Roqurum

Leaflet accompanying the packaging: information for the user

Roqurum, 10 mg/ml, solution for injection

Rocuronium bromide

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• 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 symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or nurse. See section 4.

Table of contents of the leaflet

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

1. What is Roqurum and what is it used for

The active substance of Roqurum is rocuronium bromide, which belongs to a group of muscle relaxant medicines. These medicines are used during surgical procedures, as part of general anesthesia and other medical procedures.
Roqurum is intended for use in adult patients:

• as an auxiliary medicine in general anesthesia to facilitate tracheal intubation during routine and rapid introduction to anesthesia (tracheal intubation involves the insertion of a flexible, plastic tube through the mouth into the trachea to mechanically support breathing),
• to achieve muscle relaxation during surgical procedures,
• as a supplementary medicine used in intensive care units (ICU) to facilitate intubation and mechanical ventilation.

Children and adolescents:
Roqurum is intended for use as an auxiliary medicine in general anesthesia to facilitate tracheal intubation during routine anesthesia and to achieve muscle relaxation during surgical procedures in newborns, infants, and children (0-18 years).

2. Important information before using Roqurum

When not to use Roqurum

Warnings and precautions

Before starting treatment with Roqurum, you should discuss it with your doctor, preferably an anesthesiologist:

Certain conditions/parameters may affect the action of Roqurum, such as:

• low calcium (hypocalcemia), potassium (hypokalemia), or protein levels in the blood
• high magnesium (hypermagnesemia) or carbon dioxide (hypercapnia) levels in the blood
• dehydration, e.g. due to severe vomiting, diarrhea, or excessive sweating
• overweight
• burns
• acidosis
• exhaustion of the body.

In the event of any of the above situations, your doctor will take this into account when determining the appropriate dose of Roqurum for you.

Children and the elderly

Roqurum can be used in children [in newborns (0-27 days), infants (28 days to 2 months), young children (3 to 23 months), children (2 to 11 years), and adolescents (12 to 17 years)] and the elderly, but your doctor should first assess your health condition.

Roqurum and other medicines

Tell your doctor about all medicines you are taking or have recently taken, as well as any medicines you plan to take, including those available without a prescription. Some medicines may affect the action of Roqurum.
Medicines that enhance the action of Roqurum:

• certain anesthetics used during surgical procedures
• long-term, concurrent use of corticosteroids (anti-inflammatory and antiallergic medicines) in intensive care units
• certain antibiotics (aminoglycosides, lincosamides, polypeptides, acylaminopenicillins) used to treat bacterial infections
• diuretics (medicines that increase urine excretion)
• medicines used to treat cardiovascular diseases (quinidine, calcium channel blockers, beta-adrenergic receptor blockers)
• medicines used for local anesthesia (lidocaine, bupivacaine)
• antiepileptic medicines used during surgery (phenytoin)
• medicines used to treat bipolar affective disorders (lithium salts)
• magnesium salts
• medicines used to treat malaria (quinine).

Medicines that reduce the action of Roqurum:

• long-term antiepileptic medicines (phenytoin, carbamazepine)
• medicines used to treat pancreatitis, blood clotting disorders, or acute blood loss (protease inhibitors; gabexate, ulinastatin).

Medicines that have a variable effect on Roqurum:

• other muscle relaxant medicines.

Roqurum may affect the action of the following medicines:

• accelerates the action of local anesthetics (lidocaine).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor or pharmacist for advice before using this medicine.
Rocuronium bromide can be used before cesarean section.
Rocuronium bromide may be used in breastfeeding women only if your doctor considers that the potential benefits outweigh the risks.

Driving and using machines

Roqurum affects your ability to drive and use machines.
Your doctor will tell you when you can safely drive or use machines.

Roqurum contains sodium

Roqurum contains less than 1 mmol (23 mg) of sodium per vial (10 ml), and is therefore considered 'sodium-free'.

3. How to use Roqurum

Dosage

Roqurum should only be administered by, or under the supervision of, an experienced anesthesiologist.
Your doctor will determine the correct dose of Roqurum for you. Roqurum is administered before or during a surgical procedure or other medical procedure. The usual dose is 0.6 mg/kg body weight of rocuronium bromide, which acts for 30 to 40 minutes. During the procedure, the action of Roqurum should be continuously monitored.
If necessary, a further dose of Roqurum can be administered. The dose of Roqurum depends on many factors, including possible interactions with other medicines administered at the same time, the duration of the procedure, your age, and your health condition.

Method and route of administration

Roqurum is not intended for self-administration by the patient. Roqurum is administered intravenously, either as a single injection or as a continuous infusion.

Using a higher dose of Roqurum than recommended

Medical staff monitor the action of Roqurum, so overdose is unlikely. However, if this happens, artificial respiration will be continued until the patient recovers spontaneous breathing. The action of Roqurum can be shortened by administering a medicine that reverses its action.

4. Possible side effects

Like all medicines, Roqurum can cause side effects, although not everybody gets them.
Uncommon(may affect up to 1 in 100 people) or rare side effects
(may affect up to 1 in 1,000 people):

• increased heart rate (tachycardia)
• decreased blood pressure
• weakness, increased or decreased action of Roqurum
• pain or reaction at the injection site
• prolonged muscle relaxation, delayed recovery from anesthesia.

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

• allergic reactions, including life-threatening anaphylactic shock
• pseudoallergic reactions (anaphylactoid), including anaphylactoid shock
• chest tightness caused by bronchospasm (bronchospasm)
• skin reactions: hives, redness, rash
• angioedema
• facial swelling
• weakness* or paralysis
• long-term muscle function disorders, usually observed in critically ill patients (steroid myopathy*), when Roqurum and corticosteroids (anti-inflammatory medicines) are used concurrently in intensive care units
• respiratory complications resulting from anesthesia used.

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 (myocardial infarction).

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

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or nurse. Side effects can be reported directly to the Department of Drug Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, Tel.: +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 Roqurum

Store in a refrigerator (2°C - 8°C).
Keep this medicine out of the sight and reach of children.
Do not use Roqurum after the expiry date stated on the carton and vial. The expiry date refers to the last day of the month.
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 pack and other information

What Roqurum contains

• The active substance is rocuronium bromide. 1 ml of solution contains 10 mg of rocuronium bromide.
• The other ingredients are: sodium chloride, sodium acetate trihydrate, glacial acetic acid (50% solution), water for injections.

What Roqurum looks like and contents of the pack

Roqurum is a clear solution.
The following pack sizes are available:
10 vials of 2.5 ml in a carton
10 vials of 5 ml in a carton
10 vials of 10 ml in a carton

Marketing authorization holder

Bausch Health Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland

Manufacturer

Siegfried Hameln GmbH
Langes Feld 13
31789 Hameln, Germany

Date of revision of the leaflet:

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The following information is intended for healthcare professionals only

For intravenous administration.
Like other neuromuscular blocking agents, rocuronium bromide should only be administered by, or under the supervision of, experienced clinicians familiar with the use of these agents.
As with other neuromuscular blocking agents, the dose of rocuronium bromide should be individualized for each patient.
When determining the dose, consideration should be given to the method of anesthesia, the expected duration of the surgical procedure, the method of ventilation, possible interactions with other agents administered before or during anesthesia, and the patient's condition.
Appropriate neuromuscular monitoring is recommended to assess the degree of neuromuscular blockade and its recovery.
Inhalational anesthetics potentiate the neuromuscular blocking effect of rocuronium bromide. This effect becomes clinically significant with the duration of anesthesia, when the inhaled agents reach concentrations in tissues that interact with rocuronium bromide. Therefore, during prolonged anesthesia (longer than 1 hour) with inhaled agents, the dosage of rocuronium bromide should be reduced, either by administering smaller maintenance doses or by reducing the rate of infusion (see section 4.5 of the Summary of Product Characteristics).

Dosage

Appropriate neuromuscular monitoring is recommended to assess the degree of neuromuscular blockade and its recovery.
The recommended doses of Roqurum for adults may serve as general guidelines for tracheal intubation and muscle relaxation during short and long surgical procedures and for use in Intensive Care Units.

Surgical procedures

Tracheal intubation
The standard dose for intubation during routine anesthesia is 0.6 mg/kg body weight of rocuronium bromide. Suitable conditions for intubation are achieved within 60 seconds in almost all patients. During emergency induction of anesthesia, a dose of 1.0 mg/kg body weight of rocuronium bromide is recommended, which also provides suitable conditions for intubation within 60 seconds in almost all patients. When using a dose of 0.6 mg/kg body weight of rocuronium bromide, it is recommended to intubate the patient after 90 seconds from administration of rocuronium bromide.
Larger doses
If larger doses are required in individual patients, initial doses of up to 2 mg/kg body weight of rocuronium bromide may be used, without increased risk of cardiovascular side effects. The use of larger doses of rocuronium bromide shortens the onset time and prolongs the duration of action.
Maintenance doses
The recommended maintenance dose is 0.15 mg/kg body weight of rocuronium bromide. During prolonged anesthesia with inhaled agents, the dose should be reduced to 0.075-0.1 mg/kg body weight of rocuronium bromide. Maintenance doses should be administered when the twitch response to stimulation returns to 25% of control value or when two or three responses to a train-of-four stimulation are present.
Continuous infusion
If rocuronium bromide is administered by continuous intravenous infusion, a loading dose of 0.6 mg/kg body weight of rocuronium bromide should be administered, and when neuromuscular blockade starts to recover, the infusion should be started. The rate of infusion should be adjusted to maintain a twitch response to stimulation of 10% of control value or to maintain one or two responses to a train-of-four stimulation. In adults, during intravenous anesthesia, the rate of infusion required to maintain neuromuscular blockade at this level is 0.3-0.6 mg/kg body weight/hour, and in patients anesthetized with inhaled agents, the rate of infusion is 0.3-0.4 mg/kg body weight/hour. Continuous neuromuscular monitoring is recommended due to individual requirements for infusion rates and methods of anesthesia.
Cesarean section
In patients undergoing cesarean section, rocuronium bromide can be used as part of rapid sequence induction, provided that there are no anticipated difficulties with intubation and a sufficient dose of anesthetic has been administered. Rocuronium bromide can also be used after intubation with succinylcholine. It has been shown that rocuronium bromide can be safely used in doses of 0.6 mg/kg body weight in patients undergoing cesarean section.
Note 1: during emergency induction of anesthesia, doses of 1.0 mg/kg body weight have been studied, but not in patients undergoing cesarean section. Therefore, in this patient group, only a dose of 0.6 mg/kg body weight is recommended.
Note 2: reversal of neuromuscular blockade caused by neuromuscular blocking agents may be impaired or incomplete in patients receiving magnesium salts due to eclampsia, as they increase neuromuscular blockade. Therefore, in these patients, the dose of Roqurum should be reduced and adjusted individually.

Children and adolescents

In newborns (0-27 days), infants (28 days to 2 months), young children (3 to 23 months), children (2 to 11 years), and adolescents (12 to 18 years), the recommended dose for intubation during routine anesthesia and the maintenance dose are similar to those in adults.
The action of a single intubating dose lasts longer in newborns and infants than in children (see section 5.1 of the Summary of Product Characteristics).
The rate of continuous infusion in adolescents is the same as in adults, while in children (2 to 11 years), the rate of infusion may need to be increased. In children (2 to 11 years), the same initial infusion rates as in adults are recommended, and then adjusted to maintain a twitch response to stimulation of 10% of control value or to maintain one or two responses to a train-of-four stimulation during the procedure.
Experience with the use of rocuronium bromide for rapid sequence induction in children and adolescents is limited. Therefore, the use of rocuronium bromide for facilitating tracheal intubation during rapid sequence induction in children and adolescents is not recommended.

Dosage in elderly patients, patients with liver and/or bile duct disorders and/or renal impairment

The standard dose for intubation in elderly patients and patients with liver and/or bile duct disorders and/or renal impairment is 0.6 mg/kg body weight of rocuronium bromide. In the case of emergency induction of anesthesia in patients who are expected to have prolonged action of the product, a dose of 0.6 mg/kg body weight should be considered. Regardless of the method of anesthesia, the recommended maintenance dose in these patients is 0.075-0.1 mg/kg body weight of rocuronium bromide, and the recommended infusion rate is 0.3-0.4 mg/kg body weight/hour (see also "Continuous infusion").

Dosage in obese patients

In obese patients (defined as body weight 30% or more above ideal body weight), the dose of Roqurum should be reduced, taking into account the lean body weight.

Procedures performed in Intensive Care Units

Tracheal intubation
The same doses are used for intubation as described above for surgical procedures.
Dosage for facilitating mechanical ventilation
A loading dose of 0.6 mg/kg body weight of rocuronium bromide is recommended. When the twitch response to stimulation returns to 10% of control value or one to two responses to a train-of-four stimulation are present, the continuous intravenous infusion should be started.
Dosage should always be adjusted to individual patient needs. The recommended initial infusion rate to maintain neuromuscular blockade at a level of 80 to 90% (one to two responses to a train-of-four stimulation) in adult patients is 0.3-0.6 mg/kg body weight/hour in the first hour of administration. During the next 6 to 12 hours, the infusion rate should be reduced according to individual patient needs. Later, individual needs remain relatively constant.
In controlled clinical trials, significant variability in infusion rates was observed between individual patients, with a mean infusion rate of 0.2-0.5 mg/kg body weight/hour, depending on the type and degree of organ failure, concomitantly administered medicines, and individual patient characteristics. To achieve optimal control of the patient, neuromuscular monitoring is recommended. Administration of the medicine for up to seven days has been studied.
Special patient groups
Rocuronium bromide is not recommended for use in facilitating mechanical ventilation in Intensive Care Units in children and adolescents and elderly patients due to lack of data on efficacy and safety.

Method of administration

Roqurum is administered intravenously, either as a rapid injection or as a continuous infusion.
Compatibility studies have been performed with the following intravenous infusion solutions.
Rocuronium bromide has been shown to be compatible with 0.9% sodium chloride solution and 5% glucose solution for infusion. The intravenous infusion of rocuronium bromide should be started immediately after preparation and completed within 24 hours. Unused solutions should be discarded.

Using a higher dose of Roqurum than recommended

In the event of overdose and prolonged neuromuscular blockade, the patient should continue to receive supported respiration and sedation.
Two methods are known to reverse neuromuscular blockade:

• (1) Adults can be given sugammadex to reverse intense and deep blockade. The dose of sugammadex administered depends on the level of neuromuscular blockade.
• (2) During spontaneous recovery of neuromuscular conduction, an appropriate dose of an anticholinesterase inhibitor (e.g. neostigmine, edrophonium, pyridostigmine) or sugammadex should be administered. If administration of an anticholinesterase inhibitor does not result in reversal of neuromuscular blockade, ventilation should be continued until spontaneous recovery of respiration. Repeated administration of an anticholinesterase inhibitor may be hazardous.