MINORSOL

g. 10 – 20 ml/kg/hr, and thereafter for regulation of the infusion rate according to basic and correction requirements with monitoring of relevant cardiovascular and laboratory parameters.

For fluid requirements the following reference values apply:

Neonates (0 to ≤28 days), infants (28 days to ≤1 year): 100 – 140 ml/kg body mass /day Infants aged 1 to ≤2 years: 80 – 120 ml/kg body mass /day Children aged 2 to ≤5 years: 80 – 100 ml/kg body mass /day Children aged 5 to ≤10 years: 60 – 80 ml/kg body mass /day Children aged 10 to ≤12 years and adolescents aged 12 to ≤14 years: 50 – 70 ml/kg body mass day For short-term intravascular volume replacement, the dosage should be determined individually according to the fluid needs For the treatment of isotonic dehydration in the paediatric population the rate of infusion and the daily dose should be determined individually according to the nature and severity of the electrolyte and water imbalance by monitoring the relevant cardiovascular and laboratory parameters.

If Minorsol is used in combination with other solutions for infusion the current guidelines on the total fluid supply for the relevant age group should be considered upon dosage calculation. The individual water, electrolyte, and carbohydrate requirements should be calculated and replaced accordingly; in particular, pre-term and underweight neonates, but also in all other exceptional therapeutic situations.

Balancing needs to be more exact the pre-term, younger, and underweight the patient is. Method of administration For intravenous use. Duration of administration The duration of administration depends on the patients fluid and electrolyte requirements.

As with all medicinal products for intravenous use, local site reactions associated with the method of administration cannot be excluded. The frequency of such reactions is not known (cannot be estimated from the available data). Local site reactions include febrile response, infections at the site of injection, venous thrombosis, phlebitis and extravasation extending from the site of injection.

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 Yellow Card Scheme.

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Monitoring of electrolyte and fluid status as well as the acid-base balance is necessary. Particularly careful risk-benefit assessment is required when this medicinal product is used in patients with pre-existing hyperglycaemia and metabolic alkalosis because the use of this medicinal product can deteriorate such conditions.

In this case, it is preferable to use similar electrolyte-containing solutions for infusion without glucose and/or acetate, if possible. In addition, in this patient group closer monitoring, particularly, blood glucose level and acid- base balance as well as electrolyte balance is required in order to detect resulting risks at an early stage.

Caution is required specifically in neonates and infants because the risk of developing lactic acidosis cannot be ruled out when using acetate as contained in this medicinal product in very rare disorders of acetate metabolism. These very rare disorders of acetate metabolism may appear for the first time when administering this medicinal product.

Minorsol should be used in paediatric patients with congenital disturbance of lactate utilisation after a careful risk-benefit-balance only. Controls of blood glucose levels are required postoperatively, post-traumatically and in other disorders of glucose tolerance (hyperglycaemia).

Caution is required in case of hypernatraemia, hyperkalaemia, and hyperchloraemia. If considered necessary, Benelyte should only be administered with particular caution, to patients with severe renal impairment. In patients with diminished renal function, administration of Benelyte may result in sodium and/or potassium or magnesium retention.

Cases of fatal reactions with calcium-ceftriaxone precipitates in lungs and kidneys in premature and full-term newborn infants aged less than 1 month have been described. In patients of any age ceftriaxone must not be mixed or administered simultaneously with any calcium-containing IV solutions even via different infusion lines or different infusion sites.

1, – Status of hyperhydration. – As for other calcium-containing infusion solutions, treatment with ceftriaxone and Benelyte is contraindicated in preterm newborn infants and term newborn infants (≤28 days of age), even if separate infusion lines are used (risk of fatal ceftriaxone calcium salt precipitation in the neonate’s bloodstream).