Ülke: Avustralya
Dil: İngilizce
Kaynak: Department of Health (Therapeutic Goods Administration)
sevoflurane, Quantity: 1 mL/mL
Sandoz Pty Ltd
Inhalation
Excipient Ingredients:
Inhalation
1
(S4) Prescription Only Medicine
Sevoflurane Sandoz may be used for induction and maintenance of general anaesthesia in adult and paediatric patients undergoing surgery
Visual Identification: Clear, colourless, volatile liquid inside a 250 mL, amber, Type III glass bottle with a collar on the neck, sealed with a poly-seal cap, and secured with PET film; Container Type: Bottle; Container Material: Glass Type III Coloured; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2020-03-12
SEVOFLURANE SANDOZ 1 SEVOFLURANE SANDOZ® _Sevoflurane _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about SEVOFLURANE SANDOZ. It does not contain all the information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking SEVOFLURANE SANDOZ against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET. You may need to read it again. WHAT SEVOFLURANE SANDOZ IS USED FOR Sevoflurane belongs to a group of medicines called halogenated anaesthetic agents, which are breathed in to induce and/or maintain anaesthesia. This medicine is administered by an anaesthetist in the air you breathe when you for surgery. It is a colourless liquid supplied in a bottle. It is given by your anaesthetist using a vaporiser, which turns the liquid into a gas so that you can breathe it in. SEVOFLURANE SANDOZ is used for inducing and maintaining heavy sleep needed during surgery. The medicine produces loss of consciousness and pain sensations during surgery. ASK YOUR DOCTOR IF YOU HAVE QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. BEFORE YOU RECEIVE SEVOFLURANE SANDOZ _BEFORE YOU ARE DUE TO _ _RECEIVE SEVOFLURANE _ _SANDOZ _ YOU MUST TELL YOUR DOCTOR IF 1. YOU HAVE PREVIOUSLY HAD ANY PROBLEMS WITH A GENERAL ANAESTHETIC. 2. YOU, OR ANYONE IN YOUR FAMILY HAS MALIGNANT HYPERTHERMIA (A RARE TYPE OF SEVERE FEVER). 3. YOU HAVE RECENTLY HAD ANY OTHER GENERAL ANAESTHETIC, OR HAD MORE THAN ONE GENERAL ANAESTHETIC OVER A SHORT PERIOD OF TIME 4. YOU HAVE HAD SEVOFLURANE SANDOZ BEFORE AND EXPERIENCED AN ALLERGIC REACTION. 5. YOU HAVE OR HAVE HAD THE FOLLOWING MEDICAL CONDITIONS: • Any problems with your liver including hepatitis • Growths or abnormalities in your brain • Heart disease; for example coronary artery disease, high or low blood pressure • Lung problems, for example asthma Belgenin tamamını okuyun
200706-sevoflurane-sandoz-pi Page 1 of 20 AUSTRALIAN PRODUCT INFORMATION SEVOFLURANE SANDOZ (SEVOFLURANE) INHALATION BOTTLE 1. NAME OF THE MEDICINE Sevoflurane 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Sevoflurane is a non-flammable and non-explosive liquid administered by vaporisation. Sevoflurane Sandoz is a clear, colourless, stable liquid. At least 500 ppm of water is present to provide protection from environmental Lewis acids. No other additives or chemical stabilisers are used. It is non-pungent. Some physical constants of the compound are: Specific gravity at 20 o C 1.520 - 1.525 Boiling point (760 mm Hg) 58.6°C Vapour pressure in mm Hg 157 mm Hg at 20°C 197 mm Hg at 25°C 317 mm Hg at 36°C Distribution Partition Coefficients at 37°C: Blood / Gas 0.63 - 0.69, Water / Gas 0.36, Olive Oil / Gas 47.2 - 53.9, Brain / Gas 1.15 Mean Component/Gas Partition Coefficient at 25°C: Conductive rubber 14.0, Isobutylene/isoprene copolymer (butyl rubber) 7.7, Polyvinyl chloride 17.4, Polyethylene 1.3 3. PHARMACEUTICAL FORM Sevoflurane is a non-flammable and non-explosive liquid administered by vaporisation. Sevoflurane Sandoz is a clear, colourless, stable liquid. 4. CLINICAL PARTICULARS 4.1. T HERAPEUTIC INDICATIONS Sevoflurane Sandoz may be used for induction and maintenance of general anaesthesia in adult and paediatric patients undergoing surgery. 4.2. D OSE AND METHOD OF ADMINISTRATION The concentration of sevoflurane being delivered from a vaporiser during anaesthesia should be known. This may be accomplished by using a vaporiser calibrated specifically for sevoflurane. PREMEDICATION Premedication should be selected according to the need of the individual patient, and at the discretion of the anaesthetist. 200706-sevoflurane-sandoz-pi Page 2 of 20 INDUCTION Dosage should be individualised and titrated to the desired effect according to the patient's age and clinical status. A short acting barbiturate or other intravenous induction agent may be administered followed by inhalation of sevoflurane. Induction wi Belgenin tamamını okuyun