ventilated patients receiving intensive care.,Conscious Sedation for Surgical and Diagnostic Procedures in Adults,Fresofol (1 percent) MCT / LCT may also be used in adults for monitored conscious sedation for surgical and diagnostic procedures.
Visual Identification: Fresofol 1% MCT/LCT is a sterile, milky white, isotonic, oil-in-water emulsion for intravenous infusion or injection.; Container Type: Bottle; Container Material: Glass Type II Clear; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius
Registered
2012-11-23
CMI for Fresofol 1% MCT/LCT Mar 2016 Filename: FremCMI160316-clean Page 1 of 4 Change: Address Change FRESOFOL ® 1% MCT/LCT Propofol 1% w/v CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet contains some common questions about Fresofol 1% MCT/LCT. 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. WHAT IS FRESOFOL 1% MCT/LCT 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. BEFORE YOU ARE GIVEN FRESOFOL 1% MCT/LCT _ _ _WHEN _ _YOU _ _MUST _ _NOT _ _BE _ _GIVEN _ _FRESOFOL 1% MCT/LCT _ Do not use Fresofol 1% MCT/LCT: if you are allergic (hypersensitive) to Propofol or any of the other ingredients of Fresofol 1% MCT/LCT if you are allergic (hypersensitive) to soya or peanut _ _ _TAKE SPECIAL CARE WITH FRESOFOL _ _1% MCT/LCT IF: _ you have a disorder in which your body does not handle fat properly you have any other health problems which require 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 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 Fresofol 1% MCT/LCT in children of one month of age or younger as a general anae קרא את המסמך השלם
AUSTRALIAN PRODUCT INFORMATION- FRESOFOL® 1% MCT/LCT (PROPOFOL) Page 1 of 18 1 NAME OF MEDICINE Propofol 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Fresofol 1% MCT/LCT is a sterile, milky white, isotonic, oil-in-water emulsion for intravenous infusion or injection. 1 mL of Fresofol 1% MCT/LCT contains 10 mg propofol. It also contains the following excipients: soya oil, medium chain triglycerides, glycerol, egg lecithin, sodium hydroxide, oleic acid and water for injections. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Injection for emulsion. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Induction of General Anaesthesia in Children and Adults Fresofol 1% MCT/LCT 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 Fresofol 1% MCT/LCT is a short acting intravenous anaesthetic agent suitable for maintenance of general anaesthesia in adults and children aged 3 years and older. Fresofol 1% MCT/LCT 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. Fresofol 1% MCT/LCT has no analgesic properties. Sedation During Intensive Care in Adults Fresofol 1% MCT/LCT may also be used in adults for sedation of ventilated patients receiving intensive care. Conscious Sedation for Surgical and Diagnostic Procedures in Adults Fresofol 1% MCT/LCT may also be used in adults for monitored conscious sedation for surgical and diagnostic procedures. 4.2 DOSE AND METHOD OF ADMINISTRATION Strict aseptic technique must always be maintained during handling. Do not use if contamination is suspected. Discard unused portions as directed within the required time limits (see also: 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE, Aseptic Technique). Adults _Induction of General Anaesthesia _ Fresofol 1% MCT/LCT ma קרא את המסמך השלם