Dexmedetomidine Altan

Package Leaflet: Information for the User

Dexmedetomidine Altan, 100 micrograms/ml, Concentrate for Solution for

Infusion
Dexmedetomidinum

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this package 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 package leaflet, tell your doctor. See section
• 4.

Table of Contents of the Package Leaflet

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

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

Dexmedetomidine Altan contains the active substance dexmedetomidine, which belongs to the 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 operations with preserved consciousness.

2. Important information before using Dexmedetomidine Altan

When not to use Dexmedetomidine Altan

• if you are allergic to Dexmedetomidine Altan or any of the other ingredients of this medicine (listed in section 6).
• if you have heart rhythm disorders (2nd or 3rd degree heart block).
• if you have very low blood pressure that is not responding to treatment.
• if you have recently had a stroke or other severe event that affects blood supply to the brain.

Warnings and precautions

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

• if you have an abnormally slow heart rate (due to disease or good physical condition), as this may increase the risk of cardiac arrest
• if you have low blood pressure
• if you have a small blood volume, e.g. after bleeding
• if you have certain heart conditions
• if you are elderly
• if you have a neurological disorder (e.g. head or spinal cord injury or stroke)
• if you have liver disease
• if you have ever had a high fever after taking certain

medicines, especially anesthetics. This medicine may cause excessive urine production and increased thirst. If such symptoms occur, you should contact your doctor. For further information, see section 4.
There is an increased risk of death in patients aged 65 and under who have been given this medicine, especially in patients admitted to the intensive care unit in a severe condition and for reasons other than post-operative care and at a younger age.
Your doctor will decide whether this medicine is still suitable for you. Your doctor will weigh the benefits and risks of using this medicine compared to other sedative medicines.

Dexmedetomidine Altan and other medicines

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

• 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, using Dexmedetomidine Altan at the same time may enhance this effect. Dexmedetomidine Altan should not be used with medicines that cause periodic paralysis.

Pregnancy, breastfeeding, and fertility

Dexmedetomidine Altan should not be used during pregnancy or breastfeeding unless absolutely necessary.
Before using this medicine, consult your doctor or pharmacist.

Driving and using machines

Dexmedetomidine Altan has a major impact on the ability to drive and use machines. After receiving Dexmedetomidine Altan, you should not drive, operate machinery, or work in hazardous conditions. Ask your doctor when you can resume these activities.

Dexmedetomidine Altan contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per 2 ml ampoule and 4 ml vial, i.e. the medicine is considered "sodium-free".
The medicine contains 37 mg of sodium (the main component of common salt) in each 10 ml vial.
This corresponds to 2% of the maximum recommended daily intake of sodium in the diet for adults.

3. How to use Dexmedetomidine Altan

Intensive Care Unit

Dexmedetomidine Altan is administered to the patient by a doctor or nurse in the intensive care unit.

Procedural sedation/analgesia with preserved consciousness

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

After sedation/after waking up

The doctor will monitor the patient for several hours after sedation to ensure that the patient feels well.
The patient should not return home alone.
For some time after receiving Dexmedetomidine Altan, you should not take medicines that facilitate sleep, cause sedation, or strong painkillers.
Talk to your doctor about taking these medicines and using alcohol.

In case of overdose of Dexmedetomidine Altan

If the patient has received too much Dexmedetomidine Altan, it may cause a decrease or increase in blood pressure, slowing of the heart rate, slower breathing, and a feeling of sleepiness.
The doctor knows how to treat the patient according to their condition.
If you have any further questions about the use of this medicine, ask your doctor.

4. Possible side effects

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

• slowing of the heart rate
• low or high blood pressure
• changes in breathing or cessation of breathing

Common (between 1 and 10 patients in 100)

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

Uncommon (between 1 and 10 patients in 1000)

• acid-base balance disorder
• low albumin levels in the blood
• shortness of breath
• hallucinations
• heart function disorders, cardiac arrest
• reduced efficacy of the medicine
• gastric swelling
• increased thirst.

Rare (cannot be estimated from the available data)

• excessive urine production and increased thirst - these may be symptoms of a hormonal disorder called diabetes insipidus. If such symptoms occur, you should contact your doctor.

Reporting side effects

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

5. How to store Dexmedetomidine Altan

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label and carton after "Expiry Date". The expiry date refers to the last day of the month.
There are no special storage precautions for the medicine. Store the ampoules or vials in the outer packaging to protect from light.

6. Contents of the pack and other information

What Dexmedetomidine Altan contains

The active substance is dexmedetomidine. Each ml of concentrate contains dexmedetomidine hydrochloride equivalent to 100 micrograms of dexmedetomidine.
The medicine also contains sodium chloride, sodium hydroxide (for pH adjustment), hydrochloric acid (for pH adjustment), and water for injections.
Each 2 ml ampoule contains 200 micrograms of dexmedetomidine (as hydrochloride).
Each 4 ml vial contains 400 micrograms of dexmedetomidine (as hydrochloride).
Each 10 ml vial contains 1000 micrograms of dexmedetomidine (as hydrochloride).
The concentration of the ready-to-use solution after dilution should be 4 micrograms/ml or 8 micrograms/ml.

What Dexmedetomidine Altan looks like and contents of the pack

Concentrate for solution for infusion (sterile concentrate). The concentrate is a clear, colorless solution.
Containers:
glass ampoules of 2 ml capacity
glass vials of 6 or 10 ml capacity
Pack sizes
5 ampoules x 2 ml
25 ampoules x 2 ml
4 vials x 4 ml
4 vials x 10 ml
Not all pack sizes may be marketed.

Marketing authorization holder

Altan Pharma Ltd
The Lennox Building
50 South Richmond Street
Dublin 2
D02 FK02,
Ireland

Manufacturer responsible for batch release

Altan Pharmaceuticals, S.A.
Avda. De la Constitución 198-199
Polígono Industrial Monte Boyal
45950 Casarrubios del Monte (Toledo)
Spain
Altan Pharmaceuticals, S.A.
Polígono Industrial de Bernedo
s/n, Bernedo
01118 Álava
Spain

Date of last revision of the package leaflet: 10.2023

Detailed information on this medicine is available on the website of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products (http://www.urpl.gov.pl)
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Information intended for healthcare professionals only:

Dexmedetomidine Altan 100 micrograms/ml concentrate for solution for infusion

Method of administration
Dexmedetomidine Altan should be administered by healthcare professionals specialized in the treatment of patients requiring intensive care or anesthesiological care in the operating room or during diagnostic procedures.
Dexmedetomidine Altan may only be administered as a diluted intravenous infusion using a controlled infusion set.
Preparation of the solution
To achieve the desired concentration of 4 micrograms/ml or 8 micrograms/ml, Dexmedetomidine Altan should be diluted before administration in a glucose 50 mg/ml (5%) solution, Ringer's solution, mannitol, or sodium chloride 9 mg/ml (0.9%) solution for injection.
The volumes required to prepare the infusion are given in the following table.

In case of required concentration of 4 micrograms/ml:

In case of required concentration of 8 micrograms/ml:

Gently shake the solution to ensure thorough mixing.
Before administration, Dexmedetomidine Altan should be visually inspected for particulate matter and discoloration.
It has been demonstrated that dexmedetomidine is compatible when administered with the following intravenous solutions and medicinal products:
Ringer's solution, 5% glucose solution, sodium chloride 9 mg/ml (0.9%) solution for injection, mannitol 200 mg/ml (20%), dexamethasone 4 mg, magnesium sulfate 10 mg/kg and 40 mg/kg, sufentanil 10 mcg/ml.

Shelf life

After dilution:
The chemical and physical stability of the diluted infusion (Stability of the diluted infusion) has been demonstrated for 24 hours at 25°C and under refrigeration (2°C – 8 °C).
From a microbiological point of view, the product should be used immediately. If the medicine is not used immediately, the user is responsible for the subsequent storage conditions and storage time before use.
The storage time should not normally exceed 24 hours at 2-8°C, unless the dilution has been performed under controlled and validated aseptic conditions.