Zemplar 1 microgram capsules, soft

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Zemplar 1 microgram capsules, soft

Name:
Zemplar 1 microgram capsules, soft
Company:
AbbVie Limited
Active Ingredients:
Paricalcitol
Legal Category:
Product subject to medical prescription which may be renewed (B)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 29/04/19

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Medicine Name Sevorane	Active Ingredients Sevoflurane
Medicine Name Zemplar 1 microgram capsules, soft	Active Ingredients Paricalcitol
Medicine Name Zemplar 2 micrograms capsules, soft	Active Ingredients Paricalcitol
Medicine Name Zemplar 5 microgram/ml Solution for Injection	Active Ingredients Paricalcitol

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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 29 April 2019 PIL

Reasons for updating

Correction of spelling/typing errors

Updated on 27 March 2019 PIL

Reasons for updating

Change to section 6 - date of revision
Change to other sources of information section

Updated on 18 July 2018 SmPC

Reasons for updating

File format updated to PDF

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 23 March 2018 SmPC

Reasons for updating

New SmPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 23 March 2018 SmPC

Reasons for updating

Change to section 3 - Pharmaceutical form
Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

$0SmPC for Zemplar 1mcg ang 2 mcg capsules updated toreflect approval of V88 - Type IA grouped variation toremove the Abbot logo from the capsules and to delete obsolete specification.$0$0 $0$0The following is summary of changes:$0$0 $0$0Section 3Pharmaceutical form$0$0Removal of Abbot logo from capsules.$0$0 $0$0Section10. Date of revision of the text$0$0Updated to March 2018.$0

Updated on 22 March 2018 PIL

Reasons for updating

New PIL for new product

Updated on 22 March 2018 PIL

Reasons for updating

Change to section 6 - what the product looks like and pack contents
Change to section 6 - date of revision

Updated on 21 March 2018 SmPC

Reasons for updating

Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Date of revision of text corrected to March 2018. No other changes to the text were made.

Updated on 20 March 2018 SmPC

Reasons for updating

Change to section 3 - Pharmaceutical form
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 4.5 - Interaction with other medicinal products and other forms of interaction
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 be renewed (B)

Free text change information supplied by the pharmaceutical company

$0SmPC for Zemplar 1mcg ang 2 mcg capsules updated toreflect approval of V82 Paediatric Label Update.$0$0The following is summary of changes:$0$0 $0$0Section 3Pharmaceutical form$0$0Removal of Abbot logo from capsules.$0$0 $0$0Section 4.1 Therapeutic indications$0$0Update to include paediatric subgroup into therapeutic indication. $0$0 $0$0Section 4.2Posology and method of administration$0$0Update to include information on paediatric dosing.$0$0 $0$0Section4.4 Special warnings and precautions for use$0$0Minor typo corrections.$0$0 $0$0Section 4.5 Interaction withother medicinal products and other forms of interaction$0$0Minor typo corrections.$0$0 $0$0Section4.8 Undesirable effects$0$0Update to safety profile to add paediatricinformation. Adverse reaction table updated. $0$0$0Section5.1 Pharmacodynamic properties$0$0Major update to the section – paediatric populationdata added $0$0$0$0Section5.2 Pharmacokinetic properties$0$0Paediatric population added under Special Populationheading. Minot typo corrections.$0$0 $0$0Section10. Date of revision of the text$0$0Updated to February 2018.$0

Updated on 19 March 2018 PIL

Reasons for updating

Change to section 1 - what the product is used for
Change to section 3 - dose and frequency
Change to section 3 - use in children/adolescents
Change to section 4 - possible side effects
Change to section 6 - what the product looks like and pack contents
Change to section 6 - date of revision

Updated on 7 December 2017 PIL

Reasons for updating

Change to Section 1 - what the product is
Change to section 2 - what you need to know - warnings and precautions
Change to section 2 - interactions with other medicines, food or drink
Change to section 2 - pregnancy, breast feeding and fertility
Change to section 4 - possible side effects
Change to section 6 - manufacturer
Change to section 6 - date of revision
Correction of spelling/typing errors

Updated on 11 March 2016 SmPC

Reasons for updating

Change to MA holder contact details

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Ø Update the IE MAH address:

Present:

Proposed:

AbbVie Limited

Block B

Liffey Valley Office Campus

Quarryvale

Co. Dublin

AbbVie Limited

Citywest Business Campus

Dublin 24

Ireland

Updated on 10 March 2016 PIL

Reasons for updating

Change to MA holder contact details

Updated on 17 November 2015 PIL

Reasons for updating

Change to side-effects

Updated on 17 November 2015 SmPC

Reasons for updating

Change to section 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Update section 4.8 of the Summary of Product characteristics (SmPC) and PL for Zemplar 1mcg and 2mcg Capsules to include a single tabulated list of all Adverse reactions (ADR) with their respective frequency category.

Updated on 23 September 2015 PIL

Reasons for updating

Change to MA holder contact details

Updated on 18 June 2015 PIL

Reasons for updating

Addition of manufacturer

Updated on 27 November 2014 SmPC

Reasons for updating

Change to section 4.2 - Posology and method of administration

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

To update Section 4.2 of the SPC to include dosing on renal transplant patients.

Updated on 26 November 2014 PIL

Reasons for updating

Change to warnings or special precautions for use

Updated on 11 September 2014 PIL

Reasons for updating

Correction of spelling/typing errors

Updated on 29 July 2014 SmPC

Reasons for updating

Change to Section 4.8 – Undesirable effects - how to report a side effect

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

To update the section 4.8 of the SPC and section 4 of the PIL in accordance with the update to CCDS03570713 adverse reactions.

Updated on 23 July 2014 PIL

Reasons for updating

Change to side-effects
Addition of information on reporting a side effect.

Updated on 17 July 2013 SmPC

Reasons for updating

Change to section 4.4 - Special warnings and precautions for use
Change to section 4.8 - Undesirable effects
Change to section 6.1 - List of excipients
Change to section 6.5 - Nature and contents of container
Change to section 7 - Marketing authorisation holder
Change to section 8 - MA number

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

- Section 4.4:

The following text was added:

Phosphate or vitamin D-related medicinal products should not be taken concomitantly with

paricalcitol due to an increased risk of hypercalcaemia and Ca x P product elevation (see Section

4.5).

In pre-dialysis patients, paricalcitol, like other vitamin D receptor activators, may increase

serum creatinine (and therefore decrease the estimated GFR [eGFR]) without changing true

glomerular filtration rate (GFR).

- Section 6.1:

The composition of the Black ink was updated to replace Polyethylene glycol 400 with Macrogal 400.

- Section 6.5:

This section was updated with e following text

High-density polyethylene (HDPE) bottles closed with children resistant polypropylene caps. Each bottle contains 30 capsules.

PVC/fluoropolymer/aluminium blister strips containing 7 capsules. Each carton contains 1 or 4 blisters strips. Packaged in outer cartons containing either 7 or 28 capsules.

- Section 7:

This section was update to AbbVie name and Address:

AbbVie Limited

Block B

Liffey Valley Office Campus

Quarryvale

Co. Dublin

- Section 8:

PA number updated to AbbVie new PA, PA 1824/5/1

Updated on 12 July 2013 PIL

Reasons for updating

Change to further information section
Change to MA holder contact details

Updated on 8 August 2011 SmPC

Reasons for updating

Change to section 4.8 - Undesirable effects
Change to section 5.1 - Pharmacodynamic properties

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

SPC section 4.8 - to reformat the Zemplar Solution for Injection ADR's in the Zemplar Capsules SPC
SPC section 5.1 - to inlcude 'Unlike calcitriol, paracalcitol is a selective Vitamin D receptor (VDR) activator' in line with WHO reclassification of paricalcitol from 'Vitamin D analogs' (ATC Code: A11CC) to 'Anti-parathyroid agents' (ATC Code: HO5BX).

Updated on 25 February 2011 SmPC

Reasons for 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

Legal category: Product subject to medical prescription which may be renewed (B)

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 23 February 2011 PIL

Reasons for updating

Change to drug interactions

Updated on 29 July 2010 SmPC

Reasons for updating

Change to joint SPC covering all presentations

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Removal of 4mcg presentation from joint SPC as presentation not marketed

Updated on 28 July 2010 PIL

Reasons for updating

Change to MA holder contact details

Updated on 13 January 2010 SmPC

Reasons for updating

Change to section 5.1 - Pharmacodynamic properties
Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 5.1 updated to change the pharmacotherapeutic group from 'Vitamin D and analogues A11CC' to 'Anti-parathyroid agents H05BX02'.

Updated on 21 July 2008 PIL

Reasons for updating

Change to date of revision
Change to name of manufacturer

Updated on 13 February 2008 PIL

Reasons for updating

New PIL for new product

Updated on 11 February 2008 SmPC

Reasons for updating

New SPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)