Rocuronium Aguettant 10 mg/ml solution for injection in pre-filled syringe

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Rocuronio Aguettant 10 mg/ml solution for injection in pre-filled syringe

Rocuronium bromide

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

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

Leaflet contents

1. What Rocuronio Aguettant is and what it is used for
2. What you need to know before using Rocuronio Aguettant
3. How to use Rocuronio Aguettant
4. Possible side effects
5. How to store Rocuronio Aguettant
6. Contents of the pack and other information

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

Rocuronium is a muscle relaxant used in adults and children from the age of 2 years. Muscle relaxants are used during surgery as an adjunct to general anaesthesia. During a surgical procedure, your muscles must be completely relaxed. This makes it easier for the surgeon to perform the operation. Normally, nerves send signals to your muscles. Rocuronium works by temporarily blocking these signals, thereby causing muscle relaxation. Since the muscles required for breathing are also relaxed, artificial ventilation will be provided until you are able to breathe on your own again. During surgery, the effect of the muscle relaxant will be continuously monitored and, if necessary, additional doses of the medicine may be administered. At the end of the operation, the effects of rocuronium will be allowed to wear off, enabling you to start breathing independently again. Sometimes, another medicine will be given to speed up this process. Rocuronium may also be used in the Intensive Care Unit.

2. What you need to know before using Rocuronium Aguettant

Do not use Rocuronium Aguettant

• if you are allergic to rocuronium or to any of the other ingredients of this medicine (listed in section 6).

Consult your doctor if any of the following apply to you.

Warnings and precautions

Your medical history may affect how Rocuronium Aguettant is administered to you. Inform your doctor if you have or have had any of the following conditions:

• allergy to muscle relaxants
• impaired kidney function (renal insufficiency) or kidney disease
• cardiovascular disease
• development of edema (fluid retention, for example in the ankles)
• liver, gallbladder or bile duct disease, or impaired liver function
• neuromuscular disorders (diseases affecting nerves and muscles)
• history of malignant hyperthermia (sudden fever associated with rapid heartbeat, fast breathing, and muscle stiffness, pain, and/or weakness)
• a rare tumor of the adrenal glands (pheochromocytoma); this may increase the risk of severe high blood pressure

Certain medical conditions may influence the action of Rocuronium Aguettant. For example:

• low potassium levels in the blood (hypokalemia)
• high magnesium levels in the blood (hypermagnesemia), for example when treating pregnancy toxemia with magnesium salts
• low calcium levels in the blood (hypocalcemia)
• low protein levels in the blood (hypoproteinemia)
• fluid deficiency (dehydration)
• excess acid in the blood (acidosis)
• excess carbon dioxide in the blood (hypercapnia)
• poor general health status
• obesity
• burns

If any of these conditions apply to you, your doctor will take them into account when determining the appropriate dose of Rocuronium Aguettant for you.

Children and adolescents
Rocuronium Aguettant may be used in children (2–11 years) and adolescents (12–17 years). However, the maintenance dose is not indicated in pediatric patients under 12 years of age.

Rocuronium Aguettant must not be administered to children under 2 years of age because the graduations on the pre-filled syringe do not allow accurate dosing in this population.

Other medicines and Rocuronium Aguettant

Inform your doctor if you are currently using, have recently used, or might need to use any other medicines. This will help your doctor determine the correct dose of Rocuronium Aguettant for you.

The following medicines may affect the action of Rocuronium Aguettant:

Medicines that increase the effect of Rocuronium Aguettant:

• certain anesthetics
• medicines used as muscle relaxants (succinylcholine)
• certain antibiotics used to treat bacterial infections
• certain medicines used for bipolar disorder (lithium)
• certain medicines for heart disease or high blood pressure (quinidine, calcium antagonists, beta-blockers)
• certain medicines used to treat malaria (quinine)
• medicines that increase urine output (diuretics)
• magnesium salts
• local anesthetics (lidocaine and bupivacaine)
• short-term use of antiepileptic medicines (phenytoin), for example during surgery

Medicines that decrease the effect of Rocuronium Aguettant:

• prolonged use of corticosteroids (anti-inflammatory agents) or antiepileptic medicines (phenytoin and carbamazepine)
• medicines for pancreatitis, blood clotting disorders, and acute blood loss (protease inhibitors: gabexate, ulinastatin)
• Calcium chloride, potassium chloride

Medicines with variable effects on Rocuronium Aguettant:

• other medicines used to relax muscles

Rocuronium Aguettant may affect the action of the following medicines:

• It may enhance the effect of local anesthetics (such as lidocaine)

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine.

There is very limited data on the use of rocuronium bromide during human pregnancy, and no data are available for breastfeeding women. Rocuronium Aguettant should only be administered to pregnant and breastfeeding women if the physician determines that the benefits outweigh the risks.

This medicine may be administered during cesarean section.

Driving and use of machines

Your doctor will advise you when you may resume driving or operating dangerous machinery after administration of Rocuronium Aguettant.

Rocuronium Aguettant contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per pre-filled syringe; i.e., it is essentially “sodium-free”

3. How to use Rocuronium Aguettant

Dosage

Your doctor will determine the dose of Rocuronium Aguettant based on:

• the type of anaesthesia used
• the expected duration of the surgical procedure
• other medicines you are taking
• your age and health status.

A healthcare professional will administer Rocuronium Aguettant to you before and/or during the surgical procedure. The usual dose is 0.6 mg of rocuronium bromide per kilogram of body weight, and the effect lasts for 30 to 40 minutes. During the procedure, it will be checked whether rocuronium is still effective. If necessary, additional doses will be administered.

How Rocuronium Aguettant is administered

Rocuronium is not intended for self-administration. Rocuronium will be given as a solution injected into a vein. It will be administered either as a single injection or by infusion.

If you use more Rocuronium Aguettant than you should

Since medical staff will carefully monitor your condition, it is unlikely that you will be given too much rocuronium. However, if this were to happen, artificial ventilation will be maintained until you are able to breathe on your own again. The effects of (excess) rocuronium can be reversed and your recovery accelerated by administering a medicine that counteracts the effects of rocuronium.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them. If these adverse effects occur during anaesthesia, they will be observed and treated by your doctor.

The following adverse effects may occur:

Uncommon or rare (may affect fewer than 1 in 100/1,000 people)

• increased heart rate (tachycardia)
• decreased blood pressure (hypotension)
• absence, increase or decrease in the effect of Rocuronio Aguettant
• pain at the injection site
• redness or itching at the injection site
• prolonged muscle-relaxing effect of Rocuronio Aguettant
• delayed recovery from anaesthesia

Very rare (may affect fewer than 1 in 10,000 people)

• allergic reactions such as difficulty breathing, changes in blood pressure or heart rate, shock (sudden drop in blood pressure) due to insufficient circulating blood, or skin changes (e.g. fluid accumulation, redness or skin rash)
• excessive and prolonged contraction of the respiratory tract muscles causing breathing difficulty (bronchospasm)
• muscle weakness or paralysis
• sudden accumulation of fluid in the skin and mucous membranes (e.g. throat or tongue), breathing difficulties and/or itching or skin rash, often associated with an allergic reaction (angioedema)
• fluid accumulation (edema) in the face
• airway difficulties due to anaesthesia
• skin rash, sometimes with intense itching and hives (wheals or urticaria)
• redness of the skin
• flushing

Unknown frequency (cannot be estimated from available data)

• severe and allergic spasm of the coronary blood vessels (Kounis syndrome), causing chest pain (angina pectoris) or heart attack (myocardial infarction)
• dilated pupils (mydriasis) or fixed pupils that do not change size in response to light or other stimuli

Reporting of adverse effects

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

5. Storage of Rocuronium Aguettant

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

Do not use this medicine after the expiry date stated on the label, blister, and carton.

Store in a refrigerator (2 °C – 8 °C).

Do not freeze.

Keep the pre-filled syringe in its unopened blister until use.

After opening, the medicine should be used immediately.

This medicine may be stored at a temperature up to 30 °C for a maximum of 12 weeks. In all cases, once removed from the refrigerator, the medicine must be discarded after 12 weeks.

The product must not be returned to the refrigerator once stored outside. The storage period must not exceed the expiry date stated on the packaging.

Do not use this medicine if you notice any visible signs of deterioration.

Any pre-filled syringe, even if partially used, must be properly disposed of after use.

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

6. Package contents and other information

Composition of Rocuronium Aguettant

• The active substance is rocuronium bromide.

Each ml of solution contains 10 mg of rocuronium bromide.

Each 5 ml pre-filled syringe contains 50 mg of rocuronium bromide (50 mg / 5 ml).

• The other components are sodium acetate trihydrate (E 262), sodium chloride, glacial acetic acid (E260) and water for injections.

Appearance of the product and contents of the pack

Rocuronium Aguettant is an injectable solution or for infusion, from colourless to pale yellowish-brown, contained in a 5 ml polypropylene pre-filled syringe with a transparent self-adhesive graduated label (sub-graduations of 0.2 ml, from 0 to 5 ml). Each pre-filled syringe is individually packaged in a transparent blister.

Pack size: Carton boxes of 10 pre-filled syringes.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratoire Aguettant

1 rue Alexander Fleming,

69007 Lyon

France

Manufacturer

Laboratoire Aguettant

1, rue Alexander Fleming

69007 LYON

France

Laboratoire Aguettant

Lieu Dit Chantecaille

07340 Champagne

France

Further information on this medicinal product is available upon request by contacting the local representative of the Marketing Authorization Holder:

Aguettant Ibérica

Baldiri Reixac, 4-8, Torre I, 4º

08028 Barcelona

Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

AT: Rocuroniumbromid Aguettant

FR, DE, IS, PL, RO: Rocuronium Aguettant

BE, DK, FI, LU, NO, SE: Rocuronium bromide Aguettant

IT: Rocuronio bromuro Aguettant

NL: Rocuroniumbromide Aguettant

PT: Brometo de Rocurónio Aguettant

ES: Rocuronio Aguettant 10mg/ml solution for injection in pre-filled syringe

IE: Rocuronium bromide

Date of latest revision of this package leaflet: February 2026

Detailed information on this medicinal product 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:

The pre-filled syringe is not suitable for precise administration of the product in children under 2 years of age.

The pre-filled syringe is for single-patient use only. Discard the syringe after use. Do not reuse.

Appearance of the solution

The product must be inspected visually for particulate matter and discoloration prior to administration. Only a clear, colourless to pale yellowish-brown solution, free from particles or precipitates, should be used.

Incompatibilities of the solution

Rocuronium bromide is physically incompatible with solutions of the following medicinal products: amphotericin, amoxicillin, azathioprine, cefazolin, cloxacillin, dexamethasone, diazepam, enoximone, erythromycin, famotidine, furosemide, hydrocortisone sodium succinate, insulin, methohexital, methylprednisolone, prednisolone sodium succinate, thiopental, trimethoprim and vancomycin.

Rocuronium bromide is also incompatible with Intralipid.

Use of the pre-filled syringe

The contents of an unopened and undamaged blister are sterile, and the blister must not be opened until the syringe is ready for use.

The pre-filled syringe is for single-patient use only. Discard the syringe after use. Do not reuse.

The pre-filled syringe is not suitable for precise administration of the product in children under 2 years of age.

The product must not be used if the syringe's security seal is broken.

Do not use this medicinal product if visible signs of deterioration are observed.

Please prepare the syringe carefully as follows

The outer surface of the syringe is sterile until the blister is opened. The blister must not be opened until use.

If handled using an aseptic technique, this medicinal product may be placed on a sterile field once removed from the blister.

1. Remove the sterile pre-filled syringe from the blister.

1. Connect the syringe to the vascular access device using a luer/luer lock system. Push the plunger slowly to inject the required volume. Administer the product via the appropriate route of administration.

The pre-filled syringe is not suitable for use with syringe pump drivers. The pre-filled syringe is a ready-to-administer product and is not suitable for dilution in an infusion bag.

Do not use any syringe that has been damaged or handled without maintaining sterile conditions.

Any unused product or waste material must be disposed of in accordance with local requirements.