Product Information for the Patient

Dexmedetomidine Altan 100 micrograms/mL Concentrate for Solution for Infusion

Dexmedetomidine

Read this entire product information carefully before starting to use this medicine, as it contains important information for you.

-Keep this product information, as you may need to read it again.

-If you have any questions, consult your doctor, pharmacist, or nurse.

-If you experience any adverse effects, consult your doctor, even if they are not listed in this product information. See section 4.

1. What isDexmedetomidine Altanand what is it used for

2. What you need to know before starting to useDexmedetomidine Altan

3. How to useDexmedetomidine Altan

4. Possible adverse effects

5. Storage ofDexmedetomidine Altan

6. Contents of the pack and additional information.

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

Do not administer Dexmedetomidina Altan:

-if you are allergic to dexmedetomidina or any of the other components of this medication (listed in section 6).

-if you have some heart rhythm disorders (grade 2 or 3 heart block).

-if you have very low blood pressure that does not respond to treatment.

-if you have recently had a stroke or other severe episodes that affect blood supply to the brain.

Warnings and precautions

Before using this medication, inform your doctor or nurse if you are in any of the following situations, as Dexmedetomidina Altan should be used with caution:

-if you have an abnormally slow heart rate (either due to illness or high physical condition level)as it may increase the risk of cardiac arrest.

-if you have low blood pressure

-if you have low blood volume, for example after a hemorrhage

-if you have certain heart diseases

-if you are elderly

-if you have a neurological disorder (e.g., head or spinal cord injuries or stroke)

-if you have severe liver problems

-if you have ever developed a severe fever after some medications, especially anesthetics

This medication may cause a large amount of urine and excessive thirst, contact a

doctor if these adverse effects occur. See section 4 for more information.

A higher risk of mortality has been observed in patients 65 years or older when using this medication, especially in patients admitted to the intensive care unit for reasons other than postoperative care, with more severe disease at admission to the intensive care unit, and with a younger age. The doctor will decide if this medication is still suitable for you. The doctor will consider the benefits and risks of this medication for you, compared to treatment with other sedatives.

Use of Dexmedetomidina Altan with other medications

Inform your doctor or nurse if you are using, have used recently, or may need to use any other medication.

The following medications may increase the effect of Dexmedetomidina Altan:

-medications that help you sleep or cause sedation (e.g., midazolam, propofol)

-strong pain medications (e.g., opioids such as morphine, codeine)

-anesthetic medications (e.g., sevoflurane, isoflurane)

If you are using medications that lower your blood pressure and heart rate, the concurrent administration with Dexmedetomidina Altan may increase this effect. Dexmedetomidina Altan should not be used with medications that can cause temporary paralysis.

Pregnancy, breastfeeding, and fertility

Dexmedetomidina Altan should not be used during pregnancy or breastfeeding, unless clearly necessary. Consult your doctor or pharmacist before using this medication.

Driving and operating machines

Dexmedetomidina Altan has a significant impact on your ability to drive and operate machines. Once you have been administered Dexmedetomidina Altan, do not drive, operate machines, or work in hazardous situations until the effects have completely passed. Consult with your doctor when you can resume these activities and this type of work.

Dexmedetomidina Altan contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per 2 ml ampoule; this is essentially “sodium-free”.

This medication contains 37mg of sodium (main component of cooking / table salt) in each 10 ml vial. This is equivalent to 2% of the maximum recommended daily sodium intake for an adult.

Intensive Hospital Care

Dexmedetomidina Altan is administered by a doctor or nurse in the intensive care unit of a hospital.

Procedure Sedation / Conscious Sedation

A doctor or nurse will administer Dexmedetomidina Altan before and/or during diagnostic or surgical procedures that require sedation, e.g. procedure sedation/conscious sedation.

Your doctor will decide on the appropriate dose for you. The amount of Dexmedetomidina Altan depends on your age, body weight, general health status, the level of sedation required, and how you respond to the medication. Your doctor may adjust your dose as needed and will monitor your heart and blood pressure during treatment.

Dexmedetomidina Altan is diluted and administered as an infusion (drip) into your veins.

After Sedation/Waking Up

-Your doctor will keep you under close supervision for several hours after sedation to ensure you are doing well.

-You should not go home unless accompanied.

-Medications that help you sleep, as well as those intended to relieve intense pain, may not be recommended for a period of time after treatment with Dexmedetomidina Altan. Consult with your doctor about the use of these medications and alcohol use.

If You Have Been Given Too Much Dexmedetomidina Altan

If you have been given too much Dexmedetomidina Altan, your blood pressure may rise or fall, your heart rate may be slower, and you may feel more drowsy. Your doctor will know how to treat you based on your condition.

If you have any other questions about the use of this medication, ask your doctor.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Very common(affects more than 1 in 10 people)

-slow heart rate

-low or high blood pressure

- change in breathing pattern or cessation of breathing.

Common(affects between 1 and 10 in 100 people)

-chest pain or heart attack

-rapid heart rate

-low or high blood sugar levels

-nausea, vomiting, or dry mouth

-anxiety

-high temperature

-symptoms after stopping the medicine

Rare(affects between 1 and 10 in 1,000 people))

-reduced heart function, cardiac arrest.

-stomach bloating

-thirst

-a condition in which there is too much acid in the body

-low albumin levels in the blood

-difficulty breathing

-hallucinations

-the medicine is not effective enough.

Frequency not known (cannot be estimated from available data)

-excessive urination and excessive thirst – may be symptoms of a hormonal disorder called diabetes insipidus. Contact a doctor if this occurs.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use Website:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the label and packaging after CAD. This medication does not require any special storage temperature. Store the ampoules or vials in the outer packaging to protect it from light.

Composition of Dexmedetomidina Altan

The active ingredient is Dexmedetomidina. Each ml of concentrate contains hydrochloride of dexmedetomidina equivalent to 100 micrograms of dexmedetomidina.

The other components are sodium chloride, sodium hydroxide (for pH adjustment), hydrochloric acid (for pH adjustment) and water for injectable preparations.

Each ampoule of 2 ml contains 200 micrograms of dexmedetomidina (as hydrochloride).

Each vial of 4 ml contains 400 micrograms of dexmedetomidina (as hydrochloride).

Each vial of 10 ml contains 1000 micrograms of dexmedetomidina (as hydrochloride).

The concentration of the final solution after dilution should be 4 micrograms/ml or 8 micrograms/ml.

Appearance of Dexmedetomidina Altan and packaging content

Concentrate for solution for infusion (sterile concentrate).

The concentrate is a transparent and colorless solution.

Packaging

Glass ampoules of 2 ml

Glass vials of 6 or 10 ml

Packaging sizes

5 ampoules with 2 ml

25 ampoules with 2 ml

4 vials with 4 ml

4 vials with 10 ml

Only some packaging sizes may be commercially available.

Marketing Authorization Holder

Altan Pharma Ltd

The Lennox Building

50 South Richmond Street

Dublin 2

D02 FK02

Ireland

Local Representative:

Altan Pharmaceuticals S.A.

C/ Cólquide, Nº 6, Portal 2, 1ª Planta, Oficina F.

Edificio Prisma, Las Rozas, 28230 Madrid – Spain

Manufacturer

Altan Pharmaceuticals, S.A.

Avda. de la Constitución, 198-199,

Polígono Industrial Monte Boyal,

Casarrubios del Monte, 45950 Toledo – Spain

Altan Pharmaceuticals, S.A.

P.I. Bernedo S/N.

01118 Bernedo, Álava.- Spain

Last review date of this leaflet: April 2023

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es

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This information is intended only for healthcare professionals:

Dexmedetomidina Altan 100 micrograms/ml concentrate for solution for infusion

Administration form

Dexmedetomidina Altan should be administered by healthcare professionals experienced in the management of patients requiring intensive care or in the management of anesthesia in patients in the operating room.It should be administered only as a diluted intravenous infusion using a controlled infusion device.

Preparation of the solution

Dexmedetomidina Altan can be diluted in glucose 50 mg/ml (5%), Ringer's solution, mannitol or injectable sodium chloride 9 mg/ml (0.9%) to achieve the required concentration of 4 micrograms/ml or 8 micrograms/ml before administration. See below in the form of a table for the volumes required to prepare the infusion.

In case a concentration of 4 micrograms/ml is required:

In case a concentration of 8 micrograms/ml is required:

The solution should be gently agitated to mix well.

Dexmedetomidina Altan should be visually inspected to detect particles and color before administration.

Dexmedetomidina Altan has been shown to be compatible when administered with the following intravenous fluids and medications:

Ringer's lactate, glucose solution 5%, injectable sodium chloride 9 mg/ml (0.9%), mannitol 200 mg/ml (20%), dexamethasone 4 mg, magnesium sulfate 10 mg/kg and 40 mg/kg and sufentanil 10 mcg/ml

Expiration date

After dilution:

Chemical and physical stability has been demonstrated in use for 24 hours at 25°C and under refrigerated conditions (2° - 8°C).

From a microbiological point of view, the product should be used immediately. If not used immediately, the storage times and conditions prior to use are the responsibility of the user and should not normally exceed 24 hours between 2° and 8°C, unless the dilution has been performed in controlled and validated aseptic conditions.