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CISATRACURIUM 5 MG/ML SOLUTION FOR INJECTION OR INFUSION

Active substance(s): CISATRACURIUM BESILATE

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Cisatracurium

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Holger Clas

10-12-2012 15:53
08-03-2013 14:48
+49 6172 686 6161

PACKAGE LEAFLET: INFORMATION FOR THE USER

Cisatracurium 5 mg/ml

Solution for injection or infusion
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, pharmacist or nurse.
- If you get any side effects, talk to our doctor, pharmacist or nurse. This includes
any possible side effects not listed in this leaflet.

The name of this medicine is Cisatracurium 5 mg/ml solution for injection or
infusion, called Cisatracurium injection or infusion in the rest of the leaflet.
In this leaflet:
1. What Cisatracurium injection or infusion is and what it is used for
2. What you need to know before Cisatracurium injection or infusion is
given
3. How Cisatracurium injection or infusion is given
4. Possible side effects
5. How to store Cisatracurium injection or infusion
6. Contents of the pack and other information
1. WHAT CISATRACURIUM INJECTION OR INFUSION IS AND WHAT IT
IS USED FOR
Cisatracurium injection or infusion belongs to a group of medicines called
muscle relaxants.
Cisatracurium injection or infusion is used:
• to relax muscles during a wide range of surgical procedures in adults and
children over 1 month of age,
• 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.
2. WHAT YOU NEED TO KNOW BEFORE CISARACURIUM INJECTION OR
INFUSION IS GIVEN
Cisatracurium injection or infusion must not be used if
- you are allergic (hypersensitive) to cisatracurium, atracurium or
benzenesulfonic acid.
Warnings and precautions
Before Cisatracurium injection or infusion is used, tell your doctor or nurse
if you have:
- muscle weakness, tiredness or difficulty in co-ordination of your
movements (myasthenia gravis),
- a neuromuscular disease, such as a muscle wasting disease, paralysis,
motor neurone disease or cerebral palsy,
- a burn which requires medical treatment,
- a severe acid-base and/or electrolyte disorder,
- 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,
nurse or pharmacist before you are given Cisatracurium injection or infusion.
Children
Children under the age of one month (new-born infants) should not receive
Cisatracurium injection or infusion.
Other medicines and Cisatracurium injection or infusion.
Please tell your doctor or pharmacist if you are taking or have recently taken
any other medicines, including medicines obtained without a prescription
and herbal medicines.
This is especially important with the following medicines as they may
interact with your Cisatracurium injection or infusion:
- anaesthetics (used for sedation and pain reduction during surgical
procedures, such as enflurane, isoflurane, halothane, ketamine)
- other muscle relaxants, such as suxamethonium
- antibiotics (used to treat infections, such as aminoglycosides, polymyxins,
spectinomycin, tetracyclines, lincomycin and clindamycin)

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- antiarrhythmics (used to control the heart rhythm, such as propranolol,
oxprenolol, calcium channel blockers, lidocaine, procainamide and
quinidine)
- medicines to treat high blood pressure, such as trimethaphan and
hexamethonium
- diuretics (water tablets, such as furosemide, thiazides, mannitol and
acetazolamide)
- medicines to treat rheumatism, such as chloroquine or d-penicillamine
- steroids
- anti-epileptic medicines, such as phenytoin or carbamazepine
- medicines to treat mental illness, such as lithium, or chlorpromazine
- medicines containing magnesium
- medicines to treat Alzheimer’s disease (anticholinesterases e.g.
donepezil)
It may still be alright for you to receive Cisatracurium injection or infusion
and your doctor will be able to decide what is suitable for you.
Pregnancy and breast-feeding
There is little experience in the use of Cisatracurium injection or infusion in
pregnant or breast-feeding women.
Therefore, it is not recommended to use Cisatracurium injection or infusion
during pregnancy or breast-feeding. An influence on the suckling child
is not to be expected if you restart breast-feeding after the effects of
the substance have worn off. As a precaution breast-feeding should be
discontinued during treatment and for at least 12 hours after administration
of Cisatracurium injection or infusion.
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
taking this medicine.
Driving and using machines
Cisatracurium injection or infusion is administered under general
anaesthesia. General anaesthesia has a major influence on your ability to
drive and use machinery. It can be dangerous to drive, operate machinery
or work in dangerous situations too soon after having had an operation.
Your doctor will tell you when you can start driving and using machinery
again.
3. HOW TO USE CISATRACURIUM INJECTION OR INFUSION
How your injection is given
Cisatracurium injection or infusion must only be given to you by or under
the supervision of an experienced doctor who is familiar with the use and
action of this type of medicine. It will always be given under carefully
controlled conditions, where emergency equipment is available.
Dosage
Your doctor will decide on the dose of Cisatracurium you will be given.
The amount of Cisatracurium injection or infusion you need depends on:
• your body weight
• the amount and duration of muscle relaxation required
• your expected response to the medicine
Method of administration
Cisatracurium injection or infusion will be given to you
• as a single injection into your vein (intravenous bolus injection),
• as a continuous infusion into your vein (intravenous infusion or “drip”).
This is where the drug is slowly given to you over a longer period of time.
If you receive more Cisatracurium injection or infusion than you
should
As Cisatracurium injection or infusion will always be given to you under
carefully controlled conditions, it is unlikely that you will be given too much.
If you have received too much, or if it is suspected, that you may have
received too much, appropriate action will be taken promptly by your doctor.
If you have any further questions on the use of this product, ask your doctor
or pharmacist.

The following information is intended for healthcare professionals
only:

except those mentioned in section 6.6 of the Summary of Product
Characteristics.

PREPARATION GUIDE FOR

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.

Cisatracurium 5 mg/ml solution for injection or infusion
It is important that you read the entire contents of this guide prior
to the preparation of this medicinal product.

It is not compatible with ketorolac, trometamol or propofol injectable
emulsion.
Dilution Instructions

This is a summary of the information regarding the preparation of
Cisatracurium injection or infusion. Please refer to the Summary of Product
Characteristics for full information.
Incompatibilities
This medicinal product must not be mixed with other medicinal products

Diluted to concentrations between 0.1 and 2 mg cisatracurium/ml,
Cisatracurium solution for injection or infusion is physically and chemically
stable for 24 hours at 25°C in sodium chloride 9 mg/ml (0.9%) solution; in
sodium chloride 9 mg/ml (0.9%) and glucose 50 mg/ml (5%) solution; and
in glucose 50 mg/ml (5%) solution.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Cisatracurium injection or infusion can cause side effects,
although not everybody gets them.

What Cisatracurium injection or infusion looks like and the content
of the pack
Cisatracurium injection or infusion is a clear, colourless to pale yellow or
greenish yellow solution for injection or infusion.

As with all muscle relaxants, cisatracurium can cause allergic reactions,
although serious allergic reactions are very rare (affects less than 1 in
10,000 users). Any sudden wheeziness, difficulty in breathing, swelling of
the eyelids, face or lips and rash or itching (especially affecting your whole
body) should be reported to a doctor immediately.

Cisatracurium 5mg /ml concentrate for solution for injection or infusion is
available in packs of: 1 of 5 clear glass vials (s), each containing 30 ml of
solution.

The following side effects have been reported:

Marketing Authorisation Holder
Fresenius Kabi Limited
Cestrian Court, Eastgate Way,
Manor Park, Runcorn,
Cheshire
WA7 1NT
UK

Common (affects 1 to 10 users in 100)
- decrease in heart rate
- decrease in blood pressure
Uncommon (affects 1 to 10 users in 1,000)
- a rash or redness of your skin
- bronchospasm (asthma-like symptoms)
Very rare (affects less than 1 user in 10,000)
- muscles weakness or failure
If any of the side effects becomes serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor, nurse or
pharmacist.
Also you can help to make sure that medicines remain as safe as possible by
reporting any unwanted side effects via the internet at www.mhra.gov.uk/
yellowcard. Alternatively you can call Freephone 0808 100 3352 (available
from 10 a.m. to 2 p.m. Mondays to Fridays) or fill in a paper form available
from your local pharmacy.
5. HOW TO STORE CISATRACURIUM INJECTION OR INFUSION
Keep out of the reach and sight of children.

Not all pack sizes may be marketed.

Manufacturer
Fresenius Kabi Deutschland GmbH
D-61346 Bad Homburg v.d.H
Germany’
This medicinal product is authorised in the Member States of the
EEA under the following names:
DE

Cisatracurium Kabi 2 mg/ml or Cisatracurium Kabi 5 mg/ml Injektionslösung/
Infusionslösung

BE

Cisatracurium Fresenius Kabi 2 mg/ml or Cisatracurium Fresenius 5 mg/ml
oplossing voor injectie of infusie

CZ

Cisatracurium Kabi 2 mg/ml or Cisatracurium Kabi 5 mg/ml

DK

Cisatracurium Fresenius Kabi

EE

Cisatracurium Kabi 2 mg/ml or Cisatracurium Kabi 5 mg/ml

EL

Cisatracurium/Kabi 2mg/ml or Cisatracurium Kabi 5 mg/ml, ενέσιμο διάλυμα

ES

Cisatracurio Kabi 2mg/ml or Cisatracurium Kabi 5 mg/ml solución inyectable y
para perfusión EFG

FI

Cisatracurium Fresenius Kabi 2 mg/ml

Do not use Cisatracurium injection or infusion after the expiry date which
is stated on the carton and label after “Exp.”. The expiry date refers to the
last day of that month.

FR

Cisatracurium Kabi 2 mg/ml or Cisatracurium Kabi 5 mg/ml, solution injectable/
pour perfusion

HU

Cisatracurium Kabi 2 mg/ml or Cisatracurium Kabi 5 mg/ml oldatos injekció
vagy infúzió

Storage conditions
Store in a refrigerator between 2 and 8 °C.
Do not freeze.
Keep the vials in the outer carton in order to protect from light.

IT

Cisatracurio Kabi 2mg/ml or Cisatracurium Kabi 5 mg/ml

LV

Cisatracurium Kabi 2mg/ml or Cisatracurium Kabi 5 mg/ml šķīdums injekcijām
vai infūzijām

LT

Cisatracurium Kabi 2 mg/ml or Cisatracurium Kabi 5 mg/ml injekcinis/infuzinis
tirpalas

After opening and/or after dilution
For single dose use only.
Cisatracurium injection or infusion should be used immediately after
opening and/or dilution. Any unused solution should be discarded.

LU

Cisatracurium Kabi 2 mg/ml Injektionslösung/Infusionslösung or Cisatracurium
Kabi 5 mg/ml

NL

Cisatracurium Fresenius Kabi 2 mg/ml or Cisatracurium Fresenius Kabi 5 mg/ml
oplossing voor injectie of infusie

NO

Cisatracurium Fresenius Kabi 2 mg/ml or Cisatracurium Fresenius Kabi 5 mg/ml
injeksjonsvæske, oppløsning

PL

Cisatracurium Kabi

PT

Besilato de Cisatracúrio Kabi

UK

Cisatracurium 2 mg/ml or Cisatracurium 5 mg/ml solution for injection or infusion

Do not use this medicine if you notice the solution is not clear and free of
particles or if the container is damaged.
Do not throw any medicines via wastewater. Ask your pharmacist how
to throw away medicines you no longer use. These measures will help to
protect the environment.

This leaflet was last approved in 03/2013.

6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Cisatracurium injection or infusion contains
The active substance is cisatracurium.
1 ml of Cisatracurium 5 mg/ml solution for injection or infusion contains
6.7 mg cisatracurium besilate, equivalent to 5 mg cisatracurium.
The other ingredients are benzenesulfonic acid 1% and water for
injections.

Chemical and physical in-use stability have been demonstrated for 24 hours
at 25°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 2-8°C.
Posology and method of administration
Please see the Summary of Product Characteristics.
Precautions for Disposal and other Handling
The product should be visually inspected prior to use. The solution should
only be used if it is clear and colourless or almost colourless up to slightly
yellow/greenish yellow, practically free from particles and if the container
is undamaged. If the visual appearance has changed or if the container is
damaged, the product must be discarded.
For single dose use only.

V001 xxxxxxx

The product should be used immediately after opening the ampoule.
Any unused product or waste material should be disposed of in accordance
with local requirements.
Cisatracurium has been shown to be compatible with the following
commonly used peri-operative medicinal products, 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
agents are administered through the same indwelling needle or cannula as
cisatracurium, it is recommended that each medicinal product be flushed
through with an adequate volume of a suitable intravenous fluid, e.g.,
sodium chloride 9 mg/ml (0.9%) solution.

V001 xxxxxxx

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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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