Rocuronium Kabi

Leaflet attached to the packaging: information for the user

Rocuronium Kabi, 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.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

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

Rocuronium Kabi belongs to a group of medicines called muscle relaxants.
Nerves transmit information to muscles through impulses. Rocuronium Kabi blocks the transmission of these impulses, causing muscle relaxation.
During surgery, the patient's muscles must be completely relaxed. This makes it easier for the surgeon to perform the operation.
Rocuronium Kabi can also be used in general anesthesia to facilitate the introduction of an endotracheal tube into the trachea (intubation) during mechanical ventilation (mechanical breathing support).
Rocuronium Kabi is indicated for use in adults and in newborns (0-27 days), infants and young children (from 28 days to 23 months), children (from 2 to 11 years) and adolescents (from 12 to 17 years).
Rocuronium Kabi may also be used in adults as an auxiliary medicine for short-term use in the intensive care unit (ICU) (e.g., to facilitate the introduction of an endotracheal tube into the trachea).

2. Important information before using Rocuronium Kabi

When not to use Rocuronium Kabi

allergicto rocuronium bromide, bromide ion, or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting treatment with Rocuronium Kabi, discuss with your doctor, pharmacist, or nurse if any of the following situations apply or have applied to the patient in the past:

allergyto any muscle relaxant;kidney, liver, or gallbladder disease;heart diseaseor a disease affecting blood circulation;edema(e.g., in the ankle area);disease affecting nerves and muscles(neuromuscular diseases, e.g., polio, muscular dystrophy, Eaton-Lambert syndrome);low body temperature during anesthesia(hypothermia);malignant hyperthermia(sudden fever with rapid heartbeat, rapid breathing, and muscle stiffness, pain, or weakness);fever;low calcium levels in the blood(hypocalcemia - caused, e.g., by massive blood transfusion);low potassium levels in the blood(hypokalemia, caused, e.g., by severe vomiting, diarrhea, or treatment with diuretics);high magnesium levels in the blood(hypermagnesemia);low protein levels in the blood(hypoproteinemia);dehydration;increased acid levels in the blood(acidosis);increased carbon dioxide levels in the blood(hypercapnia);tendency to breathe too quickly(hyperventilation), leading to a decrease in carbon dioxide levels in the blood (alkalosis);excessive weight loss(cachexia);
• in patients who are overweight or elderly;
burns.

Rocuronium Kabi and other medicines

Tell your doctor or pharmacist about all medicines the patient is taking or has recently taken, as well as any medicines the patient plans to take, such as:

• antibiotics;
• antidepressants: used to treat depression (e.g., lithium salts, MAO inhibitors);
• medicines used to treat heart disease or high blood pressure(e.g., quinidine, calcium channel blockers, adrenergic receptor blockers (e.g., beta-blockers));
• diuretics, i.e., water pills(medicines that increase urine production);
• certain laxatives, e.g., magnesium salts;
• quinine (used to treat pain and infections);
• medicines used to treat epilepsy(e.g., phenytoin, carbamazepine);
• corticosteroids;
• medicines used to treat muscular dystrophy(neostigmine, pyridostigmine);
• Vitamin B1(thiamine);
• azathioprine(a medicine used to prevent transplant rejection and treat autoimmune diseases);
• theophylline(a medicine used to treat asthma);
• noradrenaline(a hormone that affects blood pressure and other body functions);
• potassium chloride;
• calcium chloride;
• medicines used to treat or prevent viral infections (protease inhibitors: gabexate, ulinastatin).

Note:

It is possible that the patient may receive other medicines during surgery that may affect the action of rocuronium. These include certain anesthetics (e.g., local anesthetics, inhalation anesthetics) and other muscle relaxants, protamines that counteract the anticoagulant effect of heparin (preventing blood clot formation). The doctor will take this into account if they decide to modify the dose of the medicine for the patient.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
There is no data on the use of rocuronium bromide in pregnant women and during breastfeeding. Rocuronium Kabi should be used in pregnant women or during breastfeeding only if the doctor decides that the benefits outweigh the risk. Rocuronium Kabi can be used during cesarean section.
Breastfeeding should be stopped for 6 hours after using this medicine.

Driving and using machines

Rocuronium Kabi has a significant impact on the ability to drive and use machines.
The doctor should instruct the patient when they can drive and use machines again. After treatment, the patient should always be accompanied by a responsible adult on their way home.

Rocuronium Kabi contains sodium

The medicine contains 3.3 mg of sodium (the main component of table salt) per mL. This corresponds to 0.17% of the maximum recommended daily sodium intake in the diet for adults.

3. How to use Rocuronium Kabi

Rocuronium Kabi is administered to the patient by an anesthesiologist. The medicine is administered intravenously in a single injection or in continuous infusion (over a longer period).
Usually, the dose of the medicine used is 0.6 mg per kilogram of body weight, which ensures action for 30-40 minutes. During surgery, the action of Rocuronium Kabi is constantly monitored.
If necessary, the patient may receive additional doses. The anesthesiologist will select a dose suitable for the individual patient, depending on a series of factors, such as interactions with other medicines (cross-reactivity), the planned duration of the procedure, and the patient's age and clinical condition.
The medicine is intended for single use only. It is not recommended to use Rocuronium Kabi as a supportive treatment in the intensive care unit for children and adolescents, as well as for patients who are elderly.
Use in children and adolescents
For newborns (0-27 days), infants, and young children (28 days-23 months), children (2-11 years), and adolescents (12-17 years), the recommended doses are similar to those used in adults, except for the doses used in continuous infusion in children (2-11 years), which may be higher than in adults.
The anesthesiologist will adjust the infusion rate accordingly.
Experience with the use of rocuronium bromide in a special type of anesthesia called rapid sequence induction in children and adolescents is limited. Therefore, the use of rocuronium bromide for this purpose is not recommended in children and adolescents.

Using a higher dose of Rocuronium Kabi than recommended

During treatment with Rocuronium Kabi, the patient remains under the close supervision of the anesthesiologist, so it is unlikely that the patient will receive too high a dose of Rocuronium Kabi. If this happens, the anesthesiologist will ensure that anesthesia and mechanical ventilation are continued until the patient starts breathing on their own.

Additional questions

If you have any further questions about using this medicine, ask your doctor, pharmacist, or nurse.
To access information intended for healthcare professionals, see the relevant section below.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Hypersensitivity reactions (anaphylactic reaction/anaphylactic shock) are very rare but can be life-threatening allergic reactions. Symptoms of hypersensitivity reactions may include rash, itching, difficulty breathing, or swelling of the face, lips, throat, or tongue.
If you experience any of these symptoms, contact your doctor or nurse immediately.
Not very common(may affect up to 1 in 100 people) / rare(may affect up to 1 in 1,000 people):

• pain at the injection site;
• increased or insufficient action of the medicine or ineffectiveness of the medicine;
• prolonged duration of action of the medicine (prolonged duration of neuromuscular blockade);
• prolonged duration of anesthesia (delayed recovery from anesthesia);
• low blood pressure (hypotension);
• increased heart rate (tachycardia).

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

• increased histamine levels in the blood;
• wheezing (bronchospasm);
• rash, itching;
• flushing of the face;
• swelling of the face;
• widespread, severe rash (erythema, erythematous rash);
• muscle weakness (myopathy);
• angioedema;
• hives;
• inability to move (flaccid paralysis);
• circulatory failure (cardiovascular collapse and shock);
• breathing difficulties (respiratory failure, apnea).

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

• breathing disorders (respiratory failure);
• breathing stop (apnea);
• severe allergic coronary artery spasm (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.

Children and adolescents
In clinical trials with rocuronium bromide in children and adolescents, an increased heart rate was reported as a side effect in 1 in 10 patients.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
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 Rocuronium Kabi

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label and carton after EXP. The expiry date refers to the last day of the month.
Unopened vial: There are no special storage instructions for the medicine.
The medicine should be used immediately after opening the vial.
Do not use this medicine if the solution is not clear or contains any solid particles.
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 Kabi contains

• The active substanceof the medicine is rocuronium bromide.

1 mL contains 10 mg of rocuronium bromide.
Each 5 mL vial contains 50 mg of rocuronium bromide.
Each 10 mL vial contains 100 mg of rocuronium bromide.

• Other ingredientsare: sodium chloride, hydrochloric acid, sodium hydroxide (for pH adjustment), and water for injections.

What Rocuronium Kabi looks like and contents of the pack

Rocuronium Kabi is a clear, colorless to slightly brownish-yellow solution for injection/infusion.
Pack sizes:
Rocuronium Kabi is available in packs of 5 or 10 vials containing 5 mL or 10 mL of solution.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw

Manufacturer

Fresenius Kabi Austria GmbH
Hafnerstraße 36
8055 Graz
Austria
To obtain more detailed information, contact the marketing authorization holder:
Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw
tel. +48 22 345 67 89

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:23.01.2024

Information intended for healthcare professionals only:

For single use only.
Any unused solution should be discarded.
The medicine should be administered immediately after opening the vial.
After dilution: The chemical and physical stability of the medicine has been demonstrated after dilution for 72 hours at a temperature up to 30 °C.
From a microbiological point of view, the medicine should be used immediately. If the medicine is not used immediately, the user is responsible for the storage conditions and time of the prepared solution. Usually, this time should not exceed 24 hours at 2 to 8°C, unless the solution was prepared in controlled and validated aseptic conditions.
Pharmaceutical compatibility of Rocuronium Kabi has been demonstrated with sodium chloride 9 mg/mL (0.9%), glucose 50 mg/mL (5%), glucose 50 mg/mL (5%) in sodium chloride 9 mg/mL (0.9%), Ringer's solution with lactate, and water for injections.
If Rocuronium Kabi is administered through the same infusion line as other medicines, it is essential to remember to flush the line (e.g., with 0.9% sodium chloride solution) between the administration of Rocuronium Kabi and medicines for which pharmaceutical incompatibility has been demonstrated or not established with rocuronium bromide.
This medicine must not be mixed with other medicines, except those mentioned above.