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ATRACURIUM BESILATE 10MG/ML SOLUTION FOR INJECTION

Active substance: ATRACURIUM BESILATE

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PACKAGE LEAFLET:
INFORMATION FOR THE USER
Atracurium Besilate 10 mg/ml Solution for Injection
The active substance is atracurium besilate
Read all of this leaflet carefully before you start taking this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
In this leaflet:
1. What Atracurium Besilate Solution for Injection is and what it is used for
2. Before you are given Atracurium Besilate Solution for Injection
3. How you are given Atracurium Besilate Solution for Injection
4. Possible side effects
5. How to store Atracurium Besilate Solution for Injection
6. Further information

1. WHAT ATRACURIUM BESILATE SOLUTION FOR INJECTION IS AND WHAT IT IS USED FOR
Atracurium Besilate Solution for Injection is a medicine which acts as a muscle relaxant.
Atracurium Besilate Solution for Injection is used during surgery to relax muscles and to assist with
inserting a breathing tube and with artificial breathing. It is also used to help with artificial breathing in
patients in intensive care.

2. BEFORE YOU ARE GIVEN ATRACURIUM BESILATE SOLUTION FOR INJECTION
You will not be given Atracurium Besilate Solution for Injection

• if you are allergic (hypersensitive) to atracurium besilate or any of the other ingredients of this
drug (see section 6)

Take special care with Atracurium Besilate Solution for Injection if you






are pregnant or breast-feeding (see Pregnancy and breast-feeding)
have heart or circulation problems
have problems with your lungs
have a history of allergy or asthma
suffer from myasthenia gravis, Eaton-Lambert syndrome or other neuromuscular diseases
(these may result in muscle weakness)
• have severe electrolyte disorders (unusual levels of ions such as sodium, potassium or chloride in
your blood)
• are suffering from burns
• have had allergic reactions to other muscle relaxants (e.g. curares)

Using 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.
Some medicines are known to interact with atracurium besilate, tell your doctor if you are taking any of
the following:
• antibiotics (e.g. aminoglycosides, polymyxins, spectinomycin, tetracyclines, lincomycin, clindamycin
and vancomycin)
• antiarrhythmic medicines (used to control the rhythm of the heart) (e.g. lidocaine, procainamide,
quinidine)
• diuretics (water tablets) (e.g. frusemide, thiazides, acetazolamide, mannitol)
• medicines used to control blood pressure or angina or other heart problems (e.g. propranolol,
oxprenolol, diltiazem, nicardipine, nifedipine, trimetaphan, hexamethonium and verapamil)
• antiepileptic medicines (e.g. carbamazepine, phenytoin)
• drugs used to treat rheumatism (e.g. chloroquine, d-penicillamine)
• corticosteroids administered into your vein (used in the treatment of allergic emergencies, severe
asthma and septic shock)
• inhalation anaesthetics (drugs to put you to sleep) (e.g. isoflurane, desflurane, sevoflurane and
enflurane anaesthesia, halothane)
• others you may recognise by name (e.g. dantrolene (used in anaesthesia), magnesium sulphate (used
to treat eclampsia and pre-eclampsia in pregnant women and some heart problems), ketamine (used
in anaesthesia), lithium (used to treat bipolar disorder), quinine (used to treat malaria and leg cramps)
and chlorpromazine (used to treat some psychiatric disorders and nausea)).

Pregnancy and breast-feeding
Atracurium besilate should not be used during the first three months of pregnancy. It will not be used
during the second and third trimesters unless your doctor advises that it is necessary. Atracurium besilate
can be used during a caesarean section.
Your baby would be closely monitored if you breast-feed within 24 hours of being given atracurium
besilate.
Ask your doctor for advice before taking any medicine.

Driving and using machines
Do not drive or use machines within 24 hours of being given atracurium besilate.

3. HOW YOU ARE GIVEN ATRACURIUM BESILATE SOLUTION FOR INJECTION
Atracurium besilate is used during procedures which require you to be anaesthetised (unconscious) or
heavily sedated. The amount given to you will depend upon the length of time you will be unconscious or
heavily sedated and your body weight.

The following information is intended for medical or healthcare professionals only:
Handling and preparation:
Do not use if cloudiness or precipitate is observed.
Atracurium Besilate Solution for Injection has an acid pH and therefore should not be mixed with
alkaline solutions (e.g. barbiturate solutions) in the same syringe or administered simultaneously during
intravenous infusion through the same needle.
To avoid distress to the patient, Atracurium Besilate Injection should not be administered before
unconsciousness has been induced.
Atracurium Besilate Solution for Injection may be administered as an intravenous injection or infusion.
Do not give Atracurium besilate injection intramuscularly since this may result in tissue irritation and there
are no clinical data to support this route of administration.
When a small vein is selected as the injection site, Atracurium Besilate Injection should be flushed
through the vein with physiological saline after injection.
Atracurium Besilate Injection is hypotonic and must not be applied into the infusion line of a blood
transfusion.
Where an infusion is required, atracurium besilate infusion solutions may be prepared by admixing
Atracurium Besilate Injection with an appropriate diluent (see below) to give an atracurium besilate
concentration of 0.5 mg/ml to 5 mg/ml.
Atracurium Besilate Injection diluted to 0.5 mg/ml with the following infusion solutions, and stored at 30°C
protected from light, was shown to be stable for the times stated below.

Q76108

W 07-0000
Code 000

Component Specification

Requester

Item number:

Q76108

Request number:

AS3434

Country:

United Kingdom

I have checked this artwork against the
registered text including spelling, layout, size,
colours, registration numbers and scientific
equations, the name and address and
trademarks. Also for any possible changes to
related items.
This artwork is in conformance with the
Marketing Authorisation and can now proceed
to the printing stage.

OI template:
Amalia version:
Mulgrave version:

WB028
5
n/a

Dimensions:
Container(s):
Supplier:
Stock:
Folded dimensions:
Printed both sides:
Perforated:

500 x 170 mm
Ampoule

Pharma code:
Pharma code length:
Supplier Code:

Decimal (Binary)
## mm
XX

Colours
Black:

N/A
## x ## mm
Yes
No

Previous Item Number: Q75180
Latest QP Release Date:

Signed:
Date:
Version 1
Technician:
Date:
06/Aug/13

Version 2
Technician:
Date:

08/Aug/13

Version 3
Technician:
Date:

XX
dd/mmm/yy

Version 4
Technician:
Date:

XX
dd/mmm/yy

Version 5
Technician:
Date:

XX
dd/mmm/yy

Version 6
Technician:
Date:

XX
dd/mmm/yy

Version 7
Technician:
Date:

XX
dd/mmm/yy

Version 8
Technician:
Date:

XX
dd/mmm/yy

Version 9
Technician:
Date:

XX
dd/mmm/yy

Version 10
Technician:
Date:

XX
dd/mmm/yy

An initial dose of this medicine will be given to you of approximately 0.3 – 0.6 mg/kg of body weight,
followed by a reduced dose at specific intervals. This standard dose will be given to children and adults.
The rate this medicine is administered may vary depending on your age and if you suffer from any heart
problems. You will be monitored during use with this medicine, and the dose will be adjusted if necessary.
Atracurium besilate will be given to you by an injection into a vein.
Children less than 1 month old should not have this medicine.

If you are given more Atracurium Besilate Solution for Injection than you should be given
Atracurium besilate will only be used by doctors who are appropriately skilled in its administration. As this
medicine will be given to you whilst you are in hospital it is unlikely that you will be given too little or too
much, however tell your doctor or a healthcare professional immediately if you have any concerns.
If you have any further questions on the use of this product, ask your doctor.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Atracurium Besilate Solution for Injection can cause side effects, although not
everybody gets them.

If any of the following happen, tell the doctor immediately:
• severe allergic reaction – you may get a sudden itchy rash (hives), swelling of the hands, feet, ankles,
face, lips, mouth or throat (which may cause difficulty in swallowing or breathing), and you may feel
you are going to faint
• seizures (fits)
• shock
• heart failure
• cardiac arrest
The above are rare or very rare serious side effects. You may need urgent medical attention.

If you experience any of the following tell your doctor as soon as possible:
Common side effects (may affect up to 1 in 10 people)
• rapid heart beat
• slow heart beat
• soreness at the injection site
• wheezing
• localised rash or itching of the skin
• low blood pressure (hypotension)
• high blood pressure (hypertension)
• flushing of the skin
Uncommon side effects (may affect up to 1 in 100 people)
• difficulty breathing
• generalised rash or redness of the skin
• hives
Rare side effects (may affect up to 1 in 1,000 people)
• shortness of breath
• spasm of the vocal cords
• rapid swelling under the skin (angioneurotic oedema)
• itching
Very rare side effects (may affect up to 1 in 10,000 people)
• low blood oxygen level (hypoxemia)
Not known (frequency cannot be estimated from the available data)
• prolonged therapeutic action of the medicine
• insufficient therapeutic action of the medicine
• increased mucous secretions in the lungs
• muscle weakness/tiredness or difficulty controlling your muscles
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

5. HOW TO STORE ATRACURIUM BESILATE SOLUTION FOR INJECTION
Keep out of the reach and sight of children.
Do not use Atracurium Besilate Solution for Injection after the expiry date which is stated on the ampoule
label and carton.
The ampoules should be stored in a refrigerator (2 – 8°C) but not frozen.
The ampoules should be kept in the outer carton (in order to protect from light).

6. FURTHER INFORMATION
What Atracurium Besilate Solution for Injection contains
The active substance is atracurium besilate
The other ingredients are benzenesulphonic acid and Water for Injections

What Atracurium Besilate Solution for Injection looks like and contents of the pack
This medicinal product is a solution for injection (a solution which can be given as an injection). It is a
clear, colourless or faint yellow solution. Each millilitre (ml) of solution contains 10 milligrams (mg) of
atracurium besilate.
This medicine is presented in glass containers (ampoules). The 2.5 ml and 5 ml ampoules are available
in packs of 5. Not all presentations may be marketed.

Marketing Authorisation Holder and Manufacturer
The marketing authorisation holder and manufacturer is Hospira UK Limited, Queensway, Royal
Leamington Spa, Warwickshire, CV31 3RW, UK.
This leaflet was last revised in 08/2013

Infusion Solution

Period of stability

Sodium Chloride 0.9% Intravenous Infusion

24 hours

Glucose 5% Intravenous Infusion

24 hours

Glucose 4% and Sodium Chloride 0.18%
Intravenous Infusion

24 hours

Ringer’s Injection USP

24 hours

Compound Sodium Lactate Intravenous Infusion
(Hartmann’s Solution for Injection)

4 hours

Atracurium Besilate Injection diluted to 5 mg/ml with the following infusion solutions, and stored at 30°C
protected from light in 50 ml plastic syringes, was shown to be stable for the times stated below.
Infusion Solution

Period of stability

Sodium Chloride 0.9% Intravenous Infusion

24 hours

Glucose 5% Intravenous Infusion

24 hours

Glucose 4% and Sodium Chloride 0.18%
Intravenous Infusion

24 hours

Ringer’s Injection USP

24 hours

Compound Sodium Lactate Intravenous Infusion
(Hartmann’s Solution for Injection)

8 hours

The clinician must be prepared to assist of control ventilation, and anticholinesterase agents should be
immediately available for reversal of neuromuscular blockade.
The potential for histamine release exists in susceptible patients during administration of atracurium
besilate. Caution should be exercised in patients with a history suggestive of an increased sensitivity to
the effects of histamine.
Disposal:

Q76108

W 07-0000
Code 000

Discard residue immediately after use.

Component Specification

Requester

Item number:

Q76108

Request number:

AS3434

Country:

United Kingdom

I have checked this artwork against the
registered text including spelling, layout, size,
colours, registration numbers and scientific
equations, the name and address and
trademarks. Also for any possible changes to
related items.
This artwork is in conformance with the
Marketing Authorisation and can now proceed
to the printing stage.

OI template:
Amalia version:
Mulgrave version:

WB028
5
n/a

Dimensions:
Container(s):
Supplier:
Stock:
Folded dimensions:
Printed both sides:
Perforated:

500 x 170 mm
Ampoule

Pharma code:
Pharma code length:
Supplier Code:

Decimal (Binary)
## mm
XX

Colours
Black:

N/A
## x ## mm
Yes
No

Previous Item Number: Q75180
Latest QP Release Date:

Signed:
Date:
Version 1
Technician:
Date:
06/Aug/13

Version 2
Technician:
Date:

08/Aug/13

Version 3
Technician:
Date:

XX
dd/mmm/yy

Version 4
Technician:
Date:

XX
dd/mmm/yy

Version 5
Technician:
Date:

XX
dd/mmm/yy

Version 6
Technician:
Date:

XX
dd/mmm/yy

Version 7
Technician:
Date:

XX
dd/mmm/yy

Version 8
Technician:
Date:

XX
dd/mmm/yy

Version 9
Technician:
Date:

XX
dd/mmm/yy

Version 10
Technician:
Date:

XX
dd/mmm/yy

PACKAGE LEAFLET:
INFORMATION FOR THE USER
Atracurium Besilate 10 mg/ml Solution for Injection
The active substance is atracurium besilate
Read all of this leaflet carefully before you start taking this
medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor.
• If any of the side effects gets serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor
or pharmacist.
In this leaflet:
1. What Atracurium Besilate Solution for Injection is and what it is
used for
2. Before you are given Atracurium Besilate Solution for Injection
3. How you are given Atracurium Besilate Solution for Injection
4. Possible side effects
5. How to store Atracurium Besilate Solution for Injection
6. Further information

1. WHAT ATRACURIUM BESILATE SOLUTION FOR INJECTION IS
AND WHAT IT IS USED FOR
Atracurium Besilate Solution for Injection is a medicine which acts as a
muscle relaxant.
Atracurium Besilate Solution for Injection is used during surgery to relax
muscles and to assist with inserting a breathing tube and with artificial
breathing. It is also used to help with artificial breathing in patients in
intensive care.

2. BEFORE YOU ARE GIVEN ATRACURIUM BESILATE SOLUTION
FOR INJECTION
You will not be given Atracurium Besilate Solution for Injection

• if you are allergic (hypersensitive) to atracurium besilate or any
of the other ingredients of this drug (see section 6)

Take special care with Atracurium Besilate Solution for
Injection if you







are pregnant or breast-feeding (see Pregnancy and breast-feeding)
have heart or circulation problems
have problems with your lungs
have a history of allergy or asthma
suffer from myasthenia gravis, Eaton-Lambert syndrome or
other neuromuscular diseases (these may result in muscle
weakness)
• have severe electrolyte disorders (unusual levels of ions such as
sodium, potassium or chloride in your blood)
• are suffering from burns
• have had allergic reactions to other muscle relaxants (e.g.
curares)

Using 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.
Some medicines are known to interact with atracurium besilate, tell
your doctor if you are taking any of the following:
• antibiotics (e.g. aminoglycosides, polymyxins, spectinomycin,
tetracyclines, lincomycin, clindamycin and vancomycin)
• antiarrhythmic medicines (used to control the rhythm of the heart)
(e.g. lidocaine, procainamide, quinidine)
• diuretics (water tablets) (e.g. frusemide, thiazides, acetazolamide,
mannitol)
• medicines used to control blood pressure or angina or other
heart problems (e.g. propranolol, oxprenolol, diltiazem, nicardipine,
nifedipine, trimetaphan, hexamethonium and verapamil)
• antiepileptic medicines (e.g. carbamazepine, phenytoin)
• drugs used to treat rheumatism (e.g. chloroquine, d-penicillamine)
• corticosteroids administered into your vein (used in the treatment
of allergic emergencies, severe asthma and septic shock)
• inhalation anaesthetics (drugs to put you to sleep) (e.g. isoflurane,
desflurane, sevoflurane and enflurane anaesthesia, halothane)
• others you may recognise by name (e.g. dantrolene (used in
anaesthesia), magnesium sulphate (used to treat eclampsia and
pre-eclampsia in pregnant women and some heart problems),
ketamine (used in anaesthesia), lithium (used to treat bipolar
disorder), quinine (used to treat malaria and leg cramps) and
chlorpromazine (used to treat some psychiatric disorders and
nausea)).

Pregnancy and breast-feeding
Atracurium besilate should not be used during the first three months
of pregnancy. It will not be used during the second and third trimesters
unless your doctor advises that it is necessary. Atracurium besilate can
be used during a caesarean section.
Your baby would be closely monitored if you breast-feed within
24 hours of being given atracurium besilate.
Ask your doctor for advice before taking any medicine.

Driving and using machines
Do not drive or use machines within 24 hours of being given atracurium
besilate.

3. HOW YOU ARE GIVEN ATRACURIUM BESILATE SOLUTION FOR
INJECTION
Atracurium besilate is used during procedures which require you to be
anaesthetised (unconscious) or heavily sedated. The amount given
to you will depend upon the length of time you will be unconscious or
heavily sedated and your body weight.

The following information is intended for medical or healthcare
professionals only:
Handling and preparation:
Do not use if cloudiness or precipitate is observed.
Atracurium Besilate Solution for Injection has an acid pH and therefore
should not be mixed with alkaline solutions (e.g. barbiturate solutions)
in the same syringe or administered simultaneously during intravenous
infusion through the same needle.
To avoid distress to the patient, Atracurium Besilate Injection should not be
administered before unconsciousness has been induced.
Atracurium Besilate Solution for Injection may be administered as an
intravenous injection or infusion.
Do not give Atracurium besilate injection intramuscularly since this may
result in tissue irritation and there are no clinical data to support this route
of administration.
When a small vein is selected as the injection site, Atracurium Besilate
Injection should be flushed through the vein with physiological saline after
injection.
Atracurium Besilate Injection is hypotonic and must not be applied into the
infusion line of a blood transfusion.
Where an infusion is required, atracurium besilate infusion solutions
may be prepared by admixing Atracurium Besilate Injection with an
appropriate diluent (see below) to give an atracurium besilate concentration
of 0.5 mg/ml to 5 mg/ml.
Atracurium Besilate Injection diluted to 0.5 mg/ml with the following infusion
solutions, and stored at 30°C protected from light, was shown to be stable
for the times stated below.

Q76107
4XXXXX

Component Specification

Requester

Item number:

Q76107

Request number:

AS3433

Country:

United Kingdom

I have checked this artwork against the
registered text including spelling, layout, size,
colours, registration numbers and scientific
equations, the name and address and
trademarks. Also for any possible changes to
related items.
This artwork is in conformance with the
Marketing Authorisation and can now proceed
to the printing stage.
Previous Item Number: Q75179 / 434106

OI template:
Amalia version:
Mulgrave version:
Dimensions:
Container(s):
Supplier:
Stock:

88S119
6
5
118 x 570 mm (20 panels)
vial

Primapharm 40gsm /
Teropaque Thin Medical 40gsm

Folded dimensions: 28.5 x 118 mm
Printed both sides: Yes
Perforated:
No
Pharma code:
Decimal (Binary)
Pharma code length: ## mm
Mulgrave 4 series no.: XX

Colours
Black:


Signed:
Date:
Version 1
Technician:
Date:

06/Aug/13

Version 2
Technician:
Date:

Version 3
Technician:
Date:

XX
dd/mmm/yy

Version 4
Technician:
Date:

XX
dd/mmm/yy

Version 5
Technician:
Date:

XX
dd/mmm/yy

Version 6
Technician:
Date:

XX
dd/mmm/yy

Version 7
Technician:
Date:

XX
dd/mmm/yy

Version 8
Technician:
Date:

XX
dd/mmm/yy

Version 9
Technician:
Date:

XX
dd/mmm/yy

Version 10
Technician:
Date:

XX
dd/mmm/yy

07/Aug/13

An initial dose of this medicine will be given to you of approximately
0.3 – 0.6 mg/kg of body weight, followed by a reduced dose at specific
intervals. This standard dose will be given to children and adults. The
rate this medicine is administered may vary depending on your age and
if you suffer from any heart problems. You will be monitored during use
with this medicine, and the dose will be adjusted if necessary.
Atracurium besilate will be given to you by an injection into a vein.
Children less than 1 month old should not have this medicine.

If you are given more Atracurium Besilate Solution for
Injection than you should be given
Atracurium besilate will only be used by doctors who are appropriately
skilled in its administration. As this medicine will be given to you
whilst you are in hospital it is unlikely that you will be given too little
or too much, however tell your doctor or a healthcare professional
immediately if you have any concerns.
If you have any further questions on the use of this product, ask your
doctor.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Atracurium Besilate Solution for Injection can cause
side effects, although not everybody gets them.

If any of the following happen, tell the doctor immediately:

• severe allergic reaction – you may get a sudden itchy rash (hives),
swelling of the hands, feet, ankles, face, lips, mouth or throat (which
may cause difficulty in swallowing or breathing), and you may feel
you are going to faint
• seizures (fits)
• shock
• heart failure
• cardiac arrest
The above are rare or very rare serious side effects. You may need
urgent medical attention.

If you experience any of the following tell your doctor as soon
as possible:
Common side effects (may affect up to 1 in 10 people)
• rapid heart beat
• slow heart beat
• soreness at the injection site
• wheezing
• localised rash or itching of the skin
• low blood pressure (hypotension)
• high blood pressure (hypertension)
• flushing of the skin
Uncommon side effects (may affect up to 1 in 100 people)
• difficulty breathing
• generalised rash or redness of the skin
• hives
Rare side effects (may affect up to 1 in 1,000 people)
• shortness of breath
• spasm of the vocal cords
• rapid swelling under the skin (angioneurotic oedema)
• itching
Very rare side effects (may affect up to 1 in 10,000 people)
• low blood oxygen level (hypoxemia)
Not known (frequency cannot be estimated from the available data)
• prolonged therapeutic action of the medicine
• insufficient therapeutic action of the medicine
• increased mucous secretions in the lungs
• muscle weakness/tiredness or difficulty controlling your muscles
If any of the side effects gets serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor or
pharmacist.

5. HOW TO STORE ATRACURIUM BESILATE SOLUTION FOR
INJECTION
Keep out of the reach and sight of children.
Do not use Atracurium Besilate Solution for Injection after the expiry
date which is stated on the vial label and carton.
The vials should be stored in a refrigerator (2 – 8°C) but not frozen.
The vials should be kept in the outer carton (in order to protect from
light).

6. FURTHER INFORMATION
What Atracurium Besilate Solution for Injection contains
The active substance is atracurium besilate
The other ingredients are benzenesulphonic acid and Water for
Injections

What Atracurium Besilate Solution for Injection looks like and
contents of the pack
This medicinal product is a solution for injection (a solution which can
be given as an injection). It is a clear, colourless or faint yellow solution.
Each millilitre (ml) of solution contains 10 milligrams (mg) of atracurium
besilate.
This medicine is presented in glass containers (vials). The 25 ml vial
is available in packs containing 1 vial. Not all presentations may be
marketed.

Marketing Authorisation Holder and Manufacturer
The marketing authorisation holder and manufacturer is Hospira
UK Limited, Queensway, Royal Leamington Spa, Warwickshire,
CV31 3RW, UK.
This leaflet was last revised in 08/2013

Infusion Solution

Period of stability

Sodium Chloride 0.9% Intravenous Infusion

24 hours

Glucose 5% Intravenous Infusion

24 hours

Glucose 4% and Sodium Chloride 0.18%
Intravenous Infusion

24 hours

Ringer’s Injection USP

24 hours

Compound Sodium Lactate Intravenous Infusion
(Hartmann’s Solution for Injection)

24 hours

Atracurium Besilate Injection diluted to 5 mg/ml with the following infusion
solutions, and stored at 30°C protected from light in 50 ml plastic syringes,
was shown to be stable for the times stated below.
Infusion Solution

Period of stability

Sodium Chloride 0.9% Intravenous Infusion

24 hours

Glucose 5% Intravenous Infusion

24 hours

Glucose 4% and Sodium Chloride 0.18%
Intravenous Infusion

24 hours

Ringer’s Injection USP

24 hours

Compound Sodium Lactate Intravenous Infusion
(Hartmann’s Solution for Injection)

8 hours

The clinician must be prepared to assist of control ventilation, and
anticholinesterase agents should be immediately available for reversal of
neuromuscular blockade.
The potential for histamine release exists in susceptible patients during
administration of atracurium besilate. Caution should be exercised in
patients with a history suggestive of an increased sensitivity to the effects
of histamine.
Disposal:
Discard residue immediately after use.
Q76107
4XXXXX

Component Specification

Requester

Item number:

Q76107

Request number:

AS3433

Country:

United Kingdom

I have checked this artwork against the
registered text including spelling, layout, size,
colours, registration numbers and scientific
equations, the name and address and
trademarks. Also for any possible changes to
related items.
This artwork is in conformance with the
Marketing Authorisation and can now proceed
to the printing stage.
Previous Item Number: Q75179 / 434106

OI template:
Amalia version:
Mulgrave version:
Dimensions:
Container(s):
Supplier:
Stock:

88S119
6
5
118 x 570 mm (20 panels)
vial

Primapharm 40gsm /
Teropaque Thin Medical 40gsm

Folded dimensions: 28.5 x 118 mm
Printed both sides: Yes
Perforated:
No
Pharma code:
Decimal (Binary)
Pharma code length: ## mm
Mulgrave 4 series no.: XX

Colours
Black:


Signed:
Date:
Version 1
Technician:
Date:

06/Aug/13

Version 2
Technician:
Date:

Version 3
Technician:
Date:

XX
dd/mmm/yy

Version 4
Technician:
Date:

XX
dd/mmm/yy

Version 5
Technician:
Date:

XX
dd/mmm/yy

Version 6
Technician:
Date:

XX
dd/mmm/yy

Version 7
Technician:
Date:

XX
dd/mmm/yy

Version 8
Technician:
Date:

XX
dd/mmm/yy

Version 9
Technician:
Date:

XX
dd/mmm/yy

Version 10
Technician:
Date:

XX
dd/mmm/yy

07/Aug/13

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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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