GE-HEALTHCARE

GE Healthcare today announced results from an independent study, which showed that use of isosmolar contrast agent Visipaque^™ 320 (iodixanol 320mg I/ml) provides better image quality of coronary stents during multi-detector CT coronary angiography (MDCT-CA) than use of Iomeron^® 400 (iomeprol 400mg l/ml) when injected at the same flow rate (5.0 ml/s) and volume (80ml). Patients injected with Visipaque at 5.0 ml/s also experienced less heat sensation, fewer premature heart beats and their overall heart rate (HR) was less affected during scanning. The data were published online in Journal of Cardiovascular Computed Tomography. ¹

“Although MDCT-CA is increasingly used as a non-invasive tool for evaluating coronary stents and bypass grafts, it was unknown until now, whether iodinated contrast medium characteristics affected diagnostic performance” said Professor Daniele Andreini, lead author of the study, Centro Cardiologico Monzino, Milan, Italy.

About the Study

This study evaluated 254 patients undergoing MDCT-CA coronary stent follow-up with Iomeron 400 at 5.0 ml/s flow rate (group 1, n=83), Visipaque 320 at 6.2 ml/s flow rate (group 2, n=87) and Visipaque 320 at 5.0 ml/s flow rate (group 3, n=84). Heart rate (HR) immediately before and at the end of scanning, HR variation, premature heart beats (PHB) and heat sensation by visual analog scale (VAS) after scanning were recorded.

The study found overall stent evaluability was significantly higher in patients who received Visipaque 320 at 5.0 ml/s than those who received Visipaque 320 6.2 ml/s (98% vs. 91%) or Iomeron 400 5.0 ml/s (98% vs. 92%) due to a lower number of severe artifacts in group 3 (n=7) as compared to groups 2 (n=21) and 1 (n=26). Additionally:

• While heart rates immediately before imaging were similar in the three groups, the HR at the end of imaging was significantly lower in patients receiving Visipaque 320 5.0 ml/s than those who received either Visipaque 320 6.2 ml/s (53.7 vs. 56.7 bpm, p=0.001) or Iomeron 400 5.0ml/s (53.7 vs. 56.2 bpm, p=0.008).
• During the scan, heart rate decreased in all groups while patients held their breath. However, the heart rate decrease was significantly higher in Visipaque 320 5.0 ml/s than those who received Visipaque 320 6.2ml/s (-6.6 vs. -4.8 bpm, p=0.001) or Iomeron 400 5.0ml/s (-6.6 vs. -3.8 bpm, p=0.0001).
• The number of patients with at least one premature heart beat during the scan was significantly lower in Visipaque 320 5.0 ml/sec than in those receiving Visipaque 320 6.2 ml/s (0 vs. 7, p=0.008) or Iomeron 400 5.0ml/s (0 vs. 8, p=0.003).

Finally patients receiving Visipaque 320 at 5.0 ml/s or 6.2 ml/s experienced less heat sensation compared to those receiving Iomeron 400 at 5.0ml/s (4.3 vs. 5.3 mm, p=0.0001 ; 5.3 vs. 8 mm, p=0.001) respectively.

“This independent study, using Visipaque, is significant and adds to the growing body of evidence that supports continued research in contrast media to improve patient care,” said Jan Makela, General Manager, Core Imaging, GE Healthcare Life Sciences. “It provides relevant information to both referring physicians and imaging specialists, which may help them choose appropriate contrast media. And, most importantly, Visipaque provided more comfort for the patient during scanning.”

About GE Healthcare

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VISIPAQUE

Int’l English prescribing information

PRESCRIBING INFORMATION VISIPAQUE™ iodixanol

Indications and approvals may vary in different countries. Please refer to the local Summary of Product Characteristics [SPC] before prescribing. Further information available on request.

PRESENTATION

An isotonic, aqueous solution containing iodixanol, a non-ionic, dimeric contrast medium, available in two strengths containing either 270 mg or 320 mg iodine per ml.

INDICATIONS

This medicinal product is for diagnostic use only. X-ray contrast medium for cardioangiography, cerebral angiography, peripheral arteriography, abdominal angiography, urography, venography, CT enhancement. Lumbar, thoracic and cervical myelography. Arthrography, hysterosalpingography (HSG) and studies of the gastrointestinal tract.

DOSAGE AND ADMINISTRATION

Adults and children: Dosage varies depending on the type of examination, age, weight, cardiac output, general condition of patient and the technique used (see SPC and package leaflet).

CONTRA-INDICATIONS

Hypersensitivity to the active substance or to any of the excipients. Manifest thyrotoxicosis. History of serious hypersensitivity reaction to Visipaque.

PRECAUTIONS, WARNINGS, ETC

A positive history of allergy, asthma, or reaction to iodinated contrast media indicates need for special caution. Premedication with corticosteroids or H1 and H2 antagonists should be considered in these cases. Although the risk of serious reactions with Visipaque is regarded as low, iodinated contrast media may provoke serious, life-threatening, fatal anaphylactic/ anaphylactoid reactions or other manifestations of hypersensitivity. Therefore the necessary drugs and equipment must be available for immediate treatment. Patients should be observed for at least 30 minutes following administration of contrast medium, however delayed reactions may occur. Non-ionic contrast media have less effect on the coagulation system in vitro, compared to ionic contrast media. When performing vascular catheterization procedures one should pay meticulous attention to the angiographic technique and flush the catheter frequently (eg. with heparinised saline) so as to minimize the risk of procedure-related thrombosis and embolism. Ensure adequate hydration before and after examination especially in patients with renal dysfunction, diabetes mellitus, paraproteinemias, the elderly, children and infants or after major surgery. Special care should also be taken in patients with hyperthyroidism, serious cardiac disease, pulmonary hypertension, patients predisposed to seizures (acute cerebral pathology, tumours, epilepsy, alcoholics and drug addicts), and patients with myasthenia gravis or phaeochromocytoma. Particular care is required in patients with severe disturbance of both renal and hepatic function as they may have significantly delayed contrast medium clearance. All iodinated contrast media may interfere with laboratory tests for thyroid function, bilirubin, proteins, or inorganic substances (e.g. iron, copper, calcium, and phosphate). To prevent lactic acidosis, serum creatinine level should be measured in diabetic patients treated with metformin prior to intravascular administration of iodinated contrast medium. Normal serum creatinine/renal function: Administration of metformin should be stopped at the time of administration of contrast medium and not resumed for 48 hours or until renal function/serum creatinine is normal. The timing of this should be amended based upon serum creatinine/renal function levels. (Refer to SPC). An increased risk of delayed reactions (flu-like or skin reactions) has been associated with patients treated with interleukin-2 up to two weeks previously. Following myelography the patient should remain in a supine position with head up for a while and should not be left alone for 12 to 24 hours. The safety of Visipaque in pregnancy has not been established. Breast feeding may be continued after administration of the product.

UNDESIRABLE EFFECTS

Undesirable effects associated with Visipaque are usually mild to moderate and transient in nature. Serious reactions as well as fatalities are only seen on very rare occasions. Hypersensitivity reactions may present as respiratory or cutaneous symptoms like dyspnoea, rash, erythema, urticaria, pruritus, severe skin reactions, angioneurotic oedema, hypotension, fever, laryngeal oedema, bronchospasm or pulmonary oedema. They may appear either immediately after the injection or up to a few days later. Hypersensitivity reactions may occur irrespectively of the dose and mode of administration and mild symptoms may represent the first signs of a serious anaphylactoid reaction/shock. Administration of the contrast medium must be discontinued immediately and, if necessary, specific therapy instituted via the vascular access. Patients using beta blockers may present with atypical symptoms of hypersensitivity which may be misinterpreted as a vagal reaction. Neurological reactions, transient contrast-induced encephalopathy, including amnesia, hallucination, confusional state and other neurological symptoms, headache, dizziness, seizures, and transient motor or sensory disturbance (e.g. taste or smell alteration, transient blindness) may occur. Severe respiratory symptoms and signs (including dyspnoea and non-cardiogenic pulmonary oedema), and cough may occur. Cardiac arrest, cardio-respiratory arrest and myocardial infarction may occur. Also reported are; vagal reactions, cardiac arrhythmia, depressed cardiac function, ischaemia, hypertension and iodism. Arterial spasm may follow injection. A minor transient rise in creatinine is common. Renal failure is very rare. Post phlebographic phlebitis or thrombosis is very rare. Arthralgia is very rare.

Intrathecal use: Headache, nausea, vomiting or dizziness. Mild local pain and pain at the site of injection may occur.

Meningeal irritation giving photophobia and meningism and frank chemical meningitis have been observed with other non-ionic iodinated contrast media. The possibility of an infective meningitis should also be considered. Transient contrast-induced encephalopathy, including amnesia, hallucination, confusional state and other neurological symptoms may occur after intrathecal use.

Oral use: diarrhoea, nausea, vomiting, abdominal pain.

Hysterosalpingography (HSG): Transient pain in the lower abdomen. Vaginal bleeding/discharge, nausea, vomiting, headache, fever.

Arthrography: Pressure sensation and post procedural pain.

In patients with autoimmune diseases cases of vasculitis and SJS-like syndrome were observed.

OVERDOSE

In the unlikely event of accidental overdosing, renal function should be monitored for at least 3 days in addition to supportive measures. Haemodialysis should be considered if needed.

MARKETING AUTHORISATION HOLDER

GE Healthcare AS, Nycoveien 1-2, Postboks 4220 Nydalen, NO-0401 Oslo, Norway.

CLASSIFICATION FOR SUPPLY

Subject to medical prescription (POM).

DATE OF PREPARATION

April 2013.

*Iomeron® is a registered trademark of Bracco Diagnostics

¹ Andreini D, Pontone G, Mushtaq S, et al. Coronary Stent Evaluation with Computed Tomography Coronary Angiography: Comparison Between Low-osmolar, High-iodine Concentration Iomeprol-400 and Iso-osmolar, Lower-iodine Concentration Iodixanol-320. Journal of Cardiovascular Computed Tomograph (2014), doi: 10.1016/j.jcct.2013.12.003.

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Aleisia Gibson
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aleisia.gibson@ge.com

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