A Proven Safety Profile 1
Q Published data on 74,717 patients from Post-Marketing Surveillance Study 1
Q More than 120 million applications in over 70 countries worldwide 2
1 Kopp AF et al. Prevalence of acute reactions to iopromide: postmarketing surveillance study of 74,717 patients. Acta Radiol 49: 902 – 911 (2008).
2 Data on fi le Bayer Schering Pharma AG Adverse events should be reported.
Reporting forms and information can be found at
www.yellowcard.gov.uk. Adverse events should also be reported to Bayer Pharma AG; Tel: 01635 563500, Fax: 01635 563703, Email:
phdsguk@bayer.co.uk
PRESCRIBING INFORMATION ULTRAVIST® (iopromide) (Refer to Summary of Product Characteristics (SmPC) before prescribing) Presentation: Intravascular injections of non-ionic iopromide in strengths of 150mg, 240mg, 300mg and 370mg of iodine/ml. Indications: Delineation of the vascular and renal systems and of body cavities. Posology and administration: Intravenous urography: Adult minimum doses: Ultravist® 370: 0.8ml/kg body weight; Ultravist® 300: 1ml/kg body weight; Ultravist® 240: 1.3ml/kg body weight. For childrens’ dosage see SPC. Computed tomography: Cranial CT: Ultravist® 240: 1.5–2.5ml/kg body weight; Ultravist® 300: 1–2ml/kg body weight; Ultravist® 370: 1–1.5ml/kg body weight. Whole-body CT: Dosage depends on investigation and scanner. Angiography: Depends on age, weight, cardiac output, general condition, and investigation (see SPC). Checking function of dialysis shunt: Ultravist® 150: 10ml. Contraindications: Uncontrolled thyrotoxicosis. Warnings and precautions: In case of anaphylactoid/hypersensitivity reactions, ensure emergency drugs and equipment available. Possible increased risk of hypersensitivity reactions so caution in patients with: known hypersensitivity to Ultravist® or its excipients; previous reaction to any iodinated contrast medium; history of bronchial asthma or allergic disorders. Pre-medicate with corticosteroids if necessary. Allergy – like reactions from mild to severe possible, mostly within one hour, but delayed reactions (hours to days) may occur. To minimise risk: administer Ultravist® to recumbent patients; observe patients closely for 15 minutes and keep them in hospital for at least 1 hour after the last injection. Patients on beta-blockers may be resistant to effects of beta agonists.
If hypersensitivity reactions occur – stop administration. If severe reaction occurs, patients with cardiovascular disease more susceptible to serious or fatal outcomes. Caution in patients with: hyperthyroidism, goitre, cerebral arteriosclerosis, pulmonary emphysema, poor general health, renal insuffi ciency, dehydration, diabetes mellitus, multiple myeloma/ paraproteinaemia, repetitive and / or large doses of iodinated contrast media. With cardiac or severe coronary artery disease, increased risk of haemodynamic changes or arrhythmia. Nephrotoxicity may occur or rarely acute renal failure. Ensure adequate hydration of patients and water or electrolyte imbalances corrected before administration. Increased risk of seizures and neurological complications in patients with seizure history or CNS disorders. Do not allow Ultravist® to remain in contact with blood in a syringe. Flush intravascular catheters frequently to minimise clotting risk. With phaeochromocytoma, premedicate with an alpha-blocker. Counteract excitement, anxiety and pain with appropriate drugs. Do not use in myelography. Do not use for hysterosalpingography during pregnancy or in patients with acute pelvic infl ammation. Use during pregnancy only if essential. Stop biguanides 48 hours prior to Ultravist® administration as a precaution against precipitation of lactic acidosis. Prevalence of delayed reactions higher in patients who have received interleukin. The capacity of the thyroid to take up iodine is reduced. Visually inspect solution before use. Do not use if discoloured, crystals/sediment present or container defective. Undesirable effects: Usually mild to moderate and transient. But severe, life-threatening or fatal reactions have been reported. Nausea, headache, sensation of pain or warmth most frequent. Uncommon; anaphylactoid reactions/ hypersensitivity. Rare: fatal anaphylactic shock, coma, convulsion, paralysis, cerebral ischaemia/ infarction, stroke, cardiac arrest, other cardiac disorders, shock, respiratory arrest, other respiratory disorders, acute renal failure. For further uncommon and rare side effects please refer to the SmPC. Legal Classifi cation: POM Basic NHS Price: Ultravist® 150 10 x 50ml bottles £103.54 Ultravist® 240 10 x 50ml £148.69 Ultravist® 300 10 x 20ml £127.04 10 x 50ml £185.55 10 x 75ml £277.61 1 x 100ml £36.86 1 x 200ml £73.38 Ultravist® 370 10 x 50ml £229.29 10 x 75ml £342.24 1 x 100ml £45.55 1 x 200ml £90.50 PL Numbers: Ultravist® 150: 00010/0564 Ultravist® 240: 00010/0565 Ultravist® 300: 00010/0566 Ultravist® 370: 00010/0567 PL Holder: Bayer plc, Bayer House, Strawberry Hill, Newbury, Berkshire, RG14 1JA Further information available from: Bayer plc, Bayer Pharma AG, Bayer House, Strawberry Hill, Newbury, Berkshire, RG14 1JA, Telephone: (01635) 563000, Ultravist® is a registered trademark of Bayer Pharma AG (formerly Schering AG). Date of revision: June 2009
UK.PH.DG.ULT.09-06-03.001
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