Brinavess 20 mg/ml concentrate for solution for infusion

  • Name:

    Brinavess 20 mg/ml concentrate for solution for infusion

  • Company:
    info
  • Active Ingredients:

    Vernakalant Hydrochloride

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 13/01/20

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Summary of Product Characteristics last updated on medicines.ie: 13/1/2020

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Company Products

Medicine NameActive Ingredients
Medicine Name Brinavess 20 mg/ml concentrate for solution for infusion Active Ingredients Vernakalant Hydrochloride
Medicine Name Xydalba 500 mg powder for concentrate for solution for infusion Active Ingredients Dalbavancin hydrochloride
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When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 13 January 2020 SmPC

Reasons for updating

  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Date changed to state:

 

31 October 2019

Updated on 13 January 2020 PIL

Reasons for updating

  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

Date of revision changed to state:

10/2019

Updated on 18 December 2019 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Only the paragraphs that have been amended are indicated here

Product name “BRINAVESS” has been deleted from some sections in the SPC, in most instances this has been replaced with “vernakalant”.

The following sections of the SPC have also been updated following approval of variation 0035 (update to the product information in line with the CCDS)

4.2     Posology and method of administration

4.3       Contraindications

4.4       Special warnings and precautions for use

4.5       Interaction with other medicinal products and other forms of interaction

4.6       Fertility, pregnancy and lactation

4.7       Effects on ability to drive and use machines

4.8       Undesirable effects

4.9       Overdose

5.1     Pharmacodynamic properties

5.2     Pharmacokinetic properties

5.3     Preclinical safety data

6.4     Special precautions for storage

6.6     Special precautions for disposal and other handling

10.       DATE OF REVISION OF THE TEXT

11 December 2019

 

Updated on 18 December 2019 PIL

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 2 - driving and using machines
  • Change to section 2 - excipient warnings
  • Change to section 3 - how to take/use
  • Change to section 4 - possible side effects
  • Change to section 5 - how to store or dispose
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision
  • Change to information for healthcare professionals

Free text change information supplied by the pharmaceutical company

Only the paragraphs that have been amended are indicated here

Product name “BRINAVESS” has been deleted from some sections in the SPC, in most instances this has been replaced with “vernakalant”.

The following sections of the SPC have also been updated following approval of variation 0035 (update to the product information in line with the CCDS)

4.2     Posology and method of administration

4.3       Contraindications

4.4       Special warnings and precautions for use

4.5       Interaction with other medicinal products and other forms of interaction

4.6       Fertility, pregnancy and lactation

4.7       Effects on ability to drive and use machines

4.8       Undesirable effects

4.9       Overdose

5.1     Pharmacodynamic properties

5.2     Pharmacokinetic properties

5.3     Preclinical safety data

6.4     Special precautions for storage

6.6     Special precautions for disposal and other handling

10.       DATE OF REVISION OF THE TEXT

11 December 2019

 

Updated on 31 October 2019 PIL

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 3 - how to take/use
  • Change to information for healthcare professionals

Updated on 31 October 2019 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Only the paragraphs that have been amended are indicated here

 

New text highlighted in blue

Deleted text highlighted in red

 

4.2     Posology and method of administration

Posology

BRINAVESS is dosed by patient body weight, with a maximum calculated dose based upon 113 kg.

The recommended initial infusion is 3 mg/kg to be infused over a 10 10-minute period For patients weighing ≥ 113 kg, the with a maximum initial dose of 339 mg (84.7 ml of 4 mg/ml solution) should not be exceeded. If conversion to sinus rhythm does not occur within 15 minutes after the end of the initial infusion, a second 10 minute infusion of 2 mg/kg may be administered. For patients weighing ≥ 113 kg, the (maximum second infusion of 226 mg (56.5 ml of 4 mg/ml solution)) should not be exceeded. Cumulative doses of greater than 5 mg/kg should not be administered within 24 hours.

Patients with body weight > 113 kg:

For patients above 113 kg, vernakalant has a fixed dose. The initial dose is 339 mg (84.7 ml of 4 mg/ml solution). If conversion to sinus rhythm does not occur within 15 minutes after the end of the initial infusion, a second 10 minute infusion of 226 mg (56.5 ml of 4 mg/ml solution) may be administered. Cumulative doses above 565 mg have not been evaluated.

 

5.       PHARMACOLOGICAL PROPERTIES

5.1     Pharmacodynamic properties

Efficacy from Post-Marketing Observational Study

In the post-approval safety study SPECTRUM that included 1,778 patients with 2,009 BRINAVESS treatment episodes, effectiveness was assessed as the proportion of patients who converted to sinus rhythm for at least one (1) minute within 90 minutes from the start of BRINAVESS infusion, excluding patients who received electrical cardioversion or intravenous Class I/III antiarrhythmics for cardioversion within the 90-minute window. Overall, BRINAVESS was effective in 70.2% (1,359/1,936) of these patients. Median time to conversion to SR as reported among all patients who, as per the investigator judgement, converted to SR was 12 minutes and in most of the treatment episodes (60.4%) only one infusion was administered. The higher cardioversion rate in SPECTRUM as compared to clinical phase 3 studies (70.2% vs 47% to 51%) is correlated with a shorter duration of the duration of the index atrial fibrillation period (median duration of 11.1 hours in SPECTRUM vs 17.7 to 28.2 hours in clinical studies).

If patients who received electrical cardioversion, intravenous antiarrhythmics or oral propafenone/flecainide within 90 minutes from the start of BRINAVESS infusion are regarded as treatment failures in addition to patients who did not convert for one minute within 90 minutes, the conversion rate among the 2,009 patients who received BRINAVESS was 67.3 % (1,352/2,009). There was no meaningful difference when stratifying the analysis by therapeutic indication (i.e. non‑surgery and post-cardiac surgery patients).

 

10.       DATE OF REVISION OF THE TEXT

 

19 September 2019

 

Updated on 27 September 2016 PIL

Reasons for updating

  • Change to further information section
  • Change to date of revision

Updated on 27 September 2016 PIL

Reasons for updating

  • New PIL for new product

Updated on 30 August 2016 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 25 August 2016 PIL

Reasons for updating

  • New PIL for medicines.ie