Maa: Irlanti
Kieli: englanti
Lähde: HPRA (Health Products Regulatory Authority)
Propofol
Fresenius Kabi Limited
N01AX; N01AX10
Propofol
2 percent weight/volume
Emulsion for injection/infusion
Product subject to prescription which may not be renewed (A)
Other general anesthetics; propofol
Not marketed
2001-11-02
UK-IE Leaflet Propofol 2%_V004 1 PACKAGE LEAFLET: INFORMATION FOR THE USER PROPOFOL 2 % (20 MG/1 ML) FRESENIUS EMULSION FOR INJECTION OR INFUSION Propofol READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor, pharmacist or nurse. - If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Propofol Fresenius is and what it is used for 2. What you need to know before you are given Propofol Fresenius 3. How to use Propofol Fresenius 4. Possible side effects 5. How to store Propofol Fresenius 6. Contents of the pack and other information 1. WHAT PROPOFOL FRESENIUS IS AND WHAT IT IS USED FOR Propofol Fresenius belongs to a group of medicines called ‘general anaesthetics’. General anaesthetics are used to cause unconsciousness (sleep) so that surgical operations or other procedures can be performed. They can also be used to sedate you (so that you are sleepy but not completely asleep). PROPOFOL 2 % (20 MG/1 ML) FRESENIUS IS USED TO: induce and maintain general anaesthesia in adults and children > 3 years. sedate patients > 16 years of age receiving artificial respiration in intensive care. sedate adults and children > 3 years during diagnostic and surgical procedures, alone or in combination with local or regional anaesthesia. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN PROPOFOL FRESENIUS DO NOT USE PROPOFOL FRESENIUS - if you are allergic to propofol or any of the other ingredients of this medicine (listed in section 6). - if you are allergic to soya or peanut (see “Propofol Fresenius contains soya-bean oil and sodium” at the end of section 2). - in patients of 16 years of age or younger for sedation in intensive care. WARNINGS AND PRECAUTIONS Talk to your doctor, pharmacist or nurse before you are g Lue koko asiakirja
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Propofol 2 % (20 mg/1 ml) Fresenius emulsion for injection or infusion, vial. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml emulsion contains 20mg propofol. Each 50 ml vial contains 1000 mg propofol. Each 100 ml vial contains 2000 mg propofol. Excipients with known effect: 1 ml emulsion contains: soya-bean oil, refined 100 mg sodium max. 0.06 mg For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Emulsion for injection or infusion. White oil-in-water emulsion. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Propofol 2 % (20 mg/1 ml) Fresenius is a short-acting intravenous general anaesthetic for - induction and maintenance of general anaesthesia in adults and children > 3 years - sedation for diagnostic and surgical procedures, alone or in combination with local or regional anaesthesia in adults and children > 3 years - sedation of ventilated patients > 16 years of age in the intensive care unit 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Propofol Fresenius 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 Fresenius should not be administered by the same person conducting the surgical or diagnostic procedure. The dose of Propofol Fresenius emulsion should be individualised based on the response of the patient and premedications used. Supplementary analgesic agents are generally required in addition to Propofol Fresenius. POSOLOGY GENERAL ANAESTHESIA IN ADULTS Induction of anaesthesia: 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 ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ __ Lue koko asiakirja