Calcium Chloride 10 % Fresenius 10 ml Solution

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

Up to 10 ml CALCIUM CHLORIDE FRESENIUS injection is given according to the patient's need in an intravenous infusion or very slow intravenous injection (not more than 1 ml per minute) u2013 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 an equivalent amount of calcium gluconate. The pulse rate should be monitored during administration and should bradycardia develop, the intravenous infusion should be stopped immediately. Treatment should be stopped at once if blood calcium exceeds 2,625 mmol to 2,75 mmol per litre.

CALCIUM CHLORIDE FRESENIUS is contraindicated in:

• Patients that are hypersensitive to calcium chloride or any of the excipients in CALCIUM CHLORIDE FRESENIUS listed in section 6.1.
• Patients being treated with cardiac glycosides.
• Patients with ventricular fibrillation or hypercoagulability of blood.
• Hypercalcaemia and severe hypercalciuria (e.g. hyperparathyroidism, vitamin D overdosage, decalcifying tumours such as plasmacytoma and skeletal metastases).
• Renal failure.
• Osteoporosis due to immobilisation.
• Sarcoidosis and milk-alkali syndrome.

Do not inject intramuscularly or subcutaneously. It is irritant to tissues and causes necrosis. Intravenous infusions must be given very slowly. Injection given too quickly can cause hypotension and cardiovascular collapse (see section 4.8). Hypercalcaemia can occur because of underlying hyperparathyroidism of neoplastic disease and excessive vitamin D intake, prolonged immobilisation, sarcoidosis, hyperthyroidism, milk-alkali syndrome and acidosis (see section 4.3). Give cautiously to patients with impaired renal function or renal stone formation. Serum calcium levels should be assessed regularly, particularly with renal insufficiency and if large doses of vitamin D are used concurrently. CALCIUM CHLORIDE FRESENIUS, because of its acidifying nature, is unsuitable for the treatment of hypocalcaemia caused by renal insufficiency or in patients with respiratory acidosis or failure. Ceftriaxone must not be mixed or administered simultaneously with any calcium-containing IV solutions, even via different infusion lines or at different infusion sites. A moderate fall in blood pressure due to vasodilation may attend CALCIUM CHLORIDE FRESENIUS injection. CALCIUM CHLORIDE FRESENIUS is irritating to veins and must not be injected into tissues, since severe necrosis and sloughing may occur (see section 5.8). Great care should be taken to avoid extravasation or accidental injection into perivascular tissues. Should perivascular infiltration occur, IV administration at that site should be discontinued at once. Local infiltration of the affected area with 1 % procaine hydrochloride, to which hyaluronidase may be added, will often reduce venospasm and dilute the calcium remaining in the tissues locally. Local application of heat may also be helpful. Excessive amounts of calcium salts may cause hypercalcaemia (see section 4.8). Careful monitoring of serum electrolyte concentrations is essential throughout therapy. It is particularly important to prevent a high concentration of calcium from reaching the heart because of the danger of cardiac syncope. If injected into the ventricular cavity in cardiac resuscitation, care must be taken to avoid injection into the myocardial tissue.

CALCIUM CHLORIDE FRESENIUS potentiates effects of digitalis glycosides and may cause intoxication. It could increase the gastric acid secretion enormously. For interaction between calcium-containing products and ceftriaxone, please see section 4.4 above. CALCIUM CHLORIDE FRESENIUS is not compatible for simultaneous administration with other intravenous solutions containing citrates, soluble carbonates, phosphates, sulphates, cefalotin 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. Hypercalcaemia has occurred when CALCIUM CHLORIDE FRESENIUS was given with thiazide diuretics or vitamin D. CALCIUM CHLORIDE FRESENIUS may decrease the effectiveness of calcium channel blockers. CALCIUM CHLORIDE FRESENIUS may reduce the absorption of bisphosphonates (in the treatment of Paget's disease or hypercalcaemia of malignancy) and must be given at least 12 hours apart.

The safety of CALCIUM CHLORIDE FRESENIUS in pregnancy and lactation has not been established.

No adverse effects have been reported.

Gastrointestinal disorders: Frequency unknown: Nausea, vomiting. Skin and subcutaneous tissue disorders: Frequency unknown: Tingling of the skin, peripheral vasodilation, sweating and hot flushes. General disorders and administration site conditions: Frequency unknown: Chalk-like taste. Description of selected adverse reactions: Rapid intravenous injections may cause the patient to complain of tingling sensations, a calcium (chalk-like) taste, and a sense of distress or u201cheat waveu201d. Injections of calcium chloride are accompanied by peripheral vasodilation as well as a local burning sensation and there may be a moderate fall in blood pressure. Necrosis and sloughing with subcutaneous or intramuscular administration or if extravasation occurs have been reported (see section 4.4). Soft tissue calcification, bradycardia or dysrhythmias have also been reported. Reporting of suspected adverse reactions: Health care providers are asked to report any suspected adverse drug reactions to the Holder of the Certificate of Registration at the following email address: [email protected] and to the relevant medicineu2019s regulatory authority in the country where the product is marketed. Reporting suspected adverse reactions after authorisation of CALCIUM CHLORIDE FRESENIUS is important. It allows continued monitoring of the benefit/risk balance of CALCIUM CHLORIDE FRESENIUS. Health care providers are asked to report any suspected adverse reactions to SAHPRA via the u201c6.04 Adverse Drug Reactions Reporting Formu201d, found online under SAHPRAu2019s publications: https://www.sahpra.org.za/Publications/Index/8.

Symptoms: An overdose of CALCIUM CHLORIDE FRESENIUS would lead to hypercalcaemia. Symptoms of hypercalcaemia may include anorexia, nausea, vomiting, constipation, abdominal pain, muscle weakness, mental disturbances, thirst, polyuria, drowsiness, confusion, nephrocalcinosis, and in severe cases u2013 cardiac dysrhythmias, coma and cardiac arrest. Treatment: Initial management of hypercalcaemia should include withholding calcium administration. This will usually resolve mild hypercalcaemia in asymptomatic patients, provided renal function is adequate. When serum calcium concentrations are greater than 12 mg per 100 ml, immediate measures may be required such as rehydration by either the oral or intravenous route. In severe hypercalcaemia, administration of sodium chloride by intravenous infusion to expand the extracellular fluid may be necessary. Intravenous rehydration may be given with, or followed by, furosemide or other loop diuretics to increase calcium excretion. Thiazide diuretics should be avoided as they may increase the renal absorption of calcium. Other medicines which may be used if this treatment proves unsuccessful include calcitonins, the bisphosphonates, medicines with chelating properties, corticosteroids and plicamycin. Phosphates may be useful, but should be given by mouth and only to patients with low serum phosphate concentrations and normal renal function. Haemodialysis may be considered as a last resort.