SEVOFLURANE- sevoflurane liquid

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Halocarbon Products Corp.

INN (International Name):

Sevoflurane

Composition:

Sevoflurane 1 mL in 1 mL

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. Store at 20°-25°C (68°-77°F). Excursions permitted to 15°-30°C (59°-86°F). See USP controlled room temperature.

Authorization status:

Abbreviated New Animal Drug Application

Summary of Product characteristics

SEVOFLURANE- SEVOFLURANE LIQUID
HALOCARBON PRODUCTS CORP.
----------
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-l (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 g/mL
Vapor pressure in mm Hg
at 20°C 157
at 25°C 197
at 36°C 317
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
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 the