DEXMEDETOMIDINE HIKMA 8 micrograms/ml SOLUTION FOR INFUSION

2. What you need to know before you are given Dexmedetomidine Hikma

You should not be given Dexmedetomidine Hikma

• 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 (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 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 problems
• if you have ever developed a severe fever after some 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 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.

Other medicines and Dexmedetomidine Hikma

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 Hikma:

• 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 Hikma may increase this effect. Dexmedetomidine Hikma should not be used with medicines that can cause temporary paralysis.

Pregnancy and breastfeeding

Consult your doctor before using this medicine if you are pregnant, might be pregnant or plan to have a baby.

Dexmedetomidine Hikma should not be used during pregnancy or breastfeeding, unless clearly necessary.

Driving and using machines

Dexmedetomidine Hikma has a major impact on the ability to drive and use machines.

Once you have been given Dexmedetomidine Hikma, you should not drive, operate machines 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 Hikma contains sodium

Each 50 ml bag contains 177 mg of sodium (main component of table/cooking salt). This is equivalent to 8.9% of the maximum recommended daily sodium intake for an adult.

Each 100 ml bag contains 354 mg of sodium (main component of table/cooking salt). This is equivalent to 17.7% of the maximum recommended daily sodium intake for an adult.

Each 250 ml bag contains 885 mg of sodium (main component of table/cooking salt). This is equivalent to 44.3% of the maximum recommended daily sodium intake for an adult.

3. How Dexmedetomidine Hikma is used

Hospital Intensive Care

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

Your doctor will decide the right dose for you.

Procedural sedation/conscious sedation

Dexmedetomidine Hikma is given to you 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 right dose for you. The amount of Dexmedetomidine Hikma depends on your age, constitution, general state of health, the level of sedation needed 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 Hikma is given to you 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 make sure you are well.

• You should not go home unless accompanied.
• Medicines that help you sleep, cause sedation and those intended to relieve severe pain may not be recommended for a period of time after treatment with Dexmedetomidine Hikma. 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 Hikma

If you have been given too much Dexmedetomidine Hikma, your blood pressure may go up or down, your heart beats may be slower, you may breathe more slowly and you may feel more drowsy. Your doctor will know how to treat you based on your condition.

If you have any further questions on 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(may affect more than 1 in 10 people)

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

Common(may affect up to 1 in 10 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(may affect up to 1 in 100 people)

• reduced 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)

• 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, nurse or pharmacist, even if it is possible side effects not listed in this leaflet.

You can also report side effects directly via 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. Storage of Dexmedetomidine Hikma

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 bag after EXP. The expiry date is the last day of the month shown.

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

The solution should be used immediately after opening

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 further information

Composition of Dexmedetomidine Hikma

• The active substance is dexmedetomidine.
• Dexmedetomidine Hikma 4 micrograms/ml:

Each ml of solution for infusion contains dexmedetomidine hydrochloride equivalent to 4 micrograms of dexmedetomidine.

• Dexmedetomidine Hikma 8 micrograms/ml:

Each ml of solution for infusion contains dexmedetomidine hydrochloride equivalent to 8 micrograms of dexmedetomidine.

• The other ingredients are sodium chloride and water for injections.

Appearance of Dexmedetomidine Hikma and pack contents

Dexmedetomidine is supplied as a solution in a clear and colourless bag.

Dexmedetomidine Hikma 4 micrograms/ml:

One bag contains 50 ml, 100 ml or 250 ml of solution.

Dexmedetomidine is supplied in:

• 50 ml solution in a 50 ml flexible polypropylene bag with an aluminium overbag
• 100 ml solution in a 100 ml flexible polypropylene bag with an aluminium overbag
• 250 ml solution in a 250 ml flexible polypropylene bag with an aluminium overbag

Dexmedetomidine Hikma 8 micrograms/ml:

One bag contains 250 ml of solution.

Dexmedetomidine is supplied in:

• 250 ml solution in a 250 ml flexible polypropylene bag with an aluminium overbag

Each polypropylene bag has a single port which is secured with a rotary seal.

Pack sizes:

10 x 50 ml, 10 x 100 ml, 10 x 250 ml

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Hikma Pharmaceuticals (Portugal), S.A.

Estrada do Rio da Mó, 8 A-B – Fervença

2705-906 Terrugem SNT

Portugal

You can obtain further information on this medicine from the local representative of the marketing authorisation holder:

Hikma Spain, S.L.U.

Calle Anabel Segura nº11, Edificio A, planta 1ª, oficina 2

28108 - Alcobendas, Madrid

Spain

This medicine is authorised in the Member States of the European Economic Area under the following names:

Date of last revision of this leaflet: June 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 Hikma 4 micrograms/ml solution for infusion

Dexmedetomidine Hikma 8 micrograms/ml solution for infusion

Method of administration

• Dexmedetomidine Hikma should be administered by healthcare professionals experienced in the management of patients who require intensive care or in the management of anesthesia in patients in the operating room.

• Dexmedetomidine Hikma should not be diluted before use: it is supplied ready for use

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

• It should be administered only as an intravenous infusion using a controlled infusion device.

• Dexmedetomidine should not be administered as a bolus.

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 and 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, 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 suitable.

• 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 date:

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