AERRANE

Country: Ինդոնեզիա

language: ինդոնեզերեն

source: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

SPC SPC (SPC)
06-12-2021

active_ingredient:

ISOFLURANE

MAH:

KALBE FARMA - Indonesia

INN:

ISOFLURANE

dosage:

250 ML

pharmaceutical_form:

CAIRAN INHALASI

units_in_package:

DUS, BOTOL @ 250 ML

manufactured_by:

BAXTER HEALTH CARE CORP - U.S.A

authorization_date:

2017-05-16

SPC

                                PRESENTATION
AERRANE (Isoflurane USP) is a colourless, volatile liquid for
inhalation,
containing 100% Isoflurane USP.
INDICATIONS
AERRANE is a volatile halogenated anaesthetic for general inhalation
anaesthesia.
DOSAGE AND ADMINISTRATION
In order to be able to accurately control the precise concentration of
AERRANE, vaporisers that have been specifically calibrated for
isoflurane
should be used.
Minimum alveolar concentration (MAC) of AERRANE in humans:
AGE (YEARS)
O
2 - 100%
O
2 + N
2
0 (60%)
Neonates
1.60
- -
1 - 6 months
1.87
- -
7 - 11 months
1.80
- -
1 - 2 years
1.60
- -
3 - 5 years
1.62
- -
6 - 10 years
1.40
0.58
10 - 15 years
1.16
0.53
AGE (YEARS)
O
2 - 100%
O
2 + N
2
0 (70%)
26 ± 4
1.28
0.56
44 ± 7
1.15
0.50
64 ± 5
1.05
0.37
INDUCTION OF ANAESTHESIA:
If AERRANE is used for induction of anaesthesia, a starting
concentration
of 0.5% is recommended. Concentrations of 1.3 - 3.0% usually bring
about
surgical anaesthesia within 7 to 10 minutes.
It is recommended that use be made of a hypnotic dose of a short
acting
barbiturate or another product such as propofol, etomidate, or
midazolam
in order to avoid coughing or laryngospasm, which can arise if
induction
is carried out with AERRANE alone or in combination with oxygen or
with
an oxygen-nitrous oxide mixture.
MAINTENANCE OF ANAESTHESIA:
Anaesthesia can be maintained during surgery using a concentration of
1.0-2.5%, with the simultaneous administration of N
2
0 and O
2
.
A higher concentration of 1.5 - 3.5% of AERRANE is necessary if
AERRANE
is administered with pure oxygen.
RECOVERY
The concentration of AERRANE must be reduced to 0.5% at the end of the
operation, or to 0% during closure of the wound to allow prompt
recovery.
If all administration of anaesthetic agents has been stopped, the air
passages
of the patient should be ventilated several times with 100% oxygen
until
complete awakening occurs.
If the vector gas is a mixture of 50% O
2
and 50% N
2
O, the volume of the
minimum alveolar concentration of AERRANE is approximately 0.65%.
CONTRAINDICATION
                                
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