Страна: Ирландия
Език: английски
Източник: HPRA (Health Products Regulatory Authority)
PROPOFOL
UAB Norameda
N01AX10
PROPOFOL
10 Mg/Ml
Emulsion for Inj/Inf
Product subject to prescription which may not be renewed (A)
Other general anesthetics
Authorised
2011-08-19
1/10 PACKAGE LEAFLET: INFORMATION FOR THE USER PROPOFOL 10 MG/ML EMULSION FOR INJECTION/INFUSION Propofol READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What Propofol is and what it is used for 2. Before you are given Propofol 3. How you are given Propofol 4. Possible side effects 5. How to store Propofol 6. Further information. 1. WHAT PROPOFOL IS AND WHAT IT IS USED FOR Propofol belongs to a group of medicines called general anaesthetics. General anaesthetics are used to cause unconsciousness (deep sleep) while surgical operations or other procedures are being carried out. They can also be used to sedate you (make you sleepy without sending you to sleep). PROPOFOL IS USED TO: • induce and maintain general anaesthesia in adults , adolescents and children > 1 month • sedate patients > 16 years of age receiving artificial respiration in intensive care • sedate adults and children > 1 month during diagnostic and surgical procedures, alone or in combination with local or regional anaesthesia 2. BEFORE YOU ARE GIVEN PROPOFOL DO NOT USE PROPOFOL: - in patients allergic (hypersensitive) to propofol, or any of the other ingredients of this medicinal product - in patients allergic (hypersensitive) to soya or peanut - in patients of 16 years of age or younger for sedation in intensive care TAKE SPECIAL CARE WITH PROPOFOL You should not receive Propofol, or only under ext Прочетете целия документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Propofol 10 mg/ml Emulsion for injection/infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of emulsion for injection/ infusion contains 10 mg of propofol. Each 20 ml vial contains 200 mg of propofol Each 50 ml vial contains 500 mg of propofol Each 100 ml vial contains 1000 mg of propofol Excipient: Each ml of emulsion for injection/infusion contains: Soya bean oil refined 50 mg Sodium 0.035 mg. For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Emulsion for injection/infusion. White oil-in-water emulsion. Osmolality: 250 to 390 mOsm/Kg. pH between 6.00 and 8.50 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Propofol is a short-acting intravenous general anaesthetic agent for - induction and maintenance of general anaesthesia in adults and children > 1 month - sedation for diagnostic and surgical procedures, alone or in combination with local or regional anaesthesia in adults and children > 1 month - sedation of ventilated patients > 16 years of age in the intensive care unit. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Propofol must only be given in hospitals or adequately equipped day therapy units by physicians trained in anaesthesia or in the care of patients in intensive care. Circulatory and respiratory functions should be constantly monitored (e.g. ECG, pulse oxymetry) and facilities for maintenance of patient airways, artificial ventilation, and other resuscitation facilities should be immediately available at all times. For sedation during surgical and diagnostic procedures Propofol should not be administered by the same person conducting the surgical or diagnostic procedure. The dose of Propofol should be individualised based on the response of the patient and premedications used. Supplementary analgesic agents are generally required in addition to Propofol. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ Прочетете целия документ