Skip to Content

ROCURONIUM 10 MG/ML SOLUTION FOR INJECTION / INFUSION

Active substance(s): ROCURONIUM BROMIDE

View full screen / Print PDF » Download PDF ⇩
Transcript
809/12620353/0215

Package leaflet: Information for the user
B. Braun Melsungen AG · 34209 Melsungen, Germany

Rocuronium 10 mg/ml

877

solution for injection/infusion
Rocuronium Bromide

schwarz

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.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,
even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist or nurse. this includes any
­possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:
1. What Rocuronium 10 mg/ml solution for
­injection/infusion is and what it is used for
2. What you need to know before you use
­Rocuronium 10 mg/ml solution for injection/
infusion
3. How to use Rocuronium 10 mg/ml solution
for injection/infusion
4. Possible side effects
5. How to store Rocuronium 10 mg/ml solution
for injection/infusion
6. Contents of the pack and other information

1. What Rocuronium 10 mg/ml
­solution for injection/infusion is
and what it is used for
Rocuronium 10 mg/ml solution for injection/
infusion belongs to a group of medicines called
muscle relaxants.
Under normal circumstances your nerves send
messages to the muscles by impulses. Rocuronium 10 mg/ml solution for injection/infusion
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.
In adults and children, if you are under general
anaesthesia, Rocuronium 10 mg/ml solution for
injection/infusion may be used to ease the insertion of a tube into your windpipe (trachea)
to help you breath (mechanical assistance of
breathing) and to assure 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).
In addition you may also receive this medicine
whenever there is an emergency situation and
you need to receive a tube into your windpipe
very quickly to prepare for surgery.

2. What you need to know before
you use Rocuronium 10 mg/ml
­solution for injection/infusion
Do not use Rocuronium 10 mg/ml
­solution for injection/infusion
- if you are allergic to rocuronium, bromide or
any of the other ingredients of this medicine
(listed in section 6).

Warnings and precautions
Talk to your doctor, pharmacist or nurse before
using this medicine
- 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 one of your body areas is swelling
due to water incorporation (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, EatonLambert 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 suffer from an excessive loss of weight
(cachexia)
- if you are overweight or elderly
- if you have burns

Other medicines and Rocuronium 10 mg/
ml solution for injection/infusion
Your doctor or pharmacist has to know if you
are taking, have recently taken or might take
any other medicines, such as:
- antibiotics
- anti-depressant medicines containing lithium
- 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, alpha-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)
- long term use of corticosteroids in the ICU
- medicines used for the treatment of
myasthenia gravis (neostigmine, pyridostigmine, edrophonium, aminopyridine),
- theophylline (used for the treatment of asthma)
- 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. These include certain anaesthetics
(e.g. local anaesthetics, inhalational anaesthetics), other muscle relaxants, protamine which
reverses the anticoagulant effect (prevention
of blood clots) of heparin. Your doctor will take
this into account when he is deciding the correct dose of rocuronium for you.

Pregnancy and 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 10 mg/ml solution for injection/infusion during human pregnancy and no data on
breast-feeding women. Rocuronium 10 mg/ml
solution for injection/infusion should only be
given to pregnant and nursing women when
the doctor decides that the benefits outweigh
the risks. Rocuronium 10 mg/ml solution for injection/infusion may be given during Caesarean
section.
There are no data available on the influence of
this medicine on your fertility.

Driving and using machines
Rocuronium 10 mg/ml solution for injection/
infusion 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 10 mg/ml solution for injection/infusion 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 10 mg/ml
solution for injection/infusion
Rocuronium 10 mg/ml solution for injection/
infusion will be given to you by your anaesthetist. It is given to you intravenously either
as a single injection or as a continuous infusion
(over a longer period of time) into a vein.
Adults
The usual dose is 0.6 mg per kg body weight
and its effect will last 30 to 40 minutes. During surgery the effect of Rocuronium 10 mg/
ml solution for injection/infusion is controlled
continously. Therefore your doctor may administer further amounts of this medicine to you
depending on your individual situation.
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 drug interactions (their cross
activity), taking into consideration the estimated length of surgery as well as your age
and clinical condition.
This medicinal product is for single use only.
Use in children and adolescents
This medicine may be given to neonates (0 - 27
days), infants (28 days to 2 months) and toddlers (3 months to 23 months), children (2-11
years) and adolescents (12 to ≤17 years). The
anaesthetist 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 anaesthetic technique called
rapid sequence induction is limited in children
and adolescents. Rocuronium bromide is therefore not recommended for this purpose in children and adolescents.
Older patients, obese/overweight patients and
patients with liver and/or bile diseases and/or
kidney failure:
Your doctor might need to adapt the dosage
you will receive depending on your individual
situation.

If you receive more Rocuronium 10 mg/
ml solution for injection/infusion than
you should
Your anaesthetist will carefully monitor you
when you are under medication of Rocuronium
10 mg/ml solution for injection/infusion, therefore it is unlikely that you will be given too
much Rocuronium 10 mg/ml solution for injection/infusion. If it happens, muscle relaxation
might increase. Then your anaesthetist may
give you medicines to reverse this effect and
will make sure that anaesthesia and artificial
ventilation will be continued until you breathe
on your own again.

Further questions
If you have any further questions on the use of
this medicine, please ask your doctor or pharmacist or nurse.
For information intended for medicinal or
healthcare professionals please see accordant
section below.

4. Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them.

The following side effects may be serious. If any of the following side effects
occur, inform your doctor or nurse immediately:
Very rare (may affect up to 1 in 10 000 people):
Hypersensitivity reactions (allergic reactions)
and symptoms associated with it. A hypersensitivity reaction may include rash, itching, difficulty in breathing, low blood pressure, fast
heart beat, circulatory collapse, shock or swelling of the face, lips, throat or tongue, hives,
welt, reddening of the skin. In addition during anaesthesia there might occur the situation that you get other difficulties with your
breathing system (airway complication of anaesthesia).

B|BRAUN
12620353_Rocuronium_10mg_Vial_GIF_148x630mm_GB-IE_809.indd 1

02.02.15 10:52

Dokument = 1 48 x 630 mm (bxh)
2 Seiten
Lätus
877

GB / IE_809
809/12620353/0215
Rocuronium 10 mg/ml
GIF – Vial
Standort Jaen
Font size: 9,25 pt.
G 141595

809/12620353/0215

Not known (cannot be estimated from the
available data):
• Stopping breathing
• respiratory failure

Other side effects include:
Uncommon/rare (may affect between to 1-10
in 1 000 people):
• Increase in heart rate (tachycardia)*
• Delayed recovery from anaesthesia
• Lowering of blood pressure (hypotension)
• Medicine was ineffective
• Effect of the medicine in general was increased or decreased
• Response of your body to this medicine may
be increased or decreased
• Pain at the injection site
• Prolonged effect of muscle relaxation (prolonged neuromuscular block)

6. Contents of the pack and other
information
What Rocuronium 10 mg/ml solution for
injection/infusion 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
100% and water for injections.

What Rocuronium 10 mg/ml solution for
injection/infusion looks like and conVery rare (may affect up to 1 in 10,000 people): tents of the pack
• Increased level of histamine in the blood
• Wheezing (bronchospasm)
• Loss of movement (flaccid paralysis)
• muscle weakness (after long-term use of this
medicine in the ICU, especially if administered with cortisone)
*Clinical studies suggest that in paediatric patients an increase in heart rate is common and
may affect up to 1 in 10 people.

Reporting of side effects
If you get any side effects, talk to your doctor
or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You
can also report side effects directly (see details
below). By reporting side effects you can help
provide more information on the safety of this
medicine.
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
Ireland
HPRA Pharmacovigilance, Earlsfort Terrace,
IRL - Dublin 2; Tel: +353 1 6764971;
Fax: +353 1 6762517. Website: www.hpra.ie;
e-mail: medsafety@hpra.ie

5. How to store Rocuronium 10 mg/
ml solution for injection/infusion
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.
Store in a refrigerator (2°C - 8°C).
After first opening: 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
room temperature exposed to room light in
glass, and plastic containers. From the microbiological point of view, the product should be
used immediately. If not used immediately, inuse 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. Ask your pharmacist
how to throw away medicines you no longer
use. These measures will help protect the environment.

Rocuronium 10 mg/ml solution for injection/
infusion is a clear, colourless to pale brownishyellow solution for injection / injusion.
Pack size:
Rocuronium 10 mg/ml solution for injection/
infusion is available in packs of 10 vials containing 2.5 ml, 5 ml or 10 ml solution.
Not all pack sizes may be marketed.


Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder:
B. Braun Melsungen AG
Carl-Braun-Strasse 1
34212 Melsungen
Germany
Postal address:
34209 Melsungen
Germany
Phone: +49 5661/71-0
Fax: +49 5661/71-4567
Manufacturer:
hameln pharmaceuticals gmbh
Langes Feld 13
31789 Hameln, Germany
and
B. Braun Medical S.A.
Carretera de Terrassa, 121
08191 Rubí (Barcelona)
Spain

This medicinal product is authorised in the
Member States of the EEA under the following
names:
Austria
Belgium
Czech
Republic
Germany
Spain
Finland
Greece
Ireland
Italy
Luxembourg
Netherlands
Poland
Portugal
Sweden
Slovak
Republic
United
Kingdom

Rocuroniumbromid B. Braun
10 mg/ml
Rocuronium B. Braun 10 mg/ml
oplossing voor injectie/infusie
Rocuronium B. Braun 10 mg/ml
Rocuroniumbromid B. Braun
10 mg/ml
Rocuronio B. Braun 10 mg/ml
Rocuronium B. Braun 10 mg/ml
Rocuronium B. Braun 10 mg/ml
Rocuronium 10 mg/ml
Rocuronio B. Braun 10 mg/ml
Rocuroniumbromid B. Braun
10 mg/ml
Rocuroniumbromide B. Braun
10 mg/ml
Rocuronium B. Braun
Brometo de Rocurónio B. Braun
Rocuronium B. Braun 10 mg/ml
Rocuronium B. Braun 10 mg/ml
Rocuronium 10 mg/ml

This leaflet was last approved in 12/2014.

The following information is intended for healthcare professionals only:
Preperation guide for:
Rocuronium 10 mg/ml solution for injection/infusion
It is important that you read the entire contents of this guide prior to the preparation of
this medicinal product.

Preparation for the intravenous administration
For single use only.
Rocuronium 10 mg/ml solution for injection/infusion is administered intravenously (i.v.) either as
a bolus injection or as a continuous infusion.
Rocuronium 10 mg/ml solution for injection/infusion has been shown to be compatible with:
sodium chloride 9 mg/ml (0.9%) and glucose 50 mg/ml (5%) solution.
Any unused solutions should be discarded.
This medicinal product must not be mixed with other medicinal products except those mentioned
above.
Physical incompatibility has been documented for Rocuronium 10 mg/ml solution for injection/
infusion 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 10 mg/ml solution for injection/infusion 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 10 mg/ml solution for injection/infusion and medicinal products for which incompatibility with Rocuronium 10 mg/ml solution for
injection/infusion has been demonstrated or for which compatibility with Rocuronium 10 mg/ml
solution for injection/infusion has not been established.

B|BRAUN

12620353_Rocuronium_10mg_Vial_GIF_148x630mm_GB-IE_809.indd 2

B. Braun Melsungen AG
34209 Melsungen
Germany

02.02.15 10:52

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