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

High volume infusion must be used under specific monitoring in patients with mild to moderate cardiac or pulmonary failure (for more severe conditions: see Section 4.3).

Solutions containing sodium chloride should be administered with caution to patients with:

• mild to moderate cardiac insufficiency, peripheral or pulmonary oedema or extracellular hyperhydration (for more severe conditions: see Section 4.3),
• hypernatraemia, hyperchloraemia, hypertonic dehydration, hypertension, impaired renal function, present or imminent eclampsia, aldosteronism or other conditions or treatment (e.g. corticoids/steroids) associated with sodium retention (see also Section 4.5).

Solutions containing potassium salts should be administered with caution 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.

Because of the presence of calcium:

• Care should be taken to prevent extravasation during intravenous infusion.
• The solution should be given cautiously to patients with impaired renal function or diseases associated with elevated vitamin D concentrations such as sarcoidosis. * In case of concomitant blood transfusion, the solution must not be administered via the same infusion set.

Solutions containing metabolizable anions should be administered cautiously to patients with respiratory impairment.

Monitoring of the serum electrolytes, fluid balance, and pH is necessary.

During long-term parenteral treatment, a convenient nutritive supply must be given to the patient.

This medicinal product contains 145 mmol sodium per 1000 ml. To be taken into consideration by patients on a controlled sodium diet.

Sodium, potassium, calcium, and magnesium are present in Sterofundin ISO in the same concentrations as in plasma. Hence, the administration of Sterofundin ISO in accordance with the recommended indications and contraindications does not increase the plasma concentrations of said electrolytes. In case there is a rise of any electrolyte’s concentration due to other reasons the following interactions should be considered.

Related to sodium:

Corticoids/steroids and carbenoxolone may be associated with the retention of sodium and water (with oedema and hypertension).

Related to potassium:

• Suxamethonium,
• Potassium-sparing diuretics (amiloride, spironolactone, triamterene, alone or in association),
• Tacrolimus, cyclosporine may increase the concentration of potassium in the plasma and lead to potentially fatal hyperkalaemia notably in case of renal failure increasing the hyperkalaemic effect.

Related to calcium:

Digitalis glycosides (digitalis cardiotonics) may undergo enhancement of their effects during hypercalcaemia and lead to serious or fatal cardiac arrhythmia.

Vitamin D may induce hypercalcaemia.

There are no data from the use of Sterofundin ISO in pregnant and lactating women. In the intended indication no risks have to be expected, when volume, electrolyte and acid/base levels are carefully monitored (see section 5.3).

Sterofundin ISO should be used with caution in toxaemia of pregnancy.

Sterofundin ISO has no influence on the ability to drive and use machines.

Signs of overdose may occur, see section 4.9.

Definition of frequency terms used in this section: Rare: ≥1/10,000 to <1/1,000, Not known Frequency cannot be estimated from the available data.

Immune system disorders

Frequency not known: Hypersensitivity reactions characterized by urticaria have been occasionally described after the intravenous administration of magnesium salts.

Gastrointestinal disorders

Although oral magnesium salts stimulate peristalsis, paralytic ileus has been rarely reported after intravenous infusion of magnesium sulphate.

General disorders and administration site conditions

Adverse reactions may be associated with the technique of administration including febrile response, infection at the site of injection, local pain or reaction, vein irritation, venous thrombosis or phlebitis extending from the site of injection and extravasation. Adverse reactions may be associated to the medications added to the solution; the nature of the additive will determine the likelihood of any other undesirable effects.

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. Healthcare professionals are asked to report any suspected adverse reactions via [to be completed nationally, see national reporting system listed in Appendix V].

Admixture of the medicinal product with medications containing carbonates, phosphates, sulphates or tartrates may lead to precipitation.