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:
Bayer Limited
- Active Ingredients:
- 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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1. NAME OF THE MEDICINAL PRODUCT
1. NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
3. PHARMACEUTICAL FORM
3. PHARMACEUTICAL FORM
4. CLINICAL PARTICULARS
4. CLINICAL PARTICULARS
5. PHARMACOLOGICAL PROPERTIES
5. PHARMACOLOGICAL PROPERTIES
6. PHARMACEUTICAL PARTICULARS
6. PHARMACEUTICAL PARTICULARS
7. MARKETING AUTHORISATION HOLDER
7. MARKETING AUTHORISATION HOLDER
8. MARKETING AUTHORISATION NUMBER(S)
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10. DATE OF REVISION OF THE TEXT
10. DATE OF REVISION OF THE TEXT
Bayer 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 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