20 mg / ml, concentrate for solution for infusion 
vernakalanth hydrochloride

Read all of this leaflet carefully before you start using 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.

– If you get any side effects, talk to your doctor. This also applies to any side effectsnot mentioned in this information. See section 4.

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

1. What BRINAVESS is and what it is used for

BRINAVESS contains the active substance vernakalant hydrochloride. BRINAVESS works by changing your irregular or fast heartbeat to normal.

In adults, BRINAVESS is used if you have recently, less than or equal to 7 days ago for patients who have not undergone surgery and less than or equal to 3 days for patients who have undergone heart surgery, have had irregular or rapid heart rhythm called atrial fibrillation.

2. What you need to know before using BRINAVESS

Do not use BRINAVESS:

  • if you are allergic to vernakalant hydrochloride or any of the other ingredients of this medicine (listed in section 6)
  • if you have recently had or experienced worsening chest pain (angina) that has been assessed by your doctor as acute coronary heart disease within the last 30 days or if you have had a heart attack within the last 30 days
  • if you have a very narrow heart valve, systolic blood pressure lower than 100 mmHg, or if you have advanced heart failure with symptoms of light exertion or rest
  • if you have an abnormally slow or skipped heartbeat and do not have a pacemaker or if you have conduction disturbances (prolonged QT time ) that your doctor can see on your ECG
  • if you have used certain other intravenous medicines ( class I and III antiarrhythmics ) during the last four hours before BRINAVESS to normalize an abnormal heart rhythm.

You may not use BRINAVESS if any of the above apply to you. If you are not sure, talk to your doctor before using this medicine.

Warnings and cautions

Talk to your doctor before using BRINAVESS if you have:

  • heart failure
  • certain heart diseases involving the heart muscle, the membrane surrounding the heart, or a severe narrowing of the heart valves
  • any disease of the heart valves
  • liver problem
  • you are taking other antidote medicines.

If you have very low blood pressure or slow heart rate or some changes in your ECGwhile using this medicine, your doctor will stop your treatment.

Your doctor will consider whether you need additional rhythm control medication 4 hours after using BRINAVESS.

BRINAVESS may not work in the treatment of certain other types of abnormal heart rhythms, but your doctor will know who they are.

Tell your doctor if you have a pacemaker.

Talk to your doctor if any of the above apply to you (or if you are unsure). Detailed information on warnings and precautions for side effects that may occur is presented in section 4.

Blood tests

Before you are treated with this medicine, your doctor will decide if your blood should be tested to check how well it coagulates and to check your potassium levels.

Children and young people

Do not give this medicine to children and adolescents under 18 years of age as there is no experience of using it in this patient group.

Other medicines and BRINAVESS

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

Do not use BRINAVESS if you are taking certain other intravenous medicines ( class I and III antiarrhythmics ) that are used to normalize abnormal heart rhythms, 4 hours before BRINAVESS is to be used.

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 using this medicine.

  • BRINAVESS should preferably be avoided during pregnancy
  • It is not known whether BRINAVESS passes into breast milk

Driving and using machines

You should keep in mind that some people may experience dizziness, usually during the first 2 hours, after treatment with BRINAVESS (see section “Possible side effects”). Do not drive or use machines if you become dizzy after treatment with BRINAVESS.

BRINAVESS contains sodium

This medicine contains 32 mg sodium (the main ingredient in table salt/table salt) per 200 mg vial. This corresponds to 1.6% of the maximum recommended daily sodium intake for adults.

This medicine contains 80 mg of sodium (the main ingredient in table salt/table salt) per 500 mg vial. This corresponds to 4% of the maximum recommended daily intake of sodium for adults.

3. How to use BRINAVESS

The amount of BRINAVESS you receive depends on your weight. The recommended starting dose is 3 mg/kg body weight, where the maximum calculated dose is based on 113 kg. If you weigh more than 113 kg, you will receive a fixed dose of 339 mg. During the time you receive BRINAVESS, your breathing, your heart rate, your blood pressure, and your heart’s electrical activity are monitored.

If your heart rate has not returned to normal 15 minutes after your first dose has been completed, you may receive a second dose. This will be a slightly lower dose, 2 mg/kg body weight, where the maximum calculated dose is based on 113 kg. If you weigh more than 113 kg, you will receive a fixed dose of 226 mg. A higher dose than a total of 5 mg/kg body weight should not be over 24 hours.

BRINAVESS will be given to you by healthcare professionals. BRINAVESS should be diluted before it is given to you. Information on how to dilute the solution can be found at the end of this leaflet.

It will be given into your veins for 10 minutes.

If you take more BRINAVESS than you should

Tell your doctor immediately if you think you have been treated with too much BRINAVESS.

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.

Your doctor may decide to discontinue the infusion if he/she observes any of the following abnormal changes:

  • your heart rhythm (eg a very fast (uncommon) or very slow heartbeat (common), a missed stroke (uncommon), or a short pause in the normal activity of your heart (uncommon))
  • your blood pressure (eg very low blood pressure which can cause serious heart problems) (uncommon)
  • your heart’s electrical activity (less common)

Other side effects are

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

  • taste changes
  • sneezing

Common (may affect up to 1 in 10 people)

  • fast heartbeat
  • pain or numbness at the infusion site, numbness, decreased sensation in the skin, or tingling sensation
  • nausea and vomiting
  • feeling of warmth
  • low blood pressure, slow heartbeat, dizziness
  • cough, sore nose
  • excessive sweating, itching
  • numbness or tingling that occurs in the oral mucosa or tissue s

Uncommon (may affect up to 1 in 100 people)

  • certain types of heart rhythm problems (eg an awareness of your heartbeat (palpitations) or an extra heartbeat)
  • reduced sensitivity
  • eye irritation, watery eyes, or vision changes
  • changes in the sense of smell
  • pain in fingers and toes, a burning sensation
  • cold sweats, hot flashes
  • increased need for bowel movements, diarrhea
  • shortness of breath or tightness in the chest
  • feeling of suffocation
  • pain in the mouth or throat
  • irritation, itching at the infusion site
  • high blood pressure
  • fainting or fainting, general malaise, drowsiness or drowsiness
  • runny nose, sore throat
  • nasal congestion
  • dry mouth
  • pale skin color
  • general itching
  • fatigue
  • decreased sensation or sensitivity in the mouth

These effects, which occur within 24 hours after using BRINAVESS, should be transient. If this does not happen, talk to your doctor.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

5. How to store BRINAVESS

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

No special storage instructions.

BRINAVESS must be diluted before use. The diluted sterile concentrate is chemically and physically stable for 12 hours when stored at 25 ° C or lower.

From a microbiological perspective, the drug should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 ° C to 8 ° C, unless reconstitution and dilution have been performed under controlled and validated aseptic conditions.

Do not use this medicine if you notice that the contents are cloudy or discolored.

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 vernakalant hydrochloride. One ml of concentrate contains 20 mg of vernakalant hydrochloride equivalent to 18.1 mg of vernakalant. One vial of 200 mg vernakalant hydrochloride equivalent to 181 mg vernakalant. One vial of 500 mg vernakalant hydrochloride is equivalent to 452.5 mg vernakalant.
  • The other ingredients are citric acid, sodium chloride, sodium hydroxide (E524), and water for injections (see section 2 “Brinavess contains sodium”).

What the medicine looks like and the contents of the pack

BRINAVESS is a concentrate for solution for infusion (sterile concentrate) that is clear and colorless to pale yellow.

BRINAVESS is available in packs containing 1 vial of 200 mg or 500 mg of vernakalant hydrochloride.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder Correvio15 rue du Bicentenaire92800 PuteauxFrance ManufacturerGeodis Logistics Netherlands BVColumbusweg 165928 LC VenloNetherlands

Contact the representative of the marketing authorization holder to find out more about this medicine:

Belgium / Belgique / BelgienCorrevioTel: +32 28 08 86 20 LithuaniaCorrevioTel: +41 848 00 79 70
България 
CorrevioTel .: +41 848 00 79 70
Luxembourg / LuxemburgCorrevioTel: +41 848 00 79 70
Czech RepublicCorrevioTel: +41 848 00 79 70 HungaryCorrevioTel: +41 848 00 79 70
DenmarkCorrevioTel: +45 8082 6022 MaltaCorrevioTel: +41 848 00 79 70
GermanyCorrevioTel: +49 69 33 29 62 76 The NetherlandsCorrevioTel: +31 20 808 32 06
EestiCorrevioTel: +41 848 00 79 70 NorwayCorrevioTel: +41 848 00 79 70
GreeceCorrevio:Ηλ: +41 848 00 79 70 AustriaCorrevioTel: +41 848 00 79 70
SpainCorrevioTel: +34 93 179 05 36 PolandCorrevioTel: +41 848 00 79 70
FranceCorrevioTel: +33 1 77 68 89 17 PortugalCorrevioTel: +41 848 00 79 70
CroatiaCorrevioTel: +41 848 00 79 70 RomaniaCorrevioTel: +41 848 00 79 70
IrelandCorrevioTel: +41 848 00 79 70 SloveniaCorrevioTel: +41 848 00 79 70
IcelandCorrevioPhone: +41 848 00 79 70 Slovak RepublicCorrevioTel: +41 848 00 79 70
ItalyCorrevioTel: +39 02 600 63037 Finland / FinlandCorrevioPuh / Tel: +41 848 00 79 70
ΚύπροςCorrevio:Ηλ: +41 848 00 79 70
LatviaCorrevioTel: +41 848 00 79 70 United KingdomCorrevioTel: +44 203 002 8114

Muhammad Nadeem

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