Dexmedetomidine Altan 4 micrograms/ml solution for infusion

Package leaflet: Information for the user

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, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• If you experience any side effects, talk to your doctor, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

2. What you need to know before using Dexmedetomidine Altan

Dexmedetomidine Altan must not be given 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 other serious episodes affecting blood supply to the brain.

Warnings and precautions

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

• if you have abnormally slow heart rate (either due to illness or high physical fitness), as this 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 of advanced age.
• 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 taking certain medicines, especially anesthetics.

This medicine may cause excessive urine production and excessive thirst. Contact a doctor if these adverse effects occur. See section 4 for more information.

An increased risk of mortality has been observed in patients aged 65 years or younger when using this medicine, particularly in patients admitted to intensive care units for reasons other than postoperative care, those with more severe illness at admission, and those who are younger. Your doctor will decide whether this medicine remains appropriate for you. Your doctor will consider the benefits and risks of this medicine for you, compared with treatment with other sedatives.

Using Dexmedetomidine Altan with other medicines

Inform your doctor or nurse if you are taking, have recently taken, or might need to 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 painkillers (e.g., opioids such as morphine, codeine).
• anesthetic medicines (e.g., sevoflurane, isoflurane).

If you are taking medicines that lower your blood pressure and heart rate, using them together with Dexmedetomidine Altan may increase this effect. Dexmedetomidine Altan must 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. After receiving Dexmedetomidine Altan, you must not drive, operate machinery, or work in hazardous situations until the effects have completely worn off. Consult your doctor to find out when you can resume these activities and this type of work.

Dexmedetomidine Altan contains glucose

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

3. How to use Dexmedetomidine Altan

Hospital intensive care

This medicine is administered to you 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 requiring sedation, e.g. procedural sedation/conscious sedation.

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

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

After sedation / waking up

• Your doctor will keep you under supervision for several hours after sedation to ensure you are doing well.
• You must not go home unaccompanied.
• Medicines that help you sleep, those causing sedation, or those used to relieve severe pain may not be recommended for a period of time after treatment with Dexmedetomidine Altan. Consult your doctor regarding the use of these medicines and alcohol.

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

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Very common (affect more than 1 in 10 people)

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

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)

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

Frequency not known (cannot be estimated from available data)

• large volume of urine and excessive thirst – may be symptoms of a hormonal disorder called diabetes insipidus. Contact a doctor if this occurs.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products at www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Dexmedetomidine Altan

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

This medicine does not require special storage conditions.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

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

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

Medicines should not be disposed of via wastewater drains. Ask your doctor or pharmacist how to dispose of medicines and packaging you no longer need. 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 components are monohydrate glucose and water for injectable preparations.

Appearance of the product and contents of the pack

Dexmedetomidine is supplied in a bag as a clear, colourless solution. One bag contains 100 ml of solution.

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

• 100 ml solution in a flexible polypropylene bag of 100 ml with an aluminium overpouch

Each polypropylene bag contains a filling and closure port free of PVC and an administration port free of PVC.

Pack sizes

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

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Altan Pharmaceuticals S.A.

C/ Cólquide, Nº 6, Portal 2, 1st Floor, Office F.

Prisma Building, Las Rozas, 28230 Madrid – Spain

Manufacturer

Altan Pharmaceuticals, S.A.

Polígono Industrial de Bernedo, s/n,

01118 Bernedo, Álava – Spain

Date of the most recent revision of this summary: April 2023

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

This information is intended for healthcare professionals only:

Dexmedetomidine Altan 4 micrograms/ml 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 management of anaesthesia in operating room patients.

• Dexmedetomidine Altan must not be diluted before use: it is supplied ready for use.
• For single use only. Any unused solution must be discarded. Only a clear, particle-free, colourless solution should be used.
• Dexmedetomidine must be administered only as an intravenous infusion using a controlled infusion device.
• Dexmedetomidine must not be administered as a bolus dose.

Dosing

Indication 1. For sedation of adult patients in the ICU (Intensive Care Unit) who do not require a deeper level of sedation than awakening 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 dose range of 0.2 to 1.4 micrograms/kg/h to achieve the desired level of sedation, according to the patient's response. A lower infusion rate should be considered for fragile patients. Dexmedetomidine is highly 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 elapsed.

Maximum dose: The maximum dose of 1.4 micrograms/kg/h must 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 non-intubated adult patients before and/or during diagnostic or surgical procedures requiring 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 ophthalmic surgery, a loading infusion of 0.5 micrograms/kg administered over 10 minutes may be appropriate.

Maintenance of procedural sedation: Maintenance infusion is generally initiated 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 infusion solution must be used immediately after first opening.