GLUCOSE INTRAVENOUS INFUSION BP 5% [SIN06311P]

Product Info

GLUCOSE INTRAVENOUS INFUSION BP 5%

[SIN06311P]

Indication

4.1 Therapeutic indications

• Carbohydrate solution for intravenous liquid therapy

• Vehicle solution for compatible medicinal products

• Hypertonic dehydration

Dosing

4.2 Posology and method of administration

Carbohydrate solution for intravenous liquid therapy

The dosage depends on the age, weight, clinical and physiological (acid-base balance) conditions of the patient. The concomitant therapy should be determined by the consulting specialist.

Vehicle solution for compatible medicinal products

The volume to be chosen depends on the desired concentration of the medicinal product for which the solution is to be used as vehicle having regard to the maximum dose stated below.
Posology

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. Glucose Intravenous Infusion 5% solution for infusion may become hypotonic after administration due to glucose metabolisation in the body (see sections 4.4. 4.5 and 4.8 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Of note, provision of the entire daily fluid supply with this solution alone is contraindicated. See sections 4.3 and 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

Adults

Maximum daily intake
The maximum daily dose for Glucose Intravenous Infusion 5% Solution for Infusion results from the maximum daily fluid demand and should not exceed 40 ml per kg body weight per day, corresponding to 2 g of glucose per kg body weight per day.

Maximum infusion rate
Up to 5 ml per kg body weight per hour, corresponding to 0.25 g of glucose per kg body weight per hour.

Paediatric population

The recommended dosage for treatment fluid depletion is:

• 0–10 kg body weight: 100 ml/kg/24 h

• 10–20 kg body weight: 1000 ml + 50 ml /kg for each kg > 10 kg/24 h

• > 20 kg body weight: 1500 ml + 20 ml / kg for each kg > 20 kg/24 h

Maximum infusion rate
Up to 5 ml per kg body weight per hour, corresponding to 0.25 g of glucose per kg body weight per hour.

Dosing of this solution should be as restrictive as possible and must be accompanied by adequate electrolyte substitution. See sections 4.3 and 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

Method of administration

Intravenous use.
The possibility of peripheral venous infusion depends on the osmolarity of the prepared mixture.

Contraindications

4.3 Contraindications

• Hypersensitivity to the active substance. See section 4.4 and 4.8 for corn allergies – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information

• Hyperglycaemia, not responding to insulin doses of up to 6 units insulin/hour

• Lactic acidosis

If it is necessary to administer large volumes, further contraindications can arise on account of the fluid load:

• Hypotonic hyperhydration

• Isotonic hyperhydration

• Acute congestive heart failure

• Pulmonary oedema

This solution must not be used alone for fluid supply/rehydration because it does not contain electrolytes. See section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.