DEXMEDETOMIDINE ALTAN 4 micrograms/ml SOLUTION FOR INFUSION

Introduction

Package Leaflet: Information for the User

Dexmedetomidine Altan 4 micrograms/ml solution for infusion

Dexmedetomidine

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• If you experience any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Dexmedetomidine Altan and what is it used for
2. What you need to know before you use Dexmedetomidine Altan
3. How to use Dexmedetomidine Altan
4. Possible side effects
5. Storing Dexmedetomidine Altan
6. Contents of the pack and other information

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

This medicine contains the active substance dexmedetomidine, 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.

2. What you need to know before you use Dexmedetomidine Altan

Dexmedetomidine Altan must not be given to you:

• if you are allergic to dexmedetomidine or any of the other ingredients of this medicine (listed in section 6).
• if you have certain heart rhythm disorders (2nd or 3rd degree 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 affecting blood supply to the brain.

Warnings and precautions

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

• if you have an abnormally slow heart rate (either due to disease or a high level of physical fitness), as it may increase the risk of cardiac arrest.
• if you have low blood pressure
• if you have low blood volume, for example after bleeding
• 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 medicine may cause a large amount of urine and excessive thirst, contact a

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

A higher risk of mortality has been observed in patients 65 years or younger when using this medicine, 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. Your doctor will decide if this medicine is still suitable for you. Your doctor will consider the benefits and risks of this medicine for you, compared to treatment with other sedatives.

Using Dexmedetomidine Altan with other medicines

Tell your doctor or nurse if you are using, have recently used or might use 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)
• medicines for severe pain (e.g. opioids such as morphine, codeine)
• anesthetic medicines (e.g. sevoflurane, isoflurane)

If you are using medicines that lower your blood pressure and heart rate, taking them with Dexmedetomidine Altan may increase this effect. Dexmedetomidine Altan should not be used with medicines that can cause temporary paralysis.

Pregnancy and breastfeeding

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

Driving and using machines

Dexmedetomidine Altan has a major impact on the ability to drive and use machines. Once you have been given Dexmedetomidine Altan, you should not drive, operate machinery or work in hazardous situations until the effects have passed completely. Consult your doctor when you can resume these activities and this type of work.

Dexmedetomidine Altan contains glucose

This medicine contains glucose. Patients with diabetes mellitus should note that this medicine contains 5.5 g of glucose per 100 ml.

3. How to use Dexmedetomidine Altan

Intensive Care Hospitalization

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

Procedural Sedation / Conscious Sedation

Dexmedetomidine Altan is administered by a doctor or nurse before and/or during diagnostic or surgical procedures that require sedation, e.g. procedural sedation/conscious sedation.

Your doctor will decide on the suitable dose for you. The amount of Dexmedetomidine Altan depends on your age, body weight, general state of health, the level of sedation required and how you respond to the medicine. Your doctor may change your dose if necessary and will monitor your heart and blood pressure during treatment.

Dexmedetomidine Altan is administered as an infusion (drip) into your veins.

After sedation/waking up

• Your doctor will keep you under supervision for a few hours after sedation to ensure you are well.
• You should not go home unless accompanied.
• Medicines that help you sleep, cause sedation, or are intended to relieve intense pain may not be recommended for a period of time after treatment with Dexmedetomidine Altan. Consult your doctor about the use of these types of medicines and about the use of alcohol.

If you have been given too much Dexmedetomidine Altan:

If you have been given too much Dexmedetomidine Altan, your blood pressure may go up or down, your heart beats 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 medicine, ask your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Very common (affect more than 1 in 10 people)

• slow heart rate
• low or high blood pressure
• change in breathing pattern or breathing stop

Common (affect between 1 and 10 in 100 people)

• chest pain or heart attack
• fast heart rate
• low or high blood sugar levels
• nausea, vomiting, or dry mouth
• restlessness
• high temperature
• symptoms after stopping the medicine

Uncommon (affect between 1 and 10 in 1,000 people)

• decreased heart function, cardiac arrest
• stomach swelling
• thirst
• a condition where there is too much acid in the body
• low albumin level in the blood
• difficulty breathing
• hallucinations
• the medicine is not effective enough

Frequency not known (cannot be estimated from the available data)

• a 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 side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Surveillance System for Human Use www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Dexmedetomidine Altan

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

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date is the last day of the month stated.

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

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

Medicines should not be disposed of via wastewater or household waste. Ask your doctor or pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Dexmedetomidine Altan

• The active substance is dexmedetomidine. Each ml contains dexmedetomidine hydrochloride equivalent to 4 micrograms of dexmedetomidine.

• The other ingredients are glucose monohydrate and water for injections.

Appearance and packaging

Dexmedetomidine is supplied in a bag as a clear and colorless solution. One 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 100 ml flexible polypropylene bag with an aluminum overbag

Each polypropylene bag contains a filling and closure point for the PVC-free bag port and a PVC-free administration port.

Package sizes

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

Not all pack sizes may be marketed.

Marketing authorization holder and 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

Manufacturer

Altan Pharmaceuticals, S.A.

Polígono Industrial de Bernedo, s/n,

01118 Bernedo, Álava.- Spain

Date of last revision of this leaflet:April 2023

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es

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

This information is intended only for healthcare professionals:

Dexmedetomidine Altan 4 micrograms/ml solution for infusion

Method of administration

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 for use.
• For single use. Any unused solution should be discarded. Only a clear, 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 may be switched to dexmedetomidine with an initial infusion rate of 0.7 micrograms/kg/h, which can then be gradually adjusted within the dosage 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 steady state will not be reached until one hour has passed.

Maximum dose:The maximum dose of 1.4 micrograms/kg/h should not be exceeded. Patients who do not achieve an adequate level of sedation with the maximum dose of dexmedetomidine should be switched to an alternative sedative agent.

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

Initiation of procedural sedation: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 adequate.

Maintenance of procedural sedation: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 maintenance infusion rate should be adjusted to achieve the desired level of sedation.

Expiry

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