ULTANE- sevoflurane liquid

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

SEVOFLURANE (UNII: 38LVP0K73A) (SEVOFLURANE - UNII:38LVP0K73A)

Dostępny od:

AbbVie Inc.

INN (International Nazwa):

SEVOFLURANE

Skład:

SEVOFLURANE 250 mL in 250 mL

Droga podania:

RESPIRATORY (INHALATION)

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

ULTANE is indicated for induction and maintenance of general anesthesia in adult and pediatric patients for inpatient and outpatient surgery. ULTANE should be administered only by persons trained in the administration of general anesthesia. Facilities for maintenance of a patent airway, artificial ventilation, oxygen enrichment, and circulatory resuscitation must be immediately available. Since level of anesthesia may be altered rapidly, only vaporizers producing predictable concentrations of sevoflurane should be used. - Known or suspected genetic susceptibility to malignant hyperthermia (see WARNINGS - Malignant Hyperthermia , CLINICAL PHARMACOLOGY - Pharmacogenomics ). - Known or suspected sensitivity to sevoflurane or to other halogenated inhalational anesthetics.

Podsumowanie produktu:

ULTANE (sevoflurane), Volatile Liquid for Inhalation, is packaged in amber colored bottles containing 250 mL sevoflurane, List 4456, NDC # 0074-4456-04 (plastic).

Status autoryzacji:

New Drug Application

Charakterystyka produktu

ULTANE- SEVOFLURANE LIQUID
ABBVIE INC.
----------
ULTANE
(SEVOFLURANE)
VOLATILE LIQUID FOR INHALATION
DESCRIPTION
ULTANE (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 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 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
absorbents. Sevoflurane degradation and subsequent degradant formation
are
enhanced by increasing absorbent temperature increased sevoflurane
concentration