Summary of Product Characteristics
last updated on the eMC:
13/03/2012
When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.
Updated on 13/03/2012 and displayed until Current
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Reasons for adding or updating:
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 6.1 - List of Excipients
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Change to section 6. 5 - Nature and Contents of Container
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Change to section 9 - Date of first Authorisation/renewal of the Authorisation
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Change to section 10 date of revision of the text
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Correction of spelling/typing errors
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| Date of revision of text on the SPC: 30-Jan-2012 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 4.4 (Special warnings and precautions for use) a warning has been added in relation to hypercalcaemia and taking phosphate/vitamin D related medicines concomitantly with paricalcitol. Also, a warning has been added in relation to increased serum creatinine in pre-dialysis patients.
Section 6.1 - polyethylene glycol 400 has been amended to Macrogol 400.
Section 6.5 - Details have been amended in nature and contents of container.
Section 9 - Date of revision has been amended.
Section 10 - Date of revision has been amended.
Minor typographical errors have been corrected
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Updated on 08/03/2012 and displayed until 13/03/2012
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Reasons for adding or updating:
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 6.1 - List of Excipients
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Change to section 6. 5 - Nature and Contents of Container
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Change to section 9 - Date of first Authorisation/renewal of the Authorisation
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 20-Jan-2012 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 4.4 (Special warnings and precautions for use) a warning has been added in relation to hypercalcaemia and taking phosphate/vitamin D related medicines concomitantly with paricalcitol. Also, a warning has been added in relation to increased serum creatinine in pre-dialysis patients.
Section 6.1 - polyethylene glycol 400 has been amended to Macrogol 400.
Section 6.5 - Details have been amended in nature and contents of container.
Section 9 - Date of revision has been amended.
Section 10 - Date of revision has been amended.
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Updated on 06/03/2012 and displayed until 08/03/2012
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Reasons for adding or updating:
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 6.1 - List of Excipients
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Change to section 6. 5 - Nature and Contents of Container
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 01-Nov-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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- Section 4.4 (Special warnings and precautions for use) a warning has been added in relation to hypercalcaemia and taking phosphate/vitamin D related medicines concomitantly with paricalcitol. Also, a warning has been added in relation to increased serum creatinine in pre-dialysis patients.
- Section 6.1 - polyethylene glycol 400 has been amended to Macrogol 400.
- Section 6.5 - Details have been amended in nature and contemnts of container.
- Section 10 - Date of revision has been amended.
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Updated on 22/08/2011 and displayed until 06/03/2012
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Reasons for adding or updating:
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Change to section 5.1 - Pharmacodynamic Properties
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| Date of revision of text on the SPC: 26-Jul-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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5.1
Mechanism of Action
Paricalcitol is a synthetic, biologically active vitamin D analog of calcitriol with modifications to the side chain (D2) and the A (19-nor) ring.
Unlike calcitriol, paricalcitol is a allowing for selective vitamin D receptor (VDR) activation activator. Paricalcitol selectively upregulates the VDR in the parathyroid glands without increasing VDR in the intestine and is less active on bone resorption. Paricalcitol also upregulates the calcium sensing receptor in the parathyroid glands. As a result, paricalcitol reduces parathyroid hormone (PTH) levels by inhibiting parathyroid proliferation and decreasing PTH synthesis and secretion, with minimal impact on calcium and phosphorus levels, and can act directly on bone cells to maintain bone volume and improve mineralization surfaces. Correcting abnormal PTH levels, with normalisation of calcium and phosphorus homeostasis, may prevent or treat the metabolic bone disease associated with chronic kidney disease.
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Updated on 22/03/2011 and displayed until 22/08/2011
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Reasons for adding or updating:
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Change to section 4.8 - Undesirable Effects
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| Date of revision of text on the SPC: 18-Mar-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 4.8: The presentation of the Zemplar Solution for Injection ADR's in Section 4.8 has been re-formatted from CO-START to MeDRA terminoolgy.
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Updated on 01/03/2011 and displayed until 22/03/2011
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Reasons for adding or updating:
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 18-Feb-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.4 has been updated to add a warning regarding chronic hypercalcaemia and it's possible association with generalised vascular calcification and other soft tissue calcification.
Section 4.5 has been updated to add information on interactions with drugs that impair intestinal absorption of fat-soluble vitamins, such as cholestyramine.
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Updated on 29/11/2010 and displayed until 01/03/2011
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Reasons for adding or updating:
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Removal of Black Triangle
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| Date of revision of text on the SPC: 17-Jul-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| The Black Triangle has been removeed from the Zemplar product range.
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Updated on 28/06/2010 and displayed until 29/11/2010
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 17-Jun-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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| The address of the Marketing Authorisation Holder has changed. The date of revision has been updated in respect of this.
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Updated on 18/01/2010 and displayed until 28/06/2010
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Reasons for adding or updating:
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Change to section 5.1 - Pharmacodynamic Properties
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 21-Oct-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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| Section 5.1 has been updated to change the pharmacotherapeutic group from 'vitamin d and analogues A11CC' to 'Anti-parathyroid agents H05BX02'.
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Updated on 03/01/2008 and displayed until 18/01/2010
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Reasons for adding or updating:
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