NEPHROTRANS

Posology The dosage depends on the severity of metabolic acidosis, based on the results of blood gas analysis or determination of serum bicarbonate. The mean dosage is 3 to 5 g sodium hydrogen carbonate per day, equivalent to 40-65 mg sodium hydrogen carbonate per kg body weight per day.

The daily dose can be achieved by taking 6 to 10 capsules of Nephrotrans 500 mg. Paediatric population No data available. The safety and efficacy of Nephrotrans 500 mg in children and adolescents has not been established. Method of administration To be swallowed whole throughout the day with sufficient liquid.

This medicinal product should not be taken without medical supervision for prolonged periods, as there is a possibility for the development of hypernatremia or alkalosis. 2 require the correction of acidosis by infusion.

The following frequencies are used for the evaluation of adverse reactions:

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 (cannot be estimated from the available data) Gastrointestinal disorders Not known: flatulence and abdominal pain.

Renal and urinary disorders Not known: promotion of calcium or magnesium phosphate nephrolithiasis in chronic use. Musculoskeletal and connective tissue disorders Not known: hypocalcaemic tetany (muscle hyperexcitability due to decreased calcium) if the dose is exceeded.

g. diarrhoea, exacerbation of such disorders is possible. Skin and subcutaneous tissue disorders Very rare: allergic reactions due to soya oil. 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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

g. by pH measurement, standard bicarbonate, alkali reserve), especially at higher doses. Plasma electrolytes, especially sodium, potassium and calcium, should likewise be regularly monitored. These checks should also be performed regularly during long-term medication.

Further dosing should be determined based on the outcome of these checks. Any possible hyperalkalinity can be corrected by a dose reduction. Particular caution is required in the presence of hypoventilation, hypocalcaemia and hyperosmolar conditions.

This medicinal product contains 137 mg sodium per capsule, equivalent to approximately 7% of the WHO recommended maximum daily intake of 2 g sodium for an adult. The maximum daily dose of this product (10 capsules) is equivalent to 68% of the WHO recommended maximum daily intake for sodium.

This should be particularly taken into account for those on a low salt diet. Nephrotrans 500 mg contains 50 mg sorbitol in each capsule. Patients with rare hereditary problems of fructose intolerance (HFI) should not take this medicinal product.

1. - metabolic alkalosis - hypokalaemia - hypernatraemia - low sodium diet