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Mirvaso 3mg/g Gel

  • Name:

    Mirvaso 3mg/g Gel

  • Company:
    info
  • Active Ingredients:

    brimonidine tartrate

  • Legal Category:

    Product subject to medical prescription which may be renewed (B)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 03/07/17

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XPIL

Summary of Product Characteristics last updated on medicines.ie: 13/7/2017
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Galderma International S.A.S. c/o Galderma (U.K) Ltd.

Galderma (U

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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 July 2017 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 13 July 2017 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.4 - addition of warning regarding laser therapy
Section 4.8 - addition of bradycardia and dizziness
Section 10 - date of revision of the text updated

Updated on 3 July 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 3 July 2017 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 13 February 2017 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 3 - how to take/use
  • Change to section 6 - date of revision

Updated on 30 January 2017 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 6.5 - Nature and contents of container
  • Change to section 8 - Marketing authorisation number(s)

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.2 - Change to method of application
Section 4.4 - Information about exacerbation of rosacea
Section 6.5 - Change to packaging formnat

Updated on 19 December 2016 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

To add "pallor at the application site*onto section 4.8

Updated on 24 November 2016 PIL

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 18 January 2016 PIL

Reasons for updating

  • Change to side-effects

Updated on 15 January 2016 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Addition of hypotension and angioedema as rare adverse events in section 4.8

Updated on 3 August 2015 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

4.4     Special warnings and precautions for use

 

Mirvaso should not be applied on irritated skin or open wounds. In case of severe irritation or contact allergy, the treatment with the medicinal product should be discontinued.

 

Treatment with the medicinal product should start on a small area of the face to test the tolerance.

 

Erythema and Flushing

The effect of Mirvaso begins to diminish hours after application. In some patients, erythema and flushing were reported to return with greater severity than was present at baseline. Most of the cases were observed within the first 2 weeks of starting the treatment (see section 4.8).

 

The onset of flushing relative to application of Mirvaso varied, ranging from approximately 30 minutes to several hours (see section 4.8).

 

In the majority of these cases, erythema and flushing resolved after discontinuation of Mirvaso.

 

In case worsening of erythema occurs, Mirvaso should be discontinued. Symptomatic measures, such as cooling, NSAID and antihistamines, may help in alleviating symptoms.

 

Recurrences of aggravated erythema and flushing have been reported after re-administration of Mirvaso. Prior to resuming treatment after temporary discontinuation due to aggravated erythema or flushing, it is advisable to first ensure restoration of the skin barrier function, if necessary, and perform a test application on a small area of the face before full facial application is resumed.

 

It is important to inform the patient not to exceed the recommended dose and frequency of application: once daily use in a thin layer.

 

Mirvaso should not be applied close to the eyes.

Updated on 3 August 2015 PIL

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 21 January 2015 SmPC

Reasons for updating

  • Change to section 6.5 - Nature and contents of container
  • Change to section 8 - MA number
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

6.5 Nature and contents of container

[2g]

Polyethylene (PE)/Aluminium (Al)/ Polyethylene

(PE) laminated plastic tubes with a high density

polyethylene (HDPE) head and polypropylene (PP)

closure.

[10; 30g]

Polyethylene (PE)/Aluminium (Al)/ Polyethylene

(PE) laminated plastic tubes with a high density

polyethylene (HDPE) head and polypropylene (PP)

child resistant closure.

Or

[2g]

Polyethylene (PE)/Copolymer/Aluminium

(Al)/Copolymer/Polyethylene (PE) polyfoil plastic

tubes (kind of laminate) with a high density

polyethylene (HDPE) head and polyethylene (PE)

child resistant closure

[

 

 

10 g; 30g]

 

Polyethylene (PE)/Copolymer/Aluminium

(Al)/Copolymer/Polyethylene (PE) polyfoil plastic

tubes (kind of laminate) with a high density

polyethylene (HDPE) head and polypropylene (PP)

child resistant closure

8. MARKETING AUTHORISATION NUMBER(S)

Polyethylene (PE)/Aluminium (Al)/ Polyethylene

(PE) laminated plastic tubes :

EU/1/13/904/001

EU/1/13/904/002

EU/1/13/904/003

Polyethylene (PE)/Copolymer/Aluminium

(Al)/Copolymer/Polyethylene (PE) polyfoil plastic

tubes :

EU/1/13/904/004

EU/1/13/904/005

EU/1/13/904/006




Updated on 16 January 2015 PIL

Reasons for updating

  • Addition of information on reporting a side effect.
  • Change to date of revision
  • Introduction of new pack/pack size

Updated on 12 March 2014 SmPC

Reasons for updating

  • New SPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

None provided

Updated on 7 March 2014 PIL

Reasons for updating

  • New PIL for new product