Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about DBL Rocuronium Bromide Injection
It does not contain all the available information.
It does not take the place of talking to your doctor.
All medicines have risks and benefits. Your doctor has weighed the risks of you having
DBL Rocuronium Bromide Injection against the benefits they expect it will have for
If you have any concerns about receiving this medicine, ask your doctor.
Keep this leaflet. You may need to read it again.
What DBL Rocuronium Bromide Injection is used for
Rocuronium is one of a group of medicines called muscle relaxants.
Muscle relaxants are used during an operation as part of the general anaesthetic.
When you have an operation, your muscles must be completely relaxed. This makes it
easier for the surgeon to perform the operation.
Normally the nerves send messages to the muscles by impulses. Rocuronium acts by blocking
these impulses so the muscles are relaxed.
Because the muscles needed for breathing also become relaxed you will need help with
your breathing (artificial respiration) during and after your operation until you
can breath on your own.
During the operation the effect of the muscle relaxant is constantly checked and if
necessary some more drug is given.
At the end of the operation the effects of the medicine are allowed to wear off and
you can start breathing on your own. Sometimes another drug is given to help speed
Rocuronium can also be used in intensive care to keep your muscles relaxed.
Ask your doctor if you want any more information about this medicine.
DBL™ Rocuronium Bromide Injection is not addictive.
Before you are given DBL Rocuronium Bromide Injection
When you must not be given it
You must not be given DBL Rocuronium Bromide Injection if you have an allergy to:
any medicine containing rocuronium bromide
any of the ingredients listed at the end of this leaflet
Some of the symptoms of an allergic reaction may include:
shortness of breath,
wheezing or difficulty breathing;
swelling of the face, lips, tongue or other parts of the body;
rash, itching or hives on the skin.
DBL Rocuronium Bromide Injection should not be given to a child under the age of one
The safety of administration of rocuronium has not been established in children under
the age of one month.
Before you are given it
If you are going to have an operation it is important that you discuss the following
points with your doctor, since it can influence the way this medicine is given to
Tell your doctor if you have or have had any medical conditions, especially the following:an
allergy to muscle relaxants
liver or gallbladder disease
polio, myasthenia gravis, Eaton-Lambert Syndrome or other diseases affecting nerves
oedema (local or generalised swelling due to fluid)
Certain medical conditions may affect how DBL Rocuronium Bromide Injection works.
low potassium levels in the blood
high magnesium levels in the blood
low calcium levels in the blood
low levels of protein in the blood
too much acid in the blood
too much carbon dioxide in the blood
general ill-health (unexplained weight loss, fatigue, weakness)
If you are suffering from any of these conditions your doctor will take this into
account when deciding the correct dose of rocuronium for you.
DBL Rocuronium Bromide Injection can be used in children
(1 month old to adolescence) and the elderly but your doctor should first assess your
Tell your doctor if you have allergies to any other medicines, foods, preservatives
Tell your doctor if you are pregnant or plan to become pregnant or are breast-feeding.
Your doctor will discuss the risks and benefits of using rocuronium if you are pregnant
If you have not told your doctor about any of the above, tell them before you are
given this medicine.
Taking other medicines
Tell your doctor if you are taking any other medicines, including any that you get
without a prescription from your pharmacy, supermarket or health food shop.
Some medicines may be affected by rocuronium, or affect how well it works. These include:
anaesthetics, medicines to make you sleep during surgery
corticosteroids (anti-inflammatory medicines)
lithium, a medicine used to treat bipolar disorder
medicines used to treat heart disease or high blood pressure (quinidine, calcium channel
blockers, beta-blockers and diuretics (fluid tablets))
quinine, a medicine used to treat malaria
lignocaine and bupivacaine (local anaesthetics)
other muscle relaxants
carbamazepine and phenytoin, medicines used to treat epilepsy
You may need to use different amounts of your medicines or take different medicines.
Your doctor will advise you.
Tell your doctor if you are taking magnesium sulphate to treat toxaemia of pregnancy
The dose of rocuronium may need to be reduced.
Your doctor will have a complete list of medicines that may cause problems when used
How DBL Rocuronium Bromide Injection is given
DBL Rocuronium Bromide Injection will be given by a doctor.
It will not be given to you until you are asleep from the anaesthetic.
It will be injected into a vein before and/or during an operation.
It will be given as a single injection or continuous infusion.
The usual dose is 0.6 mg rocuronium per kg body weight and the effect lasts 30-40
minutes. During the operation your doctor will check whether rocuronium is still working.
You may be given additional doses if they are needed.
If you take too much (overdose)
As DBL Rocuronium Bromide Injection doses are carefully worked out and are given by
a doctor experienced in its use, it is extremely unlikely that you will be given too
However, if this does happen, your doctor will make sure that you continue breathing
artificially until you can breathe on your own again. Your doctor may speed-up your
recovery by giving you a drug that reverses the effects of rocuronium.
In case of overdose, immediately contact the Poisons Information Centre for advice
(telephone 13 11 26 in Australia).
After having DBL Rocuronium Bromide Injection
Things to be careful of
Be careful driving or operating machinery until you know how Rocuronium affects you.
Your doctor will tell you when it is safe to drive and operate potentially dangerous
machinery after you have been given DBL Rocuronium Bromide Injection.
Children should be careful when riding bicycles or climbing trees.
Tell your doctor if you notice anything that is making you feel unwell.
All medicines can have side effects. Sometimes they are serious, most of the time
they are not. You may need medical attention if you get some of the side effects.
Do not be alarmed by the following list of side effects. You may not experience any
Ask your doctor to answer any questions you may have.
Tell your doctor if you notice the following and they worry you:
pain at injection site
irritation at injection site
red skin rash or itchy rash
Tell your doctor immediately if you notice any of the following:
dilated or enlarged pupils, or fixed pupils that do not respond to light
fast or irregular heart beat
dizziness, light-headedness (low blood pressure) high fever
muscle weakness, rigidity or paralysis
aching muscles or weakness, not caused by exercise
rapid, shallow breathing
cold, clammy skin
a rapid, weak pulse
dizziness, weakness and fainting
swelling of the face, lips, mouth, tongue or throat which may cause difficulty in
swallowing or breathing
sudden signs of allergy such as rash, itching, hives on the skin, swelling of the
face, lips, tongue or other parts of the body, shortness of breath, wheezing or difficulty
These are serious side effects. You may need urgent medical attention.
Tell your doctor or nurse if you notice anything else that is making you feel unwell.
Other side effects not listed above may also occur in some people.
Some of these side effects, for example, changes in blood pressure or pulse rate will
be monitored by your nurse from time to time to check your progress until you leave
DBL Rocuronium Bromide Injection is stored in the hospital.
It should be kept in the refrigerator at 2-8°C and not be frozen.
DBL Rocuronium Bromide Injection can be stored outside the refrigerator at temperatures
up to 30°C for a maximum of 12 weeks. Once it has been kept outside, it must not be
placed back in the refrigerator.
What it looks like
DBL Rocuronium Bromide Injection comes in a vial containing a clear, colourless to
faintly yellow solution.
DBL Rocuronium Bromide Injection contains 10 mg/mL of rocuronium bromide as the active
It also contains:
water for injections
DBL Rocuronium Bromide Injection contains no preservative.
This medicine does not contain lactose, sucrose, gluten, tartrazine or any azo dyes
Pfizer Australia Pty Ltd
Toll Free number: 1800 675 229
DBL Rocuronium Bromide Injection is available in the following strength:
50 mg/ 5 mL vials
AUST R 161275
This leaflet was updated in October 2022
© Pfizer Australia Pty Ltd 2022.