DEXMEDETOMIDINE ALTAN

Package leaflet: Information for the user

Dexmedetomidine Altan 100 micrograms/ml concentrate for solution for infusion

Equivalent medicine
Please read all of this leaflet carefully before you use this medicine because it contains important information for you.

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

Contents of this leaflet:

1. What Dexmedetomidine Altan is and what it is used for
2. What you need to know before you use 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 Dexmedetomidina Altan is and what it is used for

Dexmedetomidina Altan contains an active substance called dexmedetomidine, which belongs to a group of medicines known as sedatives. It is used to induce sedation (a state of calmness, drowsiness, or sleep) in adult patients admitted to hospital intensive care units or to provide conscious sedation during various diagnostic or surgical procedures.

2. What you should know before using Dexmedetomidine Altan

Dexmedetomidine Altan must not be administered to you if:

• you are allergic to dexmedetomidine or to any of the other ingredients of this medicine (listed in section 6).
• you have certain heart rhythm disorders (second- or third-degree atrioventricular heart block).
• you have very low blood pressure that does not respond to treatment.
• you have recently had a stroke or another serious condition involving reduced blood flow to the brain.

Warnings and precautions
Before being treated with this medicine, inform your doctor or nurse if any of the following apply to you, as Dexmedetomidine Altan must be used with caution:

• if you have a slower than normal heart rate (due to either illness or high levels of physical fitness)
• if you have low blood pressure
• if you have low blood volume, for example after bleeding
• if you suffer from heart disorders
• if you are elderly
• if you suffer from a neurological disorder (e.g. head injury, spinal cord injury, or stroke)
• if you have severe liver problems
• if you have ever developed a high fever after taking certain medicines, particularly anaesthetics.

Other medicines and Dexmedetomidine Altan
Inform your doctor or nurse if you are taking, have recently taken, or might take any other medicines.
The following medicines may increase the effect of Dexmedetomidine Altan:

• medicines that help you 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 you are taking medicines that lower blood pressure and heart rate, concomitant administration of Dexmedetomidine Altan may enhance this effect.
Dexmedetomidine Altan must not be used with other medicines that cause temporary paralysis.
Pregnancy, breastfeeding and fertility
Dexmedetomidine Altan must not be used during pregnancy or breastfeeding unless strictly necessary.
Consult your doctor or pharmacist before using this medicine.
Driving and using machines
Dexmedetomidine Altan has a major influence on the ability to drive and use machines.
After receiving Dexmedetomidine Altan, do not drive, operate machinery, or work in hazardous situations until the effects have completely worn off. Ask your doctor when you can resume these activities and return to such work.
Dexmedetomidine Altan contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per vial, i.e. essentially 'sodium-free'.

3. How to use Dexmedetomidina Altan

Hospital intensive care therapy
Dexmedetomidina Altan is administered to you by a doctor or nurse in a hospital intensive care setting.

Procedural sedation / conscious sedation
Dexmedetomidina Altan is administered to you by a doctor or nurse before and/or during diagnostic or surgical procedures requiring sedation, i.e. procedural/conscious sedation.

The doctor will decide the appropriate dose for you. The amount of Dexmedetomidina Altan depends on your age, weight, general health, the required level of sedation, and your response to the medicine. The doctor may adjust the dose if necessary and will monitor your heart and blood pressure during treatment.

Dexmedetomidina Altan is diluted and administered to you as an intravenous infusion (intravenous drip).

After sedation / recovery

• The doctor will continue to monitor you medically for several hours after sedation to ensure you feel well.
• You must not go home unaccompanied.
• Medicines that help you sleep, cause sedation, or strong painkillers may not be appropriate for a certain period after receiving Dexmedetomidina Altan. Talk to your doctor about using these medicines and about alcohol consumption.

If you are given more Dexmedetomidina Altan than you should have
If you are given too much Dexmedetomidina Altan, your blood pressure may increase or decrease, your heart rate may slow down, your breathing may become slower, and you may feel more drowsy. The doctor will know how to treat you based on your condition.

If you have any further questions about the use of this medicine, consult your doctor.

4. Possible side effects

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

• Slowing of the heartbeat
• Low or high blood pressure

Common ( affects from 1 to 10 in 100 people )

• Chest pain or heart attack
• Fast heartbeat
• Low or high blood sugar levels (amount of sugar in the blood)
• Changes in breathing pattern or respiratory arrest
• Nausea, vomiting or dry mouth
• Agitation
• Withdrawal symptoms
• High temperature

Uncommon ( affects from 1 to 10 in 1,000 people )

• A condition in which there is too much acid in the body
• Low level of albumin in the blood
• Shortness of breath
• Hallucinations
• Reduced heart function
• The medicine is not effective enough
• Stomach swelling
• Thirst

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

• Need to urinate more than normal

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor or nurse.
You can also report side effects directly via the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide more information on the safety of this medicine.

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 the carton following
Exp.
This medicine does not require any special storage temperature. Store the vials in the outer carton to protect the medicine from light.

6. Package contents 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 excipients are sodium chloride, sodium hydroxide (for pH adjustment), hydrochloric acid (for pH adjustment), and water for injectable preparations.
Each 2 ml vial contains 200 micrograms of Dexmedetomidine Altan (as hydrochloride).
The final concentration of the solution after dilution must be 4 micrograms/ml or 8 micrograms/ml.

Description of the appearance of Dexmedetomidine Altan and package contents
Concentrate for solution for infusion (sterile concentrate).
The concentrate is a clear, colourless solution.

Containers
2 ml glass vials
5 vials of 2 ml
25 vials of 2 ml
It is possible that not all pack sizes are marketed.

Marketing Authorization Holder and Manufacturer:
Altan Pharma Ltd
2 Harbour Square
Dun Laogharie, County Dublin
Ireland

Manufacturer:
Altan Pharmaceuticals, S.A.
Polígono Industrial de Bernedo s/n –
01118 Bernedo (Alava)
Spain

Altan Pharmaceuticals, S.A.
Polígono Industrial Monte Boyal
Avenida De La Constitution 198-199
Casarrubios Del Monte
45950 Toledo
Spain

More detailed information on this medicinal product is available on the website of the Italian Medicines Agency (Agenzia Italiana del Farmaco): http://www.aifa.gov.it/

The following information is intended exclusively for physicians or healthcare professionals:
Dexmedetomidine Altan 100 micrograms/ml concentrate for solution for infusion

Route of administration
Dexmedetomidine Altan must be administered by healthcare professionals experienced in the management of patients requiring intensive care or in the anesthetic management of patients in the operating room or undergoing diagnostic procedures. It must only be given as a diluted intravenous infusion, using a controlled infusion device.

Preparation of the solution
Dexmedetomidine Altan may be diluted with glucose 50 mg/ml (5%), Ringer's solution, mannitol, or sodium chloride 9 mg/ml (0.9%) injectable solutions to obtain the required concentration of 4 micrograms/ml or 8 micrograms/ml prior to administration. See the table below for the volumes required to prepare the infusion.

When the required concentration is 4 micrograms/ml:

In the case where the required concentration is 8 micrograms/ml:

The solution should be gently shaken to mix well.
Dexmedetomidine Altan must be inspected visually for the presence of particles and changes in colour before administration.
Dexmedetomidine is compatible when administered with the following intravenous solutions and medicinal products:
Lactated Ringer's solution, 5% glucose solution, sodium chloride 9 mg/ml (0.9%) injectable solution, 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 solution (stability of the infusion solution) 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 not used immediately, the storage duration and conditions prior to use are the responsibility of the user and should normally not exceed 24 hours at 2–8°C, unless the dilution was carried out under controlled, aseptic, and validated conditions.