Package leaflet: Information for the user

Rocuronium bromide hameln 10 mg/ml solution for injection/infusion
Rocuronii bromidum
Please read the entire leaflet carefully before using Rocuronium bromide hameln, as 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.
This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, you should inform your doctor, pharmacist, or nurse. See section 4.

Table of contents

What Rocuronium bromide hameln is and what it is used for
What you need to know before using Rocuronium bromide hameln
How to use Rocuronium bromide hameln
Possible side effects
How to store Rocuronium bromide hameln
Contents of the pack and other information

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

Rocuronium bromide hameln belongs to a group of medicines called muscle relaxants.
Under normal physiological conditions, nerves communicate with muscles by sending impulses.
Rocuronium bromide hameln works by blocking these impulses, resulting in muscle relaxation.
During surgery, the patient's muscles must remain completely relaxed, which greatly facilitates the surgical procedure.
Rocuronium bromide hameln is administered during general anaesthesia to facilitate the insertion of an endotracheal tube for mechanical ventilation (mechanical respiratory support). Rocuronium bromide hameln may also be used for a short period as an adjunctive medication in intensive care units (ICU), for example, to facilitate endotracheal intubation.
Children and adolescents (0 <18 years)
Rocuronium bromide hameln is used in full-term newborns, children, and adolescents aged 0 <18 years as an adjunct to general anaesthesia to facilitate endotracheal intubation for mechanical ventilation (mechanical respiratory support) and to achieve skeletal muscle relaxation.

2. Important information before using the medicine Rocuronium bromide hameln

When not to use Rocuronium bromide hameln:
If the patient is allergic (hypersensitive) to rocuronium bromide, bromide ion, or any of the
other components of this medicine (listed in section 6).

Warnings and precautions
Before starting treatment with Rocuronium bromide hameln, discuss this with the doctor,
pharmacist, or nurse if the patient:

has had an allergic reaction to any muscle relaxants
has kidney disease, liver disease, or biliary tract disorders
has heart disease or conditions affecting blood circulation
has edema (e.g., swelling around the ankles)
has nerve or muscle disorders, such as neuromuscular diseases (e.g., polio (anterior poliomyelitis), myasthenia gravis, Eaton-Lambert syndrome)
has previously experienced low body temperature during general anesthesia (hypothermia)
has previously experienced high fever (malignant hyperthermia) during general anesthesia
currently has fever
has low calcium levels in the blood (hypocalcemia) (e.g., due to large-volume blood transfusions)
has low potassium levels in the blood (hypokalemia) (e.g., due to severe vomiting, diarrhea, or diuretic medications)
has high magnesium levels in the blood (hypermagnesemia)
has low protein levels in the blood (hypoproteinemia)
is dehydrated
has increased acid levels in the body (acidosis)
has elevated carbon dioxide levels in the blood (hypercapnia)
has rapid, irregular breathing (hyperventilation). Rapid breathing leads to low carbon dioxide levels in the blood (alkalosis)
has severe weight loss (cachexia)
is obese or elderly
has burns

Children and elderly patients
Rocuronium bromide hameln may be used in children (including neonates and adolescents) and elderly patients, but the anesthesiologist should first review the patient's medical history. The same warnings and precautions apply as for adult patients.

Rocuronium bromide hameln and other medicines
Inform the doctor or pharmacist about all medicines currently used or recently used, as well as any medicines the patient plans to take, including:

Antibiotics
Antidepressants: used to treat depression (e.g., MAO inhibitors)
Medicines used to treat heart disease or hypertension (e.g., quinidine, calcium channel blockers, adrenergic receptor blockers (e.g., beta-blockers))
Diuretics (medicines that increase urine production)
Some laxatives, e.g., magnesium salts
Quinine (used to treat pain and infections)
Anticonvulsants (used to treat epilepsy – phenytoin, carbamazepine)
Corticosteroids
Medicines used to treat myasthenia gravis (neostigmine, pyridostigmine)
Vitamin B (thiamine)
Azathioprine (used in transplant patients to prevent graft rejection and in treating autoimmune diseases)
Theophylline (used to treat asthma)
Noradrenaline (a hormone affecting blood pressure and other vital functions)
Potassium chloride
Calcium chloride
Medicines used to treat or prevent viral infections (protease inhibitors)

WARNING!
During surgery, the patient may receive other medicines that could affect the action of rocuronium. These include certain anesthetics (e.g., local anesthetics, inhaled anesthetics), other muscle relaxants, and protamine, which reverses the anticoagulant (blood clot prevention) effect of heparin. The doctor will take this into account when deciding whether to adjust the dose of the medicine.

Pregnancy, breastfeeding, and fertility
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.
Data on the use of Rocuronium bromide hameln in pregnant women are very limited. There are no data available on its use in breastfeeding women. Rocuronium bromide hameln may be administered to pregnant and breastfeeding women only if the doctor decides that the benefits outweigh the risks. Rocuronium bromide hameln may be used during cesarean section.
Breastfeeding should be postponed for 6 hours after administration of this medicine.
There are no available data on the effect of this medicine on fertility.

Driving and operating machinery
Rocuronium bromide hameln has a significant effect on the ability to drive and operate machinery. For this reason, driving or operating potentially dangerous equipment is not recommended during the first 24 hours after administration of the medicine. The doctor should inform the patient when it is safe to resume driving or operating machinery. After anesthesia, the patient should return home accompanied by an adult.

Rocuronium bromide hameln contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, meaning it is considered "sodium-free".

3. How to use Rocuronium bromide hameln

This medicine should always be used as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
Rocuronium bromide hameln will be administered to the patient by an anaesthesiologist. The medicine is
given intravenously, either as a single injection or by continuous intravenous infusion (over
a longer period).
The usual dose is 0.6 mg/kg body weight; the effect of the medicine lasts 30 to 40 minutes. During
surgical procedures, the effect of Rocuronium bromide hameln is continuously monitored. If necessary,
additional doses may be given. The dose is adjusted according to the patient's needs by the anaesthesiologist. The dose level depends on several factors, such as drug interactions (cross-activity), estimated duration of the surgical procedure, as well as the patient's age and clinical condition.
This medicine is intended for single use only.
Use in children and adolescents (0 < 18 years)
This medicine may be given to newborns (0–28 days), infants (>28 days ≤3 months), young
children (>3 months ≤2 years), children (2–11 years), and adolescents (12–17 years). Doses and
effects of the medicine in children may differ slightly from those in adults.
The anaesthesiologist adjusts the dose according to the child's needs.
In children, an increased infusion rate may be required.
Experience with the use of rocuronium bromide in children and adolescents for a special anaesthetic technique called rapid sequence induction is limited. Therefore, the use of rocuronium bromide for this purpose in children and adolescents is not recommended.
Use of a higher than recommended dose of Rocuronium bromide hameln
During treatment with Rocuronium bromide hameln, the patient remains under close supervision of the anaesthesiologist; therefore, receiving an excessive dose of Rocuronium bromide hameln is unlikely. If this occurs, the anaesthesiologist will ensure that anaesthesia and artificial ventilation are continued until the patient resumes spontaneous breathing.
If there are any further doubts regarding the use of this medicine, consult a doctor, pharmacist, or nurse.
For information intended for physicians and healthcare professionals, see the appropriate section below.

4. Possible adverse effects

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

Uncommon adverse effects
(may occur in less than 1 in 100 people)

medicine works too strongly or too weakly
prolonged effect of the medicine (delayed emergence from anaesthesia)
prolonged muscle-relaxing effect (prolonged neuromuscular block)
low blood pressure
increased heart rate
pain at the injection site

Very rare adverse effects
(may occur in less than 1 in 10,000 people)

allergic reactions - hypersensitivity (such as difficulty breathing, circulatory collapse and shock)
wheezing in the chest (bronchospasm)
anaesthetic complication affecting the airway
muscle weakness
steroid myopathy
itching, swelling, rash or redness of the skin
widespread, severe rash (exanthem)
angioedema
urticaria
inability to move (flaccid paralysis)
circulatory arrest (circulatory failure and shock)

Frequency unknown:

Respiratory arrest
Respiratory failure
Severe allergic coronary artery spasm (Kounis syndrome) causing chest pain (angina pectoris) or heart attack (myocardial infarction)
Dilated pupils or pupils that do not dilate or constrict in response to light or other stimuli

Children
Clinical studies suggest that increased heart rate (tachycardia) occurs with a frequency of 1.4% and may occur in up to 1 in 10 patients (common adverse effect).

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist or nurse.
Adverse effects can be reported directly via the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, 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
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store Rocuronium bromide hameln

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label and outer carton after "EXP". The expiry date refers to the last day of the stated month.
Store in a refrigerator (2°C–8°C).
Storage outside the refrigerator: Rocuronium bromide hameln may also be stored outside the refrigerator at temperatures below 30°C for a maximum of 12 weeks, after which it must be destroyed. If the medicine has been stored outside the refrigerator, it should not be returned to the refrigerator. The storage period must not exceed the expiry date.
The medicine should be used immediately after opening the vial/ampoule.
After dilution: the solution at a concentration of 5.0 mg/ml or 0.1 mg/ml (diluted with 9 mg/ml (0.9%) sodium chloride infusion solution or 50 mg/ml (5%) glucose solution for injection) remains chemically and physically stable for 24 hours at room temperature.
Due to the risk of microbiological contamination, the medicine should be used immediately. If this is not possible, the responsibility for the storage conditions and duration of the ready-to-use solution lies with the user. Do not use this medicine if the solution is not clear or contains any particles.
Medicines must 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 package and other information

What Rocuronium bromide hameln contains
The active substance is rocuronium bromide.
1 ml contains 10 mg of rocuronium bromide.
Each 2.5 ml vial contains 25 mg of rocuronium bromide.
Each 5 ml ampoule or vial contains 50 mg of rocuronium bromide.
Each 10 ml ampoule or vial contains 100 mg of rocuronium bromide.
Other ingredients are: sodium chloride, sodium acetate trihydrate, glacial acetic acid, and water for injections.

What Rocuronium bromide hameln looks like and contents of the pack
Rocuronium bromide hameln is a clear, colourless or slightly yellowish-brown solution for injection/infusion.

Pack sizes:
Rocuronium bromide hameln is available in packs of 5 or 10 vials containing 2.5 ml, 5 ml or 10 ml of solution, as well as in packs of 12 vials containing 5 ml or 10 ml of solution. Rocuronium bromide hameln is also available in packs of 5, 10 or 12 ampoules containing 5 ml, and in packs of 5 or 10 ampoules containing 10 ml of solution.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
hameln pharma gmbh
Inselstraße 1
31787 Hameln
Germany

Manufacturer:
Siegfried Hameln GmbH
Langes Feld 13
31789 Hameln
Germany
HBM Pharma s.r.o.
Sklabinská 30
03680 Martin
Slovakia
hameln rds s.r.o.
Horná 36
900 01 Modra
Slovakia
Solupharm Pharmazeutische Erzeugnisse GmbH
Industriestraße 3
34212 Melsungen
Germany

For further information, contact the local representative of the Marketing Authorisation Holder:
Poland
IMED Poland Sp. z o.o.
ul. Puławska 314
02-819 Warsaw
Tel: 22 663-43-03
22 663-43-10
e-mail: [email protected]

This medicinal product is authorised in the European Economic Area and the United Kingdom (Northern Ireland) under the following names:
Germany Rocuroniumbromid hameln 10 mg/ml Injektions-/Infusionslösung
Denmark Rocuronium hameln
Finland Rocuronium hameln 10 mg/ml injektio-/infuusioneste, liuos
Netherlands Rocuroniumbromide hameln 10 mg/ml oplossing voor injectie/infusie
Sweden Rocuronium hameln 10 mg/ml injektions-/infusionsvätska, lösning
United Kingdom
(Northern Ireland) Rocuronium 10 mg/ml solution for injection/infusion
Austria Rocuroniumbromid hameln 10 mg/ml Injektions-/Infusionslösung
Czech Republic Rocuronium bromide hameln
Croatia Rokuronijev bromid hameln 10 mg/ml otopina za injekciju/infuziju
Hungary Rocuronium bromide hameln 10 mg/ml oldatos injekció/infúzió
Poland Rocuronium bromide hameln
Slovenia Rokuronijev bromid hameln 10 mg/ml raztopina za injiciranje/infundiranje
Slovak Republic Rocuronium bromide hameln 10 mg/ml injekčný/infúzny roztok

Information intended exclusively for medical professionals:

Preparation method:
Rocuronium bromide hameln 10 mg/ml solution for injection/infusion
Before beginning preparation of the product for administration, the entire text of this instruction must be read.
Preparation for intravenous administration
The medicinal product Rocuronium bromide hameln is intended for intravenous (iv) administration either as a bolus injection or by continuous infusion.
The medicinal product Rocuronium bromide hameln is compatible with the following solutions: sodium chloride 9 mg/ml (0.9%) and glucose 50 mg/ml (5%).
Any unused solution must be discarded.
The medicinal product must not be mixed with other medicinal products except those listed above.
Physical incompatibility of Rocuronium bromide hameln has been documented when added to solutions containing the following medicinal products: 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.
If Rocuronium bromide hameln is administered via the same infusion line as other medicinal products, it is essential to adequately flush the infusion line (e.g. with 0.9% NaCl solution) between administration of Rocuronium bromide hameln and any medicinal product shown to be incompatible with rocuronium bromide or for which compatibility with rocuronium bromide has not been established.