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CISATRACURIUM 2MG/ML SOLUTION FOR INJECTION/INFUSION

Active substance(s): CISATRACURIUM

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PACKAGE LEAFLET: INFORMATION FOR
THE USER
Cisatracurium 2mg/ml solution for
injection/infusion
Cisatracurium
Read all of this leaflet carefully before you
are given this medicine.
• Keep this leaflet. You may need to read it
again.
• If you have any further questions, ask your
doctor, nurse or pharmacist.
• This medicine has been prescribed for you.
Do not pass it on to others. It may harm
them, even if their symptoms are the same as
yours.
• If any of the side effects get serious, or if you
notice any side effects not listed in this
leaflet, please tell your doctor, nurse or
pharmacist.
The name of your medicine is Cisatracurium
2mg/ml solution for injection/infusion
In the rest of this leaflet Cisatracurium 2mg/ml
solution for injection/infusion is called
Cisatracurium.
In this leaflet:
1. What Cisatracurium is and what it is used for
2. Before you are given Cisatracurium
3. How to use Cisatracurium
4. Possible side effects
5. How to store Cisatracurium
6. Further information
1. What Cisatracurium is and what it is used
for
The active substance is cisatracurium besilate,
which belongs to a group of medicines called
muscle relaxants.
Cisatracurium is used:
• to relax muscles during operations on adults
and children over 1 month of age, including
heart surgery
• 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. Before you are given Cisatracurium
Do not use Cisatracurium if you:
• are allergic (hypersensitive) to the active
substance, any other muscle relaxant or any of
the other ingredients in Cisatracurium (listed in
Section 6)
• have reacted badly to an anaesthetic before.
Do not receive Cisatracurium if any of the
above apply to you. If you are not sure, talk to
your doctor, nurse or pharmacist before you
receive Cisatracurium.
If you are not sure if any of the above applies to
you, talk to your doctor or nurse before using
Cisatracurium.
Take special care with Cisatracurium
Check with your doctor, nurse or pharmacist
before receiving 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
• 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 applies to
you, talk to your doctor or nurse, before having
Cisatracurium.
Using other medicines
Please tell your doctor if you are taking or have
recently taken any other medicines, including
medicines obtained 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 (antiarrhythmics)
• medicines for high blood pressure
• water tablets (diuretics), such as furusemide
• 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,
monoamine oxidase inhibitors (MAOIs) or
chlorpromazine (which can also be used for
sickness)
• medicines containing magnesium

medicines
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 this
medicine is given to you.
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 to use Cisatracurium
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.
Cisatracurium can be given:
• as a single injection into your vein
(intravenous bolus injection)
• as a continuous infusion into your vein. This is
where the medicine is slowly given to you over
a long period of time.
Your doctor will decide the way you will be
given the medicine 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.
Use in children
Children less than 1 month old should not be
given this medicine.
If you are given more Cisatracurium than
you should
Cisatracurium 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, Cisatracurium 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.

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.
Very rare (affects less than 1 in 10,000
people)
• weak or aching muscles.
If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or nurse.
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

Manufacturer: DEMO S.A., 21st km National
Road Athens-Lamia, 14568 Krioneri, Athens,
Greece.
This medicinal product is authorised in the
Member States of the EEA under the
following names:
UK: Cisatracurium 2 mg/ml Solution for
Injection/Infusion
IE: Cisatracurium 2 mg/ml Solution for
Injection/Infusion
ES: CISATRACURIO KERN PHARMA 2
MG/ML SOLUCION INYECTABLE Y PARAN
PERFUSION EFG
EL: CISATRAL 5MG/ML SOL.INJ.INF
DE: Cisatracurium Noridem 2 mg/ ml Injektions/Infusionslösung
AT: Cisatracurium Noridem 2 mg/ ml Injektions/Infusionslösung
PL: Cisatracurium Noridem

5. How to store Cisatracurium
• Keep out of the reach and sight of children.
• Do not use Cisatracurium after the expiry date
which is stated 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.
• Medicines should not be disposed of via
wastewater or household waste. Your doctor or
nurse will dispose of any medicine that is no
longer required. These measures will help to
protect the environment.

Sodium Chloride
Infusion.

6. Further information
What Cisatracurium contains
• The active substance is cisatracurium (as
besilate).
• The other ingredients are benzene sulfonic
acid and water for injection.
What Cisatracurium looks like and contents
of the pack
Cisatracurium in clear glass ampoule in a box
of 5 and box of 1.
Each 10 ml ampoule contains 20 mg of
cisatracurium
Each 5 ml ampoule contains 10 mg of
cisatracurium
Each 2.5 ml ampoule contains 5 mg of
cisatracurium
Not all pack sizes may be marketed.
Marketing
Authorisation
Manufacturer

Holder

and

Marketing Authorisation Holder: Noridem
Enterprises Ltd., Evagorou & Makariou, Mitsi
Building 3, Office 115, 1065 Nicosia, Cyprus.

The following information is intended for
medical or healthcare professionals only
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 Cisatracurium is physically and
chemically stable for at least 24 hours at 5°C
and 25°C at concentrations between 0.1 and 1
mg/mL in the following infusion fluids, in or
polypropylene containers.
(0.9%

w/v)

Intravenous

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 6.3.
Cisatracurium 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:
fentanyl citrate and midazolam hydrochloride.
Where other drugs are administered through
the same indwelling needle or cannula as
Cisatracurium, 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, Cisatracurium should be flushed through
the vein with a suitable intravenous fluid, e.g.,
sodium chloride intravenous infusion (0.9%
w/v).
This leaflet was last approved in 06/2013.

If this leaflet is difficult to see or
read please contact the following
address for help: Fannin Limited,
Fannin
House,
South
County
Business
Park,
Leopardstown,
Dublin 18, Ireland
Tel +353-1-2907000

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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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