MAINTELYTE

Posology Dosage, rate, and duration of administration are to be individualised and depend upon the indication for use, the patient’s age, weight, clinical condition, and concomitant treatment, and on the patient’s clinical and laboratory response to treatment.

8). Recommended dose for adults is 2-3 litres infusion fluid per day. Maintelyte solution for infusion: 1000 ml administered intravenously during 4 -12 hours (based on a patient weighing 70 kg). 5 ml/kg/hour.

Buffering capacity:

In order to increase pH of Maintelyte from 5 to 7, approximately 7 mmol NaOH will be needed. In order to decrease the pH of Maintelyte from 5 to 4, approximately 13 mmol HCl will be needed. Infusion rate should not exceed the patient’s glucose oxidation capacities in order to avoid hyperglycemia.

For information, the maximum glucose oxidation capacities is 5mg/kg/min for adults. 4: Use in pediatric patients).

Method of administration:

The solution should be administered by intravenous infusion (peripheral or central vein). Maintelyte solution for infusion must not be administered subcutaneously. Pressurizing intravenous solutions contained in flexible plastic containers to increase flow rates can result in air embolism if the residual air in the container is not fully evacuated prior to administration.

Use of a vented intravenous administration set with the vent in the open position could result in air embolism. Vented intravenous administration sets with the vent in the open position should not be used with flexible plastic containers.

Because of the presence of glucose, this solution should NOT be administered through the same infusion equipment as whole blood, as haemolysis and clumping of the blood cells can occur.

The frequency of the adverse drug reactions listed in this section is not known (cannot be estimated from the available data). 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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store

2). g. 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. 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.

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.

The solution is contra-indicated in patients presenting: • Hyperkalaemia • Severe renal insufficiency (with oliguria/anuria) • Uncompensated cardiac or pulmonary failure • The solution is also contraindicated in case of uncontrolled diabetes, other known glucose intolerances, hyperosmolar coma, hyperglycemia, hyperlactatemia.

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