Patient leaflet - Dexmedetomidine Accord 100 micrograms/ml concentrate for solution for infusion

1. What Dexmedetomidine Accord is and what it is used for

Dexmedetomidine Accord contains an active substance called dexmedetomidine which belongs to a medicine group called sedatives. It is used to provide sedation (a state of calm, drowsiness or sleep) for adult patients in hospital intensive care settings or awake sedation during different diagnostic or surgical procedures.

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

You must not be given Dexmedetomidine Accord

if you are allergic to dexmedetomidine or any of the other ingredients of this medicine (listed in section 6).
if you have some disorders of heart rhythm (heart block grade 2 or 3).
if you have very low blood pressure which does not respond to treatment.
if you have recently had a stroke or other serious condition affecting blood supply to the brain.

Warnings and precautions

Before you have this medicine, tell your doctor or nurse if any of the following apply as

Dexmedetomidine Accord should be used cautiously:

if you have an abnormally slow heart rate (either due to illness or high levels of physical fitness) as it may increase the risk for cardiac arrest
if you have low blood pressure
if you have low blood volume, for example after bleeding
if you have certain heart disorders
if you are elderly
if you have a neurological disorder (for instance head or spinal cord injury or stroke)
if you have severe liver problems
if you have ever developed a serious fever after some medicines, especially anaesthetics

This medicine may cause large amount of urine and excessive thirst, contact a doctor if these side effects occur. See section 4 for more information. An increased mortality risk has been seen for

patients 65 years of age and under when using this medicine, especially for patients admitted to the intensive care unit for other reasons than after surgery with a more severe disease condition on admission to the intensive care unit and with a younger age. The doctor will decide if this medicine is still suitable for you. The doctor will take into account the benefit and risks of this medicine for you, compared to treatment with other sedatives.

Other medicines and Dexmedetomidine Accord

Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines.

The following medicines may enhance the effect of Dexmedetomidine Accord:

medicines that help you sleep or cause sedation (e.g. midazolam, propofol)
strong pain medicines (e.g. opioids such as morphine, codeine)
anaesthetic medicines (e.g. sevoflurane, isoflurane) If you are using medicines which lower your blood pressure and heart rate, co-administration with Dexmedetomidine Accord may enhance this effect. Dexmedetomidine Accord should not be used with medicines that cause temporary paralysis.

Pregnancy and breast-feeding

Dexmedetomidine Accord should not be used during pregnancy or breast-feeding unless clearly necessary.

Ask your doctor for advice before having this medicine

Driving and using machines

Dexmedetomidine Accord has major impact on the ability to drive and use machines. After you have been given Dexmedetomidine Accord you must not drive, operate machinery, or work in dangerous situations until the effects are completely gone. Ask your doctor when you can start doing these activities again and when you can go back to this kind of work.

Excipients

Dexmedetomidine Accord contains less than 1 mmol sodium (23 mg) per ml, that is to say essentially ‘sodium-free’.

3. How to use Dexmedetomidine Accord

Hospital intensive care

Dexmedetomidine Accord is administered to you by a doctor or nurse in hospital intensive care.

Procedural sedation/awake sedation

Dexmedetomidine Accord is administered to you by a doctor or a nurse prior to and/or during diagnostic or surgical procedures requiring sedation, i.e. procedural/awake sedation.

Your doctor will decide on a suitable dose for you. The amount of Dexmedetomidine Accord depends on your age, size, general condition of health, the level of sedation needed and how you respond to the medicine. Your doctor may change your dose if needed and will monitor your heart and blood pressure during the treatment.

Dexmedetomidine Accord is diluted and it is given to you as an infusion (drip) into your veins.

After sedation/wake-up

The doctor will keep you under medical supervision for some hours after the sedation to make sure that you feel well.
You should not go home unaccompanied.
Medicines to help you sleep, cause sedation or strong painkillers may not be appropriate for some time after you have been given Dexmedetomidine Accord. Talk to your doctor about the use of these medicines and about the use of alcohol.

The following information is intended for healthcare professionals only:

Dexmedetomidine Accord 100 micrograms/ml concentrate for solution for infusion

Method of administration

Dexmedetomidine Accord 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 Accord can be diluted in glucose 50 mg/ml (5%), Ringers, mannitol 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.

In the case the required concentration is 4 micrograms/ml:

Volume of Volume of Total volume Dexmede- diluent of infusion tomidine Accord

100 micrograms/ml concentrate for solution for

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 the case the required concentration is 8 micrograms/ml:

Volume of Volume of Total Dexmede- diluent volume of tomidine Accord infusion 100 micrograms/ml

concentrate for solution for 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

INP112 10 4844 1 6018826 If you have been given more Dexmedetomidine Accord than you should

If you are given too much Dexmedetomidine Accord, your blood pressure may go up or down, your heartbeat may slow down, 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 stopping breathing.

Common (may affect up to 1 in 10 people)

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 (may affect up to 1 in 100 people)

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)

large amount of urine and excessive thirst – may be symptoms of a hormonal disorder called diabetes insipidus. Contact a doctor if these occur.

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 via Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Dexmedetomidine Accord

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. Keep the vials in the outer carton in order to protect from light.

After dilution

Chemical and physical in-use stability has been demonstrated for 72 hours at 25°C and 2° to 8°C.

From a microbiological point of view, 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 and would not normally be longer than 24 hours at 2° to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.

Do not use this medicine if you notice discoloration or visible particles.

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 Accord contains

The active substance is dexmedetomidine. Each ml of concentrate contains dexmedetomidine hydrochloride equivalent to 100.0 micrograms dexmedetomidine.
The other ingredients are sodium chloride and water for injections.

Each 2 ml vial contains 200 micrograms of dexmedetomidine (as hydrochloride). Each 4 ml vial contains 400 micrograms of dexmedetomidine (as hydrochloride). Each 10 ml vial contains 1000 micrograms of dexmedetomidine (as hydrochloride).

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

What Dexmedetomidine Accord looks like and contents of the pack

Concentrate for solution for infusion (sterile concentrate).

The concentrate is a clear, colourless solution.

Containers

2, 6 or 10 ml glass vials

Pack sizes

1 x 2 ml vial

4 x 2 ml vials

5 x 2 ml vials

25 x 2 ml vials

1 x 4 ml vial

4 x 4 ml vials

5 x 4 ml vials

1 x 10 ml vial

4 x 10 ml vials

5 x 10 ml vials

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Accord Healthcare Limited

Sage House, 319 Pinner Road

North Harrow, Middlesex, HA1 4HF

United Kingdom

Manufacturer:

Accord Healthcare Limited,

Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF,

United Kingdom

Accord Healthcare Polska Sp.z o.o.

ul. Lutomierska 50,

95-200 Pabianice

Poland

Laboratori Fundació Dau

C/ C, 12-14 Pol. Ind.

Zona Franca, Barcelona, 08040,

Spain

Accord Healthcare B.V.

Winthontlaan 200, 3526KV Utrecht

Netherlands

This leaflet was last revised in 11/2022.

The solution should be shaken gently to mix well. Dexmedetomidine Accord should be inspected visually for particulate matter and discoloration prior to administration.

Dexmedetomidine Accord 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 or coated natural rubber gaskets.

Shelf life