Dexmedetomidine Kalceks

Package leaflet: Information for the user

Dexmedetomidine Kalceks 100 micrograms/ml concentrate for solution for infusion

dexmedetomidine
equivalent medicine
Please read this leaflet carefully before this medicine is administered to you because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or nurse.
• If you experience any side effects, including those not listed in this leaflet, inform your doctor. See section 4.

Contents of this leaflet:

1. What Dexmedetomidine Kalceks is and what it is used for
2. What you need to know before you are given 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 Dexmedetomidina Kalceks is and what it is used for

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

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

You must not be given Dexmedetomidina Kalceks:

• if you are allergic to dexmedetomidine or to any of the other ingredients 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 another serious condition affecting blood flow to the brain.

Warnings and precautions
Before being treated with this medicine, inform your doctor or nurse if any of the following apply to you, as Dexmedetomidina Kalceks must be used with caution:

• if you have a slower than normal heart rate (due either to illness or to high levels of physical fitness), 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 suffer from heart disorders
• if you are elderly
• if you suffer from a neurological disorder (for example, head injury, spinal cord injury, or stroke)
• if you suffer from severe liver problems
• if you have previously developed a high fever after taking certain medicines, particularly anaesthetics

This medicine may cause excessive urine production and excessive thirst. Contact a doctor if you experience these side effects. See section 4 for further information.
Other medicines and Dexmedetomidina Kalceks
Inform your doctor or nurse if you are taking, have recently taken, or might take any other medicines.
The following medicines may increase the effect of Dexmedetomidina Kalceks:

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

If you are taking medicines that lower blood pressure and heart rate, the concomitant administration of Dexmedetomidina Kalceks may enhance this effect.
Dexmedetomidina Kalceks must not be used with other medicines that cause temporary paralysis.
Pregnancy and breastfeeding
Dexmedetomidina Kalceks must not be used during pregnancy or breastfeeding unless strictly necessary. Consult your doctor before using this medicine.
Driving and using machines
Dexmedetomidina Kalceks has a major impact on the ability to drive and use machines. After receiving Dexmedetomidina Kalceks, do not drive, operate machinery, or work in hazardous situations until the effects have completely worn off. Ask your doctor when you can resume these activities and return to such work.
Dexmedetomidina Kalceks contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per ml, i.e. essentially 'sodium-free'.

3. How to use Dexmedetomidine Kalceks

Hospital intensive care therapy
Dexmedetomidine Kalceks will be administered to you by a doctor or nurse in a hospital intensive care unit.

Procedural sedation / conscious sedation
Dexmedetomidine Kalceks will be administered to you by a doctor or nurse before and/or during diagnostic or surgical procedures requiring sedation, i.e. procedural/conscious sedation.

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

Dexmedetomidine Kalceks is diluted and administered to you as an intravenous infusion (intravenous drip).

Instructions for opening the vial:

1. Turn the vial with the coloured tip upwards. If any solution is present in the upper part of the vial, gently tap with your finger to bring all the solution to the lower part of the vial.
2. Use both hands to open the vial; holding the lower part of the vial in one hand, use the other hand to break off the top part of the vial in the direction opposite to the coloured mark (see figures below).

After sedation / recovery

• The doctor will monitor you for several hours after sedation to ensure you are feeling well.
• You must not go home unaccompanied.
• Medicines that help you sleep, cause sedation, or strong painkillers may not be appropriate for a certain period of time after you have been given Dexmedetomidine Kalceks. Talk to your doctor about the use of these medicines and about alcohol consumption.

If you are given more Dexmedetomidine Kalceks than you should
If you are given too much Dexmedetomidine Kalceks, your blood pressure may increase or decrease, your heartbeat may slow down, you may breathe more slowly, and you may feel more drowsy. The doctor will know how to treat you based on your condition.

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

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)

• slowing of the heartbeat
• low or high blood pressure
• changes in breathing pattern or respiratory arrest

Common (affects from 1 to 10 in 100 people)

• chest pain or heart attack
• fast heartbeat
• low or high blood sugar (glucose) levels
• nausea, vomiting, or dry mouth
• agitation
• high temperature
• symptoms of medicine withdrawal

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

• 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
• shortness of breath
• hallucinations
• medicine not effective enough

Not known (frequency cannot be estimated from the available data)

• Large amounts of urine and excessive thirst – may be symptoms of a hormonal disorder called diabetes insipidus. Consult a doctor if these occur.

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
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.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the label and carton after EXP or Exp. The expiry date refers to the last day of that month.

6. Package contents and other information

What Dexmedetomidina Kalceks contains

• The active substance is dexmedetomidine. Each ml of concentrate contains dexmedetomidine hydrochloride equivalent to 100 micrograms of dexmedetomidine.
• The excipients are sodium chloride and water for injections. Each 2 ml vial contains 200 micrograms of dexmedetomidine (as hydrochloride). Each 4 ml vial (fill volume) contains 400 micrograms of dexmedetomidine (as hydrochloride). Each 10 ml vial (fill volume) contains 1000 micrograms of dexmedetomidine (as hydrochloride).

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

Description of the appearance of Dexmedetomidina Kalceks and package contents

Concentrate for solution for infusion (sterile concentrate).
The concentrate is a clear, colourless or slightly yellow solution.
Dexmedetomidina Kalceks is supplied in 2 ml colourless glass vials and transparent glass vials (fill volume of 4 ml or 10 ml).

Pack sizes:
5 or 25 vials of 2 ml
1 or 4 vials of 4 ml
1 or 4 vials of 10 ml

It is possible that not all pack sizes are marketed.

Marketing Authorisation Holder and Manufacturer
AS KALCEKS
Krustpils iela 71E, Rīga, LV-1057, 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:

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

The following information is intended exclusively for healthcare professionals:

Dexmedetomidine Kalceks 100 microgram/ml concentrate for solution for infusion
Method of administration
Dexmedetomidine Kalceks must be administered by healthcare professionals experienced in the management of
patients requiring intensive care or in the management of anesthesia in operating room settings.
It must be administered only as a diluted intravenous infusion, using a controlled infusion device.
Preparation of the solution
This medicinal product can be diluted with glucose 50 mg/ml (5%), Ringer's solution, lactated Ringer's solution, mannitol, or sodium chloride 9 mg/ml (0.9%) injection solutions to obtain the required concentration of 4
microgram/ml or 8 microgram/ml prior to administration. See the table below for the volumes required to prepare the infusion.
When the required concentration is 4 microgram/ml:

In the case where the required concentration is 8 micrograms/ml:

The solution should be gently shaken to ensure thorough mixing.
This medicinal product must be visually inspected for the presence of particles and changes in colour before administration.
This medicinal product is compatible when administered with the following intravenous fluids and the following medicinal products:
Lactated Ringer's solution, 5% glucose solution, sodium chloride 9 mg/ml (0.9%) injectable solution, mannitol 200 mg/ml (20%), sodium thiopental, etomidate, vecuronium bromide, pancuronium bromide, succinylcholine, atracurium besylate, mivacurium chloride, rocuronium bromide, glycopyrronium bromide, phenylephrine hydrochloride, atropine sulfate, dopamine, noradrenaline, dobutamine, midazolam, morphine sulfate, fentanyl citrate, plasma expanders.
Incompatibilities
There is a potential for adsorption of dexmedetomidine by certain types of natural rubber. Although dexmedetomidine is dosed to achieve the desired effect, it is recommended to use components with synthetic or coated natural rubber closures.
Stability after dilution
The 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 duration and conditions prior to use are the responsibility of the user and normally should not exceed 24 hours at 2–8°C, unless the dilution was carried out under controlled and validated aseptic conditions.