GLUCOSTERIL 5% plastic bottle infusion solution

Glucosteril 5% infusion solution. Indications: Carrier solution for compatible electrolyte concentrates and medications, supply of free water.

For risks and side effects, read the package insert and ask your doctor or pharmacist.


INSTRUCTIONS FOR USE: INFORMATION FOR THE USER

Glucosteril 5% infusion solution

Composition:
Active ingredient: Glucose monohydrate (Ph. Eur.). 1000 ml of infusion solution contains: Glucose monohydrate (Ph. Eur.) 55.0 g, equivalent to anhydrous glucose 50.0 g. Total energy 840 kJ/l (equivalent to 200 kcal/l), pH 3.5 - 6.5, titration acidity < 1 mmol NaOH/l, theoretical osmolarity 277 mosm/l. Other ingredients: Water for injections, hydrochloric acid 25%, sodium hydroxide.

Indications:
Carrier solution for compatible electrolyte concentrates and medications, administration of free water.

Contraindications:
Hypersensitivity to the active ingredient or any of the other ingredients, untreated hyperglycemia, hypokalemia without concomitant electrolyte replacement, metabolic acidosis. The administration of Glucosteril 5% is associated with the administration of free water. Particularly if no concomitant electrolyte administration is used, the following additional contraindications may occur: hyperhydration, hypotonic dehydration.

Special patient groups:
Glucosteril 5% should be administered with particular caution to pregnant women during delivery due to the risk of hyponatremia, especially when administered in combination with oxytocin. Caution is advised in cases of hyperglycemia.

Side effects:

• Common to very common: hyperglycemia, polyuria.
• Frequency not known: Hospital-acquired hyponatremia, hyponatremic encephalopathy. Hospital-acquired hyponatremia can lead to irreversible brain damage and death due to the development of acute hyponatremic encephalopathy.

Other possible side effects are due to the type of peripheral venous infusion and are not drug-specific.

As with all substances infused via peripheral venous infusion, the following side effects may occur in addition to those listed above:
Frequency not known: local skin reactions (redness, bruising, inflammation, bleeding), pain at the injection site. Special patient groups: Children, women of childbearing age and patients with reduced cerebral compliance (e.g. meningitis, intracranial hemorrhage and cerebral contusion) are at particular risk of severe and life-threatening swelling of the brain due to acute hyponatremia. With increasing age and the severity of the illness or trauma, glucose intolerance occurs more frequently as part of post-aggression metabolism, especially if previously undiagnosed diabetes mellitus is also present.

Warnings:
Keep medicines out of the reach and sight of children. For further warnings and precautions for use, please refer to the package leaflet or the product information.

Marketing Authorisation Holder:
Fresenius Kabi Deutschland GmbH,
D-61346 Bad Homburg. Information as of: January 2025.

This leaflet was last revised in January 2025.


. Version: 12/2024

Areas of application: Carrier solution for compatible electrolyte concentrates and medications, supply of free water.

For intravenous infusion and carrier solution for electrolyte concentrates and medications