Bramitob Nebuliser Solution

Product Information *

  • Company:

    Chiesi Limited
  • Status:

    No Recent Update
  • Active Ingredients :

    *Additional information is available upon request

  • Legal Category:

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

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 16 May 2019

File name

Bramtob IE CP0066-1 (2)_1557996448.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - marketing authorisation number
  • Change to section 6 - date of revision

Updated on 16 May 2019

File name

Bramitob 300mg IE CS0013-11_1557996281.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 10 - Date of revision of the text

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

Updated on 07 May 2019

File name

Bramitob IE CP0005-10_1556892779.pdf

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 3 - dose and frequency
  • Change to section 5 - how to store or dispose
  • Change to section 6 - what the product contains
  • Change to section 6 - date of revision

Updated on 03 May 2019

File name

Bramitob 300mg IE CS0013-10_1556892558.pdf

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • 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

Type II variation.

Section 4.5 of the SmPC has been updated regarding the concomitant use with mannitol by clarifying that it only refers to intravenous mannitol and not to mannitol for inhalation. In addition, the SmPC (section 4.3)

4.3       Contraindications-  listed in section 6.1. has been added

4.5       Interaction with other medicinal products and other forms of interaction -  intravenous and oral mannitol has been added

6.6       Special precautions for disposal and other handlings - Any waste material should be discarded after use changes to Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

10.       DATE OF REVISION OF THE TEXT July 2015 changed to March 2019

Updated on 13 November 2015

File name

PIL_14408_470.pdf

Reasons for updating

  • New PIL for new product

Updated on 13 November 2015

Reasons for updating

  • Change to date of revision
  • Change to MA holder contact details

Updated on 15 September 2015

Reasons for updating

  • Change to section 10 - Date of revision of the text
  • Change to MA holder contact details

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

Free text change information supplied by the pharmaceutical company

Section 7 – Marketing Authorisation Holder - Chiesi Limited, Cheadle Royal Business Park, Highfield, Cheadle, SK8 3GY UK Changed to Chiesi Limited, 333 Styal Road, Manchester, M22 5LG UK

 

Section 10 – Date of revision of the Text – November 2014 changed to July 2015

Updated on 15 September 2015

Reasons for updating

  • New SPC for new product

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

Updated on 16 December 2014

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect

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

Free text change information supplied by the pharmaceutical company

In section 4.8  Addition of 'Reporting of suspected adverse reactions' Section

Updated on 11 December 2014

Reasons for updating

  • Addition of information on reporting a side effect.

Updated on 12 November 2013

Reasons for updating

  • Change to side-effects

Updated on 22 October 2013

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

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

Free text change information supplied by the pharmaceutical company

In section 4.4 (special warnings and precautions for use) modest and reversible hypoacusia changed to modest hypoacusia.

In section 4.8 (undesirable effects), productive cough changed from common to uncommon.

Updated on 29 February 2012

Reasons for updating

  • Change to, or new use for medicine
  • Change to side-effects
  • Change to date of revision

Updated on 02 November 2011

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • 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

Addition of further drug delivery details

Updated on 30 August 2011

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

Addition of LC Sprint nebuliser and changes to undesirable effects.

Updated on 05 August 2011

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation
  • 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

Addition of the word fertility to pregnancy and lactation section.
Further clinical trial info provided in Undesirable effects section.
Addition of new undesirable effects and change to incidences of others.

Updated on 29 July 2011

Reasons for updating

  • Change to storage instructions
  • Change to side-effects
  • Change to date of revision
  • Change to MA holder contact details
  • Change to further information section
  • Improved electronic presentation

Updated on 03 May 2011

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 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.7 - Effects on ability to drive and use machines
  • 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

Sections 4.2, 4.4, 4.5, 4.7 & 4.8 updated.

Updated on 11 September 2009

Reasons for updating

  • New SPC for medicines.ie

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

Free text change information supplied by the pharmaceutical company

None provided

Updated on 08 September 2009

Reasons for updating

  • New PIL for medicines.ie