KETALAR 10 MG/ML INJECTION

Active substance: KETAMINE HYDROCHLORIDE

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KETALAR

®

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

Ketamine hydrochloride

Important things that you SHOULD know about your medicine:
• If you have been given Ketalar in an emergency you will not have
had 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.
• If you are discharged on the same day as the operation, you should
be accompanied by another adult.
Please read the rest of this leaflet. It includes other important
information on the safe and effective use of this medicine that might be
especially important to you.
In this leaflet:
1. What Ketalar Injection is and what it is used for
2. Before you are given Ketalar Injection
3. How Ketalar Injection is given
4. Possible side effects
5. How to store Ketalar Injection
6. Further information

1. What KETALAR injection is and what it is
used for





Ketalar belongs to one of 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. The active
ingredient is ketamine hydrochloride.
Ketalar can be given alone or in combination with other anaesthetic
agents.

2. Before you are given KETALAR injection
Do not take Ketalar:
• if you have ever had a reaction to Ketalar or to any of the other
ingredients of the medicine (see Section 6 for details).
• if you are suffering from any condition in which an increase in
blood pressure 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
• if you have been pregnant and during your pregnancy you have
suffered from a condition called eclampsia or pre-eclampsia which
causes an increase in your blood pressure
• if you have recently suffered a stroke or serious head or brain
injury
• if you have severe heart disease
• if you are pregnant, trying to become pregnant or breast-feeding.
However, Ketalar may safely be used in caesarean section surgery
• have a history of or have current mental health problems
Take special care with Ketalar
Tell your doctor if any of the following apply to you, to help them decide
if Ketalar is suitable for you:
• if you drink large amounts of alcohol
• if you have a history of drug abuse or addiction

KETALAR
Ketamine (as Hydrochloride)

• have a chest infection or problems breathing
• problems with your liver
• increased pressure in the eye (glaucoma)
• have an inherited disease that affects the blood (porphyria)
• seizures
• are receiving treatment for your thyroid gland
• have had any injury to your head or abnormal growth in the brain
If before your operation the pressure in your spinal cord is raised, your
anaesthetist will pay special attention to this during the operation.
Taking other medicines
Ketalar is usually given together with other medicines during surgery.
• When used for an operation on the chest or abdominal organs,
Ketalar is usually combined with a pain-killer.
• Tell your doctor if you are taking barbiturates and 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.
Tell your doctor if you are taking any other medicines not listed above.
Taking 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
,
Do not take Ketalar if you are pregnant, trying to become pregnant or if
you are breast-feeding.
Driving and using machinery
Caution should be taken when driving or operating machinery following
treatment with Ketalar. You should not drive or operate machinery in
the first 24 hours after your operation.
Important information about some of the ingredients in Ketalar
The 10mg/ ml vials contain 52.8mg of sodium. Patients on a sodium
controlled diet should take this into consideration.

3. How KETALAR injection is given








Except in an emergency, Ketalar should only be used in hospitals
by experienced anaesthetists with resuscitation equipment
available.
Before your operation you will usually be given a medicine such as
atropine 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”.
The dose of Ketalar depends on its use and varies from person to
person. When 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.
Your anaesthetist will then keep you anaesthetised with either:
- another anaesthetic
- more Ketalar given by injection into a muscle or vein, or in a
Continued overleaf...

Onset and duration

®

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

SUMMARY OF PRODUCT CHARACTERISTICS
1. TRADE 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 Ph Eur equivalent to 10 mg
ketamine base per ml.
Ketalar 50mg/ml Injection :
ketamine hydrochloride Ph Eur equivalent to 50 mg
ketamine base per ml.
Ketalar 100mg/ml Injection:
ketamine hydrochloride Ph Eur equivalent to 100 mg
ketamine base per ml.

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.

1007

To the medical profession

PACKAGE LEAFLET: INFORMATION FOR THE USER

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
4.5mg/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

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.

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 1/2 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.

Preoperative preparations

B.

4.2

Posology and method of administration

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.

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

Contra-indications

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 preeclampsia, severe coronary or myocardial disease, cerebrovascular accident or
cerebral trauma.

4.4

Special warnings and special 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 alcohol-intoxicated 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.
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

845001501Q

To the medical profession

PACKAGE LEAFLET: INFORMATION FOR THE USER

dissociative or floating 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 medicaments 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.

4.7

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.

4.8

Nervous system
disorders

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.

Undesirable Effects

Rare

Anaphylactic reaction*

Uncommon

Anorexia
Hallucination, Abnormal dreams,
Nightmare, Confusion, Agitation,
Abnormal behaviour

Uncommon

Anxiety

Rare

Psychiatric
disorders

Frequency†

Common

Delirium* Flashback*, Dysphoria*,
Insomnia, Disorientation*
Nystagmus, Hypertonia, Tonic clonic
movements

Common

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

Common

Diplopia

Not Known

Intraocular pressure increased

Common

Blood pressure increased, Heart rate
increased

Ketalar 10mg/ml Injection:

Uncommon

Bradycardia, Arrhythmia

Ketalar 50mg/ml Injection:
Ketalar 100mg/ml Injection:

Eye disorders

Cardiac disorders
Vascular disorders
Respiratory,
thoracic and
mediastinal
disorders
Gastrointestinal
disorders

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

6.

sodium chloride, benzethonium chloride, water for
injection
benzethonium chloride, water for injection
benzethonium chloride, water for injection

Uncommon

Hypotension

6.2

Respiratory rate increased

Uncommon

Respiratory depression, Laryngospasm

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.

Rare

Obstructive airway disorder*, Apnoea*

Common

Nausea, Vomiting

Rare

Salivary hypersecretion*

6.3

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.

Incompatibilities

Shelf life

Ketalar 10mg/ml and 50mg/ml: 60 months
Ketalar 100mg/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 10mg/ml Injection:

Ketalar 50mg/ml Injection:
Ketalar 100mg/ml Injection:

4.9 Overdose

5.

PHARMACEUTICAL PARTICULARS
6.1 List of excipients

Common

Skin and
subcutaneous
Common
Erythema, Rash morbilliform
tissue disorders
Renal and urinary
Rare
Cystitis*, Haemorrhagic cystitis*
disorders
General disorders
Uncommon
Injection site pain, Injection site rash
and administration
site conditions
† 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

Concomitant use of antihypertensive agents and ketamine increases the risk of
developing hypotension.

4.6

Undesirable effects
The following Adverse Events have been reported:

MedDRA
System Organ
Class
Immune system
disorders
Metabolism and
nutrition disorders

Patients taking thyroid hormones have an increased risk of developing hypertension
and tachycardia when given ketamine.

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.

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-methylD-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.

Effects on ability to drive and use machines

6.6

20 ml white neutral glass vial with rubber closure and
aluminium flip-off cap containing 10 mg ketamine
base per ml.
12 ml vials containing 10 ml of solution as 50 mg
ketamine base per ml.
12 ml vials containing 10 ml of solution as 100 mg
ketamine base per ml.

Instructions for use/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

PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties

9.

DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION

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

10. DATE OF (PARTIAL) REVISION OF THE TEXT

1st July 2003
May 2012
Ref: KE 9_0

Pfizer Limited
Sandwich, England







drip (infusion)
- Ketalar together with another anaesthetic.
When it is injected directly into a vein, Ketalar is given over at
least a minute so that it does not slow your breathing too much.
If breathing is slowed, it can be helped mechanically.
While you are anaesthetised, your anaesthetist will watch over
you constantly, paying particular attention to your breathing,
airways, reflexes, the degree of anaesthesia and the condition of
your heart.
You 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
Machinery’).

4. Possible side effects
Like all medicines Ketalar 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’).
The side effects are classified into the following categories,
depending on how often they occur:
Common - Occur in less than 1 out of 10 people but more than 1
out of 100 people when this medicine is administered.
Uncommon - Occur in less than 1 out of 100 people but more than 1
out of 1,000 people when this medicine is administered.
Rare Occur in less than 1 out of 1,000 people but more than
1 out of 10,000 people when this medicine is
administered.
Not known – Occurrence cannot be estimated from the available data.
Common side effects
These may affect 1 to 9 patients in 100 receiving the injection
• the 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.
• unusual eye movements, increased muscle tone and muscle
twitches (which may resemble ‘fits’ or convulsions).
• double vision.
• increased blood pressure and increased pulse rate.
• breathing more quickly.
• nausea, vomiting.
• skin inflammation/rash.
Uncommon side effects
These may affect 1 to 9 patients in 1,000 receiving the injection
• loss of appetite, feeling anxious.
• slowing of heart rate, changes in heart rhythm.
• lowering of blood pressure.
• breathing more slowly, narrowing of the voice-box leading to
difficulty in breathing.

• pain, inflammation of the skin or rash at the injection site.
Rare side effects
These may affect 1 to 9 patients in 10,000 receiving the injection
• allergic symptoms (‘anaphylaxis’) such as breathing problems,
swelling and rash.
• drifting in and out of consciousness (with feeling of confusion and
hallucinations), flashbacks, feeling ill at ease, sleeplessness,
feeling disorientated.
• affect on the reflexes which keep your airways clear, resulting in
temporary inability to breathe.
• increase in salivation.
• inflammation of the bladder and/or pain when urinating
(‘cystitis’). The appearance of blood in the urine may also occur.
Side effects where the occurrence is not known
• raised pressure in the eyes.
If you experience any of the above side effects or any other unusual
effects not mentioned in this leaflet, tell your doctor at once.

5. How to store KETALAR injection





Keep vials out of the sight and reach of children.
Ketalar should not be used after the expiry date printed on the
box and on the vial. Your pharmacist will check this before the
injection is given.
Do not freeze. This medicinal product does not require any
special storage conditions. Store in the original container in
order to protect from light.

6. Further information
What Ketalar contains and contents of the pack
Ketalar is a solution for injection or infusion available in single glass
vials and comes in three strengths containing:
• 20 ml of a 10 mg per ml solution of ketamine base
• 10 ml of a 50 mg per ml solution of ketamine base
• 10 ml of a 100 mg per ml solution of ketamine base
as active substance.
The other ingredients are:
10 mg/ml vials: sodium chloride (salt), water for injections and a
preservative (benzethonium chloride).
50 mg/ml vials: water for injections and a preservative
(benzethonium chloride).
100 mg/ml vials: water for injections and a preservative
(benzethonium chloride).
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 your medicine contact Medical Information
at the following address:
Pfizer Limited, Walton Oaks, Dorking Road,
Tadworth, Surrey, KT20 7NS
Telephone 01304 616161
Leaflet last updated: May 2012

Ref: KE 9_0

Pfizer Limited
Sandwich, England
845001501Q

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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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