CISATRACURIUM BESILATE SCIECURE 5 MG / ML SOLUTION FOR INJECTION/INFUSION - patient leaflet, side effects, dosage

1. What this medicine is and what it is used for

This medicine contains a medicine called cisatracurium. This belongs to a group of medicines called muscle relaxants.

This medicine 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.

2.What you need to know before you are given this medicine

Do not use this medicine

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

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

Warnings and precautions

Talk to your doctor, nurse or pharmacist before you are given 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;
• 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 this medicine.

Other medicines and this medicine

Tell your doctor if you are taking, have recently taken or might take any other medicines. This includes any herbal products or medicines obtained 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;
• medicines 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 taking this medicine.

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

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 this medicine 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.

This medicine can be given:

• as a single injection into your vein (intravenous bolus injection);
• as a continuous infusion into your vein. This is where the medicine is slowly given to you over a long period of time.

Your doctor will decide the way you are given the medicine 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.

4.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 your 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.

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, 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 at 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.

5.how to store this medicine

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 pack after ‘EXP’. The expiry date refers to the last day of that month.

Store in a refrigerator (2°C- 8°C). Do not freeze.

Store in the original package in order to protect from light.

Chemical and physical in-use stability has been demonstrated for 24 hours at 5°C and 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 to 8°C, unless reconstitution has taken place in controlled and validated aseptic conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6.contents of the pack and other information

What this medicine contains

• The active substance is cisatracurium.

Each mL contains 2 mg cisatracurium (as 2.68 mg of cisatracurium besilate).

Each mL contains 5 mg cisatracurium (as 6.69 mg of cisatracurium besilate).

• The other ingredients are benzene sulfonic acid and water for injection.

What this medicine looks like and contents of the pack

Colourless to pale yellow or greenish yellow clear solution.

Cisatracurium besilate 2 mg/mL solution for injection/infusion is supplied in 2.5 mL, 5.0 mL and 10 mL transparent glass (type I) ampoules each containing 5, 10 and 20 mg of cisatracurium respectively. The ampoules are packaged in a cardboard box with an instruction leaflet.

Pack sizes of 1 and 5 ampoules.

Cisatracurium besilate 5 mg/mL solution for injection/infusion is supplied in 30 mL clear glass (type I) vial containing 150 mg of cisatracurium. The glass vial is sealed with a rubber stopper and an aluminium flip cap and packaged in a cardboard box with an instruction leaflet.

Pack size of 1 vial.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisarion Holder:

Sciecure Pharma Limited

5 Millmead, Guildford, Surrey, GU2 4BE, UK

Manufacturer:

Pharmathen S.A., 6 Dervenakion street, Pallini Attiki, 15351 Greece

Children less than 1 month old should not have this medicine.

If you receive more this medicine than you should

This medicine 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.

PSAUKP3

The following information is intended for medical or healthcare professionals only Instructions for use

This product is for single use only. Use only colourless to pale yellow or greenish yellow clear solution. 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.

Diluted this medicine is physically and chemically stable for at least 24 hours at 5°C and 25°C at concentrations between 0.1 and 2 mg/mL in the following infusion fluids, in either polyvinyl chloride or polypropylene containers:

• Sodium Chloride (0.9% w/v) Intravenous Infusion.
• Glucose (5% w/v) Intravenous Infusion.
• Sodium Chloride (0.18% w/v) and Glucose (4% w/v) Intravenous Infusion.
• Sodium Chloride (0.45% w/v) and Glucose (2.5% w/v) Intravenous Infusion.