Dexmedetomidine altan

Package leaflet: Information for the patient

Dexmedetomidine Altan, 4 micrograms/ml, solution for infusion
Dexmedetomidinum
Please read all of this leaflet carefully before the medicine is administered, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any further questions, please ask your doctor or nurse.
• If you experience any side effects, including any not listed in this leaflet, inform your doctor immediately. See section 4.

Contents of the leaflet

1. What Dexmedetomidine Altan is and what it is used for
2. Important information before receiving 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 Dexmedetomidine Altan is and what it is used for

Dexmedetomidine Altan contains the active substance dexmedetomidine, which belongs to a group of medicines called sedatives. It is used to provide sedation (a calm, drowsy, or sleep-like state) in adult patients in an intensive care unit (ICU) in a hospital or during various diagnostic procedures and surgical interventions where consciousness is preserved.

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 suffered a stroke or other serious condition affecting blood supply to the brain.

Warnings and precautions
Before administering this medicine, inform 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 abnormally slow heart rate (due to illness or high physical fitness), as this may increase the risk of cardiac arrest
• if the patient has low blood pressure
• if the patient has low blood volume, e.g. following 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 injury, or stroke)
• if the patient has liver disease
• if the patient has ever experienced severe fever after taking certain medicines, particularly anaesthetic agents.

This medicine may cause excessive urination and increased thirst. If these symptoms occur, contact a doctor. For further information, see section 4.
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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 who were in a more severe condition and whose admission was 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.

Other medicines and Dexmedetomidine Altan
Inform the doctor or nurse about all medicines currently used, recently used, or planned for use.
The following medicines may enhance the effects of Dexmedetomidine Altan:

• medicines that induce 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 Altan may intensify these effects. Dexmedetomidine Altan must 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 is planning to have a child, she should consult her doctor before using this medicine.
Dexmedetomidine Altan must not be used during pregnancy or breastfeeding unless absolutely necessary.

Driving and operating machinery
Dexmedetomidine Altan has a major influence on the ability to drive and operate machinery. After receiving Dexmedetomidine Altan, the patient must not drive, operate machinery, or work in 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 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 an intensive care unit.
The doctor will decide the appropriate dose for the patient.

Procedural sedation/awake sedation
Dexmedetomidine Altan is administered to the patient by a doctor or nurse before or during diagnostic procedures or surgical interventions requiring sedation, so-called procedural sedation/awake sedation.
The doctor will determine the dose appropriate for the patient. The dose of Dexmedetomidine Altan depends on the patient's age, body weight, general health condition, required level of sedation, and the body's response to the medication. If necessary, the doctor may adjust the dose and will monitor heart function and blood pressure during treatment.

Dexmedetomidine Altan is administered intravenously as an infusion (intravenous drip).

After sedation/after awakening

• The doctor will supervise the patient for several hours after sedation to ensure the patient is feeling well.
• The patient should not return home unaccompanied.
• For some time after administration of Dexmedetomidine Altan, the patient should not take medications that facilitate sleep, cause sedation, or strong painkillers. Discuss with the doctor the use of these medications and alcohol consumption.

In case of administration of a higher than recommended dose of Dexmedetomidine Altan
If the patient has received too high a dose of Dexmedetomidine Altan, 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 status.
If you have any further doubts regarding the use of this medicine, please consult your doctor.

4. Possible side effects

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

• Slowing of heart rate
• Low or high blood pressure
• Changes in breathing pattern or breathing stop

Common ( not more than 1 in 10 patients ):

• Chest pain or heart attack
• Fast heart rate
• Low or high blood sugar levels
• Nausea, vomiting or dry mouth
• Restlessness
• High body temperature
• Symptoms upon discontinuation of the medicine

Uncommon ( not more than 1 in 100 patients ):

• Reduced heart function, cardiac arrest
• Stomach swelling
• Increased thirst
• Acid-base imbalance
• Low blood albumin levels
• Shortened breathing
• Hallucinations
• Insufficient effectiveness of the medicine

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

• Excretion of large amounts of urine and excessive thirst – these may be symptoms of a hormonal disorder called diabetes insipidus. Contact your doctor if such symptoms occur.

Reporting of side effects
If any side effects occur, including any not listed in this leaflet, inform your doctor or nurse. Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the 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: [email protected]
Reporting side effects helps provide more information on the safety of this medicine.
Side effects can also be reported to the marketing authorization holder.
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5. How to store Dexmedetomidine Altan

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

6. Contents of the packaging and other information

What Dexmedetomidine Altan contains

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

What Dexmedetomidine Altan looks like and contents of the pack
Dexmedetomidine Altan is a solution in a transparent, colourless bag. Each bag contains
100 ml of solution.
Available pack:

• 100 ml of solution in a polypropylene bag, placed in an outer aluminium pouch. Each polypropylene bag has one filling and closure port without PVC and one infusion port without PVC. Pack size: Polypropylene bag: 1 x 100 ml or 4 x 100 ml. Not all pack sizes may be marketed.

Marketing Authorisation 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
For more detailed information, please contact the representative of the Marketing Authorisation Holder:
……………………………………………………………………………………………………………..
Information intended exclusively for healthcare professionals:
Dexmedetomidine Altan, 4 micrograms/ml, infusion solution
Method of administration
Dexmedetomidine Altan should be administered only by healthcare professionals specialized in the treatment of patients requiring intensive care or anaesthetic care in the operating room.

• Dexmedetomidine Altan must not be diluted before use: it is supplied ready for use.
• For single use only. Any unused solution should be discarded. Only clear solution free from particles and discoloration should be used.
• Dexmedetomidine must be administered exclusively by intravenous infusion using a controlled infusion device.
• Dexmedetomidine must 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 (level 0 to -3 on the Richmond Agitation-Sedation Scale (RASS)).
• In patients who are already intubated and under general anaesthesia, dexmedetomidine may be initiated at an initial intravenous dose of 0.7 micrograms/kg/hour, with gradual adjustment within the dose range of 0.2 to 1.4 micrograms/kg/hour depending on the patient's response, to achieve the desired level of sedation. In frail patients, a lower initial dose should be considered. Dexmedetomidine is a very potent medicinal product and the infusion rate is expressed as dose per hour. After dose adjustment, it may take up to one hour to re-establish a stable sedation level in the patient.
• Maximum dose: The maximum dose of 1.4 micrograms/kg/hour must not be exceeded. In patients who do not achieve adequate sedation at the maximum dose of dexmedetomidine, an alternative sedative agent should be administered.

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

Expiry date
The infusion solution should be used immediately after first opening.
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