PROSPECTO: INFORMATION FOR THE USER

Fresenius Kabi 10% Glucose Solution for Infusion

Glucose

Please read this entire prospectus carefully before starting to use this medication, as it contains important information for you.

• Keep this prospectus as you may need to refer to it again.
• If you have any doubts, consult your doctor or pharmacist.

• This medication has been prescribed only to you, and you should not give it to others even if they have the same symptoms, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospectus. See section 4.

Glucosa Fresenius Kabi 10%is a transparent infusion solution that belongs to the group of intravenous nutrition solutions intended for the provision of water and energy.

Glucosa Fresenius Kabi 10% is indicated for:

• Parenteral nutrition (as an energy source), when oral food intake is limited.
• States of hypertonic dehydration (without significant loss of electrolytes) or in cases where ion imbalances need to be normalized due to excess.
• Alterations in carbohydrate metabolism.
• As a vehicle for the administration of medications and electrolytes.

No use Glucosa Fresenius Kabi 10%

• If you are allergic to the active ingredient or any of the other components of this medication (listed in section 6).
• In states of hyperglycemia (high blood glucose levels).
• In states of hyperhydration (excess water in the body), or edema due to accumulation of fluids in tissues.
• If you have severe renal insufficiency (severe kidney function failure) or anuria (absence of urine production).
• In case of electrolyte depletion (loss of salts).
• If you have hyperlactatemia (presence of lactic acid in the blood).
• If you have significant alterations in glucose tolerance, including hyperosmolar.
• In case of hypotonic dehydration (with loss of salts), if not administered simultaneously.
• If you have untreated diabetes.
• Within the first 24 hours after a head trauma.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Glucosa Fresenius Kabi 10%.

• Blood glucose levels must be closely monitored during episodes of intracranial hypertension.
• In case of having suffered acute ischemic attacks (decrease or absence of circulation in arteries), as hyperglycemia has been related to an increase in ischemic brain damage and difficulty in recovery.
• In case of shock and alterations in acid-base balance, you should be administered electrolytes according to your individual needs, before starting the administration of glucose solutions. In case of sodium deficiency, the administration of solutions without sodium may cause peripheral circulatory collapse and decreased urine excretion.
• It is recommended that you undergo regular controls of serum electrolytes and water balance, as frequent and massive administration of parenteral glucose solutions can cause significant ionic depletions. In this case, you will need to be administered electrolyte supplements.
• To avoid hypokalemia (low potassium levels in the blood) produced during prolonged parenteral nutrition with glucose, you may be added potassium to the glucose solution, as a safety measure.
• The possibility of hyperhydration can be avoided by a total balance of the incorporated and lost fluid.
• It is recommended that you undergo regular controls of blood glucose levels, especially if you are diabetic. In this case, you may need to modify your insulin requirements. Also, these solutions should be used with caution if you have Addison's disease or carbohydrate intolerance.
• If you have malnutrition, as you may have a deficiency of vitamin B1. This vitamin is essential for glucose metabolism, so if necessary, this deficiency should be corrected first.
• If the 10% glucose solution is administered via peripheral vein, you should avoid continuous administration in the same injection site due to the risk of developing thrombophlebitis (inflammation of a vein associated with the formation of a clot).
• You should pay special attention if you use it in elderly patients, as they may have impaired liver and/or kidney function.
• In prolonged treatments, insulin production may be reduced.
• If you suffer from critical states, pain, postoperative stress, infections, burns, or central nervous system diseases.
• If you have any type of heart, liver, and kidney disease, and are being treated with a medication that increases the effect of vasopressin (a hormone that regulates water retention in the body) because it may increase the risk of acquiring low sodium levels in the blood (hyponatremia) in the hospital. (See section Other medications and Glucosa Fresenius Kabi 10%.)

All patients must be closely monitored. In cases where normal regulation of blood water content is altered due to increased secretion of vasopressin, also known as Antidiuretic Hormone (ADH), infusion of fluids with low sodium chloride concentration (hypotonic fluids) may result in low sodium levels in the blood (hyponatremia). This can cause headache, nausea, convulsions, lethargy, coma, cerebral edema, and death; therefore, these symptoms (acute symptomatic hyponatremic encephalopathy) are considered a medical emergency. (See section 4, Possible side effects)

Children, fertile women, and patients with brain diseases such as meningitis, cerebral hemorrhage, cerebral contusion, and cerebral edema have a special risk of suffering from severe and potentially fatal cerebral inflammation caused by acute hyponatremia.

Other medications and Glucosa Fresenius Kabi 10%

Use of Glucosa Fresenius Kabi 10% with other medications. Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Certain medications may interact with Glucosa Fresenius Kabi 10%. In this case, you may need to change the dose or interrupt treatment with one of the medications.

It is essential to inform your doctor if you use any of the following medications:

• Insulin or oral antidiabetic medications (biguanides, sulfonylureas), as intravenous administration of glucose in patients treated with these medications may lead to a reduction in the therapeutic efficacy of these medications (antagonistic action).
• Corticosteroids: Intravenous administration of glucose in patients treated with systemic corticosteroids with glucocorticoid activity (cortisol) may lead to a significant increase in plasma glucose levels, due to the hypoglycemic action of these medications. As for corticosteroids with mineralocorticoid activity, they should be administered with caution due to their ability to retain water and sodium.
• Digitoxin glucosides (digoxin), as when intravenous administration of glucose coincides with therapy with these medications, an increase in digital activity may occur, with the risk of developing intoxication with these medications. This is due to the hypokalemia that may be caused by the administration of glucose if potassium is not added to the solution.

Glucose solutions free of electrolytes should not be administered with the same infusion equipment, simultaneously, before or after administration of blood, due to the possibility of pseudoagglutination.

Medications that potentiate the effect of vasopressin

The following medications increase the effect of vasopressin, which reduces renal water excretion without electrolytes and increases the risk of hospital hyponatremia after an improperly balanced treatment with IV perfusion solutions.

• Medications that stimulate the release of vasopressin; e.g.:

chlorpropamide, clofibrate, carbamazepine, vincristine, selective serotonin reuptake inhibitors, 3,4-methylenedioxymethamphetamine, ifosfamide, antipsychotics, narcotics

• Medications that potentiate the action of vasopressin; e.g.:

chlorpropamide, NSAIDs, cyclophosphamide

• Analogues of vasopressin; e.g.:

desmopressin, oxytocin, vasopressin, terlipressin

Other medications that are known to increase the risk of hyponatremia are also diuretics in general and antiepileptic drugs such as oxcarbazepine.

Pregnancy, lactation, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

Glucosa Fresenius Kabi 10% should be administered with special caution in pregnant women during delivery, especially if administered in combination with oxytocin, due to the risk of hyponatremia (see section 4).

In case of pregnancy, your doctor will decide whether to use 10% glucose solution, as it should be used with caution in this case.

Excessive administration of glucose during pregnancy may cause hyperglycemia (high blood glucose levels), hyperinsulinemia (high insulin levels in the blood), and fetal acidosis (increase in fetal blood acidity) and, therefore, may be harmful to the newborn.

There is no evidence to suggest that Glucosa Fresenius Kabi 10% may cause adverse effects during the lactation period in the neonate. However, it is recommended to use with caution during this period.

Driving and operating machinery

There is no indication that the Glucosa Fresenius Kabi 10% solution may affect the ability to drive or operate machinery.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Glucosa Fresenius Kabi 10% is presented in the form of a solution and will be administered in the hospital by the corresponding healthcare personnel.

Glucosa Fresenius Kabi 10% is administered intravenously by infusion.

Your doctor will indicate the duration of your treatment with Glucosa Fresenius Kabi 10%. The dose may be varied according to medical criteria, depending on age, weight, clinical condition, fluid balance, electrolytes, and acid-base balance of the patient.

When used as a vehicle for the administration of other medications, the volume will depend on the medications being administered.

For the rest of the indications and unless your doctor indicates otherwise, the recommended dose is as follows:

Maximum daily dose

Adults

Maximum daily dose of 20 ml/kg body weight/day (equivalent to 2.0 g of glucose/kg body weight/day) which should only be exceeded in exceptional cases up to 6.0 g/kg body weight/day.

Maximum infusion rate

2.5 ml/kg body weight/hour (equivalent to 0.25 g of glucose/kg body weight/hour).

Due to the maximum rate of metabolic oxidation of the body, the supply of carbohydrates should be restricted to 300 – 400 g/day in normal metabolic conditions.

In cases of metabolic insufficiency, for example, during post-stress metabolism, conditions of hypoxia (lack of oxygen) or organ failure, the daily dose should be reduced to 200 – 300 g of glucose (equivalent to 3 g/kg body weight per day) to avoid high blood sugar levels (hyperglycemia), insulin resistance, and morbidity. Appropriate follow-up is required for personalized adaptation of the dosage.

Use in children

Newborns and premature neonates

The maximum dose of glucose in premature neonates should be 11.5 g per kg body weight on the first day of life. From the second day of life, the maximum daily dose of glucose should not exceed 17.3 g per kg body weight. In newborns, the maximum dose of glucose should be 7.2 g per kg body weight on the first day of life. From the second day of life, the maximum daily dose of glucose should not exceed 17.3 g per kg body weight.

Infants and children

The maximum dose of glucose depends on the body weight of infants/children and the phase of critical illness, which can be divided into acute, stable, and recovery phases. The acute phase is defined as the resuscitation phase when the patient requires organ support (sedation, mechanical ventilation, vasopressors, fluid resuscitation). The stable phase is defined as a stable or independent patient. The recovery phase is defined as a patient who is mobilizing. The maximum daily doses of glucose in g per kg body weight per day are listed in the following table according to the phase of the disease:

Recommended maximum daily dose of glucose

Monitoring of blood sugar levels is recommended during the administration of carbohydrate solutions.

To prevent overdose, the use of infusion pumps is recommended, especially for the infusion of glucose solutions with higher concentrations.

Administration form

Peripheral infusion (administration through a small vein) or central intravenous infusion (administration through a large vein).

If you use more Glucosa Fresenius Kabi 10% than you should

Given the nature of the product, if your indication and administration are correct and controlled, there is no risk of intoxication.

If the administration of the solution is not carried out correctly and controlled, some of the following signs of overdose may appear: hyperglycemia, glucosuria, liver damage, hyperhydration, or electrolyte disorders. In these cases, administration will be suspended and symptomatic treatment will be sought. In the event of an increase in capillary glucose, insulin will be administered.

In cases where glucose administration is used as a non-protein energy source in parenteral nutrition, the composition of the mixture should be modified (increasing lipid intake and reducing glucose intake).

In case of overdose or accidental ingestion, consult the Toxicological Information Service. Phone: 915 620 420.

If you have any other questions about the use of this product, ask your doctor or pharmacist.

Like all medications, Glucosa Fresenius Kabi 10% may cause adverse effects, although not everyone will experience them.

If the solution administration is performed correctly and under control, the possible complications will be those derived from the intravenous administration technique.

If administration is performed through a central vein, the main complications will be due to catheter implantation and maintenance or complications due to infections.

If administration is performed through a peripheral vein, there is a risk of developing thrombophlebitis (inflammation of a vein associated with the formation of a clot), especially when administration is prolonged. In these cases, it is recommended to vary the catheter insertion site periodically (24-48 hours).

Hyperglycemia, glucosuria (glucose in urine), or alterations in fluid or electrolyte balance may occur if the solution is administered too quickly or if the liquid volume is excessive, or in cases of metabolic insufficiency.

The resulting hyperglycemia from rapid perfusion or excessive volume should be closely monitored in severe cases of diabetes mellitus, and can be prevented by reducing the dose and perfusion rate or by administering insulin.

The following adverse reactions have been described:

Metabolic and nutritional disorders:

• Hyperglycemia
• Electrolyte imbalance
• Fluid imbalance

General disorders and administration site conditions:

• Edema at the perfusion site
• Fever
• Extravasation at the injection site
• Infection at the injection site
• Reaction at the injection site
• Pain at the injection site

Renal and urinary disorders:

• Glucosuria

Vascular disorders:

• Tromboflebitis

If used as a vehicle for the administration of other medications, the nature of the added medications will determine the probability of other adverse reactions.

Hypontremia:

Headache, nausea, convulsions, lethargy. This can be caused by low sodium levels in the blood. When sodium levels in the blood drop significantly, water enters brain cells and causes them to swell. This results in increased intracranial pressure and causes hypontremic encephalopathy.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medications for Human Use: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. In this way, you will help protect the environment.

Store below 25°C.

Glucose Fresenius Kabi 10% Composition

• The active ingredient is glucose. Each 100 ml of solution contains10 gof anhydrous glucose (equivalent to11 gof monohydrate glucose).

• The other components are water for injection and hydrochloric acid and sodium hydroxide (for pH adjustment).

Appearance of the product and contents of the package

Glucose Fresenius Kabi 10% is a transparent solution packaged in a closed glass bottle. It is available in package sizes of 250, 500, and 1000 ml.

It is also available in clinical packaging in the following presentations:

12 bottles with 250 ml

12 bottles with 500 ml

Not all package sizes may be commercially available.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder

Fresenius Kabi España S.A.U.

Torre Mapfre-Vila Olímpica

C/ Marina 16-18

08005-Barcelona (Spain)

Manufacturer responsible

Fresenius Kabi Deutschland GmbH

Freseniusstraße 1

61169, Friedberg

Germany

Fresenius Kabi Italia, S.P.A

Via Camagre, 41

37063 Isola Della Scala – Verona

Italy

Last review date of this leaflet:January 2020.

For detailed and updated information on this medication, please visit the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

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This information is intended solely for medical professionals or healthcare professionals

Glucose Fresenius Kabi 10% will be administered by infusion, through a central or peripheral vein.

The healthcare staff must ensure that the needle is properly placed in the vein, as the solution is hypertonic and its extravasation causes agreat tissue irritation.

The contents of each bottle ofGlucose Fresenius Kabi 10% arefor a single infusion.

Once the package is opened, the solution must be administered immediately. Any unused portion must be discarded.

The solution must be transparent and free of precipitates. Do not administer if otherwise.

When administering the solution and in the preparation of mixtures or addition of medications, maximum asepsis must be maintained.

Within the framework of parenteral nutrition,Glucose Fresenius Kabi 10%can be administered with other nutritional preparations together in a single bag or separately.

However, before preparing mixtures for parenteral nutrition or adding medications to the solution or administering simultaneously with other medications, it must be checked that there are no incompatibilities.

Several studies have described signs of incompatibility for glucose solutions at 10% with: ampicillin sodium, edetate calcium disodium, α-erythropoietin, lactobionate of erythromycin, heparin sodium, imipenem-cilastatin sodium, indomethacin sodium, meropenem, and thiopental sodium.

However, some of these medications may be compatible with this infusion solution depending on various factors such as the pH of the solution (such as heparin sodium and lactobionate of erythromycin), the concentration of the medication in the solution (heparin sodium), or the time elapsed between dissolution and administration (imipenem-cilastatin sodium, meropenem).

Similarly, incompatibility has been observed when some medications are diluted in solutions containing glucose, including: amrinone lactate, cisplatin, interferon alfa-2b, procainamide hydrochloride, amoxicillin sodium/clavulanic acid, teicoplanin, bleomycin sulfate, cladribine, melphalan hydrochloride, phenytoin sodium, mecloretamine hydrochloride, mitomycin, amoxicillin sodium, rifampicin, trimethoprim-sulfamethoxazole. However, we must note that some of these medications, such as amrinone lactate or amoxicillin sodium/clavulanic acid, can be injected directly into the injection site while these infusion solutions are being administered.

Glucose solutions free of electrolytes should not be administered with the same infusion equipment, simultaneously, before or after the administration of blood, due to the possibility of pseudoagglutination.

General advice

It may be necessary to monitor the water balance, serum glucose, serum sodium, and other electrolytes before and during administration, especially in patients with increased non-osmotic vasopressin release (SIADH syndrome) and in patients receiving concomitant medication with vasopressin agonists due to the risk of hyponatremia.

Serum sodium monitoring is especially important when administering hypotonic solutions. Glucose Fresenius Kabi 10% can become extremely hypotonic after administration due to the metabolism of glucose in the body (see sections 2 and 4).