active ingredients

• 940 mg D-gluconic acid, calcium salt-1-water

excipients

• water for injections
• calcium saccharate-4-water

Calcium gluconate B. Braun 10% injection solution
Electrolyte solution for injection for the treatment of acute symptomatic hypocalcaemia.

The normal plasma calcium concentration is in the range of 2.25 – 2.62 mmol per liter. The aim of treatment should be to restore these plasma calcium values. Serum calcium levels should be closely monitored during treatment.

Dosage:

Adults:
The usual starting dose for adults is 10 ml Calcium Gluconate B. Braun 10% injection solution, corresponding to 2.25 mmol calcium. If necessary, the dose may be repeated depending on the patient's clinical condition. The amount of subsequent doses depends on the current serum calcium concentration.

Children and adolescents (< 18 years):
The dose and method of administration depend on the degree of hypocalcaemia and the type and severity of the symptoms. In cases of mild neuromuscular symptoms, oral calcium administration is preferable.

Infants, toddlers and children < 4 years:
0.4 – 1 ml/kg body weight (0.09 – 0.23 mmol calcium per kg body weight) in infants, toddlers and children up to 3 years of age. In cases of severe hypocalcaemia symptoms in newborns and infants, such as cardiac symptoms, higher initial doses may be required for rapid normalization of serum calcium levels (up to 2 ml per kg body weight, 0.45 mmol calcium per kg body weight).

Children ≥ 4 to 12 years:
0.2 – 0.5 ml/kg body weight (0.05 – 0.11 mmol calcium per kg body weight) in children 4 to 12 years.

Adolescents > 12 years:
For patients over 12 years of age, the dosage should be the same as for adults. The administration may also be repeated depending on the patient's clinical condition. The amount of subsequent doses depends on the current serum calcium concentration. If necessary, subsequent treatment with oral calcium is indicated after intravenous therapy, e.g. in cases of calciferol deficiency.

Elderly:
Although there is no evidence that advanced age has a direct influence on the tolerability of calcium gluconate, factors sometimes associated with ageing, such as impaired renal function and malnutrition, may indirectly influence tolerability and may require a dose reduction.

Method of administration:
The patient should be supine and carefully monitored during the injection. Monitoring should include checking the heart rate or ECG.

Adults:
Intravenous use or intramuscular use. Because of the risk of local tissue irritation, deep intramuscular injections should only be performed when slow intravenous administration is not possible. Care should be taken to ensure that intramuscular injections are given sufficiently deep into the muscle, preferably in the gluteal region.

To ensure safe positioning of the injection in the muscle and not in the fatty tissue, a longer cannula should be chosen in obese patients.

For subsequent injections, the injection site should be changed each time.

According to the NHS guideline for the treatment of hypocalcaemia in adults, the intravenous injection rate should not exceed 2 ml (0.45 mmol calcium) per minute.

Children and adolescents (< 18 years):
Only slow intravenous injection or infusion (both after dilution) in order to achieve sufficiently low delivery rates and to avoid tissue irritation or necrosis due to accidental extravasation. The intravenous

In children and adolescents, the administration rate should not exceed 5 ml per minute of a 1:10 diluted Calcium Gluconate B. Braun 10% solution.

Intramuscular injections should be avoided in pediatric patients.

Composition:
1 ml contains 94 mg calcium gluconate as active ingredient, corresponding to 0.21 mmol calcium. 10 ml contain 940 mg calcium gluconate as active ingredient, corresponding to 2.10 mmol calcium.

Other ingredients with known effects: The product also contains calcium D-saccharate tetrahydrate in an amount equivalent to 0.02 mmol calcium per ml (or 0.15 mmol calcium per 10 ml). Total calcium content: 0.23 mmol per ml (2.25 mmol per 10 ml).

The other ingredients are:
calcium D-saccharate tetrahydrate, water for injections