Dexmedetomidine altan

Package leaflet: Information for the user

Dexmedetomidine Altan, 100 micrograms/ml, concentrate for solution for infusion
Dexmedetomidinum

Please read all of this leaflet carefully before this medicine is administered, because it contains important information for you.

• 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 experience any side effects, including any not listed in this leaflet, please tell your doctor. See section 4.

Contents of the leaflet

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

Dexmedetomidine Altan contains an active substance called dexmedetomidine, which belongs to a group of medicines known as sedatives. The medicine is used to provide sedation (a state of calmness, drowsiness, or sleep) in adult patients in an intensive care unit in hospital or during various diagnostic procedures and surgical interventions performed with preserved consciousness.

2. Important information before using Dexmedetomidine Altan

When not to use Dexmedetomidine Altan

• if the patient is allergic to Dexmedetomidine Altan or any of the other ingredients of this medicine (listed in section 6).
• if the patient has heart rhythm disorders (second- or third-degree atrioventricular 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 event 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 an unusually slow heart rate (due to illness or excellent physical fitness), as this may increase the risk of cardiac arrest
• if the patient has low blood pressure
• if the patient has reduced 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 high 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, especially in patients admitted to intensive care in a 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 of using this medicine compared to treatment with other sedative medicines.

Dexmedetomidine Altan and other medicines
Inform the doctor or nurse about all medicines currently taken or taken recently, as well as any medicines the patient plans to take.

The following medicines may enhance the effects of Dexmedetomidine Altan:

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

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

Driving and operating machinery
Dexmedetomidine Altan has a major influence on the ability to drive and operate machinery. After administration of Dexmedetomidine Altan, the patient must not drive, operate machinery, or work in hazardous conditions. Ask the doctor when it is safe to 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, meaning the medicine is considered "sodium-free".
The medicine contains 37 mg of sodium (a main component of table salt) in each 10 ml vial. This corresponds to 2% of the maximum recommended daily intake of sodium in the adult diet.

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 / sedation with maintained consciousness
Dexmedetomidine Altan is administered to the patient by a doctor or nurse before or during diagnostic procedures or surgical interventions requiring sedation, known as procedural sedation / sedation with maintained consciousness.
The doctor will determine the dose appropriate for the patient. The dose of Dexmedetomidine Altan depends on the patient's age, sex, general health status, required level of sedation, and the body's response to the drug. The doctor may adjust the dose if necessary and will monitor heart function and blood pressure during treatment.
Dexmedetomidine Altan is diluted and administered intravenously as an 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 Altan, do not take medications that facilitate sleep, cause sedation, or strong painkillers. Discuss the use of these medications and alcohol consumption with your doctor.
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, it may lead to decreased or increased blood pressure, slowed heart rate, slower breathing, and drowsiness. 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 medicine, consult your doctor.

4. Possible adverse reactions

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

Very common (more than 1 in 10 patients)

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

Common (1 to 10 in 100 patients)

• Chest pain or heart attack
• Fast heart rate
• Low or high blood sugar levels
• Nausea, vomiting, dry mouth
• Anxiety
• Withdrawal symptoms
• High body temperature

Uncommon (1 to 10 in 1,000 patients)

• Acid-base imbalance
• Low blood albumin levels
• Shortness of breath
• Hallucinations
• Heart function disorders, cardiac arrest
• Inadequate drug effectiveness
• Stomach swelling
• Increased thirst

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 a doctor if these symptoms occur.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions at the Office for Registration 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
Reporting adverse reactions helps to provide more information on the safety of the medicine.
Adverse reactions can also be reported to the marketing authorization holder.

5. How to store Dexmedetomidine Altan

Keep this 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 stated month.
There are no special storage temperature requirements for this 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 other components are 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, colourless solution.

Containers:

• Glass ampoules with a capacity of 2 ml
• Glass vials with a capacity of 4 or 10 ml

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 Authorisation 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

Detailed information on this medicinal product is available on the website of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (http://www.urpl.gov.pl)

Information intended exclusively for healthcare professionals:

Dexmedetomidine Altan 100 micrograms/ml concentrate for solution for infusion
Method of administration
Dexmedetomidine Altan should be administered by healthcare personnel specialized in the treatment of patients requiring intensive care or anaesthetic care in the operating room or undergoing diagnostic procedures.
Dexmedetomidine Altan must only be given as a diluted intravenous infusion using a controlled infusion administration set.
Preparation of the solution
To achieve the desired concentration of 4 micrograms/ml or 8 micrograms/ml, Dexmedetomidine Altan must be diluted prior to administration in glucose 50 mg/ml (5%), Ringer's solution, mannitol, or sodium chloride 9 mg/ml (0.9%) solution. The volumes required for the preparation of the infusion are given in the table 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.
Before administration, visually inspect Dexmedetomidine Altan for the presence of particulate matter and discoloration.
Dexmedetomidine has been shown to be compatible when administered with the following intravenous fluids and medicinal products:
Ringer's lactate, 5% glucose solution, sodium chloride 9 mg/ml (0.9%) 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:
Chemical and physical stability of the diluted infusion has been demonstrated for 24 hours at 25°C and under refrigerated conditions (2°C – 8°C).
From a microbiological standpoint, the product should be used immediately. If the product is not used immediately, the user is responsible for the storage period and conditions prior to use. The storage period should not normally exceed 24 hours at 2–8°C, unless dilution was carried out under controlled and validated aseptic conditions.