Isoflurane liquid for inhalation

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

isoflurane

Available from:

Piramal Enterprises Limited

ATC code:

N01AB06

INN (International Name):

isoflurane

Dosage:

100%

Pharmaceutical form:

liquid for inhalation

Units in package:

250ml glass bottle

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2017-06-22

Patient Information leaflet

Pantone Black
DNI 4285
COMPOSTION AND DESCRIPTION
Isoflurane is a colourless non-flammable general inhalation
anaesthetic
which contains no additive or stabiliser. It is
1-chloro-2,2,2-trichloroethyl
difluoromethyl ether.
INDICATIONS
General inhalation anaesthetic for use in induction and maintenance.
CONTRAINDICATIONS
Isoflurane is contraindicated in patients with known sensitivity to
Isoflurane or
to other halogenated anaesthetics.
It is also contraindicated in patients with known or suspected genetic
susceptibility to malignant hyperthermia.
PRECAUTIONS
Vaporisers specially calibrated for isoflurane should be used so that
the
concentration
of
anaesthetic
delivered
can
be
accurately
controlled.
Hypotension
and
respiratory
depression
increase
as
anaesthesia
is
deepened.
Reports
of
QT
prolongation,
associated
with
torsade
de
pointes
(in
exceptional cases, fatal), have been received.
Caution should be exercised when administering isoflurane to patients
at risk
of QT prolongation.
Caution should be exercised in administering general anaesthesia,
including
isoflurane, to patients with mitochondrial disorders.
Isoflurane, like other inhalational agents, has relaxant effects on
the uterus
with the potential risk for uterine bleeding.
Clinical judgement should be observed when using isoflurane during
obstetric
anaesthesia. Consideration should be taken to use the lowest possible
concentration of isoflurane in obstetrical operations (see 'Use in
pregnancy').
Isolated cases of increased carboxyhaemoglobin have been reported with
the
use of halogenated inhalation agents with a –CF H moiety (i.e.,
desflurane,
2
enflurane and isoflurane). No clinically significant concentrations of
carbon
monoxide are produced in the presence of normally hydrated absorbents.
Care
should
be
taken
to
follow
manufacturer's
instructions
for
CO
2
absorbents.
Isoflurane has been reported to interact with dry carbon dioxide
absorbents
during closed circuit anaesthesia, to form carbon monoxide. In order
to
minimize the risk of formation of carbon