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

Read all of this leaflet carefully before you are given 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.
• If you get any side effects, talk to your doctor, nurse or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

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

Do not use Cisatracurium injection:

• if you are allergic to cisatracurium, any other muscle relaxant or any of the other ingredients in Cisatracurium injection (listed in section 6)
• you have reacted badly to an anaesthetic before.

Do not have Cisatracurium injection if any of the above apply to you. If you are not sure, talk to your doctor, nurse or pharmacist before you have Cisatracurium injection.

Take special care with Cisatracurium injection

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)
• 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.
• 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 injection.

Other medicines and Cisatracurium injection

Tell your doctor if you are taking or have recently taken any other medicines. This includes any herbal products or medicines bought 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 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

Do not breast feed for at least 3 hours after your last dose when the effects of cisatracurium have worn off.

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 taking this medicine.

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.

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 injection 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 have this medicine.

If you receive more Cisatracurium injection than you should

Cisatracurium injection 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.

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.

Uncommon (affects less than 1 in 100 people)

• a rash or redness of your skin
• wheezing or coughing.

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, nurse or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard 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.

What Cisatracurium injection contains

• The active substance is 2 mg/ml or 5 mg/ml cisatracurium (as besilate).
• The other ingredients are benzene sulfonic acid (32% w/v) and Water for Injections.

What Cisatracurium injection looks like and contents of the pack

Cisatracurium 2mg/ml solution for injection/infusion comes:

• 2.5 ml clear glass ampoule in a box of 5 (each 2.5 ml ampoule contains 5 mg of cisatracurium)
• 5 ml clear glass ampoule in a box of 5 (each 5 ml ampoule contains 10 mg of cisatracurium)
• 10 ml clear glass ampoule in a box of 5 (each 10 ml ampoule contains 20 mg of cisatracurium)
• 25 ml clear glass ampoule in a box of 2 (each 25 ml ampoule contains 50 mg of cisatracurium)

Cisatracurium 5mg/ml solution for injection/infusion comes in a box containing one 30 ml clear glass vial. Each 30 ml vial contains 150 mg of cisatracurium.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

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