Hemosol B0 solution for haemodialysis/haemofiltration
- Name:
Hemosol B0 solution for haemodialysis/haemofiltration
- Company:
Baxter Healthcare Ltd
- Active Ingredients:
Calcium Chloride, Lactic Acid, Magnesium chloride, Sodium Chloride, Sodium Hydrogen Carbonate
- Legal Category:
Product subject to medical prescription which may not be renewed (A)
Summary of Product Characteristics last updated on medicines.ie: 27/3/2019
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Baxter Healthcare Ltd
Company Products
| Medicine Name | Active Ingredients |
|---|---|
| Medicine Name Hemosol B0 solution for haemodialysis/haemofiltration | Active Ingredients Calcium Chloride, Lactic Acid, Magnesium chloride, Sodium Chloride, Sodium Hydrogen Carbonate |
| Medicine Name PHOXILIUM 1.2 mmol/l phosphate Solution for haemodialysis/ haemofiltration | Active Ingredients Calcium Chloride, Disodium phosphate, Magnesium chloride, Potassium Chloride, Sodium Chloride, Sodium Hydrogen Carbonate |
| Medicine Name Prismasol 4 mmol/l Potassium solution for haemodialysis/haemofiltration | Active Ingredients Calcium Chloride Dihydrate, Glucose Monohydrate, Lactic Acid, Magnesium chloride, hexahydrate, Potassium Chloride, Sodium Chloride, Sodium Hydrogen Carbonate |
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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 27 March 2019
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
Updated on 17 October 2017 PIL
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
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 SPC
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
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 SmPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 10 January 2017 PIL
Reasons for updating
- New SPC for medicines.ie
Free text change information supplied by the pharmaceutical company
None provided
Updated on 10 January 2017 SPC
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