Dexmedetomidine Altan

Package Leaflet: Information for the Patient

Dexmedetomidine Altan, 4 micrograms/ml, Solution for Infusion

Dexmedetomidine

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

• -Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or nurse.
• If the patient experiences any side effects, including any not listed in this leaflet, inform the doctor. See section 4.

Table of Contents of the 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 drugs. The medicine is used to provide sedation (a state of calm, sleepiness, or sleep) in adult patients in the intensive care unit 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 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 that is resistant to treatment.
• if the patient has recently had a stroke or other severe illness affecting blood supply to the brain.

Warnings and precautions

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

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

This medicine may cause excessive urine production and increased thirst. If such symptoms occur, consult a doctor. For further information, see section 4.
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Increased risk of death has been observed in patients under 65 years of age who received this medicine, especially in patients admitted to the intensive care unit in a severe condition and for reasons other than post-surgical, as well as in younger patients.
The 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.

Other medicines and Dexmedetomidine Altan

Tell the doctor or nurse about all medicines currently being taken or recently taken, as well as any medicines the patient plans 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 the patient is taking blood pressure-lowering medicines or heart rate-slowing medicines, concurrent use of Dexmedetomidine Altan may enhance this effect. Dexmedetomidine Altan should not be used with medicines that cause periodic paralysis.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor before using this medicine.
Dexmedetomidine Altan should not be used during pregnancy or breastfeeding unless absolutely necessary.

Driving and using machines

Dexmedetomidine Altan has a major impact on the ability to drive and use machines. After administration of Dexmedetomidine Altan, the patient should not drive, operate machinery, or work in hazardous conditions until the effect of the medicine has worn off completely. The patient should ask their doctor when they can resume these activities and return to work.

Excipients

Dexmedetomidine Altan contains 5.5 g of glucose per 100 ml. This should be taken into account in patients with diabetes.

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.
The doctor will decide on the appropriate dose for the patient.

Procedural sedation/ sedation with preserved consciousness

Dexmedetomidine Altan is administered to the patient by a doctor or nurse before or during diagnostic procedures or surgical operations requiring sedation, so-called procedural sedation/sedation with preserved consciousness.
The doctor will determine the dose suitable for the patient. The dose of Dexmedetomidine Altan depends on the patient's age, weight, overall health, and required level of sedation, as well as the patient's response to the medicine. The doctor may adjust the dose if necessary and will monitor the patient's heart rate and blood pressure during treatment.
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Dexmedetomidine Altan is 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 the patient feels well.
• The patient should not return home without supervision.
• For some time after administration of Dexmedetomidine Altan, the patient should not take sleep-inducing medicines, sedatives, or strong painkillers. The patient should discuss the use of these medicines and alcohol consumption with their doctor.

In case of overdose of Dexmedetomidine Altan

If the patient has received too much Dexmedetomidine Altan, they may experience increased or decreased blood pressure, slowed heart rate, slowed breathing, and drowsiness. The doctor knows how to treat the patient according to their condition.
In case of any further doubts about the use of this medicine, consult a 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)

• slowed heart rate
• low or high blood pressure
• changes in breathing or respiratory arrest.

Common (less than 1 in 10 patients)

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

Uncommon (less than 1 in 100 patients)

• reduced heart function, cardiac arrest
• gastric swelling
• increased thirst
• acid-base imbalance
• low albumin levels in the blood
• shortness of breath
• hallucinations
• the medicine is not effective enough.

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. Consult a doctor if such symptoms occur.

Reporting side effects

If side effects occur, including any not listed in this leaflet, inform the doctor or nurse. Side effects can be reported directly to the Department of Medicinal Product Monitoring, 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
e-mail: ndl@urpl.gov.pl
Reporting side effects helps gather more information on the safety of the medicine.
Side effects can also be reported to the marketing authorization holder.

5. How to store Dexmedetomidine Altan

Store the medicine out of sight and reach of children.
There are no special storage temperature requirements for the medicine.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
The doctor or nurse knows how to store Dexmedetomidine Altan properly (see section 6).
After first opening, Dexmedetomidine Altan should be used immediately.
Medicines should not be disposed of via wastewater or household waste. Ask a pharmacist how to dispose of unused medicines. This will help protect the environment.

6. Contents of the pack and other information

What Dexmedetomidine Altan contains

• The active substance is dexmedetomidine. One ml of the solution contains dexmedetomidine hydrochloride equivalent to 4 micrograms of dexmedetomidine.
• The other ingredients are: glucose monohydrate and water for injections.

What Dexmedetomidine Altan looks like and contents of the pack

Dexmedetomidine Altan is a solution in a transparent, colorless bag. One bag contains 100 ml of solution.
Packaging available:

• 100 ml solution in a polypropylene bag, placed in an outer aluminum bag. Each polypropylene bag contains one non-PVC filling and closing port and one non-PVC infusion port. Bag size: 1 x 100 ml or 4 x 100 ml. Not all pack sizes may be marketed.

Marketing authorization holder:

Altan Pharma Limited
The Lennox Building
50 South Richmond Street
Dublin 2
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D02 FK02-Ireland

Manufacturer:

Altan Pharmaceuticals S.A.
Polígono Industrial de Bernedo, s/n
01118 Bernedo (Álava)
Spain
To obtain more detailed information, contact the representative of the marketing authorization holder:

Date of revision of the leaflet: 10.2023

……………………………………………………………………………………………………………..
Information intended for healthcare professionals only:

Dexmedetomidine Altan, 4 micrograms/ml, 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.

• Dexmedetomidine Altan should not be diluted before use: it is supplied ready for use.
• For single use only. Any unused solution should be discarded. Only clear solutions free from particles and discoloration should be used.
• Dexmedetomidine should be administered exclusively by intravenous infusion using a controlled infusion set.
• Dexmedetomidine should not be administered as a bolus.

Dosage

• -Indication 1. Sedation of adult patients in the Intensive Care Unit (ICU) requiring a level of sedation no deeper than arousal in response to voice (score from 0 to -3 on the Richmond Agitation-Sedation Scale (RASS)).
• -In patients already intubated and anesthetized, dexmedetomidine can be started at an initial intravenous dose of 0.7 micrograms/kg/h and gradually adjusted, within the dose range of 0.2 to 1.4 micrograms/kg/h, depending on the patient's response to the medicine, to achieve the desired level of sedation. In frail patients, a lower initial dose should be considered. Dexmedetomidine is a potent medicine, and the infusion rate is administered in micrograms per kilogram per hour. After adjusting the dose, it may take up to one hour to achieve a stable level of sedation in the patient.
• Maximum dose:The maximum dose should not exceed 1.4 micrograms/kg/h. Patients who do not achieve adequate sedation after administration of the maximum dose of dexmedetomidine should receive another sedative agent.

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• -Indication 2. Sedation of non-intubated patients before and/or during diagnostic procedures or surgical operations requiring sedation, e.g., procedural sedation/with preserved consciousness.
• -Initiation of procedural sedation:Administration of a loading infusion dose of 1 microgram/kg over 10 minutes. For less invasive procedures, such as ophthalmic surgery, a loading infusion dose of 0.5 micrograms/kg may be appropriate, administered over 10 minutes.
• Maintenance of procedural sedation:The maintenance infusion is usually started at a dose of 0.6-0.7 micrograms/kg/h and gradually adjusted to achieve the desired clinical effect, within the dose range of 0.2 micrograms/kg/h to 1 microgram/kg/h. The maintenance infusion rate should be adjusted to achieve the target level of sedation.

Shelf life

The solution for infusion should be used immediately after first opening.
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