INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo UROGRAFIN 60% FOR INFUSION

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

UROGRAFIN 60% FOR INFUSION

Contrast medium solution for
intravenous infusion urography

COMPOSITION
Urografin 60% for infusion contains a mixture of sodium amidotrizoate and meglumine amidotrizoate in a proportion of 10:66 in aqueous solution (amidotrizoic acid or diatrizoic acid:3,5-bis-acetamido-2,4,6-triiodobenzoic acid).
1 mL contains
meglumine amidotrizoate 520 mg, sodium amidotrizoate 80 mg.
Each 100 mL bottle contains meglumine amidotrizoate 52 g and sodium amidotrizoate 8 g (contrast medium content 60 g, iodine content 29,2 g).

PHARMACOLOGICAL CLASSIFICATION
A. 28 Contrast media.

PHARMACOLOGICAL ACTION
Urografin 60% for infusion is a radiodiagnostic agent and, in the recommended doses, has no pharmacological action.
•        Properties
Urografin 60% for infusion is excreted extremely rapidly and in high concentration by the kidneys.

INDICATIONS
Infusion urography.

CONTRA-INDICATIONS
Hypersensitivity to iodinated contrast media, thyrotoxicosis, decompensated cardiac insufficiency.

DOSAGE AND DIRECTIONS FOR USE
•        General information
Patients must present themselves in a fasted and adequately hydrated state on the day of the examination. Compensation must be made for disturbances of water and electrolyte balance. This applies in particular to patients who are predisposed to such disturbances.
In urography, the diagnostic yield is increased if the bowels are empty 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 pm. Moreover, it is appropriate to administer a laxative in the evening.
Calm management of the patients and appropriate premedication will obviate pronounced states of excitement, anxiety and pain - factors known to be able to cause side effects or intensify contrast medium-induced reactions.
Sensitive patients tolerate the contrast medium better if it is warmed to body temperature.
Intravascular administration of contrast media should, if possible, be done with the patient lying down. After the examination the patient should be kept under observation for at least 15 minutes, since about 90% of all severe incidents are known to occur within this time.
O        Dosage
Adults and adolescents
1 bottle of 100 mL.
In general, the infusion time 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.
Compression is inadvisable during the infusion of large amounts of contrast medium 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.
O        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).

SIDE EFFECTS AND SPECIAL PRECAUTIONS
Side effects such as sensations of heat or nausea normally quickly diminish after slowing down or shortly interrupting the administration.
Only in isolated cases does the paravenous administration of Urografin 60% for infusion lead to marked tissue reactions.
In patients with severe impairment of hepatic or renal function, cardiac and circulatory insufficiency, pulmonary emphysema, poor general health, cerebral arteriosclerosis, diabetes of long standing, cerebral spasmodic conditions, thyroid hyperfunction (whether manifest or not) and multiple myeloma, the need for examination merits particularly careful consideration.
Experience shows that patients with an allergic disposition suffer more frequently from hypersensitivity reactions. In such cases some examiners administer an antihistamine or corticoid prophylactically. However, contrast media and prophylactic agents should not be administered mixed together.
Fluid intake should not be restricted before the use of hypertonic contrast media in patients with multiple myeloma, diabetes of long standing, polyuria, oliguria or gout or in marastic patients. Compensation must be made for disturbances of water and electrolyte balance.
Apart from the fact that, where possible, exposure to radiation should be avoided during pregnancy, it must be pointed out that it has not yet been demonstrated whether it is safe to use Urografin 60% for infusion in pregnant patients. A contrast medium may therefore only be administered during pregnancy if the doctor regards the examination as absolutely necessary.
When thyroid diagnosis with iodine isotopes is intended, the fact that the use of iodinated renal contrast media reduces the ability of the thyroid tissue to take up iodine for up to 2 weeks, and even longer in individual cases, must be taken into account.
Premedication with alpha-receptor blockers is recommended in phaeochromocytoma patients because of the risk of blood pressure crises.
•        Test injection
At the present time there is no clinical test which is suitable for predicting an incident.
In this connection it must be emphasised that any administration of contrast material entails a certain risk and should therefore only be implemented after suitable precautionary measures have been taken. These include the ready availability of appropriate medicines (eg corticoids), an endotracheal tube and a respirator (cf "Suggestions for the management of life-threatening acute hypersensitivity reactions or acute anaphylaxis after administration of contrast media").
•        Individual hypersensitivity
With Urografin 60% for infusion as with any other iodinated contrast medium, the possibility cannot be ruled out that individual patients will react particularly sensitively to such compounds. The investigation must be interrupted if more pronounced side effects or reactions of allergy occur during the administration. If, despite this, the reactions do not disappear, or even grow worse, the investigation must be terminated. However, the cannula or catheter must be left in the vessel ready for any therapeutic measures. Even relatively minor symptoms, such as itching of the skin, sneezing, violent yawning, tickling in the throat, hoarseness, coughing fits, may be initial signs of a severe reaction (including shock), so careful attention should be paid to them (cf "Suggestions for the management of life-threatening acute hypersensitivity reactions or acute anaphylaxis after administration of contrast media").
Suggestions for the management of life-threatening acute hypersensitivity reactions or acute anaphylaxis after administration of contrast media
Give adrenaline solution 1 mL of 1:1000 concentration (1 mg) subcutaneously. Repeat if necessary 5 to 10 minutes later. If the patient does not respond immediately give 0,1-0,4 mL of 1:1000 concentration diluted in 10 mL physiological saline intravenously SLOWLY.
Maintain an open airway. An emergency tracheostomy may be necessary. Positive pressure oxygen administration may be required.
In the event of urticaria or angio-oedema, administer adrenaline subcutaneously followed by an antihistamine intravenously (eg diphenhydramine hydrochloride 20 mg).
For prolonged or severe reactions give hydrocortisone sodium succinate 250 mg or methylprednisolone sodium succinate 100 mg intravenously over 30 seconds after adrenaline and the antihistamine.
Aminophylline injection 250-500 mg should be given slowly intravenously in the presence of bronchospasm.
Intravenous fluids may be required to correct hypovolemia.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
With overdosage, the symptoms described under "Side effects and special precautions" may occur which should be treated according to the recommended procedure to be adopted in incidents after the administration of contrast media.

IDENTIFICATION
Clear, colourless to faintly yellowish, odourless solution, filled into glass 100 mL bottles.

PRESENTATION
Bottles of 100 mL.

STORAGE INSTRUCTIONS
To be stored in original packs at room temperature (below 30 C). Protect from light, heat and secondary X-rays. For shelf-life refer to the imprint on the pack. Keep out of reach of children.

REFERENCE NUMBER
F.605 (Act 101/1965)

NAME AND BUSINESS ADDRESS OF THE APPLICANT
Schering (Pty) Ltd
(Reg No: 1964/009072/07)
106 Sixteenth Road
Randjespark
Midrand        685
P O Box 5278
Halfway House        1685

DATE OF PUBLICATION OF THIS PACKAGE INSERT
14 March 1986

SCHERING (PTY) LTD
(Reg No: 1964/009072/07)
Subsidiary of
Schering AG        Germany

Updated on this site: January 2005
Source: Pharmaceutical Industry

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