Zerbaxa 1 g/0.5 g powder for concentrate for solution for infusion

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 September 2019 PIL

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 3 - dose and frequency
  • Change to section 4 - possible side effects
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision
  • Change to information for healthcare professionals

Free text change information supplied by the pharmaceutical company

Change to section 1 - what the product is used for, Change to section 2 - what you need to know - warnings and precautions, Change to section 3 - dose and frequency, Change to section 4 - possible side effects, Change to section 6 - what the product looks like and pack contents, Change to section 6 - date of revision, Change to information for healthcare professionals

Updated on 11 September 2019 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • 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 5.3 - Preclinical safety data
  • 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

Changes to sections 4.1 Therapeutic Indications, 4.2 Posology and method of administration, 4.4 Special warnings and precautions for use, 4.8 Undesirable effects, 5.1 Pharmacodynamic properties, 5.2 Pharmacokinetic properties, 5.3 Preclinical safety data, 6.6 Special precautions for disposal and other handling and section 10. Date of revision following approval of (II-20) Addition of HAP/VAP indication

Updated on 17 June 2019 SmPC

Reasons for updating

  • Improved presentation of SmPC

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

Free text change information supplied by the pharmaceutical company

Converted the SPC from word format to pdf file format

 

Updated on 27 June 2018 PIL

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision
  • Change of distributor details

Updated on 26 June 2018 SmPC

Reasons for updating

  • 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

Changes to Marketing Authorisation Holder and Date of revision of the text following approval of MA Transfer

Updated on 19 October 2016 PIL

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 19 October 2016 PIL

Reasons for updating

  • New PIL for new product

Updated on 13 October 2016 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 11 October 2016 PIL

Reasons for updating

  • New PIL for new product