国: アイルランド
言語: 英語
ソース: HPRA (Health Products Regulatory Authority)
ISOFLURANE
Baxter Healthcare Limited
ISOFLURANE
100 %v/v
Inhalation Vapour Liquid
Product subject to prescription which may not be renewed (A)
Authorised
0000-00-00
EMEA AR TWORK DESIGN CENTRE AR TWORK APPROV AL 3RD DRAFT DA TE 06 NO V 2013 RA TO APPROVE LA YOUT AND FORMA T PLANT APPROV AL HALLE ONL Y COUNTR Y N/A NAME N/A SIGNATURE N/A DATE N/A BE-30-02-137 1 READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE. 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, nurse or pharmacist. • If you get any side effects, talk to your doctor, nurse or pharmacist. This includes any possible side effects not listed in this leaflet IN THIS LEAFLET: 1. What AErrane is and what it is used for 2. What you need to know before you are given AErrane 3. How you will be given AErrane 4. Possible side effects 5. How to store AErrane 6. Contents of the pack and other information 1. WHAT AERRANE IS AND WHAT IT IS USED FOR AErrane contains isoflurane. AErrane is a general anaesthetic used in surgery. It is an inhalation anaesthetic (it is given to you as a vapour for you to breathe in). Breathing in isoflurane vapour causes you to fall into a deep, painless sleep. It also maintains a deep, painless sleep (general anaesthesia) during which you can undergo surgery. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN AERRANE YOUR DOCTOR WILL NOT GIVE YOU AERRANE IF: • you are allergic (hypersensitive) to isoflurane or other inhalation anaesthetics such as desflurane, sevoflurane, halothane and enflurane • you, or any relative suffer from a condition called malignant hyperthermia. Malignant hyperthermia is when you suddenly develop a dangerously high body temperature during or shortly after surgery. • following anaesthesia with AErrane or other inhalation anaesthetics (e.g. desflurane, sevoflurane, halothane) in the past, you have had: – liver problems – jaundice (yellowing of the skin and white of the eyeballs) – unexplained fever – increased levels of white blood cells called leucocytes (leucocytosis) – increased lev 完全なドキュメントを読む
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT AErrane (isoflurane), 100% v/v inhalation vapour, liquid 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Isoflurane 100% v/v. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Inhalation vapour, liquid Clear, colourless liquid. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Induction and maintenance of general anaesthesia in adults and children. Use of isoflurane in dental anaesthesia should be restricted to hospitals or day care units only (see Contraindications, Section 4.3). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION In order to be able to accurately control the precise concentration of isoflurane, vaporisers that have been specially calibrated for isoflurane should be used. Induction To avoid excitement and because of the irritant effects on the respiratory tract, an intravenous induction agent should be administered, followed by inhalation of isoflurane. Induction should be initiated at 0.5%. Concentrations of 1.5 - 3.0% in O 2 or O 2 /N 2 O usually produce surgical anaesthesia in 7 -10 minutes. Maintenance The usual concentration is 1 - 2.5% in O 2 /N 2 O or 1.5 – 3.5% with O 2 alone. For Caesarean section, 0.5 - 0.75% in a mixture of O 2 /N 2 O is suitable. Recovery The concentration of AErrane must be reduced to 0.5% at the end of the operation, or to 0% during closure of the wound to allow prompt recovery. If all administration of anaesthetic agents has been stopped, the air passages of the patient should be ventilated several times with 100% oxygen until complete awakening occurs. If the vector gas is a mixture of 50% O 2 and 50% N 2 O, the value of the minimum alveolar concentration of isoflurane is approximately 0.65%. IRISH MEDICINES BOARD ______________________________________________ 完全なドキュメントを読む