FLURISO- isoflurane inhalant

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

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Κατεβάστε Αρχείο Π.Χ.Π. (SPC)
05-08-2015

Δραστική ουσία:

ISOFLURANE (UNII: CYS9AKD70P) (ISOFLURANE - UNII:CYS9AKD70P)

Διαθέσιμο από:

MWI

INN (Διεθνής Όνομα):

ISOFLURANE

Σύνθεση:

ISOFLURANE 1 mL in 1 mL

Οδός χορήγησης:

RESPIRATORY (INHALATION)

Τρόπος διάθεσης:

PRESCRIPTION

Θεραπευτικές ενδείξεις:

Fluriso™  (isoflurane, USP) is used for induction and maintenance of general anesthesia in horses and dogs. Fluriso™  (isoflurane, USP) is contraindicated in horses and dogs with known sensitivity to isoflurane or to other halogenated agents.

Περίληψη προϊόντος:

Fluriso™  (isoflurane, USP) is packaged in 100 mL and 250 mL amber-colored bottles. 100 ml - NDC 13985-046-40 250 ml - NDC 13985-046-60

Καθεστώς αδειοδότησης:

Abbreviated New Animal Drug Application

Αρχείο Π.Χ.Π.

                                FLURISO- ISOFLURANE INHALANT
MWI
----------
03-A953/R3
5260-04-14
5260-04-15
FLURIS O
(ISOFLURANE, USP)
LIQUID FOR INHALATION
WARNING: NOT FOR USE IN HORSES INTENDED FOR FOOD.
INHALATION ANESTHETIC FOR USE
IN HORSES AND DOGS
CAUTION: Federal law restricts this drug to use by or on the order of
a licensed veterinarian.
DESCRIPTION:
Fluriso
(isoflurane, USP) is a nonflammable, nonexplosive general inhalation
anesthetic agent. Its
chemical name is 1-chloro-2,2,2-trifluoroethyl difluoromethyl ether,
and its structural formula is:
Each mL contains 99.9% isoflurane.
™
™
Isoflurane is a clear, colorless, stable liquid containing no
additives or chemical stabilizers. Isoflurane
has a mildly pungent, musty, ethereal odor. Samples stored in indirect
sunlight in clear, colorless glass
for five years, as well as samples directly exposed for 30 hours to a
2 amp,115 volt, 60 cycle long
wave U.V. light were unchanged in composition as determined by gas
chromatography. Isoflurane in
one normal sodium methoxide-methanol solution, a strong base, for over
six months consumed
essentially no alkali, indicative of strong base stability. Isoflurane
does not decompose in the presence
of soda lime (at normal operating temperatures) and does not attack
aluminum, tin, brass, iron or copper.
CLINICAL PHARMACOLOGY:
Fluriso
(isoflurane, USP) is an inhalation anesthetic. Induction and recovery
from anesthesia with
isoflurane are rapid.
The level of anesthesia may be changed rapidly with isoflurane.
Isoflurane is a
profound respiratory depressant. RESPIRATION MUST BE MONITORED CLOSELY
IN THE
HORSE AND DOG AND SUPPORTED WHEN NECESSARY. As anesthetic dose is
increased, both
™
2,5
3,6
tidal volume and respiratory rate decrease.
This depression is partially reversed by surgical
stimulation, even at deeper levels of anesthesia.
Blood pressure decreases with induction of anesthesia but returns
toward normal with surgical
stimulation. Progressive increases in depth of anesthesia produce
corresponding decreases in blood
pressure; however, heart r
                                
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