Valsts: Malta
Valoda: angļu
Klimata pārmaiņas: Medicines Authority
ISOFLURANE
AbbVie Ltd Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire, SL6 4UB, United Kingdom
N01AB06
ISOFLURANE 99.9 % (W/W)
INHALATION VAPOUR, LIQUID
ISOFLURANE 99.9 % (W/W)
POM
ANESTHETICS
Suspended
2006-11-29
• Skin rash, swelling of the face • Rapid rise in body temperature, shivering or chills • Wheezing and breathlessness • Cardiac arrest • Abnormal levels of certain cells or products found in your blood or urine. • Liver injury or the inability of your liver to function properly. • Changes to the heart rhythm including QT prolongation and torsade de pointes. Other side effects you may experience: Those occurring at unknown frequency • Agitation • Alterations in mood, sometimes extreme, this may last upto 6 days • Irregular heart beat or palpitations • Convulsions, mental impairment • Bleeding • Nausea and vomiting • Slow shallow breathing, shortness of breath, wheezing, chest discomfort • Muscles of your intestine may stop working temporarily, causing discomfort, bloating and vomiting. Those that will be identified following tests: • Low blood pressure • Increases in blood fluoride levels (due to your body breaking down isoflurane) or carbon monoxide levels • Fast or slow heart rate REPORTING OF SIDE EFFECTS If you get any side effects, talk to your doctor or anaesthetist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine. UNITED KINGDOM Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard MALTA ADR Reporting Website: www.medicinesauthority.gov.mt/adrportal 5. How to store Isoflurane KEEP THIS MEDICINE OUT OF THE SIGHT AND REACH OF CHILDREN. Isoflurane should be stored in a tightly closed container NOT above 25°C. Do NOT use after the expiry date printed on the packaging. Medicines should not be disposed of via wastewater or household waste. 6. Contents of the pack and other information WHAT ISOFL URANE CONTAINS: The active ingredient is Isoflurane and it is supplied as a pure liquid containing no other ingredients. WHAT ISOFL URANE LOOKS LIKE AND CONTENTS OF THE PACK: Isoflurane is an inhalation anaest Izlasiet visu dokumentu
Page 1 of 12 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Isoflurane 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Isoflurane 99.9% w/w 3 PHARMACEUTICAL FORM Isoflurane is an inhalation anaesthetic with a mildly pungent ethereal odour. No additive or stabiliser present. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Isoflurane is indicated as a general anaesthetic by inhalation. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Vaporisers specially calibrated for isoflurane should be used so that the concentration of anaesthetic delivered can be accurately controlled. MAC values for isoflurane vary with age. The table below indicates average MAC values for different age groups. ADULTS AGE AVERAGE MAC VALUE IN 100% OXYGEN 70% N2O 26 ± 4 years 1.28% 0.56% 44 ± 7 years 1.15% 0.50% 64 ± 5 years 1.05% 0.37% PAEDIATRIC POPULATION AGE AVERAGE MAC VALUE IN 100% OXYGEN Preterm neonates < 32 weeks gestational age 1.28% Preterm neonates 32-37 weeks gestational age 1.41% 0-1 month 1.60% 1-6 months 1.87% 6-12 months 1.80% 1-5 years 1.60% Page 2 of 12 PREMEDICATION: Drugs used for premedication should be selected for the individual patient bearing in mind the respiratory depressant effect of isoflurane. The use of anticholinergic drugs is a matter of choice, but may be advisable for inhalation induction in paediatrics. INDUCTION OF ANAESTHESIA IN ADULTS: A short-acting barbiturate or other intravenous induction agent is usually administered followed by inhalation of the isoflurane mixture. Alternatively, isoflurane with oxygen or with an oxygen/nitrous oxide mixture may be used. It is recommended that induction with isoflurane be initiated at a concentration of 0.5%. Concentrations of 1.5 to 3.0% usually produce surgical anaesthesia in 7 to 10 minutes. INDUCTION OF ANAESTHESIA IN CHILDREN: Isoflurane is not recommended for use as an inhalation induction agent in infants and children because of the occurrence of cough, breath-holding, desaturation, increased secretions and laryngospasm (see section 4.4). MAINT Izlasiet visu dokumentu