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

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Pharmacy Only: Prescription

Updated on 03 August 2022

File name

QRD-IE-UKNI-ZERBAXA-LFT-II-0036-BRX-NIP CRT.pdf

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 2 - use in children and adolescents
  • Change to section 3 - use in children/adolescents
  • Change to section 3 - how to take/use
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision
  • Change to other sources of information section
  • Change to information for healthcare professionals

Free text change information supplied by the pharmaceutical company

Updates to PIL following approval of ZERBAXA-II/0036 (paediatric indication cUTI/cIAI) and addition of United Kingdom (Northern Ireland) details.

Updated on 02 August 2022

File name

ZERBAXA-H-C-3772-II-036-PI-en-IE-CRT July 2022 (clean).pdf

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

Updates to SPC following approval of ZERBAXA-II/0036 (paediatric indication cUTI/cIAI).


Updated on 02 March 2021

File name

QRD-ZERBAXA-LFT-IAIN034 Mirabel name change-15022021 (002).pdf

Reasons for updating

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

Updated on 15 January 2021

File name

ZERBAXA-H-C-3772-II-032-PI-en-IE-CRT Dec 2020 (clean) (002).pdf

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 9 - Date of first authorisation/renewal of the authorisation
  • Change to section 10 - Date of revision of the text
  • Correction of spelling/typing errors

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

Free text change information supplied by the pharmaceutical company

Change to Section updated include: 5.1 Pharmacodynamic properties, 9. Date of Renewal of Authorisation, Section 10. Date of Revision of the Text and Correction of spelling/typing errors following approval of II032 EUCAST BPs update.

 

Updated on 03 July 2020

File name

ZERBAXA-H-C-3772-IB-027 QRD PIL IE (002).pdf

Reasons for updating

  • Change to section 6 - date of revision
  • Change to information for healthcare professionals

Updated on 30 June 2020

File name

ZERBAXA-H-C-3772-IB-027-PI-en-IE-CRT June 2020 (clean) (002).pdf

Reasons for updating

  • Change to section 6.3 - Shelf life
  • 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 section 6.3 - Shelf life and 10. Date of revision following approval of IB027 Shelf life extension

 

Updated on 08 May 2020

File name

ZERBAXA-H-C-3772-R-026 QRD PIL (002).pdf.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 5 - how to store or dispose
  • Change to section 6 - date of revision
  • Removal of Black Inverted Triangle

Updated on 01 May 2020

File name

ZERBAXA-H-C-3772-R-026-PI-en-IE-CRT Apr 2020 (clean) (002).pdf.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.3 - Preclinical safety data
  • Change to section 9 - Date of first authorisation/renewal of the authorisation
  • Change to section 10 - Date of revision of the text
  • Removal of Black Inverted Triangle

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

Free text change information supplied by the pharmaceutical company

Changes include: Removal of black triangle for additional monitoring, Sections 4.2 Posology and method of administration, 4.6 Fertility, pregnancy and lactation, 4.8 Undesirable effects, 5.3 Preclinical safety data, 9. Date of First Authorisation/Renewal of the Authorisation and 10. Date of revision following the approval of the Renewal

Updated on 16 September 2019

File name

ZERBAXA II20 New indication QRD PIL (002).pdf

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

File name

ZERBAXA-H-C-3772-II-020-PI-en-IE-CRT Aug 2019 (clean) (002).pdf

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

File name

ZERBAXA_SPC_T017_MAT_June 2018.pdf

Reasons for updating

  • Improved presentation of SPC

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

File name

ZERBAXA_MAT_QRD_PIL (2).pdf

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

File name

ZERBAXA_SPC_T017_MAT_June 2018 (2).docx

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

File name

PIL_16955_72.pdf

Reasons for updating

  • New PIL for new product

Updated on 19 October 2016

Reasons for updating

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

Updated on 13 October 2016

Reasons for updating

  • New SPC for new product

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

Updated on 11 October 2016

Reasons for updating

  • New PIL for new product