Source: Health Products Regulatory Authority (IE) Revision Year: 2015 Publisher: Bayer Limited, The Atrium, Blackthorn Road, Dublin 18
This medicinal product is for diagnostic use only.
Ultravist 300: For intravascular use and use in body cavities.
Contrast enhancement in computerised tomography (CT), digital subtraction angiography (DSA), intravenous urography, phlebography of the extremities, venography, arteriography, visualisation of body cavities (e.g. arthrography, hysterosalpingography, fistulography) with the exception of myelography, ventriculography, cisternography.
Contrast media which are warmed to body temperature before administration are better tolerated and can be injected more easily because of reduced viscosity.
For additional instructions see section 6.6.
In patients suffering from marked renal or cardiovascular insufficiency and in patients in a poor general condition, the contrast medium dose must be kept as low as possible. In these patients it is advisable to monitor renal function in accordance with the clinical situation. Dosage should be adapted to age, weight, cardiac output, clinical question, examination technique and the nature and volume of the vascular region to be investigated.
The dosages given below are recommendations only and represent common doses for an average normal adult weighing 70 kg. Doses are given for single injections or per kilo (kg) body weight (BW) as indicated below.
Generally, doses of up to 1.5 g iodine per kg body weight are well tolerated.
After the administration, the patient should be kept under observation for at least 30 minutes, since experience shows that the majority of all severe incidents occur within this time.
Recommended doses for single injections:
Aortic arch angiography: 50-80 ml Ultravist 300
Selective angiography: 6-15 ml Ultravist 300
Thoracic aortography: 50-80 ml Ultravist 300/370
Abdominal aortography: 40-60 ml Ultravist 300
Arteriography:
Upper extremities: 8-12 ml Ultravist 300
Lower extremities: 20-30 ml Ultravist 300
Angiocardiography:
Cardiac ventricles: 40-60 ml Ultravist 370
Intracoronary: 5-8 ml Ultravist 370
Venography:
Upper extremities: 50-60 ml Ultravist 240 or 15-30 ml Ultravist 300
Lower extremities: 50-80 ml Ultravist 240 or 30-60 ml Ultravist 300
The i.v. injection of 30–60 ml Ultravist 300/370 as a bolus (flow rate: 8–12 ml/sec. into the cubital vein; 10–20 ml/sec. into the vena cava) is only recommended for contrast demonstrations of great vessels of the trunk. The amount of contrast medium remaining in the veins can be reduced and diagnostically used by flushing with isotonic sodium chloride solution as a bolus immediately afterwards.
Adults: 30–60 ml Ultravist 300/370
Intraarterial digital subtraction angiography requires smaller volumes and lower iodine concentrations than the intravenous technique. The more selective the angiography is, the lower the dose of contrast medium can be. The values used in conventional angiography for bolus concentration, bolus volume and flow rate can be reduced for intraarterial DSA.
Whenever possible, Ultravist should be injected as an i.v. bolus, preferably using a power injector. Only for slow scanners about half of the total dosage should be administered as a bolus and the rest within 2 – 6 minutes to guarantee a relatively constant – though not maximum – blood level. Spiral CT in single but especially in multi-slice technique allows the rapid acquisition of a volume of data during single breath-hold. To optimize the effect of the i.v. administered bolus (80 – 150 ml Ultravist 300) in the region of interest (peak, time and duration of enhancement), the use of an automatic power injector and bolus tracking is strongly recommended.
In computerized tomography, the necessary doses of contrast medium and the rates of administration depend on the organs under investigation, the diagnostic problem and, in particular, the different scan and image reconstruction times of the scanners in use.
Adults:
Ultravist 240: 1.5-2.5 ml/kg BW
Ultravist 300: 1.0-2.0 ml/kg BW
Ultravist 370: 1.0-1.5 ml/kg BW
The physiologically poor concentrating ability of the still immature nephron of infantile kidneys demands relatively high doses of contrast medium.
The following dosages are recommended:
| Newborns (<1 month) | 1.2 g I/kg BW | = 5.0 ml/kg BW Ultravist 240 |
| = 4.0 ml/kg BW Ultravist 300 | ||
| = 3.2 ml/kg BW Ultravist 370 | ||
| Infants (1 month-2 years) | 1.0 g I/kg BW | = 4.2 ml/kg BW Ultravist 240 |
| = 3.0 ml/kg BW Ultravist 300 | ||
| = 2.7 ml/kg BW Ultravist 370 | ||
| Children (2-11 years) | 0.5 g I/kg BW | = 2.1 ml/kg BW Ultravist 240 |
| = 1.5 ml/kg BW Ultravist 300 | ||
| = 1.4 ml/kg BW Ultravist 370 | ||
| Adolescents and adults | 0.3 g I/kg BW | = 1.3 ml/kg BW Ultravist 240 |
| = 1.0 ml/kg BW Ultravist 300 | ||
| = 0.8 ml/kg BW Ultravist 370 |
Increasing the dose in adults is possible if this is considered necessary in special indications.
When the above dosage guidelines are observed and Ultravist 300/370 is administered over 1 to 2 minutes (3–5 minutes in the case of Ultravist 240), the renal parenchyma is usually highly opacified 3 to 5 minutes (5–10 minutes for Ultravist 240) and the renal pelvis with the urinary tract 8 to 15 minutes (12–20 minutes in the case of Ultravist 240) after the start of administration. The earlier time should be chosen for younger patients and the later time for older patients.
Normally, it is advisable to take the first film as early as 2–3 minutes after administration of the contrast medium. In newborns, infants and patients with impaired renal function later films may improve visualization of the urinary tract.
During arthrography and hysterosalpingography, injections of contrast medium should be monitored by fluoroscopy.
The dosage may vary depending on the age, weight and general condition of the patient. It also depends on the clinical problem, examination technique and the region to be investigated. The dosages given below are recommendations only and represent average doses for a normal adult.
Arthrography: 5–10 ml Ultravist 240/300/370
Hysterosalpingography: 10–25 ml Ultravist 240
Other: Dosage depends generally on the clinical question and the size of structure to be imaged.
Young infants (age <1 year) and especially newborns are susceptible to electrolyte imbalance and hemodynamic alterations. Care should be taken regarding the dose of contrast medium to be given, the technical performance of the radiological procedure and the patient status.
In a clinical study, no differences in pharmacokinetics of iopromide were observed between elderly (aged 65 years and above) and younger patients. Therefore, no specific recommendation for a dosage adjustment is given for elderly patients beside those described in subsection ‘Dosage regimen’. These general dose recommendations should not be exceeded, as the glomerular filtration rate might be physiologically slightly reduced in elderly subjects, thus increasing the risk of renal impairment aggravation by iodinated contrast agents.
Elimination of iopromide is not affected by impaired liver function as only about 2% of the dose is eliminated via feces and iopromide is not metabolized. No dosage adjustment is considered necessary in patients with hepatic impairment.
Since iopromide is excreted almost exclusively in an unchanged form via the kidneys, the elimination of iopromide is prolonged in patients with renal impairment. In order to reduce the risk of additional contrast media-induced renal impairment in patients with pre-existing renal impairment, the minimum possible dose should be used in these patients (see also sections 4.4 and 5.2)
Results from acute toxicity studies in animals do not indicate a risk of acute intoxication following use of Ultravist.
Symptoms may include fluid and electrolyte imbalance, renal failure, cardiovascular and pulmonary complications. In case of inadvertent intravascular overdosage, it is recommended to monitor fluids, electrolytes, and renal function. Treatment of overdose should be directed towards the support of vital functions. Ultravist is dialyzable (see section ‘Pharmacokinetic properties’).
3 years.
From a microbiological point of view the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user. Microbiological stability has been demonstrated for up to 10 hours at room temperature.
Do not store above 30°C. Keep the vials in the outer carton and protect from X-rays.
Vials: Glass type I
Stopper: Stopper type I, chlorobutyl-elastomer
Presentation:
Ultravist 300: Vials of 20 ml. Cartons contain 10 vials of 20 ml.
Ultravist should be warmed to body temperature prior to use (See also Section 4.2).
Ultravist is supplied ready to use as a clear, colourless to pale yellow solution. 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, crystallisation (milky-cloudy appearance and/or sediment at bottom or floating crystals) may occur very rarely.
The contrast medium solution should not be drawn into the syringe or the infusion bottle attached to the infusion set until immediately before the examination.
The rubber stopper should never be pierced more than once to prevent large amounts of microparticles from the stopper getting into the solution. The use of cannulas with a long tip and a maximum diameter 18 G is recommended for piercing the stopper and drawing up the contrast medium (dedicated withdrawal cannulas with a lateral aperture, e.g. Nocore-Admix cannulas, are particularly suitable).
Any contrast solution not used in one examination for a given patient is to be discarded.
The contrast medium must be administered by means of an automatic injector, or by other approved procedures which ensure sterility of the contrast medium.
The tube from the injector to the patient (patient’s tube) must be replaced after every patient to avoid cross contamination. The connecting tubes and all disposable parts of the injector system must be discarded when the infusion bottle is empty or ten hours after first opening the container. Instructions of the device manufacturer must be followed.
Unused Ultravist in opened containers must be discarded ten hours after first opening the container.
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