PHOSPHATES

Posology The dosage must be adjusted to the conditions of the patient, the fluid, electrolyte and acid-base-balance. Adults and Children over 12 years of age The volume of phosphates infusion given intravenously will depend upon the requirements of the patient.

The infusion must be given slowly (over 6-12 hours). 2mmol phosphate/kg of bodyweight (equivalent to 1-2 ml Polyfusor Phosphates/kg bodyweight) over 6-12 hours. 5mmol phosphate/kg of bodyweight (equivalent to 2-5 ml Polyfusor Phosphates/kg bodyweight) over 6-12 hours.

A total maximum dose of 50mmol per infusion should not be exceeded. Repeat doses may be required over subsequent days, dependant on serum phosphate determinations to correct any underlying deficiency state. Not more than 15 mmol phosphate/hour should be given.

Elderly The dosage of phosphates solution may need to be reduced in the elderly, particularly in patients with impaired renal function. Method of administration For intravenous infusion.

Prolonged infusion of phosphates solution, especially in patients with renal failure, may result in hyperphosphataemia. This may lead in turn to hypocalcaemia, which may be severe, with tetany and convulsions/neuro-excitability and to extraskeletal calcification, particularly in patients with initial hypercalcaemia.

Tissue calcification (metastatic calcium-phosphate precipitation in soft tissue) may cause hypotension and organ damage and result in acute renal failure. If the phosphate solution is administered excessively, hyperkalaemia may occur.

Symptoms include paraesthesia of the extremities, muscle weakness, cardiac arrhythmias, heart block, cardiac arrest, mental confusion, listlessness, paralysis and hypotension. In cases of excessive intake also hypernatraemia may occur with symptoms as dehydration of the brain which causes somnolence and confusion progressing to convulsions, coma and respiratory failure.

Other symptoms of hypernatraemia are thirst, reduced salivation and lachrymation, fever, tachycardia, hypertension, headache, dizziness, restlessness, irritability and weakness. Pain and phlebitis at the injection site may occur during intravenous administration.

Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard.

When administering Polyfusor Phosphates, serum electrolytes and renal function should be carefully monitored during therapy as well as ECG, fluid and acid-base- balance. In patients with renal impairment, its use must be carefully controlled by frequent determinations of plasma electrolyte concentrations.

Due to the potassium content the solution should be administered with considerable care to patients with cardiac disease or conditions predisposing to hyperkalaemia such as renal or adrenocortical insufficiency, acute dehydration, or extensive tissue destruction as occurs with severe burns.

Care should be exercised if potassium salts are given concomitantly with potassium-sparing diuretics. Potassium supplements should generally not be administered to patients receiving potassium-sparing drugs such as amiloride, spironolactone and triamterene.

Intravenous injections of potassium containing solutions should be given slowly as high blood concentrations may affect cardiac function. Potassium should generally not be given in the immediate postoperative period until urine flow is established.

Due to the sodium content the solution should be administered with caution to patients with hypertension, cardiac failure, peripheral or pulmonary oedema, impaired renal function and pre-eclampsia.

The label states:

Rapid infusion may be harmful Do not use unless the solution is clear and free from particles.

1. • Hyperphosphataemia • Hyperkalaemia • Hypernatraemia • Hypocalcaemia • Hyperhydration • Disturbance of renal function (renal insufficiency)