PROPOFLO- propofol injection, emulsion

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

PROPOFOL (UNII: YI7VU623SF) (PROPOFOL - UNII:YI7VU623SF)

متاح من:

Zoetis Inc.

INN (الاسم الدولي):

PROPOFOL

تركيب:

PROPOFOL 10 mg in 1 mL

طريقة التعاطي:

INTRAVENOUS

نوع الوصفة الطبية :

PRESCRIPTION

الخصائص العلاجية:

Propofol is an intravenous anesthetic injection for use in dogs as follows: 1. For induction of anesthesia. 2. For maintenance of general anesthesia for up to 20 minutes. 3. For induction of general anesthesia where maintenance is provided by inhalant anesthetics. Propofol injection is contraindicated in dogs with a known hypersensitivity to propofol or its components, or when general anesthesia or sedation are contraindicated. Not for human use. Keep out of the reach of children. Rare cases of self-administration have been reported, including fatalities. Propofol should be managed to prevent the risk of diversion, through such measures as restriction of access and the use of drug accountability procedures appropriate to the clinical setting. Exercise caution to avoid accidental self-injection. Overdose is likely to cause cardiorespiratory depression (such as hypotension, bradycardia and/ or apnea). Remove the individual from the source of exposure and seek medical attention. Respiratory depression shou

ملخص المنتج:

PropoFlo™ is supplied in cartons of five-20 mL (200 mg per vial) vials containing 10 mg propofol per mL.

الوضع إذن:

New Animal Drug Application

خصائص المنتج

PROPOFLO- PROPOFOL INJECTION, EMULSION
ZOETIS INC.
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PROPOFLO
For Animal Use Only
PROPOFLO
(PROPOFOL INJECTABLE EMULSION) INTRAVENOUS ANESTHETIC INJECTION FOR
USE IN
DOGS.
Fliptop vial. Each mL contains 10 mg propofol.
Shake Well Before Use.
CAUTION
Federal (USA) law restricts this drug to use by or on the order of a
licensed veterinarian.
DESCRIPTION
PropoFlo™ Injection is a sterile, nonpyrogenic emulsion containing
10 mg/mL of propofol
suitable for intravenous administration. Propofol is chemically
described as 2, 6-
diisopropylphenol and has a molecular weight of 178.27. Propofol is
very slightly soluble
in water and is therefore formulated as a white, oil-in-water
emulsion. In addition to the
active component, propofol, the formulation also contains soybean oil
(100 mg/mL),
glycerol (22.5 mg/mL), egg lecithin (12 mg/mL), and oleic acid (0.6
mg/mL) with sodium
hydroxide to adjust the pH. The propofol emulsion is isotonic and has
a pH of 6.0-9.0.
CLINICAL PHARMACOLOGY
Propofol injection is an intravenous sedative hypnotic agent for use
in the induction and
maintenance of anesthesia. Intravenous injection of propofol in the
dog is followed by
extensive metabolism of propofol in the liver to inactive conjugates
which are excreted in
the urine. Elimination from the central compartment occurs rapidly,
with an initial
elimination phase of less than 10 minutes .
Induction of anesthesia will usually be observed within 75-120 seconds
after the
beginning of propofol administration. The duration of anesthesia
following the
recommended induction doses averages 6.7 minutes in premedicated and
unpremedicated animals.
Recommended maintenance doses for anesthesia in unpremedicated
animals, animals
premedicated with acepromazine, and animals premedicated with a
combination of
agents results in anesthesia lasting an average of 3.68, 3.80 and 5.43
minutes,
respectively, after each maintenance dose.
Recovery from propofol is rapid; full standing recovery is generally
observed within 20
minutes. The use of certain preme