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ROCURONIUM BROMIDE HOSPIRA 10 MG/ML SOLUTION FOR INJECTION/INFUSION

Active substance(s): ROCURONIUM BROMIDE

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Package leaflet:
Information for the patient
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 or anaesthetist.
• If you get any side effects, talk to your doctor or anaesthetist. This includes any possible
side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Rocuronium Bromide is and what it is used for
2. What you need to know before you use Rocuronium Bromide
3. How to take 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.
Under normal circumstances your 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.

Package leaflet:
Information for the patient
Rocuronium Bromide 10 mg/ml
Solution for Injection / Infusion

In adults and children, if you are under general anaesthesia, Rocuronium Bromide may be used
to ease the insertion of a tube into your windpipe (trachea), to help with mechanical assistance of
breathing and to ensure that your muscles are relaxed during surgery.
If you are an adult your doctor may also use this medicine for a short time as an additional
medicine in the intensive care unit (ICU) (e.g. to ease the insertion of a tube into your windpipe
and whilst you are receiving mechanical breathing). You may also receive this medicine whenever
there is an emergency situation and you need to receive a tube into your windpipe very quickly.

2. What you need to know before you use Rocuronium Bromide

Rocuronium bromide

if you are elderly
if you have a very low body temperature (hypothermia)
if you have burns
if you have an increased amount of acids in the blood (acidosis)
if you suffer from an excessive loss of weight and poor physical condition (cachexia)

3. How to take Rocuronium Bromide
Dose

The following information is intended for
healthcare professionals only:

Rocuronium Bromide 10 mg/ml
Solution for Injection / Infusion

Rocuronium Bromide can be used in children (newborns and adolescents) and the elderly but
your anaesthetist should first assess your medical history.

Your anaesthetist will work out the dose of Rocuronium Bromide you need based on:
• the type of anaesthetic
• the expected length of the operation
• other medicines you are taking
• your state of health.

Other medicines and Rocuronium Bromide

The normal dose is 0.6 mg per kg body weight and the effect will last 30–40 minutes.

Your doctor or anaesthetist needs to know 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. Rocuronium Bromide may affect other medicines or be affected by them, in
particular:
• certain anti-inflammatory medicines (corticosteroids) when used for a long time with
Rocuronium Bromide, for example during intensive care
• certain antibiotics
• certain medicines for heart disease or high blood pressure (water tablets, calcium channel
blockers, beta-blockers, alpha-blockers, quinidine) and magnesium salts, which may be used
as a laxative or in certain heart conditions e.g. pre-eclampsia
• lithium used for manic depressive illness (bipolar disorder)
• certain medicines for epilepsy
• calcium chloride and potassium chloride (medicines to change the levels of potassium or
calcium in the blood)
• certain protease inhibitors called gabexate and ulinastatin (may be used for treating various
viral infections or conditions such as pancreatitis)
• azathioprine (used after transplants and for treating of auto-immune diseases)
• theophylline (used for the treatment of asthma)
• medicines used for the treatment of myasthenia gravis (neostigmine, edrophonium,
pyridostigmine)
• Aminopyridine derivatives (medicines used to treat Eaton-Lambert syndrome)
• quinine (used to treat malaria or night time leg cramps)

How Rocuronium Bromide is given

Like other neuromuscular blocking agents,
rocuronium bromide should only be
administered by, or under supervision of,
experienced clinicians who are familiar with the
action and use of these drugs.

Rocuronium Bromide will be given to you by your anaesthetist. Rocuronium Bromide is given
intravenously (into a vein), either as single injections or as a continuous infusion (a drip).

Each vial of the 50 mg presentation contains
5 ml of solution.

If you are given more Rocuronium Bromide than you need

Each vial of the 100 mg presentation contains
10 ml of solution.

As your anaesthetist will be monitoring your condition carefully it is unlikely that you will be
given too much Rocuronium Bromide. However, if this happens, your anaesthetist will keep you
breathing artificially (on a ventilator) until you can breathe on your own. You will be kept asleep
while this takes place.

Special precautions for storage

Children and the elderly

Please note
In addition, you may be given other medicines before or during surgery which can alter the effects
of Rocuronium Bromide. These include certain anaesthetics, other muscle relaxants, medicines
such as phenytoin and medicines which reverse the effects of Rocuronium Bromide. Rocuronium
Bromide may make certain anaesthetics work more quickly. Your anaesthetist will take this into
account when deciding the correct dose of Rocuronium Bromide 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 anaesthetist for advice before being given this medicine.

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

There is very limited information on the use of Rocuronium Bromide during human pregnancy
or in breast-feeding women. Rocuronium Bromide should only be given to pregnant and nursing
women when the doctor decides that the benefits outweigh the risks. Rocuronium Bromide may
be given to you if you are having a Caesarean section.

Warnings and precautions

There is no information available on the influence of this medicine on your fertility.

Talk to your doctor or anaesthetist before using Rocuronium Bromide:
• if you are allergic to any muscle relaxants
• if you have had kidney, heart, liver or gall bladder disease
• if you have a heart disease or a disease affecting your blood circulation
• if you have had diseases affecting nerves and muscles, for example poliomyelitis, myasthenia
gravis or Eaton-Lambert syndrome
• if you have fluid retention (oedema)
• if you have been told you have low levels of calcium (hypocalcaemia), potassium
(hypokalaemia) or protein (hypoproteinaemia) in your blood
• if you have been told you have high levels of magnesium (hypermagnesaemia) or carbon
dioxide (hypercapnia) in your blood
• if you have lost a lot of water from your body, for example by being sick, having diarrhoea,
sweating
• if you are very overweight (obese)

Driving and using machines

You should not receive Rocuronium Bromide:

EN-3459
Q76637







Rocuronium 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 after
full recovery from the effect of this medicine.
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
Each millilitre (ml) of Rocuronium Bromide contains 1.56 mg of sodium.
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially
“sodium- free”.

If you have any further questions on the use of this medicine, ask your doctor or anaesthetist.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. If
these side effects occur while you are under anaesthetic, they will be seen and treated by your
anaesthetist.
Tell your doctor or anaesthetist immediately if you get any of the following very rare (less than
1 in 10,000 users) serious side effects
• allergic reactions (such as wheezing, collapse, rash and shock)
• problems with your airway (such as wheezing, difficulty in breathing or other complications of
the anaesthetic)
Tell your healthcare professional as soon as possible if you experience any of the other side
effects that may occur:

Uncommon side effects
(up to 1 in 100 users are affected)
• the medicine is too effective, or not effective enough
• the medicine works for longer than expected causing weakness of your muscles
• lowering of blood pressure
• increase in heart rate
• pain near the site of injection.

Very rare side effects
(less than 1 in 10,000 users are affected)
• muscle weakness
• swelling, itching, a rash or redness of the skin.
If you get any side effects, talk to your doctor. This includes any possible side effects not listed in
this leaflet. You can also report side effects directly via the national reporting system for:
United Kingdom
Yellow Card Scheme
Website: http://www.mhra.gov.uk/yellowcard
or
Ireland
IMB Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: http://www.imb.ie
e-mail: imbpharmacovigilance@imb.ie.
By reporting side effects you can help provide more information on the safety of this medicine.

Please refer to the Summary of Product
Characteristics for full prescribing information.

Unopened product: Store in a refrigerator
(2-8°C).
Rocuronium Bromide can be stored outside
of the refrigerator at a temperature of up to
30°C for a maximum of 12 weeks. 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 first opening: Since Rocuronium Bromide
does not contain preservative, the solution
should be used immediately after opening the
vial.
Diluted product: After dilution with Infusion
fluids (‘Special precautions for disposal and
other handling’), chemical and physical in-use
stability of the diluted product has been
demonstrated for 72 hours at 30°C.
From a microbiological point of view, the
product should be used immediately after
dilution. 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.

Special precautions for disposal and
other handling
The solution is to be visually inspected prior to
use. Only clear solutions practically free from
particles should be used.
Rocuronium bromide is administered
intravenously as a bolus injection or
continuous infusion.
Compatibility studies have been conducted
with the following infusion fluids listed below.
Rocuronium Bromide in nominal
concentrations of 0.5 mg/ml and 2.0 mg/ml is
compatible with:
0.9% NaCl, 5% dextrose, 5% dextrose in 0.9%
NaCl, sterile water for injection and lactated
Ringer’s solution.
Any unused medicinal product or waste
material should be disposed of in accordance
with local requirements.

Component Specification

Requester

Item number:

Q76637

Request number:

AS3735

Country:

United Kingdom
/ Ireland

OI template:
Amalia version:

RMI003
5

I have checked this artwork against the
registered text including spelling, layout, size,
colours, registration numbers and scientific
equations, the name and address and
trademarks. Also for any possible changes to
related items.
This artwork is in conformance with the
Marketing Authorisation and can now proceed
to the printing stage.

Dimensions:
Container(s):
Supplier:
Stock:
Folded dimensions:
Printed both sides:
Perforated:

24 x 12 inches
10 or 20 ml vial
Rocky Mount
tbc
tbc
Yes
No

Pharma code:
Pharma code length:
Supplier Code:

n/a
n/a
EN-3459

Previous Item Number: n/a

Colours
Black:

Signed:
Date:
Version 1
Technician:
Date:

DM
19/Dec/13

Version 2
Technician:
Date:

SE
20/Dec/13

Version 3
Technician:
Date:

KN
24/Dec/13

Version 4
Technician:
Date:

DM
16/Jan/14

Version 5
Technician:
Date:

JH
11/Feb/14

Version 6
Technician:
Date:

JH
04/Mar/14

Version 7
Technician:
Date:

DM
13/Mar/14

Version 8
Technician:
Date:

KN
11/Apr/14

Version 9
Technician:
Date:

KN
06/May/14

Version 10
Technician:
Date:

XX
dd/mmm/yy

Incompatibilities
Rocuronium bromide is physically incompatible
with solutions of the following drugs:
amphotericin, amoxicillin, azathioprine,
cefazolin, cloxacillin, dexamethasone,
diazepam, enoximone, erythromycin,
famotidine, furosemide, hydrocortisone
sodium succinate, insulin, methohexital,
methylprednisolone, prednislone sodium
succinate, thiopental, trimethoprim and
vancomycin. Furthermore rocuronium bromide
is incompatible with Intralipid.
Rocuronium bromide should not be mixed with
other drugs, except those listed in ‘Special
precautions for disposal and other handling’.
If rocuronium bromide is administered via
the same infusion line that is used for other
drugs, it is important that this infusion line
is adequately flushed (e.g. with 0.9% NaCl)
between administration of rocuronium bromide
and drugs for which incompatibility with
rocuronium bromide has been demonstrated
or for which compatibility with rocuronium
bromide is not established.

5. How to store Rocuronium Bromide
Keep this medicine out of the sight and reach of children.
After first opening: Since Rocuronium Bromide does not contain a preservative, the solution
should be used immediately after opening the vial.
After dilution with infusion fluids, 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 and
would normally not be longer than 24 hours at 2°C to 8°C.
Store in a refrigerator (2°C – 8°C). Rocuronium Bromide can be stored outside of the refrigerator
at a temperature of up to 30°C for a maximum of 12 weeks. 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.
Do not use this medicine after the expiry date which is stated on the vial label and carton after
EXP.
Do not use Rocuronium Bromide if you notice that the solution is not clear and not free from
particles.
Rocuronium Bromide should not be disposed of via wastewater or household waste. These
measures will help to protect the environment.

6. Contents of the pack and other information

Requester

Item number:

Q76637

I have checked this artwork against the
registered text including spelling, layout, size,
colours, registration numbers and scientific
equations, the name and address and
trademarks. Also for any possible changes to
related items.
This artwork is in conformance with the
Marketing Authorisation and can now proceed
to the printing stage.

Request number:

AS3735

What Rocuronium Bromide contains

Country:







United Kingdom
/ Ireland

OI template:
Amalia version:

RMI003
5

Dimensions:
Container(s):
Supplier:
Stock:
Folded dimensions:
Printed both sides:
Perforated:

24 x 12 inches
10 or 20 ml vial
Rocky Mount
tbc
tbc
Yes
No

Pharma code:
Pharma code length:
Supplier Code:

n/a
n/a
EN-3459

The active substance is rocuronium bromide.
Each millilitre (ml) contains 10 mg of rocuronium bromide.
Each 5 ml vial contains 50 mg rocuronium bromide.
Each 10 ml vial contains 100 mg rocuronium bromide.
The other ingredients are sodium acetate anhydrous, sodium chloride, glacial acetic acid,
sodium hydroxide and water for injections.

Each 5 ml of Rocuronium Bromide contains 7.8 mg of sodium.
Each 10 ml of Rocuronium Bromide contains 15.6 mg of sodium.

What Rocuronium Bromide looks like and contents of the pack
Rocuronium Bromide is a colourless to yellow-orange solution for injection. It is available in vials
containing 50 mg (10 vials per pack) or 100 mg (10 vials per pack) of rocuronium bromide.

Marketing Authorisation Holder and Manufacturer
Hospira UK Limited
Queensway, Royal Leamington Spa
Warwickshire
CV31 3RW
United Kingdom
Alternate Batch release site:
Hospira Enterprises B.V.
Randstad 2211,
1316 BN ALMERE
The Netherlands
This leaflet was last revised in May 2014.

Q76637

Component Specification

Previous Item Number: n/a

Colours
Black:

Signed:
Date:
Version 1
Technician:
Date:

DM
19/Dec/13

Version 2
Technician:
Date:

SE
20/Dec/13

Version 3
Technician:
Date:

KN
24/Dec/13

Version 4
Technician:
Date:

DM
16/Jan/14

Version 5
Technician:
Date:

JH
11/Feb/14

Version 6
Technician:
Date:

JH
04/Mar/14

Version 7
Technician:
Date:

DM
13/Mar/14

Version 8
Technician:
Date:

KN
11/Apr/14

Version 9
Technician:
Date:

KN
06/May/14

Version 10
Technician:
Date:

XX
dd/mmm/yy

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.

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