Hemosol B0 solution for haemodialysis/haemofiltration *

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 19 April 2021

File name

ie_spc_Hemosol B0_PA2299-051-002_April 2021_1618844746.pdf

Reasons for updating

  • 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)

Updated on 16 December 2020

File name

ie_spc_Hemosol B0_PA2299-051-002_Dec 2020_1608110096.pdf

Reasons for updating

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

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

Updated on 27 March 2019

File name

ie-spc-2019-03-hemosolb0-785005002-c_1553707061.pdf

Reasons for updating

  • 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)

Updated on 17 October 2017

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • 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 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

Modification of the SmPC sections 2, 3, 4.2, 4.4, 4.5, 4.6, 4.8, 4.9, 5.1, 6.5, 6.6, 7 and 10

Section 2 - removal of text - Theoretical Osmolarity   287 mOsm/1
Section 3 - removal of text - Theoretical Osmolarity   287 mOsm/1
Section 4.2 major change in text
Section 4.4 major change in text
Section 4.5 major change in text
Section 4.6 addition of text - Pregnancy and breastfeeding and Fertility - There are no clinical data on fertility.  However no effects on fertility are anticipated
Section 4.8 major changes in text and addition of a table
Section 4.9 major text changes
Section 5.1 addition of two headings - Pharmacodynamic effects and Mechanism of action - deletion of the work Bicarbonate under heading Mechanism of action
Section 6.5 deletion of text frangible pin (PC) or
Section 6.6 major text changes
Section 7 - address change
Section 10 date change

Updated on 17 October 2017

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • 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 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • 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

Modification of the SmPC sections 2, 3, 4.2, 4.4, 4.5, 4.6, 4.8, 4.9, 5.1, 6.5, 6.6, 7 and 10

Section 2 - removal of text - Theoretical Osmolarity   287 mOsm/1
Section 3 - removal of text - Theoretical Osmolarity   287 mOsm/1
Section 4.2 major change in text
Section 4.4 major change in text
Section 4.5 major change in text
Section 4.6 addition of text - Pregnancy and breastfeeding and Fertility - There are no clinical data on fertility.  However no effects on fertility are anticipated
Section 4.8 major changes in text and addition of a table
Section 4.9 major text changes
Section 5.1 addition of two headings - Pharmacodynamic effects and Mechanism of action - deletion of the work Bicarbonate under heading Mechanism of action
Section 6.5 deletion of text frangible pin (PC) or
Section 6.6 major text changes
Section 7 - address change
Section 10 date change

Updated on 17 October 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 January 2017

Reasons for updating

  • New SPC for medicines.ie

Free text change information supplied by the pharmaceutical company

None provided

Updated on 10 January 2017

Reasons for updating

  • New SPC for medicines.ie

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

Free text change information supplied by the pharmaceutical company

None provided