Patient leaflet - Rocuronium Bromide 10 mg / ml solution for injection/infusion
1. WHAT ROCURONIUM BROMIDE IS AND WHAT IT IS USED FOR
Rocuronium bromide is one of a group of drugs called muscle relaxants.
Muscle relaxants are used during an operation as part of a general anaesthetic. When you have an operation your muscles must be completely relaxed. This makes it easier for the surgeon to perform the operation.
Normally, your nerves send messages called impulses to your muscles. Rocuronium bromide acts by blocking these impulses so that your muscles relax. Because your breathing muscles also relax, you will need help to breathe (artificial ventilation) during and after your operation until you can breathe on your own again.
During the operation your anaesthetist will keep a check on the effect of the muscle relaxant, and if necessary will give you some more. At the end of surgery, the effects of the drug are allowed to wear off and you will start breathing on your own. Sometimes the anaesthetist will give you another drug to help speed this up.
Rocuronium bromide can also be used in Intensive Care Units to keep your muscles relaxed.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE ROCURONIUM BROMIDE
Do not use Rocuronium bromide:
- if you are allergic (hypersensitive) to rocuronium, the bromide ion or any of the other ingredients of this medicine (listed in section 6). Tell your anaesthetist if this applies to you.
Warnings and precautions
Talk to your doctor or nurse before you receive Rocuronium bromide:
- if you are allergic to muscle relaxants,
- if you have had kidney, heart, liver or gall bladder disease,
- if you have had diseases affecting nerves and muscles,
- if you have fluid retention (oedema).
Tell your doctor if you have or have had the following:
- a rare tumour of the adrenal glands (pheochromocytoma); this may increase the risk of severe high blood pressure.
Tell your anaesthetist if any of these applies to you.
- if you have a history of malignant hyperthermia (sudden fever with rapid heartbeat, rapid breathing and stiffness, pain and/or weakness in your muscles).
Some conditions may influence the effects of Rocuronium bromide - for example:
- low calcium levels in the blood,
- low potassium levels in the blood,
- high magnesium levels in the blood,
- low levels of protein in the blood,
- too much carbon dioxide in the blood,
- loss of too much water from the body, for example by being sick, diarrhoea or sweating,
- burns,
- being very overweight (obesity),
- very low body temperature (hypothermia).
If you have any of these conditions, your anaesthetist will take it into account when deciding the correct dose of Rocuronium bromide for you.
Children and Elderly
Rocuronium bromide can be used in children (new-borns and adolescence) and elderly but your anaesthetist should first assess your medical history.
Other medicines and Rocuronium bromide
Tell your doctor if you are using, have recently used or might use any other medicines. This includes medicines or herbal products that you have bought without prescription. Rocuronium bromide may affect other medicines or be affected by them.
Medicines which increase the effect of Rocuronium bromide:
- certain antibiotics
- certain medicines for heart disease or high blood pressure (water tablets, calcium channel blockers, beta-blockers and quinidine)
- certain anti-inflammatory medicines (corticosteroids)
- medicines for manic depressive illness (bipolar disorder)
- magnesium salts
- certain medicines used to treat malaria
Medicines which decrease the effect of Rocuronium bromide:
- certain medicines for epilepsy
- calcium chloride and potassium chloride
- certain protease inhibitors called gabexate and ulinastatin
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 and breast-feeding
Tell your anaesthetist if you are pregnant or might be pregnant, or if you are breast-feeding.
Your anaesthetist may still give you Rocuronium bromide, but you need to discuss it first. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Rocuronium bromide may be given to you if you are having a Caesarean section. Breastfeeding should be suspended 6 hours after use of this medicine.
Driving and using machines
Do not drive or use machines until advised it is safe to do so. Because Rocuronium bromide is given as part of a general anaesthetic, you may feel tired, weak or dizzy for some time afterwards. Your doctor will be able to advise you on how long the effects are likely to last.
✂---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------PACKAGE LEAFLET: INFORMATION FOR THE USER
Rocuronium bromide 10 mg/ml solution for injection/infusion
Rocuronium bromide
This medicine contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium- free‘.
3. HOW TO USE ROCURONIUM BROMIDE
Dose
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 drugs you are taking,
- your state of health.
The recommended dose is 0.6 mg per kg body weight and the effect will last 30–40 minutes.
How Rocuronium bromide is given
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).
If you use more Rocuronium bromide than you should
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.
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.
Uncommon side effects (may affect up to 1 in 100 people)
- the drug is too effective, or not effective enough,
- the drug works for longer than expected,
- lowering of blood pressure,
- increase in heart rate,
- pain near the site of injection.
Very rare side effects (may affect up to 1 in 10,000 people)
- allergic (hypersensitivity) reactions (such as difficulty in breathing, collapse of the circulation and shock),
- wheezing of the chest,
- muscle weakness,
- sudden fever with rapid heartbeat, rapid breathing and stiffness, pain and/or weakness in your muscles
- swelling, a rash or redness of the skin.
Not known (frequency cannot be estimated from the available data):
- Severe allergic coronary blood vessels spasm (Kounis syndrome) resulting in chest pain (angina) or heart attack (myocardial infarction),
- Dilated pupils (mydriasis) or fixed pupils that do not change size with light or other stimuli.
If any of the side effects get serious or if you notice any side effects not listed in this leaflet, tell your anaesthetist or other doctor.
Reporting of side effects
If you get any side effects, talk to your doctor 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.
5. HOW TO STORE ROCURONIUM BROMIDE
Store in a refrigerator (2ºC – 8ºC).
Storage outside the refrigerator:
The medicinal product can be stored at up to 25 °C for a maximum of 16 weeks, after which it should be discarded. The medicinal product should not be stored in the refrigerator again after it has been taken out of the refrigerator. The storage period must not exceed the shelf life. The hospital will keep Rocuronium bromide according to the correct storage conditions, and will ensure that it’s in its expiry date. 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.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Rocuronium bromide contains
- The active substance is rocuronium bromide.
- The other ingredients are sodium acetate trihydrate, sodium chloride, sodium hydroxide, acetic acid, water for injections. Each ml Rocuronium bromide contains 10 mg rocuronium bromide. Each 5 ml vial contains 50 mg rocuronium bromide.
What Rocuronium bromide looks like and contents of the pack
Rocuronium bromide is a clear colourless to slightly yellow/orange solution for injection. It is available in vials containing 50 mg (10 vials per pack) of rocuronium bromide.
Marketing Authorisation Holder and Manufacturer:
Hikma Farmacêutica (Portugal), S.A.
Estrada do Rio da Mó, nº8, 8A, 8B,
Fervença
2705-906 Terrugem SNT
Portugal
This leaflet was last revised in 06/2026.
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