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Abbott Laboratories Limited
Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire, SL6 4XE, UK
Telephone: +44 (0)1628 773 355
Fax: +44 (0)1628 644 185
WWW: http://www.abbottuk.com
Medical Information e-mail: ukmedinfo@abbott.com
Out of Hours Telephone: +44 (0)1628 774 920

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?
Summary of Product Characteristics last updated on the eMC: 22/08/2011
SPC Zemplar Soft Capsules 1, 2 and 4 mcg

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 22/08/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 5.1 - Pharmacodynamic Properties
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


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.

 
Updated on 22/03/2011 and displayed until 22/08/2011
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
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
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.
Updated on 01/03/2011 and displayed until 22/03/2011
Reasons for adding or 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 10 date of revision of the text
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


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.
Updated on 29/11/2010 and displayed until 01/03/2011
Reasons for adding or updating:
  • Removal of Black Triangle
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
The Black Triangle has been removeed from the Zemplar product range.
Updated on 28/06/2010 and displayed until 29/11/2010
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 10 date of revision of the text
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
The address of the Marketing Authorisation Holder has changed. The date of revision has been updated in respect of this.
Updated on 18/01/2010 and displayed until 28/06/2010
Reasons for adding or updating:
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 10 date of revision of the text
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
Section 5.1 has been updated to change the pharmacotherapeutic group from 'vitamin d and analogues A11CC' to 'Anti-parathyroid agents H05BX02'.
Updated on 03/01/2008 and displayed until 18/01/2010
Reasons for adding or updating:
  • New SPC for new product

Active Ingredients/Generics

 
  paricalcitol