Rocuronium bromide Noridem

PATIENT INFORMATION LEAFLET

Leaflet attached to the packaging: information for the user

Rocuronium bromide Noridem, 10 mg/mL, solution for injection / infusion

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.
• In case of any doubts, consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

1. What is Rocuronium bromide Noridem and what is it used for

Rocuronium bromide Noridem belongs to a group of medicines called muscle relaxants. Muscle relaxants are used during surgical procedures as an auxiliary medicine in general anesthesia. During the operation, the patient's muscles must be completely relaxed, which greatly facilitates the surgeon's work. Physiologically, nerves communicate with muscles by sending impulses. The action of Rocuronium bromide Noridem involves blocking these impulses, causing muscle relaxation. Since the muscles needed for breathing also relax, the patient will be subjected to artificial ventilation (mechanical breathing support) until they can breathe again on their own. During the surgical procedure, the action of the muscle relaxant will be constantly monitored, and if necessary, the patient will receive an additional dose of Rocuronium bromide Noridem. After the operation, the action of Rocuronium bromide Noridem subsides, and the patient can start breathing again on their own. Sometimes, another medicine is given to accelerate this process. Rocuronium bromide Noridem can also be administered in intensive care units.

2. Important information before using Rocuronium bromide Noridem

When not to use Rocuronium bromide Noridem:

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

The patient should inform their doctor.

Warnings and precautions

• Information about the patient's health may be important when choosing the method of administering Rocuronium bromide Noridem. The doctor should be informed if the patient has ever experienced any of the following symptoms:
• allergy to muscle relaxants
• kidney weakness or kidney disease
• cardiovascular disease
• edema (fluid accumulation, e.g., swelling around the ankles)
• liver, gallbladder, or bile duct disease or liver function disorders

liver

• nervous or muscular diseases
• malignant hyperthermia in the past (sudden fever with rapid heart rate, rapid breathing, and stiffness, pain, or weakness of the muscles).
• Certain diseases may affect the action of Rocuronium bromide Noridem, 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)
• dehydration
• high acid levels in the blood (acidosis)
• high carbon dioxide levels in the blood (hypercapnia)
• general weakness
• obesity
• burns. If any of the above symptoms occur, the doctor will determine the individual dose of Rocuronium bromide Noridem for the patient.

Children and the elderly

Rocuronium bromide Noridem can be used in children (from newborns to adolescents) and the elderly.

Rocuronium bromide Noridem and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. This will help the doctor determine the appropriate dose of Rocuronium bromide Noridem. The following medicines may affect the action of Rocuronium bromide Noridem:

• Medicines that enhance the action of Rocuronium bromide Noridem:
• certain anesthetics
• long-term corticosteroids (anti-inflammatory medicines) in combination with Rocuronium bromide Noridem in intensive care units
• certain antibiotics used to treat bacterial infections
• certain medicines used to treat bipolar affective disorders (e.g., lithium salts)
• certain medicines used to treat cardiovascular diseases or hypertension (quinidine, calcium channel blockers, beta-blockers)
• medicines used to treat malaria, e.g., quinine
• diuretics
• magnesium salts
• medicines used for local anesthesia (lidocaine, bupivacaine)
• short-term antiepileptic medicines (phenytoin) e.g., used during surgery.
• Medicines that weaken the action of Rocuronium bromide Noridem:
• long-term use of corticosteroids (anti-inflammatory medicines) or antiepileptic medicines (phenytoin and carbamazepine)
• medicines used to treat pancreatitis, blood clotting disorders, or acute blood loss (protease inhibitors: gabexate, ulinastatin)
• Medicines with a varied effect on the action of Rocuronium bromide Noridem:
• other muscle relaxants.

Rocuronium bromide Noridem may affect the action of the following medicines:

• accelerates the action of local anesthetics (lidocaine).

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, suspects they may be pregnant, or plans to have a child, they should consult their doctor before using this medicine. Pregnancy Animal studies have not shown a harmful effect, but there is a lack of clinical data on the use of rocuronium bromide in pregnant women. Therefore, caution should be exercised when using rocuronium bromide in pregnant women. Cesarean section The doctor will decide whether rocuronium bromide can be administered during a cesarean section. It has been shown that a dose of 0.6 mg of rocuronium bromide per kilogram of body weight can be safely used during a cesarean section and does not have a harmful effect on the baby. Breastfeeding Breastfeeding should be postponed for 6 hours after administration of this medicine.

Driving and operating machinery

The doctor will inform the patient when they can start driving or operating potentially hazardous machinery again after using Rocuronium bromide Noridem.

Rocuronium bromide Noridem contains sodium

Each vial/ampoule contains 8.2 mg (0.36 mmol) of sodium. The medicine contains less than 1 mmol (23 mg) of sodium per vial/ampoule, i.e., the medicine is considered "sodium-free".

3. How to use Rocuronium bromide Noridem

Dosage

The doctor will determine the appropriate dose of Rocuronium bromide Noridem based on:

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

Rocuronium bromide Noridem will be administered before and/or during the surgical procedure. The usual dose is 0.6 mg of rocuronium bromide per kilogram of body weight, which acts for 30 to 40 minutes. During the procedure, the action of Rocuronium bromide Noridem will be monitored. If necessary, an additional dose of the medicine may be administered.

Method and route of administration

Rocuronium bromide Noridem is not intended for self-administration by the patient. Rocuronium bromide Noridem is administered intravenously as a single dose or in continuous infusion. The person authorized to administer the medicine is a doctor or nurse.

Using a higher dose of Rocuronium bromide Noridem than recommended

Medical staff monitor the action of the medicine, so overdosing on Rocuronium bromide Noridem is unlikely. However, if such a situation occurs, artificial respiration will be continued until the patient regains their own breathing function. The duration of action of Rocuronium bromide Noridem can be shortened by administering a medicine that reverses its action.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. If the doctor notices these side effects during anesthesia, they will administer appropriate treatment. The following side effects may occur:

Common (may affect up to 1 in 10 people):

• rapid heart rate (tachycardia) in children (from newborns to adolescents).

Uncommon/rare (may affect up to 1 in 100/1000 people):

• rapid heart rate (tachycardia) in adults
• low blood pressure (hypotension)
• lack of effect of Rocuronium bromide Noridem or its excessive or insufficient effect
• pain at the injection site
• redness or itching at the injection site
• prolonged action of Rocuronium bromide Noridem
• delayed recovery from anesthesia.

Very rare (may affect up to 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 blood circulation or skin changes (e.g., fluid accumulation, redness, or rash)
• shortness of breath caused by bronchospasm (bronchial spasm)
• weakness or paralysis of the muscles
• long-term muscle disorders, usually observed after using Rocuronium bromide Noridem in combination with corticosteroids (anti-inflammatory medicines) in intensive care units in critically ill patients (steroid myopathy)
• sudden fluid accumulation in the skin and mucous membranes (e.g., throat or tongue), difficulty breathing, and/or itching or rash, often as an allergic reaction (angioedema)
• fluid accumulation (edema) on the face
• respiratory problems caused by anesthesia
• rash, sometimes with severe itching and wheezing (urticaria)
• redness of the skin
• hot flashes.

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)
• dilated pupils (mydriasis) or fixed, non-reactive pupils.

Reporting side effects

If side effects occur, including any not listed in this leaflet, the patient should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocides of the Office for Registration of Medicinal Products, Medical Devices, and Biocides Al. Jerozolimskie 181C PL-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. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Rocuronium bromide Noridem

The medicine should be stored out of sight and reach of children. Store in a refrigerator (2°C - 8°C). Rocuronium bromide Noridem should be used immediately after opening the vial/ampoule. The diluted medicine shows chemical and physical stability for 72 hours at a temperature of 28°C - 32°C or for 72 hours at a temperature of 2°C - 8°C. From a microbiological point of view, the medicine should be used immediately after dilution. If not used immediately, the user is responsible for the storage conditions and time of the ready-to-use solution. This time should not exceed 24 hours at a temperature of 2°C to 8°C, unless dilution was performed under controlled and validated aseptic conditions. Do not use this medicine after the expiry date stated on the carton, label, and vial/ampoule after "EXP". The expiry date refers to the last day of the month. Before use, the medicine should be visually inspected. Do not use the solution if particles are visible, if the solution is not clear, or if the container is damaged. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Rocuronium bromide Noridem contains

• The active substance of the medicine is rocuronium bromide. Each mL of the solution contains 10 mg of rocuronium bromide.
• The other ingredients are: sodium acetate trihydrate, sodium chloride, glacial acetic acid, and water for injections

What Rocuronium bromide Noridem looks like and contents of the pack

Rocuronium bromide Noridem is a clear, colorless to pale yellow solution for injection / infusion, containing 10 mg of rocuronium bromide per milliliter. Rocuronium bromide Noridem is available in 3 forms:

• Glass vials containing 50 mg of rocuronium bromide (10 or 50 vials in the packaging)
• Glass ampoules containing 50 mg of rocuronium bromide (10 or 50 ampoules in the packaging)
• Plastic ampoules containing 50 mg of rocuronium bromide (10 or 50 ampoules in the packaging)

Not all pack sizes may be marketed.

Marketing authorization holder

Noridem Enterprises Limited Makariou & Evagorou 1 Mitsi Building 3, Office 115 1065 Nicosia Cyprus Tel.:+302108161802, Fax: +302108161587

Manufacturer

Demo S.A. Pharmaceutical Industry 21st Km National Road Athens Lamia 145 68 Kryoneri Greece

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

Date of last revision of the leaflet:

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Information intended for healthcare professionals only:

Preparation

Incompatibilities

Rocuronium bromide Noridem shows physical incompatibility when added to solutions containing the following medicines: 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 Noridem also shows physical incompatibility with soybean oil. Do not mix this medicine with other medicines, except those listed in the "Method of administration" section. If Rocuronium bromide Noridem is administered through the same infusion line as other medicines, it is essential to flush the infusion line with 0.9% NaCl solution between the administration of Rocuronium bromide Noridem and the administration of medicines for which incompatibility with Rocuronium bromide Noridem has been demonstrated or for which compatibility with Rocuronium bromide Noridem has not been established.

Dosage and method of administration

In adults, the following dosage recommendations serve as general guidelines for endotracheal intubation and muscle relaxation during surgical procedures of short to long duration and for use in intensive care units. Surgical proceduresEndotracheal intubation Standard dose for intubation during routine anesthesia is 0.6 mg/kg of rocuronium bromide. Suitable conditions for intubation are achieved within 60 seconds of administration in most patients. During rapid sequence induction of anesthesia, a dose of 1.0 mg/kg of rocuronium bromide is recommended, which provides suitable conditions for intubation within 60 seconds in almost all patients. Using a dose of 0.6 mg/kg of rocuronium bromide during rapid sequence induction of anesthesia, it is recommended to intubate the patient after 90 seconds of administration. Cesarean section Doses of 0.6 mg/kg of rocuronium bromide do not affect the Apgar score, fetal muscle tone, or cardiorespiratory adaptation. Umbilical cord blood samples have shown that only limited amounts of rocuronium bromide cross the placenta, which does not lead to clinical adverse effects in the newborn. Doses of 1 mg/kg were studied during rapid sequence induction of anesthesia but not in patients undergoing cesarean section. Higher doses If higher doses are required: patients were given initial doses of up to 2 mg/kg of rocuronium bromide, after which no adverse effects on the heart and blood vessels were observed. The use of higher doses of rocuronium bromide accelerates the onset of action and prolongs the duration of therapeutic action. Maintenance doses The recommended maintenance dose is 0.15 mg/kg of rocuronium bromide. During long-term anesthesia with inhalation agents, the dose should be reduced to 0.075-0.1 mg/kg of rocuronium bromide. Maintenance doses should be administered when the twitch response to stimulation returns to 25% of the control value or when two or three responses to a train-of-four stimulation occur. Continuous infusion If rocuronium bromide is administered as a continuous infusion, it is recommended to administer an initial dose of 0.6 mg/kg of rocuronium bromide, and when the neuromuscular blockade begins to subside, start the continuous infusion. The infusion rate should be adjusted to maintain a neuromuscular blockade at a level of 10% of the control value or to maintain one or two responses to a train-of-four stimulation. Children and adolescents The recommended intubation dose during routine anesthesia, as well as the maintenance dose, is similar to that in adults. However, the duration of action of a single intubation dose is longer in newborns and infants than in children. The rate of continuous infusions in children and adolescents (except for children aged 2 to 11 years) is the same as in adults. In children aged 2 to 11 years, the infusion rate may need to be increased. Therefore, in children aged 2 to 11 years, it is recommended to initially use the same infusion rate as in adults and then adjust it to maintain a twitch response to stimulation at 10% of the control value or to maintain one or two responses to a train-of-four stimulation. There is limited experience with the use of rocuronium bromide for rapid sequence induction in children and adolescents. Therefore, rocuronium bromide is not recommended for facilitating endotracheal intubation during rapid sequence induction in children and adolescents. Elderly patients and patients with liver and/or biliary and/or renal impairment The standard dose for intubation in elderly patients and patients with liver and/or biliary and/or renal impairment during routine anesthesia is 0.6 mg/kg of rocuronium bromide. During rapid sequence induction of anesthesia, a dose of 0.6 mg/kg of rocuronium bromide should be considered in patients in whom prolonged action of the medicine is expected. Regardless of the anesthesia method used, the recommended maintenance dose in these patients is 0.075-0.1 mg/kg of rocuronium bromide, and the recommended infusion rate is 0.3 to 0.4 mg/kg/h (see "Continuous infusion"). Dosing in obese patients In obese patients (defined as those with a body mass index 30% or more above their ideal body weight), the dose of the medicine should be reduced, taking into account the ideal body weight. Short-term use in intensive care unitsEndotracheal intubation To facilitate endotracheal intubation, the same doses should be used as described above for surgical procedures. Maintenance doses It is recommended to administer an initial bolus dose of 0.6 mg/kg of rocuronium bromide, and when the twitch response to stimulation returns to 10% of the initial value or when one to two responses to a train-of-four stimulation occur, start the continuous infusion. The dosage should always be adjusted to the individual needs of the patient. The recommended initial infusion rate to maintain a 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 to 0.6 mg/kg/h in the first hour of administration. During the next 6 to 12 hours, the infusion rate should be reduced depending on the individual response of the patient. Later, the individual requirement remains relatively constant. The use of Rocuronium bromide Noridem should be short-term. The total duration of administration should not exceed 7 days due to the lack of sufficient long-term data. In clinical studies, significant variability in infusion rates was observed. The average infusion rate ranged from 0.2 to 0.5 mg/kg/h, depending on the nature and severity of organ dysfunction, concomitantly administered medicines, and individual patient conditions. To optimize dosing to individual patient needs, continuous monitoring of neuromuscular blockade is strongly recommended. Administration for up to 7 days has been studied.

Special patient groups

Rocuronium bromide Noridem is not recommended for use in children and adolescents, as well as in elderly patients, to facilitate mechanical ventilation, due to the lack of data on efficacy and safety.

Method of administration

Rocuronium bromide Noridem is administered intravenously in a rapid injection or continuous infusion. Compatibility studies have been performed with the following infusion solutions: Rocuronium bromide Noridem at nominal concentrations of 0.5 mg/mL and 2.0 mg/mL has been shown to be compatible with: 0.9% NaCl solution, 5% glucose solution, 5% glucose solution in 0.9% saline solution, water for injections, Ringer's solution with lactate, and Heamacel. Administration should be started immediately after preparation of the solution and completed within 24 hours. For single use only. Before piercing the glass vial, it should be brought to room temperature to reduce the risk of breakage. Unused amounts of the solution should be discarded.

Special precautions for storage

Store in a refrigerator (2°C - 8°C). Rocuronium bromide Noridem does not contain preservatives and should be used immediately after opening the vial/ampoule. After dilution with infusion solutions, the medicine shows chemical and physical stability for 72 hours at a temperature of 28°C - 32°C or for 72 hours at a temperature of 2°C - 8°C. From a microbiological point of view, the medicine should be used immediately after dilution. If not used immediately, the user is responsible for the storage conditions and time of the ready-to-use solution. This time should not exceed 24 hours at a temperature of 2°C to 8°C, unless dilution was performed under controlled and validated aseptic conditions.

Disposal and preparation of the medicine

Any unused medicine or waste material should be disposed of in accordance with local regulations.

Overdose

In case of overdose and prolonged neuromuscular blockade, the patient should continue to receive respiratory support and appropriate sedation. In such a situation, there are two options for action to reverse the neuromuscular blockade:

• (1) Sugammadex may be used to reverse intense and deep blockade in adults. The dose of sugammadex administered depends on the level of neuromuscular blockade.
• (2) When spontaneous recovery from neuromuscular blockade begins, an appropriate dose of an acetylcholinesterase inhibitor (e.g., neostigmine, edrophonium, pyridostigmine) or sugammadex should be administered. If administration of an acetylcholinesterase inhibitor does not reverse the neuromuscular blockade, ventilation should be continued until spontaneous breathing resumes. Repeated administration of an acetylcholinesterase inhibitor may be hazardous. In animal studies, no severe cardiovascular disorders leading to heart failure were observed until a total dose of 750 × ED (135 mg/kg of rocuronium bromide) was administered.