KETAVED- ketamine hydrochloride injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

KETAMINE HYDROCHLORIDE (UNII: O18YUO0I83) (KETAMINE - UNII:690G0D6V8H)

Available from:

Vedco, Inc.

INN (International Name):

KETAMINE HYDROCHLORIDE

Composition:

KETAMINE 100 mg in 1 mL

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION

Therapeutic indications:

KETAVED may be used in cats for restraint or as the sole anesthetic agent for diagnostic or minor, brief, surgical procedures that do not require skeletal muscle relaxation. It may be used in subhuman primates for restraint. KETAVED is contraindicated in cats and subhuman primates suffering from renal or hepatic insufficiency. KETAVED is detoxified by the liver and excreted by the kidneys; therefore, any preexistent hepatic or renal pathology or impairment of function can be expected to result in prolonged anesthesia; related fatalities have been reported.

Product summary:

KETAVED (ketamine hydrochloride injection), 100 mg/mL is supplied in 10 mL vials. NDC 50989-161-06 — 10 mL vial KETAVED is a registered trademark of Vedco, Inc. 87017222 383005-04

Authorization status:

New Animal Drug Application

Summary of Product characteristics

KETAVED- KETAMINE HYDROCHLORIDE INJECTION
VEDCO, INC.
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KETAVED®
(KETAMINE HYDROCHLORIDE INJECTION)
Approved by FDA under NADA # 045-290
Veterinary Injection For Intramuscular Use in Cats and Subhuman
Primates Only
CAUTION:
Federal law restricts this drug to use by or on the order of a
licensed veterinarian.
DESCRIPTION:
KETAVED (ketamine hydrochloride injection) is a rapid-acting,
nonnarcotic,
nonbarbiturate agent for anesthetic use in cats and for restraint in
subhuman primates.
It is chemically designated _dl _2-(o-chlorophenyl)-2-(methylamino)
cyclohexanone
hydrochloride and is supplied as a slightly acid (pH 3.5 to 5.5)
solution for intramuscular
injection. Each mL contains 100 mg ketamine base (equivalent to 115 mg
ketamine
hydrochloride) and not more than 0.1 mg benzethonium chloride as a
preservative.
INDICATIONS:
KETAVED may be used in cats for restraint or as the sole anesthetic
agent for diagnostic
or minor, brief, surgical procedures that do not require skeletal
muscle relaxation. It may
be used in subhuman primates for restraint.
DOSAGE AND ADMINISTRATION:
KETAVED is well tolerated by cats and subhuman primates when
administered by
intramuscular injection.
Fasting prior to induction of anesthesia or restraint with KETAVED is
not essential;
however, when preparing for elective surgery, it is advisable to
withhold food for at least
six hours prior to administration of KETAVED.
Anesthesia may be of shorter duration in immature cats. Restraint in
subhuman primate
neonates (less than 24 hours of age) is difficult to achieve.
As with other anesthetic agents, the individual response to KETAVED is
somewhat varied
depending upon the dose, general condition and age of the subject so
that dosage
recommendations cannot be absolutely fixed.
DOSAGE – CATS:
A dose of 11 mg/kg (5 mg/lb) is recommended to produce restraint.
Dosages from 22
to 33 mg/kg (10 to 15 mg/lb) produce anesthesia that is suitable for
diagnostic or minor
surgical procedures that do not require skeletal muscle relaxation.
SUBHUMAN PR