Isoflurane liquid for inhalation

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

isoflurane

Available from:

Piramal Pharma 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:

2023-08-05

Patient Information leaflet

“Prescription medicine.
Only for hospital use in anaesthesiology”.
ISOFLURANE, 100%
INHALATION VAPOUR, LIQUID
COMPOSITION AND DESCRIPTION
Isoflurane is a colourless non-flammable general inhalation
anaesthetic which contains no additive
or stabiliser. It is 1-chloro-2,2,2- trifluoroethyl difluoromethyl
ether.
PHARMACOTHERAPEUTIC GROUP :
Nervous system; anaesthetic; general; Halogenated hydrocarbons
ATC CODE: N01AB06
INDICATIONS
Isoflurane is 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 depointes (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 ‘pregnancy’). Isolated cases of increased
carboxyhaemoglobin have
been reported with the use of halogenated inhalation agents with a
–CF
2
H moiety (i.e., desflurane,
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 instruc

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS (SMPC)
1.
NAME OF THE MEDICINAL PRODUCT
Isoflurane 100% Inhalation Vapour liquid.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Isoflurane is a colourless non-flammable general inhalation
anaesthetic which contains no
additive or stabiliser. It is 1-chloro-2,2,2-
trifluoroethyldifluoromethyl ether.
3.
PHARMACEUTICAL FORM
Liquid for inhalation
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Isoflurane is general inhalation anaesthetic for use ininduction and
maintenance.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology 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%
Premedication:
Premedication drugs should be selected according to the needs of the
patient. The respiratory
depressant effect of Isoflurane should be taken into account. The use
of anticholinergic drugs is
a matter of choice, but may we advisable for inhalation induction in
paediatrics.
Induction:
As Isoflurane has a mild pungency, inhalation should usually be
preceded by the use of a short
acting barbiturate, or other intravenous induction agent, to prevent
coughing. Alternatively,
Isoflurane with oxygen or with an oxygen/ nitrous oxide mixture may be
administered.
It is recommended that induction with Isoflurane be initiated at a
concentration of 0.5%.
Concentrations of 1.5-3.0% usually produce surgical anaesthesia in
7-10 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.
Maintenance:
Adequate anaesthesia