SUPRANE

Šalis: Izraelis

kalba: anglų

Šaltinis: Ministry of Health

Veiklioji medžiaga:

DESFLURANE

Prieinama:

BAXTER HEALTHCARE DISTRIBUTION LTD., ISRAEL

ATC kodas:

N01AB07

Vaisto forma:

SOLUTION FOR INHALATION

Sudėtis:

DESFLURANE 100 %

Vartojimo būdas:

INHALATION

Recepto tipas:

Required

Pagaminta:

BAXTER HEALTHCARE CORPORATION, USA

Farmakoterapinė grupė:

DESFLURANE

Gydymo sritis:

DESFLURANE

Terapinės indikacijos:

Sulorane is indicated as an inhalation agent for induction and/or maintenance of anesthesia in adults and maintenance of anesthesia in infants and children.

Leidimo data:

2021-05-31

Pakuotės lapelis

העדוה
העדוה
לע
לע
הרמחה
הרמחה
(
(
עדימ
עדימ
ןולעב )תוחיטב
ןולעב )תוחיטב
ל
ל
אפור
אפור
ןכדועמ(
05/2013
)
ךיראת
_______
MARCH 3, 2015
__
םש
רישכת
תילגנאב
ירפסמו
םושירה
SULORANE SOLUTION FOR INHALATION 101 32 28466 00
םש
לעב
םושירה
TEVA MEDICAL MARKETING LTD., HAORGIM ST 8 ASHDOD 77100
ספוט
הז
דעוימ
טורפל
תורמחה
דבלב
!
תורמחהה
תושקובמה
קרפ
ןולעב
טסקט
יחכונ
טסקט
שדח
INDICATION
CONTRAINDICATIONS
Desflurane should not be used for
anaesthetic induction in patients at risk
of
coronary
artery disease or in
patients where increases in heart rate
or blood pressure are undesirable.
Desflurane should not be used for anaesthetic induction in
patients at risk of coronary artery disease or in patients
where increases in heart rate or blood pressure are
undesirable.
Desflurane is contraindicated in patients with a history of
confirmed hepatitis due to a halogenated inhalational
anaesthetic or with a history of unexplained moderate to
severe hepatic dysfunction (e.g., jaundice associated with
fever and/or eosinophilia) after anaesthesia with a
halogenated inhalational anaesthetic.
Desflurane is contraindicated for use as an inhalation
induction agent in paediatric patients because of the
frequent occurrence of cough, breath holding, apnoea,
laryngospasm, and increased secretions
.
POSOLOGY, DOSAGE & ADMINISTRATION
Induction of Anaesthesia in Adults
In adults, a starting concentration of
3% is recommended, increased in 0.5-
1.0% increments every 2 to 3 breaths.
Inspired concentrations of 4-11% of
desflurane usually produce surgical
anaesthesia in 2-4 minutes.
Higher
concentrations up to 15% may be
used.
Such concentrations of desflurane will
proportionately
dilute
the
concentration
of
oxygen
and
commencing administration of oxygen
should
be
30%
or
above.
After
induction in adults with an intravenous
drug such as thiopental or propofol,
desflurane
can
be
star

Prekės savybės

1
PHYSICIAN'S PRESCRIBING INFORMATION
1. NAME OF THE MEDICINAL PRODUCT
Suprane
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Desflurane, supplied as pure drug substance
3. PHARMACEUTICAL FORM
Solution for inhalation
4. CLINICAL PARTICULARS
4.1
Therapeutic indications
Suprane is indicated as an inhalation agent for induction and/or
maintenance of
anaesthesia in adults and maintenance of anaesthesia in infants and
children.
4.2
Posology and method of administration
Method of administration
Desflurane is administered by inhalation.
Desflurane should only be administered by persons trained in the
administration of
general anaesthesia using a vaporizer specifically designed and
designated for use with
desflurane.
Premedication
Premedication should be selected according to the needs of the
individual patient taking
into account that salivary secretions are stimulated. The use of
anticholinergic drugs is a
matter of choice for the anaesthetist.
Individualization
The administration of general anaesthesia must be individualized based
on the patient's
response.
Effects on Concomitant Therapy
Opioids or benzodiazepines decrease the amount of desflurane required
to produce
anaesthesia.
Desflurane decreases the required doses of neuromuscular blocking
agents (see Table 2,
section 4.5). If added relaxation is required, supplemental doses of
muscle relaxants may
be used (See section 4.5).
Dosage
2
The minimum alveolar concentration (MAC) of desflurane decreases with
increasing
patient age. The dose of desflurane should be adjusted accordingly.
The MAC has been
determined as listed in Table 1.
Table 1: MAC for desflurane according to patient age and inhalation
mixture (Mean ± SD)
Age
N*
100% Oxygen
N*
60% Nitrous Oxide/40%
Oxygen
2 weeks
6
9.2 ± 0.0
-
-
10 weeks
5
9.4 ± 0.4
-
-
9 months
4
10.0 ± 0.7
5
7.5 ± 0.8
2 years
3
9.1 ± 0.6
-
-
3 years
-
-
5
6.4 ± 0.4
4 years
4
8.6 ± 0.6
-
-
7 years
5
8.1 ± 0.6
-
-
25 years
4
7.3 ± 0.0
4
4.0 ± 0.3
45 years
4
6.0 ± 0.3
6
2.8 ± 0.6
70 years
6
5.17 ± 0.6
6
1.67 ± 0.4
N*= number