UROGRAFIN Solution for infusion Ref.[49858] Active ingredients: Diatrizoic acid

General Information

Dietary suggestions

In the case of abdominal angiography and urography, the diagnostic yield is increased if the bowels are emptied of faecal matter and gas. On the two days prior to the examination patients should therefore avoid flatulent food, in particular peas, beans and lentils, salads, fruit, dark and fresh bread and all kinds of uncooked vegetables. On the day before the examination, patients should refrain from eating after 6 p. m. Moreover, it can be appropriate to administer a laxative in the evening.

In newborns, infants and young children, however, prolonged fasting and the administration of a laxative before the examination are contraindicated.

Hydration

Adequate hydration must be assured before and after contrast medium administration. This applies especially to patients with multiple myeloma, diabetes mellitus with nephropathy, polyuria, oliguria, hyperuricaemia, as well as to newborns, infants, small children and elderly patients. Disorders of water and electrolyte balance must be corrected before the examination.

Newborns (<1 month) and infants (1 month – 2 years)

Young infants (age <1 year) and especially newborns are susceptible to electrolyte imbalance and haemodynamic 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.

Anxiety

Pronounced states of excitement, anxiety and pain may increase the risk of side effects or intensify contrast medium-related reactions.

Warming prior to use

Contrast media which are warmed to body temperature before administration are better tolerated and can be injected more easily because of reduced viscosity. Using an incubator, only the calculated number of bottles needed for the same examination day should be warmed up to 37°C.

Pretesting

Sensitivity testing using a small test dose of contrast medium is not recommended as it has no predictive value. Furthermore, sensitivity testing itself has occasionally led to serious and even fatal hypersensitivity reactions.

Dosage for intravascular use

Intravascular administration of contrast media should, if possible, be done with the patient lying down. After the administration, the patient should be observed for at least 30 minutes, since the majority of reactions occur within this time. The dosage may vary depending on the age, weight, cardiac output and general condition of the patient.

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 for at least 3 days following the examination.

Between separate injections the body should be given enough time for the influx of interstitial fluid to normalize the increased serum osmolality. To achieve this, a period of 10–15 minutes is necessary in adequately hydrated patients. If it is necessary in particular instances to exceed a total dose of 300 to 350 ml in the adult, additional water and possibly electrolytes should be given.

Infusion urography

Adults and adolescents

1 bottle of 250 ml Urografin 30% for infusion.

In general, the infusion should not be less than 5 minutes nor much more than 10 minutes. Infusion times of 20–30 minutes are indicated in patients with cardiac insufficiency.

Children

1 bottle of 250 ml Urografin 30% for infusion.

3-12 months: 6 ml/kg body weight.

1- 8 years: 4 ml/kg body weight.

over 8 years: 3 ml/kg body weight.

Infusion time: 8–10 minutes.

Compression is contraindicated in newborns and infants and is also inadvisable during the infusion of large amounts of contrast medium in children, adolescents and adults, since, if drainage is obstructed, the increased diuresis can lead to rupture of the fornix as a result of the high pressure. Compression may, however, be applied about 10 minutes after the end of the infusion to demarcate organic from functional filling defects.

Filming times

The first film should be taken towards the end of the infusion. Further films may be taken within the next 20 minutes, or later in case of excretory disturbances.

In the event of accidental intravascular overdose in humans, the water and electrolyte losses must be compensated by infusion. Renal function needs monitoring for at least the next 3 days.

If needed, haemodialysis can be used to eliminate the bulk of the contrast medium from the patient’s system.

Unopened: 5 years.

The product should be used immediately after opening.

Any unused portion should be discarded.

Do not store above 30°C. Store in the original package to protect from light.

Protect from X-rays.

Bottle: colourless glass type II.

Stopper: stopper type I chlorobutyl-elastomer.

Presentation: Bottles of 250 ml.

The contrast medium solution should not be drawn into the syringe or the infusion bottle attached to the infusion set until immediately before examination.

Vials containing contrast medium solutions are not intended for the withdrawal of multiple doses. The rubber stopper should never be pierced more than once. The use of cannulas with a long tip and a diameter of maximally 18 G is recommended for piercing the stopper and drawing up the contrast medium (dedicated withdrawal cannulas with a side hole, e.g. Nocore-Admix cannulas, are particularly suit-able).

Contrast medium solution not used in one examination session must be discarded.