Zerbaxa 1 g/0.5 g powder for concentrate for solution for infusion
*Company:
MSD Ireland (Human Health) LimitedStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
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
MSD Ireland (Human Health) Limited
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Address:
Red Oak North, South County Business Park, Leopardstown, Dublin 18, IrelandMedical Information E-mail:
medinfo_ireland@msd.comTelephone:
+353 1 299 8700Website:
https://www.msd.ie