Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2020 Publisher: Baxter Healthcare Ltd, Caxton Way, Thetford, Norfolk, IP24 3SE, United Kingdom
Pharmacotherapeutic group: Maintenance solution
ATC code: B05BB02
The physiological balanced maintenance solutions cover the basal needs of fluid and electrolytes with a daily dose of 2000-3000 ml. The amount of glucose 50g/1000 ml is chosen with respect to the administered glucose (approx. 150g/day) which is needed to prevent a marked degradation of amino acids and production of ketone bodies.
Maintelyte solution for infusion is an hypertonic solution of electrolytes and glucose (osmolarity: 402 mOsm/l (approx)).
The pharmacological properties of Maintelyte solution for infusion are those of its components (glucose, sodium, potassium, magnesium, chloride and acetate).
Acetates are mainly metabolized by muscle and peripheral tissues to bicarbonate, without affecting the liver.
For this solution, glucose is the main source of energy, and this solution provides 200 kcal/L.
fter intravenous administration glucose exhibits fast (approximately 20 minutes) and slow phases of equilibrium. Distribution is largely through extracellular water, and intracellular water of the liver.
In the postoperative state endogenous glucose production equals the amount of glucose taken up and metabolized by all the tissues and is about 2.3 ± 0.1 mg/kg -1.min-1.
Sodium homoeostatis is complex and closely associated with fluid balance. Osmolality and volume of extracellular fluid are tightly regulated. Small changes in osmolality (plasma-sodium concentrations) are corrected by alterations of extracellular volume. The balance of plasma osmolality is achieved by the secretion or suppression of antidiuretic hormone (ADH; vasopressin), which primarily controls water excretion by the kidney.
A normal concentration of potassium in plasma is about 3.5 to 5.0 mmol per litre, but factors influencing between intracellular and extracellular shifts such as acid-base disturbances can distort the relationship between plasma concentrations and total body stores.
Parenterally administered magnesium is excreted mainly in the urine. Small amounts of magnesium are distributed into breast milk and it crosses into the placenta. The normal circulating level of total magnesium is 1.6 to 2.4 mg/dl (0.8 to 1.2 mmol/l).
Acetates, such as sodium acetate trihydrate, are metabolised to bicarbonate. Acetate can be metabolised by muscle and peripheral tissues into bicarbonate, thus avoiding the liver.
There is no preclinical data relevant to the prescribing doctor besides the one already described in the other sections of this Summary of Product Characteristics.
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