Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - byfavo

Document Subject

Generated Narrative: MedicinalProductDefinition mp288b5bf92457cec46266040e05fc3d90

identifier: http://ema.europa.eu/identifier/EU/1/20/1505/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Byfavo 20 mg powder for solution for injection

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

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part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-288b5bf92457cec46266040e05fc3d90

identifier: http://ema.europa.eu/identifier/EU/1/20/1505/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - byfavo

Attesters

What is in this leaflet

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

Byfavo is a medicine that contains the active substance remimazolam. Remimazolam is one of a group of substances known as benzodiazepines.

Byfavo is a sedative given before a medical test or procedure to make you feel relaxed and sleepy (sedated).

You must not be given Byfavo if:

• you are allergic to remimazolam or other benzodiazepines (such as midazolam) or any of the other ingredients of this medicine (listed in section 6).
• you have an unstable form of a condition called myasthenia gravis (weakness of muscles) in which your chest muscles that help you breathe get weak

Warnings and precautions
Talk to your doctor or nurse before using Byfavo if you have any severe illness or condition and in particular if:

• you have very low or very high blood pressure or tend to faint
• you have heart problems especially a very slow and/or irregular (arrhythmic) heart rate
• you have any breathing problems including shortness of breath
• you have severe liver problems.
• you have a condition called myasthenia gravis in which your muscles are weak
• you regularly take recreational drugs or you have had problems with drug use in the past.

Byfavo can cause temporary loss of memory. Your doctor will assess you before you leave the hospital or clinic and give you necessary advice.

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

Other medicines and Byfavo Tell your doctor if you are taking, have recently taken or might take any other medicines, in particular about:

• opioids (including painkillers such as morphine, fentanyl and codeine or certain cough medicines or medicines for use in drug substitution therapy)
• antipsychotics (medicines to treat certain psychiatric illnesses)
• anxiolytics (tranquilizers or medicines that reduce anxiety)
• medicines that cause sedation (for example temazepam or diazepam)
• antidepressants (medicines to treat depression)
• certain antihistamines (medicines to treat allergies)
• certain antihypertensives (medicines to treat high blood pressure)

It is important to tell your doctor or nurse if you are taking other medicines, as using more than one at the same time can change the effect of the medicines involved.

Byfavo with alcohol Alcohol can change the effect of Byfavo. Tell your doctor or nurse:

• how much alcohol you drink regularly or if you have had problems with alcohol use;

Do not drink alcohol for 24 hours before you are given Byfavo.

Pregnancy and breast-feeding You should not use Byfavo if you are pregnant or think you may be pregnant. Tell your doctor or nurse if you are pregnant or think you may be pregnant.
If you are a breastfeeding mother, do not breastfeed for 24 hours after you are given this medicine.

Driving and using machines Byfavo makes you sleepy, forgetful and affects your ability to concentrate. Even though these effects wear off rapidly, you must not drive and operate machinery until these effects are completely gone. Ask your doctor about when you can drive or operate machinery again.

Byfavo contains dextran 40 for injection
This medicine contains 79.13 mg of dextran 40 for injection in each vial. Rarely, dextrans can cause severe allergic reactions. If you have breathing difficulty or swelling or you feel faint, get medical help at once.

Your doctor will decide on the right dose for you.

Your breathing, heart rate and blood pressure will be monitored during the procedure and the doctor will adjust the dose if needed.

A doctor or nurse will give you Byfavo by injection into your vein (blood stream) before and during your medical test or procedure. Byfavo is mixed with sterile saline to make a solution before it is used.

After the procedure Your doctor or nurse will check on you for a while after sedation to make sure that you feel well and are fit to go home.

If you are given too much Byfavo If you are given too much Byfavo, you may have the following symptoms:

• you may feel dizzy
• you may get confused
• you may feel sleepy
• your eyesight may get blurry or you may have involuntary eye movements (dancing eyes)
• you may get agitated
• you may feel weak
• your blood pressure may drop
• your heartbeat may slow down
• your breathing may become slow and shallow
• you may lose consciousness

Your doctor will know how to treat you.

Ask your doctor or nurse if you have any questions about the use of this medicine.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Very common (may affect more than 1 in 10 users)

• Low blood pressure
• Unusually slow or shallow breathing (and low oxygen level in blood)

Common (may affect up to 1 in 10 users)

• Headache
• Feeling dizzy
• Slow heart rate
• Feeling sick (nausea)
• Being sick (vomiting)

Uncommon (may affect up to 1 in 100 users)

• Sleepiness
• Feeling cold
• Chills
• Hiccups

Not known (frequency cannot be estimated from the available data)

• sudden, severe allergic reaction

Reporting of side effects

If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

Professionals in the hospital or clinic are responsible for storing this medicine.

Keep this medicine out of the sigth and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and vial label. The expiry date refers to the last day of that month.

Chemical and physical in-use stability has been demonstrated for 24 h at 20 - 25 C.

From a microbiological point of view, unless the method of opening/reconstitution/dilution precludes the risk of microbial contamination, the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user (see SmPC section 6.3).

Do not use this medicine if you notice visible particulate matter or discolouration.

What Byfavo contains

• The active substance is remimazolam. Each vial contains remimazolam besylate equivalent to 20 mg of remimazolam. After reconstitution each mL contains 2.5 mg of remimazolam.

• The other ingredients are:

• Dextran 40 for injection

• Lactose monohydrate

• Hydrochloric acid

• Sodium hydroxide See section 2, Byfavo contains dextran 40 for injection .

What Byfavo looks like and contents of the pack Byfavo is a white to off-white powder for solution for injection.

Pack sizes 10 vial pack

Marketing Authorisation Holder
PAION Deutschland GmbH Heussstra e 52078 Aachen Germany

Manufacturer PAION Netherlands B.V. Vogt 6422 RK Heerlen Netherlands

PAION Deutschland GmbH Heussstra e 52078 Aachen Germany

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Belgi /Belgique/Belgien Viatris bvba/sprl T l/Tel: + 32 (0)2 658 61 Lietuva
PAION Deutschland GmbH
Tel: + 49 800 4453 4
PAION Deutschland GmbH
Te .: + 49 800 4453 4Luxembourg/Luxemburg
PAION Deutschland GmbH
T l/Tel: + 49 800 4453 4 esk republika PAION Deutschland GmbH
Tel: + 49 800 4453 4453<{e-mail}> Magyarorsz g
PAION Deutschland GmbH
Tel.: + 49 800 4453 4Danmark
PAION Deutschland GmbH
Malta PAION Deutschland GmbH
Tlf: + 49 800 4453 4Tel: + 49 800 4453 4Deutschland PAION Deutschland GmbH
Tel: + 49 800 4453 4Nederland PAION Deutschland GmbH
Tel: + 49 800 4453 4Eesti PAION Deutschland GmbH
Tel: + 49 800 4453 4Norge PAION Deutschland GmbH
Tlf: + 49 800 4453 4
Viatris Hellas Ltd : +30 210 0100 sterreich PAION Deutschland GmbH
Tel: + 49 800 4453 4Espa a Viatris Pharmaceuticals, S.L.U. Tel: + 34 900 102 Polska Mylan Healthcare Sp. z o.o. Tel.: + 48 22 546 64 France Viatris Sant
T l: +33 4 37 25 75 Portugal PAION Deutschland GmbH
Tel: + 49 800 4453 4Hrvatska
PAION Deutschland GmbH
Tel: + 49 800 4453 4Rom nia BGP Products SRL Tel: +40 372 579 Ireland
PAION Deutschland GmbH
Tel: + 49 800 4453 4Slovenija PAION Deutschland GmbH
Tel: + 49 800 4453 4 sland PAION Deutschland GmbH
S mi: + 49 800 4453 4Slovensk republika
PAION Deutschland GmbH
Tel: + 49 800 4453 4Italia Mylan Italia S.r.l. Tel: + 39 02 612 46Suomi/Finland PAION Deutschland GmbH
Puh/Tel: + 49 800 4453 4
PAION Deutschland GmbH
: + 49 800 4453 4Sverige PAION Deutschland GmbH
Tel: + 49 800 4453 4Latvija
PAION Deutschland GmbH
Tel: + 49 800 4453 4United Kingdom (Northern Ireland) PAION Deutschland GmbH
Tel: + 49 800 4453 4This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site http://www.ema.europa.eu.

The following information is intended for healthcare professionals only:

Byfavo 20 mg powder for solution for injection

FOR INTRAVENOUS USE ONLY

Must be reconstituted before use with Sodium Chloride 9 mg/mL (0.9%) solution for injection

Read the Summary of Product Characteristics (SmPC) carefully before use.
Remimazolam must only be administered by health care professionals experienced in sedation. The patient should be monitored throughout by a separate healthcare professional, who is not involved in the conduct of the procedure, and whose sole task is to monitor the patient. All personnel must be trained in the detection and management of airway obstruction, hypoventilation and apnoea, including the maintenance of a patent airway, supportive ventilation and cardiovascular resuscitation. The patient s respiratory and cardiac function must be continuously monitored. Resuscitative medicinal products and age- and size-appropriate equipment for restoring airway patency and bag/valve/mask ventilation must be immediately available. A benzodiazepine antagonist (flumazenil, a medicine for counteracting the effects of remimazolam) must be immediately available for use.

Reconstitution instructions

Note: Strict aseptic techniques must be mainted during handling, preparation and use of Byfavo.

To reconstitute, use a sterile needle and a 10 mL sterile syringe, remove the vial cap, puncture the vial stopper at an angle of 90 and add 8.2 mL of sodium chloride 9 mg/mL (0.9%) solution for injection, directing the stream of saline toward the wall of the vial. Gently swirl the vial until the contents are fully dissolved. The reconstituted solution should be clear and colourless to light yellow. The vial delivers a final concentration of 2.5 mg/mL of remimazolam.

The reconstituted solution must be inspected visually for particulate matter and discolouration prior to administration. If particles or discolouration are present then the solution should be discarded.

The reconsituted solution is for single use only, any unused portion must be disposed of in accordance with local requirements.

Incompatibilities

Byfavo is incompatible with Lactated Ringer s Solution (also known as Compound Sodium Lactate Solution or Hartmann s Solution), Acetated Ringer s Solution, and Bicarbonated Ringer s Solution for infusion.

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

Compatibilities

Reconstituted Byfavo has been shown to be compatible with the following i.v. fluids when administered through the same i.v. line:

• Glucose (5%) solution for injection
• Glucose (20%) solution for injection
• Glucose (5%) - sodium chloride (0.45%) solution for injection
• Ringers Solution
• Sodium chloride (0.9%) solution for injection Compatibility with other i.v. fluids has not been evaluated.

Shelf life

Chemical and physical in use stability has been demonstrated for 24 hours at 20 C to 25 C.

From a microbiological point of view , unless the method of opening/reconstitution/dilution precludes the risk of microbial contamination, the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user.

Special precautions for storage

Keep the vials in the outer carton in order to protect from light.

Package leaflet: Information for the patient

Byfavo 50 mg powder for concentrate for solution for injection/infusion remimazolam

This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effect you may get. See the end of section 4 for how to report side effects.

Read all of this leaflet carefully before you are given 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.