Dexmedetomidine Altan 100 micrograms/ml concentrate for infusion solution

Patient Information Leaflet

Introduction

Package Leaflet: Information for the Patient

Dexmedetomidine Altan 100 micrograms/ml concentrate for solution for infusion

Dexmedetomidine

Read the entire leaflet carefully before you start using this medicine, as 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, consult your doctor, even if they are side effects not listed in this leaflet. See section 4.

Leaflet Contents

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

• if you have abnormally slow heart rate (either due to illness or high physical fitness level), 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 elderly
• if you have a neurological disorder (e.g., head or spinal cord injury, 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 urination 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 in age. 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.

Use of 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, concomitant administration with Dexmedetomidine Altan may enhance this effect. Dexmedetomidine Altan must not be used with medicines that can cause temporary paralysis.

Pregnancy, breastfeeding and fertility

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 influence 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 regarding when you may resume these activities and types of work.

Dexmedetomidine Altan contains sodium

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

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

3. How to use Dexmedetomidina Altan

Hospital intensive care

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

Procedural sedation / conscious sedation

Dexmedetomidina 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 Dexmedetomidina 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.

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

After sedation / recovery

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

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

If you have received too much Dexmedetomidina 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 every 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 every 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 effective enough

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 Medicines Website: 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.

Do not use this medicine after the expiry date stated on the label and packaging following EXP. This medicine does not require any special storage temperature. Store the ampoules or vials in the outer packaging to protect from light.

6. Contents of the pack and other information

Composition of Dexmedetomidine Altan

The active substance is dexmedetomidine. Each ml of concentrate contains dexmedetomidine hydrochloride equivalent to 100 micrograms of dexmedetomidine.

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

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

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

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

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

Appearance of Dexmedetomidine Altan and contents of the pack

Concentrate for solution for infusion (sterile concentrate).

The concentrate is a clear, colourless solution.

Packaging

2 ml glass ampoules
6 ml or 10 ml glass vials

Pack sizes

5 ampoules with 2 ml
25 ampoules with 2 ml
4 vials with 4 ml
4 vials with 10 ml

Only certain pack sizes may be marketed.

Marketing Authorisation Holder

Altan Pharmaceuticals, S.A.
C/ Cólquide, Nº 6, Portal 2, 1st Floor, Office F.
Edificio Prisma, Las Rozas, 28230 Madrid
Spain

Local Representative:

Altan Pharmaceuticals S.A.
C/ Cólquide, Nº 6, Portal 2, 1st Floor, Office 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

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 100 micrograms/ml concentrate for solution for infusion

Method 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. It must be administered only 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 9 mg/ml (0.9%) sodium chloride injectable solution to achieve 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.

If a concentration of 4 micrograms/ml is required:

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

The solution should be gently shaken to ensure thorough mixing.

Dexmedetomidine Altan must be inspected visually for particles and discoloration before administration.

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

Ringer's lactate, 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, and sufentanil 10 mcg/ml

Expiry

After dilution:

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

From a microbiological standpoint, 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 normally should not exceed 24 hours between 2° and 8°C, unless the dilution was carried out under controlled and validated aseptic conditions.