Dexmedetomidine Kabi

Leaflet attached to the packaging: information for the user

Dexmedetomidine Kabi, 100 micrograms/ml, concentrate for solution for infusion

Dexmedetomidine

Please read carefully the contents of the leaflet before using the medicine, as it contains

important information for the patient.

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

Table of contents of the leaflet

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

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

Dexmedetomidine Kabi contains the active substance dexmedetomidine, which belongs to a group of
sedative medicines. The medicine is used to provide sedation (a state of calm, sleepiness or sleep) in
adult patients in the Intensive Care Unit in the hospital or during various diagnostic procedures and
surgical procedures with preserved consciousness.

2. Important information before using Dexmedetomidine Kabi

When not to use Dexmedetomidine Kabi

• 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 (2nd or 3rd degree heart block),
• if the patient has very low blood pressure, resistant to treatment, if the patient has recently had a stroke or other severe disease affecting blood supply to the brain.

Warnings and precautions

Before administering this medicine, please tell your doctor or nurse if any of the following situations apply to the patient, as Dexmedetomidine Kabi should be used with caution if:

• the patient has abnormal slow heart rate (due to disease or good physical condition), as this may increase the risk of cardiac arrest;
• the patient has low blood pressure;
• the patient has a small blood volume, e.g. after bleeding;
• the patient has certain cardiac disorders;
• the patient is elderly;
• the patient has a neurological disorder (e.g. head or spinal cord injury, or stroke);
• the patient has severe liver disease;

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• the patient has ever had a severe fever after administration of certain medicines, especially anesthetics.

This medicine may cause excessive urine production and increased thirst. If such symptoms occur, please contact your doctor. For further information, see section 4.
Increased risk of death has been observed in patients aged 65 and under who have used this medicine, especially in patients admitted to the intensive care unit in a more severe condition and for reasons other than post-surgical, as well as in younger patients.
Your doctor will decide whether this medicine is still suitable for the patient. The doctor will consider the benefits and risks associated with the use of this medicine compared to treatment with other sedative medicines.

Dexmedetomidine Kabi and other medicines

Please tell your doctor or nurse about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
The following medicines may enhance the effect of Dexmedetomidine Kabi:

• medicines that facilitate 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 blood pressure and slow heart rate, concurrent use of Dexmedetomidine Kabi may enhance such effects. Dexmedetomidine Kabi should not be used with medicines that cause periodic paralysis.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or plan to have a child, please consult your doctor before using this medicine.
Dexmedetomidine Kabi should not be used during pregnancy or breastfeeding, unless it is absolutely necessary.

Driving and using machines

Dexmedetomidine Kabi has a significant impact on the ability to drive and operate machines. After administration of Dexmedetomidine Kabi, you should not drive vehicles, operate machines, or work in hazardous conditions until the effect of the medicine has completely worn off. Please ask your doctor when you can resume these activities and return to this type of work.

Dexmedetomidine Kabi contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per dose, which means the medicine is considered "sodium-free".

3. How to use Dexmedetomidine Kabi

Intensive Care Unit

Dexmedetomidine Kabi is administered to the patient by a doctor or nurse in the Intensive Care Unit.

Procedural sedation/ sedation with preserved consciousness

Dexmedetomidine Kabi is administered to the patient by a doctor or nurse before or during diagnostic procedures or surgical procedures requiring sedation, so-called procedural sedation/ sedation with preserved consciousness.
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Your doctor will determine the dose suitable for you. The dose of Dexmedetomidine Kabi depends on age, sex, overall health, and the required level of sedation, as well as the patient's response to the medicine.
Your doctor may change the dose of the medicine if necessary and will monitor heart rate and blood pressure during treatment.
Dexmedetomidine Kabi is diluted and administered to the patient intravenously in an infusion (drip).

After sedation/ after waking up

• Your doctor will supervise you for several hours after sedation to ensure you feel well.
• You should not return home alone.
• For some time after administration of Dexmedetomidine Kabi, you should not take medicines that facilitate sleep, cause sedation, or strong painkillers. You should discuss the use of these medicines and the use of alcohol with your doctor.

In case of administration of a higher dose of Dexmedetomidine Kabi than recommended

If you have received too high a dose of Dexmedetomidine Kabi, you may experience increased or decreased blood pressure, slowed heart rate, slowed breathing, and a feeling of sleepiness.
Your doctor knows how to treat you according to your health condition.
If you have any further questions about the use of this medicine, please ask your doctor.

4. Possible side effects

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

• slow heart rate,
• low or high blood pressure,
• changes in breathing or cessation of breathing.

Common (may affect up to 1 in 10 people)

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

Uncommon (may affect up to 1 in 100 people)

• heart disorders, cardiac arrest,
• gastric swelling,
• increased thirst,
• acid-base balance disorder (metabolic acidosis),
• low albumin levels in the blood,
• shortness of breath,
• hallucinations,
• the medicine is not effective enough.

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Unknown (frequency cannot be estimated from the available data)

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

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please tell your doctor or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
tel.: + 48 22 49 21 301
fax: + 48 22 49 21 309
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Dexmedetomidine Kabi

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the label and carton after "EXP". The expiry date refers to the last day of the month.
There are no special precautions for storage.
Do not use this medicine if the vial is damaged.
Medicines should not be disposed of via wastewater or household waste. Please ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Dexmedetomidine Kabi contains

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

Each 2 ml vial contains 200 micrograms of dexmedetomidine.
Each 4 ml vial contains 400 micrograms of dexmedetomidine.
Each 10 ml vial contains 1000 micrograms of dexmedetomidine.
The concentration of the ready-to-use solution after dilution should be either 4 micrograms/ml or 8 micrograms/ml.

What Dexmedetomidine Kabi looks like and contents of the pack

Concentrate for solution for infusion (sterile concentrate).
The concentrate is a clear, colorless solution.
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Type of packaging
2 ml, 4 ml or 10 ml glass vials, in a cardboard box.
Package size
10 vials of 2 ml
25 vials of 2 ml
1 vial of 4 ml
4 vials of 4 ml
10 vials of 4 ml
4 vials of 10 ml
10 vials of 10 ml
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw

Manufacturer

Fresenius Kabi Austria GmbH
Hafnerstrasse 36
8055 Graz
Austria

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

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Date of last revision of the leaflet:19.10.2022
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Information intended for healthcare professionals only:

Dexmedetomidine Kabi, 100 micrograms/ml, concentrate for solution for infusion

Method of administration
Dexmedetomidine Kabi should be administered by healthcare professionals specialized in the treatment of patients requiring intensive care or anesthesiological care in the operating room. Dexmedetomidine Kabi may only be administered as a diluted intravenous infusion using a controlled infusion set.
Preparation of the solution
Before administration, Dexmedetomidine Kabi can be diluted in the following infusion solutions to achieve the required concentration of 4 micrograms/ml or 8 micrograms/ml:

• 0.9% sodium chloride solution (9 mg/ml)
• 5% glucose solution (50 mg/ml)
• Ringer's solution
• Ringer's solution with lactate
• 20% mannitol (200 mg/ml)

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The volumes required to prepare the infusion are shown in the tables below.
In the case of the required concentration of 4 micrograms/ml:
In the case of the required concentration of 8 micrograms/ml:
The solution should be gently shaken to ensure thorough mixing.
Before administration of Dexmedetomidine Kabi, the solution should be visually inspected for the presence of particles and discoloration.
It has been shown that Dexmedetomidine Kabi is compatible when administered with the following intravenous solutions and medicines:
Ringer's solution with lactate, 5% glucose solution, 0.9% sodium chloride solution for injection, 20% mannitol, thiopental sodium, etomidate, vecuronium bromide, pancuronium bromide, succinylcholine, atracurium besylate, mivacurium chloride, rocuronium bromide, glycopyrrolate, phenylephrine hydrochloride, atropine sulfate, dopamine, noradrenaline, dobutamine, midazolam, morphine sulfate, and plasma substitutes.
Shelf life
The chemical and physical stability of the diluted solution has been demonstrated for 24 hours at 25°C and for 24 hours at 2-8°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 subsequent shelf life of the product before use, which normally should not exceed 24 hours at 2-8°C, unless the dilution has been made in controlled and validated aseptic conditions.

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