DEXMEDETOMIDINE HIKMA

Package leaflet: Information for the user

Dexmedetomidine Hikma 100 micrograms/mL concentrate for solution for infusion

dexmedetomidine
Equivalent medicine
Please 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 questions, ask your doctor or nurse.
• If you get any side effects, including those not listed in this leaflet, tell your doctor or nurse. See section 4.

Contents of this leaflet:

1. What Dexmedetomidine Hikma is and what it is used for
2. What you need to know before using Dexmedetomidine Hikma
3. How to use Dexmedetomidine Hikma
4. Possible side effects
5. How to store Dexmedetomidine Hikma
6. Contents of the pack and other information

1. What Dexmedetomidina Hikma is and what it is used for

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

2. What you need to know before using Dexmedetomidina Hikma

Dexmedetomidina Hikma must not be administered 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 another serious condition affecting blood flow to the brain.

Warnings and precautions
Before being treated with this medicine, inform your doctor or nurse if any of the following apply to you, as Dexmedetomidina Hikma should be used with caution:

• if you have a slower than normal heart rate (due to either illness or high levels of 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 suffer from heart disorders
• if you are elderly
• if you suffer from a neurological disorder (e.g. head injury, spinal cord injury, or stroke)
• if you have severe liver problems
• if you have ever developed a severe fever after taking certain medicines, particularly anesthetics.

This medicine may cause excessive urination and excessive thirst. Contact a doctor if you experience these side effects. See section 4 for more information.
An increased risk of mortality has been observed in patients aged 65 years or younger during use of this medicine, particularly in patients admitted to intensive care units for reasons other than surgery, who had a more severe illness at admission and were younger in age. Your doctor will decide whether this medicine is still appropriate for you. Your doctor will weigh the benefits and risks of this medicine for you compared to treatment with other sedatives.

Other medicines and Dexmedetomidina Hikma
Inform your doctor or nurse if you are taking, have recently taken, or might take any other medicines.
The following medicines may increase the effect of Dexmedetomidina Hikma:

• 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 blood pressure and heart rate, concomitant administration of Dexmedetomidina Hikma may enhance this effect.
Dexmedetomidina Hikma must not be used with other medicines that cause temporary paralysis.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor before using this medicine.
Dexmedetomidina Hikma must not be used during pregnancy or breastfeeding unless strictly necessary.

Driving and using machines
Dexmedetomidina Hikma has a major impact on the ability to drive and use machinery.
After receiving Dexmedetomidina Hikma, you must not drive, operate machinery, or work in hazardous situations until the effects have completely worn off. Ask your doctor when you can resume these activities and return to such work.

Dexmedetomidina Hikma contains sodium
Dexmedetomidina Hikma contains less than 1 mmol of sodium (23 mg) per vial, i.e. essentially “sodium-free”.

3. How to use Dexmedetomidina Hikma

Hospital intensive care therapy
Dexmedetomidina Hikma is administered to you by a doctor or nurse in an intensive care setting within a hospital.

Procedural sedation / conscious sedation
Dexmedetomidina Hikma is administered to you by a doctor or nurse before and/or during diagnostic or surgical procedures requiring sedation, i.e. procedural/conscious sedation.

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

Dexmedetomidina Hikma is diluted and administered to you as an intravenous infusion (intravenous drip).

After sedation / recovery

• The doctor will monitor you for several hours after sedation to ensure you are feeling well.
• You must not go home unaccompanied.
• Medicines that help you sleep, cause sedation, or strong painkillers may not be appropriate for a certain period of time after receiving Dexmedetomidina Hikma. Talk to your doctor about the use of these medicines and about alcohol consumption.

If you are given more Dexmedetomidina Hikma than you should have
If you are given too much Dexmedetomidina Hikma, your blood pressure may increase or decrease, your heart rate may slow down, you may breathe more slowly, and you may feel more drowsy. The doctor will know how to treat you based on your condition.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

Very common (may affect more than 1 in 10 people)

• Slowing of heart rate
• Low or high blood pressure
• Changes in breathing pattern or respiratory arrest

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
• Agitation
• High body temperature
• Symptoms of medicine withdrawal

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 level of albumin in the blood
• Shortness of breath
• Hallucinations
• Medicine not effective enough

Not known (frequency cannot be estimated from the available data)

• Large amounts of urine and excessive thirst may be symptoms of a hormonal disorder called diabetes insipidus. Contact a doctor if you experience these effects.

Reporting of side effects
If you get any side effects, including any not listed in this leaflet, talk to your doctor or nurse.
You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Dexmedetomidine Hikma

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after Exp. The expiry date refers to the last day of that month.
This medicine requires no special storage conditions.

After dilution
Chemical and physical in-use stability has been demonstrated for 24 hours at 25°C.
From a microbiological standpoint, the product should be used immediately. If not used immediately, the duration and conditions of storage prior to use are the responsibility of the user and should normally not exceed 24 hours at a temperature of 2° to 8°C, unless dilution has taken place under controlled and validated aseptic conditions.

Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Package contents and other information

What Dexmedetomidine Hikma contains

• 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 excipients are sodium chloride and water for injections.

The concentration of the final solution after dilution must be 4 micrograms/mL or
8 micrograms/mL.
Description of the appearance of Dexmedetomidine Hikma and contents of the pack
Concentrate for solution for infusion (sterile concentrate).
The concentrate is a clear, colourless solution.
Containers
Type I glass vials of 2 mL
Pack sizes
5 vials of 2 mL
25 vials of 2 mL
Not all pack sizes may be marketed.
Marketing Authorization Holder:
Hikma Farmacêutica (Portugal), S.A.
Estrada do Rio da Mó n.º 8, 8A and 8B – Fervença
2705-906 Terrugem SNT
Portugal
Manufacturer:
Hikma Farmacêutica (Portugal), S.A.
Estrada do Rio da Mó n.º 8, 8A and 8B – Fervença
2705-906 Terrugem SNT
Portugal
This medicinal product is authorized in the European Economic Area Member States and in the United Kingdom
under the following names:

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The following information is intended exclusively for healthcare professionals:
Dexmedetomidine Hikma 100 micrograms/mL concentrate for solution for infusion
Route of administration
Dexmedetomidine Hikma must be administered by healthcare professionals specialised in the management of
patients requiring intensive care or in anaesthetic management of patients in the operating room.
It must be administered only as a diluted intravenous infusion using a controlled infusion device.
Preparation of the solution
Dexmedetomidine Hikma must be diluted with glucose 50 mg/mL (5%), Ringer, mannitol or sodium chloride 9 mg/mL (0.9%) injection solution to achieve the required concentration of 4 micrograms/mL or 8 micrograms/mL prior to administration. Please see the table below for the volumes required to prepare the infusion.
When the required concentration is 4 micrograms/mL:

In the case where the required concentration is 8 micrograms/mL:

The solution should be gently shaken to ensure thorough mixing.
Dexmedetomidine Hikma must be inspected visually for the presence of particles and discoloration before administration.
Dexmedetomidine Hikma is compatible when administered with the following intravenous fluids and the following medicinal products:
Lactated Ringer's, 5% glucose solution, 9 mg/mL (0.9%) sodium chloride injectable solution, mannitol 200 mg/mL (20%), sodium thiopental, etomidate, vecuronium bromide, pancuronium bromide, succinylcholine, atracurium besylate, mivacurium chloride, rocuronium bromide, glycopyrronium bromide, phenylephrine hydrochloride, atropine sulfate, dopamine, noradrenaline, dobutamine, midazolam, morphine sulfate, fentanyl citrate, and plasma substitutes.
Compatibility studies have shown the potential for adsorption of dexmedetomidine onto certain types of natural rubber. Although dexmedetomidine is dosed to achieve the intended effect, it is advisable to use components with synthetic or coated natural rubber stoppers.
Shelf life
Chemical and physical in-use stability has been demonstrated for 24 hours at 25°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 should normally not exceed 24 hours between 2°C and 8°C, unless the dilution has been carried out under controlled and validated aseptic conditions.