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 Περιεχόμενα  Φάρμακα Α - Ζ  Συγχορήγηση

BRIVANESS Concentrate for solution for infusion (2019)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

BRINAVESS 20 mg/ml concentrate for solution for infusion.

Qualitative and quantitative composition

Each ml of concentrate contains 20 mg of vernakalant hydrochloride which is equivalent to 18.1 mg of vernakalant. Each 10 ml vial contains 200 mg of vernakalant hydrochloride equivalent to 181 mg of vernakalant. ...

Pharmaceutical form

Concentrate for solution for infusion (sterile concentrate). Clear and colourless to pale yellow solution with a pH of approximately 5.5. The osmolality of the medicinal product is controlled between the ...

Therapeutic indications

Rapid conversion of recent onset atrial fibrillation to sinus rhythm in adults: For non-surgery patients: atrial fibrillation ≤7 days duration. For post-cardiac surgery patients: atrial fibrillation ≤3 ...

Posology and method of administration

BRINAVESS should be administered by intravenous infusion in a monitored clinical setting appropriate for cardioversion. Only a well-qualified healthcare professional should administer BRINAVESS and should ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Patients with severe aortic stenosis, patients with systolic blood pressure <100 mmHg, and patients with heart ...

Special warnings and precautions for use

Cases of serious hypotension have been reported during and immediately following vernakalant infusion. Patients should be carefully observed for the entire duration of the infusion and for at least 15 ...

Interaction with other medicinal products and other forms of interaction

No formal interaction studies have been undertaken with vernakalant injection. Vernakalant must not be administered in patients who received intravenous AADs (class I and III) within 4 hours prior to vernakalant ...

Pregnancy and lactation

Pregnancy There are no data from the use of vernakalant hydrochloride in pregnant women. Studies in animal have shown malformations after repeated oral exposure (see section 5.3). As a precautionary measure, ...

Effects on ability to drive and use machines

Vernakalant has a minor to moderate influence on the ability to drive and use machines. Dizziness has been reported within the first 2 hours after receiving it (see section 4.8).

Undesirable effects

Summary of the safety profile The safety of vernakalant has been evaluated in clinical studies involving 1,148 subjects (patients and healthy volunteers) who received treatment with it. Based on data from ...

Overdose

One patient who received 3 mg/kg of vernakalant over 5 minutes (instead of the recommended 10 minutes) developed haemodynamically stable wide complex tachycardia which resolved without sequelae.

Pharmacodynamic properties

Pharmacotherapeutic group: Cardiac therapy, other antiarrhythmics class I and III ATC code: C01BG11 Mechanism of action Vernakalant is an antiarrhythmic medicine that acts preferentially in the atria to ...

Pharmacokinetic properties

Absorption In patients, average peak plasma concentrations of vernakalant were 3.9 μg/ml following a single 10-minute infusion of 3 mg/kg vernakalant hydrochloride, and 4.3 μg/ml following a second infusion ...

Preclinical safety data

Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, single- and repeated-dose toxicity, and genotoxicity. With respect to reproduction no effects ...

List of excipients

Citric acid (E330) Sodium chloride Water for injections Sodium hydroxide (E524) (for pH-adjustment)

Incompatibilities

This medicinal product must not be mixed with other medicinal products except those mentioned in section 4.2.

Shelf life

5 years. The diluted sterile concentrate is chemically and physically stable for 12 hours at or below 25°C. From a microbiological point of view, the medicinal product should be used immediately. If not ...

Special precautions for storage

This medicinal product does not require any special storage conditions. For storage conditions after dilution of the medicinal product, see section 6.3.

Nature and contents of container

Single-use glass (Type 1) vials with a chlorobutyl rubber stopper and an aluminium overseal. Pack size of 1 vial includes either 10 ml or 25 ml of concentrate. Not all pack sizes may be marketed.

Special precautions for disposal and other handling

Read all steps before administration. Preparation of BRINAVESS for infusion Step 1: BRINAVESS vials should be visually inspected for particulate matter and discolouration before administration. Any vials ...

Marketing authorization holder

Correvio, 15 rue du Bicentenaire, 92800, Puteaux, France

Marketing authorization number(s)

EU/1/10/645/001 EU/1/10/645/002

Date of first authorization / renewal of the authorization

Date of first authorisation: 01 September 2010 Date of latest renewal: 06 September 2015

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