BYFAVO 20 mg POWDER FOR INJECTABLE SOLUTION

Introduction

Package Leaflet: Information for the Patient

Byfavo 20 mg Powder for Solution for Injection

remimazolam

This medicinal product is subject to additional monitoring, which will allow for quick identification of new safety information. You can help by reporting any side effects you may get. The last section of the leaflet includes information on how to report side effects.

Read all of this leaflet carefully before you start taking 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 Package Leaflet

1. What is Byfavo and what is it used for
2. What you need to know before you take Byfavo
3. How to take Byfavo
4. Possible side effects
5. Storage of Byfavo
6. Contents of the pack and other information

1. What is Byfavo and what is it used for

Byfavo is a medicinal product that contains the active substance remimazolam.

Remimazolam belongs to a group of substances known as benzodiazepines.

Byfavo is a sedative that is administered before a medical test or procedure to make the patient feel relaxed and drowsy (sedated).

2. What you need to know before you take Byfavo

Do not take Byfavo

• if you are allergic to remimazolam or other benzodiazepines (such as midazolam) or to any of the other ingredients of this medicinal product (listed in section 6),
• if you have an unstable form of a disease called myasthenia gravis (muscle weakness), which weakens the muscles of the chest that help you breathe.

Warnings and precautions

Talk to your doctor or nurse before taking Byfavo if you have any serious illness or disorder, in particular:

• if you have very low or very high blood pressure or if you tend to faint;
• if you have heart problems, especially if your heart rate is very low or irregular (arrhythmic);
• if you have breathing problems, including shortness of breath;
• if you have severe liver problems;
• if you have a disease called myasthenia gravis, which weakens the muscles;
• if you regularly take drugs or have had drug abuse problems in the past.

Byfavo may cause temporary memory loss. Before leaving the hospital or medical center, your doctor will provide you with the necessary advice.

Children and adolescents

Byfavo should not be given to patients under 18 years of age because it has not been tested in children or adolescents.

Other medicines and Byfavo

Tell your doctor if you are taking, have recently taken, or might take any other medicines, especially:

• opioids (including painkillers such as morphine, fentanyl, and codeine or certain cough medicines or drugs used in drug substitution treatment);
• antipsychotics (medicines for treating certain mental illnesses);
• anxiolytics (tranquilizers or medicines that reduce anxiety);
• medicines that cause sedation (such as temazepam or diazepam);
• antidepressants (medicines for treating depression);
• certain antihistamines (medicines for treating allergies);
• certain antihypertensives (medicines for treating high blood pressure).

It is important to inform your doctor or nurse if you are taking other medicines, as the simultaneous use of more than one medicine can change its effect.

Using Byfavo with alcohol

Alcohol may alter the effect of Byfavo. Inform your doctor or nurse:

• how much alcohol you usually drink or if you have had problems with alcohol consumption.

Do not drink alcohol 24 hours before taking Byfavo.

Pregnancy and breastfeeding

Do not use Byfavo if you are pregnant or think you may be pregnant. Inform your doctor or nurse if you are pregnant or think you may be pregnant.

If you are breastfeeding, do not breastfeed for 24 hours after taking this medicinal product.

Driving and using machines

Byfavo may cause drowsiness, forgetfulness, or affect your ability to concentrate. Although these effects disappear quickly, do not drive or use machines until they have completely disappeared. Ask your doctor when you can drive or use machines again.

Byfavo contains dextran 40 for injectable preparations.

This medicinal product contains 79.13 mg of dextran 40 for injectable preparations per vial. Rarely, dextran can cause severe allergic reactions. If you experience breathing difficulties or swelling or feel like you are going to faint, seek medical help immediately.

3. How to take Byfavo

Your doctor will decide what dose is suitable for you.

During the procedure, your breathing, heart rate, and blood pressure will be monitored, and your doctor will adjust the dose as needed.

A doctor or nurse will administer Byfavo to you by intravenous injection (into the bloodstream) before and during the medical test or procedure. Byfavo must be mixed with a sterile saline solution before use.

After the procedure

Your doctor or nurse will examine you for a while after sedation to make sure you feel well and are ready to go home.

If you take more Byfavo than you should

If you take more Byfavo than you should, you may experience the following symptoms:

• you may feel dizzy;
• you may feel disoriented;
• you may feel drowsy;
• you may have blurred vision or involuntary eye movements (nystagmus);
• you may feel agitated;
• you may feel weak;
• your blood pressure may drop;
• your heart rate may slow down;
• your breathing may become slower and shallower;
• you may lose consciousness.

Your doctor will know how to treat you.

If you have any other questions about the use of this medicinal product, ask your doctor or nurse.

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)

• Hypotension
• Abnormally slow or shallow breathing (and low oxygen levels in the blood)

Common (may affect up to 1 in 10 people)

• Headache
• Dizziness
• Decreased heart rate
• Nausea
• Vomiting

Uncommon (may affect up to 1 in 100 people)

• Drowsiness
• Feeling cold
• Chills
• Hiccup

Frequency not known (cannot be estimated from the available data)

• Sudden severe allergic reaction

Reporting of side effects

If you experience any side effects, talk to your doctor or nurse, even if it is possible that the side effects are not listed in this leaflet. You can also report side effects directly through the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicinal product.

5. Storage of Byfavo

Healthcare professionals in the hospital or medical center are responsible for storing this medicinal product.

Keep this medicinal product out of the sight and reach of children.

Do not use this medicinal product after the expiry date which is stated on the carton and vial label. The expiry date is the last day of the month stated.

It has been demonstrated that it is chemically and physically stable for use for 24 hours between 20°C and 25°C.

From a microbiological point of view, unless the method of opening/reconstitution/dilution eliminates the risk of microbial contamination, the product should be used immediately. If not used immediately, the user will be responsible for the storage times and conditions during use (see SmPC section 6.3).

Do not use this medicinal product if you notice visible solid particles or color changes.

6. Contents of the pack and other information

Composition of Byfavo

• The active substance is remimazolam. Each vial contains remimazolam besylate equivalent to 20 mg of remimazolam. After reconstitution, each milliliter contains 2.5 mg of remimazolam.
• The other ingredients are:

• Dextran 40 for injectable preparations
• Lactose monohydrate
• Hydrochloric acid
• Sodium hydroxide

See section 2, "Byfavo contains dextran 40 for injectable preparations".

Appearance and pack size of the product

Byfavo is a white to off-white powder for solution for injection.

Pack sizes:

Pack of 10 vials

Marketing authorisation holder

PAION Pharma GmbH

Heussstraße 25

52078 Aachen

Germany

Manufacturer

PAION Deutschland GmbH

Heussstraße 25

52078 Aachen

Germany

PAION Pharma GmbH

Heussstraße 25

52078 Aachen

Germany

You can request more information about this medicinal product from the local representative of the marketing authorisation holder:

Date of last revision of this leaflet:

Other sources of information

Detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu.

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This information is intended only for healthcare professionals:

Byfavo 20 mg Powder for Solution for Injection

FOR INTRAVENOUS USE ONLY

Must be reconstituted before use with a 9 mg/ml (0.9%) sodium chloride injection solution.

Read the summary of product characteristics (SmPC) or package leaflet carefully before using this medicinal product.

Remimazolam should only be administered by healthcare professionals with experience in sedation. The patient should be monitored throughout the procedure by another healthcare professional who is not involved in the procedure and whose sole task is to monitor the patient. All personnel must be trained in the detection and control of respiratory obstruction, hypoventilation, and apnea, including the maintenance of airway patency, auxiliary ventilation, and cardiovascular resuscitation. The patient's respiratory and cardiac function should be continuously monitored. Resuscitation medications and equipment suitable for the patient's age and size to restore airway patency and ventilation with a bag/valve/mask (ambu) should be available immediately. A benzodiazepine antagonist (flumazenil, a medicine to counteract the effects of remimazolam) should be available immediately for use.

Reconstitution instructions

Note: Strict aseptic techniques should be followed during handling, preparation, and use of Byfavo.

To perform reconstitution, use a sterile needle and a sterile 10 ml syringe, remove the cap from the vial, pierce the vial stopper with a 90° angle, and add 8.2 ml of 9 mg/ml (0.9%) sodium chloride injection solution, directing the flow of the saline solution towards the vial wall. Gently rotate the vial until the contents are completely dissolved. The reconstituted solution should be clear, colorless to pale yellow. The vial provides a final concentration of 2.5 mg/ml of remimazolam.

The reconstituted solution should be visually inspected for particulate matter and color changes before administration. If particles or color changes are observed, the solution should be discarded.

The reconstituted solution is for single use only, and any unused portion should be disposed of in accordance with local regulations.

Incompatibilities

Byfavo is incompatible with Ringer's Lactate solution (also known as sodium lactate composite solution or Hartmann's solution), Ringer's Acetate solution, and Ringer's Bicarbonate solution for perfusion.

After reconstitution, this medicinal product should not be mixed with other medicinal products, except for those mentioned below.

Compatibilities

It has been shown that when Byfavo is reconstituted, it is compatible with the following IV fluids if administered through the same IV line:

• 5% glucose injection solution;
• 20% glucose injection solution;
• 5% glucose and 0.45% sodium chloride injection solution;
• Ringer's solution;
• 0.9% sodium chloride injection solution.

Compatibility with other IV fluids has not been evaluated.

Shelf life

It has been demonstrated that it is chemically and physically stable for use for 24 hours between 20°C and 25°C.

From a microbiological point of view, unless the method of opening/reconstitution/dilution eliminates the risk of microbial contamination, the product should be used immediately. If not used immediately, the user will be responsible for the storage times and conditions during use.

Special precautions for storage

Store the vials in the outer packaging to protect them from light.