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VECURONIUM BROMIDE 10 MG POWDER FOR SOLUTION FOR INJECTION

Active substance(s): VECURONIUM BROMIDE

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Package leaflet: Information for the patient
Vecuronium bromide 10mg, powder for solution
for injection
Vecuronium bromide
Read all of this leaflet carefully before you are
given this medicine because it contains important
information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your
anaesthetist or other doctor.
- If you get any side effects, talk to your anaesthetist
or doctor. This includes any possible side effects not
listed in this leaflet. See section 4.

• over-breathing leading to too little carbon dioxide in
the blood (alkalosis)
• general ill-health
• burns
• being very overweight (obesity)
• very low body temperature (hypothermia).
If you have any of these conditions, your anaesthetist
will take this into account when deciding the correct
dose of Vecuronium bromide for you.
Other medicines and Vecuronium bromide
Tell your anaesthetist if you are taking, have recently
taken or might take any other medicines. This
includes medicines or herbal products that you have
bought without a prescription. Vecuronium bromide
may affect other medicines or be affected by them.

What is in this leaflet
1. What Vecuronium bromide is and what it is used for
2. What you need to know before Vecuronium
bromide is given to you
3. How Vecuronium bromide is given
4. Possible side effects
5. How to store Vecuronium bromide
6. Contents of the pack and other information

Medicines which increase the effect of
Vecuronium bromide:
• certain antibiotics;
• certain medicines for heart disease or high blood
pressure (water tablets, calcium channel blockers,
beta-blockers and quinidine);
• certain anti-inflammatory medicines
(corticosteroids);
• medicines for manic depressive illness (bipolar
1. What Vecuronium bromide is and what it is
disorder);
used for
• magnesium salts;
Vecuronium bromide is one of a group of drugs called • the medicine called cimetidine, used to treat
stomach ulcers, heartburn or acid reflux;
muscle relaxants.

local
anaesthetics (lidocaine);
Muscle relaxants are used during an operation as part
• medicines which cause increased volume of
of a general anaesthetic. When you have an
urine (diuretics).
operation your muscles must be completely relaxed.
This makes it easier for the surgeon to perform the
Medicines which decrease the effect of
operation.
Vecuronium bromide:
• chronic use of medicines for epilepsy (phenytoin,
Normally, your nerves send messages called
carbamazepine);
impulses to your muscles. Vecuronium bromide acts
• calcium chloride and potassium chloride.
by blocking these impulses so that your muscles
relax. Because your breathing muscles also relax, you
In addition, you may be given other medicines before
will need help to breathe (artificial ventilation) during
and after your operation until you can breathe on your or during surgery which can alter the effects of
Vecuronium bromide. These include certain
own again.
anaesthetics, other muscle relaxants, medicines such
as phenytoin and medicines which reverse the effects
During the operation your anaesthetist will keep a
of Vecuronium bromide. Vecuronium bromide may
check on the effect of the muscle relaxant, and if
make certain anaesthetics work more quickly.
necessary will give you some more. At the end of
surgery, the effects of the drug are allowed to wear off Your anaesthetist will take this into account when
deciding the correct dose of Vecuronium bromide for
and you will start breathing on your own. Sometimes
you.
the anaesthetist will give you another drug to help
speed this up.
Pregnancy and breast-feeding
Tell your anaesthetist if you are pregnant or breast2. What you need to know before Vecuronium
feeding, think you may be pregnant or are planning to
bromide is given to you
have a baby.
Your anaesthetist may still give you Vecuronium
You should not be given Vecuronium bromide:
bromide, but you need to discuss it first. Vecuronium
• if you are allergic (hypersensitive) to vecuronium,
bromide may be given to you if you are having a
the bromide ion or any of the other ingredients of
Caesarean section.
this medicine (listed in section 6).
Tell your anaesthetist if this applies to you.
Driving and using machines
Do not drive or use machines until advised it is safe to
Warnings and precautions
do so. Because Vecuronium bromide is given as part
Talk to your anaesthetist before you receive
of a general anaesthetic, you may feel tired, weak or
Vecuronium bromide:
dizzy for some time afterwards. Your anaesthetist will
• if you are allergic to muscle relaxants
be able to advise you on how long the effects are
• if you have had kidney, heart, liver or gall bladder
likely to last.
disease

• if you have had diseases affecting nerves and
muscles
• if you have fluid retention (oedema).
Tell your anaesthetist if any of these applies to you.

Some conditions may influence the effects of
Vecuronium bromide, for example:
• low calcium levels in the blood
• low potassium levels in the blood
• high magnesium levels in the blood
• low levels of protein in the blood
• too much acid in the blood
• too much carbon dioxide in the blood
• loss of too much water from the body, for example
by being sick, diarrhoea or sweating (dehydration)

3. How Vecuronium bromide is given
Vecuronium bromide will be given to you by your
anaesthetist. Vecuronium bromide is given
intravenously (into a vein), either as single injections
or as a continuous infusion (a drip).
The dose
Vecuronium bromide can be used in adults and
children of all ages including infants and newborns.
Your anaesthetist will work out the dose of
Vecuronium bromide you need based on:
• the type of anaesthetic
• the expected length of the operation
• other drugs you are taking

• your state of health
• your age.
The normal dose is 80 – 100 micrograms per kg body
weight and the effect will last 24 – 60 minutes. During
the procedure it will be checked whether Vecuronium
bromide is still working. You may be given additional
doses if they are needed.

Manufacturer: DEMO SA Pharmaceutical Industry,
21st km National Road Athens – Lamia,
14568 Krioneri, Attiki, Greece,
Tel: +30 210 8161802, Fax: +30 210 8161587.

This medicinal product is authorised in the
Member States of the EEA under the following
names:
Vecuronium bromide 10 mg
If you receive more Vecuronium bromide than you United
Kingdom:
Powder for solution for injection
should
Vecuronium BRADEX 10 mg
As your anaesthetist will be monitoring your condition Germany:
Pulver zur Herstellung einer
carefully it is unlikely that you will be given too much
Injektionslösung
Vecuronium bromide. However if this happens, your
Portugal:
Brometo de Vecurónio Bradex
anaesthetist will keep you breathing artificially (on a
10 mg Pó para solução injectável
ventilator) until you can breathe on your own. It is
possible to counteract the effects of (too much)
This leaflet was last revised in 01/2016.
vecuronium bromide and speed-up your recovery by
giving you a drug that reverses the effect of
---------------------------------------------------------vecuronium bromide. You will be kept asleep while
this takes place.
The following information is intended for
If you have any further questions on the use of this
healthcare professionals only:
medicine, ask your anaesthetist or other doctor.
Preparation and handling
Reconstitution:
Vecuronium bromide 10 mg
Like all medicines, this medicine can cause side
Addition of 5ml water for injections results in an
effects, although not everybody gets them. If these
isotonic solution of pH 4 containing 2 mg vecuronium
side effects occur while you are under anaesthetic,
bromide per ml. (2 mg/ml).
they will be seen and treated by your anaesthetist.
Alternatively, in order to obtain a solution with a lower
concentration Vecuronium bromide 10 mg may be
Uncommon (may affect up to 1 in 100 people)
• the medicine is too effective, or not effective enough reconstituted with a volume up to 10 ml of the
following infusion fluids:
• the medicine works for longer than expected

5% glucose injection fluid
• lowering of blood pressure

0.9%
sodium chloride injection fluid
• increase in heart rate.
• Lactated Ringer's solution
• Lactated Ringer's injection and 5% glucose
Very rare (may affect up to 1 in 10,000 people)
• Glucose 5% and 0.9% sodium chloride injection
• allergic (hypersensitivity) reactions (such as
difficulty in breathing, collapse of the circulation and • Water for injections.
shock)
Chemical and physical in-use (i.e. following
• wheezing of the chest
reconstitution) stability has been demonstrated for 24
• muscle weakness
hours at 25°C.
• swelling, a rash or redness of the skin
From a microbiological point of view, unless the
• pain near the site of injection.
method of reconstitution precludes the risk of
microbial contamination, the product should be used
Reporting of side effects
immediately. If not used immediately, in-use storage
If you get any side effects, talk to your doctor or
times and conditions prior to use are the responsibility
anaesthetist. This includes any possible side effects
of
the user.
not listed in this leaflet. You can also report side
effects directly via Yellow Card Scheme, Website:
Compatibilities
(www.mhra.gov.uk/yellowcard). By reporting side
When Vecuronium bromide is reconstituted with water
effects you can help provide more information on the
for injections, the resultant solution can be mixed with
safety of this medicine.
the following infusion fluids, packed in PVC or glass,
to a dilution up to 40 mg/litre:
5. How to store Vecuronium bromide
• 0.9% NaCl solution
The hospital will keep Vecuronium bromide according • 5% glucose solution
• Ringer's solution
to the correct storage conditions.
• Ringer's glucose.
The above-mentioned reconstituted solution can also
6. Contents of the pack and other information
be injected in to the line of a running infusion of the
following fluids:
What Vecuronium bromide contains
- The active substance is vecuronium bromide. Each • Lactated Ringer's solution
vial contains 10 mg of vecuronium bromide. It is
• Lactated Ringer's solution and 5% glucose
dissolved before use to make a solution.
• Glucose 5% and 0.9% sodium chloride solution
- The other ingredients are citric acid monohydrate,
• Haemaccel
disodium phosphate dihydrate, mannitol, sodium
• Dextran-40 5% in 0.9% sodium chloride solution
hydroxide, and phosphoric acid.
• Water for injections.
Compatibility studies with other infusion fluids have
What Vecuronium bromide looks like and
not been performed.
contents of the pack
Vecuronium bromide is a white powder for solution for If this leaflet is difficult to see or read
injection.
please contact the following address for
There are 1, 10, 20, 20 (2x10) and 100 vials of
help:
Vecuronium bromide per pack.
4. Possible side effects

Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation Holder: BRADEX S.A.,
Pharmaceutical Products, 27 Asklipiou str., GR-14568
Krioneri, Attiki, Greece,
Tel.: +30 2106221801, +30 2106220323,
Fax: +30 2106221802.

Athlone Laboratories, Ballymurray, Co.
Roscommon, Ireland.
Tel: +353-9066-61109. Email:
medical@athlone-laboratories.com.

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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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