100 micrograms / mL concentrate for infusion solution 
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 nurse.

– If you get any side effects, talk to your doctor. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Dexmedetomidine EVER Pharma is and what it is used for 
2. What you need to know before you use Dexmedetomidine EVER Pharma 
3. How to use Dexmedetomidine EVER Pharma 
4. Possible side effects 
5. How to store Dexmedetomidine EVER Pharma 
6. Contents of the pack and other information 

1. What Dexmedetomidine EVER Pharma is and what it is used for

Dexmedetomidine EVER Pharma 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 during awake sedation during various diagnostic or surgical procedures.

Dexmedetomidine contained in Dexmedetomidine EVER Pharma may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.

What you need to know before you use Dexmedetomidine EVER Pharma

Do not use Dexmedetomidine EVER Pharma

  • 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 the heart rhythm (heart block grade 2 or 3)
  • if you have very low blood pressure that does not respond to treatment
  • if you have recently had a stroke or 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 Dexmedetomidine EVER Pharma 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.

Other medicines and Dexmedetomidine EVER Pharma

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 Dexmedetomidine EVER Pharma:

– medicines that help you sleep or lead to sedation (eg midazolam, propofol) – strong painkillers (eg opioids such as morphine, codeine ) – anesthetic medicines (eg sevoflurane, isoflurane).

If you are taking medicines that lower your blood pressure and heart rate, concomitant use of Dexmedetomidine EVER Pharma may intensify these effects. Dexmedetomidine EVER Pharma should not be used with medicines that provide temporary muscle relaxation (muscle relaxants).

Pregnancy, breastfeeding,g, and fertility

Dexmedetomidine EVER Pharma should not be used during pregnancy or lactation unless necessary.

Talk to your doctor before using this medicine.

Driving and using machines

Dexmedetomidine EVER Pharma has a significant influence on the ability to drive and use machines.

After receiving Dexmedetomidine EVER Pharma, you must not drive, use machines, or work in dangerous situations. Ask your doctor when you can resume these activities and when you can return to this type of work.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Dexmedetomidine EVER Pharma contains excipients

This medicine contains less than 1 mmol (23 mg) sodium per milliliter, ie essentially ‘sodium-free’.

3. How to use Dexmedetomidine EVER Pharma

Intensive care in hospitals

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

Sedation during surgery / vigilant sedation

Dexmedetomidine EVER Pharma is given to you by a doctor or nurse before and/or during diagnostic or surgical procedures that require sedation, e.g. sedation during surgery / vigilant sedation.

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

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

After sedation/awakening

  • Your doctor will monitor you for a few hours after sedation to ensure that you are well.
  • You should not go home without company.
  • Medicines that help you sleep, lead to sedation, or strong painkillers may be inappropriate for some time after you receive Dexmedetomidine EVER Pharma. Talk to your doctor about using these drugs and about alcohol use.

If you take more Dexmedetomidine EVER Pharma then you should

If you take more Dexmedetomidine EVER Pharma than you should, your blood pressure may rise or fall, 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.

If you have ingested too much medicine or if e.g. If a child has inadvertently ingested the medicine, contact a doctor, hospital, or the Poison Information Center (tel. 112) for risk assessment and advice.

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 user in 10 )

  • low heart rate
  • low or high blood pressure
  • change in breathing patterns or pauses in breathing

Common ( may affect up to 1 in 10 people )

Uncommon ( may affect up to 1 in 100 people )

  • a condition when there is too much acid in the body (so-called metabolic acidosis )
  • low albumin level in the blood
  • hallucinations
  • impaired cardiac function, cardiac arrest
  • shortness of breath and temporary respiratory arrest
  • that the drug is not effective enough
  • swollen abdomen
  • thirst

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

  • need to empty the bladder more often than usual

5. How to store Dexmedetomidine EVER Pharma

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.

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

One 10 ml ampoule contains 1,000 micrograms of 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 1,000 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, 5, or 10 ml ampoules of colorless glass

2, 5, or 10 ml colorless glass vials

Pack sizes 

5 x 2 ml ampoule is

25 x 2 ml ampoule is

4 x 4 ml ampoule is

5 x 4 ml ampoule is

4 x 10 ml ampoule is

5 x 10 ml ampoule is

5 x 2 ml vials

4 x 4 ml vials

5 x 4 ml vials

4 x 10 ml vials

5 x 10 ml vials

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

EVER Valinject GmbH

Oberburgau 3

4866 Unterach am Attersee

Austria

Manufacturer

EVER Pharma Jena GmbH

Otto-Schott-Strasse 15

07745 Jena Germany

Information provided by:

FrostPharma AB

Berga Backe 2

182 53 Danderyd

Muhammad Nadeem

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