IONOLYTE

Posology Adults and paediatric patients The dose and rate of administration depends on age, body weight, clinical and biological conditions of the patient (including acid-base balance) and the concomitant therapy.

Recommended dosage:

The maximum daily dose corresponds to the fluid and electrolyte needs of the patient. To temporary restore blood volume 3 to 5 times the volume of the lost blood is required.

Typical recommended dosages are:

For adults, the elderly and adolescents (age 12 years and above): 500 ml to 3 litres/24 hours. For infants, toddlers and children (from 28 days to 11 years of age): 20 ml/kg to 100 ml/kg/24 hours.

Administration rate:

In continuous treatment outside acute fluid losses the infusion rate is usually 40 ml/kg/24 hours in adults. In paediatric patients the infusion rate is 5 ml/kg/hour in average but the value varies with the age: 6-8 ml/kg/hour for infants, 4-6 ml/kg/hour for toddlers, and 2-4 ml/kg/hour for school children.

Method of administration For intravenous use.

The undesirable effects are divided into:

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), not known (cannot be estimated from the available data) For similar products, the following adverse reactions have been described: Metabolism and nutrition disorders During administration of electrolyte solutions, the following undesirable effects have been reported: - Hyperhydration and heart failure in patients with cardiac disorder or pulmonary oedema (very common) - Oedema due to water/sodium overload (unknown frequency) General disorders and administration site conditions Adverse reactions may be associated to 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.

g. coagulation factors and other plasma proteins, and a decrease of the hematocrit. Adverse reactions may be associated to the medicinal product added to the solution; the nature of the additive will determine the likelihood of any other undesirable effects.

In case of undesirable effect(s), the infusion must be discontinued. 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.

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The patient’s clinical status and laboratory parameters (fluid balance, blood and urine electrolytes as well as acid-base balance) must be monitored, especially during use of larger volumes of this solution. Fluid overload caused by overdose should be avoided in general.

Particularly for patients with cardiac insufficiency or severe kidney dysfunctions the increased risk of hyperhydration must be taken into consideration; posology must be adapted. 9% sodium chloride solution should be preferred over alkalising solutions like Ionolyte.

Particular care must be taken in patients with severe electrolyte abnormalities, like hypernatraemia, hypermagnesaemia and hyperchloraemia. g. 5). Since this solution contains potassium, combination with potassium-sparing diuretics is not recommended.

g. 5). Precaution must be taken to use this medicine in combination with angiotensin converting enzyme inhibitors, angiotensin II receptor antagonists, suxamethonium, tacrolimus, cyclosporine or in case of severe digitalis intoxication (risk of cardiac symptoms).

Although Ionolyte has a potassium concentration similar to the concentration in plasma, it is insufficient to produce a useful effect in case of severe potassium deficiency and therefore it should not be used for this purpose. Solutions containing magnesium salts should be used with caution to patients with renal impairment, severe heart rate disorders and in patients with myasthenia gravis.

Patients should be monitored for clinical signs of excess magnesium, particularly when being treated for eclampsia. 5). Infusion of Ionolyte may cause metabolic alkalosis because of the presence of acetate ions. However, it is not suitable to treat severe metabolic or respiratory acidosis.

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

1. This medicine is contraindicated in the following situations: - Fluid overload (hyperhydration), especially in cases of pulmonary oedema and congestive cardiac failure - Severe renal insufficiency - Metabolic alkalosis and - Hyperkalaemia