Skip to Content

ROCURONIUM BROMIDE 10 MG/ML SOLUTION FOR INJECTION OR INFUSION

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

Package leaflet: Information for the user
Rocuronium Bromide 10 mg/ml Solution for Injection or 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 or pharmacist or nurse.
If you get any any side effects talk to your doctor, pharmacist or nurse This includes
possible side effects not listed in this leaflet.
What is in this leaflet:
1.
What Rocuronium Bromide 10 mg/ml Solution for Injection or Infusion is and what it
is used for
2.
What you need to know before you use Rocuronium Bromide10 mg/ml Solution for
Injection or Infusion
3.
How to use Rocuronium Bromide10 mg/ml Solution for Injection or Infusion
4.
Possible side effects
5.
How to store Rocuronium Bromide 10 mg/ml Solution for Injection or Infusion
6.
Contents of the pack and other information

1.

What rocuronium bromide 10 mg/ml solution for injection or infusion is and what
it is used for

Rocuronium Bromide belongs to a group of medicines called muscle relaxants.
Normally the nerves send messages to the muscles by impulses. Rocuronium bromide 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 may also be used if you are having an anaesthesia to ease the insertion
of a tube into your trachea (windpipe) for artificial ventilation (mechanical assistance of
breathing).

2.

What you need to know before you use rocuronium bromide 10 mg/ml solution for
injection or infusion

Do NOT use Rocuronium Bromide:
If you are allergic (hypersensitive) to rocuronium bromide or the bromide ion or any of
the other ingredients of Rocuronium bromide.
Take special care with Rocuronium Bromide:
Before you receive this medicine you must tell your doctor or anaesthetist if you have or ever
had one of the following conditions:
Kidney, heart or liver disease

Diseases affecting nerves and muscles (poliomyelitis, myasthenia gravis, EatonLambert syndrome)
Allergy to any other muscle relaxants
A slow heart rate (bradycardia)
A serious condition called malignant hyperthermia where you have a very severe fever.
When you are ill you may suffer from certain conditions which may influence the effects of
Rocuronium bromide for example:
low calcium levels in the blood (hypocalcaemia) which can occur after blood
transfusions
low potassium levels in the blood (hypokalaemia)
high magnesium levels in the blood (hypermagnesaemia)
low levels of protein in the blood (hypoproteinaemia)
too much carbon dioxide in the blood (hypercapnia)
too much acid in the blood or body tissues (acidosis)
loss of too much water from the body, e.g. by being sick, diarrhoea or sweating
(dehydration)
overbreathing (hyperventilation) leading to too little carbon dioxide in the blood
(alkalosis)
very low body temperature (hypothermia)
general ill-health (cachexia).
If you have any burns please inform your doctor or anaesthetist as they may need to adjust
your dose.
If you are suffering from any of these conditions your anaesthetist will take it into account
when deciding the correct dose of Rocuronium bromide for you.
Children
The same warnings and precautions as for adults should be taken into consideration.
Other medicines and Rocuronium Bromide 10 mg/ml Solution for Injection or Infusion
Please tell your doctor if you are taking or have recently taken any other medicines, including
medicines obtained without a prescription.
Other medicines may influence the effects of Rocuronium bromide or vice versa.
You must tell your doctor or anaesthetist if you are taking (or intend to take) other medicines,
such as:
Antibiotics
Diuretics (water pills)
Medicines for heart disease or high blood pressure
Acetylcholinesterase inhibitors (medicines for the treatment of myasthenia gravis)
Aminopyridine derivatives (medicines to treat Eaton-Lambert syndrome)
Corticosteroids
Medicines for epilepsy (e.g. phenytoin)
Medicines to treat or prevent viruses (protease inhibitors such as gabexate, ulinastatin)
Thiamine (vitamin B1)
Some antidepressants such as carbamazepine, lithium salts
Some laxatives such as magnesium salts, pyridostigmine
Theophylline (medicine for asthma)

Azathioprine (a medicine used to slow rejection of organ transplants)
Calcium chloride or potassium chloride (medicines to change the levels of potassium or
calcium in the blood).
You may be given other medicines during surgery which can alter the effects of Rocuronium
bromide. These include certain anaesthetics (such as lidocaine, bupivacaine, thiopental), other
muscle relaxants (such as suxamethonium), protamine, calcium chloride and agents which
reverse the effects of Rocuronium bromide. Your anaesthetist will take this into account when
they are deciding the correct dose of Rocuronium bromide for you.
Pregnancy and breast-feeding
If you are pregnant, or think that you might be pregnant, or if you are breast-feeding, then you
must tell your doctor or anaesthetist.
However Rocuronium bromide may be given to you if you undergo a Caesarean section.
Driving and using machines
Do not drive or use machines until advised it is safe to do so. Because Rocuromium is given
as part of a generl anaesthetic, you may feel tired, weak or dizzy for some time afterwards.
Your anaesthetist will be able to adivse you on how long the effects are likely to last.
Important information about some of the ingredients of Rocuronium bromide
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially
„sodium-free‟.

3.

How to use rocuronium bromide10 mg/ml solution for injection or infusion

The normal dose is 0.6 mg per kg body weight and the effect will last 30–40 minutes. The
dose is adjusted to your needs by your anaesthetist. Your anaesthetist will take into account
the anaesthetic, the expected duration of surgery, your body weight, other medicines you have
been given and your state of health.
Rocuronium bromide will be given to you by your anaesthetist. It is given intravenously,
either as single injections or as a continuous infusion.
If you are given more Rocuronium bromide than you should
As your anaesthetist will be monitoring your condition during the procedure it is unlikely that
you will be given too much Rocuronium bromide. 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 product, ask your doctor or pharmacist.

4.

Possible side effects

Like all medicines, Rocuronium bromide can cause side effects, although not everybody gets
them.
If the following happens tell your doctor immediately:

An allergic reaction causing swelling of the lips, face or neck leading to severe
difficulty in breathing, skin rash or hives.
This is a very serious but rare side effect. You may need urgent medical attention.
The following side effects have been reported at the approximate frequencies shown:
Very common may affect more than 1 in 10 people:
Itching, rash or pain near the site of injection.
Rare/uncommon: may affect up to 10 in 10,000 people or 10 in 1,000 people
Increase in heart rate (tachycardia)
Lowering of blood pressure (hypotension)
Drug response ineffective or decreased
Drug response increased
Itching, rash or pain near the site of injection.
Muscle weakness
Delayed recovery after anaesthsia.
Very rare may affect less than 1 in 10,000 people:
Serious allergic reaction causing difficulty in breathing or dizziness allergic reactions
Complete loss of strength in a limb or muscle (paralysis). An emergency when the
organs and tissues are not receiving enough blood (circulatory collapse and shock)
Bronchospasm (wheezing)
Severe allergic reaction which causes swelling of the face or throat
Rash (red), nettle rash, itching
Longer period of muscle relaxation leading to muscle weakness or loss of strength
(paralysis)
Airway complications of anaesthesia
Flushing (redness of the skin)
Water retention of the face.
Children
An increase in heart rate (tachycardia) has been observed in clinical studies with a frequency
of 1.4% (common) which means that it may affect up to 1 in 10 people.
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 rocuronium bromide10 mg/ml solution for injection or infusion

Keep out of the reach and sight of children.
Do not use Rocuronium bromide after the expiry date which is stated on the vial. The expiry
date refers to the last day of that month.
Storage conditions
Before opening: Store in a refrigerator (2-8 C).
Rocuronium bromide may be stored out of a refrigerator (below 25 C) for up to 3 months.
The date at which the Rocuronium bromide is taken out of the refrigerator should be written

on the specific site on the outer carton. If Rocuronium bromide has been stored at 8-25 C, it
should not be returned to the refrigerator. After 3 months it should be discarded.
After opening: The product should be used immediately after opening the vial.
After dilution: The diluted product should be used immediately. If it is not used immediately
the duration for storage and conditions for storage become the responsibility of the user or
administrator. Storage times of diluted product are usually no longer than 24 hours at 2-8 C.
Administration should be begun immediately after mixing, and should be completed within
24 hours after mixing. Any unused solution should be discarded.
For single use only.
Do not use Rocuronium bromide if you notice any particles or visible signs of deterioration.
Medicines should not be disposed of via wastewater or household waste. Your doctor should
dispose of medicines that are no longer required. These measures will help to protect the
environment.

6.

Contents of the pack and other information

What Rocuronium bromide contain
The active ingredient is rocuronium bromide. Each ml of solution for injection or
infusion contains 10 mg rocuronium bromide.
Each vial with 2.5 ml contains 25 mg rocuronium bromide.
Each vial with 5 ml contains 50 mg rocuronium bromide
Each vial with 10 ml contains 100 mg rocuronium bromide
The other ingredients are sodium acetate trihydrate, acetic acid (glacial), sodium
chloride, sodium hydroxide 10% solution and water for injections.
What Rocuronium bromide look like and contents of the pack
Rocuronium bromide 10 mg/ml solution for injection or infusion is a clear, colourless to
yellow-orange solution. The solution is supplied in colourless glass vials closed with
chlorobutyl rubber stoppers and aluminium flip off cap. Each vial contains either 2.5 ml, 5 ml
or 10 ml solution.
The 2.5 ml vials are available in packs of 1 or 10 vials.
The 5 ml vials are available in packs of 1, 10, 12 or 60 vials.
The 10 ml vials are available in packs of 1, 10 or 20 vials.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder is Teva UK Limited, Eastbourne, BN22 9AG
Manufacturer is Pharmachemie B.V., Swensweg 5, 2031 GA Haarlem, The Netherlands

This leaflet was last Revised in September 2012.
PL 00289/1083
----------------------------------------------------------------------------------------------------------------

PREPARATION GUIDE FOR USE WITH Rocuronium Bromide 10 mg/ml Solution for
Injection or Infusion
(Please note this is a Prescriber Information Leaflet NOT the SPC. For full details regarding this
product please refer to the SPC.)

The following information is intended for healthcare professionals only:
Rocuronium bromide solution for injection or infusion 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 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 section.
Mixture with other products:
Rocuronium bromide Teva solution for injection or infusion 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
Polygeline solution for infusion (3.5%).
If Rocuronium bromide Teva solution for injection or infusion 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 Teva solution for injection or infusion and medicinal
products for which incompatibility with rocuronium bromide has been demonstrated or for
which compatibility with rocuronium bromide has not been established.
Storage information
See section 5 “How to store rocuronium bromide Teva.”
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.

Hide