ROCURONIUM 10 mg /Ml Solution

Contents of the leaflet

1. Leaflet attached to the packaging: information for the user
2. Rocuronium Aguettant, 10 mg/mL, solution for injection in a pre-filled syringe
   1. Read the leaflet carefully before using the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
3. What is Rocuronium Aguettant and what is it used for
4. Important information before using Rocuronium Aguettant
   1. When not to use Rocuronium Aguettant
   2. Tell your doctor if any of the above applies to you.
   3. Warnings and precautions
   4. Children and adolescents
   5. Rocuronium Aguettant and other medicines
   6. Pregnancy, breastfeeding, and fertility
   7. Driving and using machines
   8. Rocuronium Aguettant contains sodium
5. How to use Rocuronium Aguettant
   1. Dosage
   2. Method of administration
   3. Use of a higher than recommended dose of Rocuronium Aguettant
6. Possible side effects
   1. Not very common/rare (may affect less than 1 in 100/1000 people)
   2. Very rare (may affect less than 1 in 10,000 people)
   3. Frequency not known (frequency cannot be estimated from the available data)
   4. Reporting suspected side effects
7. How to store Rocuronium Aguettant
8. Contents of the packaging and other information
   1. What Rocuronium Aguettant contains
   2. What Rocuronium Aguettant looks like and what the pack contains
   3. Marketing authorization holder and manufacturer:
   4. Marketing authorization holder
   5. Manufacturer
   6. This medicine is authorized in the Member States of the European Economic Area under the following names:
   7. Date of last revision of the leaflet: 30.04.2025

Leaflet attached to the packaging: information for the user

Rocuronium Aguettant, 10 mg/mL, solution for injection in a pre-filled syringe

Rocuronium bromide

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Rocuronium Aguettant and what is it used for
• 2. Important information before using Rocuronium Aguettant
• 3. How to use Rocuronium Aguettant
• 4. Possible side effects
• 5. How to store Rocuronium Aguettant
• 6. Contents of the packaging and other information

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

Rocuronium Aguettant belongs to a group of muscle relaxants and is intended for use in adults and children from 2 years of age. Muscle relaxants are used during surgical procedures to facilitate general anesthesia. This makes it easier for the surgeon to perform the operation. Normally, nerves send signals to muscles. Rocuronium Aguettant can temporarily block these signals, causing muscle relaxation. Since the muscles involved in the breathing process also become relaxed, the patient will be given artificial respiration until they can breathe on their own again. During the surgical procedure, the action of the muscle relaxant will be constantly monitored and, if necessary, another dose of Rocuronium Aguettant will be administered. After the surgical procedure, the action of Rocuronium Aguettant may wear off and the patient may start breathing on their own again. In some cases, another medicine will be given to speed up the return to independent breathing. Rocuronium Aguettant can also be used in intensive medical care.

2. Important information before using Rocuronium Aguettant

When not to use Rocuronium Aguettant

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

Tell your doctor if any of the above applies to you.

Warnings and precautions

Past illnesses may affect the administration of Rocuronium Aguettant. Tell your doctor if you have or have had any of the following conditions:

• allergy to muscle relaxants
• impaired kidney function (kidney disorders) or kidney disease
• cardiovascular diseases
• fluid accumulation (fluid accumulation in the body, e.g. in the ankles)
• liver, gallbladder, or bile duct diseases or impaired liver function
• diseases affecting nerve and muscle function
• malignant hyperthermia in history (sudden fever with rapid heart rate, rapid breathing, and stiffness and/or muscle pain).

Certain medical conditions may affect the action of Rocuronium Aguettant, such as:

• low potassium levels in the blood (hypokalemia)
• high magnesium levels in the blood (hypermagnesemia), e.g. during treatment of pregnancy toxemia with magnesium salts
• low calcium levels in the blood (hypocalcemia)
• low protein levels in the blood (hypoproteinemia)
• fluid deficiency (dehydration)
• excessive acid levels in the blood (acidosis)
• excessive carbon dioxide levels in the blood (hypercapnia)
• general weakness
• overweight
• burns

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

Children and adolescents

Rocuronium Aguettant can be used in children (aged 2-11) and adolescents (aged 12-17). However, the use of a maintenance dose is not recommended in children under 12 years of age.
Do not give Rocuronium Aguettant to children under 2 years of age, as the syringe graduation does not allow for accurate dosing for this age group.

Rocuronium Aguettant and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take. This will help your doctor determine the appropriate dose of Rocuronium Aguettant for you.
The following medicines may affect the action of Rocuronium Aguettant:

• Medicines that enhance the action of Rocuronium Aguettant:
• certain anesthetics
• muscle relaxants (succinylcholine)
• certain antibiotics used to treat bacterial infections
• certain medicines used to treat manic-depressive disorders (lithium)
• certain medicines used to treat heart disease or high blood pressure (quinidine, calcium channel blockers, beta-blockers)
• certain medicines used to treat malaria (quinine)
• diuretics
• magnesium salts
• local anesthetics (lidocaine and bupivacaine)
• short-term use of antiepileptic drugs (phenytoin), e.g. during surgery.

Medicines that weaken the action of Rocuronium Aguettant:

• long-term use of corticosteroids (anti-inflammatory medicines) or medicines used to treat epilepsy (phenytoin and carbamazepine)
• medicines used in pancreatitis, bleeding disorders, and acute blood loss (protease inhibitors: gabexate, ulinastatin)
• calcium chloride, potassium chloride.

Medicines with variable effects on Rocuronium Aguettant:

• other muscle relaxants.

Rocuronium Aguettant may affect the action of the following medicines:

• The action of local anesthetics (lidocaine) may be enhanced.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this medicine.
Data on the use of rocuronium bromide in pregnant women are very limited. There are no data on the use of rocuronium bromide during breastfeeding.
Rocuronium Aguettant may be given to pregnant or breastfeeding women only if the doctor decides that the benefits outweigh the risks.
This medicine may be used during cesarean section.

Driving and using machines

Your doctor will inform you when you can start driving or operating machines again after using Rocuronium Aguettant.

Rocuronium Aguettant contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per pre-filled syringe, which means that the medicine is considered "sodium-free".

3. How to use Rocuronium Aguettant

Dosage

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

• the type of anesthesia used
• the expected duration of the surgical procedure
• other medicines used in the patient
• the patient's age and health status

Rocuronium Aguettant will be administered by your doctor or nurse before and/or during the surgical procedure. The dose is usually 0.6 mg/kg of body weight of rocuronium bromide, and its action lasts from 30 to 40 minutes. During the procedure, the doctor will check if the action of Rocuronium Aguettant is maintained. If necessary, an additional dose will be administered.

Method of administration

Rocuronium Aguettant is not intended for self-administration. Rocuronium Aguettant will be administered intravenously in the form of a solution. It will be administered in a single injection or by infusion.

Use of a higher than recommended dose of Rocuronium Aguettant

Since medical personnel will closely monitor the patient's condition, it is unlikely that too high a dose of Rocuronium Aguettant will be administered. However, if this happens, artificial respiration will be continued until the patient can breathe on their own again. It is possible to reverse the action (of an excessive dose) of Rocuronium Aguettant and speed up the return to independent breathing by administering a medicine that counteracts the action of Rocuronium Aguettant.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If side effects occur during anesthesia, they will be noticed and treated by your doctor.
The following side effects may occur:

Not very common/rare (may affect less than 1 in 100/1000 people)

• rapid heartbeat (tachycardia)
• low blood pressure (hypotension)
• lack of effect of Rocuronium Aguettant, too strong an effect, or insufficient effect
• pain at the injection site
• redness or itching at the injection site
• prolonged muscle relaxation
• delayed recovery from anesthesia

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

• allergic reactions, such as breathing difficulties, changes in blood pressure or heart rate, shock (a sudden drop in blood pressure) caused by insufficient blood circulation or skin changes (e.g. fluid accumulation, redness, or rash)
• excessive and prolonged muscle contraction of the airways, causing breathing difficulties (bronchospasm)
• muscle weakness or paralysis
• sudden fluid accumulation in the skin and mucous membranes (e.g. throat or tongue), breathing difficulties, and/or itching or rash, often as an allergic reaction (angioedema)
• fluid accumulation (edema) in the face
• respiratory disorders caused by the anesthetic
• rash, sometimes with severe itching and tearing (hives)
• redness of the skin
• redness of the face

Frequency not known (frequency cannot be estimated from the available data)

• severe allergic coronary artery spasm (Kounis syndrome) causing chest pain (angina pectoris) or heart attack
• pupil dilation or fixed pupil, which does not change its size in response to light or other stimuli

Reporting suspected side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products,
Jerozolimskie Avenue 181C,
PL-02-222 Warsaw
Phone: +48 22 49 21 301,
Fax: +48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl .
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Rocuronium Aguettant

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label, blister, and carton.
Store in a refrigerator (2°C - 8°C).
Do not freeze.
Store the pre-filled syringe in the unopened blister until use.
Use the medicinal product immediately after opening.
This medicine can be stored at a temperature not exceeding 30°C for a maximum of 12 weeks. In all cases, after the first removal from the refrigerator, the medicine should be discarded after 12 weeks. The medicinal product should not be re-refrigerated if it has already been stored outside the refrigerator. The storage period of the medicinal product should not exceed the specified shelf life.
Do not use this medicine if you notice any visible signs of deterioration.
Dispose of each pre-filled syringe, even if only partially used, in accordance with local regulations.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Rocuronium Aguettant contains

• The active substance of the medicine is rocuronium bromide. Each mL of the solution contains 10 mg of rocuronium bromide. Each 5 mL pre-filled syringe contains 50 mg of rocuronium bromide (50 mg/5mL).
• The other ingredients are: sodium acetate trihydrate (E 262), sodium chloride, acetic acid, icy (for pH adjustment) (E 260), water for injections.

What Rocuronium Aguettant looks like and what the pack contains

Rocuronium Aguettant is a clear, colorless or light brown-yellow solution for injection in a 5 mL pre-filled syringe made of polypropylene, with a scaled self-adhesive transparent label (graduated in 0.2 mL increments from 0 to 5 mL). Each pre-filled syringe is packaged individually in a transparent blister.
Pack sizes: cardboard box containing 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

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

Austria, France, Germany, Iceland, Poland, Romania: Rocuronium Aguettant
Belgium, Denmark, Finland, Luxembourg, Norway, Sweden: Rocuronium bromide Aguettant
Italy: Rocuronio bromuro Aguettant
Netherlands: Rocuroniumbromide Aguettant
Portugal: Brometo de Rocurónio Aguettant
Spain: Rocuronio Aguettant
Ireland: Rocuronium bromide

Date of last revision of the leaflet: 30.04.2025

Information intended for healthcare professionals only:
The pre-filled syringe is not suitable for accurate administration of the product in children under 2 years of age.
The pre-filled syringe is intended for use in a single patient only. After use, it should be discarded. Do not reuse it.
Appearance of the solution
Before administration, the product should be visually inspected for the presence of particles and discoloration.
Only use a clear, colorless to light brown-yellow solution that is free from particles or precipitates.
Pharmaceutical incompatibilities of the solution
A physical incompatibility of rocuronium bromide with solutions of the following medicinal products has been documented: 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 the unopened and undamaged blister are sterile, so do not open the blister until the syringe is ready for use.
The pre-filled syringe is intended for use in a single patient only. After use, it should be discarded. Do not reuse it.
The pre-filled syringe is not suitable for administration of the product with the required accuracy in children under 2 years of age.
Do not use the product if the protective cap on the syringe is damaged.
Do not use this medicine if you notice any visible signs of deterioration.
Prepare the pre-filled syringe for use as follows:
The outer surface of the pre-filled syringe is sterile until the blister is opened. Do not open the blister until the pre-filled syringe is ready for use.
When handling this product with antiseptics, after removal from the blister, the pre-filled syringe can be placed in a sterile area.

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

• 2) Press the plunger to release the rubber stopper. The sterilization process may have caused the rubber stopper to stick to the syringe body.

• 3) Unscrew the end cap to break the seal. Do not touch the exposed luer connector to avoid contamination.

• 4) Check if the end cap of the syringe has been completely removed. If not, put the cap back on and twist it again.

• 5) Expel air by gently pressing the plunger.
• 6) Connect the syringe to the intravenous access using a luer/luer lock system. Slowly press the plunger to inject the required volume. Administer the product according to the recommended route of administration.

The pre-filled syringe is not suitable for infusion pumps. The pre-filled syringe contains a ready-to-use product and is not intended for dilution in an infusion bag.
Do not use the pre-filled syringe if it has been damaged or if it has been handled without maintaining sterility.
Any unused medicinal product or waste material should be disposed of in accordance with local regulations.