Rocuronium bromide hameln

B. PATIENT INFORMATION LEAFLET

Leaflet attached to the packaging: information for the user

Rocuronium bromide hameln 10 mg/ml solution for injection/infusion

Rocuronium bromide

Read the leaflet carefully before using Rocuronium bromide hameln, 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.
• 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, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

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

Rocuronium bromide hameln belongs to a group of medicines called muscle relaxants.
Physiologically, nerves communicate with muscles by sending impulses. The action of
Rocuronium bromide hameln is to block these impulses, which causes muscle relaxation.
During surgery, the patient's muscles must be completely relaxed, which greatly facilitates the
operation for the surgeon.
Rocuronium bromide hameln is administered during general anesthesia to facilitate the introduction of an endotracheal tube into the trachea for mechanical ventilation (mechanical breathing assistance). Rocuronium bromide hameln is also administered for a short period as a supplementary medication in intensive care units (ICU) (e.g., to facilitate the introduction of an endotracheal tube into the trachea).
Children and adolescents (0 <18 years)
Rocuronium bromide hameln is used in newborns, children, and adolescents aged 0 <18 years as an auxiliary medication in general anesthesia to facilitate the introduction of endotracheal tube into trachea for mechanical ventilation (mechanical breathing assistance) and achieve skeletal muscle relaxation.< p>

2. Important information before using 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 ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting treatment with Rocuronium bromide hameln, discuss it with your doctor, pharmacist, or nurse

• if the patient has experienced allergyto any muscle relaxant drugs
• if the patient has kidney disease, liver diseaseor bile duct disease
• if the patient has heart diseaseor diseases affecting blood circulation
• if the patient has edema(e.g., edema around the ankles)
• if the patient has nerve or muscle diseasessuch as (neuromuscular disorders, e.g., polio (anterior horn inflammation), myasthenia gravis, Eaton-Lambert syndrome)
• if the patient has ever had low body temperatureduring general anesthesia (hypothermia)
• if the patient has ever had high fever(malignant hyperthermia) during general anesthesia
• if the patient has fever
• if the patient has low calcium levelsin the blood (hypocalcemia) (caused by e.g., large blood transfusions)
• if the patient has low potassium levelsin the blood (hypokalemia) (caused by e.g., severe vomiting, diarrhea, or diuretic drugs)
• if the patient has high magnesium levelsin the blood (hypermagnesemia)
• if the patient has low protein levelsin the blood (hypoproteinemia)
• if the patient is dehydrated
• if the patient has increased acid levelsin the body (acidosis)
• if the patient has increased carbon dioxide levelsin the blood (hypercapnia)
• if the patient has rapid, abnormal breathing(hyperventilation). Intensive breathing leads to low carbon dioxide levels in the blood (alkalosis)
• if the patient has excessive weight loss(cachexia)
• if the patient is obeseor elderly
• if the patient has burns

Children and the elderly

Rocuronium bromide hameln can be used in children (newborns and adolescents) and the elderly, but the anesthesiologist should first review the patient's medical records.
The same warnings and precautions should be taken into account as for adults.

Rocuronium bromide hameln and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take, such as:

• Antibiotics
• Antidepressantmedicines: used to treat depression (e.g., MAO inhibitors)
• Medicines used to treat heart diseaseor high blood pressure(e.g., quinidine, calcium channel blockers, adrenergic receptor blockers (e.g., beta-blockers))
• Diureticmedicines (medicines that increase urine production)
• Certain laxativemedicines, e.g., magnesium salts
• Quinine (used to treat pain and infection)
• Antiepilepticmedicines (used to treat epilepsy - phenytoin, carbamazepine)
• Corticosteroids
• Medicines used to treat myasthenia gravis(neostigmine, pyridostigmine)
• Vitamin B(thiamine)
• Azathioprine(used in patients after transplants to prevent rejection and in the treatment of autoimmune diseases)
• Theophylline(used to treat asthma)
• Noradrenaline(hormone that affects blood pressure and other vital functions)
• Potassium chloride
• Calcium chloride
• Medicines used to treat and prevent viral infections (protease inhibitors).

WARNING!

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), other muscle relaxants, protamines that counteract the anticoagulant effect of heparin. The doctor will take this into account if they decide to adjust the dose of the medicine for the patient.

Pregnancy, breastfeeding, and fertility

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.
Data on the use of Rocuronium bromide hameln in pregnant women are very limited.
There are no data on the use of Rocuronium bromide hameln in breastfeeding women. Rocuronium bromide hameln can be administered to pregnant and breastfeeding women only if the doctor decides that the benefits outweigh the risks. The medicine Rocuronium bromide hameln can be administered 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 using machines

Rocuronium bromide hameln has a significant impact on the ability to drive and use machines. Therefore, driving or operating potentially hazardous equipment is not recommended during the first 24 hours after using the medicine.
The doctor should inform the patient when they can start driving or operating machines again. After anesthesia, the patient should go home accompanied by an adult.

Rocuronium bromide hameln contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per dose, which means the medicine is considered "sodium-free".

3. How to use Rocuronium bromide hameln

This medicine should always be used exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Rocuronium bromide hameln will be administered to you by an anesthesiologist. The medicine is administered intravenously, either as a single injection or as a continuous intravenous infusion (over a longer period).
Usually, the dose used is 0.6 mg/kg body weight, and the action of the medicine lasts 30 to 40 minutes. During surgery, the action of Rocuronium bromide hameln is continuously monitored. If necessary, the patient may receive additional doses. The dose is adjusted to the patient's needs by the anesthesiologist. The size of the dose depends on a number of factors, such as interactions with other medicines (cross-reactivity), attention is also paid to the estimated duration of the surgical procedure, as well as the patient's age and clinical condition.
The medicine is intended for single use only.

Use in children and adolescents (0 <18 years)< h4>

This medicine can be administered 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). The doses and action of the medicine in children may differ slightly from those in adults.
The anesthesiologist adjusts the dose to the child's needs.
In children, it may be necessary to increase the infusion rate.
Experience with the use of rocuronium bromide in children and adolescents in a special type of anesthesia technique called rapid sequence induction is limited. Therefore, the use of rocuronium bromide for this purpose is not recommended in children and adolescents.

Using more than the recommended dose of Rocuronium bromide hameln

During treatment with Rocuronium bromide hameln, the patient remains under close supervision of the anesthesiologist, so it is unlikely that too much Rocuronium bromide hameln will be administered. If this happens, the anesthesiologist will ensure that anesthesia and artificial ventilation will be continued until the patient starts breathing again on their own.
If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.
To view 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.
Allergic reactions (hypersensitivity) are rare but can be life-threatening. Symptoms of an allergic reaction may include: rash, itching, difficulty breathing, swelling of the face, lips, throat, or tongue.
If you experience one or more of these symptoms, tell your doctor or nurse immediately.

Uncommon side effects

(may affect up to 1 in 100 people)

• the medicine works too strongly or too weakly
• the medicine works longer than expected (prolonged recovery from anesthesia)
• prolonged muscle relaxation (long-lasting neuromuscular blockade)
• low blood pressure
• increased heart rate
• pain at the injection site

Rare side effects

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

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

Frequency not known:

• 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 trials suggest that an increased heart rate (tachycardia occurs with a frequency of 1.4% and may occur in up to 1 in 10 patients (frequent adverse reaction)).

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, PL-02-222 Warsaw
Phone: +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, you can help 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 carton after "EXP". The expiry date refers to the last day of the month.
Store in a refrigerator (2°C - 8°C)
Storage outside the refrigerator: Rocuronium bromide hameln can also be stored outside the refrigerator at a temperature below 30°C for a maximum of 12 weeks, after which it should be discarded. If the medicine has been stored outside the refrigerator, it should not be put back in the refrigerator. The storage period should not exceed the shelf life.
The medicine should be used immediately after opening the vial/ampoule.
Medicine after dilution: a solution with a concentration of 5.0 mg/ml or 0.1 mg/ml (diluted with sodium chloride 9 mg/ml (0.9%) solution for infusion or glucose 50 mg/ml (5% solution for injection)) shows chemical and physical stability for 24 hours at room temperature.
Due to the microbiological risk, the medicine should be used immediately. If this is not possible, the user is responsible for the storage time and conditions of the ready-to-use solution. Do not use this medicine if the solution is not clear or contains any particles.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Rocuronium bromide hameln contains

The active substanceof the medicine 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
The other excipientsare: 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, colorless or pale yellowish solution for injection/infusion.
Packaging types:
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, as well as in packs of 5 or 10 ampoules containing 10 ml of solution.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization 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
To obtain more detailed information, please contact your local representative of the marketing authorization holder:

Poland

IMED Poland Sp.z o.o.

ul. Puławska 314
02-819 Warszawa
Phone: 22 663-43-03
22 663-43-10
e-mail: imed@imed.com.pl
This medicine is authorized in the Member States of the European Economic Area and in 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

Date of last revision of the leaflet: 11/2023

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Information intended for healthcare professionals only:

Preparation method:

Rocuronium bromide hameln 10 mg/ml solution for injection/infusion

Before preparing the product for administration, read the entire contents of this instruction.

Preparation for intravenous administration

The medicinal product Rocuronium bromide hameln is intended for intravenous administration (i.v.) in the form of a bolus or continuous infusion.
The medicinal product Rocuronium bromide hameln is compatible with sodium chloride 9 mg/ml (0.9%) and glucose 50 mg/ml (5%) solutions.
Unused solution should be discarded.
The medicinal product should not be mixed with other medicines except those mentioned above.
Physical incompatibility of Rocuronium bromide hameln has been documented when added to solutions containing the following medicines: 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 using the same infusion line as other medicines, it is essential to flush the infusion line (e.g., with 0.9% NaCl solution) between administering Rocuronium bromide hameln and administering medicines for which incompatibility with rocuronium bromide has been demonstrated or for which compatibility with rocuronium bromide has not been established.