ATRACURIUM 10MG/ML SOLUTION FOR INJECTION/INFUSION

Active substance: ATRACURIUM BESILATE

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Atracurium 10mg/ml
Solution for Injection/Infusion
Atracurium besilate
Read all of this leaflet carefully before
you start using 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, pharmacist or nurse.
•  his medicine has been prescribed for you
T
only. Do not pass it on to others. It may
harm them, even if their symptoms are the
same as yours.
•  f you get any side effects, talk to your
I
doctor, pharmacist or nurse. This includes
any possible side effects not listed in this
leaflet. See section 4.
•  he full name of this medicine is Atracurium
T
10mg/ml Solution for Injection/Infusion
but within the leaflet it will be referred to as
Atracurium.

What is in this leaflet
1 What Atracurium is and what it is
used for
2 What you need to know before you
use Atracurium
3 How to use Atracurium
4 Possible side effects
5 How to store Atracurium
6 Contents of the pack and other
information

1 What Atracurium is and what it is
used for

Atracurium belongs to a group of medicines
called muscle relaxants. It is used to relax
muscles during surgery.

Atracurium is used:

•  uring surgery, other procedures and in
d
intensive care
•  uring general anaesthesia to ease tracheal
d
intubation (a tube into the windpipe) and
controlled ventilation.

2 What you need to know before you
use Atracurium

Do not use Atracurium

• f you allergic (hypersensitive) to atracurium,
i
cisatracurium or benzenesulfonic acid.

Warnings and Precautions

Talk to your doctor before using Atracurium . Tell
your doctor if you have:
•  disease that affects the muscles and/or
a
their nervous control (neuromuscular disease
such as myasthenia gravis or Eaton-Lambert
syndrome)
•  n electrolyte imbalance (changes to the body’s
a
normal levels of certain chemicals)
•  ancer that has spread to different parts of
c
body (carinomatosis)
•  llergy to any other muscle relaxant
a
•  recent burn that has required medical
a
attention
•  history of asthma, hay fever or allergies that
a
give you a rash, itching or shortness of breath
(histamine hypersensitivity)
•  eart diseases and low blood pressure
h

Other medicines and Atracurium

Tell your doctor or pharmacist if you are taking
or have recently taken any other medicines.
This is especially important with the following
medicines as they may interact with Atracurium :
•  ntibiotics (e.g. aminoglycosides, polymyxins,
a
spectinomycin, tetracyclines, lincomycin,
clindamycin and vancomycin)
•  ntiarrhythmic medicines (used to control
a
the rhythm of the heart e.g. lidocaine,
procainamide, quinidine)
•  iuretics (water tablets) (e.g. furosemide,
d
thiazides and mannitol)
•  edicines used to control blood pressure,
m
angina or other heart problems (e.g.
propranolol, oxprenolol, diltiazem, nicardipine,
nifedipine and verapamil)
•  ntiepileptic medicines (e.g. carbamazepine,
a
phenytoin)
•  rugs used to treat rheumatism (e.g.
d
chloroquine, D-penicillamine)
•  teroids
s
•  rimetaphan, hexamethonium (used to lower
t
blood pressure during surgery)
•  antrolene (a muscle relaxant)
d
•  cetazolamide (treatment of glaucoma)
a
•  agnesium sulphate
m
•  etamine (an anaesthetic drug)
k
• ithium, chlorpromazine (treatment of mental
l
illness)
•  uinine (treatment of malaria or leg cramps)
q
•  edicines used in the treatment of Alzheimer’s
m
disease (anticholinesterases e.g. donepezil)
It may still be all right for you to be given
Atracurium and your doctor will be able to
decide what is suitable for you.

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 or pharmacist for advice before
using this medicine
There is no adequate data on the use of
atracurium besilate during pregnancy.
Atracurium should only be administered during
pregnancy after careful risk-benefit assessment.
The use of the recommended dose in caesarean
section showed no harmful effects on the
newborn infants. Therefore Atracurium is also
suitable for maintenance of muscle relaxation
during caesarean section.
It is not known whether atracurium besilate
passes into breast milk.
As precaution you should restart breast-feeding
24 hours after administration of Atracurium ,
when the effect of the medicine has worn off.

Driving and using machines

You should not drive, operate machinery or work
in exposed situations soon after having had an
operation. The time factor should be decided
individually by the physician.
You should be accompanied on your way home
and you should not drink alcoholic drinks.

3 How to use Atracurium

Atracurium should only be used by a physician.

Dosage

Atracurium is used during procedures that
require that the patient is fully anaesthetised
(unconscious), or heavily sedated.
The dosing will be worked out by the doctor.
Atracurium must be given only by injection
directly into a vein (intravenous use). Atracurium
must not be injected into a muscle.

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AAAF6972

The following information is
intended for medical or healthcare
professionals only:
Preparation and administration of Atracurium
10mg/ml solution for injection and concentrate
for solution for infusion.
It is important that you read the entire contents
of this guide prior to the preparation of this
medicinal product.
Please refer to Summary of Product
Characteristics for full prescribing and other
information.

Incompatibility

Atracurium is inactivated by high pH and so
must not be mixed in the same syringe with
thiopentone or any alkaline agent.
Therefore the cannula has to be flushed between
infusion of Atracurium and thiopentone in order
to avoid the formation of aggregates, which
might cause an anaphylactoid reaction

Dilution instructions

Atracurium can be diluted with the following
solutions for infusion:
Solution for infusion
Period of Stability
1.  odium Chloride
S
Intravenous Infusion
BP (0.9% w/v)

24 hours
2.  lucose Intravenous Infusion
G
BP (5% w/v)

8 hours
3. Ringer’s Injection USP

8 hours
4 .  odium Chloride (0.18% w/v) and
S
8 hours
Glucose (4% w/v) Intravenous
Infusion BP
5.  ompound Sodium Lactate 
C
4 hours
Intravenous Infusion BP (Hartmann’s
Solution for Injection)
When diluted in these solutions to give
atracurium besilate concentrations of 0.5mg/ml
and above, the resultant solutions will be stable
in daylight for the stated periods at temperatures
of up to 30°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 dilution has
taken place in controlled and validated aseptic
conditions.

Posology and method of administration
The product is for single use only. Any unused
solution should be discarded.

Prior to administration it is recommended to
inspect the product visually and discard any
product where the usual appearance of the
product has changed or if the container is
damaged.
Only clear solutions practically free from particles
should be used.
In common with all neuromuscular blocking
agents, monitoring of neuromuscular function
is recommended during the use of atracurium
besilate, in order to individualise dosage
requirements.

Use in anaesthesia

In adults: Use as an injection
Atracurium besilate is administered by
intravenous injection and must not be applied
intramuscularly.
Relaxation
The dosage range recommended for adults is 0.3
to 0.6mg atracurium besilate/kg (depending on
the duration of full block required). This dose will
provide adequate relaxation for about 15 to 35
minutes.
Intubation
Endotracheal intubation can usually be
accomplished within 90 seconds from the
intravenous injection of 0.5 to 0.6mg atracurium
besilate/kg.
Repeated dose
Full block can be prolonged with supplementary
doses of 0.1 to 0.2mg atracurium besilate/
kg. Generally, the first maintenance dose is
required 20 to 45 minutes after the initial
bolus dose, then typically at 15 to 25 minutes
intervals, however, the need for maintenance
doses should be determined by the individual
patient’s requirements and responses. Successive
supplementary dosing does not produce
accumulation in neuromuscular blocking effect.
As measured by the restoration of the tetanic
response to 95% of normal neuromuscular
function, spontaneous recovery occurs about 35
minutes after a full block.

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AAAF6972

Atracurium 10 mg/ml Sol. for injection/infusion PIL - UK
item no: AAAF6972

dimensions: 148 x 520

print proof no: 5

pharmacode:

origination date: 22.07.13

min pt size: 8.5pt

1. Black
2.
3.
4.
5.
6.

originated by: DR
approved for print/date

colours/plates:

revision date: 04.11.13

Technical Approval

revised by: DR

date sent: 22.07.13

supplier: Rotexmedica

technically app. date: 24.07.13

Non Printing Colours
1.
2.
3.

Use in children:

The use of Atracurium is not recommended in
neonates (children under the age of one month).
In the case of necessary treatment in newborn
or premature newborn the dose has to be
significantly lowered.
If you have any further questions on the use of
this medicine, ask your doctor or pharmacist.
Information for medical or healthcare
professionals is provided at the end of this leaflet.

4 Possible side effects

Like all medicines, this medicine can cause side
effects, although not everybody gets them.
The frequency of possible side effects listed
below is defined using the following convention:
Very common: affects more than 1 user in 10
Common: affects 1 to 10 users in 100
Uncommon: affects 1 to 10 users in 1,000
Rare:
affects 1 to 10 users in 10,000
Very rare:
a
 ffects less than 1 user in 10,000
Not known:  requency cannot be estimated
f
from the available data

Common:

•  achycardia (rapid hearbeat)
t
•  emporary hypotension (low blood pressure)
t
•  heezing
w
•  ronchospasm (asthma-like symptoms)
b
•  kin flushing
s
•  rticaria (nettle rash)
u

Very rare:
•  yasthenia and/or myopathy (weak or nonm
working muscles)
•  evere allergic reactions including shock,
s
circulatory failure and heart attack in patients
receiving atracurium with one or more
anaesthetic drugs
•  eizures (fits) when taken with other drugs in
s
at-risk patients
• aryngospasm (spasm of the vocal cords)
l
Reporting of side effects

If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card
Scheme at: www.mhra.gov.uk/yellowcard. By
reporting side effects you can help provide more
information on the safety of this medicine.

5 How to store Atracurium

Keep this medicine out of the sight and reach of
children.
Do not use Atracurium after the expiry date
which is stated on the label and carton after
EXP. The expiry date refers to the last day of that
month.

Storage conditions

Store in a refrigerator (2°C – 8°C). Keep the
ampoules in the outer carton.

Shelf life after opening the ampoule

The solution has to be used immediately after
opening the ampoule.
When Atracurium is diluted in compatible
solutions, the resultant solutions will be stable in
daylight for 4 to 24 hours at temperatures of up
to 30°C, depending on the type of diluent (see
Dilution instructions in section ‘The following
information is intended for medical or healthcare
professionals only’ at the end of this leaflet).
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 dilution has taken place in
controlled and validated aseptic conditions.

The product is for single use only. Any unused
solution should be discarded.
Do not throw away any medicines via wastewater
or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These
measures will help protect the environment.

6 Contents of the pack and other
information

What Atracurium contains:

The active substance is atracurium besilate.
1 ml solution contains 10mg atracurium besilate.
One ampoule with 2.5 ml solution contains 25mg
atracurium besilate.
One ampoule with 5 ml solution contains 50mg
atracurium besilate.
One ampoule with 25 ml solution contains
250mg atracurium besilate
The other ingredients are: Benzensulphonic acid,
Water for injection.

What Atracurium looks like and contents
of the pack
Solution for injection and Concentrate for
solution for infusion
Clear and colourless solution
Box of 1 ampoule with 2.5 ml
Box of 5 ampoules with 2.5 ml
Box of 10 ampoules with 2.5 ml
Box of 5x5 ampoules with 2.5 ml
Box of 5x10 ampoules with 2.5 ml
Box of 1 ampoule with 5 ml
Box of 5 ampoules with 5 ml
Box of 10 ampoules with 5 ml
Box of 5x5 ampoules with 5 ml
Box of 5x10 ampoules with 5 ml
Box of 1 ampoule with 25 ml
Box of 2 ampoules with 25 ml
Box of 5 ampoules with 25 ml
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Actavis Group PTC ehf
Reykjavikurvegur 76-78,
220 Hafnarfjordur
Iceland
Manufacturers:
Actavis Deutschland GmbH & Co. KG
Willy-Brandt-Allee 2
81829 München
Germany
Actavis Group PTC ehf.
Reykjavikurvegur 76-78
220 Hafnarfjordur
Iceland
This leaflet was last revised in October 2013

If you would like a
leaflet with larger
text, please contact
01271 311257.

Prior to administration a healthcare professional
should inspect the product visually and discard
any product where the usual appearance of
the product has changed or if the container is
damaged. Only clear solutions practically free
from particles should be used.
Continued top of next column
AAAF6972

Actavis, Barnstaple, EX32 8NS, UK

The neuromuscular block produced by
atracurium besilate can be rapidly reversed by
standard doses of anticholinesterase agents, such
as neostigmine and edrophonium, accompanied
or preceded by atropine or glycopyrrolate, with
no evidence of recurarisation.
In adults: Use as an infusion
Atracurium besilate is hypotonic and must not be
administered via the infusion system of a blood
transfusion. In this case atracurium besilate has
to be administered via a separate infusion line.
After an initial bolus dose of 0.3 to 0.6mg/
kg, atracurium besilate, administered as a
continuous infusion at rates of 0.3 to 0.6mg/kg/
hour, can be used to maintain neuromuscular
block during long surgical procedures.
Atracurium besilate can be administered by
infusion during cardiopulmonary bypass surgery
at the recommended infusion rates.
Induced hypothermia with body temperature
of 25 to 26°C reduces the rate of degradation of
atracurium besilate, therefore full neuromuscular
block may be maintained with approximately
half the original infusion rate.
Atracurium can be diluted with the solutions for
infusion listed above.
Use in paediatric population
On a bodyweight basis the dosage in children
over the age of 1 month is similar to that in
adults.
Use in neonates:
The use of atracurium is not recommended
in neonates since there are insufficient data
available. In case of a necessary neuromuscular
blockade also in newborn or premature newborn
the dose has to be significantly lowered.


Use in special populations

Use in patients with cardiovascular disease:
Patients with severe cardiovascular diseases
may react more sensitively to transient states
of hypotony (see section 4.4). In these patients,
atracurium besilate should therefore be
administered slowly and/or in divided doses over
1 - 2 minutes.
Use in patients suffering from burns:
As with other non-depolarising neuromuscular
blocking agents, resistance may develop in
patients suffering from burns. Such patients may
require increased doses dependent on the time
elapsed since the burn injury and the extent of
the burn.

Use in patients in intensive care units
(ICU):

When there is a need of atracurium besilate for
long-term mechanical ventilation in intensive care
units, the benefit to risk ratio of neuromuscular
block must be considered.
After an initial bolus dose of 0.3 - 0.6mg/kg,
Atracurium besilate can be used to maintain
neuromuscular block by administration of a
continuous infusion of between 11 and 13
micrograms/kg/min (0.65 - 0.78mg/kg/h). There is,
however, a great variety of dosage requirements
between patients. Patients may require infusion
rates of as low as 4.5 micrograms/kg/min (0.27mg/
kg/h) or as high as 29.5 micrograms/kg/min
(1.77mg/kg/h). Dosage requirements may change
over time.
The speed of spontaneous recovery from
neuromuscular block after infusion of atracurium
besilate in ICU patients is independent of
the duration of administration. Spontaneous
recovery can be expected of a train-of-four ratio
of more than 0.75 (the ratio of the peak of the
fourth to the first contraction in a train of four)
which occurs on average in approximately 60
minutes with a range of approximately 32 - 108
minutes (n = 6).

Use in the elderly:
Atracurium besilate may be used at standard
dosage in elderly patients. It is recommended,
however, that the initial dose be at the lower end
of the range and that it be administered slowly.
Use in patients with reduced renal and/or hepatic
function:
Atracurium besilate may be used at standard
dosage at all levels of renal or hepatic function,
including endstage failure.
Actavis, Barnstaple, EX32 8NS, UK

Continued top of next column
AAAF6972

Atracurium 10 mg/ml Sol. for injection/infusion PIL - UK
item no: AAAF6972

dimensions: 148 x 520

print proof no: 5

pharmacode:

origination date: 22.07.13

min pt size: 8.5pt

1. Black
2.
3.
4.
5.
6.

originated by: DR
approved for print/date

colours/plates:

revision date: 04.11.13

Technical Approval

revised by: DR

date sent: 22.07.13

supplier: Rotexmedica

technically app. date: 24.07.13

Non Printing Colours
1.
2.
3.

Expand view ⇕

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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