CALCIUM GLUCONATE

5 mEq per litre in adults. Treatment should be aimed at restoring or maintaining this level. During therapy, serum calcium levels should be monitored closely. 46 mmol calcium), can be administered undiluted as a slow intravenous injection over 10 minutes with plasma-calcium and ECG monitoring.

9% and administered as a slow intravenous infusion over 10 minutes with plasma-calcium and ECG monitoring. If necessary, the dose can be repeated depending on the clinical condition of the patient. Subsequent doses should be adjusted according to the actual serum calcium level.

Paediatric population Close plasma-calcium and ECG monitoring are necessary during administration until normal calcium values are achieved. 4). The product can be administered either as a slow intravenous injection, or as a slow continuous infusion.

22 mmol calcium/kg body weight) can be administered undiluted as a slow intravenous injection over 5-10 minutes. 11 mmol calcium/kg body weight) have also been shown to be effective in alleviating hypocalcaemic symptoms. 22 mmol calcium/min.

13 mmol calcium/kg body weight) administered undiluted as a slow intravenous injection over 5-10 minutes. 22 mmol calcium/min. 4). 9% or glucose 5%. 02 mmol calcium/kg body weight/ hour) has also been shown to be effective for a correction of serum calcium levels.

022 mmol/kg body weight/hour). 9% or glucose 5%. 045 mmol/kg/hour). 4). 5 mmol/L). 69 mmol calcium) administered undiluted as a slow intravenous injection over 10 minutes. Further doses can be considered after 5 minutes, if needed, until ECG improvement is achieved.

Paediatric population The dose regimen for cardiac arrest should be followed. Treatment of cardiac arrest due to hyperkalaemia Treatment should be tailored to the individual patient. The onset of action of intravenous calcium gluconate is within three minutes.

With a relatively short duration of action (30 – 60 minutes) further doses may be necessary if hyperkalaemia remains uncontrolled. 69 mmol calcium) administered undiluted as a rapid intravenous injection. Further doses can be repeated if return of spontaneous circulation is not achieved within 5-10 minutes, or if the resuscitation attempt is prolonged.

11 mmol calcium/kg body weight) administered undiluted (in the case of emergency) as a slow intravenous injection over […]

8. Precautions for use Cardiovascular and other systemic undesirable effects are likely to occur as symptoms of acute hypercalcaemia resulting from intravenous overdose or too rapid intravenous injection. Their occurrence and frequency are directly related to the administration rate and the administered dose.

Solutions containing calcium should be administered slowly to minimise peripheral vasodilation and cardiac depression. Intravenous injections should be accompanied by heart rate or ECG control because bradycardia with vasodilatation or arrhythmia can occur when calcium is administered too quickly.

Plasma levels and urinary excretion of calcium should be monitored when high-dose parenteral calcium is administered. Calcium salts are irritant. Reddening of skin, burning sensation or pain during intravenous injection may indicate accidental perivascular injection, which may lead to tissue necrosis.

The infusion site must be monitored regularly to ensure extravasation injury has not occurred. Patients receiving calcium salts should be monitored carefully to ensure maintenance of correct calcium balance without tissue deposition.

High Vitamin D intake should be avoided. Paediatric population Due to the risk of aluminium exposure and accumulation, a maximum dose of 1 ml/kg body weight/day of Calcium Gluconate 10% solution for injection/infusion is recommended for administration in children 0 to < 18 years and those with impaired renal function.

1). A study by Bishop et al. (1997) assessed aluminium neurotoxicity in preterm infants receiving intravenous feeding solutions. 0 μg/kg/day were administered to the infants. Bayley Mental Development Index (MDI) was used to compare neurologic development between the studied groups.

The MDI scores in all groups of infants receiving the intravenous feeding solutions for 10 days or less were similar. 02) was observed when compared with those receiving the aluminium-depleted solutions. 5 Interaction with other medicinal products and other forms of interaction Cardiac glycosides The effects of digoxin and other cardiac glycosides may be potentiated by calcium, which may result in serious toxicity.

8 mmol of calcium The difference in calcium content should be accounted for to achieve the correct calcium dose when using either salt to avoid medication errors. Plasma calcium levels and calcium excretion should be monitored when calcium is administered parenterally, especially in children, in chronic renal failure or where there is evidence of calculi formation within the urinary tract.

75mmol per litre or if 24 hour urinary calcium excretion exceeds 5mg/kg, treatment should be discontinued immediately as cardiac arrhythmias may occur at these levels. 3. 5), or in the elderly. 5). Calcium Gluconate 10% solution for injection/infusion should be administered slowly (in 100 ml glucose 5% over 20 minutes).

g. haemodialysis should also be considered after consultation with specialists. 2). Care should be taken to avoid admixture of calcium gluconate and incompatible drugs in giving sets, or in the circulation after separate administration.

Serious complications, including fatalities, have occurred following microcrystallisation of insoluble calcium salts in the body following separate administration of physically incompatible solutions or total parenteral nutrition solutions containing calcium and phosphate.

Calcium Gluconate 10% solution for injection/infusion must not be mixed with or administered through the same intravenous line as sodium bicarbonate (sometimes used for treatment of severe hyperkalaemia) due to the risk of precipitation.

Renal impairment Renal impairment may be associated with hypercalcaemia and secondary hyperparathyroidism. Therefore, in patients with renal impairment, parenteral calcium should be administered only after careful assessment of the indication and the calcium-phosphate balance should be monitored.

e. haemodialysis or peritoneal dialysis) should be available due to higher risk of hypercalcemia. Patients receiving ceftriaxone Cases of fatal reactions with calcium-ceftriaxone precipitates in lungs and kidneys in premature and full-term newborns aged less than 1 month have been described.

g. in hyperparathyroidism, hypervitaminosis D, neoplastic disease with decalcification of bone, renal insufficiency, immobilisation osteoporosis, sarcoidosis, milk-alkali syndrome); • Patients with hypercalciuria; • Poisoning with cardiac glycosides; • Patients receiving cardiac glycosides.

5). 1). Calcium Gluconate 10% solution for injection/infusion is indicated for acute, symptomatic treatment only. Aluminium oxide can be leached from ampoule glass by Calcium Gluconate. 4).