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Cayston 75 mg powder and solvent for nebuliser solution

  • Name:

    Cayston 75 mg powder and solvent for nebuliser solution

  • Company:
    info
  • Active Ingredients:

    Aztreonam lysine

  • 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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Summary of Product Characteristics last updated on medicines.ie: 7/5/2019

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Gilead Sciences Ltd

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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 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 6.3: Shelf life reduced from 4 to 3 years for the solvent ampoule
• 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

• Sections 6.5 & 6.6: Addition of an alternative flip tear-off seal for drug product vials

• 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

- Minor amendment to section 5.2; which now states that protein binding of aztreonam in plasma is approximately 77% within the clinical dose range at clinically relevant plasma concentrations.

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

• Deletion of the marked text below in sections 4.4 and 4.8 of the SmPC:

“The following rare and severe adverse reactions have not been observed to date with Cayston, but have been reported after parenteral use of other aztreonam containing products: toxic epidermal necrolysis, anaphylaxis, purpura, erythema multiforme, exfoliative dermatitis, urticaria, petechiae, pruritus, diaphoresis.”

• 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

• Update of the SmPC sections 4.2, 4.4, 4.8, 5.1 and 5.2 in order to reflect study results obtained in open-label phase 2 trial GS-US-205-0162 [to evaluate the safety and efficacy of aztreonam 75 mg powder in paediatric patients with Cystic Fibrosis (CF) and new onset lower respiratory tract culture positive for Pseudomonas aeruginosa (PA)]

• 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 5.2: Inclusion of the following protein binding data in section 5.2 of the SmPC (Distribution): “The protein binding of aztreonam in plasma is approximately 77% at clinically relevant plasma concentrations.”
- 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

None provided

Updated on 20 May 2013 PIL

Reasons for updating

  • New PIL for medicines.ie