Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - dexmedetomidine

Document Subject

Generated Narrative: MedicinalProductDefinition mpe1c7e2c0315603f70cbb39f05dcc6082

identifier: http://ema.europa.eu/identifier/EU/1/19/1418/001-004

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Dexmedetomidine Accord 100 micrograms/ml concentrate for solution for infusion

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

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part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-e1c7e2c0315603f70cbb39f05dcc6082

identifier: http://ema.europa.eu/identifier/EU/1/19/1418/001-004

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - dexmedetomidine

Attesters

What is in this leaflet:

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

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.

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 .

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.

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.

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 the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

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.

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 S.L.U.
World Trade Center,
Moll de Barcelona, s/n,
Edifici Est 6 planta,
08039 Barcelona, Spain

Manufacturer:

Or Accord Healthcare Polska Sp.z o.o. ul. Lutomierska 50,
95-200 Pabianice Poland

Or Laboratori Fundaci Dau C/ C, 12-14 Pol. Ind. Zona Franca, Barcelona, 08040,
Spain

Or Accord Healthcare B.V. Winthontlaan 200, 3526KV Utrecht Netherlands

This leaflet was last revised in {MM/YYYY}.

Detailed information on this medicine is available on the European Medicines Agency web site: