Patient leaflet - CISATRACURIUM 5 MG / ML SOLUTION FOR INJECTION/INFUSION
accord
PACKAGE LEAFLET: INFORMATION FOR THE USER
Cisatracurium 5mg/ml Solution for Injection/Infusion
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.
- If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
- The full name of this medicine is Cisatracurium 5mg/ml Solution for Injection/Infusion but within this leaflet it will be referred to as Cisatracurium.
What is in this leaflet:
51
What Cisatracurium is and what it is used for
2]
What you need to know before you are given Cisatracurium
51 How Cisatracurium is given
4l
Possible side effects
51
How to store Cisatracurium
6l
Contents of the pack and other information
5] what cisatracurium is and what it is used for
Cisatracurium contains a medicine called cisatracurium besilate. 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.
51
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN CISATRACURIUM
Do not use Cisatracurium:
- if you are allergic to cisatracurium, any other muscle relaxant or any of the other ingredients in Cisatracurium (listed in Section 6)
- if you have reacted badly to an anaesthetic before.
Do not use 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.
Take special care with Cisatracurium
Talk to your doctor, nurse or pharmacist before having this medicine:
- if you have muscle weakness, tiredness or difficulty in co-ordinating your movements (myasthenia gravis)
- if you have a neuromuscular disease, such as a muscle wasting disease, paralysis, motor neurone disease or cerebral palsy
- if you have a burn which requires medical treatment
- if 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
Other medicines and Cisatracurium
Tell your doctor if you are taking, have recently taken or might take any other medicines.
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 heartbeats (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 or chlorpromazine (which can also be used for sickness)
- medicines containing magnesium
- drugs 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 you are given this medicine.
Pregnancy
Cisatracurium should not be used during pregnancy.
Breast-feeding
An adverse impact of cisatracurium on the breast-fed child cannot be excluded, however it is not expected if breast-feeding is restarted after the effects of the substance have worn off. Cisatracurium is quickly eliminated from the body. Women should abstain from breast-feeding for 3 hours after the treatment discontinuation.
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 CISATRACURIUM IS GIVEN
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 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.
Children less than 1 month old should not receive this medicine.
If you receive 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.
If you have any further questions on the use of this medicine, ask your doctor.
« POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you get any side effects, talk to you 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 and shock.
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.
- a rash or redness of your skin
- wheezing or coughing.
- weak or aching muscles.
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 Website: or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine.
MHOW TO store cisatracurium
- Keep this medicine out of the sight and reach of children.
- Do not use Cisatracurium after the expiry date which is stated on the pack and vial after ‘Exp’. The expiry date refers to the last day of that month.
- Store in a refrigerator between 2 and 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 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.
CONTENTS OF THE PACK AND OTHER INFORMATION
What cisatracurium contains
- 1ml solution for injection or infusion contains 6.70mg cisatracurium besilate equivalent to 5mg cisatracurium.
One vial of 30ml solution for injection or infusion contains 201mg of cisatracurium besilate equivalent to 150mg of cisatracurium.
- The other ingredients are: benzenesulfonic acid and water for injections.
What Cisatracurium looks like and contents of the pack
Cisatracurium 5mg/ml is a solution for injection/ infusion, colourless to pale yellow or greenish yellow, practically free from visible particulate matter, with a pH of 3.0–5.0 packed in a box containing one 30ml clear glass vial. Each 30ml vial contains 150mg of cisatracurium.
Marketing Authorisation Holder
Accord Healthcare Limited
Sage House
319 Pinner Road
North Harrow
Middlesex
HA1 4HF
United Kingdom
Manufacturer
B. Braun Medical, S.A.
Ronda de Los Olivares, Parcela 11.
Pol. Ind. Los Olivares
23009Jaen-Espana
This leaflet was last revised in June 2021.
If you would like a leaflet with larger text, please contact 01271 385257.
Continued top of next column
BBBB1274