Skip to Content

CISATRACURIUM 5 MG/ML SOLUTION FOR INJECTION/INFUSION

Active substance(s): CISATRACURIUM BESILATE / CISATRACURIUM BESYLATE

View full screen / Print PDF » Download PDF ⇩
Transcript
Take special care with Cisatracurium
Speak with your doctor before receiving this
medicine if you:

PACKAGE LEAFLET:
INFORMATION FOR THE USER
Cisatracurium 2 mg/ml
Solution for Injection/Infusion
Cisatracurium 5 mg/ml
Solution for Injection/Infusion
Cisatracurium
Read all of this leaflet carefully before
you start using this medicine
• Keep this leaflet. You may need to
read it again.
• If you have any further questions, ask
your doctor 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 gets serious,
or if you notice any side effects not
listed in this leaflet, please tell your
doctor or pharmacist.
In this leaflet
1. What Cisatracurium is and what it is used
for

• have a neuromuscular disease, such
as a muscle wasting disease, paralysis,
motor neurone disease, cerebral palsy or
myasthenia gravis
• have a burn which requires medical
treatment
• have ever had an allergic reaction to any
muscle relaxant
• are aware that you have abnormal blood
acidity or abnormal blood electrolyte
levels

Using other medicines
Please tell your doctor if you are taking or
have recently taken any other medicines,
including medicines obtained without a
prescription. This includes herbal medicines.
This is because these medicines can affect
how well Cisatracurium works or cause side
effects.
In particular tell your doctor, nurse or
pharmacist if you are taking, or have
recently received 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
frusemide

2. Before you are given Cisatracurium

• medicines for inflammation of the joints,
such as chloroquine or d-penicillamine

3. How you are given Cisatracurium

• steroids

4. Possible side effects

• medicines for fits (epilepsy), such as
phenytoin or carbamazepine

5. How to store Cisatracurium
6. Further information

1. WHAT CISATRACURIUM IS AND WHAT
IT IS USED FOR
Cisatracurium belongs to a group of
medicines called muscle relaxants. The
full name of this medicine is Cisatracurium
Solution for Injection/Infusion but for
ease of reference it will be referred to as
Cisatracurium throughout the leaflet.
Cisatracurium is used
• during surgery and other procedures and
in intensive care
• with general anaesthesia, or sedation in
the Intensive Care Unit to relax muscles

• medicines for mental illness, such as
lithium, monoamine oxidase inhibitors
(MAOIs) or chlorpromazine (which can
also be used for nausea)
• medicines containing magnesium
• medicines for Alzheimer’s disease
(anticholinesterases such as donepezil)
• other muscle relaxants

Pregnancy and breastfeeding
You should not be given this medicine if
you are pregnant. If you are pregnant and
you are given this medicine because of a
medical emergency, ask your doctor for
advice before starting breastfeeding again.
Breastfeeding may be started 24 hours after
this medicine has been given to you.

• to help insert a tube into the windpipe
(tracheal intubation) if a person needs
help to breathe (with or without a
machine).

Ask your doctor or pharmacist for advice
before taking any medicine.

Cisatracurium is used in adults and in
children over 1 month of age.

Some patients may occasionally feel dizzy,
drowsy or confused after treatment with
this medicine. If this happens to you, do
not drive or use machinery. Your doctor will
advise how long you should wait after an
operation before you can drive.

2. BEFORE YOU ARE GIVEN
CISATRACURIUM

Driving and using machines

You will not be given Cisatracurium
• if you are allergic (hypersensitive) to
cisatracurium besilate, atracurium or any
of the other ingredients in this medicine
(see section 6).

Cisatracurium 2 mg/ml
Solution for Injection/Infusion

Glucose (5% w/v) IV Infusion

Cisatracurium 5 mg/ml
Solution for Injection/Infusion

Sodium Chloride (0.45% w/v) and Glucose
(2.5% w/v) IV infusion

The following information is intended for
medical or healthcare professionals only

Incompatibilities
This medicinal product must not be mixed
with other medicinal products except those
mentioned in ‘Instructions for use and handling’
below.
Since cisatracurium is stable only in acidic
solutions it should not be mixed in the same
syringe or administered simultaneously through
the same needle with alkaline solutions, e.g.,
sodium thiopentone. It is not compatible with
ketorolac, trometamol or propofol injectable
emulsion.

Instructions for use and handling
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.
The diluted product is stable for at least
24 hours at concentrations between
0.1 – 2.0 mg/ml in the following infusion
solutions:
Sodium Chloride (0.9% w/v) IV Infusion

Sodium Chloride (0.18% w/v) and Glucose
(4% w/v) IV infusion

However, since the product contains no
antimicrobial preservative, dilution should be
carried out immediately prior to use, or failing
this the diluted solution should be stored as
directed below.
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 this medicinal product, 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).

3. HOW YOU ARE GIVEN CISATRACURIUM
Cisatracurium will be administered to
you by a healthcare professional
This medicine will only be administered
directly into a vein, either by injection or by
slow intravenous infusion. Cisatracurium
can be given as a single injection into your
vein (intravenous bolus injection) or as a
continuous infusion into your vein. This is
where the drug is slowly given to you over a
longer period of time.
Your doctor will decide how you will be given
this medicine and the dose you will receive.
This depends on the following factors:
• 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 receive more Cisatracurium than
you should
This medicine will always be given to you by
your doctor or anaesthetist under carefully
controlled conditions. It is unlikely that you
will be given too much, however, tell your
doctor or nurse if you have any concerns.

4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause
side effects, although not everybody gets
them.
The assessment of the side effects is based
on the following frequencies:
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: affects less than 1 user in
10,000
not known: frequency cannot be
estimated from the available data
The following side effects have been
reported following the administration of this
medicine:
Common
• decreased heart rate
• low blood pressure
Uncommon
• a rash or redness on your skin
• coughing or wheezing
Very rare
• muscle wasting and muscle weakness
• severe allergic reactions
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
pharmacist.

Shelf life after dilution
Shelf life after dilution: Chemical and physical
in-use stability has been demonstrated for
24 hours at 5°C and 25°C at concentrations of
0.1 and 2 mg/ml in PVC infusion bags.
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°C - 8°C, unless dilution has
taken place in controlled and validated aseptic
conditions.

5. HOW TO STORE CISATRACURIUM
Keep out of the reach and sight of children.
Do not use this medicine after the expiry
date, which is stated on the carton and the
label. The expiry date refers to the last day
of that month.
Store in a refrigerator between 2 – 8°C. Do
not freeze. Keep the vial in the outer carton
in order to protect from light.
To be used only if the solution appears clear
and almost colourless to slightly yellow/
greenish coloured. The product should be
visually inspected before use, and if the
visual appearance differs from the above
description or if the container is damaged,
the product must be discarded.
Unused portions of opened vials must not
be stored for later use.
Diluted solutions should be used
immediately, however, if this is not possible
they can, in certain circumstances, be
stored for up to 24 hours.
Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no
longer required. These measures will help to
protect the environment.

6. FURTHER INFORMATION
What Cisatracurium contains
• The active substance is cisatracurium
besilate.
Each 2.5 ml vial contains 5 mg
cisatracurium (as cisatracurium besilate)
Each 5 ml vial contains 10 mg
cisatracurium (as cisatracurium besilate)
Each 10 ml vial contains 20 mg
cisatracurium (as cisatracurium besilate)
Each 30 ml vial contains 150 mg
cisatracurium (as cisatracurium besilate)
• The other ingredients are
benzenesulfonic acid and Water for
Injections.

What this medicine looks like and the
contents of the pack
Cisatracurium is a colourless to pale yellow/
greenish solution which comes in glass
containers called vials. This medicine may
be supplied in packs containing 1 or 5 vials.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Hospira UK Limited
Queensway
Royal Leamington Spa
Warwickshire
CV31 3RW
UK

Manufacturers responsible for batch
release
Hospira Spa
Via Fosse Ardeatine, 2
20060 Liscate (MI)
Italy
This leaflet was last approved in: 10/2011

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.

Hide