Bramitob Nebuliser Solution
- Name:
Bramitob Nebuliser Solution
- Company:
Chiesi Limited
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may not be renewed (A)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 16/05/19
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Chiesi Limited
Company Products
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 PIL
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 SPC
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 7 May 2019 PIL
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 3 May 2019 SPC
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 PIL
Reasons for updating
- New PIL for new product
Updated on 13 November 2015 PIL
Reasons for updating
- Change to date of revision
- Change to MA holder contact details
Updated on 15 September 2015 SPC
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 SPC
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 SPC
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
Updated on 11 December 2014 PIL
Reasons for updating
- Addition of information on reporting a side effect.
Updated on 12 November 2013 PIL
Reasons for updating
- Change to side-effects
Updated on 22 October 2013 SPC
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 PIL
Reasons for updating
- Change to, or new use for medicine
- Change to side-effects
- Change to date of revision
Updated on 2 November 2011 SPC
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
Updated on 30 August 2011 SPC
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
Updated on 5 August 2011 SPC
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
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 PIL
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 3 May 2011 SPC
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
Updated on 11 September 2009 SPC
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
Updated on 8 September 2009 PIL
Reasons for updating
- New PIL for medicines.ie