Esmeron

Package Leaflet: Information for the User

Esmeron, 50 mg/5 ml, Solution for Injection

Esmeron, 100 mg/10 ml, Solution for Injection

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 or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

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

1. What Esmeron is and what it is used for

Esmeron is one of a group of medicines called muscle relaxants. Muscle relaxants are used during surgery, as part of the general anaesthetic.

Esmeron is used in adult patients as an auxiliary medicine in general anaesthesia to facilitate tracheal intubation during routine and rapid sequence induction of anaesthesia and to provide skeletal muscle relaxation during surgical procedures. Esmeron is also indicated as a supplementary medicine used in intensive care units (ICU) to facilitate intubation and mechanical ventilation.

Children and adolescents: Esmeron is used as an auxiliary medicine in general anaesthesia to facilitate tracheal intubation during routine anaesthesia and to provide skeletal muscle relaxation during surgical procedures in newborns, infants and adolescents (from birth to 17 years).

2. Important information before you use Esmeron

When not to use Esmeron

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

Warnings and precautions

Information about your health may be important for the choice of the way Esmeron is given to you. You should tell your anaesthetist if you have ever had:

• allergic reactions to muscle relaxants
• kidney or liver problems
• heart problems
• swelling (e.g. swelling of the ankles)
• nerve or muscle disease
• a history of malignant hyperthermia (a rare condition where the body temperature rises rapidly)

Certain medical conditions may affect the way Esmeron works, such as:

• low potassium levels in the blood
• high magnesium levels in the blood
• low calcium levels in the blood
• low protein levels in the blood
• dehydration
• acidosis
• high carbon dioxide levels in the blood (hypercapnia)
• poor general health
• obesity
• burns

If you have any of these conditions, your doctor will decide on the dose of Esmeron that is right for you.

Children and elderly people

Esmeron can be used in children and elderly people, but your doctor should first assess your health.

Esmeron and other medicines

Tell your doctor about all the medicines you are taking, have recently taken or might take.

The following medicines may affect the way Esmeron works:

• certain anaesthetics used during surgery
• corticosteroids (anti-inflammatory medicines) used for a long time and Esmeron in intensive care units
• certain antibiotics used to treat bacterial infections
• certain medicines used to treat bipolar disorder (e.g. lithium salts)
• certain medicines used to treat heart conditions (e.g. quinidine, calcium channel blockers) or to increase blood pressure
• certain medicines used to treat malaria (e.g. quinine)
• diuretics
• magnesium salts
• local anaesthetics (e.g. lidocaine, bupivacaine)
• antiepileptic medicines (e.g. phenytoin) used during surgery

Esmeron may affect the way other medicines work, such as:

• increasing the effect of local anaesthetics (e.g. lidocaine)

Children and adolescents

No formal studies have been conducted. In children and adolescents, the same interactions should be considered.

Pregnancy and breastfeeding

Before taking any medicine, consult your doctor or pharmacist.

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

You should not breastfeed for 6 hours after taking this medicine.

Driving and using machines

This medicine may affect your ability to drive or use machines.

Your doctor will tell you whether it is safe for you to drive or use machines after taking Esmeron.

Esmeron contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per vial, which is essentially sodium-free.

3. How to use Esmeron

Dose

Your doctor will decide on the dose of Esmeron that is right for you. Esmeron will be given to you before and/or during surgery. The usual dose is 0.6 mg/kg body weight of rocuronium bromide, which lasts for 30 to 40 minutes. During surgery, the effect of Esmeron will be monitored.

If necessary, a further dose of Esmeron may be given. The dose of Esmeron depends on many factors, including possible interactions with other medicines given at the same time, the length of the surgical procedure, your age and health.

Method and route of administration

Esmeron is not intended for self-administration by the patient. Esmeron is given by injection into a vein, as a single injection or as a continuous infusion.

Only a doctor or nurse is allowed to give you Esmeron.

Overdose

It is unlikely that you will be given too much Esmeron, as your doctor will be monitoring its effect. If you are given too much Esmeron, artificial respiration will be continued until you can breathe on your own again. The effect of Esmeron can be shortened by giving a medicine that reverses its effect.

Missed dose

This is not applicable.

4. Possible side effects

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

Uncommon or rare side effects (affecting 0.01% to 1% of people) include:

• increased heart rate (tachycardia)
• low blood pressure (hypotension)
• weakness or increased effect of Esmeron
• pain at the injection site
• prolonged muscle relaxation

Very rare side effects (affecting less than 0.01% of people) include:

• allergic reactions, such as changes in blood pressure or heart rate and shock due to low blood volume
• chest tightness caused by bronchospasm
• skin disorders (e.g. angioedema, redness, rash or blisters)
• muscle weakness or paralysis
• prolonged muscle disorders, usually seen in critically ill patients (steroid myopathy), when Esmeron and corticosteroids are used together in intensive care units

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

• severe allergic coronary artery spasm (Kounis syndrome) causing chest pain (angina) or heart attack (myocardial infarction)
• pupil dilation (mydriasis) or fixed pupils that do not change size in response to light or other stimuli

Children and adolescents

Clinical studies in children and adolescents with rocuronium bromide (up to 1 mg/kg body weight) showed an increased heart rate in 1.4% of patients.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

5. How to store Esmeron

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

Esmeron should only be stored in a hospital pharmacy.

Store in a refrigerator (2°C - 8°C).

The medicine can be stored outside the refrigerator, at a temperature below 30°C, for a maximum of 3 months.

The medicine can be put in and taken out of the refrigerator at any time during the 3-year shelf-life, but the total time out of the refrigerator should not exceed 3 months.

The storage period should not exceed the expiry date stated on the carton and vial.

Do not use this medicine after the expiry date which is stated on the carton and vial after “EXP”.

Do not use this medicine if you notice any particles or if the solution is not clear.

6. Contents of the pack and other information

What Esmeron contains

• The active substance is rocuronium bromide.
• The other ingredients are sodium acetate, sodium chloride, glacial acetic acid to pH 4 and water for injections. 1 ml of solution contains 1.64 mg of sodium. The medicine does not contain preservatives.

What Esmeron looks like and contents of the pack

Esmeron is a colourless to light brown solution for injection or continuous infusion containing 10 mg/ml of rocuronium bromide.

The following pack sizes are available:

• Vials containing 50 mg of rocuronium bromide in 5 ml of solution (10 vials in a pack)
• Vials containing 100 mg of rocuronium bromide in 10 ml of solution (10 vials in a pack)

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

MSD Polska Sp. z o.o.

ul. Chłodna 51

00-867 Warszawa

Tel. (+48) 22 54 95 100

[email protected]

Manufacturer

N.V. Organon, Kloosterstraat 6, 5349 AB, Oss, The Netherlands

Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands

Date of last revision of the leaflet: 07/2023

Information intended for healthcare professionals only:

For intravenous use only.

As with other neuromuscular blocking agents, Esmeron should only be administered by, or under the supervision of, experienced clinicians who are familiar with the use of these agents and with reversal agents.

The dose of Esmeron should be individualised for each patient.

During the dose-finding process, it is important to monitor the patient for the first signs of muscular blockade (e.g. fading of the adductor pollicis twitch response).

It is recommended that the monitoring of neuromuscular transmission should be continued to assess the degree of neuromuscular blockade and to adjust the dose of Esmeron accordingly.

Inhalational anaesthetics potentiate the neuromuscular blocking effect of rocuronium bromide. This potentiation is clinically relevant during the use of inhalational anaesthetics for longer than 1 hour.

The recommended dose of Esmeron for intubation and for providing skeletal muscle relaxation during surgery or in intensive care units is given below.

Surgery

Intubation

The standard intubating dose of Esmeron is 0.6 mg/kg body weight. Intubating conditions will be excellent in the majority of patients at 60 seconds.

Recovery from neuromuscular blockade

After administration of the intubating dose, the clinician should not expect a full recovery of neuromuscular transmission for 30 to 40 minutes.

When neuromuscular blockade is first detected, the dose of Esmeron is increased in increments of 0.1 to 0.2 mg/kg until the desired level of neuromuscular blockade is achieved.

Continuous infusion

Esmeron can be administered by continuous infusion to maintain neuromuscular blockade during extended surgical procedures or in an intensive care setting.

After the initial intubating dose, a continuous infusion of 0.3 to 0.6 mg/kg/h of Esmeron will normally be required to maintain adequate neuromuscular blockade.

During infusion, the rate of administration of Esmeron should be adjusted according to clinical need (e.g. to maintain at least 95% blockade of the adductor pollicis twitch response).

Once the infusion has been started, the rate of administration can be reduced to 0.3 to 0.4 mg/kg/h to maintain blockade.

Infusion rates may need to be increased in patients with hepatic or renal disease.

Paediatric population

Intubating dose

The intubating dose of Esmeron is 0.6 mg/kg body weight in children (from birth to 17 years).

Recovery from neuromuscular blockade

After administration of the intubating dose, the duration of action of Esmeron is longer in infants (28 days to 23 months) than in children (2 to 11 years).

Geriatric population

The standard intubating dose of Esmeron is 0.6 mg/kg body weight.

Patients with renal or hepatic impairment

No dose adjustment is required in patients with renal or hepatic impairment.

Obese patients

In obese patients, the dose of Esmeron should be based on ideal body weight.