Zometa 4mg/100ml solution for infusion

  • Name:

    Zometa 4mg/100ml solution for infusion

  • Company:
    info
  • Active Ingredients:

    Zoledronic acid

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 28/11/19

files-icon(Click to Download)
Summary of Product Characteristics last updated on medicines.ie: 8/4/2019

Click on this link to Download PDF directly

Novartis Ireland Limited

Novartis Ireland Limited

Company Products

Medicine NameActive Ingredients
Medicine Name Aclasta 5 mg solution for infusion Active Ingredients Zoledronic acid monohydrate
Medicine Name Afinitor Tablets Active Ingredients Everolimus
Medicine Name Aimovig Active Ingredients Erenumab
Medicine Name Atriance 5 mg/ml solution for infusion Active Ingredients Nelarabine
Medicine Name Azarga 10mg/ml + 5mg/ml eye drops, suspension Active Ingredients Brinzolamide, Timolol Maleate
Medicine Name Azopt 10mg/ml eye drops suspension Active Ingredients Brinzolamide
Medicine Name Cataflam 50 mg Coated Tablets Active Ingredients Diclofenac Potassium
Medicine Name Certican Tablets Active Ingredients Everolimus
Medicine Name CILOXAN 3 mg/ml ear drops, solution Active Ingredients Ciprofloxacin hydrochloride
Medicine Name Co-Diovan 160 mg/12.5 mg film-coated tablets Active Ingredients Hydrochlorothiazide, Valsartan
Medicine Name Co-Diovan 160mg/25mg film-coated tablets Active Ingredients Hydrochlorothiazide, Valsartan
Medicine Name Co-Diovan 320mg/12.5mg film-coated tablets Active Ingredients Hydrochlorothiazide, Valsartan
Medicine Name Co-Diovan 320mg/25mg film-coated tablets Active Ingredients Hydrochlorothiazide, Valsartan
Medicine Name Co-Diovan 80mg/12.5mg film-coated tablets Active Ingredients Hydrochlorothiazide, Valsartan
Medicine Name Cosentyx 150 mg solution for injection in pre-filled pen Active Ingredients secukinumab
Medicine Name Desferal 500mg Vials Active Ingredients Desferrioxamine Mesylate
Medicine Name Diovan 160 mg film-coated tablets Active Ingredients Valsartan
Medicine Name Diovan 320mg film-coated tablets Active Ingredients Valsartan
Medicine Name Diovan 3mg/ml Oral Solution Active Ingredients Valsartan
Medicine Name Diovan 40 mg film-coated tablets Active Ingredients Valsartan
Medicine Name Diovan 80 mg film-coated tablets Active Ingredients Valsartan
Medicine Name DuoTrav Eye Drops Solution Active Ingredients Timolol Maleate, Travoprost
Medicine Name Entresto 24mg/26mg, 49mg/51mg and 97mg/103mg film-coated tablets Active Ingredients Sacubitril, Valsartan
Medicine Name Estradot Transdermal Patches Active Ingredients Estradiol Hemihydrate
Medicine Name Eucreas 50mg / 850mg and 50mg / 1000mg film-coated tablets Active Ingredients Metformin Hydrochloride, Vildagliptin
1 - 0 of 116 items.Total: Infinity pages

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 28 November 2019 PIL

Reasons for updating

  • Change to improve clarity and readability

Updated on 28 November 2019 PIL

Reasons for updating

  • Improved presentation of PIL

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

In Section 4.4 Special warnings and precautions for use

Information has been added on Osteonecrosis of other sites along with the jaw

 

In Section 4.8 Undesirable effects

Osteonecrosis of other anatomical sites including femur and hip has been added as a very rare side effect

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 4.2, Posology and method of administration; references have been made to the package leaflet and patient reminder card.

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

Change in Address.

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 4.5 has been updated to include the statement on ONJ cases received in relation to concomitant use of Zometa with anti-angiogenic medicinal products.
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

None provided

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