Dexmedetomidine Kalceks

Package Leaflet: Information for the User

Dexmedetomidine Kalceks, 100 micrograms/ml,

Concentrate for solution for infusion.
dexmedetomidine

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

• You should keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or nurse.
• If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

• 1. What is Dexmedetomidine Kalceks and what is it used for
• 2. Before you use Dexmedetomidine Kalceks
• 3. How to use Dexmedetomidine Kalceks
• 4. Possible side effects
• 5. How to store Dexmedetomidine Kalceks
• 6. Contents of the pack and other information

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

Dexmedetomidine Kalceks contains the active substance dexmedetomidine, which belongs to a group of medicines called sedatives. The medicine is used to sedate (make sleepy or relaxed) adult patients in intensive care units in hospitals or during various diagnostic or surgical procedures where the patient remains awake.

2. Before you use Dexmedetomidine Kalceks

When not to use Dexmedetomidine Kalceks:

• if you are allergic to dexmedetomidine or any of the other ingredients of this medicine (listed in section 6)
• if you have heart rhythm disorders (second or third degree heart block)
• if you have very low blood pressure that does not respond to treatment
• if you have recently had a stroke or other severe illness or event that affects blood supply to the brain

Warnings and precautions

Before taking this medicine, tell your doctor or nurse if any of the following apply to you, as Dexmedetomidine Kalceks should be used with caution:

• if you have an unusually slow heart rate (due to illness or good physical condition), as this may increase the risk of heart arrest
• if you have low blood pressure
• if you have a small blood volume, e.g. after bleeding
• if you have certain heart disorders
• if you are elderly
• if you have a neurological disorder (e.g. head or spinal cord injury or stroke)
• if you have liver disease
• if you have ever had a high fever after taking certain medicines, especially anesthetics.

This medicine may cause excessive urine production and increased thirst. If you experience these symptoms, you should contact your doctor. For further information, see section 4.

Dexmedetomidine Kalceks with other medicines

Tell your doctor or nurse about all medicines you are taking or have recently taken, as well as any medicines you plan to take. The following medicines may enhance the effects of Dexmedetomidine Kalceks:

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

If you are taking medicines that lower your blood pressure and slow your heart rate, taking Dexmedetomidine Kalceks at the same time may increase these effects. Dexmedetomidine Kalceks should not be used with medicines that cause periodic paralysis.

Pregnancy and breastfeeding

Dexmedetomidine Kalceks should not be used during pregnancy or breastfeeding unless absolutely necessary. Consult your doctor before taking this medicine.

Driving and using machines

Dexmedetomidine Kalceks has a major impact on your ability to drive and use machines. After taking Dexmedetomidine Kalceks, do not drive, operate machinery, or work in hazardous conditions until the effects of the medicine have worn off completely. Ask your doctor when you can resume these activities and return to work.

Dexmedetomidine Kalceks contains sodium

Dexmedetomidine Kalceks contains less than 1 mmol (23 mg) of sodium per 1 ml, i.e. the medicine is considered "sodium-free".

3. How to use Dexmedetomidine Kalceks

Intensive Care Unit

Dexmedetomidine Kalceks is administered to the patient by a doctor or nurse in the intensive care unit.

Procedural sedation/relaxation with preserved consciousness

Dexmedetomidine Kalceks is administered to the patient by a doctor or nurse before or during diagnostic or surgical procedures that require sedation (so-called procedural sedation/relaxation with preserved consciousness). The doctor will determine the dose suitable for the patient. The dose of Dexmedetomidine Kalceks depends on the patient's age, sex, overall health, and required level of sedation, as well as the body's response to the medicine. The doctor may adjust the dose of the medicine and will monitor the patient's heart rate and blood pressure during treatment. Dexmedetomidine Kalceks is diluted and administered to the patient intravenously in the form of an infusion (drip). Instructions for opening the ampoule:

• 1) Turn the ampoule with the colored dot upwards. If there is any liquid in the upper part of the ampoule, gently tap it with your finger to make the solution flow to the lower part of the ampoule.
• 2) Open it using both hands; holding the lower part of the ampoule with one hand, break off the upper part of the ampoule in the direction opposite to the colored dot (see pictures below).

After sedation/after waking up

• The doctor will monitor the patient for several hours after sedation to ensure that the patient feels well.
• The patient should not return home alone.
• For some time after taking Dexmedetomidine Kalceks, do not take medicines that help you sleep, cause sedation, or strong painkillers. Discuss the use of these medicines and the use of alcohol with your doctor.

Overdose of Dexmedetomidine Kalceks

If the patient has received too much Dexmedetomidine Kalceks, they may experience increased or decreased blood pressure, slowed heart rate, slowed breathing, and drowsiness. The doctor knows how to treat the patient according to their condition. If you have any further questions about the use of this medicine, ask your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Very common (affects more than 1 in 10 people)

• slowed heart rate
• low or high blood pressure
• changes in breathing or cessation of breathing

Common (affects 1 to 10 people in 100)

• chest pain or heart attack
• rapid heart rate
• low or high blood sugar levels
• nausea, vomiting, dry mouth
• anxiety
• high temperature
• withdrawal symptoms

Uncommon (affects 1 to 10 people in 1,000)

• heart rhythm disorders, cardiac arrest
• gastric swelling
• increased thirst
• acid-base balance disorder
• low albumin levels in the blood
• shortness of breath
• hallucinations
• lack of sufficient efficacy of the medicine

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

• excessive urine production and increased thirst - these may be symptoms of a hormonal disorder called diabetes insipidus. Contact your doctor if you experience these symptoms.

Reporting of side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Monitoring of 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. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Dexmedetomidine Kalceks

Keep this medicine out of the sight and reach of children. There are no special storage instructions for this medicine. Do not use this medicine after the expiry date which is stated on the label and carton after "EXP". The expiry date refers to the last day of that month.

6. Contents of the pack and other information

What Dexmedetomidine Kalceks contains

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

Each 2 ml ampoule contains 200 micrograms of dexmedetomidine (as hydrochloride). Each vial (fill volume 4 ml) contains 400 micrograms of dexmedetomidine (as hydrochloride). Each vial (fill volume 10 ml) contains 1000 micrograms of dexmedetomidine (as hydrochloride). The concentration of the solution after dilution should be either 4 micrograms/ml or 8 micrograms/ml.

What Dexmedetomidine Kalceks looks like and contents of the pack

Concentrate for solution for infusion (sterile concentrate). The concentrate is a clear, colorless or slightly yellowish solution. Dexmedetomidine Kalceks is produced in colorless glass ampoules of 2 ml and colorless glass vials (fill volume 4 ml or 10 ml). Pack sizes: 5 ampoules of 2 ml, 25 ampoules of 2 ml, 1 or 4 vials of 4 ml, 1 or 4 vials of 10 ml. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

AS KALCEKS, Krustpils iela 71E, LV-1057 Rīga, Latvia, Tel.: +371 67083320, E-mail: [email protected]

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

Denmark: Dexmedetomidin Kalceks, Austria, Germany: Dexmedetomidin Kalceks 100 Mikrogramm/ml Konzentrat zur Herstellung einer Infusionslösung, Czech Republic, Estonia, Finland, Norway, Poland, Sweden: Dexmedetomidine Kalceks, 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: Дексмедетомидин Калцекс 100 микрограма/ml концентрат за инфузионен разтвор, Croatia: Deksmedetomidin Kalceks 100 mikrograma/ml koncentrat za otopinu za infuziju, France: DEXMEDETOMIDINE KALCEKS 100 microgrammes/mL, solution à diluer pour perfusion, 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 koncentrāts infūziju šķīduma pagatavošanai, Lithuania: Dexmedetomidine Kalceks 100 mikrogramų/ml koncentratas infuziniam tirpalui, Portugal: Dexmedetomidina Kalceks, Romania: Dexmedetomidină Kalceks 100 micrograme/ml concentrat pentru soluţie perfuzabilă, Slovakia: Dexmedetomidine Kalceks 100 mikrogramov/ml koncentrát na infúzny roztok, Slovenia: Deksmedetomidin Kalceks 100 mikrogramov/ml koncentrat za raztopino za infundiranje, Spain: Dexmedetomidina Kalceks 100 microgramos/ml concentrado para solución para perfusión EFG, Netherlands: Dexmedetomidine Kalceks 100 microgram/ml concentraat voor oplossing voor infusie

Date of last revision of the leaflet: 06/2025

Information intended for healthcare professionals only:

Dexmedetomidine Kalceks 100 micrograms/ml concentrate for solution for infusion

Administration route: Dexmedetomidine Kalceks should be administered by healthcare professionals specialized in the treatment of patients requiring intensive care or anesthesiological care in the operating room. Dexmedetomidine Kalceks may only be administered as a diluted intravenous infusion using a controlled infusion set. Preparation of the solution. To achieve the desired concentration of 4 micrograms/ml or 8 micrograms/ml before administration, Dexmedetomidine Kalceks can be diluted in glucose 50 mg/ml (5%) solution, Ringer's solution, Ringer's solution with lactate, mannitol, or sodium chloride 9 mg/ml (0.9%) solution for injections. The volumes required to prepare the infusion are listed in the table below.

In case of required concentration of 4 micrograms/ml:

In case of required concentration of 8 micrograms/ml:

Gently shake the solution to ensure thorough mixing. Before administration, Dexmedetomidine Kalceks should be visually inspected for particulate matter and discoloration. It has been shown that Dexmedetomidine Kalceks is compatible when administered with the following intravenous fluids and medicinal products: Ringer's solution with lactate, 5% glucose solution, 0.9% sodium chloride solution (9 mg/ml) for injections, 20% mannitol (200 mg/ml), sodium thiopental, etomidate, vecuronium bromide, pancuronium bromide, succinylcholine, atracurium besylate, mivacurium chloride, rocuronium bromide, glycopyrrolate, phenylephrine hydrochloride, atropine sulfate, dopamine, noradrenaline, dobutamine, midazolam, morphine sulfate, and fentanyl citrate, as well as plasma substitutes.

Incompatibilities

There is a possibility of adsorption of dexmedetomidine by certain types of natural rubber. Although dexmedetomidine is administered to achieve its effect, it is recommended to use plastic or rubber-coated stoppers.

Shelf life after dilution

Chemical and physical stability after dilution of the medicinal product has been demonstrated for 36 hours at 25°C and under refrigeration (2°C – 8°C). From a microbiological point of view, the product should be used immediately. If not used immediately, the user is responsible for the storage conditions and the storage time before use, which normally should not exceed 24 hours at 2°C – 8°C, unless dilution has been made in controlled and validated aseptic conditions.