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KETALAR 10 MG/ML INJECTION

Active substance: KETAMINE HYDROCHLORIDE

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KETALAR®
Ketamine hydrochloride

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

Read all of this leaflet carefully before you are given this medicine
because it contains important information for you.
• If 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.
• If you are discharged on the same day as the operation, you should be
accompanied by another adult.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or nurse.
• If you get any side effects, talk to your doctor or nurse. This includes
any possible side effects not listed in this leaflet.
What is in this leaflet
1. What Ketalar Injection is and what it is used for
2. What you need to know before you are given Ketalar
Injection
3. How Ketalar Injection is given
4. Possible side effects
5. How to store Ketalar Injection
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
 not take Ketalar:
Do
• if you are allergic to ketamine hydrochloride or any of the other
ingredients of this medicine (listed in section 6).
• 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

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:
• drink large amounts of alcohol
• have a history of drug abuse or addiction
• have a history of or have current mental health problems
• have a chest infection or problems breathing
• have problems with your liver
• have increased pressure in the eye (glaucoma)
• have an inherited disease that affects the blood (porphyria)
• have ever had 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.

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.
• 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 (e.g. thiopental) 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.

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.
• Do not drive while taking this medicine until you know how it affects
you.
• It is an offence to drive if this medicine affects your ability to drive.
• However, you would not be committing an offence if:
o The medicine has been prescribed to treat a medical or dental
problem and
o You have taken it according to the instructions given by the
prescriber or in the information provided with the medicine and
o It was not affecting your ability to drive safely
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
• 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 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 Machines’).
Continued overleaf...

Anaesthesia in poor-risk patients with depression of vital functions or
where depression of vital functions must be avoided, if at all possible.

To the medical profession

KETALAR®
Ketamine (as Hydrochloride)

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

Orthopaedic procedures such as closed reductions, manipulations,
femoral pinning, amputations, and biopsies.

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.

Caesarian section; as an induction agent in the absence of elevated
blood pressure.

General Anaesthesia Induction

Cardiac catheterization procedures.

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.

An infusion corresponding to 0.5 – 2 mg/kg as total induction dose.

For intravenous infusion, intravenous injection or intramuscular
injection.

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.

4.2 Posology and method of administration

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.

For the full list of excipients see section 6.1.

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.

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.

Diagnostic and operative procedures of the eye, ear, nose, and mouth,
including dental extractions.

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.

Note: Eye movements may persist during ophthalmological
procedures.

Date: 19 Feb 2015 Time: 14:50
Perigord Nº 247476
Supplier Hameln
Barcode Nº N/A
Smallest

BODY TEXT Size 6 pt

Dimensions 148 x 600 mm
Notes N/A
PAR Number PAR-2014-0026735

A solution containing 1 mg/ml of ketamine in dextrose 5% or sodium
chloride 0.9% is suitable for administration by infusion.

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.

NOTE: All doses are given in terms of ketamine base

3. PHARMACEUTICAL FORM

Supplier Nº 47266/07/15

Intravenous Infusion

Sigmoidoscopy and minor surgery of the anus and rectum,
circumcision and pilonidal sinus.

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF MEDICINAL PRODUCT

Neurodiagnostic procedures such as pneumoencephalograms,
ventriculograms, myelograms, and lumbar punctures.

A. Ketalar as the sole anaesthetic agent

Market United Kingdom
Proof Nº 01
Component Leaflet
2D Code 47266
Drawing Nº N/A

Colours
Printing

Non-Printing

Black

Profile

PMS 541

Perforation

PMS 277

Maintenance of anaesthesia
Anaesthesia may be maintained using a microdrip infusion of
10 - 45 microgram/kg/min (approximately 1 – 3 mg/min).

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

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.

47266/07/15

Package leaflet: Information for the patient

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.

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.

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.

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.

Ketalar should be used with caution in patients with the following
conditions:

C. Ketalar as supplement to anaesthetic agents

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.

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.

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
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.

4.6 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.

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:
• The medicine is likely to affect your ability to drive
• Do not drive until you know how the medicine affects you
• It is an offence to drive while under the influence of this medicine
• However, you would not be committing an offence (called
‘statutory defence’) if:
o The medicine has been prescribed to treat a medical or
dental problem and
o You have taken it according to the instructions given by
the prescriber and in the information provided with the
medicine and
o It was not affecting your ability to drive safely

4.8 Undesirable effects
The following Adverse Events have been reported:
MedDRA
System Organ Class
Immune system
disorders

Metabolism and
nutrition disorders
Psychiatric disorders

Frequency†

Undesirable Effects

Rare

Anaphylactic reaction*

Uncommon

Anorexia

Common

Hallucination, Abnormal
dreams, Nightmare, Confusion,
Agitation, Abnormal behaviour
Anxiety
Delirium* Flashback*,
Dysphoria*, Insomnia,
Disorientation*

Uncommon
Rare
Nervous system
disorders
Eye disorders

Common
Common
Not Known

Cardiac disorders

Common

Vascular disorders

Uncommon
Uncommon

Respiratory, thoracic
and mediastinal
disorders

Nystagmus, Hypertonia, Tonic
clonic movements
Diplopia
Intraocular pressure increased

Blood pressure increased,
Heart rate increased
Bradycardia, Arrhythmia
Hypotension

Common

Respiratory rate increased

Uncommon

Gastrointestinal
disorders

Common

Respiratory depression,
Laryngospasm
Obstructive airway disorder*,
Apnoea*
Nausea, Vomiting

Hepatobiliary
disorders
Skin and
subcutaneous tissue
disorders

Rare

Not known

Salivary hypersecretion*

Liver function test abnormal

Common

Erythema, Rash morbilliform

Rare

Renal and urinary
Rare
disorders
General disorders and Uncommon
administration site
conditions

Cystitis*, Haemorrhagic cystitis*
Injection site pain, Injection
site rash

† 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

4.9 Overdose

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.

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

6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients

Ketalar 10 mg/ml Injection: 
sodium chloride, benzethonium chloride,
water for injections
Ketalar 50 mg/ml Injection: 
benzethonium chloride, water for injections
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:  ml white neutral glass vial with rubber
20
closure and aluminium flip-off cap
containing 20 ml of solution as
10 mg ketamine base per ml.
Ketalar 50 mg/ml Injection:  ml vials containing 10 ml of solution
10
as 50 mg ketamine base per ml.
Ketalar 100 mg/ml Injection:  0 ml vials containing 10 ml of solution
1
as 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
02/2015
Ref: KE 13_0

Pfizer Limited
Sandwich, England

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

Date: 19 Feb 2015 Time: 14:50
Supplier Nº 47266/07/15
Perigord Nº 247476
Supplier Hameln
Barcode Nº N/A
Smallest

BODY TEXT Size 6 pt

Dimensions 148 x 600 mm
Notes N/A
PAR Number PAR-2014-0026735

Market United Kingdom
Proof Nº 01
Component Leaflet
2D Code 47266
Drawing Nº N/A

Colours
Printing

Non-Printing

Black

Profile

PMS 541

Perforation

PMS 277

Package leaflet: Information for the patient
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
• 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 may affect up to 1 in 100 people
• 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 may affect up to 1 in 1000 people
• 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.
• abnormal results to liver function tests.
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.

5. How to store Ketalar Injection
• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the
label 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.
• 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. Contents of the pack and other information
What Ketalar contains
• The 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
• The other ingredients are:
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).
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:
Hameln Pharmaceuticals GmbH, Langes Feld 13, 31789 Hameln, Germany.

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
This leaflet was last revised in 02/2015
Ref: KE 13_0
Pfizer Limited
Sandwich, England

47266/07/15

To the medical profession

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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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