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Logo INTRAMED CALCIUM CHLORIDE 10% m/v INJECTION

SCHEDULING STATUS:
S1

PROPRIETARY NAME
(and dosage form):

INTRAMED CALCIUM CHLORIDE 10% m/v INJECTION

COMPOSITION:
Each 10 mL ampoule contains 1g
calcium chloride dihydrate.
Each 10 mL ampoule contains 6,803 millimoles or 13,605 milliequivalents of calcium.

PHARMACOLOGICAL CLASSIFICATION:
A24 Mineral substitutes, electrolytes.

PHARMACOLOGICAL ACTION:
Calcium is an essential electrolyte of the tissues and the blood, in ionised and colloidal form. It is essential for normal muscle and nerve function, cardiac function and blood clotting.

INDICATIONS:
Treatment of calcium deficiency and hypocalcaemia. It is also used as an adjunct in the treatment of severe hyperkalaemia and hypermagnesia. It has an inotropic effect in cardiac resuscitation. Alleviation of pain in lead colic.

CONTRA-INDICATIONS:
Do not give to patients being treated with cardiac glycosides. Contra-indicated in patients with ventricular fibrillation or hypercoagulability of blood. Contra-indicated in hypercalcaemia and severe hypercalcinuria (e.g. hyperparathyroidism, Vit D overdosage, decalcifying tumours such as plasmacytoma and skeletal metastases). Contra-indicated in renal failure, in osteoporosis due to immobilization, in sarcoidosis and milk-alkali syndrome.

WARNINGS:
Do not inject intramuscularly; it is irritant to tissues and causes necrosis. Intravenous infusions must be given very slowly. Serum calcium levels should be assessed regularly.

DOSAGE AND DIRECTIONS FOR USE:
Up to 10 mL calcium chloride injection is given according to the patient's need in an intravenous infusion or very slow intravenous injection (not over 1 mL per minute) – too rapid administration will cause vasodilation or clotting. A maximum of 8 g in 24 hours must not be exceeded. There are about three times more calcium ions in calcium chloride than in calcium gluconate. The pulse rate should be monitored during administration and should bradycardia develop the intravenous infusion should be stopped immediately.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
See Warnings and Directions for use. Injection given too quickly can cause hypotension and cardiovascular collapse. It may cause nausea, vomiting, a chalk-like taste, tingling of the skin, peripheral vasodilation and sweating. Hypercalcaemia can occur because of underlying hyperparathyroidism of neoplastic disease and excessive Vitamin D intake, prolonged immobilization, sarcoidosis, hyperthyroidism, milk-alkali syndrome and acidosis. Give cautiously to patients with impaired renal function or renal stone formation. It potentiates digitalis and may cause intoxication, it reduces the absorption of tetracyclines. It could increase the gastric acid secretion. Treatment should be stopped at once if blood calcium exceeds 2,625 mmol to 2,75 mmol per litre. This product is not compatible for simultaneous administration with other intravenous solutions contianing citrates, soluble carbonates, phosphates, sulphates, cephalothin sodium, clindamycin phosphate, magnesium sulphate, novobiocin sodium and prednisolone sodium phosphate.
In addition incompatibilities have occurred with oxytetracycline hydrochloride, prochlorperazine, sodium bicarbonate, streptomycin sulphate and tetracycline hydrochloride.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Symptoms of hypercalcaemia may include anorexia, nausea, vomiting, constipation, abdominal pain, muscle weakness, thirst, polyuria, drowsiness, confusion, nephrocalcinosis, and in severe cases – cardiac arrhythmias, coma and cardiac arrest. Give large volumes of fluid to combat dehydration and renal deposits.
Discontinue all calcium intake. In severe hypercalcaemia, sodium chloride may be given by intravenous infusion to reduce plasma levels, but caution must be exercised in patients with renal insufficiency and diminished cardiac function. Treatment is symptomatic and supportive.

IDENTIFICATION:
A clear, colourless solution in 10 mL clear glass ampoules.

PRESENTATION:
Containers with 10 ampoules.

STORAGE INSTRUCTIONS:
Store below 25°C
KEEP OUT OF REACH OF CHILDREN

REGISTRATION NUMBER:
V/24/221

NAME AND BUSINESS ADDRESS OF APPLICANT:
INTRAMED (PTY) LTD
6 Gibaud Road
PORT ELIZABETH, 6001

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
August 1989 12-018/1-95
  Tradepak PE

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