Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - dexdor

Document Subject

Generated Narrative: MedicinalProductDefinition mp9875a9482c2e354f3a12ea545ebc4f3b

identifier: http://ema.europa.eu/identifier/EU/1/11/718/001-002, EU/1/11/718/004, EU/1/11/718/006-007

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Dexdor 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

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-9875a9482c2e354f3a12ea545ebc4f3b

identifier: http://ema.europa.eu/identifier/EU/1/11/718/001-002, EU/1/11/718/004, EU/1/11/718/006-007

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - dexdor

Attesters

What is in this leaflet:

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

Dexdor 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 Dexdor

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 Dexdor 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 Dexdor 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 Dexdor:

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 Dexdor may enhance this effect. Dexdor should not be used with medicines that cause temporary paralysis. Pregnancy and breast-feeding Dexdor 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 Dexdor has major impact on the ability to drive and use machines. After you have been given Dexdor 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 Dexdor contains less than 1 mmol sodium (23 mg) per ml, that is to say essentially sodium-free .

Hospital intensive care Dexdor is administered to you by a doctor or nurse in hospital intensive care. Procedural sedation/awake sedation Dexdor 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 Dexdor 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. Dexdor 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 Dexdor. Talk to your doctor about the use of these medicines and about the use of alcohol. If you have been given more Dexdor than you should If you are given too much Dexdor, 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 ampoules or vials in the outer carton in order to protect from light.

What Dexdor contains

The active substance is dexmedetomidine. Each ml of concentrate contains dexmedetomidine hydrochloride equivalent to 100 micrograms dexmedetomidine.

The other ingredients are sodium chloride and water for injections. Each 2 ml ampoule contains 200 micrograms of dexmedetomidine (as hydrochloride). 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 Dexdor looks like and contents of the pack Concentrate for solution for infusion (sterile concentrate). The concentrate is a clear, colourless solution. Containers 2 ml glass ampoules 2, 5 or 10 ml glass vials Pack sizes 5 x 2 ml ampoules 25 x 2 ml ampoules 5 x 2 ml vials 4 x 4 ml vials 4 x 10 ml vials Not all pack sizes may be marketed. Marketing Authorisation Holder Orion Corporation Orionintie 1 FI-02200 Espoo Finland Manufacturer Orion Corporation Orion Pharma Orionintie 1 FI-02200 Espoo Finland For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: Belgi /Belgique/Belgien Luxembourg/Luxemburg Orion Pharma BVBA/SPRL T l/Tel: +32 (0)15 64 10 Nederland Orion Pharma BVBA/SPRL Tel: +32 (0)15 64 10 Danmark Orion Pharma A/S Tlf: +45 8614 00 esk republika Orion Pharma s.r.o. Tel: +420 234 703 Eesti Orion Pharma Eesti O Tel: +372 6 644 Deutschland sterreich Orion Pharma GmbH Tel: + 49 40 899 6Espa a Orion Pharma S.L. Tel: + 34 91 599 86
Orion Pharma Hellas M.E. .E : + 30 210 980 3Ireland Orion Pharma (Ireland) Ltd. Tel: + 353 1 428 7France Orion Pharma T l: +33 (0) 1 85 18 00 Italia Orion Pharma S.r.l. Tel: + 39 02 67876 sland Vistor hf. Simi: +354 535 7Latvija Orion Corporation Orion Pharma p rst vniec ba Tel: +371 20028 Lifepharma (ZAM) Ltd .: +357 22056Magyarorsz g Orion Pharma Kft. Tel.: +36 1 239 9Lietuva UAB Orion Pharma Tel: +370 5 276 9Polska Orion Pharma Poland Sp. z.o.o. Tel.: + 48 22 8 333 Norge Orion Pharma AS Tlf: + 47 4000 4Slovenija Orion Pharma d.o.o. Tel: +386 (0) 1 600 8Portugal Orionfin Unipessoal Lda Tel: + 351 21 154 68 Suomi/Finland Orion Corporation Puh/Tel: + 358 10 4 Orion Pharma Poland Sp. z.o.o. Hrvatska PHOENIX Farmacija d.o.o. .: + 48 22 8 333 Tel: +385 1 6370Malta Orion Corporation Tel: + 358 10 4Rom nia Orion Corporation Tel: + 358 10 4Slovensk republika Orion Pharma s.r.o. Tel: +420 234 703 United Kingdom (Northern Ireland): Orion Pharma (Ireland) Ltd. Tel: +353 1 428 7Sverige Orion Pharma AB Tel: + 46 8 623 6This leaflet was last revised in Detailed information on this medicine is available on the European Medicines Agency web site: