PIL 4-xxxxxxx/00 GB

Cisatracurium

PACKAGE LEAFLET: INFORMATION FOR THE USER

Cisatracurium 2 mg/ml

Solution for injection or infusion

The name of this medicine is Cisatracurium 2 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.    Before Cisatracurium injection or infusion is used

3.    How to use Cisatracurium injection or infusion

4.    Possible side effects

5.    How to store Cisatracurium injection or infusion

6.    Further 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.    BEFORE CISATRACURIUM INJECTION OR INFUSION IS USED

Cisatracurium injection or infusion must not be used if

-    you are allergic (hypersensitive) to cisatracurium, atracurium or benzenesulfonic acid. An allergic reaction may include rash, itching, difficulty of breathing or swelling of the face, lips, throat or tongue. You may know this from earlier experience.

Take special care with Cisatracurium injection or infusion

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.

Taking other medicines

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)

-    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.

Children

Children under the age of one month (new-born infants) should not receive Cisatracurium injection or infusion.

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.

Ask your doctor or pharmacist for advice before taking any 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 medical or healthcare professionals only:

PREPARATION GUIDE FOR

Cisatracurium 2 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.

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

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.

Dilution Instructions

Diluted to concentrations between 0.1 and 2 mg cisatracurium/ml, Cisatracurium 2 mg/ml 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.

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.

The following side effects have been reported:

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.

5. HOW TO STORE CISATRACURIUM INJECTION OR INFUSION

Keep out of the reach and sight of children.

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.

Store in a refrigerator between 2 and 8 °C.

Do not freeze.

Keep the ampoules in the outer carton in order to protect from light.

Do not use Cisatracurium injection or infusion if you notice the solution is not clear and free of particles or if the container is damaged.

For single dose use only.

Cisatracurium injection or infusion should be used immediately after opening and/or dilution. Any unused solution should be discarded.

This medicine should not be disposed of via wastewater or household waste. These measures will help to protect the environment.

6. FURTHER INFORMATION

What Cisatracurium injection or infusion contains

The active substance is cisatracurium.

1 ml of Cisatracurium injection or infusion contains 2.68 mg cisatracurium besilate, equivalent to 2 mg cisatracurium.

The other ingredients are benzenesulfonic acid 1% and water for injections.

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.

Cisatracurium injection or infusion is available in packs of: 1, 5, 10, 50 clear glass ampoule(s), each containing 2.5 ml, 5 ml or 10 ml of solution.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Fresenius Kabi Limited Cestrian Court, Eastgate Way,

Manor Park, Runcorn,

Cheshire WA7 1NT UK

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 Injektionslosung/Infusionslosung
BE	Cisatracurium Fresenius Kabi 2 mg/ml oplossing voor injectie of infusie
CZ	Cisatracurium Kabi 2 mg/ml
DK	Cisatracurium Fresenius Kabi
EE	Cisatracurium Kabi 2 mg/ml
EL	Cisatracurium/Kabi 2mg/ml, eveaipo SiaAupa
ES	Cisatracurio Kabi 2mg/ml solucion inyectable y para perfusion EFG
FI	Cisatracurium Fresenius Kabi 2 mg/ml
FR	Cisatracurium Kabi 2 mg/ml, solution injectable/pour perfusion
HU	Cisatracurium Kabi 2 mg/ml oldatos injekcio vagy infuzio
IT	Cisatracurio Kabi 2mg/ml
LV	Cisatracurium Kabi 2mg/ml skldums injekcijam vai infuzijam
LT	Cisatracurium Kabi 2 mg/ml injekcinis/infuzinis tirpalas
LU	Cisatracurium Kabi 2 mg/ml Injektionslosung/Infusionslosung
NL	Cisatracurium Fresenius Kabi 2 mg/ml oplossing voor injectie of infusie
NO	Cisatracurium Fresenius Kabi 2 mg/ml injeksjonsv^ske, opplosning
PL	Cisatracurium Kabi
PT	Besilato de Cisatracurio Kabi
UK	Cisatracurium 2 mg/ml solution for injection or infusion

This leaflet was last approved in 08/2011.

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.

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.

UJl FRESENIUS II KABI

09-06-2011,09:56 29-06-2011, 15:05 12-07-2011, 16:50 +49 6172 686 6161

PACKAGE LEAFLET: INFORMATION FOR THE USER

Cisatracurium 2 mg/ml

Solution for injection or infusion

The name of this medicine is Cisatracurium 2 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.    Before Cisatracurium injection or infusion is used

3.    How to use Cisatracurium injection or infusion

4.    Possible side effects

5.    How to store Cisatracurium injection or infusion

6.    Further 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.    BEFORE CISATRACURIUM INJECTION OR INFUSION IS USED

Cisatracurium injection or infusion must not be used if

-    you are allergic (hypersensitive) to cisatracurium, atracurium or benzenesulfonic acid. An allergic reaction may include rash, itching, difficulty of breathing or swelling of the face, lips, throat or tongue. You may know this from earlier experience.

Take special care with Cisatracurium injection or infusion

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.

Taking other medicines

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)

-    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.

Children

Children under the age of one month (new-born infants) should not receive Cisatracurium injection or infusion.

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.

Ask your doctor or pharmacist for advice before taking any 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.

The following information is intended for medical or healthcare professionals only:

PREPARATION GUIDE FOR

Cisatracurium 2 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.

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 except those mentioned in section 6.6 of the Summary of Product

Characteristics.

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.

Dilution Instructions

Diluted to concentrations between 0.1 and 2 mg cisatracurium/ml, Cisatracurium 2 mg/ml 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.

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

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.

4.    POSSIBLE SIDE EFFECTS

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

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.

The following side effects have been reported:

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.

5.    HOW TO STORE CISATRACURIUM INJECTION OR INFUSION

Keep out of the reach and sight of children.

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.

Store in a refrigerator between 2 and 8 °C.

Do not freeze.

Keep the ampoules in the outer carton in order to protect from light.

Do not use Cisatracurium injection or infusion if you notice the solution is not clear and free of particles or if the container is damaged.

For single dose use only.

Cisatracurium injection or infusion should be used immediately after opening and/or dilution. Any unused solution should be discarded.

This medicine should not be disposed of via wastewater or household waste. These measures will help to protect the environment.

The other ingredients are benzenesulfonic acid 1% and water for injections.

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.

Cisatracurium injection or infusion is available in packs of: 1,5, 10, 50 clear glass ampoule(s), each containing 2.5 ml, 5 ml or 10 ml of solution.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Fresenius Kabi Limited Cestrian Court, Eastgate Way,

Manor Park, Runcorn,

Cheshire WA7 1NT UK

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:

6. FURTHER INFORMATION

What Cisatracurium injection or infusion contains

The active substance is cisatracurium.

1 ml of Cisatracurium injection or infusion contains 2.68 mg cisatracurium

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.

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.

For single dose use only.

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.

V002 4-xxxxxxx/00