Sevoflurane liquid for inhalation

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

sevoflurane

Available from:

Piramal Enterprises Limited

ATC code:

N01AB08

INN (International Name):

sevoflurane

Dosage:

100%

Pharmaceutical form:

liquid for inhalation

Units in package:

250ml glass bottle

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2017-07-10

Patient Information leaflet

DESCRIPTION AND COMPOSITION
Sevoflurane is a non-flammable, pleasant smelling, volatile liquid.
It is 1, 1, 1, 3, 3, 3-hexafluoro-2-fluoromethoxypropane and has the
following structural formula:
Some physical constants of sevoflurane are:
Relative molecular mass
200.05
Boiling point at 760mmHg
58.6°C
20
Refractive index n
1.2740 - 1.2760
Specific gravity at 20°C
1.520 - 1.525
Vapour pressure
Temp°C
mmHg
20
157
25
197
36
317
Partition coefficients at 37°C
Water/gas
0.36
Blood/gas
0.63-0.69
Olive Oil/gas
47.2-53.9
Mean partition coefficients at 25°C - component/gas
Conductive rubber
14.0
Butyl rubber
7.7
Polyvinylchloride
17.4
Polyethylene
1.3
Purity by gas chromatography 99.975% or better
Flammability
Not flammable
INDICATIONS
Induction and maintenance of general anaesthesia in adult and
paediatric patients for inpatient and outpatient surgery.
POSOLOGY AND METHOD OF ADMINISTRATION
Premedication should be selected according to the need of the
individual patient, and at the discretion of the anaesthetist.
SURGICAL ANAESTHESIA:
Sevoflurane
should
be
delivered
via
a
vaporiser
specifically
calibrated
for
use
with
sevoflurane
so
that
the
concentration
delivered can be accurately controlled. MAC (minimum alveolar
concentration) values for sevoflurane decrease with age and with the
addition of nitrous oxide. The table below indicates average MAC
values for different age groups.
Table 1: MAC values for Adults and Paediatric
patients according to age
Age of Patient
Sevoflurane
Sevoflurane in 65%
(years)
in Oxygen
N O/35% O
2
2
0 – 1 mnths*
3.3%
1 - < 6 months
3.0%
2.0%**
6 months - < 3 years
2.8%
3 - 12
2.5%
25
2.6%
1.4%
40
2.1%
1.1%
60
1.7%
0.9%
80
1.4%
0.7%
* Neonates are full term gestational age. MAC in premature infants
has not been determined.
** In 1 – <3 year old paediatric patients, 60% N O/40% O was used.
2
2
INDUCTION:
Dosage should be individualised and titrated to the desired effect
according to the patient’s age and clinical status. A short acting
barbiturate
or
other
intravenous
induction
agent
ma