DEXMEDETOMIDINE RPH PHARMA 100 micrograms/ml concentrate for infusion solution

Introduction

Package Leaflet: Information for the User

Dexmedetomidine RPH Pharma 100 micrograms/ml concentrate for solution for infusion EFG

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, 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 includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

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

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

Dexmedetomidine RPH 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 calmness, drowsiness or sleep) in adult patients in intensive care units of hospitals or conscious sedation during various diagnostic or surgical procedures.

2. What you need to know before you are given Dexmedetomidine RPH Pharma

You should not be given Dexmedetomidine RPH Pharma

• if you are allergic to dexmedetomidine or any of the other ingredients of this medicine (listed in section 6).
• if you have certain heart rhythm disorders (grade 2 or 3 heart block).
• if you have very low blood pressure that does not respond to treatment.
• if you have recently had a stroke or other severe episodes that affect blood supply to the brain.

Warnings and precautions

Before using this medicine, tell your doctor or nurse if you are in any of the following situations, as dexmedetomidine should be used with caution:

• if you have an abnormally slow heart rate (either due to disease or a high level of physical fitness) 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 certain heart diseases
• if you are elderly
• if you have a neurological disorder (e.g. head or spinal cord injuries or stroke)
• if you have severe liver problems
• if you have ever developed a severe fever after some medicines, especially anesthetics

This medicine may cause a large amount of urine and excessive thirst, contact a doctor if these side effects occur. See section 4 for more information.

A higher risk of mortality has been observed in patients 65 years or younger when using this medicine, especially in patients admitted to the intensive care unit for reasons other than postoperative care, with more severe disease upon admission to the intensive care unit and with younger age. Your doctor will decide if this medicine is still suitable for you. Your doctor will consider the benefits and risks of this medicine for you, compared to treatment with other sedatives.

Other medicines and Dexmedetomidine RPH Pharma

Tell your doctor or nurse if you are using, have recently used or might use any other medicines.

The following medicines may increase the effect of dexmedetomidine:

• medicines that help you sleep or cause sedation (e.g. midazolam, propofol)
• medicines for severe pain (e.g. opioids such as morphine, codeine)
• anesthetic medicines (e.g. sevoflurane, isoflurane)

If you are using medicines that lower your blood pressure and heart rate, taking them with dexmedetomidine may increase this effect. Dexmedetomidine should not be used with medicines that can cause temporary paralysis.

Pregnancy and breastfeeding

Dexmedetomidine should not be used during pregnancy or breastfeeding, unless clearly necessary.

Consult your doctor before using this medicine.

Driving and using machines

Dexmedetomidine has a significant impact on the ability to drive and use machines. Once you have been given dexmedetomidine, you should not drive, operate machines or work in hazardous situations until the effects have passed completely. Consult your doctor when you can resume these activities and this type of work.

Dexmedetomidine RPH Pharma contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per 2 ml ampoule/vial, i.e. essentially sodium-free.

This medicine contains less than 1 mmol of sodium (23 mg) per 4 ml vial, i.e. essentially sodium-free.

This medicine contains 35.1 mg of sodium (main component of table/cooking salt) in each 10 ml vial. This is equivalent to 1.8% of the maximum recommended daily intake of sodium for an adult.

3. How to use Dexmedetomidine RPH Pharma

Intensive care in hospital

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

Procedural sedation / conscious sedation

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

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

Dexmedetomidine is diluted and given to you as an infusion (drip) in your veins.

After sedation/waking up

• Your doctor will keep you under supervision for a few hours after sedation, to make sure you are well.
• You should not go home unless accompanied.
• Medicines that help you sleep, cause sedation and those intended to relieve intense pain may not be recommended for a period of time after treatment with dexmedetomidine. Consult your doctor about the use of these types of medicines and about the use of alcohol.

If you have been given too much Dexmedetomidine RPH Pharma

If you have been given too much dexmedetomidine, your blood pressure may go up or down, your heart beats may be slower, 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 other questions about the use of this medicine, 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 in 10 people)

• slow heart rate
• low or high blood pressure
• change in breathing pattern or breathing stop.

Common(may affect up to 1 in 10 people)

• chest pain or heart attack
• fast heart rate
• low or high blood sugar levels
• nausea, vomiting or dry mouth
• restlessness
• high temperature
• symptoms after stopping the medicine.

Uncommon(may affect up to 1 in 100 people)

• decreased heart function, cardiac arrest
• stomach swelling
• thirst
• a condition in which there is too much acid in the body
• low albumin level in the blood
• difficulty breathing
• hallucinations
• the medicine is not effective enough.

Frequency not known(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 this occurs.

Reporting of side effects

If you experience any side effects, talk to your doctor or nurse, even if it is possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Monitoring System for Human Use: https://www.notificaRAM. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Dexmedetomidine RPH 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.

This medicine does not require any special storage conditions.

After dilution

Chemical and physical stability has been demonstrated for 24 hours at 25°C and 2°C - 8°C.

From a microbiological point of view, the product should be used immediately.

Do not use this medicine if you notice signs of discoloration or visible particles.

The ampoules and vials are intended for use in a single patient.

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

6. Contents of the pack and other information

Composition of Dexmedetomidine RPH Pharma

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

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 4 micrograms/ml or 8 micrograms/ml.

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

Appearance and packaging

Concentrate for solution for infusion (sterile concentrate).

The concentrate is a clear and colorless solution

Packaging

2 ml glass ampoules

2, 4 or 10 ml glass vials

Package sizes

5 ampoules of 2 ml

25 ampoules of 2 ml

5 vials of 2 ml

25 vials of 2 ml

4 vials of 4 ml

4 vials of 10 ml

Not all pack sizes may be marketed.

Marketing authorisation holder

RPH Pharmaceuticals AB

Box 603

101 32 Stockholm

Sweden

Manufacturer

Wasserburger Arzneimittelwerk GmbH

Herderstrasse 2, Burgerfeld

83512 Wasserburg A. Inn, Bavaria

Germany

Date of last revision of this leaflet: November 2023

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This information is intended only for healthcare professionals:

Dexmedetomidine RPH Pharma 100 micrograms/ml concentrate for solution for infusion EFG

Method of administration

Dexmedetomidine should be administered by healthcare professionals experienced in the management of patients who require intensive care or in the management of anesthesia in patients in the operating room. It should be administered only as a diluted intravenous infusion using a controlled infusion device.

The ampoules and vials are designed for use in a single patient.

Preparation of the solution

Dexmedetomidine can be diluted in glucose 50 mg/ml (5%), Ringer's solution, mannitol or sodium chloride 9 mg/ml (0.9%) injectable solution to achieve the required concentration of 4 micrograms/ml or 8 micrograms/ml before administration. See the table below for the volumes required to prepare the infusion.

In case a concentration of 4 micrograms/ml is required:

In case a concentration of 8 micrograms/ml is required:

The solution should be gently shaken to mix well.

Dexmedetomidine should be visually inspected for particles and coloration before administration.

Dexmedetomidine has been shown to be compatible when administered with the following intravenous fluids and medicines:

Ringer's lactate, glucose 5% solution, sodium chloride 9 mg/ml (0.9%) injectable solution, mannitol 200 mg/ml (20%), thiopental sodium, etomidate, vecuronium bromide, pancuronium bromide, succinylcholine, atracurium besylate, mivacurium chloride, rocuronium bromide, glycopyrrolate, phenylephrine HCl, atropine sulfate, dopamine, noradrenaline, dobutamine, midazolam, morphine sulfate, fentanyl citrate, and a plasma substitute.

Compatibility studies have shown potential for adsorption of dexmedetomidine to some types of natural rubber. Although dexmedetomidine is dosed to effect, it is recommended to use components with synthetic or coated natural rubber gaskets.

Shelf life

Chemical and physical stability has been demonstrated for 24 hours at 25°C and 2°C - 8°C.

From a microbiological point of view, the product should be used immediately.