DEXMEDETOMIDINE 100 MICROGRAMS / ML CONCENTRATE FOR SOLUTION FOR INFUSION - patient leaflet, side effects, dosage

Date: 18/05/21

2. what you need to know before you are  dexmedetomidine has major impact on the

given Dexmedetomidine ability to drive and use machines. After you

• 3. How to use Dexmedetomidine have been given Dexmedetomidine you

• 4. Possible side effects must not drive, operate machinery, or work

• 5. How to store Dexmedetomidine in dangerous situations until the effects are

• 6. Contents of the pack and other completely gone. Ask your doctor when you

information can start doing these activities again and

when you can go back to this kind of work.

• 1. What Dexmedetomidine is and what

it is used for                        3. How to use Dexmedetomidine

Dexmedetomidine contains an active Hospital intensive care

substance called dexmedetomidine which Dexmedetomidine is administered to you by

belongs to a medicine group called a doctor or nurse in hospital intensive care.

sedatives. It is used to provide sedation (a

state of calm, drowsiness or sleep) for adult Procedural sedation/awake sedation

patients in hospital intensive care settings Dexmedetomidine is administered to you by

or awake sedation during different a doctor or a nurse prior to and/or during

diagnostic or surgical procedures. diagnostic or surgical procedures requiring

sedation, i.e. procedural/awake sedation.

2. what you need to know before you

are given Dexmedetomidine Your doctor will decide on a suitable dose

for you. The amount of Dexmedetomidine You must not be given Dexmedetomidine depends on your age, size, general

• – if you are allergic to dexmedetomidine condition of health, the level of sedation

or any of the other ingredients of this needed and how you respond to the

medicine (listed in section 6). medicine. Your doctor may change your

• – if you have some disorders of heart dose if needed and will monitor your heart

rhythm (heart block grade 2 or 3). and blood pressure during the treatment.

• – if you have very low blood pressure

which does not respond to treatment. Dexmedetomidine is diluted and it is given

• – if you have recently had a stroke or to you as an infusion (drip) into your veins.

other serious condition affecting blood After sedation/wake-up

supply to the brain. – The doctor will keep you under medical

supervision for some hours after the Warnings and precautions sedation to make sure that you feel well.

– You should not go home unaccompanied.

Before you have this medicine, tell your – Medicines to help you sleep, cause

doctor or nurse if any of the following apply sedation or strong painkillers may not

as Dexmedetomidine should be used be appropriate for some time after you

cautiously: have been given Dexmedetomidine.

Talk to your doctor about the use of – if you have an abnormally slow heart these medicines and about the use of

rate (either due to illness or high levels alcohol.

of physical fitness) as it may increase

the risk for cardiac arrest If you have been g iven more

• – if you have low blood pressure Dexmedetomidine than you should

• – if you have low blood volume, for

example after bleeding If you are given too much

• – if you have certain heart disorders Dexmedetomidine, your blood pressure

• – if you are elderly may go up or down, your heartbeat may

• – if you have a neurological disorder (for slow down, you may breathe more slowly

instance head or spinal cord injury or and you may feel more drowsy. Your doctor

stroke) will know how to treat you based on your

• – if you have severe liver problems condition.

• – if you have ever developed a serious If h fth ti th

If you have any further questions on the use fever after some medicines, especially of this medicine, ask your doctor.

anaesthetics ,

4. possible side effects

Other medicines and Dexmedetomidine

Tell your doctor or nurse if you are taking, Like all medicines, this medicine can cause

have recently taken or might take any other side effects, although not everybody gets medicines. them.

The following medicines may enhance the Very common (affects more than 1 user in 10 ) effect of Dexmedetomidine: – slow heart rate

• – medicines that help you sleep or cause – low or high blood pressure

sedation (e.g. midazolam, propofol) – change in breathing pattern or stopping

breathing

The following information is intended for In case the required concentration is 4 healthcare professionals only: micrograms/ml:

Dexmedetomidine 100 micrograms/ml concentrate for solution for infusion

Method of administration

Dexmedetomidine 100 micrograms/ml concentrate for solution for infusion should be administered by healthcare professionals skilled in the management of patients requiring intensive care or in the 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 solution

Dexmedetomidine 100 micrograms/ml concentrate for solution for infusion can be diluted in glucose 50 mg/ml (5%), lactated ringers, mannitol 200 mg/ml (20%) or sodium chloride 9 mg/ml (0.9%) solution for injection to achieve the required concentration of either 4 micrograms/ml or 8 micrograms/ml prior to administration. Please see below in tabulated form the volumes needed to prepare the infusion.

Volume of Dexmedetomidine 100 micrograms/ml concentrate for solution for infusion

Volume of diluent

Total volume of infusion

2 ml

48 ml

50 ml

4 ml

96 ml

100 ml

10 ml

240 ml

250 ml

20 ml

480 ml

500 ml

In case the required concentration is 8 micrograms/ml:

Volume of Dexmedetomidine 100 micrograms/ml concentrate for solution for infusion

Volume of diluent

Total volume of infusion

4 ml

46 ml

50 ml

8 ml

92 ml

100 ml

20 ml

230 ml

250 ml

40 ml

460 ml

500 ml

The solution should be shaken gently to mix well.

Common (affects 1 to 10 users in 100 )

• – chest pain or heart attack

• – fast heart rate

• – low or high blood sugar

• – nausea, vomiting or dry mouth

• – restlessness

• – high temperature

• – symptoms after stopping the medicine

Uncommon (affects 1 to 10 users in 1,000) – reduced heart function, cardiac arrest

• – swelling of the stomach

• – thirst

• – a condition where there is too much acid

in the body

• – low albumin level in blood

• – shortness of breath

• – hallucinations

• – the medicine is not effective enough.

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

• – increased need to pass urine

Reporting of side effects

If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine.

Ireland

HPRA Pharmacovigilance

Website:

United Kingdom

Yellow Card Scheme

Website: or search for MHRA Yellow Card in the Google Play or Apple App Store

5. how to store dexmedetomidine

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 temperature storage conditions.

After dilution

Chemical and physical in-use stability has been demonstrated for 24 hours at 25°C.

From a microbiological point of view, unless the method of dilution precludes the risk of microbiological contamination, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to the use are the responsibility of the user.

Do not refrigerate.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. contents of the pack and other information

What Dexmedetomidine contains

• – The active substance is dexmedetomidine. Each ml of concentrate contains dexmedetomidi ne hydrochloride equiva lent to 100 micrograms dexmedetomidine.

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

What Dexmedetomidine looks like and contents of the pack

Concentrate for solution for infusion (sterile concentrate).

Dexmedetomidine 100 micrograms/ml concentrate for solution for infusion should be inspected visually for particulate matter and discoloration prior to administration.

Dexmedetomidine 100 micrograms/ml concentrate for solution for infusion has been shown to be compatible when administered with the following intravenous fluids and medicinal products:

Lactated Ringers, 5% glucose solution, sodium chloride 9 mg/ml (0.9%) solution for injection, mannitol 200 mg/ml (20%), thiopental sodium, etomidate, vecuronium bromide, pancuronium bromide, succinylcholine, atracurium besylate, mivacurium chloride, rocuronium bromide, glycopyrrolate bromide, 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 advisable to use components with synthetic

The concentrate is a clear, colourless solution.

Container 2 ml glass vials

Pack size 5 × 2 ml vials

Marketing Authorisation Holder

Ireland

Baxter Holding B.V.

Kobaltweg 49, 3542CE Utrecht, Netherlands

United Kingdom

Baxter Healthcare Limited,

Caxton Way,

Thetford,

Norfolk,

IP24 3SE,

United Kingdom

Manufacturer

UAB Norameda

Meistru 8a,

Vilnius, 02189, Lithuania

Bieffe Medital S.p.A

Via Nuova Provinciale

23034 Grosotto (SO)

Italy

This medicinal product is authorised in the Member States of the EEA under the following names:

Netherlands	Dexmedetomidine Baxter 100 microgram/ml concentraat voor oplossing voor infusie
Austria	Dexmedetomidin Baxter 10 Mikrogramm/ml Konzentra zur Herstellung einer Infusionslosung	1400008087 |_____°
Belgium	Dexmedetomidine Baxter 100 microgrammes/ml solution a diluer pour perfusion
Denmark	Dexmedetomidine Baxter
Finland	Dexmedetomidine Baxter 100 mikrog/ml infuusiokonsen­traatti, liuosta varten
France	DEXMEDETOMIDINE BAXTER 100 microgrammes/mL, solution a diluer pour perfusion
Germany	Dexmedetomidin Baxter 100 Mikrogramm/ml Konzentrat zur Herstellung einer Infusionslosung
Greece	Dexmedetomidi­ne/Baxter 100 |jg/ml nuKvo SidAuja Yia napaaKEuq SiaAujarog npog EYXuon
Ireland	Dexmedetomidine 100 micrograms/ml concentrate for solution for infusion
Italy	Dexmedetomidina Baxter
Norway	Dexmedetomidine Baxter
Portugal	Dexmedetomidina Baxter
Spain	Dexmedetomidina Baxter 100 microgramos/ml Concentrado para solution para perfusion EFG
Sweden	Dexmedetomidine Baxter
Cyprus	Dexmedetomidi­ne/Baxter 100 pg/ml nuKvo SidAupa Yia napaoKEuq SiaAuparog npog EYXuon
Luxembourg	Dexmedetomidine Baxter 100 microgram­mes/ml, solution a diluer pour perfusion
United Kingdom	Dexmedetomidine 100 micrograms/ml concentrate for solution for infusion

This leaflet was last revised in 05/2021

or coated natural rubber gaskets.

Shelf life

Chemical and physical in-use stability has been demonstrated for 24 hours at 25°C.

From a microbiological point of view, unless the method of dilution precludes the risk of microbiological contamination, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to the use are the responsibility of the user.

Do not refrigerate.

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