PROPOFOL injection, emulsion

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Butler Animal Health Supply, LLC dba Covetrus North America

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION

Therapeutic indications:

Propofol injectable emulsion is an anesthetic injection for use in dogs and cats as follows: 1. As a single injection to provide general anesthesia for short procedures. 2. For induction and maintenance of general anesthesia using incremental doses to effect. 3. For induction of general anesthesia where maintenance is provided by inhalant anesthetics. Induction of general anesthesia will usually be observed within 30 to 60 seconds after the end of administration (administration should take 60 to 90 seconds). The doses for induction and maintenance vary depending upon species and preanesthetics. The duration of anesthesia varies depending upon species, dose, and preanesthetics. In dogs, the duration of anesthesia following the recommended induction dose (5.5 to 7.0 mg/kg without premedication) is generally 5 to 7 minutes. The duration of anesthesia after maintenance doses varies from 2 to 6 minutes following 1.1 mg/kg to 6 to 10 minutes following 3.3 mg/kg. Full standing recovery is generally observed within 10 to 20 minutes after the end of anesthesia, regardless of the duration of anesthesia. Recovery may be delayed in sighthounds or if preanesthetics are administered. In cats, the duration of anesthesia following the recommended induction dose (8.0 to 13.2 mg/kg without premedication) is generally 5 to 12 minutes. The duration of anesthesia after maintenance doses varies from 5 to 7 minutes following 1.1 mg/kg to 12 to 18 minutes following 4.4 mg/kg. Full standing recovery is generally observed within 30 to 45 minutes after the end of anesthesia, regardless of the duration of anesthesia. Recovery may be delayed if preanesthetics are administered. Propofol injectable emulsion injection is contraindicated in dogs and cats with a known hypersensitivity to propofol or its components, or when general anesthesia or sedation are contraindicated. Not for human use. Keep out of reach of children. Propofol injectable emulsion injection 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. Rare cases of self-administration of propofol have been reported, including dose-related fatalities. Preventive care should be taken to avoid self-administration; for example, use of a guarded needle until the moment of injection is recommended. Symptoms of self-administration may include cardiovascular and/or respiratory depression. Anaphylaxis to propofol may occur during its first use, especially in patients with a history of drug allergy.7 In the event of accidental self-administration, seek medical attention immediately. Contact of this product with skin, eyes, and clothes should be avoided. If contact occurs, skin and eyes should be liberally flushed with water for 15 minutes. If irritation develops and continues, consult a physician. Initial arousal following propofol anesthesia can be extremely rapid. Caution should be used at this time in manipulations involving the mouth, such as removing an endotracheal tube.

Product summary:

Propofol injectable emulsion injection is supplied in cartons of five-20 mL vials containing 10 mg propofol per mL.

Authorization status:

New Animal Drug Application

Summary of Product characteristics

PROPOFOL- PROPOFOL INJECTION, EMULSION
BUTLER ANIMAL HEALTH SUPPLY, LLC DBA COVETRUS NORTH AMERICA
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PROPOFOL INJECTABLE EMULSION
For Animals Only
COVETRUS
PROPOFOL INJECTABLE EMULSION
ANESTHETIC INJECTION
Each mL contains 10 mg propofol
Approved by FDA under NADA #141-070
Emulsion for intravenous in dogs and cats.
CAUTION: Federal law restricts this drug to use by or on the order of
a licensed
veterinarian.
DESCRIPTION
Propofol injectable emulsion 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
178.28. Propofol is
very slightly soluble in water and is therefore formulated as a white,
oil-in-water
emulsion. Each mL contains propofol (10 mg), soybean oil (100 mg),
glycerol (22.5 mg),
egg yolk phospholipid (12 mg) and sodium metabisulfite (0.25 mg), with
sodium
hydroxide to adjust the pH. The propofol emulsion is isotonic and has
a pH of 4.5-6.6.
INDICATIONS
Propofol injectable emulsion is an anesthetic injection for use in
dogs and cats as
follows:
1. As a single injection to provide general anesthesia for short
procedures.
2. For induction and maintenance of general anesthesia using
incremental doses to
effect.
3. For induction of general anesthesia where maintenance is provided
by inhalant
anesthetics.
Induction of general anesthesia will usually be observed within 30 to
60 seconds after
the end of administration (administration should take 60 to 90
seconds). The doses for
induction and maintenance vary depending upon species and
preanesthetics. The
duration of anesthesia varies depending upon species, dose, and
preanesthetics.
In dogs, the duration of anesthesia following the recommended
induction dose (5.5 to
7.0 mg/kg without premedication) is generally 5 to 7 minutes. The
duration of anesthesia
after maintenance doses varies from 2 to 6 minutes following 1.1 mg/kg
to 6 to 10
after maintenance doses varies from 2 to 6 minutes following 1.1 mg/k