Patient Leaflet Updated 23-Apr-2026 | hameln pharma ltd
Rocuronium 10 mg/ml solution for injection / infusion
Rocuronium 10 mg/ml solution for injection / infusion
Rocuronium Bromide
1. What Rocuronium is and what it is used for
2. What you need to know before you are given Rocuronium
3. How Rocuronium is given
4. Possible side effects
5. How to store Rocuronium
6. Contents of the pack and other information
Rocuronium belongs to a group of medicines called muscle relaxants.
Normally the nerves send messages to the muscles by impulses. Rocuronium 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 may be used if you are receiving anaesthesia to ease the insertion of a tube into your trachea (windpipe) for artificial ventilation (mechanical assistance of breathing). Rocuronium may also be used as an adjunct in the intensive care unit (ICU) (e.g. to ease the insertion of a tube into your windpipe), for short term use.
Children and adolescent (0 to ˂18 years)
Rocuronium may be given to paediatric patients aged 0 to ˂18 years (term neonates to adolescents), as an adjunct to general anaesthesia to ease the insertion of a tube into the trachea (windpipe) of your child for artificial ventilation (mechanical assistance of breathing) and to relax the muscles.
are sensitive or allergic to rocuronium bromide, the bromide ion or any of the other ingredients of this medicine (see section 6 for information on the other ingredients).
Talk to your doctor, pharmacist or nurse before you are given Rocuronium if you:
Rocuronium can be used in children (newborns and adolescents) and in the elderly but your anaesthetist should first assess your medical history. The same warnings and precautions as for adults should be taken into consideration.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, such as:
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, inhaled anaesthetics), other muscle relaxants and protamines which reverse the effect of heparin (a medicine used to keep blood flowing smoothly in your blood vessels). Your doctor will take this into account when he is deciding the correct dose of rocuronium for you.
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 during human pregnancy and no data on breast-feeding women. Rocuronium should only be given to pregnant and nursing women when the doctor decides that the benefits outweigh the risks. Rocuronium may be given during Caesarian section. Breastfeeding should be suspended for 6 hours after use of this medicine.
There are no data available on the influence of this medicine on your fertility.
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 following treatment.
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.
This medicine contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free‘.
Your anaesthetist will give you the injection. It is given to you into a vein either as a single injection or as a continuous infusion (over a longer period of time).
The usual dose is 0.6 mg per kg body weight and its effect will last 30 to 40 minutes.
The dose that will be given to you is determined and controlled by the anaesthetist taking into consideration the estimated length of surgery as well as your age and clinical condition.
Use in children and adolescents (0 - ˂18 years of age)
This medicine may be given to neonates (0 – 28 days), infants (28 days to ≤ 3 moths) and toddlers (˃ 3 months to ≤ 2 years), children (2-11 years) and adolescents (12 to ≤17 years). The dose and its effect in children can be slightly different from those in adults. So 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 paediatric patients. Rocuronium bromide is therefore not recommended for this purpose in paediatric patients.
Your anaesthetist will carefully monitor your condition during the procedure, therefore it is unlikely that you will be given too much Rocuronium. Should you be given too much your anaesthetist will make sure that anaesthesia and artificial ventilation will be continued until you breathe on your own. If you are concerned that you have been given too much, you should speak with your doctor.
If you have any further questions on the use of this medicine, please ask your doctor or pharmacist or nurse.
For information intended for medical or healthcare professionals please see the section below.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Allergic reactions are rare (affects 1 to 10 users in 10,000) but may be life-threatening. An allergic reaction may include rash, itching, difficulty in breathing or swelling of the face, lips, throat or tongue.
Please inform your doctor or nurse immediately if one or more of these reactions occur.
Uncommon side effects (may affect up to 1 in 100 people):
Very rare side effects (may affect up to 1 in 10,000 people):
Not known (frequency cannot be estimated from the available data):
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 you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.
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 Website: 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.
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)
Storage out of the refrigerator:
Rocuronium 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.
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.
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 ampoule/vial contains a total content of 50 mg rocuronium bromide.
Each 10 ml ampoule/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.
Rocuronium is a clear, colourless to pale brownish-yellow solution.
Pack size:
Rocuronium 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.
It is also available in packs of 5, 10 or 12 ampoules containing 5 ml as well as in packs of 5 or 10 ampoules containing 10 ml solution.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Manufacturer:
This medicinal product is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
AT Rocuroniumbromid hameln 10 mg/ml Injektions-/Infusionslösung
CZ Rocuronium bromide hameln
DE Rocuroniumbromid hameln 10 mg/ml Injektions-/Infusionslösung
DK Rocuronium ”hameln”
FI Rocuronium hameln 10 mg/ml injektio-/ infuusioneste, liuos
HR Rokuronijev bromid hameln 10 mg/ml otopina za injekciju/infuziju
HU Rocuronium bromide hameln 10 mg/ml oldatos injekció/infúzió
NL Rocuroniumbromide hameln 10 mg/ml oplossing voor injectie / infusie
PL Rocuronium bromide hameln
SE Rocuronium hameln 10 mg/ml injektions-/ infusionsvätska, lösning
SI Rokuronijev bromid hameln 10 mg/ml raztopina za injiciranje/infundiranje
SK Rocuronium bromide hameln 10 mg/ml injekčný/infúzny roztok
UK (NI) Rocuronium 10 mg/ml solution for injection/infusion
This leaflet was last revised in 02/2026.
570/07/26
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