Leaflet: information for the user

Dexmedetomidine Altan 4 micrograms/ml infusion solution

Dexmedetomidine

Read this leaflet carefully before you start using this medicine, because it contains important information for you.

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

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

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

1. What isDexmedetomidine Altanand what it is used for

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

3. How to useDexmedetomidine Altan

4. Possible side effects

5. Storage ofDexmedetomidine Altan

6. Contents of the pack and additional information.

This medication contains an active substance called dexmedetomidina, which belongs to a group of medications 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 this medication should be used with caution:

-if you have an abnormally slow heart rate (either due to illness or high physical condition), 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 disease

-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 upon 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 and breastfeeding

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 machinery

Dexmedetomidina Altan has a significant impact on your ability to drive and operate machinery. Once you have been administered Dexmedetomidina Altan, you should not drive, operate machinery, 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 glucose

This medication contains glucose. Patients with diabetes mellitus should be aware that this medication contains 5.5 g of glucose per 100 ml.

Intensive Care Hospital

This medication is administered to you by a doctor or a nurse in the intensive care unit of a hospital.

Procedure Sedation / Conscious Sedation

Dexmedetomidina Altan is administered by a doctor or a nurse 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 change your dose if necessary and will monitor your heart and blood pressure during treatment.

Dexmedetomidina Altan is administered to you as an intravenous infusion.

After Sedation/Waking Up

-Your doctor will keep you under supervision for several hours after sedation to ensure that 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 during a period of time after treatment with Dexmedetomidina Altan. Consult with your doctor about the use of these medications and about the use of alcohol.

If you have been given more Dexmedetomidina Altan than you should:

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, taking into account 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)

- large amount of urine 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 Usewww.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.

This medication does not require special conditions for conservation.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Your doctor, nurse or pharmacist knows how to store Dexmedetomidina Altan correctly (see section 6).

After the first opening, Dexmedetomidina Altan should be used preferably immediately.

Medicines should not be thrown into the drains. Ask your doctor or pharmacist how to dispose of the packaging and the medications that you no longer need. This way, you will help protect the environment.

Dexmedetomidine Altan Composition

- The active ingredient is Dexmedetomidine. Each ml contains hydrochloride of dexmedetomidine equivalent to 4 micrograms of dexmedetomidine.

- The other components are glucose monohydrate and water for injectable preparations.

Appearance of the product and contents of the package

Dexmedetomidine is supplied in a bag as a transparent and colorless solution. A bag contains 100 ml of solution.

Dexmedetomidine Altan 4 micrograms/ml solution for infusion is available in the following presentations:

- Solution of 100 ml in a flexible polypropylene bag with an aluminum overbag

Each polypropylene bag contains a point for filling and closing the PVC free port of the bag and a free PVC administration port.

Package sizes

Polypropylene bag: 1 x 100 ml, 4 x 100 ml.

Only some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Altan Pharmaceuticals S.A.

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

Edificio Prisma, Las Rozas, 28230 Madrid – Spain

Responsible manufacturer

Altan Pharmaceuticals, S.A.

Polígono Industrial de 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

----------------------------------------------------------------------------------------------------------

This information is intended solely for healthcare professionals:

Dexmedetomidine Altan 4 micrograms/ml solution for infusion

Administration form

Dexmedetomidine 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.

- Dexmedetomidine Altan should not be diluted before use: it is supplied ready to use.

- For single use only. Any unused solution should be discarded. Only a transparent, particle-free, and colorless solution should be used.

- Dexmedetomidine should be administered only as an intravenous infusion using a controlled infusion device.

- Dexmedetomidine should not be administered as a bolus dose.

Dosage

Indication 1. For sedation of adult patients in the ICU (Intensive Care Unit) who do not require a deeper level of sedation than waking up in response to verbal stimulation (corresponding to a score of 0 to -3 on the Richmond Agitation-Sedation Scale (RASS)).

Patients who are already intubated and sedated can switch to dexmedetomidine at an initial infusion rate of 0.7 micrograms/kg/h, which can then be adjusted gradually within the dose range of 0.2 to 1.4 micrograms/kg/h to achieve the desired level of sedation, based on the patient's response. A lower infusion rate should be considered for fragile patients. Dexmedetomidine is very potent, and the infusion rate is given per hour. After adjusting the dose, a new equilibrium state will not be reached until an hour has passed.

Maximum dose:The maximum dose should not be exceeded. Patients who do not achieve an adequate level of sedation with the maximum dose of dexmedetomidine should switch to an alternative sedative agent.

Indication 2. For sedation of adult patients not intubated, before and/or during diagnostic or surgical procedures that require sedation, e.g. for procedure sedation/conscious sedation.

Procedure sedation initiation:A loading infusion of 1.0 microgram/kg over 10 minutes. For less invasive procedures such as eye surgery, a loading infusion of 0.5 micrograms/kg administered over 10 minutes may be sufficient.

Procedure sedation maintenance:The maintenance infusion is usually started at 0.6-0.7 micrograms/kg/hour and adjusted to achieve the desired clinical effect with doses ranging from 0.2 to 1 microgram/kg/hour. The rate of the maintenance infusion should be adjusted to achieve the desired level of sedation.

Expiry date

The infusion solution should be used immediately, after the first opening.