Urografin

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 08/08/19

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Summary of Product Characteristics last updated on medicines.ie: 9/8/2019

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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 9 August 2019 SmPC

Reasons for updating

  • Change to section 5 - Pharmacological properties

Legal category: Product subject to restricted prescription (C)

Updated on 8 August 2019 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - excipient warnings
  • Change to section 6 - what the product contains
  • Change to section 6 - date of revision

Updated on 7 August 2019 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to restricted prescription (C)

Updated on 12 January 2015 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to restricted prescription (C)

Updated on 12 January 2015 PIL

Reasons for updating

  • New PIL for new product

Updated on 12 January 2015 SmPC

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

update to section 4.8 to include HPRA reporting of suspected adverse reaction text

 

Updated on 12 January 2015 PIL

Reasons for updating

  • Change to date of revision
  • Addition of information on reporting a side effect.

Updated on 17 August 2012 SmPC

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 10 - Date of revision of the text
  • Proven or suspected hypersensitivity to iodine-containing contrast media.
  • Manifest hyperthyroidism.
  • Decompensated cardiac insufficiency.

Legal category: Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

Section 4.3:
This section was updated to read:
 "
  • Proven or suspected hypersensitivity to iodine-containing contrast media.
  • Manifest hyperthyroidism.
  • Decompensated cardiac insufficiency.

 

Urografin is not to be used for myelography, ventriculography or cisternography, since it is likely to provoke neurotoxic symptoms (pain, convulsions and coma, often with lethal outcome) in these examinations."

Section 10:
Date of revision of text was changed to "August 2012"

Updated on 13 August 2012 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications

Updated on 4 April 2012 PIL

Reasons for updating

  • Change to date of revision

Updated on 26 October 2011 PIL

Reasons for updating

  • Change to date of revision
  • Change due to user-testing of patient information

Updated on 8 January 2009 SmPC

Reasons for updating

  • Change to section 6.5 - Nature and contents of container

Legal category: Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

Change to incorporate "colourless" into the glass type used.

Updated on 28 November 2008 PIL

Reasons for updating

  • Correction of spelling/typing errors

Updated on 28 November 2008 PIL

Reasons for updating

  • Change of trade or active ingredient name
  • Change to date of revision
  • Change to improve clarity and readability

Updated on 1 November 2007 PIL

Reasons for updating

  • Change of licence holder
  • Change to date of revision

Updated on 17 October 2007 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

Section 7. Marketing Authorisation Holder
The marketing authorisation holder was changed from "HE Clissmann, 72 Heather Road, Dublin 18." to "Bayer Limited, The Atrium, Blackthorn Road, Dublin 18, Ireland.".
 
Section 8. Marketing Authoisatin Number(s)
The Marketing authorisation number was changed from "PA 12/39/2" to "PA 1410/12/1".
 
Section 10. Date of Revision of the Text
The date was changed from "October 2006" to "August 2007"

 

Updated on 14 November 2006 PIL

Reasons for updating

  • Change of contraindications
  • Change to warnings or special precautions for use
  • Change to information about pregnancy or lactation
  • Change to information about driving or using machinery
  • Change to dosage and administration
  • Change to instructions about overdose
  • Change to side-effects

Updated on 14 November 2006 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • 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 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • 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

Legal category: Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

Main Changes to the SPC include:

 

Section 4.1 Therapeutic Indications

No change in indication.

Inclusion of the following warning: Urografin is not to be used for myelography, ventriculography or cisternography, since it is likely to provoke neurotoxic symptoms in these examinations.

Section 4.2 Posology and method of administration

No change to actual dosage.

Addition of general information regarding use of the product including dietary suggestions, advice on hydration, anxiety and use in infants and newborns. Information is also included regarding filming times, warming prior to use and pretesting.

Increased level of detail regarding intravascular use.

Section 4.3 Contraindications

Deletion of the following contraindications:

Thyrotoxicosis.

Hysterosalpingography must not be performed during pregnancy or in the presence of acute inflammatory processes in the pelvic cavity.

Section 4.4 Special warnings and precautions for use

Text has been revised / extended and has been laid out under the following headings:

Hypersensitivity, Thyroid dysfunction, Cardiovascular disease, The elderly, Very poor state of health, Renal failure, Metformin therapy, Cardiovascular disease, CNS disorders, Myeloma and paraproteinemia, Severe liver dysfunction, Phaeochromocytoma, Patients with autoimmune disorders, Myasthenia gravis, Alcoholism, Coagulation.

Section 4.5 Interaction with other medicinal products and other forms of interaction

Inclusion of information regarding use in patients who have received interleukin.

Section 4.6 Pregnancy and lactation

Use during pregnancy:

Inclusion of data from reproduction-toxicological studies.

Use during lactation:

Inclusion of information regarding risk to breast-feeding infants.

Section 4.7 Effects on ability to drive and use machines

Revised text including information regarding the possible effects of rare cases of delayed reactions.

Section 4.8 Undesirable effects

Undesirable effects have been listed according to the frequency of occurrence and system affected.

Undesirable effects listed have been updated according to the most recently available information.

Section 4.9 Overdose

Revised text: Compensation of water and electrolyte losses by infusion; necessary monitoring of renal function; possibility of use of haemodialysis to eliminate contrast medium.

Section 5.1 Pharmacodynamic properties

Addition of table showing the physico-chemical characteristics of Urografin.

Section 5.2 Pharmacokinetic properties

Section updated/extended in line with currently available data.

 

Section 5.3 Preclinical safety data

Section updated/extended in line with currently available data.

Updated on 3 August 2006 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Legal category: Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

Change to Marketing Authorisation Holder address to:
 
HE Clissmann, 72 Heather Road, Dublin 18

Updated on 3 August 2006 PIL

Reasons for updating

  • Change to marketing authorisation holder

Updated on 26 October 2005 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 25 October 2005 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Product subject to restricted prescription (C)