DEXMEDETOMIDINE HIKMA 100 micrograms/ml concentrate for infusion solution

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 less when using this medicine, especially in patients admitted to the intensive care unit for reasons other than postoperative care, with more severe disease at admission to the intensive care unit and with 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:

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before you are given this medicine.

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

Driving and using machines

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

Once you have been given dexmedetomidine, 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.

Excipients

Dexmedetomidine Hikma contains sodium

Dexmedetomidine Hikma contains less than 1 mmol of sodium (23 mg) per vial; this is essentially “sodium-free”.

3. How to use Dexmedetomidine Hikma

Intensive care in hospitals

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

Procedural sedation/conscious sedation

Dexmedetomidine 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 on the right dose for you. The amount of dexmedetomidine 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 is diluted and given to you as an infusion (drip) in 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 intense pain may not be recommended for a period of time after treatment with dexmedetomidine. 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, 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 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 (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 in which 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. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines and Healthcare Products Agency (AEMPS) website: 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.

Do not use this medicine after the expiry date which is stated on the carton and on the label after “EXP”. The expiry date refers to the last day of the month shown.

This medicine does not require any special storage conditions.

After dilution

Chemical and physical stability has been demonstrated for 24 hours at 25°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 normally should not exceed 24 hours between 2° and 8°C, unless the dilution has taken place in controlled and validated aseptic conditions.

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

6. Contents of the pack and other information

Composition of Dexmedetomidine Hikma

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

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

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

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

Appearance and pack

Concentrate for solution for infusion (sterile concentrate).

The concentrate is a clear and colourless solution.

Pack

2 ml glass vials type I

Pack sizes

5 vials of 2 ml

25 vials of 2 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 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 and in the United Kingdom (Northern Ireland) under the following names:

Germany: Dexmedetomidin Hikma 100 Mikrogramm/ml Konzentrat zur Herstellung einer Infusionslösung

Austria: Dexmedetomidin Hikma 100 Mikrogramm/ml Konzentrat zur Herstellung einer Infusionslösung

Spain: Dexmedetomidina Hikma 100 microgramos/ml concentrado para solución para perfusión EFG

France: DEXMEDETOMIDINE HIKMA 100 microgrammes/mL, solution à diluer pour perfusion

Italy: Dexmedetomidina Hikma

Netherlands: Dexmedetomidine Hikma 100 microgram/ml concentraat voor oplossing voor infusie

Portugal: Dexmedetomidina Hikma

United Kingdom:Dexmedetomidine 100 micrograms/ml concentrate for solution for infusion

Date of last revision of this leaflet: December 2023

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

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This information is intended only for healthcare professionals:

Dexmedetomidine Hikma 100 micrograms/ml concentrate for solution for infusion EFG

Method of administration

Dexmedetomidine Hikma should be administered by healthcare professionals experienced in the management of patients requiring intensive care or anaesthetic management in patients in the operating room. It should be administered only as an intravenous infusion diluted using a controlled infusion device.

Preparation of the solution

Dexmedetomidine Hikma can be diluted in glucose 50 mg/ml (5%) injection solution, Ringer's solutions, mannitol or sodium chloride 9 mg/ml (0.9%) to achieve the required concentration of 4 micrograms/ml or 8 micrograms/ml before administration. See the table below for the volumes required 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 Hikma should be visually inspected for particles and discoloration before administration.

It has been demonstrated that dexmedetomidine is compatible when administered with the following intravenous fluids and medicines:

Ringer's lactate, glucose 5% solution, sodium chloride 9 mg/ml (0.9%) injection solution, mannitol 200 mg/ml (20%), thiopental sodium, etomidate, vecuronium bromide, pancuronium bromide, succinylcholine, atracurium besylate, mivacurium chloride, rocuronium bromide, glycopyrrolate, phenylephrine HCl, atropine sulfate, dopamine, noradrenaline, dobutamine, midazolam, morphine sulfate, fentanyl citrate and a plasma substitute.

Compatibility studies have shown potential for adsorption of dexmedetomidine to some types of natural rubber. Although dexmedetomidine is dosed to effect, it is recommended to use components with synthetic or coated natural rubber gaskets.

Shelf life

Chemical and physical stability has been demonstrated for 24 hours at 25°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 normally should not exceed 24 hours between 2° and 8°C, unless the dilution has taken place in controlled and validated aseptic conditions.