ROCURONIUM KALCEKS 10 mg/ml INJECTABLE SOLUTION AND PERFUSION SOLUTION

Introduction

Package Leaflet: Information for the User

Rocuronio Kalceks 10mg/ml solution for injection and infusion EFG

Rocuronium bromide

Read all of this leaflet carefully before you are given this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your anesthesiologist or another doctor.
• If you experience any side effects, talk to your anesthesiologist or another doctor, even if they are not mentioned in this leaflet. See section 4.

Contents of the package leaflet

1. What is Rocuronio Kalceks and what is it used for
2. What you need to know before you are given Rocuronio Kalceks
3. How Rocuronio Kalceks is given to you
4. Possible side effects
5. Storage of Rocuronio Kalceks
6. Package contents and further information

1. What is Rocuronio Kalceks and what is it used for

Rocuronio Kalceks belongs to a group of medicines called muscle relaxants.

Muscle relaxants are used during an operation as part of general anesthesia. When you undergo an operation, your muscles must be completely relaxed. This makes the operation easier for the surgeon.

Rocuronio Kalceks can be used if you are receiving anesthesia to facilitate the insertion of a tube into your trachea for mechanical ventilation (mechanical assistance with breathing).

Rocuronio Kalceks can also be used in the intensive care unit to keep your muscles relaxed.

2. What you need to know before you are given Rocuronio Kalceks

Rocuronio Kalceks must not be given to you:

• if you are allergic to rocuronium or any of the other ingredients of this medicine (listed in section 6).

Tell your anesthesiologist if this applies to you.

Warnings and precautions

Tell your anesthesiologist before you are given this medicine:

• if you are allergic to any muscle relaxant
• if you have had kidney, heart, vascular, liver, gallbladder, or bile duct disease
• if you have had diseases that affect the nerves and muscles
• if you have fluid retention (edema)
• if you have a history of malignant hyperthermia (sudden fever with palpitations, rapid breathing, and muscle stiffness, pain, and/or weakness).

Tell your anesthesiologist if any of the above situations apply to you.

Certain conditions may influence the effects of Rocuronio Kalceks, for example:

• low calcium levels in the blood
• low potassium levels in the blood
• high magnesium levels in the blood
• low protein levels in the blood
• too much carbon dioxide in the blood
• excessive water loss from the body, for example, due to illness, diarrhea, or sweating
• excessive breathing that causes insufficient carbon dioxide in the blood (alkalosis)
• poor general health
• burns
• being severely overweight (obesity)
• very low body temperature (hypothermia).

If you have any of these conditions, your anesthesiologist will take them into account when deciding the correct dose of Rocuronio Kalceks for you.

Children and elderly

Rocuronio Kalceks can be used in children (newborns and adolescents) and elderly patients, but your anesthesiologist must evaluate your medical history first.

Other medicines and Rocuronio Kalceks

Tell your anesthesiologist or doctor if you are taking, have recently taken, or might take any other medicines. This includes medicines or herbal remedies bought without a prescription. Rocuronio Kalceks may affect other medicines or be affected by them.

Medicines that increase the effect of Rocuronio Kalceks:

• certain antibiotics
• certain medicines used for heart disease or high blood pressure (diuretics, calcium channel blockers, beta blockers, and quinidine)
• certain anti-inflammatory medicines (corticosteroids)
• certain medicines used to treat manic depressive syndrome (bipolar disorder)
• magnesium salts
• certain medicines used to treat malaria.

Medicines that decrease the effect of Rocuronio Kalceks:

• certain medicines used to treat epilepsy
• calcium chloride and potassium chloride
• certain protease inhibitors called gabexate and ulinastatin.

Additionally, you may be given other medicines before or during surgery that may alter the effects of Rocuronio Kalceks. These include certain anesthetics, other muscle relaxants, medicines such as phenytoin, and medicines that reverse the effect of Rocuronio Kalceks. Rocuronio Kalceks may make certain anesthetics work more quickly. Your anesthesiologist will take this into account when deciding the correct dose of Rocuronio Kalceks for you.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or anesthesiologist before you are given this medicine.

Pregnancy

No adverse effects have been observed in animal studies. However, there are no clinical data on the use of rocuronium bromide in pregnant women. Therefore, rocuronium bromide should be used with caution in pregnant women.

Cesarean section

A doctor will decide whether rocuronium bromide can be used during a cesarean section. The use of rocuronium bromide during a cesarean section has been shown to be safe with a dose of 0.6 mg/kg body weight and has no adverse effects on the baby.

Breastfeeding

Breastfeeding should be discontinued 6 hours after administration of this medicine.

Driving and using machines

Do not drive or use machines until you are told it is safe to do so. Because Rocuronio Kalceks is given as part of general anesthesia, you may feel tired, weak, or dizzy for some time after. Your anesthesiologist can advise you on the likely duration of these effects.

Rocuronio Kalceks contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per 1 ml, which is essentially "sodium-free".

3. How Rocuronio Kalceks is given to you

Dose

Your anesthesiologist will calculate the dose of Rocuronio Kalceks you need based on:

• the type of anesthetic,
• the expected duration of the operation,
• other medicines you are taking,
• your state of health.

The usual dose is 0.6 mg per kg body weight and its effect lasts for 30 to 40 minutes.

How Rocuronio Kalceks is given to you

Your anesthesiologist will give you Rocuronio Kalceks by injection into a vein, either as single injections or as a continuous infusion (with a drip).

If you are given too much Rocuronio Kalceks

Because your anesthesiologist will be monitoring your condition carefully, it is unlikely that you will be given too much Rocuronio Kalceks. However, if this happens, your anesthesiologist will keep you breathing artificially (with a respirator) until you can breathe on your own again. You will remain asleep while this happens.

If you have any further questions on the use of this medicine, ask your doctor or anesthesiologist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. If these side effects occur while you are under anesthesia, your anesthesiologist will see them and treat them.

Uncommon side effects(may affect up to 1 in 100 people)

• the medicine is too effective, not effective enough
• the medicine acts for longer than expected
• decrease in blood pressure
• increase in 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)
• chest tightness
• muscle weakness
• swelling, rash, or redness of the skin.

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

• allergic spasm and severe coronary artery spasms (Kounis syndrome) causing chest pain (angina) or heart attack (myocardial infarction)
• dilated pupils (mydriasis) or fixed pupils that do not change size with light or other stimuli.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your anesthesiologist or another doctor.

Reporting of side effects

If you experience any side effects, talk to your anesthesiologist or another doctor. Even if it is possible side effects not listed in this leaflet. You can also report side effects directly to the Spanish Medicines and Healthcare Products Agency (AEMPS) at www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Rocuronio Kalceks

Keep this medicine out of the sight and reach of children.

Store in a refrigerator (2°C‑8°C). Do not freeze.

Store below 25°C:

Rocuronium bromide can also be stored below 25°Cfor a maximum period of 12 weeks, after which it must be discarded. The product must not be returned to the refrigerator once it has been stored at room temperature. The storage period must not exceed the shelf-life.

After dilution:

After dilution with intravenous fluids, the chemical and physical stability in use has been demonstrated for 72 hours at 30°C.

From a microbiological point of view, the medicine should be used immediately. If not used immediately, the in-use storage times and conditions are the responsibility of the user and would normally not be longer than 24 hours at a temperature of 2 to 8°C, unless the dilution has been made in controlled and validated aseptic conditions.

Do not use this medicine if you notice visible signs of deterioration (e.g. particles).

Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The expiry date is the last day of the month shown.

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. Package contents and further information

Composition of Rocuronio Kalceks

• The active substance is rocuronium bromide.

1 ml of solution contains 10 mg of rocuronium bromide.

Each 5 ml vial of solution contains 50 mg of rocuronium bromide.

• The other ingredients are sodium chloride; sodium acetate trihydrate; glacial acetic acid (for pH adjustment); water for injections.

Appearance and package contents

Clear, colorless or yellowish solution for injection and infusion.

Package size:

Rocuronio Kalceks is available in packs of 10 vials with 5 ml of solution.

Marketing authorization holder and manufacturer

AS KALCEKS

Krustpils iela 71E, Riga, LV-1057, Latvia

Phone: +371 67083320

Email: kalceks@kalceks.lv

For further information about this medicine, please contact the local representative of the marketing authorization holder

EVER Pharma Therapeutics Spain SL

C/ Toledo 170

28005 Madrid

Spain

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Czech Republic, Estonia, Norway Rocuronium bromide Kalceks

Austria Rocuronium Kalceks 10 mg/ml Injektions-/Infusionslösung

Croatia Rokuronijev bromid Kalceks 10 mg/ml otopina za injekciju/infuziju

France ROCURONIUM KALCEKS 10 mg/mL, solution injectable/pour perfusion

Hungary Rocuronium Kalceks 10 mg/ml oldatos injekció vagy infúzió

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

Latvia Rocuronium bromide Kalceks 10 mg/ml šķidums injekcijām/infūzijām

Lithuania Rocuronium bromide Kalceks 10 mg/ml injekcinis ar infuzinis tirpalas

Netherlands Rocuronium Kalceks 10 mg/ml oplossing voor injectie/infusie

Poland Rocuronium Kalceks

Slovakia Rocuronium bromide Kalceks 10 mg/ml injekčný/infúzny roztok

Slovenia Rokuronijev bromid Kalceks 10 mg/ml raztopina za injiciranje/infundiranje

Spain Rocuronio Kalceks 10 mg/ml solución inyectable y para perfusión EFG

United Kingdom (Northern Ireland) Rocuronium bromide 10 mg/ml solution for injection/infusion

Date of last revision of this leaflet June 2023

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es)