STEROFUNDIN Solution for infusion Ref.[28263] Active ingredients: Calcium chloride Magnesium chloride Malic acid Potassium chloride Sodium acetate Sodium chloride

Posology

Adults, the elderly, adolescents and children

The dosage depends on the age, weight, clinical and biological conditions of the patient and concomitant therapy.

Recommended dosage

The recommended dosage is:

• for adults, the elderly and adolescents: 500 ml to 3 litres /24h, corresponding to 1 to 6 mmol sodium/kg/24 h and 0.03 to 0.17 mmol potassium/kg/24 h.
• for toddlers, infants and children : 20 ml to 100 ml/kg/24 h, corresponding to 3 to 14 mmol sodium/kg/24 h and 0.08 to 0.40 mmol potassium/kg/24 h.

Administration rate:

The maximum infusion rate depends on the needs of the patient in fluid replacement and electrolytes, his weight, clinical condition, and biological status.

In paediatric patients the infusion rate is 5 ml/kg/h on average but the value varies with age: 6-8 ml/kg/h for infants, 4-6 ml/kg/h for toddlers, and 2-4 ml/kg/h for children.

Note:

• infants and toddlers: age ranges from about 28 days to 23 months (a toddler is an infant who can walk)
• children: age ranges from about 2 years to 11 years.

Paediatric population

The safety and efficacy of Sterofundin in newborn infants (below the age of 28 days) has not been established.

Method of administration

For intravenous use as infusion only.

Sterofundin ISO can be infused into peripheral veins (see section 3 for pH and theoretical osmolarity).

If administration is by rapid infusion under pressure, all air must be withdrawn from the plastic container and infusion set prior to infusion, as otherwise there is a risk of producing air embolism during infusion.

Fluid balance, plasma electrolyte concentrations and pH must be monitored during administration. Sterofundin ISO may be administered as long as there is an indication for fluid replacement.

Overuse or too fast administration may lead to water and sodium overload with a risk of oedema, particularly when there is a defective renal sodium excretion. In this case extra renal dialysis may be necessary.

Excessive administration of potassium may lead to the development of hyperkalaemia, especially in patients with renal impairment. Symptoms include paresthesia of the extremities, muscle weakness, paralysis, cardiac arrhythmias, heart block, cardiac arrest, and mental confusion. Treatment of hyperkalaemia involves the administration of calcium, insulin (with glucose) sodium bicarbonate, exchange resins or dialysis.

Excessive parenteral administration of magnesium salts leads to the development of hypermagnesaemia, important signs of which are loss of deep tendon reflexes and respiratory depression, both due to neuromuscular blockade. Other symptoms of hypermagnesaemia may include nausea, vomiting, flushing of the skin, thirst, hypotension due to peripheral vasodilation, drowsiness, confusion, muscle weakness, bradycardia, coma, and cardiac arrest.

Excessive administration of chloride salts may cause a loss of bicarbonate with an acidifying effect.

Excessive administration of compounds, such as acetate and malate, which are metabolised to form the bicarbonate anion may lead to metabolic alkalosis, especially in patients with impaired renal function. Symptoms may include mood changes, tiredness, shortness of breath, muscle weakness, and irregular heartbeat. Patients with additional hypocalcaemia may develop muscle hypertonicity, twitching, and tetany. Treatment of metabolic alkalosis associated with an increase in bicarbonate consists mainly of appropriate correction of fluid and electrolyte balance.

Excessive administration of calcium salts may lead to hypercalcaemia. Symptoms of hypercalcaemia may include anorexia, nausea, vomiting, constipation, abdominal pain, muscle weakness, mental disturbances, polydipsia, polyuria, nephrocalcinosis, renal calculi, and, in severe cases, cardiac arrhythmias and coma. Too rapid intravenous injection of calcium salts may also lead to many of the symptoms of hypercalcaemia as well as to a chalky taste, hot flushes, and peripheral vasodilation. Mild asymptomatic hypercalcaemia will usually resolve on stopping administration of calcium and other contributory drugs such as vitamin D. If hypercalcaemia is severe, urgent treatment (such as loop diuretics, haemodialysis, calcitonin, bisphosphonates, trisodium edetate) is required.

When overdose is related to medications added to the solution infused, the signs and symptoms of overinfusion will be related to the nature of the additive being used. In the event of accidental overinfusion, treatment should be discontinued and the patient should be observed for the appropriate signs and symptoms related to the drug administered. The relevant symptomatic and supportive measures should be provided as necessary.

Shelf life of the medicinal product as packaged for sale:

• in glass bottles and polyethylene plastic bottles: 3 years
• in plastic bags: 2 years

Shelf life after first opening of the container:

From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C unless reconstitution/dilution (etc) has taken place in controlled and validated aseptic conditions.

Glass bottles and Polyethylene plastic bottles: Do not refrigerate or freeze.

Plastic bags: Do not store above 25°C. Do not refrigerate or freeze.

The solution for infusion is packed in:

• type II glass bottles with butyl rubber stoppers containing 250 ml, 500 ml or 1000ml, available in packs of 1 or 10 bottles (250 ml and 500 ml) or of 1 or 6 bottles (1000 ml);
• polyethylene plastic bottles containing 250 ml, 500 ml or 1000ml, available in packs of 1 or 10 bottles;
• plastic bags with outer protective bags. The primary bag consists of a three layer plastic laminate with a polypropylene inner layer and a polyamide outer layer. The bags contain 250 ml, 500 ml or 1000 ml and are available in packs of 1 or 20 bags (250 ml and 500 ml) or of 1 or 10 bags (1000 ml).

Not all package sizes may be marketed.

Only for intravenous use.

Single use only.

Do not reconnect partially used containers.

Unused solution should be discarded.

Do not use if container or closure is damaged. Only clear solutions practically free from particles should be used.

The solution should be administered with sterile equipment using an aseptic technique. The equipment should be primed with the solution in order to prevent air entering the system.

If using plastic bags, surrounding bag must only be removed immediately before use. For further information please refer to section 4.2.