KETALAR 10 MG/ML INJECTION

Active substance: KETAMINE HYDROCHLORIDE

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To the medical profession

KETALAR

KETALAR ® 10 mg/ml, 50 mg/ml and 100 mg/ml INJECTION

Ketamine (as Hydrochloride)

Ketamine hydrochloride

Read all of this leaflet carefully before you are given this medicine
because it contains important information for you.
I
• f you have been given Ketalar in an emergency you will not have had a
chance to read this leaflet. Your doctor or anaesthetist will have considered the
important safety information in this leaflet, but your urgent need for treatment
may have been more important than some of the usual precautions.
• f you are discharged on the same day as the operation, you should be
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accompanied by another adult.
•  eep this leaflet. You may need to read it again.
K
• f you have any further questions, ask your doctor or nurse.
I
• f you get any side effects, talk to your doctor or nurse. This includes any
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possible side effects not listed in this leaflet.
What is in this leaflet
1. 
What Ketalar Injection is and what it is used for
What you need to know before you are given Ketalar Injection
2. 
How Ketalar Injection is given
3. 
Possible side effects
4. 
How to store Ketalar Injection
5. 
6. 
Contents of the pack and other information

1. What Ketalar Injection is and what it is used for
This medicine contains ketamine hydrochloride which belongs to a group of
medicines called anaesthetic agents, which are used to put you to sleep during
an operation. Ketalar may be used in both routine and emergency surgery.
Ketalar is used in adults, the elderly and children. Ketalar can be given alone or in
combination with other anaesthetic agents.

2. What you need to know before you are given
Ketalar Injection
Do not take Ketalar:
• f you are allergic to ketamine hydrochloride or any of the other ingredients
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of this medicine (listed in section 6).
• f you are suffering from any condition in which an increase in blood pressure
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may be harmful to you or have suffered in the past from a medical condition
which may have been caused/made worse by an increase in blood pressure
• f you have been pregnant and during your pregnancy you have suffered
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from a condition called eclampsia or pre-eclampsia which causes an
increase in your blood pressure

• f you have recently suffered a stroke or serious head or brain injury
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• f you have severe heart disease
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• f you are pregnant, trying to become pregnant or breast-feeding. However,
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Ketalar may safely be used in caesarean section surgery
Warnings and precautions
Talk to your doctor or nurse if any of the following apply to you, to help them
decide if Ketalar is suitable for you. If you:
•  rink large amounts of alcohol
d
•  ave a history of drug abuse or addiction
h
•  ave a history of or have current mental health problems
h
•  ave a chest infection or problems breathing
h
•  ave problems with your liver
h
•  ave increased pressure in the eye (glaucoma)
h
•  ave an inherited disease that affects the blood (porphyria)
h
•  ave ever had seizures
h
•  re receiving treatment for your thyroid gland
a
•  ave had any injury to your head or abnormal growth in the brain
h
If before your operation the pressure in your spinal cord is raised, your
anaesthetist will pay special attention to this during the operation.
Other medicines and Ketalar
Tell your doctor if you are taking, have recently taken or might take any other
medicines.
Ketalar is usually given together with other medicines during surgery.
W
•  hen used for an operation on the chest or abdominal organs, Ketalar is
usually combined with a pain-killer.
•  ell your doctor if you are taking barbiturates (e.g. thiopental) and
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narcotics (morphine-like drugs) since use with Ketalar may slow your
recovery from anaesthesia. Otherwise, Ketalar may be used with all other
general and local anaesthetics.
Ketalar with food and drink
It is normal not to eat or drink for at least six hours before an operation;
therefore Ketalar is usually given when your stomach is empty. If in an
emergency, this is not possible, Ketalar may still be used.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are
planning to have a baby, ask your doctor for advice before being given this
medicine.

®

Driving and using machines
Caution should be taken when driving or operating machines following treatment
with Ketalar. You should not drive or operate machines in the first 24 hours after
your operation.
The medicine can affect your ability to drive as it may make you sleepy or dizzy.
•  o not drive while taking this medicine until you know how it affects you.
D
• t is an offence to drive if this medicine affects your ability to drive.
I
•  owever, you would not be committing an offence if:
H
-  he medicine has been prescribed to treat a medical or dental problem and
T
-  ou have taken it according to the instructions given by the prescriber or
Y
in the information provided with the medicine and
- t was not affecting your ability to drive safely
I
Talk to your doctor or pharmacist if you are not sure whether it is safe for you to
drive while taking this medicine.
Ketalar contains sodium
Ketalar 10 mg/ml Injection: Each 1 ml contains 2.6 mg of sodium. Patients on a
sodium controlled diet should take this into consideration.

3. How Ketalar Injection is given
•  xcept in an emergency, Ketalar should only be used in hospitals by
E
experienced anaesthetists with resuscitation equipment available.
•  efore your operation you will usually be given a medicine such as atropine
B
or hyoscine to dry up your secretions (body fluids like saliva and tears) and
another medicine called a benzodiazepine. The benzodiazepine will help you
to relax and help to prevent a side effect known as "emergence reaction".
•  he dose of Ketalar depends on its use and varies from person to person. When
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injected directly into a vein at a dose of 2 mg for every kg of your bodyweight,
Ketalar produces unconsciousness within 30 seconds and this lasts for 5 to
10 minutes. Because it works so quickly, it is important to be lying down, or
supported in some other way when the drug is given. When Ketalar is injected
into a muscle, at a dose of 10 mg for every kg of bodyweight, it takes longer to
work (3 to 4 minutes) but lasts 12 to 25 minutes.
•  our anaesthetist will then keep you anaesthetised with either:
Y
-  nother anaesthetic
a
-  ore Ketalar given by injection into a muscle or vein, or in a drip (infusion)
m
-  etalar together with another anaesthetic.
K

Continued overleaf...

10 mg/ml, 50 mg/ml
and 100 mg/ml
INJECTION

SUMMARY OF PRODUCT CHARACTERISTICS
1. Name of medicinal product
Ketalar 10 mg/ml, 50 mg/ml, 100 mg/ml Injection

2. Qualitative and quantitative
composition
Each 1 ml of solution contains:
Ketalar 10mg/ml Injection : 
ketamine hydrochloride equivalent to
10 mg ketamine base per ml.
Excipient(s) with known effect: Each 1 ml contains 2.6 mg of sodium
Ketalar 50mg/ml Injection : 
ketamine hydrochloride equivalent to
50 mg ketamine base per ml.
Ketalar 100mg/ml Injection: 
ketamine hydrochloride equivalent to
100 mg ketamine base per ml.
For the full list of excipients see section 6.1.

3. Pharmaceutical form
Solution for injection or infusion.
A clear solution for injection or infusion.

4. Clinical particulars
4.1 Therapeutic indications
Ketalar is recommended:
As an anaesthetic agent for diagnostic and surgical procedures.
When used by intravenous or intramuscular injection, Ketalar is best
suited for short procedures. With additional doses, or by intravenous
infusion, Ketalar can be used for longer procedures. If skeletal muscle
relaxation is desired, a muscle relaxant should be used and respiration
should be supported.
For the induction of anaesthesia prior to the administration of other
general anaesthetic agents.
To supplement other anaesthetic agents.
Specific areas of application or types of procedures:
When the intramuscular route of administration is preferred.
Debridement, painful dressings, and skin grafting in burned patients,
as well as other superficial surgical procedures.
Neurodiagnostic procedures such as pneumoencephalograms,
ventriculograms, myelograms, and lumbar punctures.
Diagnostic and operative procedures of the eye, ear, nose, and mouth,
including dental extractions.

Note: Eye movements may persist during ophthalmological
procedures.
Anaesthesia in poor-risk patients with depression of vital functions or
where depression of vital functions must be avoided, if at all possible.
Orthopaedic procedures such as closed reductions, manipulations,
femoral pinning, amputations, and biopsies.
Sigmoidoscopy and minor surgery of the anus and rectum,
circumcision and pilonidal sinus.
Cardiac catheterization procedures.
Caesarian section; as an induction agent in the absence of elevated
blood pressure.
Anaesthesia in the asthmatic patient, either to minimise the risks
of an attack of bronchospasm developing, or in the presence of
bronchospasm where anaesthesia cannot be delayed.

4.2 Posology and method of administration
For intravenous infusion, intravenous injection or intramuscular
injection.
NOTE: All doses are given in terms of ketamine base
Adults, elderly (over 65 years) and children:
For surgery in elderly patients ketamine has been shown to be suitable
either alone or supplemented with other anaesthetic agents.
Preoperative preparations
Ketalar has been safely used alone when the stomach was not
empty. However, since the need for supplemental agents and muscle
relaxants cannot be predicted, when preparing for elective surgery it
is advisable that nothing be given by mouth for at least six hours prior
to anaesthesia.
Premedication with an anticholinergic agent (e.g. atropine, hyoscine
or glycopyrolate) or another drying agent should be given at an
appropriate interval prior to induction to reduce ketamine-induced
hypersalivation.
Midazolam, diazepam, lorazepam, or flunitrazepam used as a
premedicant or as an adjunct to ketamine, have been effective in
reducing the incidence of emergence reactions.
Onset and duration
As with other general anaesthetic agents, the individual response
to Ketalar is somewhat varied depending on the dose, route of
administration, age of patient, and concomitant use of other agents,
so that dosage recommendation cannot be absolutely fixed. The dose
should be titrated against the patient’s requirements.
Because of rapid induction following intravenous injection, the
patient should be in a supported position during administration. An
intravenous dose of 2 mg/kg of bodyweight usually produces surgical
anaesthesia within 30 seconds after injection and the anaesthetic
effect usually lasts 5 to 10 minutes. An intramuscular dose of
10 mg/kg of bodyweight usually produces surgical anaesthesia within
3 to 4 minutes following injection and the anaesthetic effect usually
lasts 12 to 25 minutes. Return to consciousness is gradual.

A. 
Ketalar as the sole anaesthetic agent
Intravenous Infusion
The use of Ketalar by continuous infusion enables the dose to
be titrated more closely, thereby reducing the amount of drug
administered compared with intermittent administration. This results in
a shorter recovery time and better stability of vital signs.
A solution containing 1 mg/ml of ketamine in dextrose 5% or sodium
chloride 0.9% is suitable for administration by infusion.
General Anaesthesia Induction
An infusion corresponding to 0.5 – 2 mg/kg as total induction dose.
Maintenance of anaesthesia
Anaesthesia may be maintained using a microdrip infusion of
10 - 45 microgram/kg/min (approximately 1 – 3 mg/min).
The rate of infusion will depend on the patient’s reaction and response
to anaesthesia. The dosage required may be reduced when a long
acting neuromuscular blocking agent is used.
Intermittent Injection
Induction
Intravenous Route
The initial dose of Ketalar administered intravenously may range
from 1 mg/kg to 4.5 mg/kg (in terms of ketamine base). The
average amount required to produce 5 to 10 minutes of surgical
anaesthesia has been 2.0 mg/kg. It is recommended that intravenous
administration be accomplished slowly (over a period of 60 seconds).
More rapid administration may result in respiratory depression and
enhanced pressor response.
Note: the 100 mg/ml concentration of ketamine should not be injected
intravenously without proper dilution. It is recommended that the drug
be diluted with an equal volume of either sterile water for injection,
normal saline, or 5% dextrose in water.
Intramuscular Route
The initial dose of Ketalar administered intramuscularly may range
from 6.5 mg/kg to 13 mg/kg (in terms of ketamine base). A low
initial intramuscular dose of 4 mg/kg has been used in diagnostic
manoeuvres and procedures not involving intensely painful stimuli.
A dose of 10 mg/kg will usually produce 12 to 25 minutes of surgical
anaesthesia.
Dosage in Hepatic Insufficiency:
Dose reductions should be considered in patients with cirrhosis or
other types of liver impairment. (see section 4.4 Special Warnings and
Special Precautions for Use)
Maintenance of general anaesthesia
Lightening of anaesthesia may be indicated by nystagmus,
movements in response to stimulation, and vocalization. Anaesthesia
is maintained by the administration of additional doses of Ketalar by
either the intravenous or intramuscular route.
Each additional dose is from ½ to the full induction dose
recommended above for the route selected for maintenance,
regardless of the route used for induction.

The larger the total amount of Ketalar administered, the longer will be
the time to complete recovery.
Purposeless and tonic-clonic movements of extremities may occur
during the course of anaesthesia. These movements do not imply a
light plane and are not indicative of the need for additional doses of
the anaesthetic.
B. 
Ketalar as induction agent prior to the use of other general
anaesthetics
Induction is accomplished by a full intravenous or intramuscular
dose of Ketalar as defined above. If Ketalar has been administered
intravenously and the principal anaesthetic is slow-acting, a second
dose of Ketalar may be required 5 to 8 minutes following the initial
dose. If Ketalar has been administered intramuscularly and the
principal anaesthetic is rapid-acting, administration of the principal
anaesthetic may be delayed up to 15 minutes following the injection
of Ketalar.
C. 
Ketalar as supplement to anaesthetic agents
Ketalar is clinically compatible with the commonly used general and
local anaesthetic agents when an adequate respiratory exchange
is maintained. The dose of Ketalar for use in conjunction with other
anaesthetic agents is usually in the same range as the dosage stated
above; however, the use of another anaesthetic agent may allow a
reduction in the dose of Ketalar.
D. 
Management of patients in recovery
Following the procedure the patient should be observed but left
undisturbed. This does not preclude the monitoring of vital signs. If, during
the recovery, the patient shows any indication of emergence delirium,
consideration may be given to the use of diazepam (5 to 10 mg I.V. in an
adult). A hypnotic dose of a thiobarbiturate (50 to 100 mg I.V.) may be used
to terminate severe emergence reactions. If any one of these agents is
employed, the patient may experience a longer recovery period.

4.3 Contraindications
Ketalar is contra-indicated in persons in whom an elevation of
blood pressure would constitute a serious hazard (see section
4.8 Undesirable effects). Ketamine hydrochloride is contraindicated
in patients who have shown hypersensitivity to the drug or its
components. Ketalar should not be used in patients with eclampsia
or pre-eclampsia, severe coronary or myocardial disease,
cerebrovascular accident or cerebral trauma.

4.4 Special warnings and precautions for use
To be used only in hospitals by or under the supervision of
experienced medically qualified anaesthetists except under
emergency conditions.
As with any general anaesthetic agent, resuscitative equipment should
be available and ready for use.
Respiratory depression may occur with overdosage of Ketalar, in
which case supportive ventilation should be employed. Mechanical
support of respiration is preferred to the administration of analeptics.

The intravenous dose should be administered over a period of
60 seconds. More rapid administration may result in transient
respiratory depression or apnoea and enhanced pressor
response.
Because pharyngeal and laryngeal reflexes usually remain
active, mechanical stimulation of the pharynx should be
avoided unless muscle relaxants, with proper attention to
respiration, are used.
Although aspiration of contrast medium has been reported during
Ketalar anaesthesia under experimental conditions (Taylor, P A and
Towey, R M, Brit. Med. J. 1971, 2: 688), in clinical practice aspiration
is seldom a problem.
In surgical procedures involving visceral pain pathways, Ketalar should
be supplemented with an agent which obtunds visceral pain.
When Ketalar is used on an outpatient basis, the patient should not be
released until recovery from anaesthesia is complete and then should
be accompanied by a responsible adult.
Ketalar should be used with caution in patients with the following
conditions:
Use with caution in the chronic alcoholic and the acutely alcoholintoxicated patient.
Ketamine is metabolised in the liver and hepatic clearance is required
for termination of clinical effects. A prolonged duration of action may
occur in patients with cirrhosis or other types of liver impairment.
Dose reductions should be considered in these patients. Abnormal
liver function tests associated with ketamine use have been reported,
particularly with extended use (>3 days) or drug abuse.
Since an increase in cerebrospinal fluid (CSF) pressure has been
reported during Ketalar anaesthesia, Ketalar should be used with
special caution in patients with preanaesthetic elevated cerebrospinal
fluid pressure.
Use with caution in patients with globe injuries and increased
intraocular pressure (e.g. glaucoma) because the pressure may
increase significantly after a single dose of ketamine.
Use with caution in patients with neurotic traits or psychiatric illness
(e.g. schizophrenia and acute psychosis)
Use in caution in patients with acute intermittent porphyria.
Use in caution in patients with seizures.
Use in caution in patients with hyperthyroidism or patients receiving
thyroid replacement (increased risk of hypertension and tachycardia)
Use in caution in patients with pulmonary or upper respiratory infection
(ketamine sensitises the gag reflex, potentially causing laryngospasm)
Use in caution in patients with intracranial mass lesions, a presence of
head injury, or hydrocephalus.
Emergence Reaction
The psychological manifestations vary in severity between pleasant
dream-like states, vivid imagery, hallucinations, nightmares and
emergence delirium (often consisting of dissociative or floating
2014-0000903/3

Package leaflet: Information for the patient

sensations). In some cases these states have been accompanied by
confusion, excitement, and irrational behaviour which a few patients
recall as an unpleasant experience. (See section 4.8 Undesirable Effects).
Emergence delirium phenomena may occur during the recovery
period. The incidence of these reactions may be reduced if verbal
and tactile stimulation of the patient is minimised during the recovery
period. This does not preclude the monitoring of vital signs.
Because of the substantial increase in myocardial oxygen
consumption, ketamine should be used in caution in patients with
hypovolemia, dehydration or cardiac disease, especially coronary
artery disease (e.g. congestive heart failure, myocardial ischemia
and myocardial infarction). In addition ketamine should be used
with caution in patients with mild-to-moderate hypertension and
tachyarrhythmias.
Cardiac function should be continually monitored during the
procedure in patients found to have hypertension or cardiac
decompensation.
Elevation of blood pressure begins shortly after the injection of
Ketalar, reaches a maximum within a few minutes and usually returns
to preanaesthetic values within 15 minutes after injection. The median
peak rise of blood pressure in clinical studies has ranged from 20 to
25 percent of preanaesthetic values. Depending on the condition of
the patient, this elevation of blood pressure may be considered a
beneficial effect, or in others, an adverse reaction.
Cases of cystitis including haemorrhagic cystitis have been reported
in patients being given ketamine on a long term basis. This adverse
reaction develops in patients receiving long term ketamine treatment
after a time ranging from 1 month to several years. Ketamine is not
indicated nor recommended for long term use.
Ketalar has been reported as being a drug of abuse. Reports suggest
that ketamine produces a variety of symptoms including, but not
limited to, flashbacks, hallucinations, dysphoria, anxiety, insomnia,
or disorientation. Cases of cystitis including haemorrhagic cystitis
have also been reported. If used on a daily basis for a few weeks,
dependence and tolerance may develop, particularly in individuals
with a history of drug abuse and dependence. Therefore the use of
Ketalar should be closely supervised and it should be prescribed and
administered with caution.

4.5 Interaction with other medicinal products and other
forms of interaction
Prolonged recovery time may occur if barbiturates and/or narcotics
are used concurrently with Ketalar.
Ketalar is chemically incompatible with barbiturates and diazepam
because of precipitate formation. Therefore, these should not be
mixed in the same syringe or infusion fluid.
Ketamine may potentiate the neuromuscular blocking effects of
atracurium and tubocurarine including respiratory depression with
apnoea.

The use of halogenated anaesthetics concomitantly with ketamine can
lengthen the elimination half-life of ketamine and delay recovery from
anaesthesia. Concurrent use of ketamine (especially in high doses
or when rapidly administered) with halogenated anaesthetics can
increase the risk of developing bradycardia, hypotension or decreased
cardiac output.
The use of ketamine with other central nervous system (CNS)
depressants (e.g. ethanol, phenothiazines, sedating H1 – blockers
or skeletal muscle relaxants) can potentiate CNS depression and/or
increase risk of developing respiratory depression. Reduced doses
of ketamine may be required with concurrent administration of other
anxiolytics, sedatives and hypnotics.
Ketamine has been reported to antagonise the hypnotic effect of
thiopental.
Patients taking thyroid hormones have an increased risk of developing
hypertension and tachycardia when given ketamine.
Concomitant use of antihypertensive agents and ketamine increases
the risk of developing hypotension.
When ketamine and theophylline are given concurrently, a
clinically significant reduction in the seizure threshold is observed.
Unpredictable extensor-type seizures have been reported with
concurrent administration of these agents.

4.8 Undesirable effects

4.9 Overdose

The following Adverse Events have been reported:

Respiratory depression can result from an overdosage of ketamine
hydrochloride. Supportive ventilation should be employed.
Mechanical support of respiration that will maintain adequate blood
oxygen saturation and carbon dioxide elimination is preferred to
administration of analeptics.
Ketalar has a wide margin of safety; several instances of unintentional
administration of overdoses of Ketalar (up to 10 times that usually
required) have been followed by prolonged but complete recovery.

MedDRA
System Organ
Class
Immune system
disorders
Metabolism and
nutrition disorders

4.7 Effects on ability to drive and use machines
Patients should be cautioned that driving a car, operating hazardous
machinery or engaging in hazardous activities should not be
undertaken for 24 hours or more after anaesthesia.
This medicine can impair cognitive function and can affect a patient’s
ability to drive safely. This class of medicine is in the list of drugs
included in regulations under 5a of the Road Traffic Act 1988. When
prescribing this medicine, patients should be told:

T
 he medicine is likely to affect your ability to drive
D
 o not drive until you know how the medicine affects you


I
t is an offence to drive while under the influence of this
medicine
H
 owever, you would not be committing an offence (called

‘statutory defence’) if:
-  he medicine has been prescribed to treat a medical or
T
dental problem and
-  ou have taken it according to the instructions given by
Y
the prescriber and in the information provided with the
medicine and
- t was not affecting your ability to drive safely
I

Undesirable Effects

Rare

Anaphylactic reaction*

Uncommon

Anorexia

Common
Rare

Hallucination, Abnormal
dreams, Nightmare,
Confusion, Agitation,
Abnormal behaviour
Anxiety
Delirium* Flashback*,
Dysphoria*, Insomnia,
Disorientation*
Nystagmus, Hypertonia, Tonic
clonic movements
Diplopia
Intraocular pressure increased
Blood pressure increased,
Heart rate increased
Bradycardia, Arrhythmia
Hypotension
Respiratory rate increased
Respiratory depression,
Laryngospasm
Obstructive airway disorder*,
Apnoea*
Nausea, Vomiting
Salivary hypersecretion*

Not known

Liver function test abnormal

Common

Erythema, Rash morbilliform

Rare

Cystitis*, Haemorrhagic
cystitis*

Uncommon

Injection site pain, Injection
site rash

Common
Psychiatric
disorders

Uncommon
Rare

Nervous system
disorders

Common

Eye disorders

Common
Not Known

4.6 Fertility, pregnancy and lactation
Ketalar crosses the placenta. This should be borne in mind during
operative obstetric procedures in pregnancy. With the exception
of administration during surgery for abdominal delivery or vaginal
delivery, no controlled clinical studies in pregnancy have been
conducted. The safe use in pregnancy, and in lactation, has not been
established and such use is not recommended.

Frequency†

Cardiac disorders
Vascular disorders
Respiratory,
thoracic and
mediastinal
disorders
Gastrointestinal
disorders
Hepatobiliary
disorders
Skin and
subcutaneous
tissue disorders
Renal and urinary
disorders
General disorders
and administration
site conditions

Common
Uncommon
Uncommon
Common
Uncommon
Rare

† Common (≥1/100 to <1/10); Uncommon (≥1/1,000 to <1/100); Rare
(≥1/10,000 to <1/1,000); Not known (frequency cannot be estimated
from the available data)
* AE frequency estimated from post-marketing safety database

5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Ketamine is a rapidly acting general anaesthetic for intravenous or
intramuscular use with a distinct pharmacological action. Ketamine
hydrochloride produces dissociative anaesthesia characterised by
catalepsy, amnesia, and marked analgesia which may persist into the
recovery period. Pharyngeal-laryngeal reflexes remain normal and
skeletal muscle tone may be normal or can be enhanced to varying
degrees. Mild cardiac and respiratory stimulation and occasionally
respiratory depression occur.
Mechanism of Action:
Ketamine induces sedation, immobility, amnesia and marked
analgesia. The anaesthetic state produced by ketamine has been
termed “dissociative anaesthesia” in that it appears to selectively
interrupt association pathways of the brain before producing
somesthetic sensory blockade. It may selectively depress the
thalamoneocortical system before significantly obtunding the more
ancient cerebral centres and pathways (reticular-activating and
limbic systems). Numerous theories have been proposed to explain
the effects of ketamine, including binding to N-methyl-D-aspartate
(NMDA) receptors in the CNS, interactions with opiate receptors
at central and spinal sites and interaction with norepinephrine,
serotonin and muscarinic cholinergic receptors. The activity on NMDA
receptors may be responsible for the analgesic as well as psychiatric
(psychosis) effects of ketamine. Ketamine has sympathomimetic
activity resulting in tachycardia, hypertension, increased myocardial
and cerebral oxygen consumption, increased cerebral blood flow and
increased intracranial and intraocular pressure. Ketamine is also a
potent bronchodilator. Clinical effects observed following ketamine
administration include increased blood pressure, increased muscle
tone (may resemble catatonia), opening of eyes (usually accompanied
by nystagmus) and increased myocardial oxygen consumption.

5.2 Pharmacokinetic properties
Ketamine is rapidly distributed into perfused tissues including brain and
placenta. Animal studies have shown ketamine to be highly concentrated
in body fat, liver and lung. Biotransformation takes place in liver.
Termination of anaesthetic is partly by redistribution from brain to other
tissues and partly by metabolism. Elimination half-life is approximately
2-3 hours, and excretion renal, mostly as conjugated metabolites.

5.3 Preclinical safety data
Preclinical safety data does not add anything of further significance to
the prescriber.

Package leaflet: Information for the patient

6. Pharmaceutical particulars
6.1 List of excipients

Ketalar 10 mg/ml Injection: 
sodium chloride, benzethonium chloride,
water for injections
benzethonium chloride, water for injections
Ketalar 50 mg/ml Injection: 
Ketalar 100 mg/ml Injection: 
benzethonium chloride, water for injections

6.2 Incompatibilities
Ketalar is chemically incompatible with barbiturates and diazepam
because of precipitate formation. Therefore, these should not be
mixed in the same syringe or infusion fluid.

6.3 Shelf life
Ketalar 10 mg/ml and 50 mg/ml: 60 months
Ketalar 100 mg/ml: 36 months
For single use only. Discard any unused product at the end of each
operating session.
After dilution the solutions should be used immediately.

6.4 Special precautions for storage
This medicinal product does not require any special storage
conditions. Do not freeze. Store in the original container. Discard any
unused product at the end of each operating session.

6.5 Nature and contents of container
Ketalar 10 mg/ml Injection: 
25 ml white neutral glass vial with rubber
closure and aluminium flip-off cap
containing 20ml of solution as 10 mg
ketamine base per ml.
12 ml vials containing 10 ml of solution as
Ketalar 50 mg/ml Injection: 
50 mg ketamine base per ml.
Ketalar 100 mg/ml Injection:  2 ml vials containing 10 ml of solution as
1
100 mg ketamine base per ml.

6.6 Special precautions for disposal and other handling
For single use only. Discard any unused product at the end of each
operating session. See Section 4.2 Posology and method of administration.

7. marketing authorisation holder
Pfizer Limited, Sandwich, Kent CT13 9NJ, United Kingdom

8. Marketing authorisation number
PL 00057/0529, PL 00057/0530, PL 00057/0531

9. Date of first authorisation/renewal of
authorisation
1st July 2003

10. DATE OF REVISION OF THE TEXT
01/2014

Ref: KE 11_0

Pfizer Limited
Sandwich, England

•  hen it is injected directly into a vein, Ketalar is given over at least a minute
W
so that it does not slow your breathing too much. If breathing is slowed, it
can be helped mechanically.
•  hile you are anaesthetised, your anaesthetist will watch over you
W
constantly, paying particular attention to your breathing, airways, reflexes, the
degree of anaesthesia and the condition of your heart.
Y
 ou should not be released from hospital until you have completely recovered
from the anaesthetic. If you are discharged on the same day as the
operation, you should be accompanied by another adult (see also the section
on ‘Driving and Using Machines’).
If you are given more Ketalar than you should you may experience
breathing difficulties. Your doctor or nurse may provide you with equipment
to help you breath.
If you have any further questions on the use of this medicine, ask your doctor
or nurse.

4. Possible side effects
Like all medicines, this medicine can cause side effects although not everyone
gets them.
Tell your doctor immediately if you notice pain, inflammation of the skin or rash
at the injection site.
Ketalar can sometimes cause allergic symptoms (‘anaphylaxis’) such as breathing
problems, swelling and rash. Some people have hallucinations, vivid dreams,
nightmares, feel ill at ease, confused, anxious or behave irrationally while
recovering from anaesthesia with Ketalar. These side effects are collectively
known as an ‘emergence reaction’. You will be allowed to recover from the
anaesthetic in a quiet place and this helps to prevent the reaction (see Section
3 under ‘How Ketalar Injection is given’).
Common side effects may affect up to 1 in 10 people
t
• he following, while recovering from anaesthesia (these are collectively
known as an ‘emergence reaction’): hallucinations (which may include
flashbacks or floating sensation), vivid dreams, nightmares, feeling ill at ease,
confused, anxious and irrational behaviour.
u
•  nusual eye movements, increased muscle tone and muscle twitches (which
may resemble ‘fits’ or convulsions).
d
•  ouble vision.
i
• ncreased blood pressure and increased pulse rate.
b
•  reathing more quickly.
n
•  ausea, vomiting.
s
•  kin inflammation/rash.
Uncommon side effects may affect up to 1 in 100 people
l
• oss of appetite, feeling anxious.
s
•  lowing of heart rate, changes in heart rhythm.

• owering of blood pressure.
l
b
•  reathing more slowly, narrowing of the voice-box leading to difficulty in
breathing.
•  ain, inflammation of the skin or rash at the injection site.
p
Rare side effects may affect up to 1 in 1000 people
•  llergic symptoms (‘anaphylaxis’) such as breathing problems, swelling
a
and rash.
•  rifting in and out of consciousness (with feeling of confusion and
d
hallucinations), flashbacks, feeling ill at ease, sleeplessness, feeling disorientated.
•  ffect on the reflexes which keep your airways clear, resulting in temporary
a
inability to breathe.
• ncrease in salivation.
i
• nflammation of the bladder and/or pain when urinating (‘cystitis’). The
i
appearance of blood in the urine may also occur.
Side effects where the occurrence is not known
• aised pressure in the eyes.
r
•  bnormal results to liver function tests.
a
If you get any side effects, talk to your doctor or nurse. This includes any
possible side effects not listed in this leaflet.
Also you can help to make sure that medicines remain as safe as
possible by reporting any unwanted side effects via the internet at
www.mhra.gov.uk/yellowcard. Alternatively you can call Freephone
0808 100 3352 (available from 10 a.m. to 2 p.m. Mondays to Fridays) or fill in a
paper form available from your local pharmacy.

What Ketalar looks like and contents of the pack
Ketalar is a clear solution for injection or infusion available in single
glass vials and comes in three strengths. Each carton contains 1 vial.
Marketing Authorisation Holder:
Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ,
United Kingdom
Manufacturer:
Amgen Technology Ireland, Pottery Road, Dun Laoghaire, Co Dublin, Ireland.
Company contact address:
For further information on this medicine please contact Medical Information at
Pfizer Limited, Walton Oaks, Dorking Road,
Tadworth, Surrey, KT20 7NS
Telephone 01304 616161
Ref: KE 11_0
This leaflet was last revised in 01/2014
2014-0000903/3

To the medical profession

5. How to store Ketalar Injection
•  eep this medicine out of the sight and reach of children.
K
•  o not use this medicine after the expiry date which is stated on the label
D
and carton after EXP. The expiry dates refers to the last day of that month.
Your pharmacist will check this before the injection is given.
•  o not freeze. This medicinal product does not require any special storage
D
conditions. Store in the original container in order to protect from light.

6. Contents of the pack and other information
What Ketalar contains
T
•  he active ingredient is ketamine hydrochloride
Each 20 ml solution contains 10 mg of ketamine base per ml
Each 10 ml solution contains 50 mg of ketamine base per ml
Each 10 ml solution contains 100 mg of ketamine base per ml
•  he other ingredients are:
T
10 mg/ml: sodium chloride (salt), water for injections and a preservative
(benzethonium chloride).
50 mg/ml: water for injections and a preservative (benzethonium chloride).
100 mg/ml: water for injections and a preservative (benzethonium chloride).

Pfizer Limited
Sandwich, England

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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