KETAMINE HYDROCHLORIDE injection, solution

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

Mylan Institutional LLC

INN (Nome Internazionale):

KETAMINE HYDROCHLORIDE

Composizione:

KETAMINE 100 mg in 1 mL

Via di somministrazione:

INTRAMUSCULAR

Tipo di ricetta:

PRESCRIPTION

Indicazioni terapeutiche:

KETAMINE HCl 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. KETAMINE HCl is contraindicated in cats and subhuman primates suffering from renal or hepatic insufficiency. KETAMINE HCl 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.

Dettagli prodotto:

KETAMINE HCl is supplied as the hydrochloride in concentrations equivalent to ketamine base. Each 10 mL vial contains 100 mg/mL. NDC 67457-034-10 carton containing one, 10 mL multi-dose vial with 100 mg/mL Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light.

Stato dell'autorizzazione:

Abbreviated New Animal Drug Application

Scheda tecnica

KETAMINE HYDROCHLORIDE- KETAMINE HYDROCHLORIDE INJECTION, SOLUTION
MYLAN INSTITUTIONAL LLC
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KETAMINE HYDROCHLORIDE
KETAMINE HYDROCHLORIDE INJECTION, USP
1,000 MG/10 ML (100 MG/ML)
Approved by FDA under ANADA # 200-257
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
KETAMINE HCl 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 in a concentration containing the equivalent
of 100 mg ketamine base per
milliliter and contains not more than 0.1 mg/mL benzethonium chloride
as a preservative.
ACTION
KETAMINE HCl is a rapid-acting agent whose pharmacological action is
characterized by profound
analgesia, normal pharyngeal-laryngeal reflexes, mild cardiac
stimulation and respiratory depression.
Skeletal muscle tone is variable and may be normal, enhanced or
diminished. The anesthetic state
produced does not fit into the conventional classification of stages
of anesthesia, but instead
KETAMINE HCl produces a state of unconsciousness which has been termed
“dissociative” anesthesia
in that it appears to selectively interrupt association pathways to
the brain before producing somesthetic
sensory blockade.
In contrast to other anesthetics, protective reflexes, such as
coughing and swallowing are maintained
under KETAMINE HCl anesthesia. The degree of muscle tone is dependent
upon level of dose;
therefore, variations in body temperature may occur. At low dosage
levels there may be an increase in
muscle tone and a concomitant slight increase in body temperature.
However, at high dosage levels
there is some diminution in muscle tone and a resultant decrease in
body temperature, to the point where
supplemental heat may be advisable.
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