ROCURONIUM B. BRAUN 10 mg/ml INJECTABLE SOLUTION AND PERFUSION SOLUTION

2. What you need to know before you are given Rocuronium B. Braun

Do not use Rocuronium B. Braun:

• If you are allergicto rocuronium, bromide or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Tell your doctor, pharmacist or nurse before you start using this medicine:

• If you are allergicto any muscle relaxant.
• If you have kidney, liveror bile ductproblems.
• If you have heart diseaseor conditions that affect blood circulation.
• If any part of your body is swollen due to water accumulation (oedema, e.g. in the ankle area).
• If you have diseases that affect the nerves and muscles(muscle disorders such as polio (poliomyelitis), myasthenia gravis, Eaton-Lambert syndrome).
• If you have low calcium levelsin your blood (hypocalcaemia), caused for example by massive blood transfusions.
• If you have low potassium levelsin your blood (hypokalaemia), caused for example by severe vomiting, diarrhoea and diuretic therapy).
• If you have high magnesium levelsin your blood (hypermagnesaemia).
• If you have low protein levelsin your blood (hypoproteinaemia).
• If you are dehydrated.
• If you have too much acidin your blood (acidosis).
• If you have too much carbon dioxidein your blood (hypercapnia).
• If you have excessive weight loss(cachexia).
• If you are overweightor elderly.
• If you have burns.

Using Rocuronium B. Braun with other medicines

Your doctor or pharmacist should know if you are taking, have recently taken or might take any other medicines, such as:

• Antibiotics.
• Antidepressantscontaining lithium.
• Medicines for heart diseaseor high blood pressure(such as quinidine, calcium channel blockers, adrenergic blockers (e.g. beta blockers, alpha blockers).
• Diuretics(medicines to increase urine volume).
• Certain laxativessuch as magnesium salts.
• Quinine (used to treat pain and infections),
• Medicines to treat epilepsy(e.g. phenytoin, carbamazepine),
• Long-term use of corticosteroidsin the ICU,
• Medicines used to treat myasthenia gravis(neostigmine, pyridostigmine, edrophonium, aminopyridine).
• Theophylline(used to treat asthma).
• Medicines used to treat and prevent viral infections(protease inhibitors).

Note:

You may be given other medicines during the procedure that may affect the effects of rocuronium. These include certain anaesthetics (e.g. local anaesthetics, inhalation anaesthetics), other muscle relaxants, protamines which reverse the anticoagulant effect (prevention of blood clot formation) of heparin. Your doctor should take this into account when deciding on the correct dose of rocuronium for you.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine. There is limited experience with the use of Rocuronium B. Braun in pregnant women and no data on breastfeeding. Rocuronium B. Braun should only be used during pregnancy or breastfeeding if your doctor considers that the benefits outweigh the potential risks. Rocuronium B. Braun may be administered during caesarean section.

No data are available on the influence of this medicine on fertility.

Driving and using machines

Rocuronium B. Braun has a major influence on the ability to drive and use machines, so it is not recommended to drive or use potentially hazardous machinery during the first 24 hours after full recovery from the effects of this medicine. Your doctor will inform you when you can drive and use machinery again. You should be accompanied home by a responsible adult after receiving treatment.

Rocuronium B. Braun contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per dose, so it is essentially 'sodium-free'.

3. How Rocuronium B. Braun is given

Rocuronium B. Braun should be administered by your anaesthetist. It is given by injection into a vein or by continuous infusion (over a long period of time).

Adults

The usual dose is 0.6 mg per kg of body weight and its effect lasts for 30 to 40 minutes. During surgery, the effect of Rocuronium B. Braun is continuously monitored. Therefore, your doctor may give you additional amounts of this medicine, depending on your individual situation. You may be given additional doses if necessary. Your anaesthetist will adjust the dose to your needs. This depends on many factors, such as possible interactions with other medicines (cross-activity), the expected duration of the operation, your age or your state of health.

This medicine is for single use only.

Use in children and adolescents

This medicine can be given to neonates (0 to 27 days), infants (28 days to 2 months) and young children (3 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. Your doctor will take into account that higher infusion rates may be necessary for children.

Experience with rocuronium bromide in a special anaesthesia technique called rapid sequence induction is limited in children and adolescents. Therefore, the use of rocuronium bromide for this purpose is not recommended in paediatric patients.

Elderly patients, obese/overweight patients and patients with liver and/or bile duct and/or kidney problems:

Your doctor may need to adjust the dose you receive, depending on your individual situation.

If you are given more Rocuronium B. Braun than you should

The anaesthetist will be monitoring you while you are under the effects of the medicine with Rocuronium B. Braun, so it is unlikely that you will be given too much Rocuronium B. Braun. If this happens, it can increase muscle relaxation. Then, your anaesthetist may give you medicines to reverse this effect and will ensure that anaesthesia and artificial respiration are continued until you are able to breathe on your own again.

Other questions

If you have any other questions about the use of this medicine, ask your doctor, pharmacist or nurse.

Information for healthcare professionals, please see 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 you get any of the following side effects, tell your doctor or nurse immediately:

Very rare (may affect up to 1 in 10,000 people):

Hypersensitivity reactions (allergic reactions) and associated symptoms. A hypersensitivity reaction may include rash, itching, difficulty breathing, low blood pressure, fast heart rate, circulatory collapse, shock or swelling of the face, lips, throat or tongue, hives, rash, skin redness. In addition, during anaesthesia, a situation may occur in which you have difficulty with your respiratory system (complication of the airways of anaesthesia).

Frequency not known (cannot be estimated from the available data):

• Stopping breathing.
• Respiratory failure.
• Allergic and severe spasm of the coronary blood vessels (Kounis syndrome) that causes chest pain (angina) or heart attack (myocardial infarction).

Other side effects include:

Uncommon/rare (may affect between 1 and 10 in 1,000 people):

• Increased heart rate (tachycardia)*.
• Delayed recovery from anaesthesia.
• Decrease in blood pressure (hypotension).
• Lack of effect of the medicine.
• Increased or decreased effect of the medicine in general.
• Increased or decreased response of your body to this medicine.
• Pain at the injection site.
• Prolongation of the effect of muscle relaxation (prolongation of 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 this medicine in the ICU, especially if administered with corticosteroids).

Frequency not known (cannot be estimated from the available data):

• Dilated pupils (mydriasis) or unreactive pupils that do not change size with light or other stimuli.

*Clinical studies suggest that in paediatric patients, an increased heart rate is common and may affect up to 1 in 10 people.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist or nurse, even if they are not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Surveillance System for Human Use: www.notificaRAM.es

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Rocuronium B. Braun

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 of the vial and the carton (after 'EXP'). The expiry date is the last day of the month shown.

Do not store above 25°C.

After first opening: the product should be used immediately after opening the ampoule.

After dilution: Chemical and physical stability has been demonstrated for 24 hours at room temperature, exposed to ambient light, in glass and plastic containers, for 5.0 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).

From a microbiological point of view, the diluted product should be used immediately. If not used immediately, in-use storage times and conditions before use are the responsibility of the user and normally should not be longer than 24 hours at 2-8°C, unless dilution has been made in a controlled and validated aseptic environment.

Do not use this medicine if you notice that the solution is not clear and is free of particles.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Rocuronium B. Braun

• The active substanceis rocuronium bromide.

1 ml contains 10 mg of rocuronium bromide.

Each 5 ml ampoule contains a total of 50 mg of rocuronium bromide.

• The other ingredientsare gluconolactone, sodium acetate trihydrate, sodium citrate dihydrate

and water for injections.

Appearance and pack size of the product

Rocuronium B. Braunis a clear, colourless to pale brownish-yellow solution for injection or infusion.

Pack sizes:

Rocuronium B. Braun is available in packs of 20 plastic ampoules of 5 ml solution.

Marketing authorisation holder and manufacturer

• 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

This medicine is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Date of last revision of this leaflet: May 2024.

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This information is intended only for healthcare professionals:

Preparation guide for:

Rocuronium B. Braun 10 mg/ml Solution for Injection and Perfusion EFG

It is important that you read all of the contents of this guide before preparing this medicine.

Preparation for intravenous administration

For single use only.

Rocuronium B. Braun is administered intravenously by simple injection or continuous infusion.

Rocuronium B. Braun has been shown to be compatible with: sodium chloride 9 mg/ml (0.9%) and glucose 50 mg/ml (5%) solutions.

Unused solutions should be discarded.

This medicine should not be mixed with other medicines that are not mentioned above.

Chemical incompatibility of Rocuronium B. Braun has been demonstrated when added to solutions containing the following active substances: amphotericin, amoxicillin, azathioprine, cefazolin, cloxacillin, dexamethasone, diazepam, enoximone, erythromycin, famotidine, furosemide, sodium hydrocortisone succinate, insulin, Intralipid, methohexital, methylprednisolone, sodium prednisolone succinate, thiopental, trimethoprim and vancomycin.

If Rocuronium B. Braun is administered through the same infusion line as other medicines, it is important that the infusion line is properly flushed, e.g. with sodium chloride 9 mg/ml (0.9%) solution for infusion, between the administration of Rocuronium B. Braun and other medicines with demonstrated or unknown incompatibility with Rocuronium B. Braun.