GLUCOSE LAVOISIER 5 % S perf 1Poche/500ml

Solution for infusion.

Clear and colourless solution, free from visible particles.

Glucose: 278 mmol/L

Theoretical osmolarity: 278 mOsm/L

pH between 3,5 - 6,5

Glucose........................................................................................................................................................ 5 g

(as glucose monohydrate) 

for 100 ml of solution for infusion.

One bag of 50 mL contains 2,5 g of glucose

One bag of 100 mL contains 5 g of glucose

One bag of 250 mL contains 12,5 g of glucose

One bag of 500 mL contains 25 g of glucose

One bag of 1000 mL contains 50 g of glucosef

One vial of 50 mL contains 2,5 g of glucose

One vial of 100 mL contains 5 g of glucose

One vial of 125 mL contains 6,25 g of glucose

One vial of 250 mL contains 12,5 g of glucose

One vial of 500 mL contains 25 g of glucose

One vial of 1000 mL contains 50 g of glucose

One ampoule of 10 mL contains 0,5 g of glucose.

One ampoule of 20 mL contains 1 g of glucose.

Caloric intake from carbohydrates: 200 kcal/L (i.e. 837 kJ/L)

Excipients:

• Caloric intake from carbohydrates: 200 kcal/L) ;
• Prevention of intracellular and extracellular dehydration;
• Rehydration when there is a loss of water greater than the loss of electrolytes;
• Prophylaxis and treatment of ketosis in malnutrition;
• Vehicle or diluent for therapeutic administration in the preoperative, intraoperative and immediate postoperative period.

Dosage  :

The concentration and dosage of a glucose solution for intravenous use depend on several factors, including the patient's age, weight and clinical condition. Serum glucose concentrations may require close monitoring.

The recommended dosage for the treatment of water and carbohydrate depletion is as follows:

Adult  : 500 mL to 3 litres/24 h.

Paediatric population :

The infusion rate and volume depend on the patient's age, weight, clinical and metabolic status, and concomitant treatment. The solution must be administered by experienced personnel.

• 0-10 kg of body weight: 100 mL/kg/24 h.
• 10-20 kg of body weight: 1000 mL + 50 mL/kg above 10 kg / 24 h.
• > 20 kg of body weight: 1500 mL + 20 mL/kg above 20 kg / 24 h.

The infusion rate must not exceed the patient's glucose oxidation capacity (e.g., disturbed oxidative glucose metabolism in the post-operative or early post-traumatic period, or in the presence of hypoxia or organ failure), so as to avoid hyperglycaemia. Consequently, the maximum doses are 5 mg/kg/min for adults and between 10 and 18 mg/kg/min for neonates, infants and children, depending on age and total body mass.

When GLUCOSE 5 % LAVOISIER, solution for infusion is used as a vehicle or diluent for the preparation of injectable other medicinal products, the dosage and infusion rate will depend mainly on the nature and dosage of the medicinal product to be administered.

Fluid balance, serum glucose, serum sodium and other electrolytes may be monitored before or during administration, particularly in patients with excessive non-osmotic release of vasopressin (syndrome of inappropriate antidiuretic hormone secretion, SIADH) and in patients concomitantly treated with vasopressin agonist medicinal products, due to the risk of hyponatraemia.

Monitoring of serum sodium is particularly important for physiologically hypotonic solutions. GLUCOSE 5 % LAVOISIER, solution for infusion may become extremely hypotonic after administration due to the metabolism of glucose in the body (see sections Warnings and precautions, Interactions and Adverse effects).

Method of administration  :

Intravenous infusion.

When the solution is used for dilution and administration of additional medicinal products by intravenous infusion, the instructions for use of the added substances will determine the appropriate volumes for each treatment.

For precautions to be taken before handling or administering the medicinal product, see section Disposal and handling

• Hypersensitivity to maize (see sections Warnings and precautions and Adverse effects),
• Uncontrolled hyperglycaemia,
• Decompensated diabetes,
• Other known intolerances to glucose (e.g., metabolic stress situations, acute shock states, collapse),
• Hyperosmolar coma,
• Hyperlactataemia,
• Metabolic acidosis,
• Water intoxication. Administration of large volumes may in particular give rise, due to fluid overload, to the following contraindications:
  • Hyperhydration
  • Acute heart failure
  • Pulmonary oedema

The solution must not be used alone for fluid intake or rehydration as it does not contain electrolytes (see section Warnings and precautions).

Respect a slow infusion rate to avoid the risk of an undesirable osmotic diuresis. Particular clinical monitoring is necessary at the start of any intravenous infusion. Administration must be carried out under regular and careful supervision.

GLUCOSE 5 % LAVOISIER, perfusion solution is an isotonic solution. However, in the body, solutions containing glucose can become physiologically extremely hypotonic due to the rapid metabolism of glucose (see section Dosage and administration).

The infusion must be stopped immediately if abnormal signs or symptoms of an allergic reaction appear (such as sweating, fever, chills, headache, skin rashes or dyspnoea). GLUCOSE 5 % LAVOISIER, perfusion solution, contains glucose derived from corn, which causes hypersensitivity reactions in patients allergic to corn.

GLUCOSE 5 % LAVOISIER, perfusion solution must not be used for fluid replacement purposes without appropriate electrolyte intake, particularly in rehydration treatments, as its administration may lead to a significant decrease in serum electrolytes (severe hyponatraemia and hypokalaemia) (see sections Contraindications and Adverse effects), as well as the occurrence of adverse effects such as brain damage or cardiac damage.

Depending on the tonicity of the solution, the volume and rate of infusion, as well as the underlying clinical condition of the patient and their ability to metabolise glucose, intravenous administration of glucose may lead to electrolyte imbalances, the most important of which is hypo-osmotic or hyperosmotic hyponatraemia.

Hyponatraemia:

Patients with non-osmotic release of vasopressin (e.g. in acute conditions, pain, postoperative stress, infections, burns, and central nervous system pathologies), patients with cardiac, hepatic and renal pathologies, as well as patients exposed to vasopressin agonists (see section Interactions) are at particularly high risk of acute hyponatraemia associated with the infusion of hypotonic solutions.

Acute hyponatraemia can lead to acute hyponatraemic encephalopathy (cerebral oedema) characterised by headache, nausea, convulsions, lethargy and vomiting. Patients presenting with cerebral oedema are at particularly high risk of severe, irreversible brain damage that is life-threatening.

Children, women of childbearing potential and patients with reduced cerebral compliance (e.g. following meningitis, intracranial haemorrhage or cerebral contusion) are at particularly high risk of severe, life-threatening cerebral oedema due to acute hyponatraemia.

The infusion of large volumes must be carried out under special monitoring in patients with water intoxication, severe cardiac, pulmonary or renal failure, and/or oliguria/anuria.

Administration of GLUCOSE 5 % LAVOISIER perfusion solution may cause hyperglycaemia. In this context, it is recommended not to use this solution after an ischaemic cerebral accident, as hyperglycaemia has been implicated in increased ischaemic brain damage and worsened recovery.

Infusion of glucose solution is not recommended within the first 24 hours following head trauma, and blood glucose concentration should be carefully monitored during episodes of intracranial hypertension. Administration of glucose solutions to patients with impaired blood-brain barrier may lead to an increase in intracranial/intramedullary pressure.

Biological and clinical parameters, in particular blood glucose, must be monitored.

If hyperglycaemia occurs, adjust the infusion rate and/or administer insulin. If necessary, provide parenteral potassium supplements.

Glucose tolerance may deteriorate in patients with renal failure or diabetes.

In diabetic or renally impaired patients, closely monitor blood glucose and glycosuria and adjust the dosage of hypoglycaemic treatment and/or potassium as necessary.

The addition of medicinal products or the use of an incorrect administration technique may cause febrile reactions due to the possible introduction of pyrogenic substances. In the event of an adverse effect, the infusion must be stopped immediately.

In case of addition of a medicinal product, check compatibility, clarity and colour before use (see section  Incompatibilities).

Do not store the mixture (see section Disposal and handling).

Extravasation

The catheter site must be regularly checked for signs of extravasation. In the event of extravasation, administration must be stopped immediately, while keeping the inserted cannula or catheter in place for immediate management of the patient. If possible, aspiration should be performed through the inserted cannula/catheter to reduce the amount of fluid in the tissues before removing the cannula/catheter. If an extremity is affected, the limb concerned must be elevated.

Depending on the extravasated product (including products mixed with GLUCOSE 5 % LAVOISIER, where applicable) and the stage/extent of any damage, appropriate specific measures must be taken. Therapeutic options may include non-pharmacological, pharmacological and/or surgical interventions. If the affected area deteriorates (continuous pain, necrosis, ulceration), a plastic surgeon must be consulted immediately (see section Adverse effects).

The extravasation site must be checked at least every 4 hours during the first 24 hours, then once a day.

Refeeding syndrome

Refeeding of severely malnourished patients may lead to refeeding syndrome, characterised by the shift of potassium, phosphorus and magnesium intracellularly as the patient becomes anabolic. Thiamine deficiency and water retention may also develop. Implementing particular monitoring and progressively increasing nutrient intake while avoiding overfeeding can prevent these complications.

Risk of gas embolism(see section Disposal and handling)

Population geriatric

When selecting the type of infusion solution and the infusion volume/rate for an elderly patient, it is necessary to take into account the susceptibility of these patients to cardiac, renal, hepatic or other diseases, as well as their concomitant medicinal treatments.

Paediatric population  

The infusion rate and volume depend on the age, weight, metabolic and clinical condition of the patient, the associated treatment, and must be determined by an experienced physician.

Newborns, particularly premature infants and those with low birth weight, have a high risk of developing hypo- or hyperglycaemia and therefore require close monitoring throughout the duration of treatment with intravenous glucose solutions, in order to ensure appropriate glycaemic control and avoid possible long-term adverse effects.

Hypoglycaemia in newborns may lead to convulsions, coma and brain damage.

Hyperglycaemia in newborns has been associated with cases of intraventricular haemorrhage, late-onset bacterial and fungal infection, retinopathy of prematurity, necrotising enterocolitis, bronchopulmonary dysplasia, prolonged hospitalisation and death.

Children, infants and newborns are at increased risk of developing hypoosmotic hyponatraemia as well as hyponatraemic encephalopathy. Therefore, plasma electrolyte concentrations must be closely monitored in the paediatric population. Rapid correction of hypoosmotic hyponatraemia is potentially dangerous (risk of severe neurological complications). The dosage, rate and duration of administration must be determined by an experienced physician.

In order to avoid excessive, potentially fatal, intravenous infusion in newborns, particular attention must be paid to the mode of administration. When using a syringe pump for intravenous administration of solutions or medicinal products to newborns, the fluid bag must not remain connected to the syringe.

When using an infusion pump, all clamps on the intravenous administration set must be closed before removing the administration set or before switching off the pump. This is necessary whether or not the administration set has an anti-free-flow device.

The intravenous infusion device and administration equipment must be checked regularly.

Medicinal products increasing the effect of vasopressin.

The medicinal products listed below increase the effect of vasopressin, which results in a decrease in renal excretion of water without electrolytes and an increased risk of nosocomial hyponatremia following treatment with incorrectly balanced intravenous solutions (see sections Dosage and administration, Warnings and precautions and Adverse effects).

• Medicinal products stimulating the release of vasopressin, e.g.: chlorpropamide, clofibrate, carbamazepine, vincristine, selective serotonin reuptake inhibitors, 3,4-methylenedioxy-N-methamphetamine, ifosfamide, antipsychotics, narcotics
• Medicinal products potentiating the release of vasopressin, e.g.: chlorpropamide, non-steroidal anti-inflammatory drugs (NSAIDs), cyclophosphamide
• Vasopressin analogues, e.g.: desmopressin, oxytocin, vasopressin, terlipressin

Other medicinal products that also increase the risk of hyponatremia include diuretics in general and antiepileptics such as oxcarbazepine.

Do not administer blood simultaneously, using the same infusion device, due to the risk of pseudo-agglutination and haemolysis.

As with all parenteral solutions, the compatibility of additives with the solution must be checked before administration of this medicinal product (see section Incompatibilities).

Given the available data, use in pregnant or breastfeeding women is possible.

The risks and benefits for each patient must be carefully considered before administering the glucose solution.

Intravenous glucose infusion during labour may lead to a risk of foetal hyperglycaemia and metabolic acidosis, resulting in foetal insulin production and rebound hypoglycaemia in the newborn.

Particular precautions are required when administering GLUCOSE 5 % LAVOISIER for infusion to pregnant women during labour, particularly if it is administered in combination with oxytocin, due to the risk of hyponatraemia (see sections Warnings and precautions, Interactions and Adverse effects). 

GLUCOSE 5 % LAVOISIER, solution for infusion, has no or negligible influence on the ability to drive and use machines.

The undesirable effects that may occur in patients treated with GLUCOSE 5 % LAVOISIER by intravenous infusion are listed below.

The adverse effects listed in this section are reported according to the following convention: very common (≥ 1/10), common (≥ 1/100 and < 1/10), uncommon (≥ 1/1000 and < 1/100), rare (≥ 1/10000 and < 1/1000), very rare (< 1/10000) and frequency not known (cannot be estimated from the available data).

 

System Organ Class(SOC)	Adverse effect (MedDRA Term)	Frequency
Immune system disorders	Anaphylactic reaction*	Not known
	Hypersensitivity*
Metabolism and nutrition disorders	Electrolyte imbalance Nosocomial hyponatremia***
	Hypokalaemia
	Hypomagnesaemia
	Hypophosphataemia	Not known
	Hyperglycaemia
	Dehydration
	Hypervolaemia Hyperlactataemia
Nervous system disorders	Hyponatremic encephalopathy***	Not known
Vascular disorders	Venous thrombosis Thrombophlebitis	Not known
Renal and urinary disorders	Polyuria Glycosuria	Not known
General disorders and administration site conditions	Chills*
	Fever*
	Infusion site infection
	Infusion site irritation	Not known
	Extravasation
	Local reaction
	Local pain** Necrosis / ulcer**

* Potential manifestation in patients with a corn allergy (see sections Contraindications and Warnings and precautions).

** Adverse effects that may be associated in particular with extravasation

*** Nosocomial hyponatremia may cause irreversible brain damage and lead to death due to the development of acute hyponatremic encephalopathy (see sections Dosage and administration and Warnings and precautions).

When GLUCOSE 5 % LAVOISIER, solution for infusion is used as a vehicle or diluent for injectable preparations of other medicinal products, other adverse effects associated with the medicinal product added to the solution may occur.

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 national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centres - Website:www.signalement-sante.gouv.fr.

Symptoms

Prolonged administration or rapid infusion of large volumes of glucose 5% infusion solutionmay cause two types of adverse effects that may be life-threatening (see sections Warnings and precautions and Adverse effects) :

• due to hyperglycaemia: hyperosmolarity leading to hyponatraemia, intracellular dehydration, hyperglycaemia, glycosuria, osmotic diuresis, which may progress to extracellular dehydration, hyperglycaemic hyperosmolar coma and electrolyte imbalances, including loss of sodium and potassium (see section Warnings and precautions) and acid-base disturbances.
• due to the amount of free water (once glucose is metabolised): water overload with oedema or water intoxication, leading to severe acute hypo-osmotic hyponatraemia, resulting in intracellular hyperhydration, and potentially cerebral oedema that is life-threatening (hyponatraemic encephalopathy). Symptoms include convulsions, nausea, lethargy and vomiting (see sections Warnings and precautions and Adverse effects).

Severe hyperglycaemia and hyponatraemia may be fatal.

Treatment

A clinically significant overdose of glucose solutions is therefore a medical emergency.

Depending on the type and severity of the disorders: immediately stop the infusion, initiate appropriate symptomatic and supportive treatment as needed (in particular administration of electrolytes, diuretics or insulin).

In case of use as a vehicle or diluent for injectable preparation of other medicinal products, other symptoms of overdose related to this medicinal product may occur. Also refer to the summary of product characteristics of this medicinal product.

Rapid correction of hyponatraemia may be life-threatening due to the risk of osmotic demyelination and serious neurological complications. Treatment and monitoring must be determined by an experienced physician.

Pharmacotherapeutic class: Intravenous solutions, ATC code: B05BA03

(B: blood and blood-forming organs)

Isotonic glucose solution (approximate osmolarity: 278 mOsm/L).

The pharmacodynamic properties of this solution are those of glucose with a carbohydrate caloric intake of 200 kcal/L.

Glucose, a natural substrate of the body's cells, is metabolised ubiquitously. Under physiological conditions, glucose is the main energy source with a caloric value of approximately 17 kJ/g or 4 kcal/g.

In case of addition of a medicinal product, the pharmacodynamics of the preparation will also depend on the added medicinal product.

Absorption

Bioavailability

As the solution is administered intravenously, its bioavailability is 100 %.

Distribution

After administration, glucose first passes into the intravascular compartment, then into the intracellular compartment.

Biotransformation

During glycolysis, glucose is metabolised to pyruvate. Under aerobic conditions, pyruvate is fully oxidised to give carbon dioxide and water. In case of hypoxia, pyruvate is converted to lactate.

Elimination

The final metabolites resulting from the complete oxidation of glucose are eliminated by the lungs as carbon dioxide and by the kidneys as water.

In healthy subjects, glucose is practically not eliminated by the kidneys.

In pathological metabolic states associated with hyperglycaemia (e.g. diabetes mellitus or post-aggression syndrome), glucose is excreted by the kidneys.

In case of addition of a medicinal product, the pharmacokinetics of the preparation will also depend on the medicinal product added.

Safety data concerning glucose in animals are not applicable to humans, given that glucose is a normal component of plasma in both animals and humans.

The safety data of the additive should be considered separately.

As with all parenteral solutions, the compatibility of medicinal products with the solution must be checked before addition.

The incompatibility of the medicinal product with the GLUCOSE 5 % LAVOISIER solution must be determined by checking for a possible change in colour and/or possible formation of a precipitate, insoluble complex or crystals. Also refer to the package leaflet accompanying the medicinal product to be added.

In case of addition of a medicinal product, check whether the medicinal product is compatible with the pH range of the GLUCOSE 5 % LAVOISIER solution.

When a compatible medicinal product is added to the GLUCOSE 5 % LAVOISIER solution, the mixture must be administered immediately.

Medicinal products known to be incompatible must not be used.

Do not administer blood simultaneously, through the same infusion set, due to the risk of pseudo-agglutination and haemolysis (see section Interactions).

Before opening

Vial and ampoule (colourless glass)

3 years.

Bag (PVC), Vial (polyethylene)

3 years.

Bag (PP)

50 ml: 2 years

100 ml, 250 ml, 500 ml, and 1000 ml: 3 years.

Shelf life after use

After opening/dilution, the product must be used immediately.

For vials and ampoules

This medicine does not require any particular storage precautions.

For bags

Store at a temperature not exceeding 25°C.

For storage conditions of the medicinal product after first opening/dilution, see section Shelf life.

Do not use if the pack / ampoule / bag / vial is damaged.

Do not reuse: single use only.

Discard any partially used bag / ampoule / vial.

Do not reconnect a partially used bag.

Remove the overpouch immediately before use. The primary packaging maintains the sterility of the product.

In case of addition of a medicinal product, mix the solution well before use.

The solution must be visually inspected to detect any particles, any damage to the bag/ampoule/vial and any visible sign of deterioration before administration.

When adding a medication, the solution must be administered using sterile equipment and an aseptic technique.

Any unused product or waste must be disposed of in accordance with the regulations in force.

Risk of gas embolism  

Do not use plastic bags for connections in series. This use could lead to gas embolism due to the aspiration of residual air from the first bag before the end of administration of solution from the second bag.

Applying pressure to the flexible plastic container containing the intravenous solution to increase the flow rate may lead to gas embolism if the residual air contained in the container is not completely evacuated before administration.

Use of an intravenous administration set with an air intake in the open position could result in a gas embolism. Intravenous administration sets with an air intake in the open position must not be used with flexible plastic containers.

List I

Marketing authorisation (AMM)

CIP 3400930586556 (Fl/500ml). CIP 3400936299221 (10Amp/10ml). CIP 3400930131350 (1Poche/50ml). CIP 3400930131367 (1Poche/100ml). CIP 3400955048787 (50Poche/100ml). CIP 3400930131374 (1Poche/250ml). CIP 3400930131398 (1Poche/500ml). CIP 3400930131404 (1Poche/1000ml).

Price:

1,71 euros (1Poche/50ml). 1,92 euros (1Poche/100ml). 1,98 euros (1Poche/250ml). 2,28 euros (1Poche/500ml). 2,99 euros (1Poche/1000ml).

Reimbursed by Social Security at 65% (1Poche/50ml, 1Poche/100ml, 1Poche/250ml, 1Poche/500ml, 1Poche/1000ml) in the indications:

• Indication(s) appearing in the marketing authorisation at the date of publication of this decree (1Poche/50ml, 1Poche/100ml, 1Poche/250ml, 1Poche/500ml, 1Poche/1000ml)

Not reimbursed by Social Security (Fl/500ml, 10Amp/10ml).
Hospital model(s) (50Poche/100ml).
Collect (Fl/500ml, 1Poche/50ml, 1Poche/100ml, 50Poche/100ml, 1Poche/250ml, 1Poche/500ml, 1Poche/1000ml).