CALCIUM CHLORIDE Sterile solution for slow intravenous infusion Ref.[8814] Active ingredients: Calcium chloride

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2020  Publisher: Aurum Pharmaceuticals Ltd, Bampton Road, Harold Hill, Romford, RM3 8UG, UK

Therapeutic indications

Calcium Chloride Injection is indicated for use in Cardio-pulmonary Resuscitation where there is also hyperkalaemia or hypocalcaemia or calcium channel block toxicity.

It is also used for the treatment of hypocalcaemia and of calcium deficiency states (a decrease in plasma-calcium concentration below the normal range of 2.15-2.60 mmol/L) as a result of impaired or reduced absorption from the gastrointestinal tract, increased deposition in bone, or to excessive losses, for instance during lactation.

Additionally, hypocalcaemia may develop during transfusions utilising citrated blood or during long-term parenteral nutrition unless prophylactic calcium supplementation is employed. Other causes of hypocalcaemia include decreased parathyroid hormone activity, vitamin D deficiency and hypomagnesaemia.

Posology and method of administration

This medicinal product is not intended to deliver volumes of less than 2 mL

Adults and elderly

In Cardiopulmonary Resuscitation (CPR) a single dose of 10ml (10% w/v) should be considered, according to the algorithm recommended by the European Resuscitation Council & the Resuscitation Council (UK).

Adults in acute hypocalcaemia, a typical dose is 2.25 to 4.5 mmol (approximately 3-7ml of a 10% w/v solution) of calcium given by slow intravenous infusion and repeated as required.

Paediatric population

This medicine is not recommended for use in children.

Method of administration

For slow intravenous infusion only. Not for intramuscular use, or subcutaneous use

Overdose

Symptoms

An overdose of Calcium Chloride would lead to hypercalcaemia and produce the signs and symptoms described above (see Section 4.8).

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 12mg per 100ml, 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 drugs which may be used if this treatment proves unsuccessful include calcitonins, the bisphosphonates, chelating agents, 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.

Shelf life

3 years.

Special precautions for storage

Do not store above 25°C.

Nature and contents of container

Type 1 glass pre-filled syringe, containing 10ml of a 10% w/v Calcium Chloride sterile solution for slow intravenous infusion only.

Special precautions for disposal and other handling

Discard any contents after use in appropriate manner.

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