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

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Rocuronium 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 questions, ask your doctor, pharmacist or nurse.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any side effects not listed in this leaflet. See section 4.

Contents of this leaflet:

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

2. What you need to know before using Rocuronium Kabi

3. How to use Rocuronium Kabi

4. Possible side effects

5. How to store Rocuronium Kabi

6. Contents of the pack and other information

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

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

Normally, nerves send messages to muscles through impulses. Rocuronium Kabi works by blocking these impulses, causing the muscles to relax.

When you undergo surgery, your muscles need to be completely relaxed. This makes it easier for the surgeon to perform the procedure.

Rocuronium Kabi may also be used if you are under anesthesia to facilitate the insertion of a tube into your trachea for mechanical ventilation (artificial respiratory support).

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

Rocuronium Kabi may also be used in adults only as an adjunct in the intensive care unit (ICU) (for example, to facilitate tracheal intubation) for short-term use.

2. What you need to know before using Rocuronium Kabi

Do not use Rocuronium Kabi

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

Warnings and precautions

Consult your doctor, pharmacist, or nurse before using Rocuronium Kabi if any of the following conditions apply to you or have affected you in the past:

• if you are allergic to other muscle relaxants
• if you have kidney disease, liver disease, or gallbladder disease
• if you have heart disease or a condition affecting blood circulation
• if you have edema (e.g., in the ankle area)
• if you have a disease affecting nerves and muscles (neuromuscular diseases, e.g., polio (poliomyelitis), myasthenia gravis, Lambert-Eaton syndrome)
• if you have ever developed abnormally low body temperature during anesthesia (hypothermia)
• if you have a history of malignant hyperthermia (sudden fever with rapid heartbeat, fast breathing, and muscle stiffness, pain, and/or weakness)
• if you have a fever
• if you have low calcium levels in the blood (hypocalcemia), (for example, caused by massive transfusions)
• if you have low potassium levels in the blood (hypokalemia), (for example, caused by severe vomiting, diarrhea, or diuretic therapy)
• if you have high magnesium levels in the blood (hypermagnesemia)
• if you have low protein levels in the blood (hypoproteinemia)
• if you are dehydrated
• if you have an increased level of acids in the blood (acidosis)
• if you have an increased level of carbon dioxide in the blood (hypercapnia)
• if you suffer from excessive weight loss (cachexia)
• if you are obese or elderly
• if you have burns
• if you have a rare tumor of the adrenal glands (pheochromocytoma); this may increase the risk of severe high blood pressure

Use of Rocuronium Kabi with other medicines

Inform 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 conditions 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 to prevent transplant rejection and to treat
  autoimmune diseases)
• medicines used to treat or prevent viral infections (protease inhibitors: gabexate, ulinastatin)

To keep in mind:

You may be given other medicines during the procedure that could influence the effects of rocuronium. These include certain anesthetics (e.g., local anesthetics, inhaled anesthetics) and other muscle relaxants. Your doctor will take this into account when determining the correct dose of rocuronium for you.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor, pharmacist, or nurse before using this medicine.

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

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

Breastfeeding should be suspended for 6 hours after using this medicine.

Driving and use of machines

Rocuronium Kabi has a major influence on driving and operating machinery.

Therefore, driving a car or operating potentially dangerous machinery is not recommended during the first 24 hours.

Your doctor should advise you on when you may resume driving or operating machinery. After treatment, you must always be accompanied home by a responsible adult.

Rocuronium Kabi contains sodium

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

3. How to use Rocuronium Kabi

Your anaesthetist will administer Rocuronium Kabi to you. It will be given intravenously as a single injection or as a continuous infusion (over a prolonged 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 Rocuronium Kabi is continuously monitored.

If necessary, additional doses may be administered. Your anaesthetist will adjust the dose according to your individual needs, depending on various factors such as drug interactions (cross-activity), the anticipated duration of surgery, your age, and your clinical condition. For paediatric patients and elderly individuals, the use of Rocuronium Kabi as a supplement 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 that the rate of continuous infusion in children (2–11 years) may be higher than in adults. The anaesthetist will adjust the infusion rate accordingly.

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

If you receive more Rocuronium Kabi than you should

Your anaesthetist will carefully monitor you while you are receiving Rocuronium Kabi, so it is unlikely that you will receive too much. If this does occur, your anaesthetist will ensure that anaesthesia and artificial ventilation are continued until you are able to breathe on your own again.

Other questions

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

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

4. Possible adverse effects

Like all medicines, Rocuronium Kabi may cause adverse effects, although not everyone experiences them.

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

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

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 ineffective
• The medicine lasts longer than expected (prolongation of neuromuscular blockade)
• The medicine prolongs narcosis (delays recovery from anesthesia)
• Decreased blood pressure (hypotension)
• Increased heart rate (tachycardia)

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

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

Unknown frequency

• Respiratory failure
• Cessation of breathing (apnea)
• Severe allergic coronary artery spasm (Kounis syndrome), which may cause chest pain (angina) or heart attack (myocardial infarction)
• Dilated pupils (mydriasis) or fixed pupils that do not change size in response to light or other stimuli

Paediatric patients:

In clinical studies with paediatric patients treated with rocuronium bromide, the adverse effect increased heart rate occurred in 1 out of 10 people.

Reporting of adverse effects

If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Rocuronium 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 container after EXP.

The expiry date refers to the last day of the month indicated.

Unopened vial: This medicine does not require 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 clear or free from particles.

Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of Rocuronium 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 components are sodium acetate, sodium chloride, sodium hydroxide, hydrochloric acid, and water for injections.

Appearance of the product and contents of the container

Rocuronium Kabi is a clear, colourless or pale yellowish-brown injectable solution for infusion.

Pack sizes:

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

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Holder:

Fresenius Kabi España S.A.U
Marina 16-18
08005 Barcelona
Spain

Manufacturer:

Fresenius Kabi Austria GmbH
Hafnerstraße 36
8055 Graz
Austria

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

Date of the most recent review of this leaflet: January 2024

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

This information is intended for healthcare professionals only:

For single use only.

Unused solutions must be discarded.

The medicine should be used immediately after opening the vial.

After dilution: Physical and chemical stability in use of the diluted product has been demonstrated for 72 hours at temperatures up to 30°C.

From a microbiological standpoint, the medicine 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 adequately flush the infusion line (e.g., with sodium chloride 9 mg/ml (0.9%) between the administration of rocuronium bromide and other medicines with which rocuronium bromide has been shown to be incompatible or for which compatibility with rocuronium bromide has not been demonstrated.

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

Physical incompatibility for Rocuronio Kabi has been documented 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.