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ROCURONIUM BROMIDE 10 MG/ML SOLUTION FOR INJECTION / INFUSION

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Package leaflet: Information for the user
Rocuronium bromide Mylan 10 mg/ml solution for injection/infusion
Rocuronium Bromide

Read all of this leaflet carefully before you start using 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 doctor, pharmacist or nurse.
- If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any
possible side effects not listed in this leaflet.
What is in this leaflet:
1.
What Rocuronium bromide Mylan is and what it is used for
2.
What you need to know before you use Rocuronium bromide Mylan
3.
How to use Rocuronium bromide Mylan
4.
Possible side effects
5.
How to store Rocuronium bromide Mylan
6.
Contents of the pack and other information

1.

What Rocuronium bromide Mylan is and what it is used for

Rocuronium bromide Mylan belongs to a group of medicines called muscle relaxants.
Normally the nerves send messages to the muscles by impulses. Rocuronium bromide Mylan
acts by blocking these impulses so that the muscles become relaxed.
When you have an operation your muscles must be completely relaxed. This makes it easier
for the surgeon to perform the operation.
Rocuronium bromide Mylan may also be used if you are having anaesthesia to ease the
insertion of a tube into your trachea (windpipe) for artificial ventilation (mechanical assistance
of breathing).
Your doctor may also use this medicine as an adjunct in the intensive care unit (ICU) (e.g. to
ease the insertion of a tube into your windpipe).
Children and adolescents
This medicine may be given to paediatric patients aged 0 to <18 years (term neonates to
adolescents), as an adjunct to general anaesthesia to ease the insertion of a tube into the trachea
(windpipe) of your child for artificial ventilation (mechanical assistance of breathing) and to
relax the muscles.

2.

What you need to know before you use Rocuronium bromide Mylan

Do not use Rocuronium bromide Mylan:
-

if you are allergic to rocuronium bromide, the bromide ion or any of the other
ingredients of this medicine (listed in section 6).

Warning and precautions
Talk to your doctor, pharmacist or nurse before using Rocuronium bromide Mylan:
- if you are allergic to any muscle relaxant
- if you have a kidney, a liver or a biliary disease
- if you have a heart disease or a disease affecting your blood circulation
- if you have oedema (an accumulation of fluid beneath the skin, e.g. in the ankle area)
- if you have a disease affecting the nerves and muscles (neuromuscular diseases, e.g. polio
(poliomyelitis), myasthenia gravis, Eaton-Lambert syndrome)
- if you ever developed a drop in body temperature during anaesthesia (hypothermia)
- if you ever developed a severe fever (malignant hyperthermia) during anaesthesia
- if you have a fever
- if you have a low calcium level in the blood (hypocalcaemia), caused for example by massive
transfusions
- if you have a low potassium level in the blood (hypokalaemia), caused for example by severe
vomiting, diarrhoea or diuretic therapy
- if you have a high magnesium level in the blood (hypermagnesaemia)
- if you have a low level of proteins in the blood (hypoproteinaemia)
- if you suffer from dehydration (the loss of water and fluids essential for normal body
function)
- if you have an increased amount of acids in the blood (acidosis)
- if you have an increased amount of carbon dioxide in the blood (hypercapnia)
- if you tend to overbreathe (hyperventilation). Overbreathing leads to too little carbon dioxide
in the blood (alkalosis).
- if you suffer from excessive loss of weight (cachexia)
- if you are overweight or elderly
- if you have burns
Other medicines and Rocuronium bromide Mylan
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines, such as:
- antibiotics
- anti-depressants: medicines used to treat depression (e.g. MAO inhibitors)
- medicines used for the treatment of heart diseases or high blood pressure (e.g. quinidine,
calcium channel blocking agents, adrenergic blocking agents (e.g. beta blockers)
- diuretics or water pills (medicines which increase the amount of urine),
- some laxatives such as magnesium salts
- quinine (used to treat pain and infections)
- medicines used for epilepsy treatment (e.g. phenytoine, carbamazepine)
- corticosteriods

- medicines used for the treatment of myastenia gravis (neostigmine, pyridostigmin),
- vitamin B1 (thiamine)
- azathioprin (used for transplant rejection prevention and treatment of auto-immune diseases)
- theophylline (used for the treatment of asthma)
- noradrenaline (a hormone which impacts blood pressure and other body functions)
- potassium chloride
- calcium chloride
- medicines used for the treatment or prevention of a virus infection (protease inhibitors)
Please note:
You may be given other medicines during the procedure which can influence the effects of
Rocuronium bromide Mylan. These include certain anaesthetics (e.g. local anaesthetics,
inhalation anaesthetics), other muscle relaxants, protamines which reverse the anticoagulant
effect (prevention of blood clots) of heparin. Your doctor will take this into account when he
is deciding the correct dose of this medicine for you.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a
baby, ask your doctor or pharmacist for advice before using this medicine.
There are very limited data on the use of Rocuronium bromide Mylan during human pregnancy
and no data on breast-feeding women. Rocuronium bromide Mylan should only be given to
pregnant and nursing women when the doctor decides that the benefits outweigh the risks.
This medicine may be given during Caesarian section.
There are no data available on the influence of this medicine on your fertility.
Driving and using machines
Rocuronium bromide Mylan has a major influence on driving and using machines.
Therefore, it is not recommended to drive a car or use potentially dangerous machines during
the first 24 hours.
Your doctor should advise you when you can start driving and using machines again. You
should always be accompanied home by a responsible adult after your treatment.
Rocuronium bromide Mylan contains sodium
This medicinal product contains less than 1 mmol sodium (23mg) per dose, i.e. essentially
‘sodium free’.
3.

How to use Rocuronium bromide Mylan

Rocuronium will be given to you by your anaesthetist. It is given to you intravenously either
as a single injection or as a continous infusion (over a longer period of time) into a vein. The
usual dose is 0.6 mg per kg body weight and its effect will last 30 to 40 minutes. During the
surgery the effect of Rocuronium bromide Mylan is controlled continuously.
If necessary, additional doses could be administered to you. The dose is adjusted to your needs
by your anaesthetist. It depends on many factors, such as medicine interactions (their cross
activity), taking into consideration the estimated length of surgery as well as your age and
clinical condition.

Use in children and adolescents
This medicine may be given to neonates (0 - 28 days), infants (28 days to ≤ 3 months) and
toddlers (> 3 months to ≤ 2), children (2-11 years) and adolescents (12 to ≤ 17 years).
The anesthetist will adjust the dose according to the needs of your child. Your doctor will take
into account that for children higher infusion rates might be necessary.
The experience with rocuronium bromide in a special type of anaestetic technique called ‘rapid
sequence induction’ is limited in paediatric patients. Therefore, this medicine is not
recommended for this purpose in paediatric patients.
If you are given more Rocuronium bromide Mylan than you should
As your anaesthetist will be monitoring your conditions during the procedure it is unlikely that
you will be given too much Rocuronium bromide Mylan. However, if this happens and your
lungs are not working, your anaesthetist will make sure that you continue breathing artificially
until you can breathe on your own. You may need to be kept asleep while recovery takes place
however this is not unusual.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or
nurse.
4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Hypersensitivity reactions (allergic reactions) are rare, ie. they may affect up to 1 in 1,000
people but may be life-threatening. A hypersensitivity reaction may include rash, itching,
difficulty in breathing or swelling of the face, lips, throat or tongue.
Please inform your doctor or nurse immediately if one or more of these reactions occur.
Other possible side effects include:
Very common (may affect more than 1 in 10 people):
Pain at the injection site
Very rare (may affect up to 1 in 10,000 people):
Increased level of histamine in the blood
Increase in heart rate (tachycardia)*
Wheezing (bronchospasm)
Itching or rash
Wide spread, severe rash (exanthema)
Prolonged effect of muscle relaxation (prolonged neuromuscular block)
Lowering of blood pressure (hypotension)
Welts (angioedema)
Hives (urticaria)
Loss of movement (paralysis)
Failure of circulation (circulatory collapse and shock)
Anaphylactic reaction/shock (a life-threatening allergic reaction)
* Clinical studies suggest that in paediatric patients an increase in heart rate is common and
may affect up to 1 in 10 people.
Not known (frequency cannot be estimated from the available data):

-

Breathing (respiratory) failure
Stop breathing (apnoea)
Muscle weakness

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible
side effects not listed in this leaflet.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. You can also report side effects directly via the Yellow
Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects, you can help provide
more information on the safety of this medicine.

5.

How to store Rocuronium Bromide Mylan

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the vial, after ‘EXP.’. The
expiry date refers to the last day of that month.
Before opening: Store in a refrigerator (2–8°C).
Storage out of the refrigerator:
This medicine may also be stored outside of the refrigerator at a temperature of up to 30°C for
a maximum 12 weeks, after which it should be discarded. The product should not be placed
back into the refrigerator, once it has been kept outside. The storage period must not exceed
the shelf-life.
After dilution: Chemical and physical in-use stability has been demonstrated for 72 hours
at 30°C. From a microbiological point of view, the diluted product should be used
immediately. If not used immediately, in-use storage times and conditions prior to use are
the responsibility of the user/administrator and would normally not be longer than 24 hours
at 2 to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.
For single use only.
Do not use Rocuronium bromide Mylan if you notice any particles or visible signs of
deterioration.
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.

Contents of the pack and other information

What Rocuronium bromide Mylan contains
- The active ingredient is rocuronium bromide.
Each ml of solution for injection/infusion contains 10 mg of rocuronium bromide.
Each 5 ml vial contains 50 mg rocuronium bromide.
- The other ingredients are sodium acetate trihydrate, acetic acid (glacial), sodium

chloride, sodium hydroxide and water for injections.

What Rocuronium bromide Mylan looks like and contents of the pack
Rocuronium bromide Mylan is a clear colorless to yellow or orange solution. The solution is
supplied in tubular glass vials with a rubber closure and yellow flip off aluminium seal.
Rocuronium bromide Mylan is available in packs of 10 vials containing 5ml solution.
Marketing Authorisation Holder and Manufacturer
Mylan,
Potters Bar,
Hertfordshire, EN6 1TL,
United Kingdom
Manufacturer
Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park, Paola, PLA 3000
Malta.
This leaflet was last revised in 10/2014
This leaflet was last revised 02/2017
<-------------------------------------------------------------------------------------------------------------->
The following information is intended for medicinal or healthcare professionals only:
PREPARATION GUIDE FOR USE WITH
Rocuronium bromide Mylan 10 mg/ml Solution for injection/infusion
Rocuronium bromide Mylan is administered intravenously (i.v.) either as a bolus injection or
as a continuous infusion. Administration should be begun immediately after mixing, and should
be completed within 24 hours.
Rocuronium bromide Mylan should be administered only by experienced staff familiar with
the use of neuromuscular blocking agents. Adequate facilities and staff for endotracheal
intubation and artificial ventilation have to be available for immediate use.
Incompatibilities
Physical incompatibility has been documented for Rocuronium bromide Mylan when added
to solutions containing the following active substance:
Amphotericin, amoxicillin, azathioprine, cefazolin, cloxacillin, dexamethasone, diazepam,
enoximone, erythromycin, famotidine, furosemide, hydrocortisone sodium succinate, insulin,
intralipid, methohexital, methylprednisolone, prednisolone sodium succinate, thiopental,
trimethoprim and vancomycin.
This medicinal product must not be mixed with other medicinal products except those
mentioned in the following sections.
Mixture with other products:

Rocuronium bromide Mylan has been shown to be compatible with: sodium chloride 9 mg/ml
(0.9%), glucose 50 mg/ml (5%), glucose 50 mg/ml (5%) in sodium chloride 9 mg/ml (0.9%),
water for injections, Lactated Ringers solution and Haemaccel for in-use concentrations of 0.5
mg/ml and 2 mg/ml.
If Rocuronium bromide Mylan is administered via the same infusion line with other medicinal
products, it is important that the infusion line is adequately flushed (e.g. with sodium chloride
9 mg/ml (0.9 %) solution for infusion) between administration of Rocuronium bromide Mylan
and medicinal products for which incompatibility with Rocuronium bromide Mylan has been
demonstrated or for which compatibility with Rocuronium bromide Mylan has not been
established.
Shelf-life
Unopened vial: 2 years
After dilution: Chemical and physical in-use stability has been demonstrated for 72 hours at
30°C. From a microbiological point of view, the diluted product should be used immediately.
If not used immediately, in-use storage times and conditions prior to use are the responsibility
of the user/administrator and would normally not be longer than 24 hours at 2 to 8°C, unless
dilution has taken place in controlled and validated aseptic conditions.
Storage information
Before opening: Store in a refrigerator (2–8°C)
Storage out of the refrigerator:
Rocuronium bromide solution for injection may also be stored outside of the refrigerator at a
temperature of up to 30°C for a maximum 12 weeks, after which it should be discarded. The
product should not be placed back into the refrigerator, once it has been kept outside. The
storage period must not exceed the shelf-life.
Special precautions for handling
For Intravenous use only as a bolus injection or as a continuous infusion.
Administration should be begun immediately after mixing, and should be completed within
24 hours.
This medicinal product is for single use only, any unused solutions should be discarded.
The solution is to be visually inspected prior to use. Only clear solutions free from particles
should be used.
Disposal
Any unused product or waste material should be disposed of in accordance with local
requirements.

Expand Transcript

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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