Country: Ирска
Језик: Енглески
Извор: HPRA (Health Products Regulatory Authority)
PROPOFOL
Hospira Enterprises B.V.
PROPOFOL
10 Micromol
Emulsion for Inj/Inf
Product subject to prescription which may not be renewed (A)
Withdrawn
2013-07-31
PACKAGE LEAFLET: INFORMATION FOR THE USER PROPOFOL 10 MG/ML, EMULSION FOR INJECTION OR INFUSION Propofol READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor. - This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor. IN THIS LEAFLET: 1. What Propofol 10 mg/ml is and what it is used for 2. Before you use Propofol 10 mg/ml 3. How to use Propofol 10 mg/ml 4. Possible side effects 5 How to store Propofol 10 mg/ml 6. Further information 1. WHAT IS PROPOFOL 10 MG/ML AND WHAT IT IS USED FOR MEDICINAL PRODUCT GROUP Propofol 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 too sedate you (so that you are sleepy but not completely asleep). WHAT IS PROPOFOL USED FOR? • TO induce and maintain general anaesthesia in adults and children more than 1 month • To sedate patients more than 16 years of age receiving artificial respiration in intensive care • To sedate adults and children more than 1 month during diagnostic and surgical procedures, alone or in combination with local or regional anaesthesia 2. BEFORE YOU USE PROPOFOL 10 MG/ML DO NOT USE PROPOFOL 10 MG/ML: − in patients of 16 years of age or younger for sedation in intensive care − if you are allergic (hypersensitive) to the Propofol active substance or to any of the excipients − if you are allergic to peanut or soya. Propofol 10 mg/ml contains Soya oil. TAKE SPECIAL CARE WITH PROPOFOL 1 Прочитајте комплетан документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Propofol 10mg/ml emulsion for injection or infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml Emulsion for injection or infusion contains 10 mg Propofol. Excipient: 1 ml Emulsion for injection or infusion contains 100 mg Soya-bean oil. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Emulsion for injection or infusion. White to slight off-white emulsion for injection or infusion. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Propofol 10 mg/ml is a short acting intravenous general anaesthetic for: • Induction and maintenance of general anaesthesia in adults and children more than 1 month. • Sedation of ventilated patients more than 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 more than 1 month. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Supplemental analgesic agents are normally needed during Propofol administration. In addition, please refer to Section 4.4 Special Warnings and Special Precautions for Use, for additional usage information. _General Anaesthesia in Adults_ Induction: Propofol 10 mg/ml may be used for induction of anaesthesia as slow bolus injection or infusion. Propofol should be titrated to clinical response, where the patient shows sign of anaesthesia (usually about 20-40 mg every 10 seconds). Most adults under 55 years of age will need 1.5 to 2.5 mg/kg. Elderly patients usually need lower doses. Patients in ASA class 3 and 4, especially those with impaired cardiac function, the dosage requirements will be less and the total dose may be reduced to a minimum of 1 mg of propofol/kg body. The total dose could be reduced Прочитајте комплетан документ