CALCIUM GLUCONATE

62 mmol per litre. Treatment should be aimed at restoring this level. During therapy, serum calcium levels should be monitored closely. 25 mmol of calcium. If necessary, the dose may be repeated, depending on the patient’s clinical condition.

Subsequent doses should be adjusted according to the actual serum calcium level.

Paediatric patients (< 18 years):

The dose and the route of administration depend on the degree of hypocalcaemia and the nature and severity of the symptoms. In the case of mild neuromuscular symptoms oral calcium administration should be preferred. g. 45 mmol calcium per kg body weight) may be necessary for a quick restoration of a normal serum calcium level.

Also, if necessary, the dose may be repeated, depending on the patient’s clinical condition. Subsequent doses should be adjusted according to the actual serum calcium level. g. in cases of calciferol deficiency. 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 5-10 minutes.

The dose should be given centrally whenever possible. 9% to five times the volume. The dose can be repeated if ECG changes persist after 5-10 minutes following administration of the first dose. 11 mmol calcium/kg body weight) by slow intravenous injection over 5-10 minutes.

In the case of emergency, Calcium gluconate 10 % w/v Injection BP can be administered undiluted via central IV access. 9% over 10 minutes. The dose can be repeated if ECG changes persist after 5-10 minutes following administration of the first dose.

46 mmol calcium) can be given. Elderly patients Although there is no evidence that tolerance of calcium gluconate injection is directly affected by advanced age, factors that may sometimes be associated with ageing, such as impaired renal function and poor diet, may indirectly affect tolerance and may require a reduction in dosage.

Method of administration The patient should be in the lying position and should be closely observed during injection. Monitoring should include heart rate or ECG. Adults Intravenous use or intramuscular use. Because of the risk of local irritation, deep intramuscular injections should only be performed if slow intravenous injection is not possible.

8). In the case of adipose patients a longer needle will have to be chosen for safe positioning of the injection into the muscle and not into adipose tissues. If repeated injections are necessary, the injection site should be changed every time.

According to the NHS guideline for the treatment of hypocalcaemia in adults the intravenous administration rate should not exceed 2 ml (0,45 mmol of calcium) per minute. Paediatric patients (< 18 years) Only slow intravenous injection or intravenous infusion (both after dilution), in order to achieve sufficiently low administration rates and to avoid irritation/necrosis in case of accidental extravasation.

6) of Calcium Gluconate 10% B. Braun in children and adolescents. Intramuscular injections should not be performed in paediatric patients.

The frequency of undesirable effects listed below is defined using the following convention: Very common ≥1/10 Common ≥1/100 to <1/10 Uncommon ≥1/1,000 to <1/100 Rare ≥1/10,000 to <1/1,000 Very rare <1/10,000 Not known Frequency cannot be estimated from the available data.

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 is directly related to the administration rate and the administered dose.

Cardiac disorders Not known:

Bradycardia, cardiac arrhythmia Vascular disorders Not known: Hypotension, vasodilatation, circulatory collapse (possibly fatal), flushing, mainly after too rapid injection Gastrointestinal disorders Not known: Nausea, vomiting General disorders and administration site conditions Not known: Heat sensations, sweating Not known: Intramuscular injection may be accompanied by pain sensations or erythema.

Ceftriaxone-calcium salt precipitation Rarely, severe, and in some cases, fatal, adverse reactions have been reported in pre-term and full-term neonates (aged < 28 days) who had been treated with intravenous ceftriaxone and calcium.

Precipitations of ceftriaxone-calcium salt have been observed in lung and kidneys post-mortem. 2).

Adverse reactions only occurring with improper administration technique:

If intramuscular injection is not performed sufficiently deep intramuscularly, infiltration into the adipose tissue may occur with subsequent abscess formation, tissue induration, and necrosis. Calcinosis cutis, possibly followed by skin ablation and necrosis, due to extravasation, has been reported.

Reddening of skin, burning sensation or pain during intravenous injection may indicate accidental perivascular injection, which may lead to tissue necrosis. Reporting of suspected adverse reactions Reporting of 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.

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. 5), or in the elderly. 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. 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.

2). 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. However, in patients older than 28 days of age ceftriaxone and calcium-containing solutions may be administered sequentially one after another if infusion lines at different sites are used or if the infusion lines are replaced or thoroughly flushed between infusions with physiological salt-solution to avoid precipitation.

Sequential infusions of ceftriaxone and calcium-containing products must be avoided in case of hypovolaemia. 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.

Precautions for use 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.

In paediatic patients, Calcium Gluconate 10 % w/v Injection BP should not be injected intramuscularly but only slowly intravenously. Patients receiving calcium salts should be monitored carefully to ensure maintenance of correct calcium balance without tissue deposition.

Plasma levels and urinary excretion of calcium should be monitored when high-dose parenteral calcium is administered. Calcium Gluconate 10 % w/v Injection BP should not be injected in adipose tissue as calcium is insoluble in adipose tissue and may cause infiltration and subsequent abscess formation, tissue indurations and necrosis.

8). Extravasation must be avoided; the injection site should be monitored carefully. High Vitamin D intake should be avoided.

g. in patients with hyperparathyroidism, hypervitaminosis D, decalcifying malignancies, renal insufficiency, immobilisation osteoporosis, sarcoidosis, milk-alkali syndrome) - Hypercalciuria - Intoxication with cardiac glycosides - Therapy with cardiac glycosides.

5). - Concomitant use of ceftriaxone and intravenous calcium-containing products is contraindicated in premature neonates and neonates (≤ 28 days of age). Ceftriaxone should not be used in premature neonates and neonates (≤ 28 days of age) if they are receiving (or are expected to receive) calcium-containing intravenous products.