Dexmedetomidine Kalceks 100 micrograms/ml concentrate for infusion solution EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

DexmedetomidineKalceks100micrograms/ml concentrate for solution for infusion EFG

Dexmedetomidine

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or nurse.
• If you experience any adverse effects, consult your doctor, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Dexmedetomidine Kalceks is and what it is used for
2. What you need to know before Dexmedetomidine Kalceks is administered to you
3. How to use Dexmedetomidine Kalceks
4. Possible adverse effects
5. How to store Dexmedetomidine Kalceks
6. Contents of the pack and other information

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

Dexmedetomidine Kalceks contains an active substance called dexmedetomidine, which belongs to a group of medicines known as sedatives. It is used to provide sedation (a state of calmness, drowsiness, or sleep) in adult patients in hospital intensive care units or conscious sedation during various diagnostic or surgical procedures.

2. What you need to know before Dexmedetomidine Kalceks is administered to you

Do not administer Dexmedetomidine Kalceks:

• if you are allergic to dexmedetomidine or to any of the other components of this medicine (listed in section 6).
• if you have certain heart rhythm disorders (second- or third-degree atrioventricular block).
• if you have very low blood pressure that does not respond to treatment.
• if you have recently had a stroke or other serious episodes affecting blood supply to the brain.

Warnings and precautions

Before this medicine is used, inform your doctor or nurse if you are in any of the following situations, as Dexmedetomidine Kalceks should be used with caution:

• if you have abnormally slow heart rate (either due to illness or high physical fitness level), as this may increase the risk of cardiac arrest
• if you have low blood pressure
• if you have low blood volume, for example after bleeding
• if you have certain heart diseases
• if you are elderly
• if you have a neurological disorder (e.g., head or spinal cord injuries, or stroke)
• if you have severe liver problems
• if you have ever developed a severe fever after taking certain medicines, especially anesthetics

This medicine may cause excessive urine production and excessive thirst. Contact a doctor if these adverse effects occur. See section 4 for more information.

Use of Dexmedetomidine Kalceks with other medicines

Inform your doctor or nurse if you are taking, have recently taken, or might need to take any other medicines.

The following medicines may increase the effect of Dexmedetomidine Kalceks:

• medicines that help you sleep or cause sedation (e.g., midazolam, propofol)
• strong painkillers (e.g., opioids such as morphine, codeine)
• anesthetic medicines (e.g., sevoflurane, isoflurane)

If you are taking medicines that lower your blood pressure and heart rate, concomitant administration with Dexmedetomidine Kalceks may enhance this effect. Dexmedetomidine Kalceks must not be used with medicines that can cause temporary paralysis.

Pregnancy and breastfeeding

Dexmedetomidine Kalceks must not be used during pregnancy or breastfeeding unless clearly necessary. Consult your doctor before using this medicine.

Driving and using machines

Dexmedetomidine Kalceks has a major impact on the ability to drive and use machines. After receiving Dexmedetomidine Kalceks, you must not drive, operate machinery, or work in hazardous situations until the effects have completely worn off. Consult your doctor regarding when you may resume these activities and types of work.

Dexmedetomidine Kalceks contains sodium

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

3. How to use Dexmedetomidina Kalceks

Hospital Intensive Care

Dexmedetomidina Kalceks is administered by a doctor or nurse in the intensive care unit of a hospital.

Procedural sedation / conscious sedation

Dexmedetomidina Kalceks is administered by a doctor or nurse before and/or during diagnostic or surgical procedures requiring sedation, i.e., for procedural sedation / conscious sedation.

Your doctor will decide the appropriate dose for you. The amount of Dexmedetomidina Kalceks depends on your age, body weight, general health, the level of sedation required, and how you respond to the medicine. Your doctor may adjust your dose if necessary and will monitor your heart and blood pressure during treatment.

Dexmedetomidina Kalceks is diluted and administered as an intravenous infusion (drip) into your veins.

Ampoule opening instructions:

1. Turn the ampoule with the coloured mark facing upwards. If there is any drop of solution at the top of the ampoule, gently tap with your finger to bring all the solution to the bottom of the ampoule.
2. Use both hands to open. While holding the lower part of the ampoule with one hand, use the other hand to break the top part of the ampoule in the direction opposite to the coloured mark (see images below).

After sedation / waking up

• Your doctor will keep you under supervision for several hours after sedation to ensure you are well.
  • You must not go home unaccompanied.
  • Medicines that help you sleep, as well as sedatives or those intended to relieve severe pain, may not be recommended for a period of time after treatment with Dexmedetomidina Kalceks. Consult your doctor regarding the use of these medicines and regarding alcohol consumption.

If you have been given more Dexmedetomidina Kalceks than you should

If too much Dexmedetomidina Kalceks has been administered, your blood pressure may rise or fall, your heart rate may become slower, your breathing may slow down, and you may feel more drowsy. Your doctor will know how to treat you based on your condition.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 91 562 04 20, indicating the medication and the amount ingested.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

Very common (affect more than 1 in 10 users)

• slow heart rate
• low or high blood pressure
• change in breathing pattern or breathing stoppage

Common (affect between 1 and 10 in every 100 users)

• chest pain or heart attack
• fast heart rate
• low or high blood sugar levels
• nausea, vomiting, or dry mouth
• restlessness
• high body temperature
• symptoms after stopping the medicine

Uncommon (affect between 1 and 10 in every 1,000 users)

• reduced heart function, cardiac arrest
• stomach swelling
• thirst
• a condition in which there is too much acid in the body
• low level of albumin in the blood
• difficulty breathing
• hallucinations
• medicine not effective enough

Frequency not known (cannot be estimated from available data)

• large volume of urine and excessive thirst – may be symptoms of a hormonal disorder called diabetes insipidus. Contact a doctor if this occurs.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it involves possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Dexmedetomidine Kalceks

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

This medicine does not require any special storage conditions.

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

6. Package contents and other information

Composition of Dexmedetomidine Kalceks

• The active substance is dexmedetomidine. Each ml of concentrate contains dexmedetomidine hydrochloride equivalent to 100 micrograms of dexmedetomidine.
• The other components are sodium chloride and water for injections.

Each 2 ml ampoule contains 200 micrograms of dexmedetomidine (as hydrochloride).

Each 4 ml vial contains 400 micrograms of dexmedetomidine (as hydrochloride).

Each 10 ml vial contains 1000 micrograms of dexmedetomidine (as hydrochloride).

The final concentration of the solution after dilution must be 4 micrograms/ml or 8 micrograms/ml.

Appearance of Dexmedetomidine Kalceks and package contents

Concentrate for solution for infusion (sterile concentrate).

The concentrate is a clear, colourless or slightly yellow solution.

Dexmedetomidine Kalceks is supplied in colourless glass ampoules of 2 ml and colourless glass vials of 4 ml or 10 ml.

Pack sizes:

5 or 25 ampoules of 2 ml

1 or 4 vials of 4 ml

1 or 4 vials of 10 ml

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

AS KALCEKS

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

Tel.: +371 67083320

E-mail: [email protected]

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

Grindeks Kalceks España, S.L.

c/ José Abascal, 58 2º dcha

28003 Madrid

Spain

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

Denmark Dexmedetomidin Kalceks

Austria Dexmedetomidin Kalceks 100 Mikrogramm/ml Konzentrat zur Herstellung einer Infusionslösung

Belgium Dexmedetomidine Kalceks 100 microgrammes/ml solution à diluer pour perfusion / Dexmedetomidine Kalceks 100 microgram/ml concentraat voor oplossing voor infusie / Dexmedetomidine Kalceks 100 Mikrogramm/ml Konzentrat zur Herstellung einer Infusionslösung

Bulgaria ??????????????? ??????? 100 ??????????/ml ?????????? ?? ?????????? ???????

Croatia Deksmedetomidin Kalceks 100 mikrograma/ml koncentrat za otopinu za infuziju

Czech Republic Dexmedetomidine Kalceks

Estonia Dexmedetomidine Kalceks

Finland Dexmedetomidine Kalceks

France DEXMEDETOMIDINE KALCEKS 100 microgrammes/mL, solution à diluer pour perfusion

Germany Dexmedetomidin Ethypharm 100 Mikrogramm/ml Konzentrat zur Herstellung einer Infusionslösung

Hungary Dexmedetomidine Kalceks 100 mikrogramm/ml koncentrátum oldatos infúzióhoz

Ireland Dexmedetomidine 100 micrograms/ml concentrate for solution for infusion

Italy Dexmedetomidina Kalceks

Latvia Dexmedetomidine Kalceks 100 mikrogrami/ml koncentrats infuziju škiduma pagatavošanai

Lithuania Dexmedetomidine Kalceks 100 mikrogramu/ml koncentratas infuziniam tirpalui

Norway Dexmedetomidine Kalceks

Poland Dexmedetomidine Kalceks

Portugal Dexmedetomidina Kalceks

Romania Dexmedetomidina Kalceks 100 micrograme/ml concentrat pentru solutie perfuzabila

Slovakia Dexmedetomidine Kalceks 100 mikrogramov/ml infúzny koncentrát

Slovenia Deksmedetomidin Kalceks 100 mikrogramov/ml koncentrat za raztopino za infundiranje

Spain Dexmedetomidina Kalceks 100 microgramos/ml concentrado para solución para perfusión EFG

Sweden Dexmedetomidine Kalceks

Netherlands Dexmedetomidine Kalceks 100 microgram/ml concentraat voor oplossing voor infusie

Date of most recent review of this summary: September 2023.

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

This information is intended for healthcare professionals only:

Dexmedetomidine Kalceks 100 micrograms/ml concentrate for solution for infusion EFG

Method of administration

Dexmedetomidine Kalceks must be administered by healthcare professionals experienced in managing patients requiring intensive care or in managing anaesthesia in the operating theatre. It must be administered only as a diluted intravenous infusion using a controlled infusion device.

Preparation of the solution

Dexmedetomidine Kalceks can be diluted with glucose 50 mg/ml (5%), Ringer's solution, lactated Ringer's solution, mannitol, or 9 mg/ml (0.9%) sodium chloride injection solution to achieve the required concentration of 4 micrograms/ml or 8 micrograms/ml prior to administration. See the table below for the volumes required to prepare the infusion.

If a concentration of 4 micrograms/ml is required:

In case a concentration of 8 micrograms/ml is required:

The solution should be gently shaken to ensure thorough mixing.

This medicine should be inspected visually for particles and discoloration prior to administration.

This medicine has been shown to be compatible when administered with the following intravenous fluids and medications:

Ringer's lactate, 5% glucose solution, 9 mg/ml (0.9%) sodium chloride injectable solution, mannitol 200 mg/ml (20%), sodium thiopental, etomidate, vecuronium bromide, pancuronium bromide, succinylcholine, atracurium besylate, mivacurium chloride, rocuronium bromide, glycopyrrolate bromide, phenylephrine HCl, atropine sulfate, dopamine, noradrenaline, dobutamine, midazolam, morphine sulfate, fentanyl citrate, and a plasma substitute.

Incompatibilities

Compatibility studies have shown potential for adsorption of dexmedetomidine to certain types of natural rubber. Although dexmedetomidine is dosed according to effect, it is recommended to use components with synthetic rubber or coated natural rubber stoppers.

Stability period after dilution

Chemical and physical stability of the diluted infusion has been demonstrated for 36 hours at 25°C and under refrigerated conditions (2°C – 8°C).

From a microbiological standpoint, the product should be used immediately. If not used immediately, the storage times and conditions prior to use are the responsibility of the user and normally should not exceed 24 hours between 2° and 8°C, unless the dilution was carried out under controlled and validated aseptic conditions.