Country: Ireland
Bahasa: Inggeris
Sumber: HPRA (Health Products Regulatory Authority)
Isoflurane
AbbVie Limited
N01AB; N01AB06
Isoflurane
99.9 percent weight/weight
Inhalation Gas
Product subject to prescription which may not be renewed (A)
Halogenated hydrocarbons; isoflurane
Marketed
1983-06-23
FORANE TECHNICAL LEAFLET COMPOSITION AND DESCRIPTION Isoflurane (not less than 99.9% w/w) Forane is a non flammable inhalational liquid, administered by inhalation of the vapour. It is 1-chloro- 2,2,2,-trifluoroethyl difluoromethyl ether and its structural formula is: F H F F C C O C H F Cl F Some physical constants of Forane are: Molecular weight 184.5 Boiling point at 760 mm Hg 48.5 o C Refractive index n 20 D 1.2990-1.3005 Specific gravity at 25 o C 1.496 Vapour pressure, mm Hg at 20 o C 238 at 25 o C 295 at 30 o C 367 at 35 o C 450 Partition coefficients at 37 o C: water/gas 0.61 blood/gas 1.43 oil/gas 90.8 Partition coefficients at 25 o C for rubber and plastics: Conductive rubber/gas 62.0 Butyl rubber/gas 75.0 Polyvinyl chloride/gas 110.0 Polyethylene/gas ca2.0 Polyurethane/gas ca1.4 Polyolefin/gas ca1.1 Butyl acetate/gas ca2.5 Purity by gas chromatography: better than 99.9% Flammability in oxygen or nitrous oxide: at 9 joules/sec. and 23 o C non flammable at 900 joules/sec. and 23 o C non flammable at anaesthetic concentrations. The table below indicates average MAC values for different age groups ADULTS AGE AVERAGE MAC VALUE IN 100 % OXYGEN 70% N 2 O 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% Forane is a stable, colourless liquid, with no added chemical stabiliser. Forane has a slightly pungent, musty odour. No change in the composition of samples exposed for 5 years to indirect sunlight in clear colourless bottles, nor in that of samples exposed for 30 hours to UV light was detectable by gas chromatography. There was no consumption of alkali when Forane was exposed for more than 6 months to a 1 N sodium methoxide in methanol solution, demonstrating high Baca dokumen lengkap
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Forane 99.9% w/w, Inhalation Vapour, Liquid 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Isoflurane (not less than 99.9% w/w). 3 PHARMACEUTICAL FORM Inhalation Vapour, Liquid. Clear colourless liquid with slightly musty odour for vaporisation and administration as an inhalation gas. 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 section 4.3). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Vaporisers specially calibrated for Forane should be used so that the concentration of anaesthetic delivered can be accurately controlled. Overall, MAC values for Forane diminish with age. The table below indicates average MAC values for different age groups. Method of administration ADULTS AGE AVERAGE MAC VALUE IN 100 % OXYGEN 70% N 2 O 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% H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _D_ _a_ _t_ _e_ _ _ _P_ _r_ _i_ _n_ _t_ _e_ _d_ _ _ _0_ _3_ _/_ _1_ _0_ _/_ _2_ _0_ _1_ _6_ _C_ _R_ _N_ _ _ _2_ _1_ _8_ _3_ _6_ _6_ _5_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ PREMEDICATION: Drugs used for pre Baca dokumen lengkap