ISOFLURANE USP TERRELL

Land: Israël

Taal: Engels

Bron: Ministry of Health

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Download Bijsluiter (PIL)
06-12-2017
Download Productkenmerken (SPC)
02-10-2022

Werkstoffen:

ISOFLURANE

Beschikbaar vanaf:

PHARMA MEDIS

ATC-code:

N01AB06

farmaceutische vorm:

LIQUID FOR INHALATION

Samenstelling:

ISOFLURANE 100 %V/V

Toedieningsweg:

INHALATION

Prescription-type:

Required

Geproduceerd door:

PIRAMAL CRITICAL CARE INC., USA

Therapeutische categorie:

ISOFLURANE

Therapeutisch gebied:

ISOFLURANE

therapeutische indicaties:

General inhalation anesthetic.

Autorisatie datum:

2022-04-30

Bijsluiter

                                .תשפיחש המ תא ונאצמ אל
הנוכנ תנזהש תבותכה םא קודבל יאדכ
תבותכב עייסל חמשנ
info@gov.il
(
1
)
                                
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Productkenmerken

                                1 / 12
PHYSICIAN'S PRESCRIBING INFORMATION
1.
NAME OF THE MEDICINAL PRODUCT
Isoflurane USP, Terrell
TM
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Isoflurane 100%
Each 100 ml bottle Isoflurane contains 100 ml isoflurane.
Each 250 ml bottle Isoflurane contains 250 ml isoflurane.
3.
PHARMACEUTICAL FORM
Liquid for inhalation
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
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
Isoflurane 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 Isoflurane is necessary if
Isoflurane is
administered with pure oxygen.
RECOVERY:
The concentration of Isoflurane 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.
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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% N2O
26 ± 4 years
1.28%
0.56%
44 ± 7 years
1.15%
0.50%
64 ± 5 years
1.05%
0.37
                                
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