Forane 99.9% w/w, Inhalation Vapour, Liquid

Land: Irland

Sprache: Englisch

Quelle: HPRA (Health Products Regulatory Authority)

Wirkstoff:

Isoflurane

Verfügbar ab:

AbbVie Limited

ATC-Code:

N01AB; N01AB06

INN (Internationale Bezeichnung):

Isoflurane

Dosierung:

99.9 percent weight/weight

Darreichungsform:

Inhalation Gas

Verschreibungstyp:

Product subject to prescription which may not be renewed (A)

Therapiebereich:

Halogenated hydrocarbons; isoflurane

Berechtigungsstatus:

Marketed

Berechtigungsdatum:

1983-06-23

Gebrauchsinformation

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

Fachinformation

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%
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PREMEDICATION:
Drugs used for pre