Indicatios:

 Glucose and Sodium Chloride Injection 5%+0.9% solution is indicated for:

Treatment of sodium depletion, extracellular dehydration or hypovolaemia in cases where supply of water and carbohydrates is required due to restriction of the intake of fluids and electrolytes by normal routes.

Dosage and administration：

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 should 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. Glucose and Sodium Chloride Injection 5%+0.9% solution may become extremely hypotonic after administration due to glucose metabolisation in the body.

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.

Method of administration

The administration is performed by intravenous infusion.

Contraindications:

The solution is contraindicated in patients presenting with:

• Known hypersensitivity to the product

• Extracellular hyperhydration or hypervolaemia

• Fluid and sodium retention

• Severe renal insufficiency (with oliguria/anuria)

• Uncompensated cardiac failure

• Hypernatraemia or hyperchloraemia

• General oedema and ascitic cirrhosis

Clinically significant hyperglycaemia. The solution is also contraindicated in case of uncompensated diabetes, other known glucose intolerances (such as metabolic stress situations), hyperosmolar coma or hyperlactataemia.

Precautions:

Hypokalaemia

Sodium retention, fluid overload and oedema

Primary hyperaldosteronism

Secondary hyperaldosteronism

Patients taking medications that may increase the risk of sodium and fluid retention, such as corticosteroids

Hyperosmolality, serum electrolytes and water imbalance

Electrolyte balance

Hyponatraemia

Hyperglycaemia

Hypersensitivity Reactions

Refeeding syndrome

Severe renal impairment

Paediatric use

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

Paediatric glycaemia-related issues

Newborns, especially those born premature and with low birth weight, are at increased risk of developing hypo- or hyperglycaemia. Close monitoring during treatment with intravenous glucose solutions

Drug interactions:

l Both the glycaemic and effects on water and electrolyte balance should be taken into account when administering Sodium chloride 0.9% w/v and Glucose 5% w/v solution to patients treated with other substances that affect glycaemic control, or fluid and/or electrolyte balance.

l Drugs leading to an increased vasopressin effect

Storage:

Store below 25°C in a dry place.