Zyvox 100mg/5ml Granules for Oral Suspension

Home
Medicines
Zyvox 100mg/5ml Granules for Oral Suspension

« Back to Medicines list

Name:
Zyvox 100mg/5ml Granules for Oral Suspension
Company:
Pfizer Healthcare Ireland
Active Ingredients:
Linezolid
Legal Category:
Product subject to medical prescription which may not be renewed (A)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 25/03/19

(Click to Download)

Summary of Product Characteristics last updated on medicines.ie: 13/2/2017

Print ViewKeyword Search SmPC

1. NAME OF THE MEDICINAL PRODUCT

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

3. PHARMACEUTICAL FORM

4. CLINICAL PARTICULARS

5. PHARMACOLOGICAL PROPERTIES

6. PHARMACEUTICAL PARTICULARS

7. MARKETING AUTHORISATION HOLDER

8. MARKETING AUTHORISATION NUMBER(S)

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

10. DATE OF REVISION OF THE TEXT

Company Products

Medicine Name	Active Ingredients
Medicine Name Nimenrix powder and solvent for solution for injection in pre-filled syringe	Active Ingredients Meningococcal Group A, C, W135 and Y conjugate vaccine
Medicine Name NIPENT 10mg Powder for solution for injection or infusion	Active Ingredients Pentostatin
Medicine Name Nivestim 12 MU/ 0.2 ml solution for injection/infusion, Nivestim 30 MU/ 0.5 ml solution for injection/infusion, Nivestim 48MU/ 0.5 ml solution for injection/infusion	Active Ingredients Filgrastim
Medicine Name Noradrenaline (Norepinephrine) 1:1000, Concentrate for Solution for Infusion	Active Ingredients Noradrenaline tartrate
Medicine Name Noriday Tablets 350 microgram	Active Ingredients Norethisterone
Medicine Name Octreotide 100 micrograms/1 ml Solution for Injection	Active Ingredients octreotide acetate
Medicine Name Octreotide 200 micrograms/ml Solution for Injection	Active Ingredients octreotide acetate
Medicine Name Octreotide 50 micrograms/1 ml Solution for Injection	Active Ingredients octreotide acetate
Medicine Name Octreotide 500 micrograms1 ml Solution for Injection	Active Ingredients octreotide acetate
Medicine Name Ovranette 150micrograms/30micrograms Coated Tablets	Active Ingredients Ethinylestradiol, Levonorgestrel
Medicine Name Pancuronium Bromide 2 mg/ml Solution for Injection	Active Ingredients Pancuronium Bromide
Medicine Name Premarin 0.625 mg Prolonged-release tablets.	Active Ingredients Estrogens Conjugated
Medicine Name Premarin 1.25 mg Prolonged-release tablets.	Active Ingredients Conjugated oestrogens
Medicine Name Prevenar 13 suspension for injection	Active Ingredients Pneumococcal polysaccharide conjugate vaccine
Medicine Name PRO-EPANUTIN	Active Ingredients Fosphenytoin Sodium
Medicine Name Prostin E2 1 mg Vaginal Gel;	Active Ingredients Dinoprostone
Medicine Name Prostin E2 1mg/ml Concentrate for Solution for Infusion	Active Ingredients Dinoprostone
Medicine Name Prostin E2 Vaginal Gel 2 mg	Active Ingredients Dinoprostone
Medicine Name Prostin E2 Vaginal Tablets 3 mg	Active Ingredients Dinoprostone
Medicine Name Provera 10mg Tablets	Active Ingredients Medroxyprogesterone Acetate
Medicine Name Provera 5mg Tablets	Active Ingredients Medroxyprogesterone Acetate
Medicine Name Provera Tablets 100 mg	Active Ingredients Medroxyprogesterone Acetate
Medicine Name Provera Tablets 2.5mg	Active Ingredients Medroxyprogesterone Acetate
Medicine Name Rapamune 0.5mg, 1mg and 2mg coated tablets	Active Ingredients Sirolimus
Medicine Name Rapamune 1 mg/ml oral solution	Active Ingredients Sirolimus

Items Per Page :

151 - 175 of 227 items.Total: 10 pages

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 25 March 2019 PIL

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 SmPC

Reasons for updating

New SmPC for new product

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

Updated on 13 February 2017 SmPC

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 9 February 2017 PIL

Reasons for updating

New PIL for new product

Updated on 9 February 2017 PIL

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 PIL

Reasons for updating

Change to side-effects

Updated on 13 October 2014 SmPC

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 8 October 2014 PIL

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 SmPC

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 PIL

Reasons for updating

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

Updated on 18 June 2013 SmPC

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 PIL

Reasons for updating

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

Updated on 29 April 2013 PIL

Reasons for updating

Change of manufacturer

Updated on 11 February 2013 SmPC

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 2 May 2012 SmPC

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 3 April 2012 SmPC

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 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

SPC changes to sections 7 & 10

Updated on 18 October 2011 PIL

Reasons for updating

Change to marketing authorisation holder

Updated on 23 June 2011 PIL

Reasons for updating

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

Updated on 23 June 2011 SmPC

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 12 November 2010 SmPC

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 9 December 2009 SmPC

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 4 December 2009 PIL

Reasons for updating

Change to side-effects

Updated on 5 August 2009 SmPC

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 PIL

Reasons for updating

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

Updated on 20 November 2008 PIL

Reasons for updating

Change due to user-testing of patient information

Updated on 1 August 2007 SmPC

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 PIL

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 SmPC

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 PIL

Reasons for updating

Change to marketing authorisation holder

Updated on 11 January 2007 SmPC

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 SmPC

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 SmPC

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 PIL

Reasons for updating

Change to side-effects

Updated on 5 April 2005 SmPC

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 4 November 2004 PIL

Reasons for updating

New PIL for medicines.ie

Updated on 30 June 2003 SmPC

Reasons for updating

New SPC for medicines.ie

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