Rocuronium B. Braun

PACKAGE LEAFLET: INFORMATION FOR THE USER

Rocuronium B. Braun 10 mg/ml injection solution or infusion solution

rocuronium bromide
Please read this leaflet carefully before you use this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

1. What Rocuronium B. Braun 10 mg/ml is and what it is used for.
2. What you need to know before using Rocuronium B. Braun 10 mg/ml.
3. How to use Rocuronium B. Braun 10 mg/ml.
4. Possible side effects.
5. How to store Rocuronium B. Braun 10 mg/ml.
6. Contents of the pack and other information.

1. What Rocuronium B. Braun 10 mg/ml is and what it is used for

Rocuronium B. Braun 10 mg/ml belongs to a group of medicines called muscle relaxants.
Under normal circumstances, nerves send signals to muscles in the form of impulses. Rocuronium B. Braun 10 mg/ml works by blocking these impulses, causing the muscles to relax.
During surgery, muscles need to be completely relaxed. This allows the surgeon to perform the procedure more easily.
In adults and children undergoing general anaesthesia, Rocuronium B. Braun 10 mg/ml can be used to facilitate the insertion of a tube into the trachea to assist mechanical ventilation (artificial respiration) and to ensure that muscles remain relaxed during surgery.
In adults, the doctor may use this medicine for a short period as an adjunct in the intensive care unit (ICU) (e.g. to facilitate tracheal intubation). This medicine may also be used in emergency situations when rapid tracheal intubation is required prior to surgery.

2. What you need to know before using Rocuronium B. Braun 10 mg/ml

Do not use Rocuronium B. Braun 10 mg/ml
➢ 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 kidney, liver, or biliary disease
➢ if you have heart disease or a condition affecting blood circulation
➢ if one or more areas of your body are swollen due to fluid accumulation (e.g. in the ankle area)
➢ if you have a nerve or muscle disorder (neuromuscular diseases, e.g. polio (poliomyelitis), myasthenia gravis, Eaton-Lambert syndrome)
➢ if you have previously experienced episodes of abnormally low body temperature during anaesthesia (hypothermia)
➢ if you have low calcium levels in your blood (hypocalcaemia), (e.g. caused by massive transfusions)
➢ if you have low potassium levels in your blood (hypokalaemia), (e.g. caused by severe vomiting, diarrhoea, or diuretic therapy)
➢ if you have high magnesium levels in your blood (hypermagnesaemia)
➢ if you have low protein levels in your blood (hypoproteinaemia)
➢ if you are dehydrated
➢ if you have increased acidity in your blood (acidosis)
➢ if you have increased carbon dioxide levels in your blood (hypercapnia)
➢ if you have excessive weight loss (cachexia)
➢ if you are overweight or elderly
➢ if you have burns
➢ if you have a rare tumour of the adrenal glands (pheochromocytoma); this may increase the risk of severe high blood pressure

Other medicines and Rocuronium B. Braun 10 mg/ml
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, such as:
➢ antibiotics
➢ antidepressant medicines: containing lithium
➢ medicines used to treat heart conditions or high blood pressure (e.g. quinidine, calcium antagonists, adrenergic blockers such as beta-blockers, alpha-blockers)
➢ diuretics (medicines that increase the amount of urine produced)
➢ certain laxatives such as magnesium salts
➢ quinine (used to treat pain and infections)
➢ medicines used to treat epilepsy (e.g. phenytoin, carbamazepine)
➢ long-term use of corticosteroids in the ICU
➢ medicines used to treat myasthenia gravis (neostigmine, pyridostigmine, edrophonium, aminopyridine)
➢ theophylline (used to treat asthma)
➢ medicines used to treat or prevent viral infections (protease inhibitors)

Note:
During the procedure, you may be given other medicines that can affect the effects of rocuronium. These include certain anaesthetics (e.g. local anaesthetics, inhalational anaesthetics), other muscle relaxants, and protamine, which reverses the anticoagulant effect (prevention of blood clots) of heparin. Your doctor will take these into account when deciding the correct dose of rocuronium for you.

Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
Data on the use of Rocuronium B. Braun 10 mg/ml during pregnancy in humans are very limited, and there are no data in breastfeeding women. Rocuronium B. Braun 10 mg/ml should be administered to pregnant and breastfeeding women only when the doctor decides that the benefits outweigh the risks. Rocuronium B. Braun 10 mg/ml may be administered during caesarean section.
There are no data available on the effects of this medicine on fertility.

Driving and using machines
Rocuronium B. Braun 10 mg/ml has a major influence on the ability to drive and use machines.
Therefore, driving a vehicle or operating potentially dangerous machinery is not recommended until 24 hours after full recovery from the effects of this medicine.
Your doctor will advise you when you may resume driving and using machines. You must always be accompanied home by a responsible adult after your treatment.

Rocuronium B. Braun 10 mg/ml contains sodium
This medicinal product contains less than 1 mmol of sodium (23 mg) per dose, i.e. it is essentially ‘sodium-free’.

3. How to use Rocuronium B. Braun 10 mg/ml

Rocuronium B. Braun 10 mg/ml will be administered to you by an anaesthetist. It will be given intravenously either as a single injection or as a continuous infusion (over an extended period of time) into a vein.

Adults
The usual dose is 0.6 mg per kg of body weight, and its effect lasts between 30 and 40 minutes. During surgery, the effect of Rocuronium B. Braun 10 mg/ml will be continuously monitored. Therefore, your doctor may administer additional amounts of this medicine depending on your specific condition.

If necessary, supplemental doses may be given. The dose will be adjusted to your needs by the anaesthetist. This depends on many factors, such as drug interactions (their cross activity), the expected duration of surgery, as well as the patient's age and health status.

This medicinal product is for single use only.

Use in children and adolescents
This medicine can be administered to newborns (0 to 27 days), infants (28 days to 2 months), young children (3 months to 23 months), children (2 to 11 years), and adolescents (12 to ≤ 17 years). The anaesthetist will adjust the dose according to your child's needs. The doctor should consider that higher infusion rates may be required in children.

Experience with rocuronium bromide in a particular anaesthetic technique called rapid sequence induction is limited in children and adolescents. Therefore, rocuronium bromide is not recommended for this purpose in children and adolescents.

Elderly patients, obese or overweight patients, and patients with liver and/or biliary tract diseases and/or renal impairment:
Your doctor may adjust the dose you receive based on your specific condition.

If you receive more Rocuronium B. Braun 10 mg/ml than you should
The anaesthetist will closely monitor you while you are under the effects of Rocuronium B. Braun 10 mg/ml, so it is unlikely that you will receive too much. However, if this does happen, muscle relaxation could increase. In such a case, the anaesthetist may give you medicines to reverse this effect and will ensure that anaesthesia and artificial ventilation are continued until you are able to breathe independently again.

Further questions
If you have any doubts about using this medicine, consult your doctor, pharmacist, or nurse.

For information intended for physicians and healthcare professionals, see the respective section below.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects can be serious. If you experience any of these side effects,
contact your doctor or nurse immediately:
Very rare (may affect up to 1 in 10,000 patients):
Hypersensitivity reactions (allergic reactions) and symptoms associated with them. A hypersensitivity
reaction may include skin rash, itching, difficulty breathing, low blood pressure, rapid heartbeat,
circulatory collapse, shock, or swelling of the face, lips, throat or tongue, hives, skin rash, skin redness.
Additionally, during anaesthesia you may experience increased difficulty in breathing (respiratory
complication of anaesthesia).
Not known (frequency cannot be estimated from the available data):

• Cessation of breathing
• Respiratory failure
• Severe allergic spasm of the coronary blood vessels (Kounis syndrome), leading to chest pain (angina) or heart attack (myocardial infarction)

Other side effects:
Uncommon/rare (may affect up to 1–10 in 1,000 patients):
✓ Increased heart rate (tachycardia)*
✓ Delayed recovery from anaesthesia
✓ Low blood pressure (hypotension)
✓ Medicine not working
✓ Increased or decreased effectiveness of the medicine
✓ Increased or decreased body reaction to the medicine
✓ Pain at the injection site
✓ Prolonged effect of muscle relaxation (prolonged neuromuscular blockade)
Very rare (may affect up to 1 in 10,000 people):
✓ Increased histamine levels in the blood
✓ Wheezing (bronchospasm)
✓ Loss of movement (flaccid paralysis)
✓ Muscle weakness (after long-term use of the medicine in the ICU, especially if administered together with cortisone)
Not known (frequency cannot be estimated from the available data):
✓ Dilated pupils (mydriasis) or fixed pupils that do not change in size in response to light or other stimuli

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, contact your doctor, pharmacist or nurse.
You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Rocuronium B. Braun 10 mg/ml

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label and packaging following
“EXP”. The expiry date refers to the last day of that month.
Do not store above 25 °C.
After first opening: use the product immediately after opening the vial.
After dilution: chemical and physical in-use stability of a solution at 5 mg/ml and 0.1 mg/ml (diluted
with sodium chloride 9 mg/ml (0.9%) and glucose 50 mg/ml (5%) infusion solution) has been demonstrated for 24 hours at room temperature, under artificial light, in plastic and glass containers. From a microbiological standpoint, the product should be used immediately. If not used immediately, storage times and conditions prior to use are the responsibility of the user and should normally not exceed 24 hours at 2–8 °C, unless the dilution has been carried out under controlled and validated aseptic conditions.
Do not use this medicine if you notice that the solution is not clear or contains particles.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Rocuronium B. Braun 10 mg/ml contains
The active substance is rocuronium bromide.
1 ml contains 10 mg of rocuronium bromide.
Each 5 ml vial contains a total of 50 mg of rocuronium bromide.
The other excipients are gluconolactone, sodium acetate trihydrate, sodium citrate, and water for
injections.

Description of the appearance of Rocuronium B. Braun 10 mg/ml and package contents
Rocuronium B. Braun 10 mg/ml is a clear, injectable or infusion solution, colourless to slightly brownish-yellow.

Pack sizes:
Rocuronium B. Braun 10 mg/ml is available in packs of 20 plastic vials containing 5 ml of solution.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
B. BRAUN MELSUNGEN AG
Carl Braun Strasse, 1
34212 Melsungen
Germany

This medicinal product is authorised in the European Economic Area and the United Kingdom (Northern Ireland) under the following names:

01/2026
The following information is intended exclusively for physicians or healthcare professionals:
PREPARATION GUIDE FOR:
Rocuronium B. Braun 10 mg/ml solution for injection or infusion
It is important to read this entire guide thoroughly before preparing this
medicinal product.
PREPARATION FOR INTRAVENOUS ADMINISTRATION
For single use only.
Rocuronium B. Braun 10 mg/ml is administered intravenously (IV), either as a bolus injection or as a continuous infusion.
Rocuronium B. Braun 10 mg/ml has been shown to be compatible with: sodium chloride 9 mg/ml (0.9%) solution and glucose 50 mg/ml (5%).
Unused solutions must be discarded.
This medicinal product must not be mixed with other products except those mentioned above.
Physical incompatibility has been documented for Rocuronium B. Braun 10 mg/ml 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 B. Braun 10 mg/ml is administered through the same infusion line as other medicinal products, it is important that the infusion line be adequately flushed (e.g., with 0.9% NaCl) between the administration of Rocuronium B. Braun 10 mg/ml and any medicinal products with which compatibility has been demonstrated to be incompatible or for which compatibility with Rocuronium B. Braun 10 mg/ml has not been established.