国家: 澳大利亚
语言: 英文
来源: Department of Health (Therapeutic Goods Administration)
sevoflurane, Quantity: 1 mL/mL
Device Technologies Australia Pty Ltd
Sevoflurane
Inhalation
Excipient Ingredients:
Inhalation
1 x 250 mL bottle
(S4) Prescription Only Medicine
Piramal Sevoflurane may be used for induction and maintenance of general anaesthesia in adult and paediatric patients undergoing surgery.
Visual Identification: clear, colourless liquid; Container Type: Bottle; Container Material: Glass Type III Coloured; Container Life Time: 5 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
2014-02-28
Piramal Sevoflurane™ CMI Version 3 – 18 July 2014 Page 1 of 2 PIRAMAL SEVOFLURANE™ _SEVOFLURANE _ _ _ Liquid for inhalation, anaesthetic 100% v/v bottle CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET? This leaflet answers some common questions about Piramal Sevoflurane™. It does not contain all the available 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 Piramal Sevoflurane™ 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 PIRAMAL SEVOFLURANE ™ IS USED FOR? Piramal 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 go for surgery. It is a colourless liquid supplied in a glass bottle. It is given by your anaesthetist using a vaporiser, which turns the liquid into a gas so that you can breathe it in. Piramal Sevoflurane™ 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 ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU . BEFORE YOU RECEIVE PIRAMAL SEVOFLURANE ™ _BEFORE YOU ARE DUE TO _ _RECEIVE PIRAMAL _ _SEVOFLURANE_ ™ 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 PIRAMAL SEVOFLURANE™ BEFORE AND EXPERIENCED AN ALLERGIC REACTION. 5. YOU HAVE OR HAVE HAD THE FOLLOWING MEDICAL CONDITIONS: Any problems with your liver including hep 阅读完整的文件
AUSTRALIAN PRODUCT INFORMATION PIRAMAL SEVOFLURANE™ (SEVOFLURANE) INHALATION Piramal Sevoflurane™ PI Page 1 of 20 1. NAME OF THE MEDICINE Sevoflurane 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Piramal Sevoflurane TM inhalation contains sevoflurane 100%v/v. Sevoflurane is a non-flammable and non-explosive liquid administered by vaporisation. Not more than 130ppm of water is present in Piramal Sevoflurane TM . No other additives or chemical stabilisers are used. It is non-pungent. 3. PHARMACEUTICAL FORM Piramal Sevoflurane™ is an inhalation anaesthetic. Piramal Sevoflurane TM is a clear, colourless, stable liquid. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Piramal Sevoflurane™ may be used for induction and maintenance of general anaesthesia in adult and paediatric patients undergoing surgery. 4.2 DOSE 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. Filling occurs directly from the bottle with an integrated adaptor, multi-component closure or, in the case of the bottle without the integrated adaptor multi-component closure, with the use of an appropriate adaptor calibrated specifically to fit the sevoflurane vaporiser. PREMEDICATION Premedication should be selected according to the need of the individual patient, and at the discretion of the anaesthetist. 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 with sevoflurane may be achieved in oxygen or in combination with oxygen-nitrous oxide mixtures. In adults inspired concentrations of up to 5% sevoflurane usually produce surgical anaesthesia in less than 2 minutes. In children inspired concentrations of up to 7% sevoflurane usually produce surgical anaesthesia in less than 阅读完整的文件