PROPOFLO 28- propofol injection, emulsion

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

Zoetis Inc.

INN (International Nazwa):

PROPOFOL

Skład:

PROPOFOL 10 mg in 1 mL

Droga podania:

INTRAVENOUS

Typ recepty:

PRESCRIPTION

Wskazania:

PropoFlo™ 28 is an anesthetic injection for use in dogs as follows: For induction of anesthesia. For maintenance of general anesthesia by intermittent bolus injections for short procedures. For induction of general anesthesia where maintenance is provided by inhalant anesthetics. PropoFlo™ 28 injection is contraindicated in dogs with a known hypersensitivity to propofol or its components, or when general anesthesia or sedation are contraindicated.

Podsumowanie produktu:

PropoFlo™ 28 is supplied in cartons of five-20 mL (200 mg per vial), or two-50 ml (500 mg per vial) vials containing 10 mg propofol per mL.

Status autoryzacji:

New Animal Drug Application

Charakterystyka produktu

PROPOFLO 28- PROPOFOL INJECTION, EMULSION
ZOETIS INC.
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PROPOFLO 28
For Animal Use Only
PROPOFLO 28
(propofol injectable emulsion)
Intravenous Anesthetic Injection for Use in Dogs.
CAUTION
Federal (USA) law restricts this drug to use by or on the order of a
licensed veterinarian.
DESCRIPTION
PropoFlo™ 28 is a sterile, nonpyrogenic emulsion containing 10 mg/mL
of propofol in a
multidose vial for intravenous administration. Each mL contains 10 mg
propofol.
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), benzyl
alcohol (20 mg/mL),
oleic acid (0.6 mg/mL), and egg lecithin (12 mg/mL), with sodium
hydroxide to adjust the
pH. The PropoFlo™ 28 emulsion is isotonic and has a pH of 6.0-8.5.
PropoFlo™ 28 does
not meet the propofol injectable emulsion USP specification for free
fatty acids.
INDICATIONS
PropoFlo™ 28 is an anesthetic injection for use in dogs as follows:
For induction of anesthesia.
For maintenance of general anesthesia by intermittent bolus injections
for short
procedures.
For induction of general anesthesia where maintenance is provided by
inhalant
anesthetics.
DOSAGE AND ADMINISTRATION
Administer by intravenous injection only. Shake the vial thoroughly
before opening.
Propofol is a white stable emulsion; do not use if there is evidence
of separation of the
phases. Do not use if there is evidence of excessive creaming or
aggregation, if large
droplets are visible, or if there are other forms of phase separation
indicating that the
stability of the product has been compromised. Slight creaming, which
should disappear
after shaking, may be visible upon prolonged standing. Do not use if
particulate matter
and discoloration are present. Strict aseptic techniques must always
be maintained
during handling. Failure to follo