Dexmedetomidine kalceks

Patient Information Leaflet

Dexmedetomidine Kalceks, 100 micrograms/ml,
concentrate for solution for infusion.
dexmedetomidine
Please read carefully all the information in this leaflet before the medicine is used, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any questions, please consult your doctor or nurse.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor. See section 4.

Leaflet Contents

1. What Dexmedetomidine Kalceks is and what it is used for
2. What you need to know before using 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 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. The medicine is used to provide sedation (a calm, drowsy, or sleepy state) in adult patients in an intensive care unit in hospital or during various diagnostic procedures and surgical interventions performed with preserved consciousness.

2. Important information before using Dexmedetomidine Kalceks

When not to use Dexmedetomidine Kalceks:

• if the patient is allergic to dexmedetomidine or any of the other ingredients of this medicine (listed in section 6)
• if the patient has heart rhythm disorders (heart block of grade 2 or 3)
• if the patient has very low blood pressure that is resistant to treatment
• if the patient has recently had a stroke or another serious illness or event affecting blood supply to the brain

Warnings and precautions
Before administering this medicine, inform the doctor or nurse if any of the following situations apply to the patient, as Dexmedetomidine Kalceks should then be used with caution:

• if the patient has an unusually slow heart rate (due to illness or excellent physical fitness), as this may increase the risk of cardiac arrest
• if the patient has low blood pressure
• if the patient has reduced blood volume, e.g. following bleeding
• if the patient has specific cardiac disorders
• if the patient is elderly
• if the patient has a neurological disorder (e.g. head or spinal injury, or stroke)
• if the patient has liver disease
• if the patient has ever experienced high fever after administration of certain medicines, especially anaesthetics.

This medicine may cause excessive urination and excessive thirst. If these symptoms occur, contact a doctor. For further information, see section 4.
Dexmedetomidine Kalceks with other medicines
Inform the doctor or nurse about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
The following medicines may enhance the effect of Dexmedetomidine Kalceks:

• medicines that facilitate sleep or cause sedation (e.g. midazolam, propofol)
• strong pain-relieving medicines (e.g. opioids such as morphine, codeine)
• anaesthetic medicines (e.g. sevoflurane, isoflurane)

If the patient is taking medicines that lower blood pressure and slow heart rate, concomitant use of Dexmedetomidine Kalceks may intensify these effects. Dexmedetomidine Kalceks must not be used with medicines causing periodic paralysis.
Pregnancy and breastfeeding
Dexmedetomidine Kalceks must not be used during pregnancy or breastfeeding unless absolutely necessary. Consult a doctor before using this medicine.
Driving and operating machinery
Dexmedetomidine Kalceks has a major influence on the ability to drive and operate machinery. After receiving Dexmedetomidine Kalceks, the patient must not drive, operate machinery, or work under hazardous conditions until the effect of the medicine has completely subsided. Ask the doctor when it is safe to 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, meaning 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/awake sedation
Dexmedetomidine Kalceks is administered to the patient by a doctor or nurse before or during diagnostic procedures or surgical interventions requiring sedation (so-called procedural sedation/awake sedation).
The doctor will determine the appropriate dose for the patient. The dose of Dexmedetomidine Kalceks depends on the patient's age, sex, general health condition, required level of sedation, and the body's response to the drug. If necessary, the doctor may adjust the dose and will monitor heart function and blood pressure during treatment.
Dexmedetomidine Kalceks is diluted and administered intravenously by infusion (drip).

Instructions for opening the ampoule:

1. Turn the ampoule with the coloured dot facing upwards. If liquid is visible in the upper part of the ampoule, gently tap with a finger so that the entire solution collects in the lower part of the ampoule.
2. Open using both hands; holding the lower part of the ampoule with one hand, break off the top part with the other hand in the direction opposite to the coloured dot (see images below).

After sedation/waking up

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

Use of a higher than recommended dose of Dexmedetomidine Kalceks
If the patient has received too high a dose of Dexmedetomidine Kalceks, this may lead to increased or decreased blood pressure, slowed heart rate, slowed breathing, and drowsiness.
The doctor knows how to appropriately treat the patient according to their health status.
If you have any further doubts regarding the use of this medicine, please consult your doctor or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.
Very common ( more than 1 in 10 patients )

• slowing of heart rate
• low or high blood pressure
• changes in breathing pattern or breathing stoppage

Common ( in 1 to 10 patients out of 100 )

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

Uncommon ( in 1 to 10 patients out of 1,000 )

• heart function disorders, cardiac arrest
• stomach swelling
• excessive thirst
• acid-base imbalance
• low blood albumin levels
• shortness of breath
• hallucinations
• lack of sufficient drug efficacy

Unknown ( frequency cannot be estimated from the available data )

• excessive urination and extreme thirst – these may be symptoms of a hormonal disorder called diabetes insipidus. Contact a doctor if such symptoms occur.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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
Reporting adverse reactions helps to provide more information on the safety of using the medicine.
Adverse reactions can also be reported to the marketing authorization holder.

5. How to store Dexmedetomidine Kalceks

Keep this medicine out of the sight and reach of children.
There are no special storage requirements for this medicine.
Do not use this medicine after the expiry date stated on the label and carton
after “Expiry date (EXP)”. The expiry date refers to the last day of the stated month.

6. Contents of the package 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 prepared 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, colourless or slightly yellow solution.
Dexmedetomidine Kalceks is supplied in colourless glass ampoules with a capacity of 2 ml and colourless 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 European Economic Area countries 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

Information intended exclusively for medical professionals:

Dexmedetomidine Kalceks 100 micrograms/ml concentrate for solution for infusion
Route of administration
Dexmedetomidine Kalceks should be administered by healthcare personnel specialized in the treatment of patients requiring intensive care or anesthesia care in the operating room. Dexmedetomidine Kalceks must only be given as a diluted intravenous infusion using a controlled infusion set.
Preparation of the solution
To obtain the desired concentrations of 4 micrograms/ml or 8 micrograms/ml prior to administration, Dexmedetomidine Kalceks may be diluted with glucose 50 mg/ml (5%) solution, Ringer's solution, Ringer's lactate solution, mannitol, or sodium chloride 9 mg/ml (0.9%) for injection.
The volumes required for preparing the infusion are given in the table below.
For the required concentration of 4 micrograms/ml:

In case of required concentration of 8 micrograms/ml:

Gently shake the solution to ensure thorough mixing.
Visually inspect Dexmedetomidine Kalceks for particulate matter and discoloration prior to administration.
Compatibility of Dexmedetomidine Kalceks has been demonstrated when administered with the following intravenous fluids and medicinal products:
Ringer's lactate solution, 5% glucose solution, 0.9% sodium chloride (9 mg/ml) solution for injection, 20% mannitol (200 mg/ml), thiopental sodium, etomidate, vecuronium bromide, pancuronium bromide, succinylcholine, atracurium besylate, mivacurium chloride, rocuronium bromide, glycopyrrolate bromide, phenylephrine hydrochloride, atropine sulfate, dopamine, noradrenaline, dobutamine, midazolam, morphine sulfate, fentanyl citrate, and plasma substitutes.
Incompatibilities
Adsorption of dexmedetomidine by certain types of natural rubber may occur.
Although dexmedetomidine is dosed to achieve its effect, the use of plastic stoppers or those coated with natural rubber is recommended.
Stability after dilution
Chemical and physical stability of the diluted product 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 user is responsible for the storage duration and conditions prior to use, which generally should not exceed 24 hours at 2°C – 8°C, unless dilution was carried out under controlled and validated aseptic conditions.