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Zyvox 2 mg/ml Solution for Infusion

*
Pharmacy Only: Prescription

  • Company:

    Pfizer Healthcare Ireland Unlimited Company

  • Status:

    No Recent Update

  • Legal Category:

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

  • Active Ingredient(s):

    Linezolid

    *Additional information is available within the SPC or upon request to the company

Updated on 17 October 2024

File name

Reg HCP Leaflet ZY 24_0 & PIL ZY 27_0 2mg-ml Inj IE - clean.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

The PIL has been updated to reflect the SPC change for the MAH name and address

Updated on 17 October 2024

File name

Reg SPC ZY 21_0 2mg-ml IE - clean.pdf

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

The SPC has been updated as follows:

Section 7 Change of MAH name and address. 


Updated on 31 July 2024

File name

Reg SPC ZY 20_3 2mg-ml IE CLEAN.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • 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 SPC has been updated as follows:

Section 4.4 'Special warnings and precautions for use' has been updated with the addition of Rhabdomyolysis

Section 4.8 'Undesirable effects' has been updated to add Rhabdomyolysis with a frequency of 'Rare', and ADR reporting details for HPRA in line with the QRD. 

Section 10 : Date of Revision of the Text.

Updated on 30 July 2024

File name

Reg SPC ZY 20_3 2mg-ml IE CLEAN.pdf

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 SPC has been updated as follows:

Section 4.4 'Special warnings and precautions for use' has been updated with the addition of Rhabdomyolysis

Section 4.8 'Undesirable effects' has been updated to add Rhabdomyolysis with a frequency of 'Rare', and ADR reporting details for HPRA in line with the QRD. 

Section 10 : Date of Revision of the Text.


Updated on 30 July 2024

File name

Reg HCP Leaflet ZY 24_0 & PIL ZY 26_0 2mg-ml Inj IE CLEAN.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 12 April 2024

File name

Reg HCP Leaflet ZY 230 PIL ZY 2502 mg ml Inj IE CLEAN.pdf

Reasons for updating

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

Updated on 20 February 2023

File name

Reg SPC ZY 15_1 2mg-ml IE.pdf

Reasons for updating

  • Document format updated

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

Updated on 08 October 2020

File name

Reg HCP Leaflet ZY 16_2 PIL ZY 19_0 2mg-ml Inj IE - clean.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision
  • Change to information for healthcare professionals

Updated on 13 February 2017

File name

PIL_9208_680.pdf

Reasons for updating

  • New PIL for new product

Updated on 13 February 2017

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 2 - excipient warnings
  • Change to section 3 - dose and frequency
  • Change to section 3 - use in children/adolescents
  • Change to section 3 - how to take/use
  • Change to section 3 - overdose, missed or forgotten doses
  • Change to section 4 - possible side effects
  • Change to section 5 - how to store or dispose
  • Change to section 6 - what the product contains
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - marketing authorisation number
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision
  • Change to information for healthcare professionals
  • Correction of spelling/typing errors

Updated on 10 February 2017

Reasons for updating

  • New SPC for new product

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

Updated on 10 February 2017

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • 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 4.6 - Pregnancy and lactation
  • 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 6.1 - List of excipients
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • 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

The SPC has been updated as follows:

Editorial, formatting and QRD changes to section 1, 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 5.1, 5.2, 5.3, 6.1, 6.4, 6.5, 6.6, 10

Updated on 12 January 2017

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - use in children and adolescents
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 2 - excipient warnings
  • Change to section 3 - dose and frequency
  • Change to section 3 - how to take/use
  • Change to section 3 - overdose, missed or forgotten doses
  • Change to section 4 - possible side effects
  • Change to section 6 - what the product contains
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 11 July 2016

Reasons for updating

  • Change of manufacturer
  • Change to date of revision

Updated on 13 October 2014

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects

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

Free text change information supplied by the pharmaceutical company

Section 4.6 – Fertility, pregnancy and lactation: added wording Fertility In animal studies, linezolid caused a reduction in fertility (see section 5.3).

Section 4.8 – Undesirable effects updated in relation to the frequency of side effects

Updated on 08 October 2014

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to information about pregnancy or lactation
  • Change to date of revision

Updated on 31 October 2013

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6.4 - Special precautions for storage

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

Free text change information supplied by the pharmaceutical company

Update to section 2 and update to 6.4

Updated on 24 October 2013

Reasons for updating

  • Change to date of revision
  • Change to improve clarity and readability

Updated on 14 October 2013

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • Change to section 10 - Date of revision of the text
  • Change to 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

Change to MA Holder
Change to licence holder

Updated on 09 October 2013

Reasons for updating

  • Change of licence holder
  • Change to date of revision
  • Change to marketing authorisation holder

Updated on 09 July 2013

Reasons for updating

  • New individual SPC (was previously included in combined SPC)

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 27 April 2012

Reasons for updating

  • Change to packaging
  • Introduction of new pack/pack size

Updated on 18 October 2011

Reasons for updating

  • Change to marketing authorisation holder

Updated on 23 June 2011

Reasons for updating

  • Change to information about driving or using machinery
  • Change to side-effects

Updated on 12 November 2010

Reasons for updating

  • Change to side-effects

Updated on 11 November 2010

Reasons for updating

  • Change to side-effects

Updated on 04 December 2009

Reasons for updating

  • Change to side-effects

Updated on 28 July 2009

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to drug interactions

Updated on 20 November 2008

Reasons for updating

  • Change due to user-testing of patient information

Updated on 18 August 2008

Reasons for updating

  • Correction of spelling/typing errors

Updated on 18 May 2007

Reasons for updating

  • Change to, or new use for medicine
  • Change to side-effects
  • Change to warnings or special precautions for use

Updated on 15 January 2007

Reasons for updating

  • Change to marketing authorisation holder

Updated on 22 June 2005

Reasons for updating

  • Change to side-effects

Updated on 11 April 2005

Reasons for updating

  • Change to dosage and administration

Updated on 23 March 2005

Reasons for updating

  • Change to dosage and administration
  • Change to date of revision

Updated on 12 January 2005

Reasons for updating

  • New PIL for medicines.ie