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MIVACRON INJECTION 2MG/ML

Active substance: MIVACURIUM CHLORIDE

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10000000108944

Summary of Product Characteristics

Injection 2 mg/ml
mivacurium
Product Summary
1. Trade Name of the Medicinal Product
Mivacron Injection 2mg/ml
2. Qualitative and Quantitative Composition
Mivacurium chloride 2.14mg in each 1ml of product
3. Pharmaceutical Form
Liquid for injection
Clinical Particulars
4.1 Therapeutic Indications
Mivacron is a highly selective, short-acting, non-depolarising neuromuscular
blocking agent with a fast recovery profile. Mivacron is used as an adjunct to
general anaesthesia to relax skeletal muscles and to facilitate tracheal intubation
and mechanical ventilation in adults, children and infants 2 months and over.
This formulation contains no antimicrobial preservative and is intended for single
patient use.
4.2 Posology and Method of Administration
Use By Injection In Adults
Mivacron is administered by intravenous injection. The mean dose required to
produce 95% suppression of the adductor pollicis single twitch response to ulnar
nerve stimulations (ED95) is 0.07 mg/kg (range 0.06 to 0.09) in adults receiving
narcotic anaesthesia.
The recommended bolus dose range for healthy adults is 0.07-0.25 mg/kg.
The duration of neuromuscular blockade is related to the dose. Doses of 0.07,
0.15, 0.20 and 0.25 mg/kg produce clinically effective block for approximately
13, 16, 20 and 23 minutes respectively.
Doses of up to 0.15 mg/kg may be administered over 5 to 15 seconds. Higher
doses should be administered over 30 seconds in order to minimise the
possibility of occurrence of cardiovascular effects.
The following dose regimens are recommended for tracheal intubation:
I A dose of 0.2 mg/kg, administered over 30 seconds, produces good to excellent
conditions for tracheal intubation within 2 to 2.5 minutes.
II A dose of 0.25 mg/kg administered as a divided dose (0.15 mg/kg followed
30 seconds later by 0.1 mg/kg) produces good to excellent conditions for
tracheal intubation within 1.5 to 2.0 minutes of completion of administration
of the first dose portion.
With Mivacron, significant train-of-four fade is not seen during onset.
It is often possible to intubate the trachea before complete abolition of the
train-of-four response of the adductor pollicis muscle has occurred.
Full block can be prolonged by maintenance doses of Mivacron.
Doses of 0.1 mg/kg administered during narcotic anaesthesia each provide
approximately 15 minutes of additional clinically effective block.
Successive supplementary doses do not give rise to accumulation of
neuromuscular blocking effect.
The neuromuscular blocking action of Mivacron is potentiated by isoflurane
or enflurane anaesthesia. If steady-state anaesthesia with isoflurane or
enflurane has been established, the recommended initial Mivacron dose
should be reduced by up to 25%. Halothane appears to have only a minimal
potentiating effect on Mivacron and dose reduction of Mivacron is probably
not necessary.
Once spontaneous recovery is underway it is complete in approximately
15 minutes and is independent of the dose of Mivacron administered.
The neuromuscular block produced by Mivacron can be reversed with standard
doses of anticholinesterase agents. However, because spontaneous recovery
after Mivacron is rapid, a reversal may not be routinely required as it shortens
recovery time by only 5-6 minutes.
Use as an Infusion in Adults
Continuous infusion of Mivacron may be used to maintain neuromuscular
block. Upon early evidence of spontaneous recovery from an initial Mivacron
dose, an infusion rate of 8 to 10 micrograms/kg/min (0.5 to 0.6 mg/kg/hr) is
recommended.
The initial infusion rate should be adjusted according to the patient’s response
to peripheral nerve stimulation and clinical criteria. Adjustments of the infusion
rate should be made and should be increments of approximately
1 microgram/kg/min (0.06 mg/kg/hr). In general, a given rate should be
maintained for at least 3 minutes before a rate change is made. On average, an
infusion rate of 6 to 7 micrograms/kg/minute will maintain neuromuscular
block within the range of 89% to 99% for extended periods in adults receiving
narcotic anaesthesia. During steady-state isoflurane or enflurane anaesthesia,
reduction in the infusion rate by up to 40% should be considered. A study has
shown that the mivacurium infusion rate requirement should be reduced by up
to 50% with sevoflurane.
With halothane, smaller reductions in infusion rate may be required.
Spontaneous recovery after Mivacron infusion is independent of the duration of
infusion and comparable to recovery reported for single doses.
Continuous infusion of Mivacron has not been associated with the development
of tachyphylaxis or cumulative neuromuscular blockade.
Mivacron (2 mg/ml) may be used undiluted for infusion.
Mivacron is compatible with the following infusion fluids.
Sodium chloride intravenous infusion (0.9% w/v)
Glucose intravenous infusion (5% w/v)
Sodium chloride (0.18% w/v) and glucose (4% w/v) intravenous infusion
Lactated Ringer’s Injection USP
When diluted with the listed infusion solutions in the proportion of 1 plus 3
(i.e. to give 0.5 mg/ml) Mivacron injection has been shown to be chemically
and physically stable for at least 48 hours at 30°C. However, since the
product contains no antimicrobial preservative, dilution should be carried out
immediately prior to use, administration should commence as soon as possible
thereafter, and any remaining solution should be discarded.
Doses in Infants and Children Aged 2 Months - 12 Years
Mivacron has a faster onset, shorter clinically effective duration of action and
more rapid spontaneous recovery profile in infants and children than in adults.
The ED95 in infants aged 2 to 6 months is approximately 0.07 mg/kg; and in
infants and children aged 7 months to 12 years is approximately 0.1 mg/kg.

Pharmacodynamic data for recommended initial doses in infants and children are
summarised in the following table:
Age
Dose for
Time to
Duration of
Tracheal
Maximum
Clinically
Intubation Neuromuscular Effective Block
Block (min)
(min)
0.15 mg/kg
1.4
9
2 - 6 monthsA
0.2 mg/kg
1.7
9
7 months - 12 yearsB
AData obtained during halothane anaesthesia.
BData obtained during halothane or narcotic anaesthesia.
Since maximum block is usually achieved within 2 minutes following administration
of these doses, tracheal intubation should be possible within this time.
Infants and children generally require more frequent maintenance doses and
higher infusion rate than adults. Pharmacodynamic data for maintenance doses
are summarised in the table below together with recommended infusion rates:
Age
Maintenance Duration of
Average Infusion
Dose
Clinically
Rate Required to
Effective
Maintain 89-99%
Block (min) Neuromuscular Block
0.1 mg/kg
6-9
11 - 14 mcg/kg/min
2 months - 12 yearsA
(0.7 - 0.9 mg/kg/hr)
AData obtained during halothane or narcotic anaesthesia.
The neuromuscular blocking action of mivacurium is potentiated by inhalational
agents. A study has shown that the mivacurium infusion rate requirement should
be reduced by up to 70% with sevoflurane in children aged 2 – 12 years.
Once spontaneous recovery is underway, it is complete in approximately 10 minutes.
Dose in Neonates and Infants < 2 Months of Age
The safety and efficacy of Mivacron in neonates and infants < 2 months has not
yet been established. Currently available data are described in section 5.1, but no
recommendation on posology can be made.
Dose in the Elderly
In elderly patients receiving single bolus doses of Mivacron, the onset time,
duration of action and recovery rate may be extended relative to younger
patients by 20 to 30%. Elderly patients may also require decreased infusion rates
or smaller or less frequent maintenance bolus doses.
Dose in Patients with Cardiovascular Disease
In patients with clinically significant cardiovascular disease, the initial dose of Mivacron
should be administered over 60 seconds. Mivacron has been administered in this way
with minimal haemodynamic effects to patients undergoing cardiac surgery.
Dose in Patients with Reduced Renal Function
In patients with end-stage renal failure the clinically effective duration of block
produced by 0.15 mg/kg is approximately 1.5 times longer than in patients with
normal renal function. Subsequently, dosage should be adjusted according to
individual clinical response.
Prolonged and intensified neuromuscular blockade may also occur in patients
with acute or chronic renal failure as a result of reduced levels of plasma
cholinesterase (see section 4.4 Special Warnings and Precautions for Use).
Dose in Patients with Reduced Hepatic Function
In patients with end-stage liver failure the clinically effective duration of block
produced by 0.15 mg/kg is approximately three times longer than in patients
with normal hepatic function. This prolongation is related to the markedly
reduced plasma cholinesterase activity seen in these patients. Subsequently,
dosage should be adjusted according to individual clinical response.
Dose in Patients with Reduced Plasma Cholinesterase Activity
Mivacurium is metabolised by plasma cholinesterase. Plasma cholinesterase activity
may be diminished in the presence of genetic abnormalities of plasma cholinesterase
(e.g. patients heterozygous or homozygous for the atypical plasma cholinesterase
gene), in various pathological conditions (see section 4.4 Special Warnings and
Precautions for Use) and by the administration of certain drugs (see interactions with
other medicaments). The possibility of prolonged neuromuscular block following
administration of Mivacron must be considered in patients with reduced plasma
cholinesterase activity. Mild reductions (i.e. within 20% of the lower limit of the
normal range) are not associated with clinically significant effects on duration (See
Contra-indications and Special Warnings and Precautions for information about use in
patients who are homozygous or heterozygous for the plasma cholinesterase gene).
Dose in Obese Patients
In obese patients (those weighing 30% or more above their ideal bodyweight for
height), the initial dose of Mivacron should be based upon ideal bodyweight and
not actual bodyweight.
Instructions to open the ampoule
Ampoules are equipped with the OPC (One Point Cut) opening system and must
be opened following the below instructions:
1. hold with the hand the bottom part of the
ampoule as indicated in picture 1
2. put the other hand on the top of the ampoule
positioning the thumb above the coloured point
and press as indicated in picture 2
Picture 1
Picture 2
Monitoring
In common with all neuromuscular blocking agents, monitoring of
neuromuscular function is recommended during the use of Mivacron in order to
individualise dosage requirements.
4.3 Contra-indications
Mivacron should not be administered to patients known to have allergic
hypersensitivity to the drug.
Mivacron is contraindicated in pregnancy since there is no information
on the use of Mivacron in pregnant women.
Mivacron is contraindicated in patients known or suspected of being
homozygous for the atypical plasma cholinesterase gene (see “special warnings
and precautions for use” section).
4.4 Special Warnings and Precautions for Use
In common with all the other neuromuscular blocking agents, Mivacron paralyses
the respiratory muscles as well as the other skeletal muscles but has no effect on
consciousness. Mivacron should be administered only by or under close
supervision of an experienced anaesthetist with adequate facilities for
endotracheal intubation and artificial ventilation.
Prolonged and intensified neuromuscular blockade following mivacurium may
occur secondary to reduced plasma cholinesterase activity in the following states
or pathological conditions:
• hysiological variation as in pregnancy and the puerperium (see Pregnancy
P
and Lactation).
• enetically determined abnormalities of plasma cholinesterase (see below and
G
Contraindications).
• evere generalised tetanus, tuberculosis and other severe or chronic infections.
S
• Chronic debilitating disease, malignancy, chronic anaemia and malnutrition.
• Myxoedema and collagen diseases.
• Decompensated heart disease.
• Peptic ulcer.

Package Leaflet: Information for the User

Injection 2 mg/ml

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mivacurium
Read all of this leaflet carefully before
you start having this medicine.
• eep this leaflet. You may need to read it
K
again.
• f you have any further questions about your
I
illness or your medicine, ask your doctor,
nurse or pharmacist.
• f any of the side effects get serious, or if you
I
notice any side effects not listed in this leaflet,
please tell your doctor, nurse or pharmacist.
In this leaflet:
1. What Mivacron is and what it is used for
2. Before you have Mivacron
3. How to have Mivacron
4. Possible side effects
5. How to store Mivacron
6. Further information

1. What Mivacron is and what it is
used for
Mivacron contains a medicine called mivacurium.
This belongs to a group of medicines called
muscle relaxants.
Mivacron is used:
• o relax muscles during operations on adults
t
and children over 2 months of age, including
heart surgery
• o help insert a tube into the windpipe (tracheal
t
intubation), if a person needs help to breathe

Ask your doctor if you would like more
explanation about this medicine.

2. Before you have Mivacron
Do not have Mivacron if:
• ou are allergic to mivacurium, any other
y
muscle relaxant or any of the other ingredients
in Mivacron (listed in Section 6)
• ou or your family have reacted badly to an
y
anaesthetic before.
Do not have Mivacron if any of the above apply to
you. If you are not sure, talk to your doctor, nurse
or pharmacist before you have Mivacron.
Take special care with Mivacron
Check with your doctor, nurse or pharmacist
before having this medicine if:

• ou have muscle weakness, tiredness or
y
difficulty in co-ordinating your movements
(myasthenia gravis)
• ou have a neuromuscular disease, such as
y
a muscle wasting disease, paralysis, motor
neurone disease or cerebral palsy
• ou have a burn which requires medical treatment.
y
• ou have ever had an allergic reaction to any
Y
muscle relaxant that was given as part of an
operation.

Check with your doctor before having this medicine,
if you have or have ever had any of the following:
• Tetanus
• severe or long-standing infection such as
A
tuberculosis (TB)
• ny long-standing illness which has left you
A
weak
• Cancer
• Anaemia
• Malnutrition
• An under-active thyroid gland
• Heart disease
• Stomach ulcers
• Burns
• Liver or kidney disease
Please tell your doctor if:
• You are pregnant or have been pregnant recently

or you have given birth in the last 6 months
• ou have been diagnosed as having
Y
a genetically determined abnormal
cholinesterase.
If you are not sure if any of the above
apply to you, talk to your doctor, nurse or
pharmacist before you are given Mivacron.
Taking other medicines
Please tell your doctor, nurse or pharmacist if
you are taking or have recently taken any other
medicines. This includes medicines obtained
without a prescription, including herbal medicines.
This is because these medicines can affect how
well Mivacron works or can cause side effects.

• Burns (see below).
• End-stage hepatic failure, (see Dosage and Administration).
• Acute, chronic or end-stage renal failure (see Dosage and Administration).
• atrogenic: following plasma exchange, plasmapheresis, cardiopulmonary
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bypass, and as a result of concomitant drug therapy (see Interactions).
In common with suxamethonium/succinylcholine, adult and paediatric patients
homozygous for the atypical plasma cholinesterase gene (1 in 2500 patients) are
extremely sensitive to the neuromuscular blocking effect of Mivacurium. In three such
adults patients, a small dose of 0.03 mg/kg (approximately the ED10-20 in genotypically
normal patients) produced complete neuromuscular block for 26 to 128 minutes.
In patients heterozygous for the atypical plasma cholinesterase gene, the
clinically effective duration of block of mivacurium 0.15 mg/kg is approximately
10 min longer than in control patients.
Once spontaneous recovery had begun, neuromuscular block in these patients
was antagonised with conventional doses of neostigmine.
Patients with burns may develop resistance to non-depolarising neuromuscular
blocking agents and require increased doses. However such patients may also have
reduced plasma cholinesterase activity, requiring dose reduction. Consequently
burn patients should be given a test dose of 0.015-0.020 mg/kg Mivacron followed
by appropriate dosing guided by monitoring of block with a nerve stimulator
Caution should be exercised in administering Mivacron to patients with a history
suggestive of an increased sensitivity to the effects of histamine e.g. asthma. If
Mivacron is used in this group of patients it should be administered over 60 seconds.
High rates of cross-sensitivity (greater than 50%) between neuromuscular blocking
agents have been reported. Therefore, where possible, before administering
mivacurium, hypersensitivity to other neuromuscular blocking agents should be
excluded. Mivacurium should only be used when absolutely essential in susceptible
patients. Patients who experience a hypersensitivity reaction under general anaesthesia
should be tested subsequently for hypersensitivity to other neuromuscular blockers.
Mivacron should be administered over a period of 60 seconds to patients who
may be unusually sensitive to falls in arterial blood pressure, for example those
who are hypovolaemic.
In adults, doses of Mivacron > 0.2 mg/kg (> 3 x ED95) have been associated
with histamine release when administered by rapid bolus injection. However, the
slower administration of the 0.2 mg/kg Mivacron dose and the divided
administration of the 0.25 mg/kg Mivacron dose minimised the cardiovascular
effects of these doses. Cardiovascular safety did not appear to be compromised
in children given a rapid bolus dose of 0.2 mg/kg in clinical studies.
The use in neonates and infants < 2 months is not recommended due to limited
data (see also section 4.2 and 5.1).
Mivacron does not have significant vagal or ganglion blocking properties in the
recommended dosage range. Recommended doses of Mivacron consequently have
no clinically significant effects on heart rate and will not counteract the bradycardia
produced by many anaesthetic agents or by vagal stimulation during surgery.
In common with other non-depolarising neuromuscular blocking agents, increased
sensitivity to mivacurium can be expected in patients with Myasthenia Gravis,
other forms of neuromuscular disease and cachectic patients. Severe acid base or
electrolyte abnormalities may increase or reduce sensitivity to mivacurium.
Mivacron solution is acidic (approximately pH 4.5) and should not be mixed in
the same syringe or administered simultaneously through the same needle as
highly alkaline solutions (e.g. barbiturate solutions). It has been shown to be
compatible with some commonly used peri-operative drugs supplied as acidic
solutions e.g. Fentanyl, Alfentanil, Sufentanil, Droperidol and Midazolam. Where
other anaesthetic agents are administered through the same indwelling needle
or cannula as used for Mivacron, and compatibility has not been demonstrated,
it is recommended that each drug is flushed through with physiological saline.
Studies in malignant hyperthermia-susceptible pigs, indicated that Mivacron
does not trigger this syndrome. Mivacron has not been studied in malignant
hyperthermia-susceptible patients.
No data are available on the long-term use of Mivacron in patients undergoing
mechanical ventilation in the intensive care unit.
Reversal of Neuromuscular Block: as with other neuromuscular blocking agents,
evidence of spontaneous recovery should be observed prior to administration of reversal
agent (e.g. neostigmine). The use of a peripheral nerve stimulator to evaluate recovery
prior to and following reversal of neuromuscular block is strongly recommended.
Pharmaceutical Precautions
Since no antimicrobial preservative is included, Mivacron must be used under full
aseptic conditions and any dilution carried out immediately before use. Any
unused solution in open ampoules should be discarded.
Mivacron injection is acidic (approximately pH 4.5) and should not be mixed with
highly alkaline solutions (e.g. barbiturates). Mivacron has been shown to be
compatible with some commonly used peri-operative drugs supplied as acidic
solutions. Where such agents are administered through the same indwelling needle or
cannula as used for Mivacron injection, and compatibility has not been demonstrated,
it is recommended that each drug is flushed through with physiological saline.
The pack will contain the following statements:
Store below 25°C.
Do not freeze.
Protect from light.
Any portion of the contents remaining after use should be discarded.
Keep out of reach of children.
4.5 Interaction with other Medicaments and other forms of Interaction
The neuromuscular block produced by Mivacron may be increased by the
concomitant use of inhalational anaesthetics such as enflurane, isoflurane,
sevoflurane and halothane.
Mivacron has been safely administered following succinylcholine facilitated
intubation. Evidence of spontaneous recovery from succinylcholine should be
observed prior to administration of Mivacron.
In common with all non-depolarising neuromuscular blocking agents, the
magnitude and/or duration of non-depolarising neuromuscular block may be
increased and infusion requirements may be reduced as a result of interaction
with; antibiotics, including the aminoglycosides, polymyxins, Spectinomycin,
tetracyclines, Lincomycin and Clindamycin; anti-arrhythmic drugs: Propranolol,
calcium channel blockers, lignocaine, Procainamide and Quinidine, diuretics:
furosemide and possibly thiazides, Mannitol and Acetazolamide, magnesium salts,
ketamine, lithium salts, ganglion blocking drugs: Trimetaphan, Hexamethonium.
Drugs that may reduce plasma cholinesterase activity may also prolong the
neuromuscular blocking action of Mivacron. These include anti-mitotic drugs,
monoamine oxidase inhibitors, ecothiophate iodine, pancuronium,
organophosphates, anticholinesterases, certain hormones, bambuterol.
Rarely, certain drugs may aggravate or unmask latent Myasthenia Gravis or
actually induce a Myasthenic syndrome: increased sensitivity to Mivacron would
be consequent on such a development. Such drugs include various antibiotics,
beta-blockers. (Propranolol, Oxprenolol), antiarrhythmic drugs (Procainamide,
Quinidine), antirheumatic drugs (Chloroquine, D-Pencillamine), Trimetaphan,
Chlorpromazine, Steroids, Phenytoin and Lithium.
The administration of combinations of non-depolarising neuromuscular blocking
agents in conjunction with Mivacron may produce a degree of neuromuscular
blockade in excess of that which might be expected from an equipotent total dose
of Mivacron. Any synergistic effect may vary between different drug combinations.
A depolarising muscle relaxant such as suxamethonium chloride should not be
administered to prolong the neuromuscular blocking effects of non-depolarising
agents, as this may result in a prolonged and complex block which can be
difficult to reverse with anticholinesterase drugs.

In particular tell your doctor, nurse or pharmacist
if you are taking any of the following:
• naesthetics (used to reduce sensation and
a
pain during surgical procedures)
• antibiotics (used to treat infections)
• edicines for uneven heart beats
m
(anti-arrhythmics)
• medicines for high blood pressure
• water tablets (diuretics), such as frusemide
• edicines for inflammation of the joints, such
m
as chloroquine or d-penicillamine
• steroids
• edicines for fits (epilepsy), such as phenytoin
m
or carbamazepine
• edicines for mental illness, such as lithium,
m
monoamine oxidase inhibitors (MAOIs) or
chlorpromazine (which can also be used for
sickness)
• medicines containing magnesium.
Pregnancy and breast-feeding
Talk to your doctor before having this medicine if
you are pregnant, trying to become pregnant or
are breast-feeding.
Driving and using machines
It can be dangerous to drive or operate machinery
too soon after having had an operation. Your
doctor will tell you how long to wait before you
can drive and use machinery.

3. How to have Mivacron
How your injection is given
You will never be expected to give yourself this
medicine. It will always be given to you by a
person who is qualified to do so.
Mivacron can be given:
• s a single injection into your vein (intravenous
a
bolus injection)
• s a continuous infusion into your vein. This is
a
where the drug is slowly given to you over a
long period of time.
Your doctor will decide the way you are given the
drug and the dose you will receive. It will depend on:
• your body weight
• he amount and duration of muscle relaxation
t
required

.
4.6 Pregnancy and Lactation
Fertility studies have not been performed.
. .
Animal studies have indicated that mivacurium has no adverse effect
on foetal development.
Mivacurium should not be used during pregnancy unless the expected clinical
benefit to the mother outweighs any potential risk to the foetus.
Plasma cholinesterase levels decrease during pregnancy. Mivacurium has been
used to maintain neuromuscular block during Caesarean section, but due to the
reduced levels of plasma cholinesterase, dosage adjustments to the infusion rate
were necessary. A further reduction in the infusion rate may also be required
during Caesarean section in patients pre-treated with MgSO4, due to the
potentiating effects of Mg2+.
It is not known whether mivacurium is excreted in human milk.
4.7 Effect on Ability to Drive and Use Machines
This precaution is not relevant to the use of mivacurium. Mivacurium will always
be used in combination with a general anaesthetic and therefore the usual
precautions relating to performance of tasks following general anaesthesia apply.
4.8 Undesirable Effects
Adverse events are listed below by system organ class and frequency.
Frequencies are defined as: very common (≥1/10), common (≥1/100, <1/10),
uncommon (≥1/1000, <1/100), rare (≥1/10000, <1/1000) and very rare
(<1/10,000) including isolated reports.
Immune disorders
Very rare:
Severe anaphylactic or anaphylactoid reaction. Severe anaphylactic
or anaphylactoid reactions have been reported in patients
receiving mivacurium chloride in conjunction with one or more
anaesthetic agents.
Cardiac disorders
Uncommon: Transient tachycardia*
Vascular disorders
Very common: Flushing*
Uncommon: Hypotension*
Respiratory, thoracic and mediastinal disorders
Uncommon: Bronchospasm*
Skin and subcutaneous tissue disorders
Uncommon: Erythema* , urticaria*
*Associated with the use of Mivacron there have been reports of skin flushing,
erythema, urticaria, hypotension, transient tachycardia or bronchospasm which have
been attributed to histamine release. These effects are dose related and more common
following initial doses of ≥0.2 mg/kg or more when given rapidly and are reduced if
Mivacron is injected over 30 to 60 seconds or in divided doses over 30 seconds.
The safety profile in children is similar to that in adults.
4.9 Overdose
Prolonged muscle paralysis and its consequences are the main signs of overdosage
with neuromuscular blocking agents. However, the risk of haemodynamic
side-effects especially decreases in blood pressure, may be increased.
It is essential to maintain a patent airway together with assisted positive
pressure ventilation until spontaneous respiration is adequate. Full sedation will
be required since consciousness is not impaired. Recovery may be hastened by
the administration of anticholinesterase agents accompanied by atropine or
glycopyrrolate, once evidence of spontaneous recovery is present. Cardiovascular
support may be provided by proper positioning of the patient and administration
of fluids or vasopressor agents as required.
Pharmacological Properties
5.1 Pharmacodynamic Properties
Mivacurium is a short-acting, non-depolarising skeletal muscle relaxant which is
hydrolysed by plasma cholinesterase. Mivacurium binds competitively with
cholinergic receptors on the motor end-plate to prevent the action of acetylcholine,
resulting in a blockade of neuromuscular transmission. This is rapidly reversed by
the administration of the cholinesterase inhibitors, neostigmine and edrophonium.
5.2 Pharmacokinetic Properties
Mivacurium chloride is a mixture of three stereoisomers, the trans-trans and
cis-trans stereoisomers comprise 92% to 96% of mivacurium chloride and when
studied in cats their neuromuscular blocking potencies are not significantly different
from each other or from mivacurium chloride. The cis-cis isomer has been estimated
from studies in cats to have one-tenth of the neuromuscular blocking potency of
the other two stereoisomers. Enzymatic hydrolysis by plasma cholinesterase is the
primary mechanism for inactivation of mivacurium and yields a quaternary alcohol
and a quaternary monoester metabolite. Pharmacological studies in cats and dogs
have shown that metabolites possess insignificant neuromuscular, autonomic or
cardiovascular activity at concentrations higher than seen in man.
5.3 Preclinical Safety Data
Mivacurium has been evaluated in four short term mutagenicity tests. Mivacurium
was non-mutagenic in the Ames salmonella assay, the mouse lymphoma assay,
the human lymphocyte assay and the in vivo rat bone marrow cytogenetic assay.
There is no information available on whether Mivacurium has carcinogenic potential.
Fertility studies have not been performed.
Animal studies have indicated that mivacurium has no adverse effect on foetal
development.
Pharmaceutical Particulars
6.1 List of Excipients
Hydrochloric Acid
EP
Water for Injections
EP
6.2 Incompatibilities
None known
6.3 Shelf Life
18 months
6.4 Special Precautions for Storage
Store below 25°C. Do not freeze. Protect from light.
6.5 Nature and Contents of Container
Neutral glass ampoules containing 5 ml or 10 ml of product.
6.6 Instructions for Use/Handling
No special instructions are required.
Administrative Data
7. Marketing Authorisation Holder
The Wellcome Foundation Ltd., 980 Great West Road, Brentford, Middlesex TW8 9GS
trading as GlaxoSmithKline UK, Stockley Park West, Uxbridge, Middlesex UB11 1BT
8. Marketing Authorisation Number
PL 00003/0325
9. Date of First Authorisation/Renewal of Authorisation
21st January 2009
10. Date of (Partial) Revision of Text for the DIL
November 2012
11. Legal Status
POM

• your expected response to the medicine.
Children under 2 months old should not have this
medicine.
If you receive more Mivacron than you should
Mivacron will always be given under carefully
controlled conditions. However, if you think that
you have been given more than you should tell
your doctor or nurse immediately.

4.

Possible side effects

Like all medicines, Mivacron can cause side
effects, although not everybody gets them. If any
of the side effects gets serious, or if you notice
any side effects not listed in this leaflet, please
tell your doctor, nurse or pharmacist.
Allergic reactions (affects less than 1 in
10,000 people)
If you have an allergic reaction, tell your doctor or
nurse straight away. The signs may include:
• udden wheeziness, chest pain or chest
s
tightness
• welling of your eyelids, face, lips, mouth or
s
tongue
• lumpy skin rash or ‘hives’ anywhere on your
a
body
• collapse
a
Talk to your doctor, nurse or pharmacist if you
notice any of the following:
Very Common (affects more than 1 in 10
people)
• reddening of the skin
Uncommon (affects less than 1 in 100
people)
• increase in heart rate
• decrease in blood pressure
• wheezing or coughing
• rash

5. How to store Mivacron
• Keep out of the reach and sight of children.
• o not use Mivacron after the expiry date
D
which is stated on the pack after ‘Exp’.
• Do not store above 25°C. Do not freeze.
• Store in the original package to protect from light.

• hen Mivacron is made up it should be used
W
straight away. Any unused solution should be
thrown away.

6. Further information
What Mivacron contains
• The active substance is mivacurium.
• he other ingredients are hydrochloric acid and
T
water.
What Mivacron looks like and contents of
the pack
• Mivacron solution for injection comes in

ampoules containing 5 ml or 10 ml of the product.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation holder: GlaxoSmithKline
UK, Stockley Park West, Uxbridge, Middlesex
UB11 1BT
Manufacturer: GlaxoSmithKline Manufacturing
S.p.A., Strada Provinciale Asolana 90,
43056 San Polo di Torrile, Parma, Italy.
Other formats:
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
Mivacron injection 2 mg/ml
Reference number
00003/0325

.
. .

This is a service provided by the Royal National
Institute of Blind People.
Leaflet date: June 2012
Mivacron is a registered trademark of the
GlaxoSmithKline group of companies
© 2012 GlaxoSmithKline group of companies

10000000108944

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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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