SEVOFLURANE liquid

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Sevoflurane (UNII: 38LVP0K73A) (Sevoflurane - UNII:38LVP0K73A)

Available from:

Akorn

Administration route:

RESPIRATORY (INHALATION)

Prescription type:

PRESCRIPTION

Therapeutic indications:

Sevoflurane is indicated for induction and maintenance of general anesthesia in dogs. Sevoflurane is contraindicated in dogs with a known sensitivity to sevoflurane or other halogenated agents.

Product summary:

Sevoflurane is packaged in amber colored bottles containing 250 mL sevoflurane. NDC 59399-107-01

Authorization status:

Abbreviated New Animal Drug Application

Summary of Product characteristics

SEVOFLURANE- SEVOFLURANE LIQUID
AKORN ANIMAL HEALTH, INC.
----------
SEVOFLURANE
INHALATION ANESTHETIC FOR USE IN DOGS
CAUTION: FEDERAL LAW RESTRICTS THIS DRUG TO USE BY OR ON THE ORDER OF
A LICENSED VETERINARIAN.
DESCRIPTION:
Sevoflurane, a volatile liquid, is a halogenated general inhalation
anesthetic drug. Its chemical name is
fluoromethyl 2,2,2-trifluoro-I (trifluoromethyl) ethyl ether, and its
structural formula is:
Sevoflurane Physical Constants are:
Molecular weight
200.05
Boiling point at 760 mm Hg
58.6ºC
Specific gravity at 20ºC
1.520-1.525 g/mL
Vapor pressure in mm Hg
at 20ºC 157
at 25ºC 197
at 36ºC 317
Distribution Partition Coefficients at 37ºC:
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
Polyvinyl chloride
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, stable liquid containing no
additives or chemical stabilizers.
Sevoflurane is nonpungent. It is miscible with ethanol, ether,
chloroform and petroleum benzene, and it
is slightly soluble in water. Sevoflurane is stable when stored under
normal room lighting condition
according to instructions.
INDICATIONS:
Sevoflurane is indicated for induction and maintenance of general
anesthesia in dogs.
DOSAGE AND ADMINISTRATION:
INSPIRED CONCENTRATION: The delivered concentration of sevoflurane
should be known. Since the depth
of anesthesia may be altered easily and rapidly, only vaporizers
producing predictable percentage
concentrations of sevoflurane should be used. Sevoflurane should be
vaporized using a precision
vaporizer specifically calibrated for sevoflurane. Sevoflurane
contains no stabilizer. Nothing in the
drug product alters calibration or operation of these vaporizers. The
administration of general
anesthesia must be individualized based on