Patient leaflet - Rocuronium 10 mg / ml solution for injection / infusion
1. What Rocuronium 10 mg/ml solution for injection/ infusion 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. 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 Rocuronium 10 mg/ml solution for injection/infusion
- 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 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, 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 suffer from an excessive loss of weight (cachexia). – if you are overweight or elderly.
- if you have burns.
- if you have a rare tumour of the adrenal glands (phaeochromocytoma); this may increase the risk of severe high blood pressure.
Other medicines and Rocuronium 10 mg/ml solution for injection/infusion
Tell your doctor or pharmacist if you are using, have recently used or might use 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 bromide. 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 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 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 medicine contains less than 1 mmol sodium (23 mg) per 5 ml ampoule, that is to say 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 bromide 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 use 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.
If you have any further questions on the use of this medicine, please ask your doctor or pharmacist or nurse.
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).
Not known (cannot be estimated from the available data):
- Stopping breathing
- Respiratory failure
- Severe allergic coronary blood vessels spasm (Kounis syndrome) resulting in chest pain (angina) or heart attack (myocardial infarction)
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) Very rare (may affect up to 1 in 10,000 people):
- 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)
Not known (cannot be estimated from the available data):
- Dilated pupils (mydriasis) or fixed pupils that do not change its size with light or other stimuli
*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, 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 or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects, you can help provide more information on the safety of this medicine.
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.
Do not store above 25 °C.
Do not freeze.
Package leaflet: Information for the user
B. Braun Melsungen AG · 34209 Melsungen, Germany
Rocuronium 10 mg/ml solution for injection/infusion
rocuronium bromide
B|BRAUN
Dimension: 210 x 594 mm LLD-Spec.: L94B
Production code: 1180
GB___0709
0709/12632857/0626 GIF (MPc)
Production site: Berlin
V-0100
0709/12632857/0626
B. Braun Melsungen AG
34209 Melsungen, Germany B|BRAUN
Marketing Authorisation Holder
B. Braun Melsungen AG
Carl-Braun-Str. 1
34212 Melsungen
Germany
Postal address:
34209 Melsungen
Germany
Manufacturer
B. Braun Melsungen AG
Mistelweg 2
12357 Berlin
Germany
This medicine is authorised in the Member States of the European Economic Area and in the United Kingdom (GB and NI) under the following names:
Austria, Germany,
Luxembourg Rocuroniumbromid B. Braun 10 mg/ml
Belgium Rocuronium B. Braun 10 mg/ml oplossing voor injectie/infusie
Bulgaria Рокурониум Б. Браун 10 mg/ml инжекционен/
инфузионен разтвор
Croatia Rokuronijev bromid B. Braun 10 mg/ml otopina za injekciju/infuziju Cyprus ROCURONIUM B. BRAUN 10mg/ml Czeck Republic, Finland,
Slovak Republic, Sweden Rocuronium B. Braun 10 mg/ml
Ireland, United Kingdom
(GB and NI) Rocuronium 10 mg/ml
Italy, Spain Rocuronio B. Braun 10 mg/ml Netherlands Rocuroniumbromide B. Braun 10 mg/ml
Slovenia Rokuronijev bromid B. Braun 10 mg/ml raztopina za injiciranje/infudiranje This leaflet was last revised in 05/2026.
After first opening:
The product should be used immediately after opening the ampoule.
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 %)) has been demonstrated for 72 hours at 25 °C in glass and LDPE containers as well as PVC infusion sets.
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. 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 10 mg/ml solution for injection/infusion contains
The active substance is rocuronium bromide.
1 ml contains 10 mg of rocuronium bromide.
Each 5 ml ampoule contains a total content of 50 mg rocuronium bromide.
The other ingredients are hydrochloric acid, sodium chloride, sodium hydroxide, and water for injections.
What Rocuronium 10 mg/ml solution for injection/infusion looks like and contents of the pack
Rocuronium 10 mg/ml solution for injection/infusion is a clear, colourless to pale brownish-yellow solution for injection/infusion. Rocuronium 10 mg/ml solution for injection/infusion is available in packs of 20 plastic ampoules containing 5 ml solution.
The following information is intended for healthcare professionals only:
Preparation 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.
0709/12632857/0626