Leaflet: information for the user

Rocuronio B. Braun 10 mg/ml injectable solution and for infusion EFG

bromuro de rocuronio

Read the entire leaflet carefully before using the medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist or nurse.
• If you experience adverse effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

1. What is Rocuronio B. Braun and for what it is used

2. What you need to know before starting to use Rocuronio B. Braun

3. How to use Rocuronio B. Braun

4. Possible adverse effects

5. Storage of Rocuronio B. Braun

6. Contents of the package and additional information

Rocuronio B. Braun belongs to a group of medications called muscle relaxants. Normally, nerves send messages to muscles through impulses. Rocuronio B. Braun acts by blocking these impulses, causing muscles to relax.

When you must undergo an operation, your muscles must be completely relaxed. This facilitates the operation for the surgeon.

Inadults and children, if you are under general anesthesia, Rocuronio B. Braun may be used to facilitate the insertion of a tube into your trachea to help you breathe (mechanical respiratory assistance) and to ensure that your muscles are relaxed during the operation.

If you are anadult, your doctor may also use this medication for a brief time as a complementary medication in the intensive care unit (ICU), (for example, to facilitate the insertion of a tube into your trachea). Additionally, you may receive this medication each time there is an emergency and you need a tube quickly inserted into your trachea to prepare you for the operation.

Do not use Rocuronio B. Braun:

• If you areallergicto rocuronio, bromide or any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor, pharmacist or nurse before starting to use this medication:

• If you areallergicto any muscle relaxant.
• If you have kidney, liver or gallbladder disorders.
• If you suffer from heart disease or circulatory disorders.
• If any part of your body is inflamed due to water accumulation (e.g., edema in the ankle area).
• If you suffer from nerve and muscle disorders (e.g., polio, myasthenia gravis, Eaton-Lambert syndrome).
• If you have low levels of calcium in your blood (hypocalcemia), caused for example by massive blood transfusions.
• If you have low levels of potassium in your blood (hypokalemia), caused for example by severe vomiting, diarrhea and diuretic therapy.
• If you have high levels of magnesium in your blood (hypermagnesemia).
• If you have low levels of proteins in your blood (hypoproteinemia).
• If you are dehydrated.
• If you have excessive acidity in your blood (acidosis).
• If you have excessive carbon dioxide in your blood (hypercapnia).
• If you suffer from excessive weight loss (caquexia).
• If you are overweight or of advanced age.
• If you have burns.

Use of Rocuronio B. Braun with other medications

Your doctor or pharmacist should be aware if you are taking, have taken recently or may need to take any other medication, such as:

• Antibiotics.
• Antidepressantscontaining lithium.
• Medications for the treatment of heart disease or high blood pressure (e.g., quinidine, calcium channel blockers, adrenergic blockers).
• Diuretics(medications to increase urine volume).
• Some laxatives, such asmagnesium salts.
• Quinine (used for pain and infection treatment),
• Medications forepilepsy treatment(e.g., phenytoin, carbamazepine),
• Long-term use ofcorticosteroidsin the ICU,
• Medications used formyasthenia gravis treatment(neostigmine, pyridostigmine, edrophonium, aminopyridine).
• Theophylline(used for asthma treatment).
• Medications used for the treatment and prevention of viral infections (protease inhibitors).

Important:

You may be administered other medications during the procedure that may affect the effects of rocuronio. These include certain anesthetics (e.g., local anesthetics, inhalation anesthetics), other muscle relaxants, protamines that reverse the anticoagulant effect (prevention of blood clot formation) of heparin. Your doctor should take this into account to decide the correct dose of rocuronio for you.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medication. Available data on the use of Rocuronio B. Braun in pregnant women are very limited and there is no data on breastfeeding. Rocuronio B. Braun should only be administered during pregnancy or breastfeeding if the doctor considers that the benefits outweigh the potential risks. Rocuronio B. Braun can be administered during cesarean section.

No data are available on the effect of this medication on fertility.

Driving and operating machinery

Rocuronio B. Braun has a significant effect on your ability to drive and operate machinery, so it is not recommended to drive or operate potentially hazardous machinery during the first 24 hours after complete recovery from the effects of this medication. Your doctor will inform you when you can drive and use machinery again. You should be accompanied home by an adult responsible person after receiving treatment.

Rocuronio B. Braun contains sodium

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

Rocuronio B. Braun must be administered by your anesthesiologist. It is administered intravenously via simple injection or 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 30 to 40 minutes. During surgery, the effect of Rocuronio B. Braun is continuously controlled. Therefore, your doctor may administer additional amounts of this medication, depending on your individual situation. You may be administered additional doses if necessary. Your anesthesiologist will adjust the dose to your needs. This depends on many factors, for example, possible interactions with other medications (cross-reactivity), the expected duration of the operation, your age, or your health status.

This medication is for single use only.

Use in children and adolescents

This medication may be administered to neonates (0 to 27 days), infants (28 days to 2 months), and small children (3 to 23 months), children (2 to 11 years), and adolescents (12 to ≤17 years). The anesthesiologist will adjust the dose according to the needs of your child. Your doctor will take into account that for children, higher infusion rates may be necessary.

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

Older patients, obese/overweight patients, and patients with liver and/or biliary diseases and/or renal insufficiency:

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

If you receive more Rocuronio B. Braun than you should

The anesthesiologist will be monitoring you while you are under the effects of the medication with Rocuronio B. Braun, so it is unlikely that you will receive an excess of Rocuronio B. Braun. If that occurs, it may increase muscle relaxation. Then, your anesthesiologist may administer medications to reverse this effect and will ensure that anesthesia and artificial respiration continue until you are able to breathe on your own again.

Other questions

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

Information for healthcare professionals, please see the section below.

Like all medicines, this medicine may cause side effects, although not everyone will experience 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):

Allergic reactions and symptoms associated with them. An allergic reaction may include rashes, itching, difficulty breathing, low blood pressure, rapid heart rate, circulatory collapse, shock, or swelling of the face, lips, throat, or tongue, urticaria, hives, redness of the skin. Additionally, during anesthesia, you may experience difficulty with your respiratory system (anesthesia airway complication).

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

• Stopping breathing.
• Respiratory failure.
• Severe allergic spasm and coronary artery spasm (Kounis syndrome) that causes chest pain (angina) or heart attack (myocardial infarction).

Other side effects include:

Rare (may affect between 1 and 10 in every 1,000 people):

• Increased heart rate (tachycardia)*.
• Delayed recovery from anesthesia.
• Low blood pressure (hypotension).
• Medication ineffectiveness.
• Increased or decreased effect of the medication in general.
• Increased or decreased body response to this medication.
• 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 muscle movement (flaccid paralysis).
• Muscle weakness (after long-term use of this medication in the ICU, especially if administered with cortisone).

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

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

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

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es

By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the vial label and the packaging (after «CAD»). The expiration date is the last day of the month indicated.

Do not store at a temperature above 25°C.

After the first opening:The product must be used immediately after the ampoule is opened.

After dilution:Chemical and physical stability has been demonstrated in use 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%) infusion solution).

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

Do not use this medication if you observe that the solution is not transparent and free of particles.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

Composition of Rocuronio B. Braun

• Theactive principleis bromide of rocuronio.

1 ml contains 10 mg of bromide of rocuronio.

Each ampoule of 5 ml contains a total content of 50 mg of bromide of rocuronio

• Theother componentsare gluconolactone, sodium acetate trihydrate, sodium citrate dihydrate

and water for injectable preparations.

Aspect of the product and content of the packaging

Rocuronio B. Braunis a transparent, colorless to pale yellowish-brown injectable or perfusion solution.

Package sizes:

Rocuronio B. Braun is available in 20 plastic ampoules with 5 ml of solution.

Holder of the marketing authorization and responsible for manufacturing

B. 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 authorized in the member states of the European Economic Areaand in the United Kingdom (Northern Ireland)with thefollowing names:

Last review date of this leaflet: May2024.

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This information is intended solely for healthcare professionals:

Guidelines for preparation for:

Rocuronio B. Braun 10 mg/ml injectable and perfusion solution EFG

It is essential that you read the entire content of this guide before preparing this medicine.

Preparation for intravenous administration

For single use.

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

Rocuronio 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 medications that are not mentioned above.

Rocuronio B. Braun has been shown to be incompatible with the following active substances when added to solutions: amphotericin, amoxicillin, azathioprine, cefazolin, cloxacillin, dexamethasone, diazepam, enoximone, erythromycin, famotidine, furosemide, sodium succinate of hydrocortisone, insulin, Intralipid, methohexital, methylprednisolone, sodium succinate of prednisolone, thiopental, trimethoprim and vancomycin.

If Rocuronio B. Braun is administered through the same infusion line as other medications, it is essential that the infusion line is properly drained, for example: with sodium chloride 9 mg/ml (0.9%) solution for infusion, between the administration of Rocuronio B. Braun and other medications that have been shown to be incompatible or not established with Rocuronio B. Braun.