Xofigo 1100 kBq/mL solution for injection

  • Name:

    Xofigo 1100 kBq/mL solution for injection

  • Company:
    info
  • Active Ingredients:

    radium-223 dichloride

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 21/12/18

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Summary of Product Characteristics last updated on medicines.ie: 26/11/2019
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions.

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Bayer Limited

Bayer Limited

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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 26 November 2019 SmPC

Reasons for updating

  • 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

Section 6.5: Update - Colourless Type I glass vial closed with a grey brompbutyl rubber stopper or a brompbutyl rubber stopper  either with or without foil-clad made of Ethylene tertrafluoroethylene (ETFE), both capped with alumnium seal, containing 6 ml of solution for injection.

 

 

Updated on 21 December 2018 PIL

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 2 - what you need to know - contraindications
  • 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 4 - possible side effects

Updated on 24 October 2018 PIL

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - interactions with other medicines, food or drink

Updated on 17 October 2018 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties

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

Updated on 31 July 2018 SmPC

Reasons for updating

  • Change to section 10 - Date of revision of the text

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

Free text change information supplied by the pharmaceutical company

Adding date of revision of the text to PDF file. No other changes.

Updated on 9 July 2018 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
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 5.1 - Pharmacodynamic properties

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

Free text change information supplied by the pharmaceutical company

Changes made to 4.2 Posology and method of administration -

Addition of 'Special Populations' heading.

Formatting Changes - " There is no relevant use of Xofigo in the paediatric population in the indication of prostate cancer."

Changes made to 4.4 Special warnings and precautions for use

Excipients with known effect  - Addition of WHO recommended intake - Depending on the volume administered, this medicinal product can contain up to 2.35 mmol (54 mg) sodium per dose, equivalent to 2.7% of the WHO recommended maximum daily intake of 2 g sodium for an adult.

Changes made to 4.7 Effects on ability to drive and use machines  - formatting changes - Xofigo has no or negligible influence on the ability to drive and use machines.

5.1 Pharmacodynamic properties - Formatting changes to Pharmacotherapeutic group:

5.1 Pharmacodynamic properties - Paediatric population  - "The European Medicines Agency has waived the obligation to submit the results of studies with Xofigo in all subsets of the paediatric population in the treatment of all conditions included in the category of malignant neoplasms (except central nervous system tumours, haematopoietic and lymphoid tissue neoplasms) and in the treatment of multiple myeloma (see section 4.2 for information on paediatric use)."

 

 

 

 

 

 

 

Updated on 9 July 2018 PIL

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - excipient warnings
  • Change to section 4 - possible side effects
  • Change to section 6 - what the product looks like and pack contents

Updated on 15 May 2018 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 11 - Dosimetry

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

Updated on 24 April 2018 SmPC

Reasons for updating

  • Change to section 4.3 - Contraindications

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

Free text change information supplied by the pharmaceutical company

Update to Section 4.3, 4.4 and 5.1

Updated on 29 March 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 29 March 2018 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions

Updated on 18 April 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 18 April 2017 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

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

Free text change information supplied by the pharmaceutical company

The MA Holder has changed from:
Bayer Pharma AG, 13342 Berlin, Germany
to
Bayer AG, 51368 Leverkusen, Germany

The date of revision is now April 2017

Updated on 7 April 2017 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 14 July 2016 PIL

Reasons for updating

  • Addition of information on reporting a side effect.

Updated on 6 April 2016 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 10 - Date of revision of the text
  • Change to section 12 - Instructions for preparation of radiopharmaceuticals

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

Free text change information supplied by the pharmaceutical company



Following revision of the primary standardisation for radium-223 by the National Institute of Standards and Technology (NIST) in 2015, the numerical value of the radioactivity concentration (in Bq/mL) contained in vials of Xofigo and hence the patient dose in Bq/kg body weight increased by approx. 10%. It is a change only in the numerical value of the radioactive content and patient dose of Xofigo and comes into effect once the product released according to the updated NIST 2015-traceable reference material becomes available from April 14th, 2016 onwards.

 

The main changes are:

o             an increase of the nominal value for the radioactivity from 1000 kBq/mL to 1100 kBq/mL at reference date and

o             an apparent increase in patient dose, from 50 kBq/kg body weight to 55 kBq/kg body weight.

 

This does not reflect a real change in the actual product radioactivity or in the amount of radioactivity given to the patient and therefore will not impact the safety and efficacy of Xofigo (radium-223 dichloride).

Updated on 6 April 2016 PIL

Reasons for updating

  • Change to, or new use for medicine
  • Change to date of revision
  • Change to dosage and administration

Updated on 17 February 2015 SmPC

Reasons for updating

  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text

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

Free text change information supplied by the pharmaceutical company


Section 6.6 has been revised from

Colourless Type I glass vial closed with a grey chlorobutyl rubber stopper and aluminium seal, containing 6 mL of solution for injection.


to

Colourless Type I glass vial closed with a grey bromobutyl rubber stopper with foil-clad made of Ethylene tetrafluoroethylene (ETFE) and aluminium seal, containing 6 mL of solution for injection.

Updated on 17 February 2015 PIL

Reasons for updating

  • Change to further information section

Updated on 29 April 2014 PIL

Reasons for updating

  • Change to date of revision
  • Correction of spelling/typing errors

Updated on 20 January 2014 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 20 January 2014 PIL

Reasons for updating

  • New PIL for new product