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 or nurse. This also applies to any side effects not mentioned in this information. See section 4.

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

What Dexmedetomidine Teva is and what it is used for

Dexmedetomidine Teva 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.

Dexmedetomidine contained in Dexmedetomidine Teva 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 take Dexmedetomidine Teva

You should not receive Dexmedetomidine Teva:

  • 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 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 Teva 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 Teva

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 Teva:

  • drugs that help you sleep or lead to sedation (eg midazolam, propofol)
  • strong painkillers (eg opioids such as morphine, codeine )
  • anesthesia drugs (eg sevoflurane, isoflurane)

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

Pregnancy and breastfeeding

Dexmedetomidine Teva should not be used during pregnancy or lactation unless clearly necessary.

Consult a physician before receiving this medicine.

Driving and using machines

Dexmedetomidine Teva has a major influence on the ability to drive and use machines. Once you have received Dexmedetomidine Teva, 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 and when you can return to this type of work.

Dexmedetomidine Teva contains sodium

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

How to use Dexmedetomidine Teva

Intensive care in hospitals

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

Vigilant sedation

Dexmedetomidine Teva 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 Dexmedetomidine Teva depends on your age, body weight, general health, sedation level 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 Teva 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.
  • Medicines that help you sleep, have sedatives or strong painkillers may be inappropriate for some time after you receive Dexmedetomidine. Talk to your doctor about the use of these drugs and the use of alcohol.

If you take more Dexmedetomidine Teva then you should

If you take more Dexmedetomidine Teva 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.

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 1,000 users):

  • impaired cardiac function, cardiac arrest
  • swollen abdomen
  • thirst
  • a condition when there is too much acid in the body (metabolic acidosis )
  • low albumin level 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

5. How to store Dexmedetomidine Teva

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 vial and carton label after EXP. The expiration date is the last day of the specified month.

No special storage instructions.

After dilution

Chemical and physical in-use stability has been demonstrated for 24 hours at 25 ° C.

From a microbiological point of view, the product should be used immediately, unless the method of opening/dilution excludes the risk of microbial contamination. If the product is not used immediately, the storage time and circumstances before use are the responsibility of the user.

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 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 provided in a vial with a rubber stopper and a cap.

Pack sizes

1 x 2 ml vial

5 x 2 ml vials

25x 2 ml vials

4 x 4 ml vials

4 x 10 ml vials

Not all pack sizes may be marketed.

Manufacturer

Teva Pharma BV

Swensen 5, Haarlem,

2031GA, The Netherlands

PLIVA Hrvatska doo (PLIVA Croatia Ltd.)

Prilaz baruna Filipovića 25, Zagreb, 10000, Croatia

Muhammad Nadeem

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