COMPOUND SODIUM LACTATE & GLUCOSE

The choice of the specific sodium chloride and glucose concentration, dosage, volume, rate and duration of administration depends on the age, weight, clinical condition of the patient and concomitant therapy. It should be determined by a physician.

For patients with electrolyte and glucose abnormalities and for paediatric patients, consult a physician experienced in intravenous fluid therapy. Fluid balance, serum glucose, serum sodium and other electrolytes may need to be monitored before and during administration, especially in patients with increased non-osmotic vasopressin release (syndrome of inappropriate antidiuretic hormone secretion, SIADH) and in patients co-medicated with vasopressin agonist drugs due to the risk of hyponatraemia.

Monitoring of serum sodium is particularly important for physiologically hypotonic fluids. 8). Rapid correction of hyponatraemia and hypernatraemia is potentially dangerous (risk of serious neurologic complications). Electrolyte supplementation may be indicated according to the clinical needs of the patient.

Adults, older patients and adolescents (age 12 years and over):

The Recommended dosage is 500 ml to 3 L/24h Administration rate The infusion rate is usually 40 ml/kg/24h and should not exceed the patient’s glucose oxidation capacities in order to avoid hyperglycaemia. Therefore the maximum acute administration rate is 5 mg/kg/min.

18% sodium chloride and 4% glucose should be restricted to specialist paediatric settings such as renal, hepatic and cardiac units, high dependency units and intensive care units. The dosage varies with weight: 0-10 kg body weight: 100 ml/kg/24h 10-20 kg body weight: 1000 ml + (50 ml/kg over 10 kg)/24h > 20 kg body weight: 1500 ml + (20 ml/kg over 20 kg)/24h.

The administration rate varies with weight: 0-10 kg body weight: 6-8 ml/kg/h 10-20 kg body weight: 4-6 ml/kg/h > 20 kg body weight: 2-4 ml/kg/h The infusion rate should not exceed the patient’s glucose oxidation capacities in order to avoid hyperglycaemia.

Therefore the maximum acute administration rate is 10-18 mg/kg/min, depending on the total body mass. For all patients, a gradual increase of flow rate should be considered when starting administration of glucose containing products.

Method of administration The administration is performed by intravenous infusion. 18 % w/v and Glucose 4 % w/v solution is hypotonic and hyperosmolar, due to the glucose content. Precautions to be taken before manipulating or administering the product Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.

Do not administer unless the solution is clear and the seal is intact. Administer immediately following the insertion of infusion set. Do not remove unit from overwrap until ready for use. The inner bag maintains the sterility of the product.

The solution should be administered with sterile equipment using an aseptic technique. The equipment should be primed with the solution in order to prevent air entering the system. Do not use plastic containers in series connections.

Such use could result in air embolism due to residual air being drawn from the primary container before the administration of the fluid from the secondary container is completed. 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.

Additives may be introduced before or during infusion through the resealable medication port. When additive is used, verify tonicity prior to parenteral administration. Hyperosmolar solutions may cause venous irritation and phlebitis.

Thus, any hyperosmolar solution is recommended to be administered through a large central vein, for rapid dilution of the hyperosmotic solution. 6.

The following adverse reactions have been reported in post-marketing experience, listed by MedDRA System Organ Class (SOC), then where feasible, by Preferred Term in order of severity. 4). Adverse reactions may be associated to the medicinal product(s) added to the solution; the nature of the additive will determine the likelihood of any other adverse reactions.

System Organ Class Adverse reactions (Preferred Terms) Frequency Metabolism and nutrition disorders Hypervolaemia Not known Vein injury Not known Vascular disorders Thrombophlebitis superficial Not known Chills Not known Pyrexia Not known Application site infection Not known Application site pain Not known Application site reaction Not known Injection site phlebitis Not known General disorders and administration site conditions Injection site extravasation Not known 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. uk/yellowcard

4. Compound Sodium Lactate & Glucose 5% solution is also contraindicated in patients with • A known hypersensitivity to sodium lactate. • Extracellular hyperhydration or hypervolemia • Severe renal insufficiency (with oliguria/anuria) • Uncompensated cardiac failure • Hyperkalemia • Hypercalcaemia • Metabolic alkalosis • Ascitic cirrhosis • Severe metabolic acidosis • Conditions associated with increased lactate levels (hyperlactatemia) including lactic acidosis, or impaired lactate utilization, such as severe hepatic insufficiency.

• Concomitant digitalis therapy (see section

As for other calcium-containing infusion solutions, concomitant administration of ceftriaxone and Compound Sodium Lactate & Glucose 5% solution is contraindicated in newborns (≤28 days of age), even if separate infusion lines are used (risk of fatal ceftriaxone-calcium salt precipitation in the neonate’s bloodstream).

For patients over 28 days of age please see section