Zometa 4mg/100ml solution for infusion
- Name:
Zometa 4mg/100ml solution for infusion
- Company:
Novartis Ireland Limited
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may not be renewed (A)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 22/01/19
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Novartis Ireland Limited
Company Products
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 8 April 2019 SmPC
Reasons for updating
- File format updated to PDF
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 22 January 2019 PIL
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 21 May 2018 SmPC
Reasons for updating
- Change to MA holder contact details
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 27 June 2017 SmPC
Reasons for updating
- New SmPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 27 June 2017 SmPC
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 21 February 2017 PIL
Reasons for updating
- New PIL for new product
Updated on 21 February 2017 PIL
Reasons for updating
- Change to section 4 - possible side effects
Updated on 29 June 2016 SmPC
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
The following side effect has been added under Renal and urinary disorders:
Acquired Fanconi syndrome with frequency rare
Updated on 19 January 2016 PIL
Reasons for updating
- Change to side-effects
Updated on 8 December 2015 SmPC
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
In Section 4.4 Special warnings and precautions for use Information has been added on osteonecrosis of the external auditory canal
In Section 4.8 Undesirable effects the following has been added as a Very rare side effect; Osteonecrosis of the external auditory canal (bisphosphonate class adverse reaction)
Updated on 13 July 2015 SmPC
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
In Section 4.4 Special Warnings and Precautions for Use; additional information has been provided on Osteonecrosis of the jaw.
Updated on 6 May 2015 SmPC
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 16 February 2015 PIL
Reasons for updating
- Change to MA holder contact details
Updated on 17 December 2014 PIL
Reasons for updating
- Change to warnings or special precautions for use
Updated on 24 October 2014 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
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 5.2 - Pharmacokinetic properties
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
In Section 4.4 Special warnings and precautions for use additional information has been added on “Hypocalcaemia”.
In Section 4.5 Interaction with other medicinal products and other forms of interaction; Caution has been added on taking calcitonin or loop diuretics at the same time as Zometa.
In Section 4.6 Fertility, pregnancy and lactation; The additional statement has been added Women of child-bearing potential should be advised to avoid becoming pregnant.
In Section 4.8 Undesirable effects; Interstitial lung disease has been added as an important identified risks with Zometa . Some side effects have been changed from very rare to rare and terminology has changed.
How to report a side effect has been added.
In Section 5.2 Pharmacokinetic properties; Updated information on an in vitro study has been added.
Updated on 17 February 2014 PIL
Reasons for updating
- Change to side-effects
- Change to marketing authorisation holder
- Addition of information on reporting a side effect.
Updated on 28 November 2013 SmPC
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 6.5 - Nature and contents of container
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
In Section 4.2 Posology and method of administration, typographical changes have been made.
In Section 4.8 Undesirable effects, Arthritis and joint swelling as a symptom of acute phase reaction has been added as a rare adverse reaction and information on the Reporting of suspected adverse reactions has been added.
In section 6.5 Nature and contents of container, information has been changed.
Updated on 26 November 2013 PIL
Reasons for updating
- Change to warnings or special precautions for use
Updated on 24 June 2013 PIL
Reasons for updating
- Change to warnings or special precautions for use
Updated on 18 June 2013 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
- Change to section 4.8 - Undesirable effects
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
In Section 4.4, Special warnings and precautions for use; Information has been added on Hypocalcaemia.
In Section 4.5, Interaction with other medicinal products and other forms of interaction; Information on anti-angiogenic medicinal products when administered with Zometa, and the incidence of ONJ has been added.
In Section 4.8, Undesirable effects; Some very rare side effects and information on Hypocalcaemia-related ADRs have been added.
Updated on 11 March 2013 SmPC
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
In Section 4.4 (Special warnings and precautions for use), severe cases of hypocalcaemia and risk factors for osteonecrosis have been added.
In Section 4.8 (Undesirable effects), additional information on interstitial lung disease has been added.
Updated on 19 July 2012 PIL
Reasons for updating
- Change to date of revision
Updated on 29 February 2012 SmPC
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.8 - Undesirable effects
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.8 has been updated to include information on renal impairment.
Updated on 2 February 2012 SmPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 9 December 2008 PIL
Reasons for updating
- Change to date of revision
- Change to information about pregnancy or lactation
Updated on 30 June 2006 PIL
Reasons for updating
- Change to side-effects
Updated on 2 June 2005 PIL
Reasons for updating
- Improved electronic presentation
Updated on 23 May 2005 PIL
Reasons for updating
- Change to warnings or special precautions for use
Updated on 26 August 2004 PIL
Reasons for updating
- New PIL for medicines.ie