Skip to Content

ROCURONIUM BROMIDE 10 MG/ML SOLUTION FOR INJECTION / INFUSION

View full screen / Print PDF » Download PDF ⇩
Transcript
Package leaflet: Information for the user
Rocuronium bromide 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 is and what it is used for
2.
What you need to know before Rocuronium bromide is used
3.
How to use Rocuronium bromide
4.
Possible side effects
5.
How to store Rocuronium bromide
6.
Contents of the pack and other information
1.

What Rocuronium bromide 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. This medicine 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.
This medicine 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).
Rocuronium bromide is used in children and adolescents (0 to < 18 years) and in
adults.
2.

What you need to know before Rocuronium bromide is used

Rocuronium bromide must not be used
- if you are allergic to rocuronium bromide, the bromide ion or any of the other
ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor, pharmacist or nurse before Rocuronium bromide is used
- 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 an oedema (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 too low body temperature during an anaesthesia
(hypothermia)

-

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
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 overbreathing (hyperventilation). Overbreathing leads to too little
carbon dioxide in the blood (alkalosis).
if you suffer from an excessive loss of weight (cachexia)
if you are overweight or elderly
if you have burns

Children and adolescents
The same warnings and precautions as for adults should be taken into consideration.
Other medicines and Rocuronium bromide
Please tell your doctor or pharmacist if you are taking or have recently taken any
other medicines, including medicines obtained without a prescription, such as:
-

antibiotics
medicines for manic depressive illness (bipolar disorder)
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. phenytoin, carbamazepine)
corticosteriods
medicines used for the treatment of myastenia gravis (neostigmine,
pyridostigmine)
potassium chloride
calcium chloride
medicines used for the treatment or prevention of a virus infection (protease
inhibitors e.g. gabexate, ulinastatin)

Please note:
You may be given other medicines during the procedure which can influence the
effects of rocuronium. These include certain anaesthetics (e.g. local anaesthetics,
inhalational anaesthetics), other muscle relaxants. Your doctor will take this into
account when he is deciding the correct dose of rocuronium for you.
Pregnancy and breast-feeding
If you are pregnant or brest-feeding, think you may be pregnant or are planning to
have a baby, ask your doctor or pharmacist for advice before using any medicine.
There are no data on the use of Rocuronium during human pregnancy and no data on
breast-feeding women. Rocuronium bromide 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 caesarean section.
Driving and using machines
Rocuronium bromide 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 contains sodium
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e.
essentially ‘sodium- free‘.
3.

How to use Rocuronium bromide

The usual dose is 0.6 mg per kg body weight and its effect will last 30 to 40 minutes.
The dose and its effect in children can be slightly different from those in adults. During
the surgery the effect of Rocuronium bromide is controlled continuously.
If necessary, additional doses could be administered to you. The dose is adjusted to
your needs by your anaesthetist. This depends on many factors, such as drug
interactions (their cross activity), taking into consideration the estimated length of
surgery as well as your age and clinical condition.
Rocuronium bromide will be given to you by your anaesthetist. It is given to you
intravenously (IV) either as a single injection or as a continuous infusion (over a
longer period of time) into a vein.
This medicinal product is for single use only.
If you receive more Rocuronium bromide than you should
Your anaesthetist will carefully monitor you when you are under medication of
Rocuronium bromide, therefore it is unlikely that you will be given too much of this
medicine. If it happens, your anaesthetist will make sure that anaesthesia and
artificial ventilation will be continued until you breathe on your own.
If you have any further questions on the use of this medicine, please 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 but may be life-threatening. A
hypersensitivity reaction may include rash, itching, difficulty in breathing or swelling of
the face, lips, throat or tongue or collapse of the circulation and shock. Please inform
your doctor or nurse immediately if one or more of these reactions occur.
The following side effects have been reported:
Uncommon (may affect up to 1 in 100 people):
• prolonged effect of muscle relaxation (prolonged neuromuscular block)
• the drug is too effective, or not effective enough
• the drug works for longer than expected
• lowering of blood pressure (hypotension)
• increase in heart rate
• pain at the injection site

Very rare (may affect up to 1 in 10,000 people):
• increased level of histamine in the blood
• wheezing (bronchospasm)
• itching,swelling, rash or redness of the skin
• wide spread, severe rash (exanthema)
• welts (angioedema)
• hives (urticaria)
• loss of movement (paralysis)
• failure of circulation (circulatory collapse and shock)
• allergic (hypersensitivity) reactions (such as difficulty in breathing, collapse of
the circulation and shock)
• muscle weakness
Not known (frequency cannot be estimated from the available data):
• Breathing (respiratory) failure
• Stop breathing (apnoea)
Children and adolescents
An increase in heart rate (tachycardia) has been observed in clinical studies with a
frequency of 1.4%.
If you get any side effects, talk to your doctor, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet.
5.

How to store Rocuronium bromide

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 label and carton
after “EXP.” The expiry date refers to the last day of that month.
The hospital will keep Rocuronium bromide according to the correct storage
conditions as mentioned in the following section.
Store in a refrigerator (2°C - 8°C)
Storage out of the refrigerator:
Rocuronium bromide 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.
The product should be used immediately after opening the vial.
After dilution: Chemical and physical in-use stability of a 5 mg/ml and 0.1 mg/ml
solution (diluted with sodium chloride 9 mg/ml (0.9%) and glucose 50 mg/ml (5%)
solution for infusion) has been demonstrated for 24 hours at 25 °C (± 2 °C). From the
microbiological point of view, the product should be used immediately. If not used
immediately, in-use storage times and conditions prior to use are the responsibility of
the user 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.

Do not use this medicine if you notice the solution is not clear or free from particles.
Do not throw away any medicines via wastewater or household waste. These
measures will help protect the environment.
6.

Contents of the pack and other information

What Rocuronium bromide contains
The active substance is rocuronium bromide.
1 ml contains 10 mg of rocuronium bromide.
Each 2.5 ml vial contains a total content of 25 mg rocuronium bromide.
Each 5 ml vial contains a total content of 50 mg rocuronium bromide.
Each 10 ml vial contains a total content of 100 mg rocuronium bromide.
The other ingredients are sodium acetate trihydrate, sodium chloride, glacial acetic
acid (for pH adjustment) and water for injections.
What Rocuronium bromide looks like and contents of the pack
Rocuronium bromide is a clear, colourless to pale brownish-yellow solution for
injection / infusion.
This medicine is available in packs of 5 or 10 vials containing 2.5 ml, 5 ml or 10 ml
solution as well as in packs of 12 vials containing 5 ml or 10 ml solution.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Pfizer Limited
Ramsgate Road
Sandwich
Kent
CT13 9NJ
United Kingdom
Manufacturer
hameln pharmaceuticals gmbh
Langes Feld 13
31789 Hameln, Germany

This leaflet was last revised in 11/2012.
----------------------------------------------------------------------------------------------------------------The following information is intended for healthcare professionals only:
PREPARATION GUIDE FOR:
Rocuronium bromide solution for injection / infusion
It is important that you read the entire contents of this guide prior to the
preparation of this medicinal product.

This is a summary of the information regarding the preparation of Rocuronium
bromide. Please refer to the Summary of Product Characteristics for full information.
PREPARATION FOR THE INTRAVENOUS ADMINISTRATION
Rocuronium bromide is administered intravenously (IV) either as a bolus injection or
as a continuous infusion.
For single use only. Any unused solutions should be discarded.
Rocuronium bromide has been shown to be compatible with: sodium chloride 9 mg/ml
(0.9%) and glucose 50 mg/ml (5%) solution.
This medicinal product must not be mixed with other medicinal products except those
mentioned above.
Physical incompatibility has been documented for Rocuronium bromide when added
to solutions containing the following active substances: 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.
If Rocuronium bromide is administered via the same infusion line with other medicinal
products, it is important that this infusion line is adequately flushed (e.g. with 0.9 %
NaCl) between administration of Rocuronium bromide and medicinal products for
which incompatibility with Rocuronium bromide has been demonstrated or for which
compatibility with Rocuronium bromide has not been established.

Expand view ⇕

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