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Zyvox 100mg/5ml Granules for Oral Suspension

*
Pharmacy Only: Prescription

  • Company:

    Pfizer Healthcare Ireland

  • 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 14 February 2023

File name

DEC202005631_Reg SPC ZY 17_1 100mg per 5ml IE - clean.pdf

Reasons for updating

  • Document format updated

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

Updated on 30 January 2020

File name

DEC202005631_Reg SPC ZY 17_1 100mg per 5ml IE - clean.pdf

Reasons for updating

  • Change to section 3 - Pharmaceutical form

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 3 Pharmaceutical form has been updated (description

Updated on 30 January 2020

File name

DEC202005631_Reg PIL ZY 16_1 100mg_5ml UK & IE-clean.pdf

Reasons for updating

  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision

Updated on 25 March 2019

File name

DEC201914718_Reg PIL ZY 15_1 100mg_5ml UK & IE - clean.pdf

Reasons for updating

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

Updated on 13 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 13 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, 2, 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 4.8, 5.1, 5.2, 5.3, 6.1, 6.2, 6.3, 6.4, 6.6, 10

Updated on 09 February 2017

File name

PIL_8799_343.pdf

Reasons for updating

  • New PIL for new product

Updated on 09 February 2017

Reasons for updating

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

Updated on 10 July 2015

Reasons for updating

  • Change to side-effects

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 29 October 2013

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 6.1 - List of excipients

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
update section 4.4
section 6.1.

Updated on 23 October 2013

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to date of revision

Updated on 18 June 2013

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • Change to marketing authorisation holder
  • Change to MA holder contact details

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

Free text change information supplied by the pharmaceutical company

Change from Pharmacia to Pfizer Healthcare Ireland

Updated on 13 June 2013

Reasons for updating

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

Updated on 29 April 2013

Reasons for updating

  • Change of manufacturer

Updated on 11 February 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

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 7 & Section 8

Updated on 02 May 2012

Reasons for updating

  • Change to section 6.5 - Nature and contents of container

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

Free text change information supplied by the pharmaceutical company

Section 6.5 amended to reflect the addition of the new freeflex bags for the IV dosage form.

Updated on 03 April 2012

Reasons for updating

  • 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

New date added to section 10

Updated on 20 October 2011

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

SPC changes to sections 7 & 10

Updated on 18 October 2011

Reasons for updating

  • Change to marketing authorisation holder

Updated on 23 June 2011

Reasons for updating

  • 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

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

Free text change information supplied by the pharmaceutical company

Updated sections 4.4, 4.5, 4.7 & 4.8

Updated on 23 June 2011

Reasons for updating

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

Updated on 12 November 2010

Reasons for updating

  • 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

SmPC : Addition of Toxic Epidermal Necrolysis as an adverse event in section 4.8.

Updated on 09 December 2009

Reasons for updating

  • 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

Alopecia has been added as an Adverse Event – also post marketing adverse events have been added to AE Frequency Table (as reported post marketing actual frequency cannot be estimated from the available data – so assigned – “Not Known”)

Updated on 04 December 2009

Reasons for updating

  • Change to side-effects

Updated on 05 August 2009

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 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • 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

Paediatric Wording -

To update sections 4.2 (Posology and method of administration), 4.8 (Undesirable effects), 5.1 (Pharmacodynamic properties) and 5.2 (Pharmacokinetic properties) of the SPC and consequentially the leaflet following the assessment of the paediatric data submitted as part of the European Paediatric Worksharing project.

 


To update sections 4.4 (Special warnings and precautions for use) and 4.5 (Interaction with other medicinal products and other forms of interaction) of the SPC and consequentially the PIL by adding some warnings according to the company core data sheet.


 

To update section 4.8 (Undesirable effects) of the SPC and consequentially the leaflet by adding Pseudomembranous colitis and tooth discoloration as undesirable effects according to the company core data sheet.

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 01 August 2007

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties

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

Free text change information supplied by the pharmaceutical company

 

5.1 Update of information on breakpoints, susceptibility and resistance.

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 16 May 2007

Reasons for updating

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

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

Free text change information supplied by the pharmaceutical company

 

Section 4.1

 

Community acquired and nosocomial pneumonia.

 

Addition of a statement “Linezolid is not active against infections caused by Gram negative pathogens. Specific therapy against Gram negative organisms must be initiated concomitantly if a Gram negative pathogen is documented or suspected.”

 

Complicated skin and soft tissue infections.

 

Addition of statement “Zyvox is indicated for the treatment of complicated skin and soft tissue infections only when microbiological testing has established that the infection is known to be caused by susceptible Gram positive bacteria.”

 

Addition of “such as a microbiologist or infectious diseases specialist” following the statement starting “Linezold should only……”

 

Deletion of the statement. “Combination therapy will be necessary if a concomitant Gram negative pathogen is documented or suspected.”

 

 

 

Section 4.4

 

Addition of warning “In complicated skin and soft tissue infections linezolid should only be used in patients with known or possible co-infection with Gram negative organisms if there are no alternative tre  atment options available. In these circumstances treatment against Gram negative organisms must be initiated concomitantly.”

 

Addition of statement regarding convulsions and the following “Patients should be advised to inform their physician if they have a history of seizures.”

 

Section 4.8

 

Section has been reformatted also additional adverse events anaphylaxis and angioedema have been added

 

Section 5.1

 

Removal of the statement that linezolid has in vitro activity against some Gram negative bacteria.

 

Section 5.3

 

Information regarding studies in mice and rats has been added.

Updated on 15 January 2007

Reasons for updating

  • Change to marketing authorisation holder

Updated on 11 January 2007

Reasons for updating

  • 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 4.8 - Undesirable effects
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.3 - Shelf life
  • 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

 
Section 4.4: Statement included reporting incidences of serious anaemia and lactic acidosis in compassionate use studies
 
Section 4.5: Section updated with one report of a patient experiencing serotonin syndrome-like effects while taking linezolid (Post Marketing experience). Review of selective serotonin re-uptake inhibitors (SSRI) contraindication
 
Section 4.8: addition of anaemia and lactic acidosis based on controlled clinical trials and post marketing experience
 
Section 5.2: Section updated with Pharmacokinetic properties in children and adolescents
 
Section 6.3: Shelf life extended to 3 years for Zyvox 600mg Tablets only
 
Section7 – MAH address updated

Updated on 11 November 2005

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use

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

Updated on 24 June 2005

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

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

Updated on 22 June 2005

Reasons for updating

  • Change to side-effects

Updated on 05 April 2005

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.2 - Pharmacokinetic properties

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

Updated on 04 November 2004

Reasons for updating

  • New PIL for medicines.ie

Updated on 30 June 2003

Reasons for updating

  • New SPC for medicines.ie

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