Rocuronium kabi

Package leaflet: Information for the user

Rocuronium Kabi, 10 mg/mL, solution for injection / for infusion
Rocuronii bromidum
Please read all of this leaflet carefully before using this medicine, because it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any further questions, please consult your doctor, pharmacist or nurse.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of the leaflet

1. What Rocuronium Kabi is and what it is 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 pack and other information

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

Rocuronium Kabi belongs to a group of medicines called muscle relaxants.
Nerves transmit signals to muscles via impulses. Rocuronium Kabi blocks the transmission of these impulses, thereby causing muscle relaxation.
During surgical procedures, the patient's muscles must be completely relaxed. This facilitates the surgeon in performing the operation.
Rocuronium Kabi may also be used during general anaesthesia to facilitate insertion of an endotracheal tube into the trachea (intubation) during mechanical ventilation (mechanical respiratory support).
Rocuronium Kabi is indicated for use in adults, as well as in neonates (0–27 days), infants and young children (from 28 days to 23 months of age), children (from 2 to 11 years of age), and adolescents (from 12 to 17 years of age).
Rocuronium Kabi may also be used in adults as an adjunctive agent for short-term use in the intensive care unit (ICU) (e.g. to facilitate endotracheal intubation).

2. Important information before using Rocuronium Kabi

When not to use Rocuronium Kabi

• if the patient is allergic to 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 a doctor, pharmacist, or nurse if any of the following situations apply or have previously applied to the patient:

• if the patient has had an allergic reaction to any muscle relaxant;
• if the patient has kidney, liver, or gallbladder disease;
• if the patient has heart disease or a condition affecting blood circulation;
• if the patient has swelling (e.g. around the ankles);
• if the patient has a neuromuscular disease (nerve and muscle disorders such as poliomyelitis, myasthenia gravis, Eaton-Lambert syndrome);
• if the patient has experienced low body temperature during anaesthesia (hypothermia);
• if the patient has previously experienced malignant hyperthermia (sudden fever with rapid heartbeat, rapid breathing, and muscle stiffness, pain and/or weakness);
• if the patient currently has fever;
• if the patient has low calcium levels in the blood (hypocalcaemia – e.g. due to transfusion of large amounts of blood);
• if the patient has low potassium levels in the blood (hypokalaemia, caused e.g. by severe vomiting, diarrhoea, or treatment with diuretics);
• if the patient has high magnesium levels in the blood (hypermagnesaemia);
• if the patient has low protein levels in the blood (hypoproteinaemia);
• if the patient has dehydration;
• if the patient has increased acid levels in the blood (acidosis);
• if the patient has increased carbon dioxide levels in the blood (hypercapnia);
• if the patient has a tendency to breathe too rapidly (hyperventilation), leading to reduced carbon dioxide levels in the blood (alkalosis);
• if the patient has excessive weight loss (cachexia);
• in patients who are overweight or elderly;
• if the patient has suffered burns.

Rocuronium Kabi and other medicines
Inform the doctor or pharmacist about all medicines currently used, recently used, or planned for use, including:

• 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 (water tablets) (medicines that increase urine output);
• 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 myasthenia gravis (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 affecting 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 influence the effect of rocuronium. These include certain anaesthetics (e.g. local anaesthetics, inhaled anaesthetics) and other muscle relaxants, as well as protamine used to reverse the anticoagulant effect of heparin (preventing blood clots). The doctor will take this into account when considering dose adjustments.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
There is insufficient data on the use of rocuronium bromide in pregnant or breastfeeding women. Rocuronium Kabi should only be used during pregnancy or breastfeeding if the doctor decides that the benefits outweigh the risks. Rocuronium Kabi may be used during caesarean section.
Breastfeeding should be discontinued for 6 hours after administration of this medicine.

Driving and using machines
Rocuronium Kabi has a significant effect on the ability to drive and use machinery.
The doctor should advise the patient when it will be safe to resume driving and operating machinery. After treatment, a responsible adult should always accompany the patient home.

Rocuronium Kabi contains sodium
This medicine contains 3.3 mg of sodium (a main component of table salt) in each mL. This corresponds to 0.17% of the maximum recommended daily intake of sodium in the adult diet.

3. How to use Rocuronium Kabi

Rocuronium Kabi is administered to the patient by an anaesthesiologist. The medicine is given intravenously as a single injection or by continuous infusion (over a longer period).
The usual dose of the medicine is 0.6 mg per kilogram of body weight, which provides an effect lasting 30-40 minutes. During surgery, the effect of Rocuronium Kabi is continuously monitored.
If necessary, additional doses may be given. The anaesthesiologist will adjust the dose according to individual patient factors, such as drug interactions (cross-activity), the planned duration of surgery, and the patient's age and clinical condition.
This medicine is intended for single use only. The use of Rocuronium Kabi as a supportive treatment in intensive care units is not recommended in children and adolescents or in elderly patients.

Use in children and adolescents
Recommended doses in newborns (0-27 days), infants and young children (28 days-23 months), children (2-11 years) and adolescents (12-17 years) are similar to those used in adults, except for doses administered by continuous infusion in children (2-11 years), which may be higher than in adults. The anaesthesiologist will appropriately adjust the infusion rate.
Experience with the use of rocuronium bromide for a special type of anaesthesia 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.

Administration of a higher than recommended dose of Rocuronium Kabi
During treatment with Rocuronium Kabi, the patient remains under close supervision of the anaesthesiologist, making it unlikely that an excessive dose will be administered. If this occurs, the anaesthesiologist will ensure that anaesthesia and artificial ventilation are continued until the patient resumes spontaneous breathing.

Additional questions
If you have any further questions regarding the use of this medicine, please consult your doctor, pharmacist, or nurse.
For information intended for physicians and healthcare professionals, see the appropriate section below.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Hypersensitivity reactions (anaphylactic reaction/anaphylactic shock) are very rare, but they may be life-threatening allergic reactions. Symptoms of hypersensitivity may include rash, itching, difficulty breathing, or swelling of the face, lips, throat or tongue.
If any of these symptoms occur, contact a doctor or nurse immediately.

Uncommon (may affect up to 1 in 100 patients) / Rare (may affect up to 1 in 1,000 patients):

• pain at the injection site;
• excessive or insufficient effect of the medicine, or lack of effectiveness;
• prolonged duration of action of the medicine (prolonged neuromuscular blockade);
• prolonged duration of anaesthesia (delayed emergence from anaesthesia);
• low blood pressure (arterial hypotension);
• increased heart rate (tachycardia).

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

• increased blood histamine concentration (a mediator of allergic reactions);
• wheezing (bronchospasm);
• rash, itching;
• facial flushing;
• facial swelling;
• extensive, severe rash (urticaria, erythematous rash);
• muscle weakness (myopathy);
• angioedema;
• urticaria;
• inability to move (flaccid paralysis);
• circulatory failure (circulatory collapse and shock);
• breathing difficulties (respiratory failure, apnoea).

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

• respiratory disorders (respiratory failure);
• respiratory arrest (apnoea);
• 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 using rocuronium bromide in children and adolescents, increased heart rate was reported as an adverse reaction in 1 out of 10 patients.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the 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 stated month.
Unopened vial: No special storage conditions required.
The medicine should be used immediately after opening the vial.
Do not use this medicine if the solution is not clear or contains any particulate matter.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Rocuronium Kabi contains

• The active substance 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 ingredients are: 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, colourless 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 Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw
Manufacturer
Fresenius Kabi Austria GmbH
Hafnerstraße 36
8055 Graz
Austria
For further information, contact the Marketing Authorisation Holder:
Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw
tel. +48 22 345 67 89
This medicinal product is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Information intended solely for healthcare professionals:

For single use only.
Any unused portions of the solution must be discarded.
The medicinal product should be administered immediately after opening the vial.
After dilution: Chemical and physical stability has been demonstrated for 72 hours at temperatures up to 30°C.
From a microbiological standpoint, the product should be used immediately. If not used immediately, the duration and conditions of storage of the ready-to-use solution are the responsibility of the user. Normally, this period should not exceed 24 hours at a temperature of 2 to 8°C, unless the solution has been prepared under 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 lactate solution, and water for injections.
If Rocuronium Kabi is administered through the same infusion line as other medicinal products, it is important to adequately flush the line (e.g., with 0.9% sodium chloride solution) between administration of Rocuronium Kabi and any medicinal products with which rocuronium bromide is known to be incompatible or for which compatibility has not been established.
This medicinal product must not be mixed with other medicinal products except those mentioned above.
Physical incompatibility of Rocuronium Kabi has been documented when added to solutions containing the following active substances: amphotericin, amoxicillin, azathioprine, cefazolin, cloxacillin, dexamethasone, diazepam, enoximone, erythromycin, famotidine, furosemide, hydrocortisone sodium succinate, insulin, intralipid, methohexital, methylprednisolone, prednisolone sodium succinate, thiopental, trimethoprim, and vancomycin.