Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Desflurane
Baxter Holding B.V.
N01AB; N01AB07
Desflurane
100 percent volume/volume
Inhalation vapour, solution
Halogenated hydrocarbons; desflurane
Marketed
1999-12-16
PACKAGE LEAFLET: INFORMATION FOR THE USER SUPRANE 100% INHALATION VAPOUR, SOLUTION Active substance: desflurane READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE BECAUSE 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 or pharmacist. • If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4. IN THIS LEAFLET: 1. What Suprane is and what it is used for 2. What you need to know before you are given Suprane 3. How you will be given Suprane 4. Possible side effects 5. How to store Suprane 6. Contents of the pack and other information 1. WHAT SUPRANE IS AND WHAT IT IS USED FOR Suprane contains desflurane. Suprane 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 desflurane 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. In adults, Suprane is used for induction and maintenance of anaesthesia. In intubated infants and children under 12 years, Suprane is used for maintenance of anaesthesia only. Intubation is when a tube is placed into the airways to help breathing. Suprane can sometimes be used for dental procedures in hospitals and day care units. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN SUPRANE YOUR ANAESTHETIST (DOCTOR) WILL NOT GIVE YOU SUPRANE IF: - you are a child to bring on (induce) anaesthesia. This is because using Suprane in this way can cause more unwanted side effects such as: - coughing - holding one’s breath - stopping breathing (apnoea) - a muscle spasm of the vocal chords (voice box) called a laryngospasm - increased secretions in the airways - you are allergic (hypersensitive) to desflurane or other inhalation anaesthetics such as isoflurane, sevoflurane, halothane and enflurane - there are me Read the complete document
Health Products Regulatory Authority 04 March 2024 CRN00DHXV Page 1 of 10 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Suprane Inhalation vapour, solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Desflurane 100% v/v For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Inhalation vapour, solution. A clear, colourless to practically odourless solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Desflurane is indicated as an inhalation agent for induction and maintenance of anaesthesia in adults. Desflurane is indicated for maintenance of anaesthesia in intubated infants and children under 12 years. Desflurane is not indicated for induction of anaesthesia in paediatric patients. (See Section 4.3) Use of desflurane in dental anaesthesia should be restricted to hospitals and day care units only. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Method of administration Desflurane is administered by inhalation. The concentration of desflurane should be delivered from a vaporizer specifically designed and designated for use with desflurane. Premedication The premedication should be chosen to suit the individual requirements of the patient. Studies to date have not shown an effect of premedication on respiratory tract reactions associated with inhalational induction of anaesthesia. Individualization The administration of general anaesthesia must be individualized based on the patient's response. Effects on Concomitant Therapy Opioids or benzodiazepines decrease the amount of desflurane required to produce anaesthesia. Desflurane decreases the required doses of neuromuscular blocking agents (see Table 2, section 4.5). If added relaxation is required, supplemental doses of muscle relaxants may be used. (See section 4.5) Dosage The minimum alveolar concentration (MAC) of desflurane decreases with increasing patient age. The dose of desflurane should be adjusted accordingly. The MAC has been determined as listed in Table 1. Table 1 MAC for desflurane according to patient age and inhal Read the complete document