Rocuronium B. Braun

Package Leaflet: Information for the User

Rocuronium B. Braun 10 mg/ml solution for injection/infusion
Rocuronium bromide

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this package leaflet, you may need to read it again.
• Ask your doctor, pharmacist, or nurse if you need advice or further information.
• This medicine has been prescribed specifically for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, pharmacist, or nurse. See section 4.

Contents of the package leaflet:

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

1. What Rocuronium B. Braun is and what it is used for

Rocuronium B. Braun belongs to a group of medicines called muscle relaxants.
Under normal conditions, nerves transmit information to muscles through impulses. The action
of Rocuronium B. Braun is to block these impulses, resulting in muscle relaxation.
During surgery, the patient's muscles should be completely relaxed. This makes it easier for the
surgeon to perform the operation.
In adults and childrenunder general anesthesia, this medicine can be used to facilitate the introduction
of a tube into the trachea to facilitate breathing (mechanical ventilation) and to ensure muscle
relaxation during surgical procedures.
In adults, the doctor may also use this medicine for a short period as a supplement to treatment in the
intensive care unit (e.g., to facilitate intubation). Additionally, the patient may receive this medicine
in an emergency situation where rapid introduction of a tube into the trachea is necessary to prepare
the patient for surgery.

2. Important information before using Rocuronium B. Braun

When not to use Rocuronium B. Braun:

• 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, consult your doctor, pharmacist, or nurse

• if the patient has allergyto any muscle relaxant;
• if the patient has kidney, liver, or bile duct disease;
• if the patient has heart diseaseor a condition affecting blood circulation;
• if the patient has swellingof a body part due to water accumulation (e.g., edemain the ankle joint);
• if the patient has a disease affecting nerves and muscles(neuromuscular diseases, e.g., polio, myasthenia gravis, Eaton-Lambert syndrome);
• if the patient has low body temperature during anesthesia(hypothermia);
• if the patient has high fever(malignant hyperthermia) during anesthesia;
• if the patient has fever;
• if the patient has low calcium levelsin the blood (hypocalcemia), (e.g., due to massive blood transfusion);
• if the patient has low potassium levelsin the blood (hypokalemia), (e.g., due to severe vomiting, diarrhea, or treatment with diuretics);
• 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 high acid levelsin the blood (acidosis);
• if the patient has high carbon dioxide levelsin the blood (hypercapnia);
• if the patient has excessive weight loss(cachexia);
• if the patient is overweightor elderly;
• if the patient has burns.

Other medicines and Rocuronium B. Braun

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

• antibiotics;
• antidepressants- medicines used to treat depression (e.g., MAO inhibitors) containing lithium;
• medicines used to treat heart diseaseand high blood pressure(e.g., quinidine, calcium channel blockers, adrenergic receptor blockers (e.g., beta blockers, alpha blockers));
• diuretics, i.e., urine-inducing medicines;
• certain laxatives, e.g., magnesium salts;
• quinine (used to treat pain and infections);
• medicines used to treat epilepsy(e.g., phenytoin, carbamazepine);
• corticosteroids used for a long time in the intensive care unit;
• medicines used to treat myasthenia gravis(neostigmine, edrophonium, pyridostigmine, aminopyridine);
• theophylline(used to treat asthma);
• medicines used to treat or prevent viral infections (protease inhibitors).

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), other muscle relaxants, and protamine that reverses 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, breastfeeding, or think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Data on the use of Rocuronium B. Braun in pregnant and breastfeeding women are very limited. Rocuronium B. Braun can be administered to pregnant and breastfeeding women only if the doctor decides that the benefits outweigh the risks. The medicine Rocuronium B. Braun may be administered during cesarean section.
There is no available data on the effect of this medicine on fertility.

Driving and using machines

Rocuronium B. Braun has a significant impact on the ability to drive vehicles and operate machinery. Therefore, it is not recommended to drive vehicles or operate potentially hazardous equipment during the first 24 hours after using the medicine, until the full effect of the medicine has worn off.
The doctor should inform the patient when they can start driving vehicles or operating machinery again. After anesthesia, the patient at home should remain under constant adult supervision.

Rocuronium B. Braun contains sodium

The medicine contains less than 1 mmol of sodium (23 mg) per single dose, which qualifies it as "sodium-free".

3. How to use Rocuronium B. Braun

Rocuronium B. Braun will be administered to the patient by an anesthesiologist. The medicine is administered by a single injection or continuous intravenous infusion (over a longer period).
Adults
The usual dose is 0.6 mg per kg of body weight, and the effect of the medicine lasts 30 to 40 minutes. During surgery, the effect of Rocuronium B. Braun is continuously monitored. Therefore, the doctor may administer an additional amount of the medicine depending on the individual situation of the patient.
If necessary, the patient may receive additional doses. The dose is adjusted according 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), as well as the estimated duration of the surgical procedure and the patient's age and condition.
The medicine is intended for single use only.
Use in children and adolescents
This medicine can be administered to newborns (0-27 days), infants (28 days-2 months), young children (3-23 months), children (2-11 years), and adolescents (12-17 years). The anesthesiologist adjusts the dose according 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 in children and adolescents is not recommended.
Elderly patients, obese patients, and patients with liver, bile duct, and/or kidney disease:
It may be necessary to adjust the dose by the doctor according to the individual situation of the patient
There is no data to support the recommendation for the use of rocuronium bromide in newborns (0-1 month).

Using more than the recommended dose of Rocuronium B. Braun

During treatment with Rocuronium B. Braun, the patient remains under close supervision of the anesthesiologist, so it is unlikely that the patient will receive too much Rocuronium B. Braun. If this happens, it may enhance the muscle relaxation effect. In this case, the anesthesiologist may administer medicines to reverse this effect and ensure that anesthesia and artificial ventilation are continued until the patient starts breathing again on their own.

Questions about using the medicine

If you have any further questions about using this medicine, ask your doctor, pharmacist, or nurse.
To view information intended for doctors and 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.

The following side effects may be serious. If you experience any of the following side effects, tell your doctor or nurse immediately:

Very rare (may affect up to 1 in 10,000 patients):
Allergic reactions (hypersensitivity) and related symptoms are rare, i.e., may affect more than 1 in 1,000 patients, but may be life-threatening. Symptoms of an allergic reaction may include: rash, itching, difficulty breathing, low blood pressure, rapid heartbeat, circulatory collapse, shock, or swelling of the face, lips, tongue, or throat, hives, wheals, redness of the skin. Additionally, during anesthesia, other respiratory problems (anesthesia-related respiratory complications) may occur..
Unknown (frequency cannot be estimated from available data):

• respiratory arrest;
• respiratory failure;
• severe allergic coronary artery spasm (Kounis syndrome) causing chest pain (angina pectoris) or heart attack (myocardial infarction).

Other side effects include:

Uncommon/rare (may affect 1 to 10 in 1,000 patients):

• increased heart rate (tachycardia)*;
• delayed recovery from anesthesia;
• decreased blood pressure (hypotension);
• ineffectiveness of the medicine;
• increased or decreased overall effect of the medicine;
• increased or decreased response to the medicine;
• pain at the injection site;
• prolonged muscle relaxation effect (prolonged neuromuscular blockade).

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

• increased histamine levels in the blood;
• wheezing (bronchospasm);
• inability to move (flaccid paralysis);
• muscle weakness (after long-term use of this medicine in the intensive care unit, especially if administered with corticosteroids)

*Clinical studies suggest that an increased heart rate in children and adolescentsoccurs frequently and may affect up to 1 in 10 patients.

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, 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 B. Braun

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging and carton after "expiry date". The expiry date refers to the last day of that month.
Do not store above 25°C.
After first opening: The medicine should be used immediately after opening the ampoule.
After dilution: The ready-to-use solution with a concentration of 5.0 mg/ml or 0.1 mg/ml (diluted with sodium chloride 9 mg/ml (0.9%) or glucose 50 mg/ml (5%)) shows chemical and physical stability for 24 hours at room temperature under light exposure in glass and plastic containers.
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. Usually, the storage time should not exceed 24 hours at 2-8°C, unless dilution is performed under controlled and validated aseptic conditions.
Do not use this medicine if the solution is not clear or contains 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 B. Braun contains

The active substance of the medicine is rocuronium bromide.
1 ml contains 10 mg of rocuronium bromide.
Each 5 ml ampoule contains 50 mg of rocuronium bromide.
Other ingredients of the medicine are glucuronolactone, sodium acetate trihydrate, sodium citrate dihydrate, and water for injections.

What Rocuronium B. Braun looks like and contents of the pack

Rocuronium B. Braunis a clear, colorless or light brown-yellow solution for injection or infusion.
Pack sizes:
Rocuronium B. Braun is available in packs of 20 plastic ampoules containing 5 ml of solution.

Marketing authorization holder and manufacturer

Marketing authorization holder
B.Braun Melsungen AG
Carl-Braun-Strasse 1
34212 Melsungen
Germany
Address for correspondence:
34209 Melsungen
Phone: +49 5661/71-0
Fax: +49 5661/71-4567
This medicine is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of the package leaflet: 2020-02-28

The following information is intended for healthcare professionals only:

Preparation method:

Rocuronium B. Braun 10 mg/ml solution for injection/infusion

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

Preparation for intravenous administration

The medicine is intended for single use only.
Rocuronium B. Braun is intended for intravenous (iv) administration as a bolus or continuous infusion.
Rocuronium B. Braun is compatible with sodium chloride 9 mg/ml (0.9%) and glucose 50 mg/ml (5%) solutions.
Unused solution should be discarded.
The medicine should not be mixed with other medicines except those mentioned above.
Physical incompatibility of rocuronium bromide 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 B. Braun is administered using the same infusion line as other medicines, it is essential to flush the infusion line (e.g., with 0.9% NaCl) between administering Rocuronium B. Braun and using medicines for which incompatibility with rocuronium bromide has been demonstrated or for which compatibility with rocuronium bromide has not been established.