NORCURON 10MG VIALSView full screen / Print PDF » Download PDF ⇩
RA 8720 UK S9 (ref 3.0)
For Position Only
powder for solution for injection
The infusion rate should be adjusted to maintain twitch response at
10% of control twitch height or to maintain 1 to 2 responses to train
of four stimulation.
In adults, the infusion rate required to maintain neuromuscular
block at this level, ranges from 0.8 to 1.4 micrograms vecuronium
bromide/kg/min. For neonates and infants see below. Repeat
monitoring of neuromuscular block is recommended since infusion
rate requirements vary from patient to patient and with the
anaesthetic method used.
Norcuron® 10 mg, powder for solution for injection
Dosing in elderly patients
The same intubation and maintenance doses as for younger adults
(80 – 100 micrograms/kg and 20 -30 micrograms/kg, respectively)
can be used. However, the duration of action is prolonged in elderly
compared to younger subjects due to changes in pharmacokinetic
mechanisms. The onset time in elderly is similar to younger adults.
2 Qualitative and quantitative composition
Dosing in paediatric patients:
Norcuron 10 mg
1 vial contains 10 mg vecuronium bromide, which corresponds
to 2 mg vecuronium bromide per ml.
For excipients, see 6.1.
Adolescents (12 – 17 years)
Although there is very little information on dosage in adolescents,
it is advised to use the same dose as in adults, based on the
physiological development at this age.
3 Pharmaceutical form
Children (2 – 11 years)
Dose requirements in children are higher than for adults and neonates
(see ‘Paediatric patients’ in section 5.1). However, the same intubation
and maintenance doses as for adults (80 – 100 micrograms/kg and
20-30 micrograms/kg, respectively) are usually sufficient. Since the
duration of action is shorter in children, maintenance doses are
required more frequently.
1 Name of the medicinal product
Powder for solution for injection.
4 Clinical particulars
4.1 Therapeutic indications
Norcuron is indicated as an adjunct to general anaesthesia
to facilitate tracheal intubation and to provide skeletal muscle
relaxation during surgery in adults, neonates, infants, children
4.2 Posology and method of administration
As with other neuromuscular blocking agents, Norcuron
should only be administered by, or under supervision of,
experienced clinicians who are familiar with the action and
use of these drugs.
As with all other neuromuscular blocking agents, the dosage of
Norcuron should be individualised in each patient. The anaesthetic
method used, the expected duration of surgery, the possible
interaction with other drugs that are administered before or
during anaesthesia and the condition of the patient should be
taken into account when determining the dose.
The use of an appropriate neuromuscular monitoring technique
is recommended to monitor neuromuscular block and recovery.
Inhalational anaesthetics potentiate the neuromuscular
blocking effects of Norcuron. This potentiation however,
becomes clinically relevant in the course of anaesthesia, when
the volatile agents have reached the tissue concentrations
required for this interaction. Consequently, adjustments with
Norcuron should be made by administering smaller maintenance
doses at less frequent intervals or by using lower infusion rates
of Norcuron during long lasting procedures (longer than 1 hour)
under inhalational anaesthesia (see section 4.5).
In adult patients the following dosage recommendations
may serve as a general guideline for tracheal intubation
and muscle relaxation for short to long lasting surgical
The standard intubating dose during routine anaesthesia is
80 to 100 micrograms vecuronium bromide per kg body weight,
after which adequate intubation conditions are established
within 90 to 120 seconds in nearly all patients.
Dosages of Norcuron for surgical procedures after intubation
Recommended doses: 30 to 50 micrograms vecuronium
bromide per kg body weight.
If suxamethonium is used for intubation, the administration
of Norcuron should be delayed until the patient has clinically
recovered from the neuromuscular block induced by
The recommended maintenance dose is 20 to 30 micrograms
vecuronium bromide per kg body weight.
These maintenance doses should best be given when twitch
height has recovered to 25% of control twitch height.
Dose requirements for administration of Norcuron by continuous
If Norcuron is administered by continuous infusion, it is
recommended to give a loading dose first (see ‘Tracheal
Intubation’) and, when neuromuscular block starts to recover,
to start administration of Norcuron by infusion.
Neonates (0 – 27 days) and infants (28 days - 23 months)
Because of the possible variations of the sensitivity of the
neuromuscular junction, especially in neonates and probably in
infants up to 4 months of age, an initial test dose of 10 – 20 micrograms
vecuronium bromide per kg body weight followed by incremental
doses until 90 to 95% depression of twitch response is achieved
is recommended. In neonatal surgery the dose should not exceed
Dose requirements in older infants (5-23 months) are the same as in
adults. However, since the onset time of Norcuron in these patients
is considerably shorter than in adults and children, the use of high
intubating doses in general is not required for early development of
good intubating conditions.
Since the duration of action and recovery time with Norcuron is longer
in neonates and infants than in children and adults, maintenance doses
are required less frequently (see ‘Paediatric patients’ in section 5.1).
Preterm newborn infants
There are insufficient data to support dose recommendations for
the use of vecuronium bromide in preterm newborn infants.
Continuous infusion in paediatric patients
There are insufficient data concerning continuous infusion
of Vecuronium in paediatric patients, therefore, no dosing
recommendations can be made.
Dosing in overweight and obese patients:
When used in overweight or obese patients (defined as patients
with a body weight of 30% or more above ideal body weight), doses
should be reduced taking into account an ideal body weight.
Should there be reason for selection of larger doses in individual
patients, initial doses ranging from 150 micrograms up to
300 micrograms vecuronium bromide per kg body weight have been
administered during surgery both under halothane and neurolept
anaesthesia without adverse cardiovascular effects being noted
as long as ventilation is properly maintained. The use of these high
dosages of Norcuron pharmacodynamically decreases the onset
time and increases the duration of action.
In caesarean section (see also section 4.6) and neonatal surgery
the dose should not exceed 100 micrograms/kg.
Method of Administration
Norcuron should be administered following reconstitution with
water. Norcuron is administered intravenously either as a bolus
injection or as a continuous infusion (see also section 6.6).
Hypersensitivity to vecuronium or the bromide ion or to any of the
excipients of Norcuron.
4.4 Special warnings and precautions for use
Since Norcuron causes paralysis of the respiratory muscles,
ventilatory support is mandatory for patients treated with this drug
until adequate spontaneous respiration is restored.
As with other neuromuscular blocking agents, residual neuromuscular
blockade has been reported for Norcuron. In order to prevent
complications resulting from residual neuromuscular blockade, it
is recommended to extubate only after the patient has recovered
sufficiently from neuromuscular block. Other factors which could
cause residual neuromuscular blockade after extubation in the
post-operative phase (such as drug interactions or patient condition)
should also be considered. If not used as part of standard clinical
practice, the use of a reversal agent should be considered, especially in
those cases where residual neuromuscular blockade is more likely to occur.
High rates of cross-sensitivity between neuromuscular blocking agents
have been reported. Therefore, where possible, before administering
Norcuron, hypersensitivity to other neuromuscular blocking agents
should be excluded. Norcuron 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.
Since Norcuron has no cardiovascular effects within the clinical
dosage range, it does not attenuate bradycardia that may occur due
to the use of some types of anaesthetics and opiates or due to vagal
reflexes during surgery. Therefore, reassessment of the use and/or
dosage of vagolytic drugs such as atropine for premedication or at
induction of anaesthesia, may be of value for surgical procedures
during which vagal reactions are more likely to occur (e.g. surgical
procedures where anaesthetic drugs with known vagal stimulatory
effects are used, opthalmic, abdominal or anorectal surgery, etc.).
In general, following long term use of neuromuscular blocking agents
in the ICU, prolonged paralysis and/or skeletal muscle weakness
has been noted. In order to help preclude possible prolongation of
neuromuscular block and/or overdosage it is strongly recommended
that neuromuscular transmission is monitored throughout the use of
neuromuscular blocking agents. In addition, patients should receive
adequate analgesia and sedation. Furthermore, muscle relaxants
should be titrated to effect in the individual patients by or under
supervision of experienced clinicians who are familiar with their
actions and with appropriate neuromuscular monitoring techniques.
Myopathy after long term administration of non-depolarising
neuromuscular blocking agents in the ICU in combination with
corticosteroid therapy has been reported frequently. Therefore,
for patients receiving both neuromuscular blocking agents and
corticosteroids, the period of use of the neuromuscular blocking
agent should be limited as much as possible.
The following conditions may influence the pharmacokinetics
and/or pharmacodynamics of Norcuron:
Hepatic and/or biliary tract disease and renal failure.
Because vecuronium is excreted in bile and in urine, Norcuron
should be used with caution in patients with clinically significant
hepatic and/or biliary diseases and/or renal failure. In these patient
groups prolongation of action has been observed, especially when
high doses of vecuronium (200 micrograms/kg bodyweight) were
administered in patients with hepatic disease.
Prolonged circulation time
Conditions associated with prolonged circulation time such as
cardiovascular disease, old age, oedematous state resulting in an
increased volume of distribution, may contribute to an increase in
the onset time of neuromuscular block. The duration of action may
also be prolonged due to a reduced plasma clearance.
As with other neuromuscular blocking agents, Norcuron should be
used with extreme caution in patients with neuromuscular disease
or after poliomyelitis since the response to neuromuscular blocking
agents may be considerably altered in these cases. The magnitude
and direction of this alteration may vary widely. In patients with
myasthenia gravis or the myasthenic (Eaton Lambert) syndrome,
small doses of Norcuron may have profound effects and Norcuron
should be titrated to the response.
In operations under hypothermia, the neuromuscular blocking effect
of Norcuron is increased and the duration is prolonged.
Like other neuromuscular blocking agents, Norcuron may exhibit a
prolonged duration and a prolonged spontaneous recovery in obese
patients, when the administered doses are calculated on actual
Patients with burns are known to develop resistance to nondepolarising agents. It is recommended that the dose is titrated to
4.5 Interaction with other medicinal products and other
forms of interaction
The following drugs have been shown to influence the
magnitude and/or duration of action of non-depolarising
neuromuscular blocking agents:
Effect of other drugs on Norcuron
Halogenated volatile anaesthetics potentiate the
neuromuscular block of Norcuron. The effect only becomes
apparent with maintenance dosing (see also section 4.2).
Reversal of the block with anticholinesterase inhibitors
could also be inhibited.
After intubation with suxamethonium (see section 4.2).
Long-term concomitant use of corticosteroids and Norcuron
in the ICU may result in prolonged duration of neuromuscular
block or myopathy (see also section 4.4 and 4.8).
• antibiotics: aminoglycoside, lincosamide and polypeptide
antibiotics, acylamino-penicillin antibiotics.
• diuretics, quinidine, magnesium salts, calcium channel
blocking agents, lithium salts, cimetidine, lidocaine and
acute administration of phenytoin or ß-blocking agents.
Recurarisation has been reported after post-operative
administration of: aminoglycoside, lincosamide, polypeptide
and acylamino-penicillin antibiotics, quinidine and
magnesium salts (see section 4.4).
Prior chronic administration of phenytoin or carbamazepine
Calcium chloride, potassium chloride
Administration of other non-depolarising neuromuscular
blocking agents in combination with Norcuron may produce
attenuation or potentiation of the neuromuscular block,
depending on the order of administration and the neuromuscular
blocking agent used.
Suxamethonium given after the administration of
Norcuron may produce potentiation or attenuation of the
neuromuscular blocking effect of Norcuron.
Effect of Norcuron on other drugs
Effect of Norcuron on lidocaine
Norcuron combined with lidocaine may result in a quicker
onset of action of lidocaine.
4.6 Fertility, pregnancy and lactation
Animal studies do not indicate an effect on fertility.
There are insufficient data on the use of Norcuron during
animal or human pregnancy to assess potential harm to
the foetus. Norcuron should be given to a pregnant woman
only when the attending physician decides that the benefits
outweigh the risks.
Studies with Norcuron, administered in doses up to
100 micrograms/kg, have shown its safety for use in
caesarean section. In caesarean section the dose should
not exceed 100 micrograms/kg.
In several clinical studies Norcuron did not affect Apgar
score, foetal muscle tonus or cardiorespiratory adaptation.
From umbilical cord blood sampling it is apparent that only
very little placental transfer of Norcuron occurs which did
not lead to the observation of any clinical adverse effect in
Reversal of Norcuron-induced neuromuscular block may be
inhibited or unsatisfactory in patients receiving magnesium
sulphate for toxaemia of pregnancy because magnesium
salts enhance neuromuscular block.
Therefore, in patients receiving magnesium sulphate, the
dosage of Norcuron should be reduced and be carefully
titrated to twitch response.
Other conditions which may increase the effects of Norcuron are:
Hypokalaemia (e.g. after severe vomiting, diarrhoea, and diuretic therapy),
hypermagnesaemia, hypocalcaemia (after massive transfusions),
hypoproteinaemia, dehydration, acidosis, hypercapnoea, cachexia.
Severe electrolyte disturbances, altered blood pH or dehydration should
therefore be corrected when possible.
It is unknown whether vecuronium bromide is excreted in
human breast milk. The excretion of vecuronium bromide in
milk has not been studied in animals. A decision on whether
to continue/discontinue breast-feeding or to continue/
discontinue therapy with vecuronium bromide should be made
taking into account the benefit of breast-feeding to the child and
the benefit of vecuronium bromide therapy to the woman.
Based on preclinical findings, Norcuron may cause a reduction
in the partial thromboplastin time and the prothrombin time, like
pancuronium bromide, d-tubocurarine or other non-depolarising
neuromuscular blocking agents.
4.7 Effects on ability to drive and use machines
Since Norcuron is used as an adjunct to general
anaesthesia, the usual precautionary measures after a
general anaesthesia should be taken for ambulatory patients.
1 What Norcuron is and what it is used for
RA 8720 UK P8 (ref 3.0)
Norcuron is one of a group of drugs called muscle relaxants.
Muscle relaxants are used during an operation as part of a general
anaesthetic. When you have an operation your muscles must be
completely relaxed. This makes it easier for the surgeon to perform
powder for solution for injection
Information for the patient
Norcuron 10 mg, powder for solution for injection
Read all of this leaflet carefully before you are given this
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your anaesthetist.
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your anaesthetist or
In this leaflet
What Norcuron is and what it is used for
Before Norcuron is given
How Norcuron is given
Possible side effects
How Norcuron is stored
For Position Only
Normally, your nerves send messages called impulses to your
muscles. Norcuron acts by blocking these impulses so that your
muscles relax. Because your breathing muscles also relax, you will
need help to breathe (artificial ventilation) during and after your
operation until you can breathe on your own again.
During the operation your anaesthetist will keep a check on the
effect of the muscle relaxant, and if necessary will give you some
more. At the end of surgery, the effects of the drug are allowed to
wear off and you will start breathing on your own. Sometimes the
anaesthetist will give you another drug to help speed this up.
2 Before Norcuron is given
You should not receive Norcuron
if you are allergic (hypersensitive) to vecuronium, the
bromide ion or any of the other ingredients of Norcuron.
Tell your anaesthetist if this applies to you.
Take special care with Norcuron
Your anaesthetist needs to know before you receive this medicine:
if you are allergic to muscle relaxants
if you have had kidney, heart, liver or gall bladder disease
if you have had diseases affecting nerves and muscles
if you have fluid retention (oedema).
Tell your anaesthetist if any of these applies to you.
Medicines which increase the effect of Norcuron:
certain medicines for heart disease or high blood
pressure (water tablets, calcium channel blockers, betablockers and quinidine)
certain anti-inflammatory medicines (corticosteroids)
medicines for manic depressive illness (bipolar disorder)
the medicine called cimetidine, used to treat stomach
ulcers, heartburn or acid reflux.
Medicines which decrease the effect of Norcuron:
certain medicines for epilepsy
calcium chloride and potassium chloride.
Some conditions may influence the effects of Norcuron for example:
low calcium levels in the blood
low potassium levels in the blood
high magnesium levels in the blood
low levels of protein in the blood
too much carbon dioxide in the blood
loss of too much water from the body, for example by being sick,
diarrhoea or sweating
over-breathing leading to too little carbon dioxide in the blood
being very overweight (obesity)
very low body temperature (hypothermia).
In addition, you may be given other medicines before or during
surgery which can alter the effects of Norcuron. These include
certain anaesthetics, other muscle relaxants, medicines such as
phenytoin and medicines which reverse the effects of Norcuron.
Norcuron may make certain anaesthetics work more quickly.
If you have any of these conditions, your anaesthetist will take into
account when deciding the correct dose of Norcuron for you.
Driving and using machines
Other medicines and Norcuron
Tell your anaesthetist if you are taking other medicines or have
recently taken them. This includes medicines or herbal products that
you have bought without a prescription. Norcuron may affect other
medicines or be affected by them.
Your anaesthetist will take this into account when deciding
the correct dose of Norcuron for you.
Pregnancy and breast feeding
Tell your anaesthetist if you are pregnant or might be
pregnant, or if you are breast feeding.
Your anaesthetist may still give you Norcuron, but you need
to discuss it first. Norcuron may be given to you if you are
having a Caesarean section.
Do not drive or use machines until advised it is safe to
do so. Because Norcuron is given as part of a general
anaesthetic, you may feel tired, weak or dizzy for some
time afterwards. Your anaesthetist will be able to
advise you on how long the effects are likely to last.
4.8 Undesirable effects
Adverse drug reactions (ADRs) are rare (<1/1000). The most
commonly occurring ADRs include changes in vital signs
and prolonged neuromuscular block. The most frequently
reported ADR during post-marketing surveillance is
‘anaphylactic and anaphylactoid reactions’ and associated
symptoms (reporting frequency <1/100 000). See also the
explanations below the table.
(<1/100, >1/10 000) (<1/10 000)
Cardiac disorders Tachycardia
Vascular disorders Hypotension
collapse and shock
General disorders Drug ineffective
Injection site pain
and administration Decreased drug
effect/ therapeutic Injection site
MedDRA version 8.0
Frequencies are estimates derived from post-marketing
surveillance reports and data from the general literature.
after long-term use in the ICU
Prolonged Neuromuscular block
The most frequent adverse reaction to nondepolarising
blocking agents as a class consists of an extension of the
drug’s pharmacological action beyond the time period
needed. This may vary from skeletal muscle weakness to
profound and prolonged skeletal muscle paralysis resulting
in respiratory insufficiency or apnea. A few cases of
myopathy have been reported after Norcuron was used in the
ICU in combination with corticosteroids (see section 4.4).
Although very rare, severe anaphylactic reactions to
neuromuscular blocking agents, including Norcuron, have
been reported. Anaphylactic/anaphylactoid reactions usually
comprise of several signs or symptoms e.g. bronchospasm,
cardiovascular changes (e.g. hypotension, tachycardia,
circulatory collapse – shock), and cutaneous changes
(e.g. angioedema, urticaria). These reactions have, in some
cases, been fatal. Due to the possible severity of these
reactions, one should always assume they may occur and
take the necessary precautions.
Histamine release and histaminoid reactions
Since neuromuscular blocking agents are known to be
capable of inducing histamine release both locally at the
site of injection and systemically, the possible occurrence
of itching and erythematous reactions at the site of injection
and/or generalised histaminoid (anaphylactoid) reactions (see
also under anaphylactic reactions above) should always be taken
into consideration when administering these drugs.
Experimental studies with intradermal injection of Norcuron
have demonstrated that this drug has only a weak capacity for
inducing local histamine release. Controlled studies in man failed
to demonstrate any significant rise in plasma histamine levels after
intravenous administration of Norcuron. Nevertheless, such cases
have rarely been reported during large scale use of Norcuron.
In the event of overdosage and prolonged neuromuscular block,
the patient should continue to receive ventilatory support and
sedation. In this situation there are two options for the reversal of
neuromuscular block: (1) sugammadex can be used for reversal of
intense (profound) and deep block. The dose of Sugammadex to be
administered depends on the level of neuromuscular block. The use
of Sugammadex for the purposes of reversal of vercuronium-induced
blockade is recommended for use only in the adult population. (2) An
acetylcholinesterase inhibitor (e.g. neostigmine, edrophonium,
pyridostigmine) can be used once spontaneous recovery starts and
should be administered in adequate doses. When administration of
a cholinesterase inhibiting agent fails to reverse the neuromuscular
effects of Norcuron, ventilation must be continued until spontaneous
breathing is restored. Repeated dosage of a cholinesterase inhibitor
can be dangerous.
5 Pharmacological properties
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: muscle relaxants, peripherally acting
agents, ATC code: MO3A C03.
Norcuron (vecuronium bromide) is a non-depolarising
neuromuscular blocking agent, chemically designated as the
aminosteroid 1-(3a, 17b-diacetoxy-2b piperidino-5a -androstan16b-y1)-1 methylpiperidinium bromide.
Norcuron blocks the transmission process between the motor
nerve-ending and striated muscle by binding competitively with
acetylcholine to the nicotinic receptors located in the motor
end-plate region of striated muscle.
Unlike depolarising neuromuscular blocking agents, such as
suxamethonium, Norcuron does not cause muscle fasciculations.
Within the clinical dosage range, vecuronium does not block the
sympathetic nicotininic receptors, and thus exerts no ganglion
blocking activity. In addition, in this dose range vecuronium does
not block the parasympathetic muscarinic receptors, and thus
exerts no vagolytic activity.
Within 90 to 120 seconds following intravenous administration of
a dose of 80 to 100 micrograms vecuronium bromide per kg body
weight, good to excellent conditions for endotracheal intubation
occur and within 3 to 4 minutes following administration of these
dosages, general muscle paralysis adequate for any type of surgery
is established. The duration of action to 25% recovery of control
twitch height (clinical duration) with this dose is 24 to 60 minutes.
The time to 95% recovery of control twitch height following this dose
is approximately 60 to 80 minutes. With higher dosages of Norcuron, onset
time to maximal block is shortened and duration of action is prolonged.
Continuous intravenous infusion
When Norcuron is administered by continuous intravenous infusion,
a steady state neuromuscular block of 90% can be maintained at
a constant rate of drug delivery and without clinically significant
prolongation of the recovery time from neuromuscular block at
termination of the infusion.
Norcuron has no cumulative effects if maintenance doses are
administered at 25% recovery of control twitch height. Several
maintenance doses can therefore be given in succession.
These properties allow the use of Norcuron in short, medium and
long lasting surgical procedures.
Reversal of neuromuscular block
Administration of acetylcholinesterase inhibitors, such as
neostigmine, pyridostigmine or edrophonium, antagonises the
action of Norcuron.
Neonates and infants:
In neonates and infants the ED95 dose of vecuronium bromide under
balanced anaesthesia was found to be approximately the same
(approx. 47 micrograms/kg body weight) as in adults.
The onset time of Norcuron in neonates and infants is considerably
shorter as compared to children and adults, probably due to
the shorter circulation time and larger cardiac output. Also, a
greater sensitivity of the neuromuscular junction to the action of
neuromuscular blocking agents in these patients may account for a
more rapid onset of action.
The duration of action and recovery time with Norcuron is longer
in neonates and infants than in adults. Maintenance doses of
Norcuron should therefore be less frequently administered.
In children the ED95 dose of vecuronium bromide under balanced
anaesthesia was found to be higher than in adults (81 vs
43 micrograms/kg bodyweight, respectively). In comparison to
adults, the duration of action and recovery time with Norcuron
in children are in general approximately 30% and 20-30% shorter
Similar to adults, cumulative effects with repeat maintenance doses of
approximately one quarter of the initial dose and administered at 25%
recovery of control twitch height are not observed in paediatric patients.
5.2 Pharmacokinetic properties
After intravenous administration of 100–150 micrograms/kg
vecuronium, the distribution half-life of vecuronium amounts to
Vecuronium is mainly distributed in the extracellular fluid
compartment. At steady state, the volume of distribution is
0.18-0.51 l.kg-1 in adult patients.
The plasma clearance of vecuronium amounts to 3.0-6.4 ml.kg-1.min-1
and its plasma elimination half-life is 36-117 minutes.
The extent of metabolism of vecuronium is relatively low. In
humans, a 3-hydroxy derivative having approximately 50% less
neuromuscular blocking potency than vecuronium is formed in
the liver. In patients not suffering from renal or hepatic failure, the
plasma concentration of this derivative is below detection limit,
and does not contribute to the neuromuscular block occurring after
administration of Norcuron.
Biliary excretion is the main elimination route. It is estimated that
within 24 hours after intravenous administration of Norcuron, 40 to 60%
of the dose administered is excreted into the bile as monoquaternary
compounds. Approximately 95% of these monoquaternary compounds
is unchanged vecuronium and less than 5% is 3-hydroxy vecuronium.
Prolonged duration of action has been observed in patients with liver
disease and/or biliary tract disease, probably as a result of decreased
clearance leading to an increased elimination half-life.
Renal elimination is relatively low. The amount of monoquaternary
compounds excreted in the urine collected by intravesical catheter
for 24 hours following Norcuron administration is 20-30% of the
dose administered. In patients with renal failure, the duration of
action may be prolonged. This is probably the result of an increased
sensitivity to vecuronium, but it could also be the result of a reduced
There are limited pharmacokinetic data for vecuronium in the
paediatric population. After intravenous administration, vecuronium
plasma clearance is similar across neonates, infants and children
(2.8-9.0 ml.kg-1.min-1) and not different from the clearance in adults.
Volume of distribution at steady state (Vdss), in infants is similar to
the one in adult patients (0.29-0.43 l/kg), whereas it is slightly smaller
in children (0.13 – 0.32 l/kg).
5.3 Preclinical safety data
Vecuronium bromide showed no genotoxic, embryotoxic or
teratogenic potential. Single and repeated dose toxicity studies in
rats, dogs and cats revealed no special hazard for humans.
6 Pharmaceutical particulars
6.1 List of excipients
Norcuron is supplied as a freeze dried powder containing:
• Citric acid monohydrate
• Disodium hydrogen phosphate dihydrate
• Mannitol (E421)
• Sodium hydroxide (for pH correction)
• Phosphoric acid (for pH correction)
No preservative has been added.
As is the case for many other drugs, incompatibility has been
documented for Norcuron when added to thiopental.
Except for those solutions with which Norcuron has been shown to
be compatible, it is not recommended to mix Norcuron with other
solutions, or drugs in the same syringe or bag (see Section 6.6).
If Norcuron is administered via the same infusion line that is
also used for other drugs, it is important that this infusion line
is adequately flushed (e.g. with 0.9% sodium chloride) between
administration of Norcuron and drugs for which incompatibility with
Norcuron has been demonstrated or for which compatibility with
Norcuron has not been established.
Chemical and physical in-use (i.e. following reconstitution)
stability has been demonstrated for 24 hours at 15 to 25°C.
From a microbiological point of view, the product should be
used immediately. If not used immediately, in-use storage
times and conditions prior to use are the responsibility of
the user and would normally not be longer than 24 hours at
2 to 8°C, unless reconstitution/dilution (etc.) has taken place
in controlled and validated aseptic conditions.
The date mentioned after “EXP.” on the label of the vial is the
expiry date up to which Norcuron may be used.
6.4 Special precautions for storage
Do not store above 25°C. Keep vials in the outer carton in
order to protect from light.
For storage conditions of the reconstituted solution, see
Do not use Norcuron when the solution after reconstitution
contains particles or is not clear.
6.5 Nature and contents of containers
Packaging of 10 vials each containing 10 mg vecuronium
Vials are made of type I glass.
In correspondence please quote batch number.
6.6 Special precautions for disposal and other handling
Norcuron 10 mg
Addition of 5ml water for injections results in an isotonic
solution of pH 4 containing 2 mg vecuronium bromide per ml.
Alternatively, in order to obtain a solution with a lower
concentration Norcuron 10 mg may be reconstituted with a
volume up to 10 ml of the following infusion fluids:
• 5% glucose injection fluid
• 0.9% sodium chloride injection fluid
• Lactated Ringer’s solution
• Lactated Ringer’s injection and 5% glucose
• Glucose 5% and 0.9% sodium chloride injection
• Water for injections
When Norcuron is reconstituted with water for injections,
the resultant solution can be mixed with the following
infusion fluids, packed in PVC or glass, to a dilution up to
• 0.9% NaCl solution
• 5% glucose solution
• Ringer’s solution
• Ringer’s glucose
The above-mentioned reconstituted solution can also be
injected in to the line of a running infusion of the following
• Lactated Ringer’s solution
• Lactated Ringer’s solution and 5% glucose
• Glucose 5% and 0.9% sodium chloride solution
• Dextran-40 5% in 0.9% sodium chloride solution
• Water for injections
Compatibility studies with other infusion fluids have not been
7 Marketing authorisation holder
N V Organon, Kloosterstraat 6, PO Box 20, 5340 BH, Oss,
8 Marketing authorisation number(s)
UK: PL 05003/0044
Malta: MA 031/00301
9 Date of first authorisation/renewal of the authorisation
Date of first authorisation: 04 Oct 1991
Date of latest renewal: 04 Aug 2000
10 Date of revision of the text
6.3 Shelf life
Norcuron can be kept until the expiry date indicated on the
packaging, provided it is stored under the prescribed conditions.
The shelf life is as follows:
Norcuron 10mg - 2 years
3 How Norcuron is given
Norcuron can be used in adults and children of all ages. Your
anaesthetist will work out the dose of Norcuron you need
the type of anaesthetic
the expected length of the operation
other drugs you are taking
your state of health
The normal dose is 80 – 100 micrograms per kg body weight
and the effect will last 24 – 60 minutes. During the procedure
it will be checked whether Norcuron is still working. You may
be given additional doses if they are needed.
How Norcuron is given
Norcuron will be given to you by your anaesthetist. Norcuron
is given intravenously (into a vein), either as single injections
or as a continuous infusion (a drip).
As your anaesthetist will be monitoring your condition
carefully it is unlikely that you will be given too much
Norcuron. However if this happens, your anaesthetist will
keep you breathing artificially (on a ventilator) until you can
breathe on your own. You will be kept asleep while this takes
4 Possible side effects
Like all medicines, Norcuron can cause side effects, but not
everybody gets them. If these side effects occur while you
are under anaesthetic, they will be seen and treated by your
Uncommon side effects
(up to 1 in 100 people given Norcuron are affected)
the drug is too effective, or not effective enough
the drug works for longer than expected
lowering of blood pressure
increase in heart rate.
Very rare side effects
5 How Norcuron is stored
The hospital will keep Norcuron according to the correct
6 Further information
What Norcuron contains
The active substance of Norcuron is vecuronium bromide
10 mg per vial. It is dissolved before use, to make a solution.
The other ingredients are citric acid monohydrate, disodium
hydrogen phosphate dihydrate, mannitol (E421), sodium
hydroxide and phosphoric acid.
What Norcuron looks like and contents of the pack
Norcuron is a white powder, for solution for injection.
There are 10 vials of Norcuron per pack.
Marketing Authorisation Holder and Manufacturer
(less than 1 in 10,000 people given Norcuron are affected)
allergic (hypersensitivity) reactions (such as difficulty in
breathing, collapse of the circulation and shock)
wheezing of the chest
swelling, a rash or redness of the skin
pain near the site of injection.
Marketing Authorisation Holder: N.V. Organon,
Kloosterstraat 6, PO Box 20, 5340 BH Oss, The Netherlands.
Manufacturer: NV Organon, Kloosterstraat 6, PO Box 20,
5340 BH Oss, The Netherlands
or Schering-Plough, Saint Charles, 60590 Eragny sur Epte,
If any of the side effects gets serious
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: Norcuron
Reference Number: PL 05003/0044
Or if you notice any side effects not listed in this leaflet:
Tell your anaesthetist or other doctor.
Problems reading this leaflet?
This is a service provided by the Royal National Institute of
This leaflet was last updated in July 2012.
For Position Only
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.