DEXMEDETOMIDINE ALTAN 100 micrograms/ml concentrate for infusion solution

Introduction

Package Leaflet: Information for the Patient

Dexmedetomidine Altan 100 micrograms/ml concentrate for 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, even if you think they are not serious. 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. Storage of Dexmedetomidine Altan
6. Contents of the pack and other information

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

Dexmedetomidine Altan contains the active substance dexmedetomidine, which belongs to a group of medicines called sedatives. It is used to provide sedation (a state of calm, drowsiness, or sleep) in adult patients in intensive care units in hospitals or conscious sedation during different diagnostic or surgical procedures.

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

Dexmedetomidine Altan must not be administered to:

• 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 that affect 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 Dexmedetomidine Altan 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 problems
• if you have ever developed a severe fever after taking certain medicines, 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 illness 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, 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 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 sodium

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

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

3. How to use Dexmedetomidine Altan

Hospital Intensive Care

Dexmedetomidine Altan is administered by a doctor or nurse in the hospital's intensive care unit.

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 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 diluted and 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 relieve severe pain may not be recommended for a period after treatment with Dexmedetomidine Altan. Consult your doctor about the use of these types of medicines and 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 rise or fall, your heartbeats 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 levels in the blood
• difficulty breathing
• hallucinations
• the medicine is not effective enough

Rare (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 you think they are not serious. You can also report side effects directly through the Spanish Medicines Agency's website: www.notificaRAM.es. By reporting side 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 which is stated on the label and carton after EXP. This medicine does not require any special storage conditions. 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 ingredients are sodium chloride, sodium hydroxide (for pH adjustment), hydrochloric acid (for pH adjustment), and water for injections.

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

Appearance and pack of Dexmedetomidine Altan

Concentrate for solution for infusion (sterile concentrate).

The concentrate is a clear and colorless solution

Packs

2 ml glass ampoules

4 ml or 10 ml glass vials

Pack sizes

5 ampoules of 2 ml

25 ampoules of 2 ml

4 vials of 4 ml

4 vials of 10 ml

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Altan Pharmaceuticals, S.A.

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

Edificio Prisma, Las Rozas, 28230 Madrid

Spain

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

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

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This information is intended only for healthcare professionals:

Dexmedetomidine Altan 100 micrograms/ml concentrate for 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. It should be administered only as a diluted intravenous infusion using a controlled infusion device.

Preparation of the solution

Dexmedetomidine Altan can be diluted in glucose 50 mg/ml (5%), Ringer's solution, mannitol, or sodium chloride 9 mg/ml (0.9%) injection solution to achieve the required concentration of 4 micrograms/ml or 8 micrograms/ml before administration. See the table below for the volumes needed 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 shaken to mix well.

Dexmedetomidine Altan should be visually inspected for particles and coloration before administration.

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

Ringer's solution, glucose 5% solution, sodium chloride 0.9% injection solution, mannitol 20% solution, dexamethasone 4 mg, magnesium sulfate 10 mg/kg and 40 mg/kg, and sufentanil 10 mcg/ml

Shelf life

After dilution:

Chemical and physical stability has been demonstrated 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 before use are the responsibility of the user and should not normally exceed 24 hours between 2° and 8°C, unless the dilution has been carried out under controlled and validated aseptic conditions.