FRESENIUS GLUCOSE 5% Solution for IV infusion Bag/500ml

Solution for infusion.

Clear, colourless to slightly yellow solution.

Osmolality: 300 mosmol/kg

Osmolarity: 278 mosmol/l

Carbohydrate caloric intake: 200 kcal/l

pH = 3,5 to 6,5

Anhydrous glucose...................................................................................................................................................... 50,00 g/l

Equivalent to glucose monohydrate ................................................................................................................55,00 g/l

1 ml contains 50 mg of glucose

Excipients:

This medicine is recommended in the following cases:

rehydration when there is a loss of water greater than the loss of sodium chloride and other osmoles;

prevention of dehydration;

vehicle for therapeutic administration in the pre-operative, intra-operative and immediate post-operative period;

prophylaxis and treatment of ketosis in malnutrition.

Dosage

The dosage is to be adapted according to the clinical condition of the patient, based on weight, diet and any additional therapies.

The infusion rate must not exceed a volume corresponding to 0,5 gram of glucose per minute.

Method of administration

Central or peripheral intravenous route.

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 products whose sodium concentration is lower than the serum sodium concentration. After infusion of GLUCOSE FRESENIUS 5 %, rapid active transport of glucose into cells occurs. This promotes an effect that may be considered as an intake of free water and may lead to severe hyponatraemia (see sections Warnings and precautions, Interactions and Adverse effects).

The administration of this medicine is contraindicated in the following cases:

water intoxication;

glucose intolerance.

Special warnings

Adhere to a slow infusion rate due to the risk of an undesirable osmotic diuresis occurring.

Before use, check the clarity of the solution, the integrity of the container and its closure. Discard any damaged or partially used container.

Precautions for use

Monitor the clinical and biological status (blood and urine), in particular the hydrosodium balance, blood glucose, glycosuria and acetonuria, serum potassium and serum phosphate.

If necessary, supplement parenteral intake of insulin and potassium.

In diabetic patients, monitor blood glucose and glycosuria and adjust the insulin dose if necessary.

Do not administer blood simultaneously through the same infusion set because of the risk of pseudo-agglutination.

Intravenous glucose infusion solutions at 5% are isotonic. More concentrated glucose solutions are hypertonic. However, in the body, glucose-containing solutions can lead to an effect that may be considered as a supply of free water due to rapid active transport of glucose into cells. This may result in severe hyponatremia (see section Dosage and administration).

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.

Hyponatremia:

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.

Precautions for use of the bag

Do not use an air inlet.

Purge the infusion system so that no air passes through.

Do not connect in series because residual air from the first container may be carried along by the solution coming from the second container and cause a risk of gas embolism.

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.

Physicochemical compatibilities

It is the responsibility of the physician to judge the incompatibility of the medicinal product to be added to the GLUCOSE FRESENIUS 5 % solution by checking for any change in colour and/or any formation of precipitate, insoluble complex or crystals.

Before adding any medicinal product, check whether the pH range in which it is effective corresponds to that of the GLUCOSE FRESENIUS 5 % solution (pH between 3,5 and 6,5).

Refer to the package leaflet of the added medicinal product.

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

This product may be administered during pregnancy or breastfeeding if needed.

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

System organ class	Symptoms (MedDRA Lowest Level Terms)	Frequency
Metabolism and nutrition disorders	Hyperglycaemia Nosocomial hyponatraemia*	Not known
Nervous system disorders	Hyponatraemic encephalopathy*
Renal and urinary disorders	Glucose polyuria
General disorders and administration site conditions	Local reaction Fever Infection at the injection site Venous thrombosis Phlebitis Extravasation spreading from the injection site.

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

•

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

Overdose may cause the following effects: hyperosmolarity, dehydration, hyperglycaemia, hyperglycosuria and osmotic diuresis.

Treatment is symptomatic.

Pharmacotherapeutic class: PLASMA SUBSTITUTES AND SOLUTIONS FOR INFUSION / CARBOHYDRATES. ATC code: B05BA03.

The pharmacological properties of this solution are those of glucose. The caloric intake is 200 kcal/L, i.e. 836 kJ/L.

This solution also provides water without providing electrolytes.

Glucose is metabolised to carbon dioxide and water.

• Check for any possible change in colour and/or the formation of a precipitate, insoluble complex or crystals.

• Before adding a medicinal product, check whether the medicinal product is compatible with the pH range of the FRESENIUS GLUCOSE 5% solution (pH between 3,5 and 6,5).

• When a medicinal product is added to this solution, the mixture must be administered immediately.

Glass vials:

Before opening: 5 years

After opening: use immediately

Polyethylene vials:

Before opening: 3 years

After opening: use immediately

PERFUFLEX bags:

50 ml before opening: 1 year,

100 ml before opening: 18 months,

250 ml, 500 ml and 1000 ml before opening: 2 years.

After opening: use immediately

Bags (Polypropylene/Styrene ethylene butadiene)

Before opening: 2 years.

After opening: use immediately

Bags (Polyester – polyethylene copolymer – polypropylene/styrene ethylene butadiene):

50 ml and 100 ml before opening: 2 years

250 ml, 500 ml and 1000 ml before opening: 3 years

After opening: use immediately

Bags (Polypropylene/SIS-polypropylene/Styrene ethylene butadiene):

50 ml before opening: 18 months

100 ml, 250 ml, 500 ml and 1000 ml before opening: 2 years.

After opening: use immediately.

For the vials (glass), the bags (Perfuflex), the bags (Polypropylene/Styrene-Ethylene-Butadiene), the bags (polyester-polyethylene copolymer-polypropylene/styrene-ethylene-butadiene) and the bags (polypropylene/SIS-polypropylene/styrene-ethylene-butadiene): Store at a temperature not exceeding 25° C.

For the vials (polyethylene): This medicinal product does not require any special storage precautions.

For storage conditions of the medicine after first opening, see section Shelf life.

Use in the paediatric population

Precautions for use of the bags:

• do not use an air inlet;

• purge the infusion system so as not to allow air to pass through;

• single use only.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

 Preparation instructions before administration - bags with vial adapter:

For single-dose powder or liquid medication vials only (up to 10 ml) with 20 mm closures.

Use aseptic technique

Assembly
	Remove the cap from the vial
	a) Remove the cap from the vial
	b) Disinfect the stopper
	Tilt and pull the vial adapter cap to remove it
	c) Gently tilt the adapter cap back and forth to break the seals and dislodge it from its place
	d) Once dislodged, pull the adapter cap to remove it
	e) Check that the vial adapter does not contain moisture. Discard it if you find moisture
	Push the vial adapter down into the top of the vial
	f) Hold the vial firmly in an upright position
	g) Push the adapter into the vial until it clicks into place. DO NOT TWIST
	h) Pull lightly on the vial to make sure it is securely attached
	i) Squeeze the bag and check that the vial is still dry
	j) Use only if the vial is securely attached and dry
Reconstitution
	Turn the vial to the right to open it
	k) Turn the vial to the right until the yellow indicator is in the OPEN position
	For a powder medication vial, squeeze the bag until the vial is half filled with solution
	Note: For liquid medication vials, skip step 5 and go directly to step 6.
	l) Hold the bag while keeping the vial in an upright position
	m) Squeeze the bag until the vial is half filled with solution
	n) Shake the vial to suspend the medication in the solution
	With the vial upside down, squeeze and release the bag to drain the solution from the vial
	o) Turn the bag so that the vial is upside down
	p) Squeeze the bag to let air into the vial
	q) Release the bag to drain the suspended medication from the vial into the bag
	r) Repeat steps 5 and 6 until the vial is empty of medication and the solution is well mixed. empty of medication and the solution is well mixed. Make sure the medication is completely dissolved. Do not remove the medication vial
	Turn the vial to the left to close it
	s) Turn the vial to the left until the yellow indicator is in the CLOSE position to prevent any backflow. The medication vial must remain in place for the entire duration of the infusion.

 

List I

Marketing authorisation (AMM)

CIP 3400936762930 (Bag/500ml). CIP 3400936763012 (Bag/1000ml). CIP 3400936762640 (Overpouch bag/50ml). CIP 3400936762701 (Overpouch bag/100ml). CIP 3400936762879 (Overpouch bag/250ml). CIP 3400941572241 (Luer bag/50ml). CIP 3400941572302 (Luer bag/100ml). CIP 3400941572470 (Luer bag/250ml). CIP 3400941572531 (Luer bag/500ml). CIP 3400941572760 (Luer bag/1000ml).

Price:

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

Social security reimbursement at 65% (Bag/500ml, Bag/1000ml, Overpouch bag/50ml, Overpouch bag/100ml, Overpouch bag/250ml).
Not reimbursed by social security (Luer bag/50ml, Luer bag/100ml, Luer bag/250ml, Luer bag/500ml, Luer bag/1000ml).
Collection.