MAINTELYTE Solution for infusion Ref.[27872] Active ingredients: Glucose Magnesium chloride Potassium chloride Sodium acetate Sodium chloride

Fluid balance / renal function

Hyponatraemia

Treatment with intravenous fluids having a lower sodium concentration than the patient’s serum sodium may cause hyponatraemia (see section 4.2). Children, patients with reduced cerebral compliance, patients with non-osmotic vasopressin release (e.g. in acute illness, trauma, post-operative stress, central nervous system diseases), and patients exposed to vasopressin agonists and other drugs that can lower serum sodium (see section 4.5) are at particular risk of acute hyponatraemia. Acute hyponatraemia can lead to acute brain oaedema and life-threatening brain injury.

Risk of fluid and/or solute overload and electrolyte disturbances

The patient’s clinical status and laboratory parameters (fluid balance, blood and urine electrolytes as well as acid-base balance) must be monitored during use of this solution.

Depending on the volume and rate of infusion, intravenous administration of Maintelyte solution can cause fluid and/or solute overload resulting in overhydration/hypervolaemia therefore high volume infusion must be used under specific monitoring in patients with cardiac, pulmonary or renal failure.

Use in patients with hypervolaemia or overhydration, or conditions that cause sodium retention and oaedema

Maintelyte solution should be administered with particular caution to hypervolaemic or overhydrated patients. Solutions containing sodium chloride should be carefully administered to patients with hypertension, heart failure, peripheral or pulmonary oaedema, impaired renal function, pre-eclampsia, aldosteronism, or other conditions associated with sodium retention (see also 4.5).

Use in patients with severe renal impairment

Maintelyte solution should be administered with particular caution to patients with severe renal impairment. In such patients administration of Maintelyte solution may result in sodium and/or potassium or magnesium retention.

Electrolyte balance

Maintelyte solution’s magnesium concentration is inadequate for the treatment of symptomatic hypomagnesemia.

Use in patients with or at risk for hyperkalaemia

The plasma potassium level of the patient should be particularly closely monitored in patients at risk of hyperkalaemia. 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.

The following combinations are not recommended; they increase the concentration of potassium in the plasma and may lead to potentially fatal hyperkalaemia notably in case of renal failure increasing the hyperkalaemic effects (see section 4.5).

• Angiotensin converting enzyme inhibitors (ACEi) and, by extrapolation, angiotensin II receptor antagonists: hyperkalaemia potentially lethal
• Tacrolimus, cyclosporine.

Use in patients with hypocalcaemia

Maintelyte solution contains no calcium, and an increase in plasma pH due to its alkalinizing effect may lower the concentration of ionized (not protein-bound) calcium. Maintelyte solution should be administered with particular caution to patients with hypocalcaemia.

Use in patients with or at risk for and from hypermagnesemia

Solutions containing magnesium salts should be used with caution to patient 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 (see also in 4.5 “Interactions with other medicinal products and other forms of interaction”).

Acid base balance

Use in patients with or at risk for alkalosis

Maintelyte solution should be administered with particular caution to patients with alkalosis or at risk for alkalosis. Excess administration of Maintelyte solution can result in metabolic alkalosis because of the presence of acetate ions. However, this solution is not suitable to treat severe metabolic or respiratory acidosis.

Other warnings

Hypersensitivity reactions

Hypersensitivity/infusion reactions, including anaphylactoid reactions, have been reported with Maintelyte solution.

The infusion must be stopped immediately if any signs or symptoms of a suspected hypersensitivity reaction develop. Appropriate therapeutic counter measures must be instituted as clinically indicated.

Solutions containing glucose should be used with caution in patients with known allergy to corn or corn products, see section 4.8".

Administration in the postoperative period after neuromuscular block should be used with caution since magnesium salts can lead to a recurring effect.

Refeeding syndrome

For patients who are severely malnourished or have undergone a long period of starvation, caution should be exercised initially when administering glucose. The dose may be gradually increased as glucose metabolism improves. During long-term parenteral treatment, other convenient nutritive supply must be given to the patient.

Use in patients with or at risk for hyperglycaemia

Solutions containing glucose should be used with caution in patients with impaired glucose tolerance or diabetes mellitus. In diabetic patients, the amount of infused glucose has to be taken into account and insulin requirements may be modified. If hyperglycaemia occurs, rate of infusion should be adjusted or insulin administered.

Due to glucose presence, this solution is contra-indicated in the first 24 hours following head trauma and blood glucose concentration should be closely monitored during intracranial hypertension episodes.

Hyperglycaemia has been implicated in increasing cerebral ischemic brain damage and impairing recovery after acute ischemic strokes. Caution is recommended in using dextrose-containing solutions in such patients.

Osmolarity

Maintelyte solution for infusion is an hypertonic solution of electrolytes and glucose (osmolarity: 402 mOsm/l (approx)).

Administration of hypertonic solutions may cause venous irritation, including phlebitis.

Hyperosmolar solutions should be administered with caution to patients with hyperosmolar states.

Use in pediatric patients

Safety and effectiveness of Maintelyte solution in children have not been established by adequate and well-controlled trials.

The infusion rate and volume depends on the age, weight, clinical and metabolic conditions of the patient, concomitant therapy and should be determined by the consulting physician experienced in pediatric intravenous fluid therapy.

Newborns – especially those born premature and with low birth weight – are at increased risk of developing hypo- or hyperglycaemia and therefore need close monitoring during treatment with intravenous glucose solutions to ensure adequate glycaemic control in order to avoid potential long term adverse effects. Hypoglycaemia in the newborn can cause prolonged seizures, coma and brain damage. Hyperglycaemia has been associated with intraventricular hemorrhage, late onset bacterial and fungal infection, retinopathy of prematurity, necrotizing enterocolitits, bronchopulmonary dysplasia, prolonged length of hospital stay, and death.

Plasma electrolyte concentrations should be closely monitored in the paediatric population as this population may have impaired ability to regulate fluids and electrolytes.

The infusion of low sodium containing fluids together with the non-osmotic secretion of ADH may result in hyponatraemia. Hyponatraemia can lead to headache, nausea, seizures, lethargy, coma, cerebral oaedema and death. Therefore, acute symptomatic hyponatraemic encephalopathy is considered a medical emergency.

Use in elderly

When selecting the type of infusion solution and the volume/rate of infusion for a older people, consider that older people are generally more likely to have cardiac, renal, hepatic, and other diseases or concomitant drug therapy.

Interaction with sodium

• Corticoids/Steroids and carbenoxolone may cause retention of sodium and water (with oaedema and hypertension).

Interaction with potassium

• Potassium-sparing diuretics (amiloride, spironolactone, triamterene, alone or in association).
• Angiotensin converting enzyme inhibitors (ACEi) and angiotensin II receptor antagonists.
• Tacrolimus and cyclosporine increase concentration of potassium in the plasma and the combination may lead to potentially fatal hyperkalaemia notably in case of a renal failure contributing to the hyperkalaemia.

Interaction with acetate

Caution is advised when administering Maintelyte solution to patients treated with drugs for which renal elimination is pH dependent. Due to its alkalinizing effect (formation of bicarbonate), Maintelyte solution may interfere with the elimination of such drugs.

• Renal clearance of acidic drugs such as salicylates, barbiturates and lithium may be increase because of the alkalinisation of urine by the bicarbonate resulting from acetate and gluconate metabolism.
• Renal clearance of alkaline drugs, notably such as sympathomimetics (e.g. ephedrine, pseudoephedrine) and stimulants (e.g. quinidine, dexamphetamine sulphate, phenfluramine hydrochloride) may be decreased.

Interactions with magnesium

• Magnesium salts may potentiate the effect of depolarising neuromuscular blocker such as suxamethonium, vecuronium or tubocurarine. Therefore, the combination with these substances is not recommended.

Interaction with drugs that can increase the risk for hyponatraemia

Drugs that can lower serum sodium may increase the risk of acquired hyponatraemia following treatment with intravenous fluids inappropriately balanced to the need of the patient in terms of fluid volume and sodium content (see sections 4.2, 4.4, 4.6 and 4.8). Examples are diuretics, non-steroid anti-inflammatory drugs (NSAIDs), antipsychotics, selective serotonin reuptake inhibitors, opioids, antiepileptics, oxytocin, and chemotherapy

When Maintelyte solution for infusion is administrated to pregnant women during labour, particularly if administered in combination with oxytocin, there may be an increased risk for hyponatraemia (see section 4.4, 4.5 and 4.8).

Intrapartum maternal intravenous infusion of glucose containing solutions may result in fetal insulin production, with an associated risk of fetal hyperglycaemia and metabolic acidosis as well as rebound hypoglycaemia in the neonate. Physicians should carefully consider the potential risks and benefits for each specific patient before administering Maintelyte solution.

Maintelyte solution has no or negligible influence on the ability to drive or use machines.

The following adverse reactions have been reported in the postmarketing experience, with unspecified Maintelyte solution, listed by MedDRA System Organ Class (SOC), then in order of severity, where feasible.The frequency of the adverse drug reactions listed in this section is not known (cannot be estimated from the available data).

^* Potential manifestation in patients with allergy to corn, see section 4.4.

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 the Yellow Card Scheme.

Incompatibility of the medicinal product to be added with the solution in Viaflo container must be assessed before addition.

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

The instruction for use of the medicinal product to be added must be consulted.

Before adding a drug, verify it is soluble and stable in water at the pH of Maintelyte solution for infusion (pH 4.5 to 6.5).

Glucose should not be administered concomitantly with blood in the same infusion set due to the risk of clotting of red blood cells.