Cayston 75 mg powder and solvent for nebuliser solution
- Name:
Cayston 75 mg powder and solvent for nebuliser solution
- Company:
Gilead Sciences Ltd
- 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: 07/05/19

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Gilead Sciences Ltd

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 7 May 2019 PIL
Reasons for updating
- Change to section 3 - how to take/use
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
Updated on 7 May 2019 SPC
Reasons for updating
- Change to section 6.5 - Nature and contents of container
- 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)
Updated on 5 June 2018 SPC
Reasons for updating
- Change to section 7 - Marketing authorisation holder
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 June 2018 PIL
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 2 August 2017 PIL
Reasons for updating
- New PIL for new product
Updated on 2 August 2017 PIL
Reasons for updating
- Change to section 6 - date of revision
- Change to MA holder contact details
Updated on 15 June 2016 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 15 June 2016 SPC
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- 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 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
- Change to section 6.5 - Nature and contents of container
- Change to section 9 - Date of renewal of authorisation
- 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
· Section 2
o Qualitative & Quantitative text reduced
· Section 3
o ‘lyphilised’ removed
· Section 4.2
o Inclusion of sentence describing dosing for children 6 years and older which is the same as adults
o Text describing the paediatric population re-worded
o The word ‘Elderly’ replaces ‘Older people’ throughout the SmPC
· Section 4.4 & 4.5
o In some cases, Cayston is replaced with aztreonam. This occurs throughout the SmPC
· Section 4.7
o Wording has been reduced and simply says ‘Cayston has no or negligible influence on the ability to drive or use machines’
· Section 4.8
o Removal of text describing the patient population & dosing regimen in the Phase 3 trials
o In some cases, Cayston is replaced with aztreonam. This occurs throughout the SmPC
· Section 4.8
o In some cases, Cayston is replaced with aztreonam. This occurs throughout the SmPC
· Section 5.1, 5.2, 5.3, 6.5
o In some cases, Cayston is replaced with aztreonam. This occurs throughout the SmPC
· Section 9
o Date of latest renewal updated
· Section 10
o Date of revision updated
Updated on 14 June 2016 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to further information section
- Change to MA holder contact details
- Change to improve clarity and readability
Updated on 4 September 2015 SPC
Reasons for updating
- Change to section 6.3 - Shelf life
- Change to section 7 - Marketing authorisation holder
- 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
• Section 7: Minor correction of the name of the marketing authorisation holder (MAH)
• Section 10: Change to the date of revision to August 2015
Updated on 3 September 2015 PIL
Reasons for updating
- Change to date of revision
- Change to MA holder contact details
Updated on 13 March 2015 PIL
Reasons for updating
- Change to date of revision
- Change to name of manufacturer
Updated on 20 November 2014 SPC
Reasons for updating
- Change to section 6.5 - Nature and contents of container
- 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
• Section 10: Change to the date of revision to November 2014
Updated on 18 November 2014 PIL
Reasons for updating
- Change to packaging
- Change to date of revision
Updated on 20 August 2014 SPC
Reasons for updating
- Change to section 5.2 - Pharmacokinetic properties
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 10 July 2014 SPC
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 not be renewed (A)
Free text change information supplied by the pharmaceutical company
“The following rare and severe adverse reactions
• Change to the date of revision to June 2014 in section 10
Updated on 8 July 2014 PIL
Reasons for updating
- Change to date of revision
Updated on 24 June 2014 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 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic 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
• Change to the date of revision to May 2014
Updated on 20 June 2014 PIL
Reasons for updating
- Change to date of revision
Updated on 6 May 2014 SPC
Reasons for updating
- Change to section 5.2 - Pharmacokinetic 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
- Section 10: Change to the date of revision.
Updated on 22 May 2013 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 20 May 2013 PIL
Reasons for updating
- New PIL for medicines.ie