Dexmedetomidine kabi

Patient Information Leaflet

Dexmedetomidine Kabi, 100 micrograms/ml, concentrate for solution for infusion
Dexmedetomidinum
Please read all of this leaflet carefully before this medicine is used, because it contains
important information for the patient.

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

Contents of the leaflet

1. What Dexmedetomidine Kabi is and what it is used for
2. What you need to know 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 Dexmedetomidine Kabi is and what it is used for

Dexmedetomidine Kabi 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 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 atrioventricular block),
• if the patient has very low blood pressure unresponsive to treatment, or if the patient has recently suffered a stroke or other serious condition affecting blood supply to the brain.

Warnings and precautions
Before administration of this medicine, inform the doctor or nurse if any of the following situations apply to the patient, because Dexmedetomidine Kabi must be used with caution if:

• the patient has abnormally slow heart rate (due to disease or high physical fitness), as this may increase the risk of cardiac arrest;
• the patient has low blood pressure;
• the patient has reduced blood volume, e.g. following bleeding;
• the patient has certain cardiac disorders;
• the patient is elderly;
• the patient has a neurological disorder (e.g. head or spinal injury, or stroke);
• the patient has severe liver disease;
• the patient has ever experienced severe fever after administration of certain medicines, particularly anaesthetic agents.

This medicine may cause increased urine production and excessive thirst. If these symptoms occur, contact a doctor. For further information, see section 4.
An increased risk of death has been observed in patients aged 65 years and younger who were treated with this medicine, particularly in patients admitted to intensive care units in more severe condition and for reasons other than post-surgical recovery, as well as in younger patients.
The doctor will decide whether this medicine remains appropriate for the patient. The doctor will consider the benefits and risks associated with using this medicine compared to treatment with other sedative medicines.

Dexmedetomidine Kabi and other medicines
Inform the doctor or nurse about all medicines currently used, recently used, or planned to be used.
The following medicines may enhance the effects of Dexmedetomidine Kabi:

• 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 Kabi may intensify these effects. Dexmedetomidine Kabi should not be used together with medicines causing intermittent paralysis.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult a doctor before using this medicine.
Dexmedetomidine Kabi should not be used during pregnancy or breastfeeding unless absolutely necessary.

Driving and operating machinery
Dexmedetomidine Kabi has a major influence on the ability to drive and operate machinery. After administration of Dexmedetomidine Kabi, the patient must not drive, operate machinery, or work under hazardous conditions until the effects of the medicine have completely worn off. Ask the doctor when it is safe to resume these activities and return to such work.

Dexmedetomidine Kabi contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, meaning 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 interventions requiring sedation, so-called procedural sedation / sedation with preserved consciousness.
The doctor will determine the dose appropriate for the patient. The dose of Dexmedetomidine Kabi 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 of the medication and will monitor heart function and blood pressure during treatment.
Dexmedetomidine Kabi is diluted and administered intravenously by infusion (drip).
After sedation / after awakening

• The doctor will supervise 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 Kabi, medications that facilitate sleep, cause sedation, or strong painkillers should not be used. Please discuss with your doctor the use of these medications and alcohol consumption.

In case of administration of a higher than recommended dose of Dexmedetomidine Kabi
If the patient has received too high a dose of Dexmedetomidine Kabi, blood pressure may increase or decrease, heart rate may slow down, breathing may become slower, and drowsiness may occur.
The doctor knows how to treat the patient appropriately according to their health condition.
If you have any further doubts regarding the use of this medicinal product, please consult your doctor.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.

Very common (may occur in more than 1 in 10 patients)

• slow heart rate,
• low or high blood pressure,
• changes in breathing pattern or breathing stop.

Common (may occur in 1 to 10 in 100 patients)

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

Uncommon (may occur in 1 to 10 in 1,000 patients)

• heart function disorders, cardiac arrest,
• stomach distension,
• excessive thirst,
• acid-base imbalance (metabolic acidosis),
• low blood albumin levels,
• shortness of breath,
• hallucinations,
• insufficient effectiveness of the medicine.

Unknown (frequency cannot be estimated from available data)

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

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Dexmedetomidine Kabi

Keep this medicine 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 specified month.
No special storage conditions apply for this medicine.
Do not use this medicine if the vial is damaged.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the package and other information

What Dexmedetomidine Kabi 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 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 prepared 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, colourless solution.
Type of container
Glass vials with a capacity of 2 ml, 4 ml or 10 ml, in a cardboard box.
Pack sizes
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 Authorisation Holder and Manufacturer
Marketing Authorisation 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 medicinal product is authorised in the European Economic Area and the United Kingdom (Northern Ireland) under the following names:

Information intended exclusively for medical professionals:

Dexmedetomidine Kabi, 100 micrograms/ml, concentrate for solution for infusion
Route of administration
Dexmedetomidine Kabi should be administered by medical personnel specialized in the care of patients requiring intensive care or anesthesia care in the operating room. Dexmedetomidine Kabi must be given only as a diluted intravenous infusion using a controlled infusion device.
Preparation of the solution
Before administration, Dexmedetomidine Kabi may be diluted with the following infusion fluids 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 lactate solution
• 20% mannitol (200 mg/ml)

The volumes required to prepare the infusion are given in the tables 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 the Dexmedetomidine Kabi solution for the presence of particulate matter and discoloration prior to administration.

Dexmedetomidine Kabi has been shown to be compatible when administered with the following intravenous fluids and medications:
Ringer's lactate solution, 5% glucose solution, sodium chloride 9 mg/ml (0.9%) for injection, mannitol 200 mg/ml (20%), sodium thiopental, 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.

Shelf life
Chemical and physical stability has been demonstrated for 24 hours at 25°C and for 24 hours at 2–8°C after dilution.
From a microbiological standpoint, the medicine should be used immediately. If not used immediately, the user is responsible for the storage conditions and duration prior to use, which generally should not exceed 24 hours at 2–8°C, unless dilution was carried out under controlled and validated aseptic conditions.