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CISATRACURIUM 2MG/ML SOLUTION FOR INJECTION/INFUSION

Active substance(s): CISATRACURIUM / CISATRACURIUM / CISATRACURIUM BESYLATE / CISATRACURIUM / CISATRACURIUM BESYLATE

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Package leaflet: Information for the user

Cisatracurium 2 mg/ml
solution for injection/infusion
cisatracurium

Read all of this leaflet carefully before you start
using this medicine because it contains important
information for you
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor.
• This medicine has been prescribed for you only. Do not
pass it on to others. It may harm them, even if their signs
of illness are the same as yours.
• If you get any side effects, talk to your doctor. This
includes any possible side effects not listed in this leaflet.
See section 4.

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 apply to you, talk
to your doctor, nurse or pharmacist before you are given
Cisatracurium.

What is in this leaflet:

Other medicines and Cisatracurium
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 (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, monoamine
oxidase inhibitors (MAOIs) or chlorpromazine (which can
also be used for sickness)
• medicines containing magnesium
• drugs for Alzheimer’s disease (anticholinesterases e.g.
donepezil).

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

1. WHAT Cisatracurium is and what it is
used for
Cisatracurium contains a medicine called cisatracurium.
This 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. What you need to know before you use
Cisatracurium
Do not use Cisatracurium:
• if you are allergic to cisatracurium, any other muscle
relaxant or any of the other ingredients of this medicine
(listed in Section 6)
• if you have reacted badly to an anaesthetic before.
Do not have Cisatracurium if any of the above apply to you.
If you are not sure, talk to your doctor, nurse or pharmacist
before you have Cisatracurium.
Warnings and Precautions
Talk to your doctor, pharmacist or nurse before using
Cisatracurium if:

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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
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)

The following information is intended for healthcare professionals only:

Cisatracurium 2 mg/ml solution for injection/infusion
Cisatracurium

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 to be up to 24 hours at 2-8°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 (0.45% w/v) Intravenous Infusion.
Sodium Chloride (0.45% w/v) and Glucose (5% w/v) Intravenous Infusion.



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.

Do not use this medicine 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.

Children less than 1 month old should not have this
medicine.

If diluted, store the infusion solution at 25°C or between
2°C to 8°C and use within 24 hours. Any unused infusion
solution should be discarded 24 hours after it was prepared.

If you use 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.

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.

4. Possible side effects

6. Contents of the pack and other
information

Like all medicines, this medicine 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:

What Cisatracurium contains
• The active substance is 2 mg/ml or 5 mg/ml cisatracurium
(as besilate).
• The other ingredients are benzene sulfonic acid and water
for injection.
What Cisatracurium looks like and contents of the
pack
Cisatracurium 2 mg/ml solution for injection/infusion comes:
2.5 ml clear glass ampoule in a box of 10 and 50
(each 2.5 ml ampoule contains 5 mg of cisatracurium)
• 5 ml clear glass ampoule in a box of 10 and 50
(each 5 ml ampoule contains 10 mg of cisatracurium)
• 10 ml clear glass ampoule in a box of 10 and 50
(each 10 ml ampoule contains 20 mg of cisatracurium)


Common (affects less than 1 in 10 people)
• decrease in heart rate
• decrease in blood pressure.

Not all pack sizes may be marketed.

Uncommon (affects less than 1 in 100 people)
• a rash or redness of your skin
• wheezing or coughing.

Marketing Authorisation Holder:
Hikma Farmacêutica (Portugal) S.A.
Estrada do Rio da Mó, nº8, 8A e 8B - Fervença
2705-906 Terrugem SNT
Portugal

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 or nurse. This
includes any possible side effects not listed in this leaflet.
You can also report side effects directly via Yellow Card
Scheme, Website: 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 Cisatracurium

Marketing Authorisation Holder and Manufacturer

Manufacturer:
Hikma Italia S.P.A.
Viale Certosa, 10, 27100 Pavia
Italy
Distributed by:
Consilient Health (UK) Ltd.
No. 1 Church Road, Richmond upon Thames, Surrey,
TW9 2QE
This leaflet was last revised in April 2017

Keep this medicine out of the sight and reach of children.

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P0586

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 package leaflet
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: alfentanil hydrochloride,
droperidol, fentanyl citrate, midazolam hydrochloride and sufentanil citrate. 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).

Expand Transcript

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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