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

Logo CALCIUM GLUCONATE INJECTION INTRAMED

SCHEDULING STATUS:
S1

PROPRIETARY NAME
(and dosage form):

CALCIUM GLUCONATE INJECTION INTRAMED

COMPOSITION:
Each 10 mL ampoule contains 950 mg
Calcium gluconate. Stabilised with 50 mg Calcium saccharate.

PHARMACOLOGICAL CLASSIFICATION:
A.24 (Mineral substitutes, electrolytes).

PHARMACOLOGICAL ACTION:
Calcium is essential to body metabolism and must be supplemented when deficient owing to disease states or other conditions.

INDICATIONS:
All conditions where supplemental calcium is indicated. Calcium gluconate is the preferred form for injection.

CONTRA-INDICATIONS:
Should not be given concurrently with digitalis therapy.

DOSAGE AND DIRECTIONS FOR USE:
1 to 2 g by intramuscular or intravenous injection.
Children up to 1 year, up to 300 mg; 1 to 5 years, 300 –600 mg; 6 to 12 years, 600 to 1000 mg, by slow intravenous injection.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Intramuscular injection in infants has been reported to cause abscess formation. The oral or intravenous route should be used.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Overdosage with calcium salts results in hypercalcaemia.
Symptoms include anorexia, lassitude, muscle and joint pains, nausea and vomiting, thirst and polyuria. The deposition of calcium in the kidneys leads to loss of renal concentrating capacity and renal damage. Elevated serum calcium concentrations can produce bradycardia and cardiac arrhythmias. Treatment consists of withdrawal of all calcium supplements, and administration of large volumes of fluids. In mild cases sodium phosphate, sulphate, chloride or citrate may be given intravenously. Furosemide and ethacrynic acid may be useful adjuncts but the thiazide diuretics are not effective. Disodium edetate has been used but renal damage may occur with high dosage.

CONDITIONS OF REGISTRATION:

IDENTIFICATION:
A clear solution in colourless glass ampoules.

PRESENTATION:
Ampoules of 10 mL in 10's and 100's.

STORAGE INSTRUCTIONS:
Store below 25°C
Keep out of reach of children.

APPLICATION NUMBER:
E1581 (Act 101/1965).

NAME AND BUSINESS ADDRESS OF APPLICANT:
INTRAMED (Pty.) Ltd.
6 Gibaud Road
Port Elizabeth 6001

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
August 1972 12-085/11-92
  KOHLER C&P P.E.

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