AERRANE

Land: Israel

Språk: engelsk

Kilde: Ministry of Health

Aktiv ingrediens:

ISOFLURANE

Tilgjengelig fra:

BAXTER HEALTHCARE DISTRIBUTION LTD., ISRAEL

ATC-kode:

N01AB06

Legemiddelform:

LIQUID FOR INHALATION

Sammensetning:

ISOFLURANE 100 ML / 100 ML

Administreringsrute:

INHALATION

Resept typen:

Required

Produsert av:

BAXTER HEALTCARE COPORATION, USA

Terapeutisk gruppe:

ISOFLURANE

Terapeutisk område:

ISOFLURANE

Indikasjoner:

Aerrane is a volatile halogenated anesthetic for general inhalation anesthesia.

Autorisasjon dato:

2020-06-30

Informasjon til brukeren

העדוה
העדוה
לע
לע
הרמחה
הרמחה
(
(
עדימ
עדימ )תוחיטב )תוחיטב
ןולעב
ןולעב
ל
ל
אפור
אפור
ךיראת
____________
APRIL 15, 2015
___
םש
רישכת
סמו_תילגנאב
םושיר
_
AERRANE LIQUID FOR INHALATION
051
79
23531
00
םש
לעב
_םושירה
TEVA MEDICAL MARKETING LTD, HAORGIM ST. 2, ASHDOD 77100
ספוט
הז
דעוימ
טורפל
תורמחהה
דבלב
!
םיטרפ
לע
םי/יונישה
םי/שקובמה
קרפ
ןולעב
טסקט
יחכונ
טסקט
שדח
WARNINGS AND
PRECAUTIONS
AERRANE must only be used by a licensed
anaesthetist. Since the depth of anaesthesia can
change easily and rapidly with AERRANE,
only
vaporisers
that
have
been
specially
calibrated for this product may be used. The
extent
of
blood-
pressure
reduction
and
respiratory depression can be an indication of
the extent of anaesthesia.
Spontaneous respiration must be carefully
monitored and must be assisted if necessary.
With the use of halogenated anaesthetics,
disruption of the liver function, icterus, and
fatal liver necrosis have been reported. Such
reactions appear to indicate hypersensitivity
reactions to anaesthetics.
Cirrhosis, viral
hepatitis, or other pre-existing liver disease can
be a reason to select an anaesthetic other than a
halogenated anaesthetic
Patients with Myasthenia Gravis are extremely
sensitive to drugs that produce respiratory
depression. These effects are potentiated with
some general anaesthetics. AERRANE should
be used with caution in these patients.
It is recommended that ventilation be controlled
in neurosurgery patients: cerebral blood flow
remains unchanged in the course of light
anaesthesia, but tends to rise in the course of
deeper anaesthesia. An increase in intracranial
pressure may be averted or abolished by
hyperventilation of the subject before or during
anaesthesia.
AERRANE should not be administered to
patients who can develop broncho-constriction
since bronchospasms can occur. In the case of
neurosurgical operations, respirat

Preparatomtale

1 / 12
The format of this leaflet was determined by the Ministry of Health
and its contents
was checked an approved in June 2019.
PHYSICIAN'S PRESCRIBING INFORMATION
1.
NAME OF THE MEDICINAL PRODUCT
Aerrane
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 100ml bottle Aerrane contains 100ml isoflurane.
3.
PHARMACEUTICAL FORM
Liquid for inhalation
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Aerrane is a volatile halogenated anaesthetic for general inhalation
anaesthesia.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
In order to be able to accurately control the precise concentration of
isoflurane,
vaporisers that have been specially calibrated for isoflurane should
be used.
INDUCTION OF ANAESTHESIA:
If isoflurane 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
O and O
2
.
A higher concentration of 1.5 - 3.5% of Aerrane is necessary if
Aerrane is
administered with pure oxygen.
_ _
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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 value of the minimum
alveolar concentration of isoflurane is approximately 0.65%.
ADULTS
AGE
AVERAGE MAC VALUE
IN 100% OXYGEN
70% N
2
O
2