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MARCAIN HEAVY 0.5% SOLUTION FOR INJECTION

Active substance(s): BUPIVACAINE HYDROCHLORIDE

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28044321

Medical Information Leaflet

Marcain Heavy 0.5% solution for injection
bupivacaine hydrochloride

4.3  Contraindications

Hypersensitivity to the active substance or
to any of the excipients listed in section 6.1.
Hypersensitivity to local anaesthetics of the
amide type.

Intrathecal anaesthesia, regardless of the local
anaesthetic used, has its own contraindications,
which include:

Active disease of the central nervous system
such as meningitis, poliomyelitis, intracranial
haemorrhage, sub-acute combined degeneration
of the cord due to pernicious anaemia and
cerebral and spinal tumours.

Spinal stenosis and active disease (e.g.
spondylitis, tuberculosis, tumour) or recent
trauma (e.g. fracture) in the vertebral column.
Septicaemia.

Pyogenic infection of the skin at or adjacent to
the site of lumbar puncture.

Cardiogenic or hypovolaemic shock.

Coagulation disorders or ongoing anticoagulation
treatment.
4.4 Special Warnings and Precautions for Use

Intrathecal anaesthesia should only be
undertaken by clinicians with the necessary
knowledge and experience.

Regional anaesthetic procedures should always
be performed in a properly equipped and staffed
area. Resuscitative equipment and drugs should
be immediately available and the anaesthetist
should remain in constant attendance.

Intravenous access, e.g. an i.v. infusion, should
be in place before starting the intrathecal
anaesthesia. The clinician responsible should take
the necessary precautions to avoid intravascular
injection and be appropriately trained and familiar
with the diagnosis and treatment of side effects,
systemic toxicity and other complications. If signs
of acute systemic toxicity or total spinal block
appear, injection of the local anaesthetic should
be stopped immediately, see sections 4.8 & 4.9.

Like all local anaesthetic drugs, bupivacaine may
cause acute toxicity effects on the central nervous
and cardiovascular systems, if utilised for local
anaesthetic procedures resulting in high blood
concentrations of the drug. This is especially the
case after unintentional intravascular administration
or injection into highly vascular areas.

Ventricular arrhythmia, ventricular fibrillation,
sudden cardiovascular collapse and death have
been reported in connection with high systemic
concentrations of bupivacaine. Should cardiac
arrest occur, a successful outcome may require
prolonged resuscitative efforts. High systemic
concentrations are not expected with doses
normally used for intrathecal anaesthesia.

There is an increased risk of high or total
spinal blockade, resulting in cardiovascular and
respiratory depression, in the elderly and in
patients in the late stages of pregnancy. The dose
should therefore be reduced in these patients.

Intrathecal anaesthesia with any local anaesthetic
can cause hypotension and bradycardia
which should be anticipated and appropriate
precautions taken. These may include preloading
the circulation with crystalloid or colloid solution.
If hypotension develops it should be treated
with a vasopressor such as ephedrine 10-15 mg
intravenously. Severe hypotension may result
from hypovolaemia due to haemorrhage or
dehydration, or aorto-caval occlusion in patients
with massive ascites, large abdominal tumours
or late pregnancy. Marked hypotension should be
avoided in patients with cardiac decompensation.

Patients with hypovolaemia due to any cause can
develop sudden and severe hypotension during
intrathecal anaesthesia.

Intrathecal anaesthesia can cause intercostal
paralysis and patients with pleural effusions may
suffer respiratory embarrassment. Septicaemia
can increase the risk of intraspinal abscess
formation in the postoperative period.

Neurological injury is a rare consequence
of intrathecal anaesthesia and may result in
paraesthesia, anaesthesia, motor weakness and
paralysis. Occasionally these are permanent.

Before treatment is instituted, consideration
should be taken if the benefits outweigh the
possible risks for the patient.

Patients in poor general condition due to ageing
or other compromising factors such as partial or
complete heart conduction block, advanced liver
or renal dysfunction require special attention,
although regional anaesthesia may be the
optimal choice for surgery in these patients.

Patients treated with anti-arrhythmic drugs class III
(e.g. amiodarone) should be kept under close
surveillance and ECG monitoring considered,
since cardiac effects may be additive (see
section 4.5).

1.

2.


Name of the Medicinal Product
Marcain Heavy, 0.5% solution for injection.
Qualitative and Quantitative Composition
Bupivacaine Hydrochloride BP 5.28 mg/ml
equivalent to 5 mg/ml bupivacaine hydrochloride
anhydrous. For the full list of excipients, see
section 6.1.
3. Pharmaceutical Form

Solution for injection. Clear, colourless solution.
4. Clinical Particulars
4.1 Therapeutic Indications

Marcain Heavy 0.5% solution for injection is
indicated in adults and children of all ages for
intrathecal (subarachnoid) spinal anaesthesia
for surgery (urological and lower limb surgery
lasting 2-3 hours, abdominal surgery lasting
45-60 minutes).

Bupivacaine is a long acting anaesthetic agent
of the amide type. Marcain Heavy has a rapid
onset of action and long duration. The duration
of analgesia in the T10-T12 segments is 2-3 hours.
Marcain Heavy produces a moderate muscular
relaxation of the lower extremities lasting
2-2.5 hours. The motor blockade of the abdominal
muscles makes the solution suitable for performance
of abdominal surgery lasting 45-60 minutes. The
duration of the motor blockade does not exceed the
duration of analgesia. The cardiovascular effects of
Marcain Heavy are similar or less than those seen
with other spinal agents. Bupivacaine 5 mg/ml with
glucose 80 mg/ml is exceptionally well tolerated by
all tissues with which it comes in contact.
4.2 Posology and Method of Administration

Adults and children above 12 years of age

The doses recommended below should be
regarded as a guide for use in the average
adult. The figures reflect the expected average
dose range needed. Standard textbooks should
be consulted for factors affecting specific block
techniques and for individual patient requirements.

The clinician’s experience and knowledge of
the patient’s physical status are of importance
in calculating the required dose. The lowest
dose required for adequate anaesthesia should
be used. Individual variations in onset and
duration occur, and the extent of the spread of
anaesthesia may be difficult to predict, but will
be affected by the volume of the drug used,
especially with the isobaric (plain) solution.

Dosage recommendations

Intrathecal anaesthesia for surgery:

2-4 ml (10-20 mg bupivacaine hydrochloride).

The dose should be reduced in the elderly and
in patients in the late stages of pregnancy, see
Section 4.4.

Neonates, infants and children up to 40 kg

Marcain Heavy may be used in children.

One of the differences between small children
and adults is a relatively high CSF volume in
infants and neonates, requiring a relatively larger
dose/kg to produce the same level of block as
compared to adults.

Paediatric regional anaesthesia procedures should
be performed by qualified clinicians who are
familiar with this population and the techniques.

The doses in the table should be regarded as
guidelines for use in paediatric patients. Individual
variations occur. Standard textbooks should be
consulted for factors affecting specific block
technique and for individual patient requirements.
The lowest dose required for adequate
anaesthesia should be used.

Dosage recommendations in neonates,
infants and children
Body weight (kg)
Dose (mg/kg)
<5
0.40‑0.50 mg/kg
5 to 15
0.30‑0.40 mg/kg
15 to 40
0.25‑0.30 mg/kg

The spread of anaesthesia obtained with
Marcain Heavy depends on several factors
including the volume of solution and the position
of the patient during and following the injection.

When injected at the L3-L4 intervertebral space,
with the patient in the sitting position, 3 ml of
Marcain Heavy spreads to the T7-T10 spinal
segments. With the patient receiving the injection
in the horizontal position and then turned supine,
the blockade spreads to T4-T7 spinal segments.
It should be understood that the level of spinal
anaesthesia achieved with any local anaesthetic
can be unpredictable in a given patient.

The recommended site of injection is below L3.

The effects of injections of Marcain Heavy
exceeding 4 ml have not yet been studied
and such volumes can therefore not be
recommended.

Method of administration

Route of administration: For intrathecal injection.

Package leaflet: Information for the user

Marcain Heavy 0.5% solution for injection
bupivacaine hydrochloride

Read all of this leaflet carefully before this
medicine is given to you because it contains
important information for you.
• K
 eep 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. See section 4.
What is in this leaflet:
1. What Marcain Heavy is and what it is used for
2. What you need to know before Marcain Heavy
is given to you
3. How Marcain Heavy is given to you
4. Possible side effects
5. How to store Marcain Heavy
6. Contents of the pack and other information

In
of



particular, tell your doctor if you are taking any
the following medicines:
Other local anaesthetics.
Medicines used to treat an uneven heart beat
(arrhythmia), such as amiodarone.
Your doctor needs to know about these medicines
to be able to work out the correct dose of
Marcain Heavy for you.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think that
you may be pregnant or are planning to have a
baby, ask your doctor for advice before taking this
medicine.
Driving and using machines
Marcain Heavy may make you feel sleepy and
affect the speed of your reactions. After you have
been given Marcain Heavy, you should not drive or
use tools or machines until the next day.
Marcain Heavy contains sodium
This medicinal product contains less than 1 mmol
sodium (23 mg) per ampoule. This is considered
essentially sodium free.

1. What Marcain Heavy is and what it is used for
Marcain Heavy contains a medicine called
bupivacaine hydrochloride. It belongs to a group of
medicines called local anaesthetics.
Marcain Heavy is used to numb (anaesthetise)
parts of the body during surgery in adults and
children of all ages. It stops pain happening during
surgery (operations).

3. How Marcain Heavy is given to you
Marcain Heavy will be given to you by a doctor,
who will decide the correct dose. It will be given
to you as an injection into the lower part of
your spine.
Use in children and adolescents
Marcain Heavy is injected slowly into the
spinal channel (part of the spine) by a doctor
experienced in paediatric anaesthetic techniques.
Dosage depends on the age and weight of the
patient and will be determined by the doctor.
When Marcain Heavy is injected, it stops the
nerves from being able to pass pain messages to
the brain.
If you have been given too much Marcain Heavy
Serious side effects from getting too much
Marcain Heavy need special treatment and the
doctor treating you is trained to deal with these
situations. The first signs of being given too much
Marcain Heavy are usually as follows:
• Feeling dizzy or light-headed.
• Numbness of the lips and around the mouth.
• Numbness of the tongue.
• Hearing problems.
• Problems with your sight (vision).
To reduce the risk of serious side effects, your
doctor will stop giving you Marcain Heavy as
soon as these signs appear. This means that
if any of these happen to you, or you think you
have received too much Marcain Heavy, tell your
doctor immediately.
More serious side effects from being given
too much Marcain Heavy include tremors, fits
(seizures) and heart problems.

2. What you need to know before
Marcain Heavy is given to you
You must not be given Marcain Heavy:
• If you are allergic to bupivacaine hydrochloride
or any of the other ingredients of this medicine
(listed in Section 6).
• If you are allergic to any other local
anaesthetics of the same class (such as
lidocaine or ropivacaine).
• If you have a skin infection near to where the
injection will be given.
• If you have blood poisoning (septicaemia).
• If you have something called cardiogenic shock
(a serious condition where the heart is unable
to supply enough blood to the body).
• If you have something called hypovolaemic
shock (very low blood pressure leading to
collapse).
• If you have problems with clotting of your blood.
• If you have diseases of the brain or spine such
as meningitis, polio or spondylitis.
• If you have a severe headache caused
by bleeding inside the head (intracranial
haemorrhage).
• If you have problems with your spinal cord due
to anaemia.
• If you have had a recent trauma, tuberculosis
or tumours of the spine.
You must not be given this medicine if any of
the above apply to you. If you are not sure, talk
to your doctor or nurse before you are given this
medicine.
Warnings and precautions
Talk to your doctor or nurse before having
Marcain Heavy:
• If you have heart, liver or kidney problems. This
is because your doctor may need to adjust the
dose of Marcain Heavy.
• If you have been told that you have decreased
volumes of blood (hypovolaemia).
• If you have fluid in your lungs.
If you are not sure if any of the above apply to
you, talk to your doctor or nurse before you are
given this medicine.
Other medicines and Marcain Heavy
Tell your doctor if you are taking, have recently
taken or might take any other medicines.
This includes medicines that you buy without
a prescription and herbal medicines. This is
because Marcain Heavy can affect the way some
medicines work and some medicines can have an
effect on Marcain Heavy.

4. Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
Severe allergic reactions (rare, may affect up to
1 in 1,000 people)
If you have a severe allergic reaction, tell your
doctor immediately. The signs may include
sudden onset of:
• Swelling of your face, lips, tongue or throat.
This may make it difficult to swallow.
• Severe or sudden swelling of your hands, feet
and ankles.
• Difficulty breathing.
• Severe itching of the skin (with raised lumps).
• Very low blood pressure which can make you
feel faint or collapse.

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4.5 Interaction with Other Medicinal Products
and Other Forms of Interaction

Bupivacaine should be used with caution in
patients receiving other local anaesthetics or
agents structurally related to amide-type local
anaesthetics, e.g. certain anti-arrhythmics, such
as lidocaine and mexiletine, since the systemic
toxic effects are additive.

Specific interaction studies with bupivacaine and
anti-arrhythmic drugs class III (e.g. amiodarone)
have not been performed, but caution is advised
(see also section 4.4).
4.6 Fertility, Pregnancy and Lactation
Pregnancy

There is no evidence of untoward effects in
human pregnancy. In large doses there is
evidence of decreased pup survival in rats and
an embryological effect in rabbits if Marcain is
administered in pregnancy. Marcain should not
therefore be given in early pregnancy unless the
benefits are considered to outweigh the risks.

It should be noted that the dose should be
reduced in patients in the late stages of
pregnancy, see section 4.4.
Breast-feeding

Bupivacaine enters the mother’s milk, but in such
small quantities that there is generally no risk of
affecting the child at therapeutic dose levels.
4.7 Effects on Ability to Drive and Use Machines

Besides the direct anaesthetic effect, local
anaesthetics may have a very mild effect
on mental function and coordination even in
the absence of overt CNS toxicity and may
temporarily impair locomotion and alertness.
4.8 Undesirable Effects
4.8.1 General

The adverse reaction profile for Marcain Heavy
is similar to those for other long acting local
anaesthetics used for intrathecal anaesthesia.
Frequencies are defined as very common (≥1/10),
common (≥1/100 to <1/10), uncommon (≥1/1,000 to
<1/100), rare (≥1/10,000 to<1/1,000), or not known
(cannot be estimated from the available data).
Table of Adverse Drug Reactions
System Organ Frequency
Adverse Drug
Class
Classification Reaction
Immune system Rare
Allergic
disorders
reactions,
anaphylactic
shock
Nervous system Common
Postdural
disorders
puncture
headache
Uncommon
Paraesthesia,
paresis,
dysaesthesia
Rare
Total
unintentional
spinal block,
paraplegia,
paralysis,
neuropathy,
arachnoiditis
Cardiac
Very Common Hypotension,
disorders
bradycardia
Rare
Cardiac arrest
Rare
Respiratory
Respiratory,
depression
thoracic and
mediastinal
disorders
Gastrointestinal Very Common Nausea
disorders
Common
Vomiting
Muscle
Musculoskeletal Uncommon
weakness,
and connective
back pain
tissue disorders
Renal and
Common
Urinary
urinary disorders
retention,
urinary
incontinence

Adverse reactions caused by the drug per se
are difficult to distinguish from the physiological
effects of the nerve block (e.g. decrease in blood
pressure, bradycardia, temporary urinary retention),
events caused directly (e.g. spinal haematoma)
or indirectly (e.g. meningitis, epidural abcess)
by needle puncture or events associated to
cerebrospinal leakage (e.g. postdural puncture
headache).
4.8.2 Acute systemic toxicity

Marcain Heavy, used as recommended, is not
likely to cause blood levels high enough to
cause systemic toxicity. However, if other local
anaesthetics are concomitantly administered,
toxic effects are additive and may cause
systemic toxic reactions.

Systemic toxicity is rarely associated with spinal
anaesthesia but might occur after accidental
intravascular injection. Systemic adverse reactions
are characterised by numbness of the tongue,
light-headedness, dizziness and tremors, followed
by convulsions and cardiovascular disorders.

4.8.3 Treatment of acute systemic toxicity:

No treatment is required for milder symptoms of
systemic toxicity but if convulsions occur then it
is important to ensure adequate oxygenation and
to arrest the convulsions if they last more than
15-30 seconds. Oxygen should be given by face
mask and the respiration assisted or controlled
if necessary. Convulsions can be arrested by
injection of thiopental 100-150 mg intravenously
or with diazepam 5-10 mg intravenously.
Alternatively, succinylcholine 50-100 mg
intravenously may be given but only if the clinician
has the ability to perform endotracheal intubation
and to manage a totally paralysed patient.

High or total spinal blockade causing respiratory
paralysis should be treated by ensuring and
maintaining a patent airway and giving oxygen by
assisted or controlled ventilation.

Hypotension should be treated by the use
of vasopressors, e.g. ephedrine 10–15 mg
intravenously and repeated until the desired level
of arterial pressure is reached. Intravenous fluids,
both electrolytes and colloids, given rapidly can
also reverse hypotension.

Paediatric population

Adverse drug reactions in children are similar to
those in adults, however, in children, early signs
of local anaesthetic toxicity may be difficult to
detect in cases where the block is given during
sedation or general anaesthesia.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after
authorisation of the medicinal product is
important. It allows continued monitoring of the
benefit/risk balance of the medicinal product.
Healthcare professionals are asked to report any
suspected adverse reactions via the Yellow Card
Scheme. Website: www.mhra.gov.uk/yellowcard.
4.9 Overdose

Marcain Heavy, used as recommended, is not
likely to cause blood levels high enough to
cause systemic toxicity. However, if other local
anaesthetics are concomitantly administered,
toxic effects are additive and may cause
systemic toxic reactions.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties

Pharmacotherapeutic group (ATC code): N01B B01

Bupivacaine is a long acting local anaesthetic
agent of the amide type. Moderate muscular
relaxation of lower extremities. Motor blockade of
the abdominal muscles.

Marcain Heavy is hyperbaric and its initial spread
in the intrathecal space is affected by gravity.
5.2 Pharmacokinetic Properties

Rapid onset of action and long duration i.e.
T10-T12 segments - duration 2-3 hours.

Muscular relaxation of lower extremities lasts
2-2.5 hours.

Blockade of the abdominal muscles lasts
45-60 minutes. The duration of motor blockade
does not exceed duration of analgesia.

In children the pharmacokinetics are similar to
that in adults.
5.3 Preclinical Safety Data

Bupivacaine hydrochloride is a well-established
active ingredient.
6. Pharmaceutical Particulars
6.1 List of Excipients

Glucose anhydrous and/or glucose monohydrate,
sodium hydroxide and water for injections.
6.2 Incompatibilities

Not applicable.
6.3 Shelf Life

3 years.
6.4 Special Precautions for Storage

Do not store above 25°C.
6.5 Nature and Contents of Container

4 ml sterile wrapped glass ampoules or
One Point Cut ampoules. Not all pack sizes may
be marketed.
6.6 Special precautions for disposal and other
handling

The solution should be used immediately after
opening of the ampoule. Any remaining solution
should be discarded. Any unused medicinal
product or waste material should be disposed of
in accordance with local requirements.
7. Marketing Authorisation Holder

AstraZeneca UK Limited,

600 Capability Green,

Luton, LU1 3LU, UK.
8. Marketing Authorisation Number

PL 17901/0142
This leaflet was last revised in November 2014
© AstraZeneca 2014
Marcain is a trade mark of the AstraZeneca group
of companies.
PAI 14 0036

Other possible side effects:
Very common (may affect more than 1 in
10 people)
• Low blood pressure. This might make you feel
dizzy or light-headed.
• Feeling sick (nausea).
• Slow heart beat.
Common (may affect up to 1 in 10 people)
• Headache.
• Being sick (vomiting).
• Difficulty in passing urine or being incontinent.
Uncommon (may affect up to 1 in 100 people)
• Itching, numbness, burning or tingling of
the skin.
• Back pain.
• Muscle weakness for a short time.
Rare (may affect up to 1 in 1,000 people)
• Heart attack.
• Difficulty breathing.
• Weakness or loss of feeling or loss of
movement in your lower body.
• Long-lasting pain in your back or legs.
• Reduced or strange sensation or feeling in
the skin.
Some symptoms can happen if the injection was
given in the wrong way by mistake, or if you have
been given it with other local anaesthetics. These
include fits (seizures), feeling dizzy or light-headed,
trembling and numbness of the tongue.
Possible side effects seen with other local
anaesthetics which might also be caused by
Marcain Heavy include:
• Damaged nerves. Rarely (affecting less than
1 in 1,000 people), this may cause permanent
problems.
• If too much Marcain Heavy is given into the
spinal fluid, the whole body may become
numbed (anaesthetised).
Additional side effects in children and
adolescents
Side effects in children are similar to those
in adults.
Do not be concerned by this list of possible side
effects. You may not get any of them.
Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card
Scheme at: www.mhra.gov.uk/yellowcard. By
reporting side effects you can help provide more
information on the safety of this medicine.

Marketing Authorisation Holder and
Manufacturer
The Marketing Authorisation for Marcain Heavy is
held by AstraZeneca UK Ltd, 600 Capability Green,
Luton, LU1 3LU, UK.
Marcain Heavy is manufactured by Cenexi,
52 Rue Marcel et Jacques Gaucher,
94120 Fontenay sous Bois, France.

To listen to or request a copy of this
leaflet in Braille, large print or audio
please call, free of charge:
0800 198 5000 (UK only)
Please be ready to give the following
information:
Product name
Marcain Heavy

0.5% solution

for injection
Reference number 17901/0142
This is a service provided by the
Royal National Institute of Blind People.
This leaflet was last revised in November 2014.
© AstraZeneca 2014.
Marcain is a trade mark of the AstraZeneca group
of companies.
PAI 14 0036

5. How to store Marcain Heavy
• K
 eep this medicine out of the sight and reach
of children.
• Do not use this medicine after the expiry date
which is stated on the container after EXP. The
expiry date refers to the last day of that month.
• Do not store above 25°C.
• Your doctor or the hospital will normally store
Marcain Heavy and they are responsible for
the quality of the product when it has been
opened if it is not used immediately. They are
also responsible for disposing of any unused
Marcain Heavy correctly.
6. Contents of the pack and other information
What Marcain Heavy contains
The active ingredient is bupivacaine hydrochloride
anhydrous. Each millilitre (ml) of solution contains
5 mg of bupivacaine hydrochloride anhydrous.
The other ingredients are glucose anhydrous
and/or glucose monohydrate, sodium hydroxide
and water for injections.
What Marcain Heavy looks like and contents
of the pack
Marcain Heavy is a clear, colourless solution for
injection. It comes in glass ampoules containing
4 ml of solution.

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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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