מדינה: דרום אפריקה
שפה: אנגלית
מקור: South African Health Products Regulatory Authority (SAHPRA)
Abbvie (Pty) Ltd
See ingredients
LIQUID
100 ML SEVOFLURANE 100 ML
Registered
1998-03-03
Page 1 of 5 CCDS02190617 PATIENT INFORMATION LEAFLET SCHEDULING STATUS: PROPRIETARY NAME AND DOSAGE FORM: ULTANE Liquid Sevoflurane READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU RECEIVE ULTANE Keep this leaflet. You may need to read it again. If you have further questions, please ask your doctor or your pharmacist WHAT ULTANE CONTAINS: ULTANE contains sevoflurane, which is a clear colourless liquid. WHAT ULTANE IS USED FOR: ULTANE is a breathed in (inhalation) anaesthetic used to induce and maintain a deep, pain-free sleep (general anaesthesia) in adults and children during an operation. BEFORE YOU RECEIVE ULTANE: DO NOT RECEIVE ULTANE: If you are hypersensitive (allergic) to sevoflurane or to any other inhaled anaesthetic. If you have a neuromuscular disease, especially one called Duchene muscular dystrophy. S5 Page 2 of 5 CCDS02190617 If you or any member of your family has experienced a condition called malignant hyperthermia (rapid rise in body temperature) during an operation. TAKE SPECIAL CARE WITH ULTANE: Tell your doctor, surgeon or anaesthetist if you have previously been exposed to general anaesthetics, particularly if repeated over a short period of time. Some anaesthetics can cause problems in the liver which can cause yellowing of the skin (jaundice). Tell your doctor, surgeon or anaesthetist if you are suffering from any illness, other than those connected with your operation, such as kidney, brain or heart problems, severe headaches, nausea, vomiting, or a neuromuscular disease (a condition that affects muscles e.g. Duchenne muscular dystrophy). PREGNANCY AND BREASTFEEDING: Safety of ULTANE in pregnancy and breastfeeding has not been established. The safety of ULTANE in labour and delivery has not been demonstrated. ULTANE may be used for anaesthesia during Caesarean section. If you are pregnant or could be pregnant or breastfeeding your baby while receiving ULTANE, it is important to consult your ward doctor, surgeon or anaesthetist. DRIVING AND USING MACHINERY: You sho קרא את המסמך השלם
Page 1 of 24 CCDS02190617 PACKAGE INSERT SCHEDULING STATUS: S5 PROPRIETARY NAME AND DOSAGE FORM ULTANE Liquid COMPOSITION Sevoflurane, which is chemically identified as fluoromethyl-2,2,2-trifluoro-1-(trifluoromethyl) ethyl ether. Lewis Acid Degradation: At least 300 ppm of water is added as a Lewis Acid inhibitor. No other additives or chemical stabilisers are utilised. PHARMACOLOGICAL CLASSIFICATION A 2.1 - Anaesthetics PHARMACOLOGICAL ACTION PHARMACODYNAMIC PROPERTIES Sevoflurane is a halogenated anaesthetic given by inhalation. Sevoflurane depresses respiratory function and blood pressure in a dose-related manner. Sevoflurane is a dose-related cardiac depressant. Sevoflurane does not produce increases in heart rate at doses less than 2 minimum alveolar concentration (MAC). A study investigating the epinephrine (adrenaline) induced prodysrhythmogenic effect of sevoflurane in adult patients undergoing transsphenoidal hypophysectomy demonstrated that the threshold dose of epinephrine (i.e. the dose at which the first sign of dysrhythmia was observed) producing multiple ventricular dysrhythmias was 5 micrograms/kg. Page 2 of 24 CCDS02190617 Animal studies have shown that regional blood flow (e.g. hepatic, renal, cerebral, coronary circulations) is well maintained with sevoflurane. Sevoflurane has minimal effect on neurodynamics or ICP (intracranial pressure) and preserves CO 2 responsiveness. Sevoflurane does not affect renal concentrating ability. MINIMUM ALVEOLAR CONCENTRATION (MAC): The minimum alveolar concentration (MAC) is the concentration at which 50 % of the population tested does not move in response to a single stimulus of skin incision. For MAC equivalents for sevoflurane for various age groups See DOSAGE AND DIRECTIONS FOR USE. The MAC of sevoflurane in oxygen was determined to be 2,05 % for a 40 year old adult. MAC decreases with age and with the addition of nitrous oxide Tracheobronchial tree secretions are mildly stimulated. PHARMACOKINETIC PROPERTIES Solubility: The low solubility of sevoflurane קרא את המסמך השלם