Prospecto: information for the user

DexmedetomidinaKalceks100microgramos/ml concentrate forsolution for infusion EFG

Dexmedetomidina

Read this prospect carefully before starting to use this medicine, because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or nurse.
• If you experience adverse effects, consult your doctor, even if they are not listed in this prospect. See section4.

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

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

3.How to use Dexmedetomidina Kalceks

4.Possible adverse effects

5.Storage of Dexmedetomidina Kalceks

6.Contents of the package and additional information

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

Do not administer Dexmedetomidina Kalceks:

• if you are allergic to dexmedetomidina or any of the other components of this medication (listed in section 6).
• if you have some heart rhythm disorders (grade 2 or 3 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 episodes that affect blood supply to the brain.

Warnings and precautions

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

• if you have an abnormally slow heart rate (either due to illness or high physical condition level)as it may increase the risk of cardiac arrest
• if you have low blood pressure
• if you have low blood volume, for example after a hemorrhage
• if you have certain heart diseases
• if you are elderly
• if you have a neurological disorder (for example, head or spinal cord injuries or stroke)
• if you have severe liver disease
• if you have ever developed a severe fever after some medications, especially anesthetics

This medication may cause a large amount of urine and excessive thirst, contact a doctor if these adverse effects occur. See section 4 for more information.

Use of Dexmedetomidina Kalceks with other medications

Inform your doctor or nurse if you are using, have used recently, or may need to use any other medication.

The following medications may increase the effect of Dexmedetomidina Kalceks:

If you are using medications that lower your blood pressure and heart rate, the concurrent administration with Dexmedetomidina Kalceks may increase this effect. Dexmedetomidina Kalceks should not be used with medications that can cause temporary paralysis.

Pregnancy and breastfeeding

Dexmedetomidina Kalceks should not be used during pregnancy or breastfeeding, unless clearly necessary. Consult your doctor before using this medication.

Driving and operating machines

Dexmedetomidina Kalceks has a significant impact on your ability to drive and operate machines. Once you have been administered Dexmedetomidina Kalceks, you should not drive, operate machines, or work in hazardous situations until the effects have completely passed. Consult your doctor when you can resume these activities and this type of work.

Dexmedetomidina Kalcekscontains sodium

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

Hospital Intensive Care

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

Procedure Sedation / Conscious Sedation

A doctor or nurse will administer Dexmedetomidina Kalceks before and/or during diagnostic or surgical procedures that require sedation, that is, for procedure sedation / conscious sedation.

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

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

Instructions for opening the ampule:

1)Turn the ampule with the colored point upwards. If there is any drop of the solution at the top of the ampule, gently tap with your finger to bring all the solution to the bottom of the ampule.

2)Use both hands to open. While holding the bottom of the ampule with one hand, use the other hand to break the top of the ampule in the opposite direction to the colored point (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 should not go home unless accompanied.
  • Medications that help you sleep, cause sedation themselves, and those intended to relieve intense pain may not be recommended for a period of time after treatment with Dexmedetomidina Kalceks. Consult your doctor about the use of these medications and about the use of alcohol.

If You Have Been Given Too Much Dexmedetomidina Kalceks

If too much Dexmedetomidina Kalceks has been given, your blood pressure may rise or fall, your heartbeats may be slower, you may breathe more slowly, 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, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

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

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Very Frequent(affects more than 1 in 10 users)

• slow heart rate

• low or high blood pressure
• change in breathing pattern or respiratory arrest

Frequent(affects between 1 and 10 in 100 users)

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

Rare(affects between 1 and 10 in 1,000 users)

• decreased heart function,cardiac arrest
• gastric distension
• thirst
• a condition in which there is too much acid in the body
• low albumin levels in the blood
• difficulty breathing
• hallucinations
• the medication is not effective enough

Unknown Frequency(cannot be estimated from available data)

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

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es

By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

This medication does not require special storage conditions.

Do not use this medication after the expiration date that appears on the label and packaging after CAD. The expiration date is the last day of the month indicated.

Composition of Dexmedetomidine Kalceks

• The active ingredient is dexmedetomidine. Each milliliter of concentrate contains hydrochloride of dexmedetomidine equivalent to 100 micrograms of dexmedetomidine.
• The other components are sodium chloride and water for injection.

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

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

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

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

Appearance of Dexmedetomidine Kalceks and packaging content

Concentrate for solution for infusion (sterile concentrate).

The concentrate is a transparent and colorless or yellowish solution.

Dexmedetomidine Kalceks is produced in colorless glass ampoules of 2 ml and colorless glass vials of 4 ml or 10 ml.

Packaging sizes:

5 or 25 ampoules of 2 ml

1 or 4 vials of 4 ml

1 or 4 vials of 10 ml

Only some packaging sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

AS KALCEKS

Krustpils iela 71E, Riga, LV 1057, Latvia

Tel.: +371 67083320

E-mail: [email protected]

Further information about this medicinal product can be obtained by contacting the local representative of the marketing authorization holder:

Grindeks Kalceks España, S.L.

c/ José Abascal, 58 2º dcha

28003 Madrid

Spain

This medicinal product is authorized in the Member States of the European Economic Area with the following names:

DenmarkDexmedetomidin Kalceks

AustriaDexmedetomidin Kalceks 100 Mikrogramm/ml Konzentrat zur Herstellung einer Infusionslösung

BelgiumDexmedetomidine 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?????????? ?? ?????????? ???????

CroatiaDeksmedetomidin Kalceks100mikrograma/mlkoncentratzaotopinuzainfuziju

Czech RepublicDexmedetomidineKalceks

EstoniaDexmedetomidineKalceks

FinlandDexmedetomidineKalceks

FranceDEXMEDETOMIDINEKALCEKS100microgrammes/mL,solutionàdiluerpourperfusion

GermanyDexmedetomidin Ethypharm 100 Mikrogramm/ml Konzentrat zur Herstellung einer Infusionslösung

HungaryDexmedetomidine Kalceks 100 mikrogramm/ml koncentrátum oldatos infúzióhoz

IrelandDexmedetomidine 100 micrograms/ml concentrate for solution for infusion

ItalyDexmedetomidina Kalceks

LatviaDexmedetomidine Kalceks 100 mikrogrami/ml koncentrats infuziju škiduma pagatavošanai

LithuaniaDexmedetomidine Kalceks 100 mikrogramu/ml koncentratas infuziniam tirpalui

NorwayDexmedetomidine Kalceks

PolandDexmedetomidine Kalceks

PortugalDexmedetomidina Kalceks

RomaniaDexmedetomidina Kalceks 100 micrograme/ml concentrat pentru solutie perfuzabila

SlovakiaDexmedetomidine Kalceks 100 mikrogramov/ml infúzny koncentrát

SloveniaDeksmedetomidin Kalceks 100 mikrogramov/ml koncentrat za raztopino za infundiranje

SpainDexmedetomidina Kalceks100 microgramos/ml concentrado para solución para perfusión EFG

SwedenDexmedetomidine Kalceks

NetherlandsDexmedetomidine Kalceks 100 microgram/ml concentraat voor oplossing voor infusie

Last review date of this leaflet:September 2023.

Further detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

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This information is intended solely for healthcare professionals:

DexmedetomidineKalceks100microgramos/ml concentrate forsolution for infusion EFG

Administration route

Dexmedetomidine Kalceks should be administered by healthcare professionals experienced in the management of patients requiring intensive care or in the management of anesthesia in patients in the operating room. It should be administered only as a diluted intravenous infusion using a controlled infusion device.

Preparation of the solution

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

In case a concentration of 4 micrograms/ml is required:

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

The solution should be gently agitated to mix well.

This medicinal product should be visually inspected to detect particles and color before administration.

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

Lactate Ringer's solution, glucose 5% solution, sodium chloride 0.9% injection solution, mannitol 20%, thiopental sodium, etomidate, vecuronium bromide, pancuronium bromide, succinylcholine, atracurium besilate, mivacurium chloride, rocuronium bromide, glycopyrrolate bromide, phenylephrine HCl, atropine sulfate, dopamine, norepinephrine, dobutamine, midazolam, morphine sulfate, fentanyl citrate, and a plasma substitute.

Incompatibilities

Compatibility studies have shown potential for dexmedetomidine adsorption to some types of natural rubber.Although dexmedetomidine is dosed based on effect, it is recommended to use components with synthetic or rubber-coated natural rubber joints.

Period of validity 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 point of view, the product should be used immediately. If not used immediately, storage times and conditions prior to use are the responsibility of the user and should not normally exceed 24 hours between 2° and 8°C, unless the dilution has been prepared in controlled and validated aseptic conditions.