SOJOURN SEVOFLURANE USP

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

SEVOFLURANE

Available from:

PHARMA MEDIS

ATC code:

N01AB08

Pharmaceutical form:

LIQUID

Composition:

SEVOFLURANE 100 %V/V

Administration route:

INHALATION

Prescription type:

Required

Manufactured by:

PIRAMAL CRITICAL CARE INC., USA

Therapeutic group:

SEVOFLURANE

Therapeutic area:

SEVOFLURANE

Therapeutic indications:

General inhalation anesthetic.

Authorization date:

2023-09-30

Patient Information leaflet

4 Fierberg St. P.O.Box 2820 Holon 5812801 Israel
Tel: [phone] [phone]
Fax: [phone] [phone]
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Your Trusted Pharma Partner.
,ה/דבכנ ה/אפור
ה/דבכנ ת/חקור
,
SOJOURN SEVOFLURANE USP
תרבח
סידמ המראפ
םינוכדע לע עידוהל תשקבמ
ןולעב
.ןודנבש רישכתה לש אפורל :רישכתה תיוותה
Induction and maintenance of general anesthesia in adult and pediatric
patients for inpatient and
outpatient surgery :ליעפ ביכרמ
100%
SEVOFLURANE רישכתה לש ןתמה תרוצ
:
INHALATION תנוכתמב) ןכרצל ןולעב םיירקיעה
םינוכדעה ןלהל
ןולע
אפורל
:(
WARNINGS
Reports of QT prolongation, associated with torsade de pointes (in
exceptional cases, fatal), have been
received. Caution should be exercised when administering sevoflurane
to susceptible patients (e.g. patients
with congenital Long QT Syndrome or patients taking drugs that can
prolong the QT interval).
MALIGNANT HYPERTHERMIA
In clinical trials, one case of malignant hyperthermia was reported.
In addition, there have been post marketing
reports of malignant hyperthermia. Some of these cases have been fatal
PEDIATRIC NEUROTOXICITY
Published animal studies demonstrate that the administration of
anesthetic and sedation drugs that block
NMDA receptors and/or potentiate GABA activity increase neuronal
apoptosis in the developing brain and
result in long-term cognitive deficits when used for longer than 3
hours. The clinical significance of these
findings is not clear. However, based on the available data, the
window of vulnerability to these changes is
believed to correlate with exposures in the third trimester of
gestation through the first several months of life,
but may extend out to approximately three years of age in humans (see
PRECAUTIONS - PREGNANCY,
PRECAUTIONS - PEDIATRIC USE).
Some published studies in children suggest that similar deficits may
occur after repeated or prolonged
exposur

Summary of Product characteristics

SOJOURN SEVOFLURANE USP
(SEVOFLURANE 100%)
LIQUID FOR INHALATION
THERAPEUTIC INDICATIONS
Sevoflurane is indicated for induction and maintenance of general
anesthesia in adult and pediatric patients
for inpatient and outpatient surgery.
DESCRIPTION
SOJOURN SEVOFLURANE USP (sevoflurane), volatile liquid for inhalation,
a nonflammable and
nonexplosive liquid administered by vaporization, is a halogenated
general inhalation anesthetic drug.
Sevoflurane is fluoromethyl 2,2,2,-trifluoro-1 - (trifluoromethyl)
ethyl ether and its structural formula is:
SEVOFLURANE, PHYSICAL CONSTANTS ARE:
Molecular weight
200.05
Boiling point at 760 mm Hg
58.6°C
Specific gravity at 20°C
1.520-1.525
Vapor pressure in mm Hg
157 mm Hg at 20°C
197 mm Hg at 25°C
317 mm Hg at 36°C
DISTRIBUTION PARTITION COEFFICIENTS AT 37°C:
Blood/Gas
0.63-0.69
Water/Gas
0.36
Olive Oil/Gas
47-54
Brain/Gas
1.15
MEAN COMPONENT/GAS PARTITION COEFFICIENTS AT 25°C FOR POLYMERS USED
COMMONLY IN MEDICAL
APPLICATIONS:
Conductive rubber
14.0
Butyl rubber
7.7
Polyvinylchloride
17.4
Polyethylene
1.3
Sevoflurane is nonflammable and nonexplosive as defined by the
requirements of International
Electrotechnical Commission 601-2-13.
Sevoflurane is a clear, colorless, liquid containing no additives.
Sevoflurane is not corrosive to stainless
steel, brass, aluminum, nickel-plated brass, chrome-plated brass or
copper beryllium. Sevoflurane is non-
pungent. It is miscible with ethanol, ether, chloroform, and benzene,
and it is slightly soluble in water.
Sevoflurane is stable when stored under normal room lighting
conditions according to instructions. No
discernible degradation of sevoflurane occurs in the presence of
strong acids or heat. When in contact with
alkaline CO
2
absorbents (e.g., Baralyme
®
and to a lesser extent soda lime) within the anesthesia machine,
sevoflurane can undergo degradation under certain conditions.
Degradation of sevoflurane is minimal, and
degradants are either undetectable or present in non-toxic amounts
when used as directed with fresh
absorb