Страна: Мальта
мова: англійська
Джерело: Medicines Authority
PROPOFOL
B Braun Melsungen AG Carl-Braun-Strasse 1, D34212 Melsungen, Germany
N01AX10
PROPOFOL 10 mg/ml
EMULSION FOR INFUSION OR INJECTION
PROPOFOL 10 mg/ml
POM
ANESTHETICS
Authorised
2006-10-27
Page 1 of 7 PACKAGE LEAFLET: INFORMATION FOR THE USER PROPOFOL-LIPURO 10 MG/ML EMULSION FOR INJECTION OR INFUSION Propofol READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 or pharmacist. ● If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Propofol-Lipuro is and what it is used for 2. What you need to know before you use Propofol-Lipuro 3. How to use Propofol-Lipuro 4. Possible side effects 5. How to store Propofol-Lipuro 6. Contents of the pack and other information 1. WHAT PROPOFOL-LIPURO IS AND WHAT IT IS USED FOR Propofol-Lipuro 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 Lipuro is used to: ● induce and maintain general anaesthesia in adults 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. WHAT YOU NEED TO KNOW BEFORE YOU USE PROPOFOL-LIPURO DO NOT USE PROPOFOL-LIPURO: ● if you are allergic to propofol, soya, peanut or any of the other ingredients of this medicine (listed in section 6). It must not be used in patients of 16 years of age or younger for sedation during intensive care. Safety and efficacy for these age groups have not been demonstrated. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before receiving Propofol. Special care has to be taken ● if you have serious head injuries, ● if you have a mitochondrial disease, Page 2 of 7 Прочитайте повний документ
Page 1 of 13 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Propofol-Lipuro 10 mg/ml emulsion for injection or infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Propofol-Lipuro 10 mg/ml contains per 1 ml per 10 ml ampoule per 20 ml ampoule or vial per 50 ml vial per 100 ml vial Propofol 10 mg 100 mg 200 mg 500 mg 1000 mg Excipients with known effect 1 ml emulsion for injection or infusion contains Soya-bean oil, refined 50 mg For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Emulsion for injection or infusion White milky oil-in-water emulsion 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Propofol-Lipuro 10 mg/ml is a short-acting intravenous general anaesthetic for ● induction and maintenance of general anaesthesia in adults and children > 1 month ● sedation of ventilated patients > 16 years of age in the intensive care unit ● sedation for diagnostic and surgical procedures, alone or in combination with local or regional anaesthesia in adults and children > 1 month. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION GENERAL INSTRUCTIONS Propofol-Lipuro 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 oximeter) and facilities for maintenance of patent airways, artificial ventilation, and other resuscitation facilities should be immediately available at all times. For sedation during surgical or diagnostic procedures Propofol-Lipuro should not be given by the same person that carries out the surgical or diagnostic procedure. Page 2 of 13 Supplementary analgesic medicinal products are generally required in addition to Propofol-Lipuro. _POSOLOGY _ Propofol-Lipuro is given intravenously. The dosage is adjusted individually according to the patient’s response. ● _General anaesthesia in adults _ Induction of anaesthesia: For induction of anaesthesia Propofol-Lipuro should be ti Прочитайте повний документ