Urografin

BP22036, REC30610

Note:

Text in blue = added text

Text in red with strikethrough = deleted text

6. Contents of the pack and other information

[…]

Marketing Authorisation Holder:

Bayer Limited, 1st Floor, The Grange Offices, The Grange, Brewery Road, Stillorgan, Co. Dublin, A94 H2K7, The Atrium, Blackthorn road, Dublin 18, Ireland

[…]

This leaflet was last revised in: January 2020September 2022

BP22036, REC30610

REC19543 – PA number reformat *Please note deletion of space between PA and 1410 and additional zeros have been added.

Note:

Text in colour = added text

Text in red with strikethrough = deleted text

7. MARKETING AUTHORISATION HOLDER

Bayer Limited

1^st Floor

The Grange Offices

The Grange

Brewery Road

Stillorgan

Co. Dublin

A94 H2K7

The Atrium

Blackthorn Road

Dublin 18

Ireland

8. MARKETING AUTHORISATION NUMBER

 PA1410/012/001

10. DATE OF REVISION OF THE TEXT

 July 2019September2022

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

• 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"

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.