Bayer plc

All updates are due to change of ownership, from Schering Healthcare Ltd to Bayer Plc effective from 1 May

Section 7: MAH now Bayer plc
Section 8: Licence number is now PL 00010/ 0564
Section 9: Date of first authorisation is now 1 May 2008
Section 10: Revision date is now 1 May 2008 

Section 6.6

Add: Contrast media should be visually inspected prior to use and must not be used if discoloured, nor in the presence of particulate matter (including crystals) or defective containers.  As Ultravist is a highly concentrated solution, crystallization (milky-cloudy appearance and/or sediment at bottom, or floating crystals) may occur very rarely.

Section 10.

Date changed to 16 January 2007

Section 2          -           iodine equivalent added

Section 4.2       -           Intraarterial DSA –Text changed from “Intraarterial digital subtraction angiography requires smaller volumes, lower iodine concentrations and reduced flow rate than with the intravenous technique” to “Intraarterial digital subtraction angiography requires smaller volumes and lower iodine concentrations than with conventional angiography”.

The following text has been deleted “The more selective the angiography, the lower the dose of contrast medium can be. This method is therefore recommended for patients with impaired renal function”.

Section 4.4       -           the text has been extensively revised and re-formatted under the following headings :Hypersensitivity reactions; Thyroid dysfunction; Cerebral arteriosclerosis, pulmonary emphysema or poor general health; Renal impairment; Hydration; Cardiovascular disease; CNS disorders; Thromboembolic events; Phaeochromocytoma; Anxiety; Myelography.

Section 4.5       -           addition of the heading “Biguanides (metformin) to the paragraph relating to diabetic nephropathy.

Deletion of “Hypersensitivity reactions can be aggravated in patients on beta-blockers”

Insertion of “ Beta-blockers: Patients who experience hypersensitivity reactions while taking beta-blockers may be resistant to treatment effects of beta agonists (see section 4.4)”

Insertion of new heading “Interleukin:”

Insertion of “Radioisotopes: If iodine isotopes are to be administered for the diagnosis of thyroid disease, it should be borne in mind that after the administration of iodinated contrast media which are excreted via the kidneys, the capacity of the thyroid tissue to take up iodine will be reduced for 2 weeks and sometimes up to 6 weeks.” (moved from section 4.5)

Section 4.8       -           the section has been extensively revised and the side effects presented in a table with associated frequencies. Information given on the basis for frequency estimates.

Section 4.9       -           deletion of “Acute symptoms of poisoning are unlikely with intravascular administration. In special cases … and electrolytes should be adjusted” Insertion of new text “ Symptoms may include fluid and electrolyte imbalance, renal failure, cardiovascular and pulmonary complications. Monitor fluids, electrolytes and renal function. Treatment of overdose should be directed towards the support of vital functions. Ultravist is dialyzable”.

Section 5.1       -           addition of a table listing the physico-chemical characteristics of the Ultravist range.

Section 10        -           date of revision of text revised to 8 August 2006