SEVORANE

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

SEVOFLURANE

Available from:

ABBVIE BIOPHARMACEUTICALS LTD, ISRAEL

ATC code:

N01AB08

Pharmaceutical form:

LIQUID FOR INHALATION

Composition:

SEVOFLURANE 100 %

Administration route:

INHALATION

Prescription type:

Required

Manufactured by:

ABBVIE LTD., UK

Therapeutic area:

SEVOFLURANE

Therapeutic indications:

Sevoflurane is indicated for induction and maintenance of general anesthesia in adult and pediatric patients for inpatient and outpatient surgery.

Authorization date:

2012-08-31

Patient Information leaflet

העדוה
העדוה
לע
לע
הרמחה
הרמחה
(
(
עדימ
עדימ
ןולעב )תוחיטב
ןולעב )תוחיטב
ל
ל
אפור
אפור
ןכדועמ(
ןכדועמ(
05.2013
05.2013
)
)
ךיראת :
28
-
APRIL-2013
םש
רישכת :תילגנאב
SEVORANE
רפסמ :םושירה
106-99-28917-00
םש
לעב
םושירה :
ABBVIE BIOPHARMACEUTICALS LTD
.
ספוט
הז
דעוימ
טורפל
תורמחהה
דבלב
!
תורמחהה
תושקובמה
קרפ
ןולעב
טסקט
יחכונ
טסקט
שדח
WARNINGS
טל ופסוה תורמחה
טסק
ה
ירוקמ
Sevoflurane may cause respiratory depression, which
may be augmented by narcotic premedication or other
agents causing respiratory depression. Respiration
should be supervised and if necessary, assisted
_MALIGNANT HYPERTHERMIA_
Sevoflurane can induce malignant hyperthermia in
genetically susceptible individuals, such as those with
certain inherited ryanodine receptor mutations
.
DRUG
INTERACTIONS
טל ופסוה תורמחה
טסק
ה
ירוקמ
Beta-sympathomimetic agents like isoprenaline and
alpha- and beta- sympathomimetic agents like adrenaline
and noradrenaline should be used with caution during
Sevoflurane narcosis, due to a potential risk of ventricular
arrhythmia.
Non-selective MAO-inhibitors: Risk of crisis during the
operation. It is generally recommended that treatment
should be stopped 2 weeks prior to surgery.
Sevoflurane may lead to marked hypotension in patients
treated with calcium antagonists, in particular
dihydropyridine derivates.
Caution should be exercised when calcium antagonists
are used concomitantly with inhalation anesthetics due to
the risk of additive negative inotropic effect.
Concomitant use of succinylcholine with inhaled
anesthetic agents has been associated with rare
increases in serum potassium levels that have resulted in
cardiac arrhythmias and death in pediatric patients during
the post-operative period.
_ADVERSE _
_REACTIONS_
טל ופסוה תורמחה
טסק
ה
ירוקמ
Nausea, vomiting, and
delirium
have b

Summary of Product characteristics

SEV API APR 2021 CL
1
SEVORANE
®
(SEVOFLURANE 100%)
SOLUTION FOR INHALATION
INDICATIONS AND USAGE
Sevoflurane is indicated for induction and maintenance of general
anesthesia in adult and
pediatric patients for inpatient and outpatient surgery.
DESCRIPTION
SEVORANE (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
SEV API APR 2021 CL
2
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 nonpungent. 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
direc