NIMBEX 2MG/ML SOLUTION FOR INJECTION/INFUSION

Active substance: CISATRACURIUM BESILATE

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10000000122937
GSK-ITA-Parma-ITPAR
United Kingdom-GBR

10000000122937

Information for the Physician
Nimbex®

cisatracurium
Please refer to the Summary of Product Characteristics (SPC) for
further details on this product.

Trade name of the medicinal product
Nimbex 2 mg/ml solution for injection/infusion
Nimbex Forte 5 mg/ml solution for injection/infusion

Qualitative and quantitative composition

Nimbex

Dosage in paediatric patients
Tracheal Intubation (paediatric patients aged 1 month to 12 years):
As in adults, the recommended intubation dose of Nimbex is 0.15 mg/kg
(body weight) administered rapidly over 5 to 10 seconds. This dose produces
good to excellent conditions for tracheal intubation 120 seconds following
injection of Nimbex. Pharmacodynamic data for this dose are presented in
the tables 2, 3 and 4..
Nimbex has not been studied for intubation in ASA Class III-IV paediatric
patients. There are limited data on the use of Nimbex in paediatric patients
under 2 years of age undergoing prolonged or major surgery.
In paediatric patients aged 1 month to 12 years, Nimbex has a shorter
clinically effective duration and a faster spontaneous recovery profile
than those observed in adults under similar anaesthetic conditions. Small
differences in the pharmacodynamic profile were observed between the age
ranges 1 to 11 months and 1 to 12 years which are summarised in the tables
2 and 3.

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Nimbex 2 mg/ml, solution for injection:
Cisatracurium 2 mg as cisatracurium besilate 2.68 mg per 1 ml
one ampoule of 10 ml contains 20 mg of cisatracurium
one ampoule of 25 ml contains 50 mg of cisatracurium
Nimbex Forte 5 mg/ml, solution for injection:
Cisatracurium 5 mg as cisatracurium besilate 6.70 mg per 1 ml
one vial of 30 ml contains 150 mg of cisatracurium

Table 2: Paediatric Patients aged 1 to 11 months

Pharmaceutical form

1

Table 3: Paediatric Patients aged 1 to 12 years

Solution for injection/infusion.
Colourless to pale yellow or greenish yellow solution. Practically free from
visible particulate matter.

D00055LEA

Therapeutic indications
Nimbex is indicated for use during surgical and other procedures in adults
and children aged 1 month and over. Nimbex is also indicated for use in
adults requiring intensive care. Nimbex can be used as an adjunct to general
anaesthesia, or sedation in the Intensive Care Unit (ICU) to relax skeletal
muscles, and to facilitate tracheal intubation and mechanical ventilation.

Posology and method of administration

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Page 1 of 2

Nimbex should be only administered by or under the supervision of
anaesthetists or other clinicians who are familiar with the use and action
of neuromuscular blocking agents. Facilities for tracheal intubation, and
maintenance of pulmonary ventilation and adequate arterial oxygenation
have to be available.
Please note that Nimbex should not be mixed in the same syringe or
administered simultaneously through the same needle as propofol injectable
emulsion or with alkaline solutions such as sodium thiopentone.
Nimbex contains no antimicrobial preservative and is intended for single
patient use.
Monitoring advice
As with other neuromuscular blocking agents, monitoring of neuromuscular
function is recommended during the use of Nimbex in order to individualise
dosage requirements.
Use by intravenous bolus injection
Dosage in adults
Tracheal Intubation. The recommended intubation dose of Nimbex for
adults is 0.15 mg/kg (body weight). This dose produced good to excellent
conditions for tracheal intubation 120 seconds after administration of
Nimbex, following induction of anaesthesia with propofol.
Higher doses will shorten the time to onset of neuromuscular block.
Table 1 summarises mean pharmacodynamic data when Nimbex was
administered at doses of 0.1 to 0.4 mg/kg (body weight) to healthy adult
patients during opioid (thiopentone/fentanyl/midazolam) or propofol
anaesthesia.
Table 1: Mean Pharmacodynamic Data Following a Range of
Cisatracurium Doses
Initial NIMBEX Anaesthetic Time to 90%
Time to
Time to 25%
Dose mg/kg Background
T1*
Maximum
Spontaneous
(body weight)
Suppression
T1*
T1*Recovery
(minutes)
Suppression
(minutes)
(minutes)
0.1
Opioid
3.4
4.8
45
0.15
Propofol
2.6
3.5
55
0.2
Opioid
2.4
2.9
65
0.4
Opioid
1.5
1.9
91
* T1 Single twitch response as well as the first component of the
Train-of-four response of the adductor pollicis muscle following
supramaximal electrical stimulation of the ulnar nerve.
Enflurane or isoflurane anaesthesia may extend the clinically effective
duration of an initial dose of Nimbex by as much as 15%.
Maintenance. Neuromuscular block can be extended with maintenance
doses of Nimbex. A dose of 0.03 mg/kg (body weight) provides
approximately 20 minutes of additional clinically effective neuromuscular
block during opioid or propofol anaesthesia.
Consecutive maintenance doses do not result in progressive prolongation of
effect.
Spontaneous Recovery. Once spontaneous recovery from neuromuscular
block is underway, the rate is independent of the Nimbex dose administered.
During opioid or propofol anaesthesia, the median times from 25 to
75% and from 5 to 95% recovery are approximately 13 and 30 minutes,
respectively.
Reversal. Neuromuscular block following Nimbex administration is readily
reversible with standard doses of anticholinesterase agents. The mean times
from 25 to 75% recovery and to full clinical recovery (T4:T1 ratio ≥ 0.7) are
approximately 4 and 9 minutes respectively, following administration of the
reversal agent at an average of 10% T1 recovery.

Package Leaflet: Information for the User
Nimbex®

cisatracurium
Nimbex 2 mg/ml solution for injection/
infusion
Nimbex Forte 5 mg/ml solution for injection/
infusion

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Read all of this leaflet carefully before
you are given this medicine because it
contains important information for you.
• eep this leaflet. You may need to read it
K
again.
• f you have any further questions, ask your
I
doctor.
• f you get any side effects, talk to your
I
doctor, nurse or pharmacist. This includes
any possible side effects not listed in this
leaflet. See section 4.
What is in this leaflet:
1 What Nimbex is and what it is used for
2 What you need to know before you are
given Nimbex
3 How Nimbex is given
4 Possible side effects
5 How to store Nimbex
6 Contents of the pack and other
information

1 What Nimbex is and what it is used for
Nimbex contains a medicine called cisatracurium.
This belongs to a group of medicines called
muscle relaxants.
Nimbex is used:
• to relax muscles during operations on adults
and children over 1 month of age, including
heart surgery

NIMBEX Dose
mg/kg
(body weight)

Anaesthetic
Background

0.15
0.15

Halothane
Opioid

NIMBEX Dose
mg/kg
(body weight)

Anaesthetic
Background

0.15
0.15

Halothane
Opioid

Time to 90%
Time to
Suppression Maximum
(minutes)
Suppression
(minutes)
1.4
2.0
1.4
1.9
Time to
90%
Suppression
(minutes)
2.3
2.6

Time to 25%
Spontaneous
T1 Recovery
(minutes)
52
47

Time to
Time to 25%
Maximum Spontaneous
Suppression T1 Recovery
(minutes)
(minutes)
3.0
43
3.6
38

When Nimbex is not required for intubation: A dose of less than 0.15 mg/kg
can be used. Pharmacodynamic data for doses of 0.08 and 0.1 mg/kg for
paediatric patients aged 2 to 12 years are presented in the table below:
Table 4: Paediatric patients aged 2 to 12 years
NIMBEX Dose Anaesthetic
mg/kg
Background
(body weight)
0.08
0.1

Time to 90%
Suppression
(minutes)

Halothane
Opioid

1.7
1.7

Time to
Maximum
Suppression
(minutes)
2.5
2.8

Time to 25%
Spontaneous
T1 Recovery
(minutes)
31
28

Administration of Nimbex following suxamethonium has not been studied in
paediatric patients.
Halothane may be expected to extend the clinically effective duration of
a dose of Nimbex by up to 20%. No information is available on the use of
Nimbex in children during anaesthesia with other halogenated fluorocarbon
anaesthetic agents, but these agents may also be expected to extend the
clinically effective duration of a dose of Nimbex.
Maintenance (paediatric patients aged 2-12 years). Neuromuscular
block can be extended with maintenance doses of Nimbex. In paediatric
patients aged 2 to 12 years, a dose of 0.02 mg/kg (body weight) provides
approximately 9 minutes of additional clinically effective neuromuscular
block during halothane anaesthesia. Consecutive maintenance doses do not
result in progressive prolongation of effect.
There are insufficient data to make a specific recommendation for
maintenance dosing in paediatric patients under 2 years of age. However,
very limited data from clinical studies in paediatric patients under 2 years of
age suggest that a maintenance dose of 0.03 mg/kg may extend clinically
effective neuromuscular block for a period of up to 25 minutes during opioid
anaesthesia.
Spontaneous Recovery. Once recovery from neuromuscular block is
underway, the rate is independent of the Nimbex dose administered. During
opioid or halothane anaesthesia, the median times from 25 to 75% and from
5 to 95% recovery are approximately 11 and 28 minutes, respectively.
Reversal. Neuromuscular block following Nimbex administration is readily
reversible with standard doses of anti-cholinesterase agents. The mean times
from 25 to 75% recovery and to full clinical recovery (T4:T1 ratio ≥ 0.7) are
approximately 2 and 5 minutes respectively, following administration of the
reversal agent at an average of 13% T1 recovery.
Use by intravenous infusion
Dosage in adults and children aged 2 to 12 years
Maintenance of neuromuscular block may be achieved by infusion of
Nimbex. An initial infusion rate of 3 μg/kg (body weight)/min (0.18 mg/kg/hr)
is recommended to restore 89 to 99% T1 suppression following evidence
of spontaneous recovery. After an initial period of stabilisation of
neuromuscular block, a rate of 1 to 2 μg/kg (body weight)/min (0.06 to
0.12 mg/kg/hr) should be adequate to maintain block in this range in most
patients.
Reduction of the infusion rate by up to 40% may be required when Nimbex
is administered during isoflurane or enflurane anaesthesia.
The infusion rate will depend upon the concentration of cisatracurium
in the infusion solution, the desired degree of neuromuscular block, and
the patient’s weight. Table 5 provides guidelines for delivery of undiluted
Nimbex.
Table 5: Infusion Delivery Rate of Nimbex injection 2 mg/ml
Patient
(body weight)
(kg)
20
70
100

Dose (µg/kg/min)
1.0
0.6
2.1
3.0

1.5
0.9
3.2
4.5

2.0
1.2
4.2
6.0

Infusion Rate
3.0
1.8
6.3
9.0

ml/hr
ml/hr
ml/hr

Steady rate continuous infusion of Nimbex is not associated with a
progressive increase or decrease in neuromuscular blocking effect.

• to help insert a tube into the windpipe
(tracheal intubation), if a person needs help to
breathe
• to relax the muscles of adults in intensive care.
Ask your doctor if you would like more
explanation about this medicine.

2 What you need to know before you are
given Nimbex
Do not use Nimbex:
• if you are allergic to cisatracurium, any other
muscle relaxant or any of the other ingredients
in Nimbex (listed in section 6)
• you have reacted badly to an anaesthetic
before.
Do not have Nimbex if any of the above apply to
you. If you are not sure, talk to your doctor, nurse
or pharmacist before you have Nimbex.
Take special care with Nimbex
Talk to your doctor, nurse or pharmacist before
having this medicine:
• if you have muscle weakness, tiredness or
difficulty in co-ordinating your movements
(myasthenia gravis)
• you have a neuromuscular disease, such as
a muscle wasting disease, paralysis, motor
neurone disease or cerebral palsy
• if you have a burn which requires medical
treatment.
• you have ever had an allergic reaction to any
muscle relaxant which was given as part of an
operation

If you are not sure if any of the above apply to
you, talk to your doctor, nurse or pharmacist
before you are given Nimbex.
Other medicines and Nimbex
Tell your doctor if you are taking or have recently
taken any other medicines. This includes any
herbal products or medicines bought without a
prescription.

In particular tell your doctor if you are taking any
of the following:
• anaesthetics (used to reduce sensation and
pain during surgical procedures)
• antibiotics (used to treat infections)
• medicines for uneven heart beats
(anti-arrhythmics)
• medicines for high blood pressure
• water tablets (diuretics), such as furosemide
• medicines for inflammation of the joints, such
as chloroquine or d-penicillamine
• steroids
• medicines for fits (epilepsy), such as phenytoin
or carbamazepine
• medicines for mental illness, such as lithium
or chlorpromazine (which can also be used for
sickness)
• medicines containing magnesium
• drugs for Alzheimer’s disease
(anticholinesterases e.g. donepezil).
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you
may be pregnant or are planning to have a baby,
ask your doctor for advice before taking this
medicine.
Driving and using machines
If you are only staying in hospital for the day,
your doctor will tell you how long to wait before
leaving the hospital or driving a car. It can be
dangerous to drive too soon after having an
operation.

3 How Nimbex is given
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.
Nimbex can be given:
.
• as a single injection into your vein
. .
(intravenous bolus injection)

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10000000122937
GSK-ITA-Parma-ITPAR
United Kingdom-GBR
Nimbex
1

Following discontinuation of infusion of Nimbex, spontaneous
recovery from neuromuscular block proceeds at a rate comparable
to that following administration of a single bolus.

Intensive Care Unit (ICU) Patients
When administered to laboratory animals in high doses, laudanosine, a
metabolite of cisatracurium and atracurium, has been associated with
transient hypotension and in some species, cerebral excitatory effects. In
the most sensitive animal species, these effects occurred at laudanosine
plasma concentrations similar to those that have been observed in some ICU
patients following prolonged infusion of atracurium.
Consistent with the decreased infusion rate requirements of cisatracurium,
plasma laudanosine concentrations are approximately one third those
following atracurium infusion.
There have been rare reports of seizures in ICU patients who have received
atracurium and other agents. These patients usually had one or more
medical conditions predisposing to seizures (e.g. cranial trauma, hypoxic
encephalopathy, cerebral oedema, viral encephalitis, uraemia). A causal
relationship to laudanosine has not been established.

.
. .

Dosage in neonates (aged less than 1 month)
The use of Nimbex in neonates is not recommended as it has not been
studied in this patient population.
Dosage in elderly patients
No dosing alterations are required in elderly patients. In these patients
Nimbex has a similar pharmacodynamic profile to that observed in young
adult patients but, as with other neuromuscular blocking agents, it may have
a slightly slower onset.
Dosage in patients with renal impairment
No dosing alterations are required in patients with renal failure. In these
patients Nimbex has a similar pharmacodynamic profile to that observed in
patients with normal renal function but it may have a slightly slower onset.

Pharmaceutical particulars

Dosage in patients with hepatic impairment
No dosing alterations are required in patients with end-stage liver disease.
In these patients Nimbex has a similar pharmacodynamic profile to that
observed in patients with normal hepatic function but it may have a slightly
faster onset.

Benzene sulfonic acid solution 32% w/v, Water for Injections.

Shelf life
Shelf life before dilution: 2 years.
Chemical and physical in-use stability has been demonstrated for at least
24 hours at 5°C and 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 has taken place in
controlled and validated aseptic conditions.

Dosage in patients with cardiovascular disease
When administered by rapid bolus injection (over 5 to 10 seconds) to adult
patients with serious cardiovascular disease (New York Heart Association
Class I-III) undergoing coronary artery bypass graft (CABG) surgery, Nimbex
has not been associated with clinically significant cardiovascular effects at
any dose studied (up to and including 0.4 mg/kg (8 x ED95)). However, there
are limited data for doses above 0.3 mg/kg in this patient population.
Nimbex has not been studied in children undergoing cardiac surgery.

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D00055LEA

Special precautions for storage

Dosage in Intensive Care Unit (ICU) patients
Nimbex may be administered by bolus dose and/or infusion to adult patients
in the ICU.
An initial infusion rate of Nimbex of 3 μg/kg (body weight)/min
(0.18 mg/kg/hr) is recommended for adult ICU patients. There may
be wide interpatient variation in dosage requirements and these may
increase or decrease with time. In clinical studies the average infusion
rate was 3 μg/kg/min [range 0.5 to 10.2 μg/kg (body weight)/min
(0.03 to 0.6 mg/kg/hr )]. Table 6 provides guidelines for delivery of undiluted
Nimbex Forte (5 mg/ml) injection.
The median time to full spontaneous recovery following long-term (up to
6 days) infusion of Nimbex in ICU patients was approximately 50 minutes.

Store in a refrigerator (2 to 8°C). Do not freeze.
Store in the original package in order to protect from light.
For storage conditions of the diluted medicinal product, see section 5 of the
Package Leaflet.

Instructions for use/handling
This product is for single use only. Use only clear and almost colourless up
to slightly yellow/greenish yellow coloured solutions. The product should be
visually inspected before use, and if the visual appearance has changed or if
the container is damaged, the product must be discarded.
Diluted Nimbex is physically and chemically stable for at least 24 hours at
5°C and 25°C at concentrations between 0.1 and 2 mg/ml in the following
infusion fluids, in either polyvinyl chloride or polypropylene containers.
Sodium Chloride (0.9% w/v) Intravenous Infusion.
Glucose (5% w/v) Intravenous Infusion.
Sodium Chloride (0.18% w/v) and Glucose (4% w/v) Intravenous Infusion.
Sodium Chloride (0.45% w/v) and Glucose (2.5% w/v) Intravenous Infusion.
However, since the product contains no antimicrobial preservative, dilution
should be carried out immediately prior to use, or failing this be stored as
directed under section 5 of the Package Leaflet.
Nimbex has been shown to be compatible with the following commonly used
peri-operative drugs, when mixed in conditions simulating administration
into a running intravenous infusion via a Y-site injection port: alfentanil
hydrochloride, droperidol, fentanyl citrate, midazolam hydrochloride and
sufentanil citrate. Where other drugs are administered through the same
indwelling needle or cannula as Nimbex, it is recommended that each drug
be flushed through with an adequate volume of a suitable intravenous fluid,
e.g., Sodium Chloride Intravenous Infusion (0.9% w/v).
As with other drugs administered intravenously, when a small vein is
selected as the injection site, Nimbex should be flushed through the vein
with a suitable intravenous fluid, e.g., sodium chloride intravenous infusion
(0.9% w/v).
Any unused medicinal product or waste material should be disposed of in
accordance with local requirements.

Table 6: Infusion Delivery Rate of Nimbex Forte injection 5 mg/ml
Patient
(body weight)
(kg)
70
100

Dose (μg/kg/min)
1.0
0.8
1.2

1.5
1.2
1.8

2.0
1.7
2.4

Infusion Rate
3.0
2.5
3.6

ml/hr
ml/hr

The recovery profile after infusions of Nimbex to ICU patients is independent
of duration of infusion.

Contraindications
Nimbex is contraindicated in patients known to be hypersensitive to
cisatracurium, atracurium, or benzene sulfonic acid.

Special warnings and special precautions for use

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Page 2 of 2

Cisatracurium paralyses the respiratory muscles as well as other skeletal
muscles but has no known effect on consciousness or pain threshold.
Nimbex should be only administered by or under the supervision of
anaesthetists or other clinicians who are familiar with the use and action
of neuromuscular blocking agents. Facilities for tracheal intubation, and
maintenance of pulmonary ventilation and adequate arterial oxygenation
have to be available.
Great caution should be exercised when administering Nimbex to patients
who have shown hypersensitivity to other neuromuscular blocking
agents since a high rate of cross-sensitivity (greater than 50%) between
neuromuscular blocking agents has been reported.
Cisatracurium does not have significant vagolytic or ganglion- blocking
properties. Consequently, Nimbex has no clinically significant effect on heart
rate and will not counteract the bradycardia produced by many anaesthetic
agents or by vagal stimulation during surgery.
Patients with myasthenia gravis and other forms of neuromuscular disease
have shown greatly increased sensitivity to non-depolarising blocking
agents. An initial dose of not more than 0.02 mg/kg Nimbex is recommended
in these patients.
Severe acid-base and/or serum electrolyte abnormalities may increase or
decrease the sensitivity of patients to neuromuscular blocking agents.
There is no information on the use of Nimbex in neonates aged less than one
month since it has not been studied in this patient population.
Cisatracurium has not been studied in patients with a history of malignant
hyperthermia. Studies in malignant hyperthermia-susceptible pigs indicated
that cisatracurium does not trigger this syndrome.
There have been no studies of cisatracurium in patients undergoing surgery
with induced hypothermia (25 to 28°C). As with other neuromuscular
blocking agents the rate of infusion required to maintain adequate surgical
relaxation under these conditions may be expected to be significantly
reduced.
Cisatracurium has not been studied in patients with burns; however, as with
other non-depolarising neuromuscular blocking agents, the possibility of
increased dosing requirements and shortened duration of action must be
considered if Nimbex injection is administered to these patients.
Nimbex is hypotonic and must not be applied into the infusion line of a
blood transfusion.

• as a continuous infusion into your vein. This is
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
• the amount and duration of muscle relaxation
required
• your expected response to the medicine.
Children less than 1 month old should not have
this medicine.

TEXT SIZE CONTAINED IN THIS ARTWORK
Body text size: 8.0pt
Leading: 8.75pt
Horizontal Scale: 100%
Smallest text size: 8.0pt
Microtext: N

If you receive more Nimbex than you should
Nimbex 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.
If you have any further questions on the use of
this medicine, ask your doctor.

4 Possible side effects
Like all medicines, Nimbex can cause side effects,
although not everybody gets them.
If you get any side effects, talk to your doctor,
nurse or pharmacist. This includes any possible
side effects not listed in this leaflet.
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:
• sudden wheeziness, chest pain or chest tightness
• swelling of your eyelids, face, lips, mouth or tongue
• a lumpy skin rash or ‘hives’ anywhere on your
body
• a collapse.
Talk to your doctor, nurse or pharmacist if you
notice any of the following:
Common (affects less than 1 in 10 people)
• decrease in heart rate
• decrease in blood pressure.
Uncommon (affects less than 1 in 100 people)
• a rash or redness of your skin
• wheezing or coughing.

Nimbex 2 mg/ml solution for injection/infusion
Instructions to open the ampoule (only applicable to 2 mg/ml ampoule)
Ampoules are equipped with the OPC (One Point Cut) opening system and
must be opened following the below instructions:
• Hold the bottom part of the ampoule with the hand as indicated in picture 1
• 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

Information for the physician leaflet date: February 2014
Nimbex is a registered trademark of the GlaxoSmithKline group of
companies
© 2014 GlaxoSmithKline group of companies. All rights reserved

Very rare (affects less than 1 in 10,000 people)
• weak or aching muscles.
Reporting of side effects
If you get any side effects, talk to your doctor,
nurse or pharmacist. 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.

5 How to store Nimbex
• Keep Nimbex out of the sight and reach of
children.
• Do not use Nimbex after the expiry date shown
on the pack after ‘Exp’. The expiry date refers
to the last day of that month.
• Store in a refrigerator (2°C - 8°C). Do not
freeze.
• Store in the original package in order to
protect from light.
• If diluted, store the infusion solution between
2°C and 8°C and use within 24 hours. Any
unused infusion solution should be discarded
24 hours after it was prepared.
• Do not throw away any medicines via wastewater
or household waste. Your doctor or nurse will
throw away any medicine that is no longer
required. This will help protect the environment.

6 Contents of the pack and other information
What Nimbex contains
• The active substance is 2 mg/ml or 5 mg/ml
cisatracurium (as besilate).
• The other ingredients are benzene sulfonic acid
(32% w/v) and Water for Injections.
What Nimbex looks like and contents of the
pack
Nimbex 2 mg/ml solution for injection/infusion comes:
• 2.5 ml clear glass ampoule in a box of
5 (each 2.5 ml ampoule contains 5 mg of
cisatracurium)
• 5 ml clear glass ampoule in a box of 5 (each
5 ml ampoule contains 10 mg of cisatracurium)

• 10 ml clear glass ampoule in a box of
5 (each 10 ml ampoule contains 20 mg of
cisatracurium)
• 25 ml clear glass ampoule in a box of
2 (each 25 ml ampoule contains 50 mg of
cisatracurium)
Nimbex Forte 5 mg/ml solution for injection/
infusion comes in a box containing one 30 ml
clear glass vial. Each 30 ml vial contains 150 mg
of cisatracurium.
Not all pack sizes may be marketed.
Marketing authorisation holder and
manufacturer
Marketing Authorisation Holder:
The Wellcome Foundation Limited,
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
Nimbex 2 mg/ml
solution for injection
Nimbex Forte 5 mg/ml
solution for injection
Reference number 00003/0364
This is a service provided by the Royal
National Institute of Blind People.
Leaflet date: February 2014
Nimbex is a registered trademark of the
GlaxoSmithKline group of companies
© 2014 GlaxoSmithKline group of companies.
All rights reserved
.
. .
10000000122937

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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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