Ultravist 300 mg/ml Solution for injection (50 ml, 75 ml, 100 ml, 150 ml and 200 ml)

  • Name:

    Ultravist 300 mg/ml Solution for injection (50 ml, 75 ml, 100 ml, 150 ml and 200 ml)

  • Company:
    info
  • Active Ingredients:

    Iopromide

  • Legal Category:

    Product subject to restricted prescription (C)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 14/03/17

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Summary of Product Characteristics last updated on medicines.ie: 14/7/2015
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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 14 March 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 14 July 2015 PIL

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text
  • Introduction of new pack/pack size

Free text change information supplied by the pharmaceutical company

Ultravist – PA 1410/11/3
15143
BEC 5590
www.medicines.ie

(Inserted Text; Deleted Text)

 

1              Name of the medicinal product

Ultravist 300 mg/ml Solution for injection  (50 ml, 75 ml, 100 ml, 150ml, and 200ml and 500ml)

 

6.5          Nature and contents of container

 

Infusion bottles:               Glass type II

Stopper:                              Stopper type I, chlorobutyl-elastomer

 

Presentation:

 

Ultravist 300:

 

Bottles of 50, 75, 100, 150, and 200ml and 500ml

Cartons contain:               10 bottles of 50ml

                                                10 bottles of 75ml

                                                1 bottle of 100ml

                                                1 bottle of 150ml

                                                1 bottle of 200ml

                                                1 bottle of 500ml

 

10           Date of revision of the text

December 2014 July 2015

 

Updated on 14 July 2015 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text
  • Introduction of new pack/pack size

Legal category: Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

Ultravist – PA 1410/11/3
15143
BEC 5590
www.medicines.ie

(Inserted Text; Deleted Text)

 

1              Name of the medicinal product

Ultravist 300 mg/ml Solution for injection  (50 ml, 75 ml, 100 ml, 150ml, and 200ml and 500ml)

 

6.5          Nature and contents of container

 

Infusion bottles:               Glass type II

Stopper:                              Stopper type I, chlorobutyl-elastomer

 

Presentation:

 

Ultravist 300:

 

Bottles of 50, 75, 100, 150, and 200ml and 500ml

Cartons contain:               10 bottles of 50ml

                                                10 bottles of 75ml

                                                1 bottle of 100ml

                                                1 bottle of 150ml

                                                1 bottle of 200ml

                                                1 bottle of 500ml

 

10           Date of revision of the text

December 2014 July 2015

 

Updated on 14 July 2015 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to restricted prescription (C)

Updated on 13 January 2015 PIL

Reasons for updating

  • New individual SPC (was previously included in combined SPC)

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 13 January 2015 SmPC

Reasons for updating

  • New individual SPC (was previously included in combined SPC)

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