5% W/V GLUCOSE INTRAVENOUS

Posology Fluid balance, serum glucose, 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. 4. 8). Of note, provision of the entire daily fluid supply with this solution alone is contraindicated. 3 and

g. 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.

4. Carbohydrate solution for intravenous liquid therapy The dosage depends on the age, weight, clinical and physiological (acid-base balance) conditions of the patient, having regard to the maximum dose states below. 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.

Adults Maximum daily intake Up to 40 ml per kg body weight per day, corresponding to 2 g of glucose per kg body weight per day. 25 g of glucose per kg body weight per hour. When administering this solution the total daily fluid and glucose requirements should be taken into account.

Paediatric population The dosage depends on the age, weight, clinical and physiological (acid-base balance) conditions of the patient, the concomitant therapy and should be determined by the consulting specialist. Generally, dosing of this solution should be as restrictive as possible and must be accompanied by adequate electrolyte substitution.

4. When administering this solution the total daily fluid and glucose requirements should be taken into account. The maximum daily dose, in g of glucose per kg body weight and in ml of solution per kg body weight per day, is for: Pre-term neonates: 18 g per kg body weight 180 ml per kg body weight Term neonates : 15 g per kg body weight 150 ml per kg body weight 1st – 2nd year: 15 g per kg body weight 150 ml per kg body weight 3rd – 5th year: 12 g per kg body weight 120 ml per kg body weight 6th – 10th year: 10 g per kg body weight 100 ml per kg body weight 11th – 14th year: 8 g per kg body weight 80 ml per kg body weight When administering this solution, the total daily fluid intake must be taken into account.

The recommended daily parenteral fluid intake for children is as follows: 1st day of life: 60 – 120 ml per kg body weight per day 2nd day of life: 80 – 120 ml per kg body weight per day 3rd day of life: 100 – 130 ml per kg body weight per day 4th day of life: 120 – 150 ml per kg body weight per day 5th day of life: 140 – 160 ml per kg body weight per day 6th day of life: 140 – 180 ml per kg body weight per day 1st month, prior to establishment of stable growth: 140 – 170 ml per kg body weight per day 1st month, after establishment of stable growth: 140 – 160 ml per kg body weight per day 2nd – 12th month of life: 120 – 150 ml per kg body weight per day 2nd year: 80 – 120 ml per kg body weight per day 3rd – 5th year: 80 – 100 ml per kg body weight per day 6th – 12th year: 60 – 80 ml per kg body weight per day 13th – 18th year: 50 – 70 ml per kg body weight per day Method of administration Intravenous use.

• Hyperglycaemia, not responding to insulin doses of up to 6 units insulin/hour • Lactic acidosis If it is necessary to administer large volumes, further contra-indications 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.

4.