PROSPECTO : INFORMATION FOR THE USER

Rocuronio Kabi 10 mg/ml injectable solution and for infusion EFG

Bromide of rocuronium

Read this prospectus carefully before starting to use this medicine as it contains important information for you.

-Keep this prospectus, 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 prospectus.See section 4.

1.What is Rocuronio Kabi and what it is used for

2.What you need to know before starting to use Rocuronio Kabi

3.How to use Rocuronio Kabi

4.Possible adverse effects

5Storage of Rocuronio Kabi

6.Contents of the package and additional information

Rocuronio Kabibelongs to a group of medicines called muscle relaxants.

Normally, nerves send messages to muscles through impulses. Rocuronio Kabi acts by blocking these impulses so that muscles relax.

When undergoing an operation, muscles must be completely relaxed. This makes it easier for the surgeon to perform the operation.

Rocuronio Kabi can also be used if you are anesthetized to facilitate the insertion of a tube into the trachea for artificial ventilation (mechanical respiratory assistance).

Rocuronio Kabi is indicated for adults and neonates (0-27 days), infants and small children (28 days to 23 months), children between 2 and 11 years, and adolescents between 12 and 17 years.

Rocuronio Kabi can also be used in adults only as an adjunct in the intensive care unit (ICU) (for example, to facilitate the insertion of a tube into your trachea) for short-term use.

No use Rocuronio Kabi

-If you areallergicto bromide rocuronio, bromide ion 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 Rocuronio Kabi if any of the following conditions affect you or have affected you in the past:

-If you areallergicto other muscle relaxants

-If you have a kidney disease, liver disease orgallbladder disease

-If you have aheart diseaseor a disease that affects blood circulation

-If you have anedema(e.g. in the ankle area)

-If you have aneuromuscular disease(e.g. polio (poliomyelitis), myasthenia gravis, Eaton-Lambert syndrome)

-If you have ever developedhypothermiaduring anesthesia

-If you have a history ofmalignant hyperthermia(sudden fever with rapid heart rate, rapid breathing and stiffness, pain and/or weakness in the muscles)

-If you havefever

-If you have alow calcium levelin the blood (hypocalcaemia), (caused for example by massive transfusions)

-If you have alow potassium levelin the blood (hypokalemia), (caused for example by severe vomiting, diarrhea and diuretic therapy)

-If you have ahigh magnesium levelin the blood (hypermagnesemia)

-If you have alow protein levelin the blood (hypoproteinemia)

-If you suffer fromdehydration

-If you have anincrease in the amount of acidsin the blood (acidosis)

-If you have anincrease in the amount of carbon dioxidein the blood (hypercapnia)

-If you suffer from anexcessive weight loss(caquexia)

-If you areobeseorelderly

-If you haveburns

Use of Rocuronio Kabi with other medications

Inform your doctor or pharmacist if you are using or have used recently other medications, such as:

-antibiotics

-antidepressants:medications used to treat depression (e.g. lithium salts, MAO inhibitors)

-medications used to treatheart diseaseorhigh blood pressure(e.g. quinidine, calcium channel blockers, adrenergic blockers (e.g. beta-blockers)

-diuretics(medications that increase urine production)

-some laxatives such asmagnesium salts

-quinine (used to treat pain and infections)

-medications used to treatepilepsy(e.g. phenytoin, carbamazepine)

-corticosteroids

-medications used to treatmyasthenia gravis(neostigmine, pyridostigmine)

-azathioprine(used to prevent transplant rejection and treat autoimmune diseases)

-medications used to treat or prevent a viral infection (protease inhibitors:gabexate, ulinastatin)

Important note:

You may be given other medications during the procedure that can affect the effects of rocuronio. These include certain anesthetics (e.g. local anesthetics, inhalation anesthetics) and other muscle relaxants. Your doctor will take this into account when deciding the correct dose of rocuronio for you.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor, pharmacist or nurse before using this medication.

There are no clinical data on the use of Rocuronio Kabi during pregnancy and breastfeeding.

Rocuronio Kabi should be administered to pregnant women or breastfeeding women only when the doctor decides that the benefits outweigh the risks. Rocuronio Kabi can be used during cesarean section.

Breastfeeding should be suspended 6 hours after the use of this medication.

Driving and operating machinery

Rocuronio Kabi has a significant effect on driving and operating machinery.

Therefore, it is not recommended to drive a car or operate potentially hazardous machinery during the first 24 hours.

Your doctor should advise you on when to start driving or operating machinery again. After treatment, you should always be accompanied home by a responsible adult.

Rocuronio Kabi contains sodium

This medication contains 3.3 mg of sodium (main component of table salt) in each ml. This is equivalent to 0.17% of the maximum recommended daily sodium intake for an adult.

Your anesthesiologist will administer Rocuronio Kabi to you. It will be administered intravenously as a single injection or as a continuous infusion (over a long period of time) in a vein.

The usual dose is 0.6 mg per kg of body weight and its effect lasts 30-40 minutes. During surgery, the effect of Rocuronio Kabi is continuously monitored.

If necessary, additional doses may be administered to you. Your anesthesiologist will adjust the dose according to your needs. This depends on many factors, such as the interaction between medications (their cross-activity), taking into account the estimated duration of surgery as well as your age and clinical condition. For pediatric patients and elderly individuals, the use of Rocuronio Kabi as a supplement in the intensive care unit is not recommended.

Use in Children and Adolescents

For neonates (0-27 days), infants, and small children (28 days – 23 months), children (2-11 years), and adolescents (12-17 years), the recommended doses are similar to those for adults, except for the speed of the continuous infusion in children (2-11 years), which may be higher than in adults. The anesthesiologist will adjust the infusion speed accordingly.

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

If You Receive More Rocuronio Kabi Than You Should

Your anesthesiologist will closely monitor you under medication with Rocuronio Kabi, so it is unlikely that you will receive too much Rocuronio Kabi. If this happens, your anesthesiologist will ensure that anesthesia and artificial ventilation continue until you breathe on your own again.

Other Questions

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

For information intended for healthcare professionals, see the corresponding section below.

Like all medicines, Rocuronio Kabi can cause side effects, although not everyone will experience them.

Allergic reactions (hypersensitivity reactions) are very rare but can be life-threatening. An allergic reaction may include skin rash, itching, difficulty breathing or swallowing in the face, lips, throat, or tongue.

Please inform your doctor or nurse immediately if any of these reactions occur.

Rare(may affect up to 1 in 100 people)/ Very rare(may affect up to 1 in 1,000 people):

• Pain at the injection site

• The medicine is too effective, not effective enough, or ineffective.
• The medicine acts for longer than expected (prolonged neuromuscular blockade)
• The medicine prolongs anesthesia (delays recovery from anesthesia)
• Decreased blood pressure (hypotension)
• Increased heart rate (tachycardia)

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

• Increased histamine levels (mediator of allergic reactions) in the blood
• Difficulty breathing (bronchospasm)
• Rash, itching
• Redness
• Swelling of the face (facial edema)
• Severe and widespread skin rash (exanthema, erythematous rash)
• Muscle weakness (myopathy)
• Swelling (angioedema)
• Urticaria
• Loss of movement (flaccid paralysis)
• Circulatory failure (circulatory collapse and shock)
• Difficulty breathing (respiratory failure, apnea)

Unknown

• Respiratory failure
• Stop breathing (apnea)
• Severe allergic coronary artery spasm (Kounis syndrome) that can cause chest pain (angina) or heart attack (myocardial infarction)
• Dilated pupils (mydriasis) or fixed pupils that do not change size with light or other stimuli

Pediatric patients:

In clinical studies with pediatric patients treated with rocuronium bromide, the adverse effect

increased heart rate appeared in 1 in 10 people.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting adverse 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 packaging after CAD.

The expiration date is the last day of the month indicated.

Unopened vial: This medication does not require special storage conditions.

The medication must be used immediately after opening the vial.

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

Do not dispose of any medication through the drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you do not need. In this way, you will help protect the environment.

Composition of Rocuronio Kabi

The active principle is bromide of rocuronium

Each ml contains 10 mg of bromide of rocuronium.

Each vial of 5 ml contains 50 mg bromide of rocuronium.

Each vial of 10 ml contains 100 mg bromide of rocuronium.

The other components are sodium chloride acetate, sodium hydroxide, hydrochloric acid and water for injectable preparations.

Aspect of the product and content of the packaging

Rocuroni Kabi is a transparent, colorless or pale yellow-brown injectable or perfusion solution.

Formats:

Rocuronio Kabi is available in vials of 5 or 10 with 5 ml or 10 ml of solution.

Only some sizes of packaging may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder:

Fresenius Kabi España S.A.U

Marina 16-18

08005 Barcelona

Spain

Responsible for manufacturing:

Fresenius Kabi Austria GmbH

Hafnerstraße 36

8055 Graz

Austria

This medicine is authorized in the member states of the European Economic Areaand the United Kingdom (Northern Ireland)with the following names:

Last review date of this leaflet: January 2024

The detailed and updated information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Products (AEMPS)http://www.aemps.gob.es

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This information is intended solely for healthcare professionals:

For single use only.

Unused solutions must be discarded.

The medicine must be used immediately after opening the vial.

After dilution: Physical and chemical stability has been demonstrated for 72 hours at a temperature of up to 30°C.

From a microbiological point of view, the medicine must be used immediately. If not used immediately, the previous storage times and conditions prior to use are the responsibility of the user and should not exceed 24 hours at 2 – 8°C, unless the dilution has been carried out under validated aseptic conditions.

Rocuronio Kabi has been shown to be compatible with: sodium chloride 9 mg/ml (0.9%), glucose 50 mg/ml (5%), glucose 5 mg/ml (5%) in sodium chloride 9 mg/ml (0.9%), Ringer Lactate solution and sterile water for injection.

If Rocuronio Kabi is administered through the same infusion line as other medicines, it is essential to properly clean the infusion line (e.g. with sodium chloride 9 mg/ml (0.9 %) between the administration of bromide of rocuronium and other medicines for which incompatibility with bromide of rocuronium has been demonstrated or for which compatibility with bromide of rocuronium has not been demonstrated.

The medicine must not be mixed with other medicines except those mentioned above.

Incompatibility has been documented for Rocuronio Kabi when added to solutions containing the following active substances: amphotericin, amoxicillin, azathioprine, cefazolin, cloxacillin, dexamethasone, diazepam, enoximone, erythromycin, famotidine, furosemide, sodium succinate of hydrocortisone, insulin, lipid emulsion, methohexital, methylprednisolone, sodium succinate of prednisolone, thiopental, trimethoprim and vancomycin.