ATRACURIUM 10MG/ML SOLUTION FOR INJECTION OR INFUSION

Active substance: ATRACURIUM BESILATE

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Product + Component:

Atracurium Hikma

Identifier:
Country:

United Kingdom / Ireland

Dimensions:

160 x 290 mm

Scale:

1:1

Circular for Corrections:

04

Date:

06.06.2014

Colours:

Black

Front/Reverse:

Front

Fonts:

Frutiger

Front
175 mm
1 mm 9 mm 1 mm

PACKAGE LEAFLET: INFORMATION FOR THE USER

Atracurium 10 mg/ml Solution for injection or infusion
Atracurium besilate
Read all of this leaflet carefully before you start receiving
Atracurium.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet.
See section 4.
In this leaflet
1. What Atracurium is and what it is used for
2. What you need to know before you take Atracurium
3. How to take Atracurium
4. Possible side effects
5. How to store Atracurium
6. Contents of the pack and other information

1. WHAT ATRACURIUM IS AND WHAT IT IS USED FOR
The active substance in Atracurium is atracurium besilate. This belongs to
a group of medicines called muscle relaxants.
Atracurium is used:
• to relax muscles during operations on 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. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
ATRACURIUM
Do not take Atracurium if:
• you are allergic to atracurium besilate, any other muscle relaxant or
any of the other ingredients in Atracurium (listed in Section 6)
• you have reacted badly to an anaesthetic before.

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Do not take Atracurium if any of the above applies to you.
If you are not sure, talk to your doctor, nurse or pharmacist before you
have Atracurium.

Warnings and precautions
Talk to your doctor or pharmacist before receiving Atracurium.
• 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
• you have a history of sensitivity to histamine. In particular, spasm of
the airways may occur if you have a history of allergy or asthma

Children and adolescents
The dosage in children over the age of one month is similar to that in
adults on a bodyweight basis.
The use of Atracurium is not recommended in neonates since there are
insufficient data available.

Other medicines and Atracurium
Tell your doctor, nurse or pharmacist if you are receiving or have recently
taken any other medicines. This includes medicines obtained without a
prescription, including herbal medicines.
This is because these medicines can affect how well Atracurium works or
can cause side effects.
In particular tell your doctor, nurse or pharmacist if you are receiving any
of the following:
• anaesthetics (used to reduce sensation and pain during surgical
procedures)
• antibiotics (used to treat infections)
• medicines for heart conditions
• medicines for high blood pressure
• water tablets (diuretics), such as furosemide
• medicines for fits (epilepsy), such as phenytoin or carbamazepine
• medicines containing magnesium, such as those to treat indigestion
and heart burn
• drugs for Alzheimer’s disease (anticholinesterases e.g. donepezil)
• medicines for mental illness, such as lithium
• medicines for inflammation of the joints, such as chloroquine or
D-penicillamine
• steroids

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 receiving this
medicine.
Atracurium should only be administered during pregnancy after careful
risk-benefit assessment.
Atracurium can be used during a caesarean section.
As precaution restart breast feeding 24 hours after administration of
Atracurium.

Driving and using machines
Do not drive or use machines in exposed situations after anesthesia.

3. HOW TO TAKE ATRACURIUM
How Atracurium is given
Atracurium will be administered to you by a healthcare professional.
Atracurium 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.

----------------------------------------------------------------------------------------------------------------------------------------------------------------------------The following information is intended for healthcare professionals only:

Atracurium 10 mg/ml
Solution for injection or infusion
Atracurium besilate

Therapeutic indications
Atracurium is a highly selective, competitive or non-depolarising
neuromuscular blocking agent. It is used as an adjunct to general
anaesthesia or sedation in the intensive care unit (ICU), to relax skeletal
muscles, and to facilitate tracheal intubation and mechanical ventilation.

Posology and method of administration

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Administration by injection in adults
Route of administration: Intravenous injection or continuous infusion.
The dosage range recommended for adults is 0.3 to 0.6 mg/kg
(depending on the duration of full block required) and will provide
adequate relaxation for about 15 to 35 minutes.
Endotracheal intubation can usually be accomplished within 90 seconds
from the intravenous injection of 0.5 to 0.6 mg/kg.
Full block can be prolonged with supplementary doses of 0.1 to
0.2 mg/‌ g as required. Successive supplementary dosing does not give
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rise to accumulation of neuromuscular blocking effect.
Spontaneous recovery from the end of full block occurs in about
35 minutes as measured by the restoration of the tetanic response to
95% of normal neuromuscular function.

The neuromuscular block produced by Atracurium can be rapidly reversed
by standard doses of anticholinesterase agents, such as neostigmine and
edrophonium, accompanied or preceded by atropine, with no evidence of
recurarisation.
Administration by infusion in adults
After an initial bolus dose of 0.3 to 0.6 mg/kg, Atracurium can be used
to maintain neuromuscular block during long surgical procedures by
administration as a continuous infusion at rates of 0.3 to 0.6 mg/‌ g/‌ our.
k h
Atracurium can be administered by infusion during cardiopulmonary
bypass surgery at the recommended infusion rates. Induced hypothermia
to a body temperature of 25° to 26°C reduces the rate of inactivation
of atracurium, therefore full neuromuscular block may be maintained by
approximately half the original infusion rate at these low temperatures.
Children
The dosage in children over the age of one month is similar to that in
adults on a bodyweight basis.
Neonates
The use of Atracurium is not recommended in neonates since there are
insufficient data available (see section 5.1).
Elderly
Atracurium may be used at standard dosage in elderly patients. It is
recommended, however, that the initial dose be at the lower end of the
range and that it be administered slowly.

Product + Component:

Atracurium Hikma

Identifier:
Country:

United Kingdom / Ireland

Dimensions:

160 x 290 mm

Scale:

1:1

Circular for Corrections:

04

Date:

06.06.2014

Colours:

Black

Front/Reverse:

Reverse

Fonts:

Frutiger

Reverse
175 mm
1 mm 9 mm 1 mm

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 Atracurium than you should
Atracurium 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.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Atracurium can cause side effects, although not
everybody gets them.
The following effects may happen with this medicine:

Allergic reactions
If you have an allergic reaction, tell your doctor or nurse straight away.
The signs may include:
Common side effects (affects less than 1 person in 10)
• decrease in blood pressure
• rash or redness of your skin
Uncommon side effects (affects less than 1 person in 100)
• wheezing or coughing
Rare side effects (affects less than 1 person in 1000)
• a lumpy skin rash or ‘hives’ anywhere on your body
Very Rare side effects (affects less than 1 person in 10,000)
• sudden wheeziness, chest pain or chest tightness
• decrease in heart rate
• shock, circulatory failure, cardiac arrest
• swelling of your eyelids, face, lips, mouth or tongue
Very rarely a severe allergic reaction can occur when given one or more
anaesthetic agent.
Other side effects (unknown frequency) that you may experience are:
• seizures
• muscle weakness
If any of the side effects gets serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor, nurse or pharmacist.
If you get any side effects, talk to your doctor, this includes any possible
side effects not listed in this leaflet you can also report side effects
directly for the following contacts. By reporting side effects you can help
provide more information on the safety of this medicine.
IMB Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.imb.ie
e-mail: imbpharmacovigilance@imb.ie

5. HOW TO STORE ATRACURIUM

Do not use Atracurium after the expiry date which is stated on the label
and carton, after EXP. The expiry date refers to the last day of that month.
Keep out of the sight and reach of children.
Store in a refrigerator 2 and 8°C.
Do not freeze.
Keep the container in the outer carton in order to protect from the light.
Do not use this medicine if you notice an unclear solution and
extraneous particles or if the container is damaged.
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. FURTHER INFORMATION
What Atracurium contains
- The active substance of Atracurium is atracurium besilate.
- The other ingredients for Atracurium are: benzenesulfonic acid,
water for injections
1 ml solution contains 10 mg of atracurium besilate.
Each 2.5 ml ampoule contains 25 mg of Atracurium Besilate.
Each 5 ml ampoule contains 50 mg of Atracurium Besilate.

What Atracurium looks like and contents of the pack
This medicine is clear and colourless solution.
This medicine is supplied in transparent 3 or 5 ml glass ampoule, type I.
Each ampoule contains 10 mg/ml of the active ingredient atracurium
besilate.
Atracurium is packed in carton boxes. Each box can contain 5 or 10
ampoules.

Marketing Authorisation Holder and Manufacturer
Hikma Farmacêutica (Portugal), S.A.
Estrada do Rio da Mó 8, 8A e 8B – Fervença
2705-906 Terrugem SNT, Portugal
Tel.: +351 219608410
Fax: +351 219615102
e-mail: geral@hikma.pt
This medicinal product is authorised in the Member States of EEA under
the following names:
France:
Atracurium Hikma 10 mg/ml Solution injectable/ pour

perfusion
Ireland:
Atracurium 10 mg/ml Solution for injection or

infusion
Portugal:
Besilato de Atracúrio Hikma
Spain:
Atracurium Hikma 10 mg/ml Solución inyectable y

para perfusión
United Kingdom: Atracurium 10 mg/ml Solution for injection or

infusion
This leaflet was last approved in 06/2014.

----------------------------------------------------------------------------------------------------------------------------------------------------------------------------Reduced renal and/or hepatic function
Atracurium may be used at standard dosage at all levels of renal or
hepatic function, including end stage failure.

Shelf life

Cardiovascular disease
In patients with clinically significant cardiovascular disease, the initial
dose of Atracurium should be administered over a period of 60 seconds.

The solution has to be used immediately after opening the container.

Intensive care unit (ICU)
After an optional initial bolus dose of Atracurium of 0.3 to 0.6 mg/‌ g,
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Atracurium can be used to maintain neuromuscular block by
administering a continuous infusion at rates of between 11 and
13 micrograms/kg/‌ in (0.65 to 0.78 mg/kg/hr). There may be wide
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inter-patient variability in dosage requirements and these may increase
or decrease with time. Infusion rates as low as 4.5 microgram/kg/min
(0.27 mg/kg/hr) or as high as 29.5 microgram/kg/min (1.77 mg/kg/hr)
are required in some patients.

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United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard

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

Spontaneous recovery to a train-of-four ratio >0.75 (the ratio of the
height of the fourth to the first twitch in a train-of-four) can be expected
to occur in approximately 60 minutes. A range of 32 to 108 minutes has
been observed in clinical trials.

Monitoring
In common with all neuromuscular blocking agents, monitoring
of neuromuscular function is recommended during the use of
Atracurium in order to individualise dosage requirements.

Special precautions for storage
Store between 2 and 8°C. Do not freeze.

Special precautions for disposal and other handling
Atracurium is compatible with the following infusion solutions for the
times stated below:
Infusion Solution Stability
Sodium Chloride Intravenous Infusion BP (0.9% w/v)
Glucose Intravenous Infusion BP (5% w/v)
Ringer’s Injection USP
Sodium Chloride (0.18% w/v) and Glucose (4% w/v)
Intravenous Infusion BP
Compound Sodium Lactate Intravenous Infusion BP
(Hartmann’s Solution for Injection)

Period of
24 hours
8 hours
8 hours
8 hours
4 hours

When diluted in these solutions to give Atracurium concentrations of
0.5 mg/ml and above, the resultant solutions will be stable in daylight for
the stated periods at temperatures of up to 30°C.

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The rate of spontaneous recovery from neuromuscular block after
infusion of Atracurium in ICU patients is independent of the duration of
administration.

Shelf life before first opening
18 months

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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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