0.

125"
Acepromazine may also
be used. However, recent
information indicates that
Ketamine some phenothiazine
Hydrochloride derivatives may potentiate
the toxic effects of organic
Injection phosphate compounds

1.53125"
Veterinary Injection such as found in flea collars
and certain anthelmintics.

1.65625"
For Intramuscular Use A study has indicated that
in Cats and Subhuman ketamine hydrochloride
Primates Only alone does not potentiate
the toxic effects of organic
Caution: Federal law phosphate compounds.
restricts this drug to use To report suspected adverse
by or on the order of a events, to obtain a Safety
licensed veterinarian. Data Sheet or for technical
Description: Ketamine assistance, call Dechra at
Hydrochloride Injection (866) 933-2472.
is a rapid-acting, For additional information
nonnarcotic, about adverse drug
nonbarbiturate agent experience reporting for
for anesthetic use in animal drugs, contact FDA at
cats and for restraint 1-888-FDA-VETS, or online at
in subhuman primates. www.fda.gov/reportanimalae.
It is chemically

1.59375"
designated dl 2- Action: Ketamine
(o-chlorophenyl)-2- Hydrochloride Injection is
(methylamino) a rapid-acting agent whose
1.59375"

cyclohexanone pharmacological action is

hydrochloride and is characterized by profound
supplied as a slightly analgesia, normal
acid (pH 3.5 to 5.5) pharyngeal-laryngeal
solution for intramuscular reflexes, mild cardiac
injection. stimulation and
respiratory depression.
Each mL contains 100 mg Skeletal muscle tone is
ketamine base (equivalent variable and may be
to 115 mg ketamine normal, enhanced or
hydrochloride) and not diminished. The
more than 0.1 mg anesthetic state
benzethonium chloride as produced does not fit
a preservative. into the conventional
Indications: Ketamine classification of stages
Hydrochloride Injection of anesthesia, but
may be used in cats for

1.59375"
instead Ketamine
restraint or as the sole Hydrochloride Injection
anesthetic agent for produces a state
diagnostic or minor,
1.59375"

of unconsciousness
brief, surgical procedures which has been termed
that do not require skeletal “dissociative” anesthesia
muscle relaxation. It may in that it appears to
be used in subhuman selectively interrupt
primates for restraint. association pathways
Dosage and to the brain before
Administration: producing somesthetic
Ketamine Hydrochloride sensory blockade.
Injection is well tolerated In contrast to other
by cats and subhuman anesthetics, protective
primates when administered reflexes, such as
by intramuscular injection. coughing and swallowing
Fasting prior to induction are maintained under
of anesthesia or restraint Ketamine Hydrochloride
with Ketamine Hydrochloride Injection anesthesia. The
Injection is not essential; degree of muscle tone is
however, when preparing dependent upon level 1.53125"
for elective surgery, it is of dose; therefore,
advisable to withhold food variations in body
1.53125"

for at least six hours prior temperature may occur.

to administration of At low dosage levels
Ketamine Hydrochloride there may be an
Injection. increase in muscle tone
Anesthesia may be and a concomitant slight
of shorter duration in increase in body
immature cats. Restraint temperature. However,
in subhuman primate at high dosage levels
neonates (less than there is some diminution
24 hours of age) is difficult in muscle tone and a
to achieve. resultant decrease in
As with other anesthetic body temperature, to
agents, the individual the point where
response to Ketamine supplemental heat
Hydrochloride Injection may be advisable.
1.53125"

is somewhat varied In cats, there is usually

depending upon the some transient
dose, general condition cardiovascular
1.53125"

and age of the subject stimulation, increased

so that dosage cardiac output with
recommendations slight increase in mean
cannot be absolutely fixed. systolic pressure with
Dosage: little or no change in total
Cats: peripheral resistance.
A dose of 11 mg/kg At higher doses the
(5 mg/lb) is recommended respiratory rate is usually
to produce restraint. decreased.
Dosages from 22 to The assurance of a
33 mg/kg (10 to 15 mg/lb) patent airway is greatly
produce anesthesia that enhanced by virtue
is suitable for diagnostic of maintained
or minor surgical pharyngeal-laryngeal
procedures that do not reflexes. Although some
require skeletal muscle salivation is occasionally
noted, the persistence of
1.59375"

relaxation.
Subhuman Primates: the swallowing reflex aids
in minimizing the hazards
1.59375"

The recommended
restraint dosages of associated with ptyalism.
Ketamine Hydrochloride Salivation may be
Injection for the effectively controlled
following species are: with atropine sulfate in
Cercocebus torquatus dosages of 0.04 mg/kg
(white-collared (0.02 mg/lb) in cats and
mangabey), 0.01 to 0.05 mg/kg
Papio cynocephalus (0.005 to 0.025 mg/lb)
(yellow baboon), in subhuman primates.
Pan troglodytes verus Other reflexes, e.g.,
(chimpanzee), corneal, pedal, etc., are
Papio anubis maintained during
(olive baboon), Ketamine Hydrochloride
Pongo pygmaeus Injection anesthesia, and
(orangutan), should not be used as
Macaca nemestrina criteria for judging depth
(pig-tailed macaque) of anesthesia. The eyes
1.5"

5 to 7.5 mg/kg; normally remain open

Presbytis entellus with the pupils dilated.
It is suggested that a
1.5"

(entellus langur)
3 to 5 mg/kg; bland ophthalmic
Gorilla gorilla gorilla ointment be applied to
(gorilla) 7 to 10 mg/kg; the cornea if anesthesia
Aotus trivirgatus is to be prolonged.
(night monkey) Following administration
10 to 12 mg/kg; of recommended doses,
Macaca mulatta cats become ataxic in
(rhesus monkey) about 5 minutes with
5 to 10 mg/kg; anesthesia usually
Cebus capucinus lasting from 30 to
(white-throated capuchin) 45 minutes at higher
13 to 15 mg/kg; and doses. At the lower
Macaca fascicularis doses, complete
(crab-eating macaque), recovery usually occurs
Macaca radiata in 4 to 5 hours but with
1.5"

(bonnet macaque) and higher doses recovery

Saimiri sciureus time is more prolonged
(squirrel monkey) and may be as long as
12 to 15 mg/kg. 24 hours.
1.5"

A single intramuscular In studies involving

injection produces 14 species of subhuman
restraint suitable for primates represented by
TB testing; radiography, at least 10 anesthetic
physical examination episodes for each
or blood collection. species, the median time
Contraindications: to restraint ranged from
Ketamine Hydrochloride 1.5 [Aotus trivirgatus
Injection is contraindicated (night monkey) and
in cats and subhuman Cebus capucinus
primates suffering from (white-throated capuchin)]
renal or hepatic to 5.3 minutes [Macaca
insufficiency. nemestrina (pig-tailed
Ketamine Hydrochloride macaque)]. The median
1.59375"

Injection is detoxified by duration of restraint

the liver and excreted by ranged between 20 and
the kidneys; therefore, 55 minutes in all but five
1.59375"

any preexistent hepatic of the species studied.

or renal pathology or Total time from injection
impairment of function to end of restraint
can be expected to result ranged from 43 [Saimiri
in prolonged anesthesia; sciureus (squirrel monkey)]
related fatalities have to 183 minutes
been reported. [Macaca nemestrina
Precautions: In cats, (pig-tailed macaque)]
doses in excess of after injection. Recovery
50 mg/kg during any is generally smooth and
single procedure should uneventful. The duration
not be used. The is dose related.
maximum recommended By single intramuscular
dose in subhuman injection, Ketamine
primates is 40 mg/kg. Hydrochloride Injection
To reduce the incidence usually has a wide margin
1.53125"

of emergence reactions, of safety in cats and

animals should not be subhuman primates. In cats,
1.53125"

stimulated by sound or cases of prolonged recovery

handling during the and death have been
recovery period. reported.
However, this does not Clinical Studies:
preclude the monitoring Ketamine hydrochloride
of vital signs. injection has been clinically
Apnea, respiratory studied in subhuman
arrest, cardiac arrest and primates in addition to
death have occasionally those species listed under
been reported with Dosage and Administration.
ketamine used alone, Dosages for restraint in
and more frequently these additional species,
when used in conjunction based on limited clinical
with sedatives or other data, are: Cercopithecus
anesthetics. Close aethiops (grivet), Papio
monitoring of patients is papio (guinea baboon)
1.53125"

strongly advised during 10 to 12 mg/kg;

induction, maintenance Erythrocebus patas
and recovery from patas (patas monkey)
1.53125"

anesthesia. 3 to 5 mg/kg; Hylobates lar

(white-handed gibbon)
Color of solution may 5 to 10 mg/kg; Lemur catta
vary from colorless to (ringtailed lemur)
very slightly yellowish 7.5 to 10 mg/kg;
and may darken upon Macaca fuscata
prolonged exposure to (Japanese macaque)
light. This darkening 5 mg/kg; Macaca speciosa
does not affect potency. (stumptailed macaque) and
Do not use if precipitate Miopithecus talapoin
appears. (mangrove monkey)
Adverse Reactions: 5 to 7.5 mg/kg; and,
Respiratory depression Symphalangus syndactylus
may occur following (siamangs) 5 to 7 mg/kg.
administration of high Storage Information:
doses of Ketamine Store at controlled room
Hydrochloride Injection. temperature, 68-77° F
1.59375"

If at any time respiration (20-25° C).

becomes excessively Protect from light.
1.59375"

depressed and the animal

becomes cyanotic, How Supplied:
resuscitative measures Ketamine Hydrochloride
should be instituted Injection, 100 mg/mL is
promptly. Adequate supplied in 10 mL vials.
pulmonary ventilation Approved by FDA under
using either oxygen or ANADA # 200-073
room air is recommended Manufactured for:
as a resuscitative measure. Dechra Veterinary Products
Adverse reactions 7015 College Boulevard
reported have included Suite 525, Overland Park
emesis, salivation, KS 66211 USA
vocalization, erratic Product of Germany
recovery and prolonged © 2022 Dechra Veterinary
recovery, spastic Products, LLC
jerking movements,
convulsions, muscular Rev. January 2022
tremors, hypertonicity,
1.59375"

opisthotonos, dyspnea
and cardiac arrest. In the
1.59375"

cat, myoclonic jerking

and/or mild tonic
(Base Template 117-300-1006)
Leaflet Template 117-300-1007

convulsions can be
controlled by
ultrashort-acting
barbiturates which
should be given to effect.
The barbiturates should
be administered
intravenously at a dose
level of one-sixth to
10 mL
Net Contents:
ANADA # 200-073
Approved by FDA under
veterinarian.
or on the order of a licensed
restricts this drug to use by
CAUTION: Federal law
100 mg/mL
Hydrochloride Injection
Ketamine

one-fourth the usual

dose for the product
being used.
(Fold Tolerance +/- 0.0625”)
117-300-1007

1.65625"
Rev. January 2022 1000001250
Overland Park, KS 66211 USA
Dechra Veterinary Products
Manufactured for:
Do not use if precipitate appears.
Protect from light.
temperature, 68-77° F (20-25° C).
Storage: Store at controlled room
refer to package insert.
For complete product information,
subhuman primates only.
For intramuscular use in cats and
1.53125"

0.125"

----------------------Please delete everything below this line---------------------------

Template Number: 117-300-1007

Product: ........................................ Ketamine - US - Label-leaflet Proof: Date: Proof: Date:

1.1 (NH) 23-12-2021
Dimensions:.OVERALL SIZE: 22.0” (+/- .0156”) WIDE x 1.087” (+/- .0156”) HIGH 1.2 (NH) 23-12-2021
1.3 (EM) 18-01-2022
Primary brand name font size: ............................ 10.74pt and 8.12pt on the label 1.4 (KO) 21-01-2022
Established name fant size ............................................. 8pt and 5pt on the label 1.5 (KO) 07-03-2022

Primary brand description font size:........................... 6.44pt and 5pt on the label
Body text font size: ....................................................................... 6pt and 4.75pt
Item code: ....................................................................................... 1000001250
Pharmacode: ..................................................................................................N/A
Pantone reference guide STYLE DEVIATIONS
Colours to be printed: Label front panel - volume point size reduced owing to a lack of space.
541 Cool Grey 3 - 50% Label front panel - text reduced to 5pt owing to a lack of space.
Label front panel - there are no animal type pictograms or product type pictogram owing to a lack of space.
315 Cool Grey 3 - 20% Label front panel - text under the brand name has a horizontal scale of -10, 85%.
Label back panel - the text has a horizontal scale of -10, 85%.
BLACK Label back panel - text reduced to 4.75pt owing to a lack of space.
Label back panel - the address information has been abbreviated.
Leaflet text is not 15pt smaller than the leaflet brand name owing to a lack of space.

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