Quofenix 300 mg powder for concentrate for solution for infusion *

  • Company:

    A. Menarini Pharmaceuticals Ireland Ltd
  • Status:

    No Recent Update
  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)
  • Active Ingredient(s):

    This medicinal product is subject to additional monitoring.

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

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 07 April 2021

File name

ie-smpc Quofenix powder for solution March 2021_1617783786.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 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

Section 4.1 - Addition of new indication - community-acquired pneumonia (CAP)

Section 4.2 - New information added for CAP

Section 4.4 - Limitations of the clinical data section updated to include information on CAP

Section 4.8 - New information added for CAP and frequencies updated

Section 5.1 - Section updated with new info on CAP

Section 5.2 - New information added for distribution 

Section 10 - Date of revision updated

Updated on 07 April 2021

File name

ie-PIL Powder for Solution March 2021_1617783364.pdf

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 3 - how to take/use
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

Change to section 1 - Addition of new Indication - Pneumonia

Change to section 3 - How to use Quofenix - new details added for Pneumonia

Change to section 4 - Section updated with new and updated information around frequencies 

Change to section 4 - Date of revision updated

Updated on 03 December 2020

File name

ie-pl powder for solution Clean 09-11-20_1606993680.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 6 - date of revision

Free text change information supplied by the pharmaceutical company

The changes relate to the requested actions following the PRAC recommendation concerning the signal of “heart valve regurgitation, cervical artery dissection and aortic aneurysm and dissection” associated with Fluoroquinolones intake.

 The following sections are updated:

2.         What you need to know before you take Quofenix

Warnings and precautions

…Talk to your doctor or pharmacist or nurse before taking Quofenix if:

 

4.         Possible side effects

 

Updated on 03 December 2020

File name

ie-smpc Quofenix powder for solution Clean 09-11-20_1606993587.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 changes relate to the requested actions following the PRAC recommendation concerning the signal of “heart valve regurgitation, cervical artery dissection and aortic aneurysm and dissection” associated with Fluoroquinolones intake.

The following sections are updated:

Section 4.4     Special warnings and precautions for use

 [..] 

Aortic dissection and aneurysm, and heart valve regurgitation/incompetence

Further information added.

 

Section 4.8     Undesirable effects

Cardiac disorders** 

Vascular disorders**   

** Cases of aortic aneurysm and dissection, sometimes complicated by rupture (including fatal ones), and of regurgitation/incompetence of any of the heart valves have been reported in patients receiving fluoroquinolones (see section 4.4).

 

Updated on 28 May 2020

File name

ie-smpc Quofenix powder for solution 16-12-19_1590674169.pdf

Reasons for updating

  • New SPC for new product

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

Updated on 28 May 2020

File name

ie-pl powder for solution 16-12-19_1590674121.pdf

Reasons for updating

  • New PIL for new product