100 micrograms / ml concentrate for solution for infusion dexmedetomidine

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

– Save this information, you may need to read it again.

– If you have any further questions, ask your doctor or healthcare professional.

– If you get any side effects, talk to your doctor. This also applies to any side effects not mentioned in this information.

This leaflet contains information about: 
1. What Dexdor is and what it is used for 
2. What you need to know before you use Dexdor 
3. How to use Dexdor 
4. Possible side effects 
5. How to store Dexdor 
6. Contents of the packaging and other information 

1. What Dexdor is and what it is used for

Dexdor contains an active substance called dexmedetomidine which belongs to a group of medicines called sedatives. It is used to provide sedation (a state of calm, drowsiness, or sleep) in adult patients in intensive care units in hospitals or awake sedation during diagnostic or surgical procedures.

2. What you need to know before using Dexdor

Do not use Dexdor

You should not get Dexdor

– if you are allergic to dexmedetomidine or any of the other ingredients of this medicine (listed in section 6).

– if you have any disturbances in your heart rhythm (Atrioventricular block grade II or III, unless you are pacemaker-treated).

– if you have very low blood pressure that does not respond to treatment.

– if you have recently had a stroke or any other serious condition that affects blood flow to the brain.

Warnings and cautions

Before you take this medicine, talk to your doctor or nurse if any of the following apply as Dexdor should be used with caution:

– if you have an unusually low heart rate (either due to illness or due to good physical condition) as it may increase the risk of cardiac arrest

– if you have low blood pressure

– if you have low blood volume, for example after bleeding

– if you have some heart problems

– if you are older

– if you have a neurological injury (for example, head injury, spinal cord injury, or stroke )

– if you have severe liver disease

– if you have ever had a severe fever after taking any medicine, especially in connection with anesthesia ( anesthesia )

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 increase the effect of Dexdor:

– medicines that help you sleep or lead to sedation (eg midazolam, propofol)

– strong painkillers (eg opioids such as morphine, codeine )

– anesthetic drugs (eg sevoflurane, isoflurane)

If you are taking medicines that lower your blood pressure and your heart rate, concomitant use of Dexdor may increase these effects. Dexdor should not be used with medicines that, in connection with anesthesia, provide temporary muscle relaxation (muscle relaxants).

Pregnancy, breastfeeding, and fertility

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

Talk to your doctor before using this medicine.

Driving and using machines

Dexdor has a major impact on the ability to drive and use machines. Once you have received Dexdor, you must not drive, use machines, or work in dangerous situations until the effect is completely gone. Ask your doctor when you can start these activities again.

Dexdor contains sodium

Dexdor contains less than 1 mmol sodium (23 mg) per ml, ie essentially ‘sodium-free’.

3. How to use Dexdor

Intensive care in hospitals

Dexdor is given to you by a doctor or nurse in an intensive care unit of a hospital.

Vigilant sedation

Dexdor is administered to you by a doctor or nurse before and/or during diagnostic or surgical procedures that require sedation, ie awake sedation.

Your doctor will determine the appropriate dose for you. The amount of Dexdor depends on your age, body weight, general health, needed sedation level, and how you respond to treatment. Your doctor may change your dose if necessary and will monitor your heart and blood pressure during treatment.

Dexdor is diluted and given to you as an infusion (drip) into a blood vessel.

After sedation/awakening

  • Your doctor will keep you under medical supervision for a few hours after sedating you to make sure you are well.
  • You should not go home alone.
  • Medications that help you sleep, have sedatives or strong painkillers may be inappropriate for some time after you receive Dexdor. Talk to your doctor about the use of these drugs and the use of alcohol.

If you use more Dexdor than you should  

If you have been given too much Dexdor, your blood pressure may increase or decrease, your heart rate may drop, you may breathe more slowly and you may feel drowsy. Your doctor will know how to treat you based on your condition.

If you have any further questions on the use of this product, ask your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Very common (affects more than 1 patient in 10)

– low heart rate

– low or high blood pressure

change in breathing patterns or pauses in breathing.

Common (affects more than 1 patient in 100 but less than 1 in 10 patients)

– chest pain or heart attack

– high heart rate

low or high blood sugar

nausea, vomiting, or dry mouth

restlessness

high body temperature

symptoms after stopping the medicine.

Uncommon (affects more than 1 in 1,000 patients but less than 1 in 100 patients)

– impaired heart function, cardiac arrest

– swollen abdomen

– thirst

– a condition when there is too much acid in the body (so-called metabolic acidosis )

– low albumin levels in the blood

– shortness of breath

– hallucinations

– that the drug is not effective enough.

Has been reported (occurs in an unknown number of users): 

need to empty the bladder more often than usual.

Reporting of side effects ar

If you get any side effects, talk to your doctor or nurse. This also applies to side effects that are not mentioned in this information. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help increase drug safety information.

5. How to store Dexdor

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 after “EXP” and the carton after “EXP”.

No special temperature instructions. Store the ampoules or vials in the outer carton. Sensitive to light.

6. Contents of the packaging and other information

Content declaration

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

– The other ingredients are sodium chloride and water for injections.

One 2 ml ampoule contains 200 micrograms dexmedetomidine (as hydrochloride).

One 2 ml vial contains 200 micrograms of dexmedetomidine (as hydrochloride).

One 4 ml vial contains 400 micrograms of dexmedetomidine (as hydrochloride).

One 10 ml vial contains 1000 micrograms of dexmedetomidine (as hydrochloride).

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

What the medicine looks like and the contents of the pack

Concentrate for solution for infusion (sterile concentrate).

The concentrate is a clear, colorless solution.

Packaging:

2 ml ampoule is made of glass

2, 5, or 10 ml glass vials

Pack sizes:

5 x 2 ml ampoule is

25 x 2 ml ampoule is

5 x 2 ml vials

4 x 4 ml vials

4 x 10 ml vials

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

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 Authorization Holder

Belgium / Belgique / BelgienLuxembourg / LuxemburgOrion Pharma BVBA / SPRLTel: +32 (0) 15 64 10 20

The NetherlandsOrion Pharma BVBA / SPRLTel: +32 (0) 15 64 10 20
DenmarkOrion Pharma A / STel: +45 8614 00 00
 Czech RepublicOrion Pharma sroTel: +420 234 703 305 EestiOrion Pharma Eesti Oü Tel: +372 6 644 550
Germany AustriaOrion Pharma GmbHTel: + 49 40 899 6890 SpainOrion Pharma SLTel: + 34 91 599 86 01
GreeceOrion Pharma Hellas MEΠ.E:Ηλ: + 30 210 980 3355 IrelandOrion Pharma (Ireland) Ltd.Tel: + 353 1 428 7777
FranceCenter for Pharmaceutical SpecialtiesTel: + 33 (0) 1 47 04 80 46
ItalyOrion Pharma SrlTel: + 39 02 67876111
IcelandVistor hf.Phone: +354 535 7000
LatviaOrion Corporation in LatviaTel: + 371 6745 5569
ΚύπροςLifepharma (ZAM) Ltd.:Ηλ .: +357 22347440 HungaryOrion Pharma Kft.Tel .: +36 1 239 9095
LithuaniaUAB Orion PharmaTel: +370 5 276 9499 PolandOrion Pharma Poland Sp. ZooTel .: + 48 22 8 333 177
NorwayOrion Pharma ASTel: + 47 4000 4210 SloveniaOrion Pharma doo 
Tel: +386 (0) 1 600 8015
PortugalOrionfin Unipessoal LdaTel: + 351 21 154 68 20  Finland / FinlandOrion CorporationPuh / Tel: + 358 10 4261
BulgariaOrion CorporationTel: + 358 10 4261
CroatiaPHOENIX Pharmacy dooTel: +385 1 6370450
MaltaOrion CorporationTel: + 358 10 4261
RomaniaOrion CorporationTel: + 358 10 4261


Muhammad Nadeem

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