Biloptin

Patients should be put on a scanty, low-residue and non-flatulent diet 24 hours before the examination. Easily digestible food and clear liquids, eg tea without milk or clear, fat-free soup can be given. Eggs, rusks, fruits, oatmeal, pasta, milk products, peas and beans, salads, smoked goods, coarse, dark or freshly-baked bread and all vegetables are prohibited.
From 6 pm on the day before the examination, patients should refrain from eating until after the examination the following day. Neither should they smoke after the administration of the contrast medium, but may drink water or weak tea if they feel thirsty.
If a laxative is prescribed, it should be taken about 20 hours before the examination.

 

The 6 capsules should be swallowed whole with plenty of water.
Unless otherwise directed by the doctor, 6 Biloptin capsules are taken 12 hours prior to the X-ray examination (ie usually between 8 and 10 pm).
In order to attain a more intensive and longer lasting contrast 12 Biloptin capsules can be taken. These are to be taken either in one dose the night before the examination or in 2 doses - one the previous night and one the early morning on the day of the examination.
Dosage and the time of administration can be varied by the doctor. Therefore his instructions must be carefully heeded.

• Dosage for children
For children under 8 years of age the X-ray examination with meglumine iotroxate offers the best prospects of success.
For the use of Biloptin capsules in youths the following doses are recommended:
Children over 8 years:

 

SIDE EFFECTS AND SPECIAL PRECAUTIONS
Sensitive patients occasionally complain about heaviness at the pit of the stomach or nausea. Diarrhoea or vomiting occur only in exceptional cases. Isolated cases of urticarial skin reactions have been reported.
If allergic symptoms occur, an antihistamine or high-dose corticoids are indicated.
Thyroid hyperfunction can increase for some time after the examination with biliary contrast media.
If iodine isotopes are to be administered for diagnosing thyroid disease, it should be borne in mind that following the administration of iodine-containing biliary contrast media, the capacity of the thyroid tissue to take up iodine is reduced for 8 to 10 weeks or longer.
Apart from the fact that X-ray examinations should, if possible, be avoided during pregnancy, it must be pointed out that it has not yet been proved that Biloptin may be used without hesitation in pregnant patients. Therefore, such an examination with a contrast medium during pregnancy should be carried out only if considered absolutely necessary by the doctor.

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
If three to four times the normal dose of 6 capsules is taken within 12 hours, the symptoms described under "Side effects and special precautions" may occur. Allergic symptoms should be treated with an antihistamine or high-dose corticoids.

IDENTIFICATION
Long, ochre, soft gelatine capsules containing a yellowish-white, oily paste. The capsules may be imprinted with a black "B" in a regular hexagon.

PRESENTATION
20 x 6 capsules.

STORAGE INSTRUCTIONS
In original packs at room temperature, below 30°C. Keep out of reach of children.

REFERENCE NUMBER
H.2840 (Act 101/1965)

NAME AND BUSINESS ADDRESS OF THE APPLICANT
Schering (Pty) Ltd
(Reg No: 64/09072/07)
106 Sixteenth Road
Randjespark
Midrand 1685
P O Box 5278
Halfway House 1685

DATE OF PUBLICATION OF THIS PACKAGE INSERT
6 February 1979

SCHERING (PTY) LTD
(Reg No: 64/09072/07)
Subsidiary of
Schering AG Germany

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