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Bayer plc

Bayer House, Strawberry Hill, Newbury, Berkshire, RG14 1JA
Telephone: +44 (0)1635 563 000
Fax: +44 (0)1635 563 393
WWW: http://www.bayer.co.uk

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Summary of Product Characteristics last updated on the eMC: 25/01/2007
SPC Ultravist 240, 300, 370

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 25/01/2007 and displayed until Current
Reasons for adding or updating:
  • Change to section 6. 6 - Instructions for use, handling and disposal
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

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

Updated on 28/09/2006 and displayed until 25/01/2007
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • 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 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   08/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Section 2          -           iodine equivalent added

 

Section 4.2       -           IV urography – adults -deletion of examples obesity or   impaired renal function after the text “It may be necessary to increase the dose in individual cases”. Whole body CT -deletion of the text “ Infusion is preferable for slow scanners and injection for fast scanners”

 

Section 4.3       -           deletion of “Hysterosalpingography must not be carried out during pregnancy or in patients with acute inflammatory conditions in the pelvic cavity”. This text has been moved to section 4.4.

 

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; Hysterosalpingography.

 

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 

Updated on 11/04/2006 and displayed until 28/09/2006
Reasons for adding or updating:
  • Change to section 6.1 - List of Excipients
Updated on 26/01/2005 and displayed until 11/04/2006
Reasons for adding or updating:
  • Change to section 9 - Date of Renewal of Authorisation
Updated on 07/07/2003 and displayed until 26/01/2005
Reasons for adding or updating:
  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 (date of (partial) revision of the text
Updated on 28/08/2001 and displayed until 07/07/2003
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 17/08/2001 and displayed until 28/08/2001
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 25/07/2001 and displayed until 17/08/2001
Reasons for adding or updating:
  • Transferred from eMC version 1
Updated on 13/09/2000 and displayed until 25/07/2001
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
   iopromide