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

Logo A.T. 10 Solution

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

A.T. 10 Solution

COMPOSITION:
1 mL solution contains 1 mg
dihydrotachysterol U.S.P. in neutral oil.

PHARMACOLOGICAL CLASSIFICATION:
A.22.1.4 Vitamins

PHARMACOLOGICAL ACTION:
A.T. 10
(antitetanic preparation No. 10) increases the serum calcium level even in relatively small doses.

INDICATIONS:
Hypocalcaemia of hypoparathyroidism. Acute, chronic and latent parathyroid tetany. Treatment of vitamin D resistant rickets.

CONTRA-INDICATIONS:
None known

WARNINGS:
A.T. 10
solution acts similarly to injections of calcium and parathyroid hormone. During pregnancy, extreme sensitivity or excess dosage has been observed to correlate with congenital aortic stenosis in the foetus.

DOSAGE AND DIRECTIONS FOR USE:
A.T. 10
solution is administered orally after meals or on an empty stomach. Larger doses are preferably taken with food. The necessary daily dose of the solution and the duration of treatment is determined by the physician.
In mild cases: 30 - 40 drops daily. Note: 1 mL A.T. 10 = about 30 drops.
After a total of about 15 mL has been administered the calcium level of the blood is determined and further dosage is determined by the physician.
In severe cases: 8 - 15 mL in one dose. Serum calcium level must be examined on about the 7th day. Further dosage depends on the result of the blood calcium test. During the further course of treatment, controls of the calcium level of the blood are advisable. The normal physiological blood calcium level is 9,5 - 11 mg %.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:
In rare cases a too high dosage or particular hypersensitivity can lead to anorexia, lassitude, nausea, diarrhoea, polyuria thirst headache or palpitations. In such cases the physician should be informed. Suppression of parathyroid function in the newborn may be associated with maternal hypercalcaemia.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
With acute overdosage, the same symptoms are observed as following too large intravenous doses of calcium: general lassitude, anorexia, vomiting, diarrhoea, circulatory disorders, gastric haemorrhage, symptoms of paralysis, kidney failure and pathological calcium deposits.
The effects are reversible if treatment is stopped in time. Advisable measures are ample fluid intake, low calcium diet and where necessary, administration of glucocorticoids.

IDENTIFICATION:
Clear yellowish oily solution.

PRESENTATION:
Dropper bottle of 15 mL.

STORAGE INSTRUCTIONS:
Protect from light and store below 25°C. Keep out of reach of children.

REGISTRATION NUMBER:
K/22.1.4/143

NAME AND BUSINESS ADDRESS OF APPLICANT:
Bayer (Pty) Ltd.
Wrench Road Isando 1600
68/11192/07

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
January 1983
        Davbar Dbn.
        C9267/0896

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