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CISATRACURIUM 2 MG/ML SOLUTION FOR INJECTION/INFUSION

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

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• have ever had an allergic reaction to any
muscle relaxant
• are aware that you have abnormal blood
acidity or abnormal blood electrolyte
levels

PACKAGE LEAFLET:
INFORMATION FOR THE USER

Using 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. This includes herbal medicines.
This is because these medicines can affect
how well Cisatracurium works or cause side
effects.

Cisatracurium 2 mg/ml
Solution for Injection/Infusion
Cisatracurium 5 mg/ml
Solution for Injection/Infusion
Cisatracurium

In particular tell your doctor, nurse or
pharmacist if you are taking, or have
recently received any of the following:

Read all of this leaflet carefully before
you start using this medicine.

• anaesthetics (used to reduce sensation
and pain during surgical procedures)

• Keep this leaflet. You may need to
read it again.

• antibiotics (used to treat infections)
• medicines for uneven heart beats
(anti-arrhythmics)

• If you have any further questions, ask
your doctor or pharmacist.

• medicines for high blood pressure

• 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.

• water tablets (diuretics), such as
frusemide
• medicines for inflammation of the joints,
such as chloroquine or d-penicillamine

• 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. See section 4.

• 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 nausea)

In this leaflet:
1. What Cisatracurium is and what it is used
for

• medicines containing magnesium

2. What you need to know before you use
Cisatracurium
3. How to use Cisatracurium

• medicines for Alzheimer’s disease
(anticholinesterases such as donepezil)

4. Possible side effects

• other muscle relaxants

5. How to store Cisatracurium

Pregnancy and breast-feeding

6. Contents of the pack and other
information

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 using this medicine.

1. WHAT CISATRACURIUM IS AND WHAT
IT IS USED FOR

You should not be given this medicine if you
are pregnant.

This medicine 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.

If you are breast-feeding and you are
given this medicine because of a medical
emergency, ask your doctor for advice
before starting breast-feeding again.
Breast-feeding may be started 12 hours
after this medicine has been given to you.

Cisatracurium is used
• during surgery and other procedures and
in intensive care

Driving and using machines
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.

• with general anaesthesia, or sedation in
the Intensive Care Unit to relax muscles
• to help insert a tube into the windpipe
(tracheal intubation) if a person needs
help to breathe (with or without a
machine).

3. HOW TO USE CISATRACURIUM

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

Cisatracurium will be administered to
you by a healthcare professional.

2. WHAT YOU NEED TO KNOW BEFORE
YOU USE CISATRACURIUM

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.

Do not use Cisatracurium
• If you are allergic (hypersensitive) to
cisatracurium besilate, atracurium, or any
of the ingredients in this medicine (listed
in section 6)

Warnings and Precautions

Your doctor will decide how you are given
this medicine and the dose you will receive.
This depends on the following factors:

Talk to your doctor before using this
medicine if you:

• your body weight

• have a neuromuscular disease, such
as a muscle wasting disease, paralysis,
motor neurone disease, cerebral palsy or
myasthenia gravis

• the amount and duration of muscle
relaxation required
• your expected response to the medicine.

• have a burn which requires medical
treatment

Cisatracurium 2 mg/ml
Solution for Injection/Infusion
Cisatracurium 5 mg/ml
Solution for Injection/Infusion
The following information is intended for
medical or healthcare professionals only

Incompatibilities
This medicinal product must not be mixed with
other medicinal product 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.

Sodium Chloride (0.18% w/v) and Glucose
(4% w/v) IV infusion
Sodium Chloride (0.45% w/v) and Glucose
(2.5% 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).

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
Glucose (5% w/v) IV Infusion

K101760C

Date: 04 Apr 2017
Time:
Product Details:

20:21

K101760C
Version No:03
PAR-2017-0001831
United Kingdom
Perigord No: 306115

LII005-6

Smallest Body Text
9 pt

Packaging Site

Black

Liscate

Dimensions:
150 x 580 mm

Pharmacode:
34 (IIIXX)

Barcode:
N/A

Use in Children

Diluted solutions should be used
immediately, however, if this is not possible
they can, in certain circumstances, be
stored for up to 24 hours.

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 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.

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. These measures will
help to protect the environment.

6. CONTENTS OF THE PACK AND
OTHER INFORMATION

4. POSSIBLE SIDE EFFECTS

What Cisatracurium contains

Like all medicines, this medicine can cause
side effects, although not everybody gets
them.

Allergic reactions (may affect up to 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

• 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)

• a collapse

• The other ingredients are
benzenesulfonic acid and Water for
Injections.

The following side effects have been
reported following the administration of this
medicine:

What this medicine looks like and the
contents of the pack

Common (may affect up to 1 in 10 people):
• decreased heart rate
• low blood pressure

Cisatracurium is a colourless to pale
yellow/greenish yellow solution which
comes in glass containers called vials.
This medicine may be supplied in packs
containing 1 or 5 vials.

Uncommon (may affect up to
1 in 100 people):

Not all pack sizes may be marketed.

• a rash or redness on your skin

Marketing Authorisation Holder

• coughing or wheezing
Very rare (may affect up to
1 in 10,000 people):
• muscle wasting and muscle weakness
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.
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:

Hospira UK Limited
Horizon, Honey Lane,
Hurley, Maidenhead,
SL6 6RJ,
United Kingdom

Manufacturers responsible for batch
release
Hospira Spa
Via Fosse Ardeatine, 2
20060 Liscate (MI)
Italy
This leaflet was last revised in: 04/2017
Ref: UK gxCA 3_0

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

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.
Ref: UK gxCA 3_0

K101760C

Date: 04 Apr 2017
Time:
Product Details:

20:21

K101760C
Version No:03
PAR-2017-0001831
United Kingdom
Perigord No: 306115

LII005-6

Smallest Body Text
9 pt

Packaging Site

Black

Liscate

Dimensions:
150 x 580 mm

Pharmacode:
34 (IIIXX)

Barcode:
N/A

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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