Dexmedetomidine Galenica Senese

Package leaflet: Information for the user

DEXMEDETOMIDINE GALENICA SENESE 100 micrograms/ml concentrate for solution for

infusion
Dexmedetomidine
Generic medicine
Read this leaflet carefully before you are given 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 experience any side effects, including those not listed in this leaflet, tell your doctor. See section 4. Contents of this leaflet:
  1. What DEXMEDETOMIDINE GALENICA SENESE is and what it is used for
  2. What you need to know before you are given DEXMEDETOMIDINE GALENICA SENESE
  3. How to use DEXMEDETOMIDINE GALENICA SENESE
  4. Possible side effects
  5. How to store DEXMEDETOMIDINE GALENICA SENESE
  6. Contents of the pack and other information

1. What DEXMEDETOMIDINE GALENICA SENESE is and what it is used for

DEXMEDETOMIDINE GALENICA SENESE 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 hospitalized in intensive care units or to induce conscious sedation during various diagnostic or surgical procedures.

2. What you need to know before you are given DEXMEDETOMIDINE GALENICA SENESE

DEXMEDETOMIDINE GALENICA SENESE 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 heart block)
• you have very low blood pressure that does not respond to treatment with medicines
• you have recently had a stroke or another serious condition involving reduced blood flow to the brain

Warnings and precautions

Talk to your doctor or nurse before you are treated with this medicine. DEXMEDETOMIDINE GALENICA SENESE should be administered with caution if you have:

• a slower than normal heart rate (either due to illness or high levels of physical fitness), as this may increase the risk of cardiac arrest
• low blood pressure
• low blood volume, for example after bleeding
• heart disorders
• neurological disorders (e.g. head injury, spinal cord injury, or stroke)
• severe liver problems
• a history of developing high fever after taking certain medicines, particularly anaesthetics

This medicine may cause excessive urination and excessive thirst. Contact a doctor if you experience these side effects. See section 4 for further information.

An increased risk of mortality has been observed in patients aged 65 years and younger during use of this medicine, particularly in patients admitted to intensive care units for reasons other than post-surgical care, who have more severe illness at the time of ICU admission and who are relatively younger in age. Your doctor will decide whether this medicine is still appropriate for you. Your doctor will consider the benefits and risks of this medicine for you compared to treatment with other sedatives.

Elderly

This medicine should be administered with caution if you are elderly, as you may be more predisposed to an increased risk of low blood pressure.

Children and adolescents

The safety and efficacy of DEXMEDETOMIDINE GALENICA SENESE in children and adolescents aged between 0 and 18 years have not been established.

Other medicines and DEXMEDETOMIDINE GALENICA SENESE

Tell 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 DEXMEDETOMIDINE GALENICA SENESE:

• medicines that help you sleep or cause sedation (e.g. midazolam, propofol)
• strong painkillers (e.g. opioids such as morphine, codeine)
• anaesthetic medicines (e.g. sevoflurane, isoflurane)

Medicines that help you sleep, cause sedation, or strong painkillers may not be appropriate for a certain period of time after you have been given DEXMEDETOMIDINE GALENICA SENESE. Talk to your doctor about the use of these medicines and about alcohol consumption.

If you are taking medicines that lower blood pressure and heart rate, the concomitant administration of DEXMEDETOMIDINE GALENICA SENESE may enhance this effect.

DEXMEDETOMIDINE GALENICA SENESE must not be used together with other medicines that cause temporary paralysis.

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or nurse before using this medicine.

DEXMEDETOMIDINE GALENICA SENESE: should not be used during pregnancy or breastfeeding unless strictly necessary.

Driving and using machines

DEXMEDETOMIDINE GALENICA SENESE has a major impact on the ability to drive and use machines. After receiving DEXMEDETOMIDINE GALENICA SENESE, do 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.

DEXMEDETOMIDINE GALENICA SENESE contains sodium

DEXMEDETOMIDINE GALENICA SENESE contains less than 1 mmol of sodium (23 mg) per ml and is therefore essentially "sodium-free".

3. How DEXMEDETOMIDINE GALENICA SENESE must be administered to you

This medicine will be administered to you by specialized medical personnel. If you have any doubts, consult your doctor or nurse.

Hospital intensive care
DEXMEDETOMIDINE GALENICA SENESE will be administered to you by a doctor or nurse in a hospital intensive care setting.

Procedural sedation / conscious sedation
DEXMEDETOMIDINE GALENICA SENESE will be administered to you by a doctor or nurse before and/or during diagnostic or surgical procedures requiring sedation, i.e. procedural/conscious sedation.

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

DEXMEDETOMIDINE GALENICA SENESE is diluted and administered to you as an intravenous infusion (intravenous drip).

After sedation / recovery

• Your doctor will keep you under medical observation for several hours after sedation to ensure you feel 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 after you have been given Dexdor. Talk to your doctor about the use of these medicines and about alcohol consumption.

If you are given more DEXMEDETOMIDINE GALENICA SENESE than you should
If you are given too much DEXMEDETOMIDINE GALENICA SENESE, your blood pressure may increase or decrease, your heartbeat may slow down, you may breathe more slowly, and you may feel excessively drowsy. Your doctor will know how to treat you based on your condition. If you have any doubts about the use of this medicine, consult your doctor or nurse.

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 )

• Slowing of the heartbeat
• Low or high blood pressure
• Changes in breathing pattern or respiratory arrest

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

• Chest pain or heart attack
• Fast heartbeat
• Low or high blood sugar levels (blood glucose)
• Nausea, vomiting or dry mouth
• Agitation
• High temperature
• Symptoms due to stopping treatment with the medicine

Uncommon ( may affect from 1 to 10 in 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
• Shortness of breath
• Hallucinations
• The medicine is 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. Consult a doctor if these occur.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or nurse. You can also report side effects directly via the national reporting system at 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 GALENICA SENESE

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 carton after Exp.
This medicine does not require any special storage temperature.
Do not use the vials if they are damaged or broken.

6. Package contents and other information

What DEXMEDETOMIDINE GALENICA SENESE contains

• The active substance is dexmedetomidine. Each ml of concentrate contains dexmedetomidine hydrochloride equivalent to 100 micrograms of dexmedetomidine.
• The excipients are sodium chloride and water for injections. Each 2 ml vial contains 200 micrograms of dexmedetomidine (as hydrochloride). The final concentration of the solution after dilution must be 4 micrograms/ml or 8 micrograms/ml.

Description of the appearance of DEXMEDETOMIDINE GALENICA SENESE and contents of the pack
Concentrate for solution for infusion (sterile concentrate). The concentrate is a clear, colourless solution free from visible particles.
Containers
2 ml glass vials
Pack sizes
5 vials of 2 ml
10 vials of 2 ml
25 vials of 2 ml

Marketing Authorization Holder and Manufacturer
Industria Farmaceutica Galenica Senese S.r.l.
Via Cassia Nord, 351 - 53014 Monteroni d'Arbia (SI), Italy.

The following information is intended exclusively for physicians or healthcare professionals:
DEXMEDETOMIDINE GALENICA SENESE
100 micrograms/ml concentrate for solution for
infusion
dexmedetomidine
Route of administration
DEXMEDETOMIDINE GALENICA SENESE must be administered by healthcare professionals specialized in the management of patients requiring intensive care or in the anesthetic management of patients in the operating room. It must be given only by diluted intravenous infusion, using a controlled infusion device.

Preparation of the solution
DEXMEDETOMIDINE GALENICA SENESE may be diluted with glucose 50 mg/ml (5%), mannitol, or sodium chloride 9 mg/ml (0.9%) injection solutions to obtain 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.

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 mix well.
DEXMEDETOMIDINE GALENICA SENESE must be visually inspected for the presence of
particles and changes in color prior to administration.
Shelf life
Chemical and physical stability in use 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 normally should not exceed 24 hours at 2-8°C, unless the dilution was carried out under controlled and validated aseptic conditions.