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CISATRACURIUM 2 MG/ML SOLUTION FOR INJECTION OR INFUSION

Active substance(s): CISATRACURIUM BESILATE

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PIL 4-xxxxxxx/00 GB
Cisatracurium

• black

3 Corr
4 Corr
Holger Clas

29-06-2011, 14:22
12-07-2011, 16:54
+49 6172 686 6161

Size
Spezifikation
Code
Smallest Font Size

2D-Matrix

90x568 mm
xxxx
xxxx
7 pt.
xxxx

PACKAGE LEAFLET: INFORMATION FOR THE USER

Cisatracurium 2 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 or pharmacist.
- This medicine has been prescribed for you. Do not pass it on to others. It may
harm them, even if their symptoms are the same as yours.
- If any of the side effects becomes serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.

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 Injektionslösung/Infusionslösung

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, ενέσιμο διάλυμα

ES

Cisatracurio Kabi 2mg/ml solución inyectable y para perfusión 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 injekció vagy infúzió

IT

Cisatracurio Kabi 2mg/ml

LV

Cisatracurium Kabi 2mg/ml šķīdums injekcijām vai infūzijām

LT

Cisatracurium Kabi 2 mg/ml injekcinis/infuzinis tirpalas

LU

Cisatracurium Kabi 2 mg/ml Injektionslösung/Infusionslösung

NL

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

NO

Cisatracurium Fresenius Kabi 2 mg/ml injeksjonsvæske, oppløsning

PL

Cisatracurium Kabi

PT

Besilato de Cisatracúrio Kabi

UK

Cisatracurium 2 mg/ml solution for injection or infusion

This leaflet was last approved in 08/2011.

V002

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.

V002 4-xxxxxxx/00

PIL 4-xxxxxxx/00 GB
Cisatracurium

• black

2 Corr
3 Corr
4 Corr
Holger Clas

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
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 or pharmacist.
- This medicine has been prescribed for you. Do not pass it on to others. It may
harm them, even if their symptoms are the same as yours.
- If any of the side effects becomes serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.

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

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

Size
Spezifikation
Code
Smallest Font Size

2D-Matrix

180x340 mm
xxxx
xxxx
8 pt.
xxxx

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.

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.

Cisatracurium 2 mg/ml solution for injection or infusion
It is not compatible with ketorolac, trometamol or propofol injectable
emulsion.
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.

Dilution Instructions

Incompatibilities

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.

This medicinal product must not be mixed with other medicinal products
except those mentioned in section 6.6 of the Summary of Product

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.

besilate, equivalent to 2 mg cisatracurium.

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.

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.

If you have any further questions on the use of this product, ask your doctor
or pharmacist.

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

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.
4. POSSIBLE SIDE EFFECTS
Not all pack sizes may be marketed.
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)

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 Injektionslösung/Infusionslösung

Very rare (affects less than 1 user in 10,000)
- muscles weakness or failure

BE

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

CZ

Cisatracurium Kabi 2 mg/ml

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.

DK

Cisatracurium Fresenius Kabi

EE

Cisatracurium Kabi 2 mg/ml

EL

Cisatracurium/Kabi 2mg/ml, ενέσιμο διάλυμα

ES

Cisatracurio Kabi 2mg/ml solución inyectable y para perfusión 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 injekció vagy infúzió

IT

Cisatracurio Kabi 2mg/ml

LV

Cisatracurium Kabi 2mg/ml šķīdums injekcijām vai infūzijām

LT

Cisatracurium Kabi 2 mg/ml injekcinis/infuzinis tirpalas

LU

Cisatracurium Kabi 2 mg/ml Injektionslösung/Infusionslösung

NL

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

NO

Cisatracurium Fresenius Kabi 2 mg/ml injeksjonsvæske, oppløsning

PL

Cisatracurium Kabi

PT

Besilato de Cisatracúrio Kabi

UK

Cisatracurium 2 mg/ml solution for injection or infusion

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 leaflet was last approved in 08/2011.

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

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

V002

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.

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.
V002 4-xxxxxxx/00

Expand view ⇕

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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