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, pharmacist, or nurse.

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

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

What Dexmedetomidine Mylan is and what it is used for

Dexmedetomidine Mylan 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 Mylan 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 Mylan

You should not receive Dexmedetomidine Mylan

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

– if you have any disorders of the heart rhythm (Atrioventricular block grade II or III).

– 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 taking this medicine, talk to your doctor or nurse if any of the following apply to you, as Dexmedetomidine Mylan 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 Dexmedetomidine Mylan

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 Mylan:

– 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 heart rate, concomitant use of Dexmedetomidine Mylan may intensify these effects. Dexmedetomidine Mylan should not be used with medicines that provide temporary muscle relaxation ( anesthesia ) during anesthesia (muscle relaxants).

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine. Dexmedetomidine Mylan should not be used during pregnancy or breast-feeding unless clearly necessary.

Driving and using machines

Dexmedetomidine Mylan has a major influence on the ability to drive and use machines. Once you have received Dexmedetomidine Mylan, 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.

Dexmedetomidine Mylan contains sodium

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

3. How to use Dexmedetomidine Mylan

Intensive care in hospitals

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

Vigilant sedation

Dexmedetomidine Mylan 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 Mylan 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 Mylan 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 sedation 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 Mylan. Talk to your doctor about the use of these drugs and the use of alcohol.

If you take more Dexmedetomidine Mylan then you should

If you take more Dexmedetomidine Mylan than you should, 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 or pharmacist.

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 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)

  • impaired cardiac function, cardiac arrest
  • swollen abdomen
  • thirst
  • a condition when there is too much acid in the body (so-called 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.

Reporting of side effects ar

If you get any side effects , talk to your doctor or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly (see details below). By reporting side effects , you can help increase drug safety information.

The Medical Products Agency

Box 26

751 03 Uppsala

5. How to store Dexmedetomidine Mylan

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.

The expiration date is the last day of the specified month.

This medicine does not require any special storage instructions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is dexmedetomidine. 1 ml of concentrate contains dexmedetomidine hydrochloride equivalent to 100 micrograms dexmedetomidine. 
    2 ml of concentrate contains 200 micrograms dexmedetomidine (equivalent to 236 micrograms dexmedetomidine hydrochloride).
  • The other ingredients are sodium chloride and water for injections.

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

Type I glass vials, gray chlorobutyl rubber stopper

Pack sizes

5 x 2 ml vials

25 x 2 ml vials

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Mylan Teoranta

Coill Rua, Inverin, Co.

Galway

Ireland

Muhammad Nadeem

Leave a Reply