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ROCURONIUM KABI 10 mg/ml INJECTABLE SOLUTION AND PERFUSION SOLUTION

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About the medicine

How to use ROCURONIUM KABI 10 mg/ml INJECTABLE SOLUTION AND PERFUSION SOLUTION

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This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.

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Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

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

Rocuronium bromide

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

  • Keep this leaflet, you may need to read it again.
  • If you have any further questions, ask your doctor, pharmacist or nurse.
  • If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information:

  1. What is Rocuronio Kabi and what is it used for
  2. What you need to know before you use Rocuronio Kabi
  3. How to use Rocuronio Kabi
  4. Possible side effects

5 Conservation of Rocuronio Kabi

  1. Contents of the pack and further information

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

Rocuronio Kabi belongs to a group of medicines called muscle relaxants.

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

When you are having an operation, your 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 under anesthesia to facilitate the insertion of a tube into your trachea for artificial ventilation (mechanical respiratory assistance).

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

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

Doctor consultation

Not sure if this medicine is right for you?

Discuss your symptoms and treatment with a doctor online.

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

Do not use Rocuronio Kabi

  • If you are allergic to rocuronium bromide, bromide ion or any of the other components of this medicine (listed in section 6).

Components of this medicine (listed in section 6).

Warnings and precautions

Tell your doctor, pharmacist or nurse before starting treatment with Rocuronio Kabi if any of the following conditions apply to you or have applied in the past:

  • If you are allergic to other muscle relaxants
  • If you have kidney, liver or gallbladder disease
  • If you have heart disease or a disease that affects blood circulation
  • If you have edema (e.g. in the ankle area)
  • If you have a disease that affects the nerves and muscles (neuromuscular diseases, e.g. polio (poliomyelitis), myasthenia gravis, Eaton-Lambert syndrome)

Diseases that affect the nerves and muscles (neuromuscular diseases, e.g. polio (poliomyelitis), myasthenia gravis, Eaton-Lambert syndrome)

  • If you have ever developed a body temperature that is too low during anesthesia (hypothermia)
  • If you have a history of malignant hyperthermia (sudden fever with rapid heart rate, rapid breathing and stiffness, pain and/or weakness in the muscles)
  • If you have a fever
  • If you have low calcium levels in your blood (hypocalcemia), (caused for example by massive transfusions)
  • If you have low potassium levels in your blood (hypokalemia), (caused for example by severe vomiting, diarrhea and diuretic therapy)
  • If you have high magnesium levels in your blood (hypermagnesemia)
  • If you have low protein levels in your blood (hypoproteinemia)
  • If you are dehydrated
  • If you have an increase in acid levels in your blood (acidosis)
  • If you have an increase in carbon dioxide levels in your blood (hypercapnia)
  • If you are suffering from excessive weight loss (cachexia)
  • If you are obese or elderly
  • If you have burns

Using Rocuronio Kabi with other medicines

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

  • Antibiotics
  • Antidepressants: medicines used to treat depression (e.g. lithium salts, MAO inhibitors)
  • Medicines used to treat heart diseases or high blood pressure (e.g. quinidine, calcium channel blockers, adrenergic blockers (e.g. beta blockers)
  • Diuretics (medicines that increase urine production)
  • Certain laxatives such as magnesium salts
  • Quinine (used to treat pain and infections)
  • Medicines used to treat epilepsy (e.g. phenytoin, carbamazepine)
  • Corticosteroids
  • Medicines used to treat myasthenia gravis (neostigmine, pyridostigmine)
  • Azathioprine (used for the prevention of transplant rejection and the treatment of autoimmune diseases)

Autoimmune diseases)

  • Medicines used to treat or prevent viral infections (protease inhibitors: gabexate, ulinastatin)

To be considered:

You may be given other medicines during the procedure that may affect the effects of rocuronium. 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 rocuronium for you.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor, pharmacist or nurse for advice before using this medicine.

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

Rocuronio Kabi should be administered to pregnant 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 discontinued 6 hours after the use of this medicine.

Driving and using machines

Rocuronio Kabi has a major influence on the ability to drive and use machines.

Therefore, it is not recommended to drive a car or use potentially dangerous machines during the first 24 hours.

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

Rocuronio Kabi contains sodium

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

3. How to use Rocuronio Kabi

Your anesthetist will administer Rocuronio Kabi to you. It will be given to you intravenously as a single injection or as a continuous infusion (over a long period of time) into 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, you may be given additional doses. Your anesthetist will adjust the dose according to your needs. It depends on many factors, such as the interaction between medicines (their cross-activity), taking into account the estimated duration of the surgery as well as your age and clinical condition. For pediatric patients and elderly people, the use of Rocuronio Kabi as an adjunct in the intensive care unit is not recommended.

Use in children and adolescents

For neonates (0-27 days), infants and young 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 continuous infusion in children (2-11 years), which may be higher than in adults. The anesthetist will adapt the infusion rate accordingly.

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 is not recommended in pediatric patients.

If you receive more Rocuronio Kabi than you should

Your anesthetist will carefully monitor you under medication with Rocuronio Kabi, so it is unlikely that you will be given too much Rocuronio Kabi. If this happens, your anesthetist will ensure that anesthesia and artificial ventilation are continued until you can breathe on your own again.

Other questions

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

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

Medicine questions

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4. Possible side effects

Like all medicines, Rocuronio Kabi can cause side effects, although not everybody gets them.

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

Please inform your doctor or nurse immediately if one of these reactions occurs.

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

  • Pain at the injection site
  • The medicine is too effective, not effective enough or is ineffective.
  • The medicine works for longer than expected (prolongation of neuromuscular blockade)
  • The medicine prolongs anesthesia (delays recovery from anesthesia)
  • Decrease in blood pressure (hypotension)
  • Increased heart rate (tachycardia)

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

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

Unknown

  • Respiratory failure
  • Stopping breathing (apnea)
  • Severe allergic coronary artery spasm (Kounis syndrome) that can cause chest pain (angina) or a 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 of increased heart rate occurred in 1 in 10 people.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Spanish Medicines Agency's website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Conservation of Rocuronio Kabi

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 carton after EXP.

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

Unopened vial: This medicine does not require any special storage conditions.

The medicine should be used immediately after opening the vial.

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

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of Rocuronio Kabi

The active substance is rocuronium bromide

Each ml contains 10 mg of rocuronium bromide.

Each 5 ml vial contains 50 mg of rocuronium bromide.

Each 10 ml vial contains 100 mg of rocuronium bromide.

The other ingredients are sodium acetate, sodium chloride, sodium hydroxide, hydrochloric acid and water for injections.

Appearance of the product and pack contents

Rocuronio Kabi is a clear, colorless or pale yellow-brown solution for injection or infusion.

Formats:

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

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Fresenius Kabi España S.A.U.

Marina 16-18

08005 Barcelona

Spain

Manufacturer:

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) under the following names:

Austria

Rocuroniumbromid Kabi 10 mg/ml Injektionslösung / Infusionslösung

Belgium

Rocuronium bromide Fresenius Kabi 10 mg/ml oplossing voor injectie/infusie / solution injectable/solution pour perfusion / Injektionslösung/Infusionslösung

Bulgaria

?????????? ???? 10 mg/ml ???????????/?????????? ???????

Croatia

Rokuronijev bromid Fresenius Kabi 10 mg/ml otopina za injekciju/infuziju

Czech Republic

Rocuronium Fresenius Kabi

Estonia

Rocuronium bromide Fresenius Kabi

Germany

Rocuroniumbromid Kabi 10 mg/ml Injektionslösung / Infusionslösung

Denmark

Rocuronium Fresenius Kabi

Finland

Rocuronium Fresenius Kabi 10 mg/ml injektio-/infuusioneste, liuos

France

ROCURONIUM KABI 10 mg/mL, solution injectable/pour perfusion

Hungary

Rocuronium Fresenius Kabi 10 mg/ml oldatos injekció vagy infúzió

Ireland

Rocuronium 10 mg/ml solution for injection / infusion

Italy

Rocuronio Kabi 10 mg/ml Soluzione iniettabile o per infusione

Malta

Rocuronium Kabi 10 mg/ml solution for injection/infusion

Netherlands

Rocuroniumbromide Fresenius Kabi 10 mg/ml oplossing voor injectie/infusie

Norway

Rokuroniumbromid Fresenius Kabi

Poland

Rocuronium Kabi

Portugal

Brometo de Rocurónio Kabi

Romania

Rocuronium Kabi 10 mg/ml, solutie injectabila/perfuzabila

Slovakia

Rocuronium Fresenius Kabi 10 mg/ml

Slovenia

Rokuronijev bromid Kabi 10 mg/ml raztopina za injiciranje/infundiranje

Spain

Rocuronio Kabi 10 mg/ml solución inyectable y para perfusión EFG

Sweden

Rocuronium Fresenius Kabi injektions-/infusionsvätska, lösning

United Kingdom

(Northern Ireland)

Rocuronium 10 mg/ml solution for injection / infusion

Date of last revision of this leaflet: January 2024

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es

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This information is intended only for healthcare professionals:

For single use only.

Unused solutions should be discarded.

The medicine should be used immediately after opening the vial.

After dilution: The physical and chemical stability of the diluted product has been demonstrated for 72 hours at a temperature of up to 30°C.

From a microbiological point of view, the product should be used immediately. If not used immediately, the 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's lactate solution and sterile water for injections.

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

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

Physical 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 hydrocortisone succinate, insulin, lipid emulsion, methohexital, methylprednisolone, sodium prednisolone succinate, thiopental, trimethoprim and vancomycin.

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Tomasz Grzelewski

Dermatology 21 years exp.

Dr Tomasz Grzelewski is an MD, PhD specialist in allergy, paediatrics, general practice and sports medicine, with a clinical focus on dermatology, endocrinology, allergology and sports-related health. He has more than 20 years of clinical experience and completed his medical training at the Medical University of Łódź, where he defended his PhD thesis with distinction. His doctoral research was recognised by the Polish Society of Allergology for its innovative contribution to the field. Throughout his career, he has gained extensive expertise in diagnosing and managing a wide range of allergic and paediatric conditions, including modern allergen desensitisation techniques. For five years, Dr Grzelewski served as the Head of two paediatric departments in Poland, managing complex clinical cases and leading multidisciplinary teams. He also worked in medical centres in the United Kingdom, gaining experience across both primary care and specialist environments. With over a decade of telemedicine experience, he has provided online consultations across Europe and is valued for his clear, structured and evidence-based medical guidance. Dr Grzelewski is actively involved in clinical programmes focused on modern anti-allergic therapies. As a Principal Investigator, he leads research projects on sublingual and oral allergen desensitisation, supporting evidence-based progress in allergy treatment for both children and adults. In addition to his background in allergology and paediatrics, he completed dermatology studies through the Cambridge Education Group (Royal College of Physicians of Ireland) and a Clinical Endocrinology course at Harvard Medical School. This advanced training enhances his ability to manage skin manifestations of allergies, atopic conditions, urticaria, endocrine-related symptoms and complex immunological reactions. Patients commonly seek his care for: 

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Dr Tomasz Grzelewski is known for his clear communication style, structured medical approach and ability to explain treatment options in a concise and accessible way. His multidisciplinary background across allergy, paediatrics, dermatology and endocrinology allows him to provide safe, up-to-date and comprehensive care for patients of all ages.

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Yevgen Yakovenko

General surgery 12 years exp.

Dr. Yevgen Yakovenko is a licensed surgeon and general practitioner in Spain and Germany. He specialises in general, paediatric, and oncological surgery, internal medicine, and pain management. He offers online consultations for adults and children, combining surgical precision with therapeutic support. Dr Yakovenko works with patients across different countries and provides care in Ukrainian, Russian, English, and Spanish.

Areas of medical expertise:

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  • 12+ years of clinical experience in university hospitals in Germany and Spain.
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If you are unsure about a diagnosis, preparing for surgery, or want to discuss your test results – Dr Yakovenko will help you evaluate your options and move forward with confidence.

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Joao Silva

General medicine 6 years exp.

Dr. João Silva is a physician with training and experience in the field of General and Family Medicine, dedicated to providing healthcare focused on the well-being and quality of life of his patients. Throughout his professional career, he has developed broad clinical competencies, striving to maintain a medical practice based on scientific evidence and continuous knowledge updates.

Between 2013 and 2019, he completed the Integrated Master's Degree in Medicine at the Abel Salazar Institute of Biomedical Sciences in Porto, where he acquired a solid academic and clinical education.

Subsequently, between January 2021 and December 2021, he completed the General Internship at the Entre Douro e Vouga Hospital Center in Santa Maria da Feira, where he had the opportunity to work in different hospital settings and deepen his competencies in several areas of medicine.

From January 2022 until March 2026, he works as a Resident Physician in General and Family Medicine at USF Salvador Machado in Oliveira de Azeméis, developing clinical activities in primary healthcare, follow-up of chronic patients, and health promotion in the community.

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Bulat Garipov

General medicine 15 years exp.

Dr. Bulat Garipov is a radiologist with more than 15 years of experience, specializing in magnetic resonance imaging (MRI). Throughout his professional career, he has worked in leading diagnostic imaging centers, both in on-site practice and teleradiology, which has allowed him to develop a broad and versatile approach to radiology.

Over the years, he has gained solid experience in interpreting MRI studies in various areas, including:

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You could consult Dr. Bulat Garipov in cases where accurate interpretation of MRI studies or a second expert opinion is required. His expertise is especially valuable in cases of suspected neurological conditions, back and joint pain, vascular disorders, as well as in the diagnosis of abdominal and pelvic diseases. The doctor also provides support in complex or unclear clinical situations, including the review of previously performed studies, which helps improve diagnostic accuracy and determine the optimal treatment strategy. A teleradiology format is available, allowing you to receive a professional opinion remotely.

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Frequently Asked Questions

Is a prescription required for ROCURONIUM KABI 10 mg/ml INJECTABLE SOLUTION AND PERFUSION SOLUTION?
ROCURONIUM KABI 10 mg/ml INJECTABLE SOLUTION AND PERFUSION SOLUTION requires a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.
What is the active substance in ROCURONIUM KABI 10 mg/ml INJECTABLE SOLUTION AND PERFUSION SOLUTION?
The active ingredient in ROCURONIUM KABI 10 mg/ml INJECTABLE SOLUTION AND PERFUSION SOLUTION is rocuronium bromide. This information helps identify medicines with the same composition but different brand names.
Who manufactures ROCURONIUM KABI 10 mg/ml INJECTABLE SOLUTION AND PERFUSION SOLUTION?
ROCURONIUM KABI 10 mg/ml INJECTABLE SOLUTION AND PERFUSION SOLUTION is manufactured by Fresenius Kabi España, S.A.U.. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of ROCURONIUM KABI 10 mg/ml INJECTABLE SOLUTION AND PERFUSION SOLUTION online?
Doctors such as Family doctors, Psychiatrists, Dermatologists, Cardiologists, Endocrinologists, Gastroenterologists, Pulmonologists, Nephrologists, Rheumatologists, Hematologists, Infectious disease physicians, Allergists, Geriatricians, Paediatricians, Oncologists may assess whether ROCURONIUM KABI 10 mg/ml INJECTABLE SOLUTION AND PERFUSION SOLUTION is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.
What are the alternatives to ROCURONIUM KABI 10 mg/ml INJECTABLE SOLUTION AND PERFUSION SOLUTION?
Other medicines with the same active substance (rocuronium bromide) include ESMERON 10 mg/ml INJECTABLE SOLUTION AND PERFUSION SOLUTION, ROCURONIUM AGUETTANT 10 mg/mL Injectable Solution in Pre-filled Syringe, ROCURONIUM B. BRAUN 10 mg/ml INJECTABLE SOLUTION AND PERFUSION SOLUTION. These may have different brand names or formulations but contain the same therapeutic ingredient. Always consult a doctor before switching or starting a new medicine.
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