– Energy supply;

– Vehicle solution for supplementary medication.

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. Glucose B. Braun 100 mg/ml may become hypotonic after administration due to glucose metabolisation in the body (see sections 4.4. 4.5 and 4.8).

Dosage

The dose is to be adjusted according to the individual glucose and fluid requirements

Dosage for adults, the elderly and adolescents from 15^th year of age

The maximum daily dose is 40 ml per kg body weight (BW), corresponding to 4 g of glucose per kg BW.

Note

In the presence of metabolic disorders (e.g. postoperatively or after injuries, hypoxia, organ insufficiencies), the oxidative metabolism of glucose may be impaired. In such situations the glucose intake should be limited to 2 – 4 g/kg BW/day. The blood glucose level should not exceed 6.1 mmol/l (110 mg/100 ml).

The maximum infusion rate is 2.5 ml per kg BW per hour, corresponding to 0.25 g of glucose per kg BW per hour. The maximum drop rate is 0.8 drops per kg BW per minute.

Thus for a patient weighing 70 kg the maximum infusion rate is approx. 175 ml/hour (corresponding maximum drop rate 58 drops/min), resulting in a glucose intake of 17.5 g/hour.

Dosage for paediatric patients

The daily dose is limited by the maximum fluid intake:

The corresponding glucose amounts are below the maximum recommended glucose doses for the respective age groups.

If the solution is used as vehicle solution, a volume should be chosen that yields the desired concentration of the medicament to be dissolved or diluted.

Method of administration

Intravenous infusion. The solution can be administered peripherally.

If 10 % w/v Glucose Intravenous Infusion is used as vehicle solution the possibility of peripheral infusion depends on the characteristics of the mixture prepared.

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

– Decompensated diabetes mellitus, diabetic coma

– Untreated diabetes insipidus

– Acute states of shock or collapse

– Intracranial or spinal haemorrhage

– Metabolic acidosis

– Renal failure (oligo- or anuria) in absence of renal replacement therapy

– Hyperhydration

– Pulmonary oedema

– Acute cardiac failure

10% w/v Glucose Intravenous Infusion BP is a hypertonic solution. In the body, however, glucose containing fluids can become physiologically hypotonic due to rapid glucose metabolization (see section 4.2).

Depending on the tonicity of the solution, and depending on a patient's underlying clinical condition and capability to metabolize glucose, intravenous administration of glucose can cause electrolyte disturbances most importantly hypo- or hyperosmotic hyponatraemia.

Hyponatraemia:

Patients with non-osmotic vasopressin release (e.g. in acute illness, pain, post-operative stress, infections, burns, and CNS diseases), patients with heart-, liver- and kidney diseases and patients exposed to vasopressin agonists (see section 4.5) are at particular risk of acute hyponatraemia upon infusion of hypotonic fluids.

Acute hyponatraemia can lead to acute hyponatraemic encephalopathy (brain oedema) characterized by headache, nausea, seizures, lethargy and vomiting. Patients with brain oedema are at particular risk of severe, irreversible and life-threatening brain injury.

Children, women in the fertile age and patients with reduced cerebral compliance (e.g. meningitis, intracranial bleeding, and cerebral contusion) are at particular risk of the severe and life-threatening brain swelling caused by acute hyponatraemia.

Administration of glucose solutions is not recommended after acute ischaemic strokes as hyperglycaemia was reported to worsen ischaemic brain damage and impair recovery.

This solution should be used with caution in patients with hypervolemia, renal insufficiency and impending or manifest cardiac decompensation.

The solution should also be administered with caution to patients with increased serum osmolarity.

Disorders of fluid and electrolyte balance like hypotonic dehydration or pathologically low levels of serum electrolytes, must be corrected prior to administration of Glucose 10 % w/v solution for infusion.

Special attention must be paid to hypokalaemia. Then supplementation of potassium is absolutely mandatory.

Unstable metabolism (e.g. postoperatively or after injuries, hypoxia, organ insufficiencies) impairs oxidative metabolism of glucose and may lead to metabolic acidosis.

States of hyperglycaemia should be adequetely monitored and treated with insulin. The application of insulin causes additional shifts of potassium into the cells and may therefore cause or increase hypokalaemia.

Solutions containing glucose should be used with caution in patients with manifest or known subclinical diabetes mellitus or carbohydrate intolerance for any reason.

Profound hypoglycemia may follow sudden discontinuation of high glucose infusion rates because of the accompanying high serum insulin concentrations. This applies especially to children less than 2 years of age, patients with diabetes mellitus and other disease states with impaired glucose homeostasis. In obvious cases the glucose infusion should be tapered off within the last 30 – 60 minutes of the infusion. As a precaution it is recommended that each individual patient be monitored for 30 minutes for hypoglycemia on the first day of abrupt discontinuation of parenteral nutrition.

Refeeding or repletion of malnourished or depleted patients may in particular cause hypokalaemia, hypophosphataemia and hypomagnesaemia. Adequate supplementation of electrolytes according to deviations from normal values is necessary.

Clinical monitoring should include blood glucose, serum electrolytes, fluid and acid-base balance in general. Frequency and kind of laboratory testing depend on the overall condition of the patient, the prevailing metabolic situation and the administered dose. Also monitor total volume and amount of glucose administered.

Electrolytes and vitamins should be supplied as necessary. Vitamin B, especially thiamine, is needed for glucose metabolism.

Glucose infusions should not be administered through the same infusion equipment, simultaneously with, before, or after administration of blood, because of the possibility of pseudo-agglutination.

Interactions with medicinal products with an influence on glucose metabolism should be considered.

Drugs leading to an increased vasopressin effect.

The below listed drugs increase the vasopressin effect, leading to reduced renal electrolyte free water excretion and increase the risk of hospital acquired hyponatraemia following inappropriately balanced treatment with i.v. fluids (see sections 4.2, 4.4 and 4.8).

• Drugs stimulating vasopressin release, e.g.: Chlorpropamide, clofibrate, carbamazepine, vincristine, selective serotonin reuptake inhibitors, 3.4-methylenedioxy-N-methamphetamine, ifosfamide, antipsychotics, narcotics

• Drugs potentiating vasopressin action, e.g.: Chlorpropamide, NSAIDs, cyclophosphamide

• Vasopressin analogues, e.g.: Desmopressin, oxytocin, vasopressin, terlipressin

Other medicinal products increasing the risk of hyponatraemia also include diuretics in general and antiepileptics such as oxcarbazepine.

Prescribers should refer to the information provided with the product concerned.

For 10 % w/v glucose solutions for infusion no controlled clinical data on exposed pregnancies are available. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foeta1 development, parturition or postnatal development.

Yet caution should be exercised when prescribing to pregnant or nursing women and careful monitoring of blood glucose is necessary.

10% w/v Glucose Intravenous Infusion BP should be administrated with special caution for pregnant women during labour particularly if administered in combination with oxytocin due to the risk of hyponatraemia (see section 4.4, 4.5 and 4.8).

No effects to be expected.

Provided the product is used in accordance with the directions given, undesirable effects are not to be expected.

The following side effects, which are not directly related to the product but to the conditions of administration, underlying disorders or accompanying treatment, may occur:

Metabolism and nutrition disorders

Not known: Hospital Acquired Hyponatraemia

– Hypokalemia may be related to insulin therapy. In addition, hypokalaemia, hypomagnesaemia and hypophosphataemia may be caused by refeeding with glucose especially in malnourished patients.

– Abrupt discontinuation and/or insulin application may cause rebound hypoglycemia, especially in patients with glucose tolerance disorders.

Neurological disorders :

Not known: Hyponatraemic encephalopathy

Hospital acquired hyponatraemia may cause irreversible brain injury and death due to develop-ment of acute hyponatraemic encephalopathy (see sections 4.2 and 4.4)

Vascular disorders

Thrombophlebitis may be caused by osmolarities above 800 mmol/l. The osmolarity of the added medication should be kept in mind.

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 at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Symptoms

Overdose may cause hyperglycaemia, glucosuria, serum hyperosmolarity, possibly leading to hyperosmotic and hyperglycaemic coma, further hyperhydration and electrolyte disorders.

Emergency treatment, antidotes

The disorders mentioned above can be corrected by reduction of the glucose intake, administration of insulin and/or appropriate supplementation of electrolytes.

Pharmaco-therapeutic group:

Solutions for parenteral nutrition, carbohydrates, ATC code: B05B A03

Glucose is metabolised ubiquitously as the natural substrate of the cells of the body. Under physiological conditions glucose is the most important energy-supplying carbohydrate with a caloric value of approx. 17 kJ or 4 kcal/g. Nervous tissue, erythrocytes and medulla of the kidneys are amongst the tissues with an obligate requirement for glucose. In adults, the normal concentration of glucose in blood is 60 – 100 mg/100 ml, or 3.3 – 5.6 mmol/l (fasting).

Glucose serves to maintain the blood glucose level and for the synthesis of important body components. It serves for the synthesis of glycogen, the storage form of glucose. Primarily insulin, glucagon, glucocorticosteroids and catecholamines are involved in the regulation of the blood glucose concentration.

A normal electrolyte and acid-base status is a prerequisite for the optimal utilization of administered glucose. So acidosis, in particular, can indicate impairment of oxidative glucose metabolism.

Metabolism of glucose and electrolytes are closely related to each other. Potassium, magnesium and phosphate requirements may increase and may therefore have to be monitored and supplemented according to individual needs. Especially cardiac and neurological functions may be impaired without supplementation.

Glucose intolerance may occur under pathological conditions, e.g. diabetes mellitus and metabolic stress (e.g. intra-, and postoperatively, severe disease, injury, sepsis). Severity of hyperglycaemia and glucosuria are related to the severity of the pathological state.

Infusion of higher concentrated glucose solutions can aggravate brain damage and cerebral oedema in cases of head injury, cerebrovascular accidents and ischemia.

On infusion glucose is first distributed in the intravascular space and then is taken up into the intracellular space.

In glycolysis, glucose is metabolised to pyruvate or to lactate. Lactate can be partially re-introduced into the glucose metabolism (Cori cycle). Under aerobic conditions pyruvate is completely oxidized to carbon dioxide and water. The final products of the complete oxidation of glucose are eliminated via the lungs (carbon dioxide) and the kidneys (water).

Practically no glucose is excreted renally by healthy persons. In pathological metabolic conditions (e.g. diabetes mellitus, postaggression metabolism) associated with hyperglycaemia, glucose is also excreted via the kidneys (glucosuria) when the maximum tubular resorption capacity (at blood glucose levels higher than 180 mg/100 ml or 10 mmol/l) is exceeded.

There are no pre-clinical data of relevance to the prescriber which are additional to the safety instructions already stated in other sections of the SPC.

Water for injections

Because of its acid pH, the solution may be incompatible with other medicaments.

In the unopened container the product has a shelf life of 3 years

This medicinal product does not require any special storage conditions.

Polyethylene containers;

contents: 500, 1000 ml.

available in packs of

10 x 500 ml

10 x 1000 ml.

Single-dose container. Discard unused contents.

Only to be used if the solution is clear and the container or its closure do not show visible signs of damage.