Glucosum 5% Fresenius

Package Leaflet: Information for the User

GLUCOSUM 5% FRESENIUS, 50 mg/ml, Solution for Infusion

Glucosum

Read the Package Leaflet Carefully Before Using the Medicinal Product

• Keep this package leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicinal product has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this package leaflet, please inform your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Package Leaflet

• 1. What is GLUCOSUM 5% FRESENIUS and What is it Used For
• 2. Important Information Before Using GLUCOSUM 5% FRESENIUS
• 3. How to Use GLUCOSUM 5% FRESENIUS
• 4. Possible Side Effects
• 5. How to Store GLUCOSUM 5% FRESENIUS
• 6. Contents of the Package and Other Information

1. What is GLUCOSUM 5% FRESENIUS and What is it Used For

GLUCOSUM 5% FRESENIUS is a glucose solution (simple sugar) used by the body as an energy source. One gram of glucose provides 16.8 kJ (4 kcal) of energy. The medicinal product is administered intravenously.

• Indications for use:
• parenteral fluid and carbohydrate supplementation (when the patient is not taking food orally);
• dilution and dissolution of electrolyte concentrates and medicinal products.

2. Important Information Before Using GLUCOSUM 5% FRESENIUS

When Not to Use GLUCOSUM 5% FRESENIUS

Do not use GLUCOSUM 5% FRESENIUS:

• if the patient has hyperglycemia (elevated blood glucose levels);
• if the patient has hypokalemia (decreased potassium levels in the blood);
• if the patient has acidosis (accumulation of excessive amounts of acidic substances in the blood);
• if the patient has overhydration (excess fluid in the body);
• if the patient is dehydrated (significant reduction in body water due to fluid loss).

Warnings and Precautions

• The medicinal product should be administered with caution if the patient has diabetes or carbohydrate intolerance (disorders of absorption of certain sugars).
• The medicinal product may cause fluid overload, leading to a decrease in blood electrolyte levels and the possibility of peripheral edema (swelling in the ankles and feet) and pulmonary edema (causing severe shortness of breath).
• During prolonged administration of GLUCOSUM 5% FRESENIUS, the doctor will monitor fluid balance (amount of fluid taken in and excreted), blood electrolyte levels, and acid-base balance.
• Excessive infusion rate or metabolic disorders may cause hyperglycemia and glycosuria (see section: Possible Side Effects); the doctor will order regular blood glucose and urine tests.
• Glucose solutions should not be administered with blood through the same infusion set.
• The medicinal product should be used with caution in newborns whose mothers have diabetes.

Before starting treatment with GLUCOSUM 5% FRESENIUS, inform your doctor or nurse if you have a condition that may cause increased vasopressin levels (hormone regulating water content in the body). Increased vasopressin levels in the body may occur:

• if you have had a sudden or severe illness;
• if you are experiencing severe pain;
• if you have undergone surgery;
• if you have an infection, burn, or central nervous system disease;
• if you have heart, liver, or kidney disease;
• if you are taking certain medicinal products. This may increase the risk of low sodium levels in the blood, which can lead to headache, nausea, seizures, lethargy, coma, brain edema, and death. Brain edema increases the risk of death and brain damage. The risk of brain edema is higher in:
• children;
• women (especially of childbearing age);
• patients with cerebral fluid volume disorders, which may be caused by meningitis, intracranial hemorrhage, or brain damage.

Patients should be closely monitored. In cases where normal regulation of water content in the blood is disrupted due to increased antidiuretic hormone (ADH) secretion, infusion of low-sodium fluids (hypotonic fluids) may lead to low sodium levels in the blood (hyponatremia). This can cause headache, nausea, seizures, lethargy, coma, brain edema, and death, so the occurrence of these symptoms (severe symptomatic hyponatremic encephalopathy) is considered a life-threatening condition.

GLUCOSUM 5% FRESENIUS and Other Medicinal Products

Tell your doctor or pharmacist about all medicinal products you are taking or have recently taken, as well as any medicinal products you plan to take.

• medicinal products that affect vasopressin action, including:
• antidiabetic medicinal products (chlorpropamide);
• cholesterol-lowering medicinal products (clofibrate);
• antiepileptic medicinal products (carbamazepine);
• medicinal products with an amphetamine-like structure (including MDMA);
• certain anticancer medicinal products (vincristine, ifosfamide, cyclophosphamide);
• selective serotonin reuptake inhibitors (used to treat depression);
• antipsychotic medicinal products;
• opioids used to treat severe pain;
• analgesic and/or anti-inflammatory medicinal products (also known as nonsteroidal anti-inflammatory drugs, NSAIDs);
• medicinal products that mimic or enhance the action of vasopressin, such as desmopressin (used to treat increased thirst and urination), terlipressin (used to treat bleeding from the esophagus), and oxytocin (used to induce labor);
• other medicinal products that increase the risk of hyponatremia, including all diuretics and antiepileptic medicinal products such as oxcarbazepine.

The following medicinal products should not be added to the glucose solution:

• aminophylline (a medicinal product used to treat asthma);
• soluble barbiturates (medicinal products used to treat insomnia and epilepsy);
• erythromycin (an antibiotic used to treat bacterial infections);
• hydrocortisone (a steroid medicinal product used to treat, among other things, atopic dermatitis);
• warfarin (an anticoagulant medicinal product used to reduce blood clotting);
• kanamycin (a potent antibiotic used to treat bacterial infections, such as sepsis);
• soluble sulfonamides (medicinal products used to treat bacterial infections);
• vitamin B.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor or pharmacist for advice before using this medicinal product.

Glucose solutions can be used in pregnant women and during breastfeeding, provided that the recommended dosage and contraindications are taken into account.

GLUCOSUM 5% FRESENIUS should be used with caution in pregnant women due to the possibility of fetal hyperglycemia, hyperinsulinemia (elevated insulin levels in the blood), and acidosis, which can lead to hypoglycemia in the newborn.

Particular caution should be exercised when administering this medicinal product to pregnant women during labor, especially in combination with oxytocin (a hormone used to induce labor and reduce bleeding), due to the risk of hyponatremia.

Driving and Using Machines

This medicinal product does not affect the ability to drive or use machines.

3. How to Use GLUCOSUM 5% FRESENIUS

This medicinal product is administered only by medical personnel. Do not use it yourself.

In case of doubts, consult your doctor.

The dosage is determined by the doctor individually for each patient, depending on age, body weight, and clinical condition.

The doctor will monitor fluid balance, blood acidity, urine flow, and electrolyte levels (especially sodium) in the blood (mainly in patients with high vasopressin activity or patients taking other medicinal products that enhance vasopressin action), at the beginning of infusion and during its administration.

Overdose of GLUCOSUM 5% FRESENIUS

In case of overdose, inform your doctor or nurse immediately.

Overdose of the medicinal product may cause:

• hyperglycemia and glycosuria, which, if left undiagnosed, may lead to disturbances of consciousness, coma, dehydration, and eventually death;
• fluid overload;
• electrolyte imbalance.

In case of any further doubts regarding the use of this medicinal product, consult your doctor or nurse.

4. Possible Side Effects

Like all medicinal products, GLUCOSUM 5% FRESENIUS can cause side effects, although not everybody gets them.

Frequency Not Known(frequency cannot be estimated from the available data):

• hyperglycemia (elevated blood glucose levels);
• glycosuria (presence of glucose in the urine);
• phlebitis or thrombophlebitis at the infusion site (inflammation and small blood clots in the vein, manifested by palpable hardening of the vein, redness around it, pain, and tenderness);
• fluid balance disorders (excess or deficiency of fluids);
• acid-base balance disorders (changes in blood pH confirmed by laboratory tests);
• decreased electrolyte levels in the blood (e.g., potassium, magnesium, and phosphorus);
• peripheral edema (swelling in the ankles and feet);
• vitamin B deficiency;
• low sodium levels in the blood (hyponatremia) that can lead to brain damage and death due to brain edema (see section: Warnings and Precautions).

Reporting Side Effects

If you experience any side effects, including any not listed in this package leaflet, inform your doctor, pharmacist, or nurse.

Side effects can be reported directly to the Department of Medicinal Product Monitoring, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.

Side effects can also be reported to the marketing authorization holder.

Reporting side effects will help to gather more information on the safety of this medicinal product.

5. How to Store GLUCOSUM 5% FRESENIUS

Polyethylene container KabiPac with cap:

Do not freeze.

Polypropylene container KabiClear with cap, polypropylene bag of "free flex" and "free flex +" type, or glass bottle:

Store in a temperature below 25°C. Do not freeze.

Keep the medicinal product out of the sight and reach of children.

After opening, the packaging cannot be stored and used again. Unused remainder of the medicinal product is not suitable for further use.

Do not use this medicinal product after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.

Labeling on the packaging: EXP - expiry date, Lot - batch number.

Do not use the medicinal product if it is contaminated, discolored, or if the packaging is damaged.

Medicinal products should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicinal products that are no longer needed. This will help protect the environment.

6. Contents of the Package and Other Information

What GLUCOSUM 5% FRESENIUS Contains

The medicinal product is a colorless and clear solution.

• The active substance is glucose in the form of glucose monohydrate.

1000 ml of the solution contains 50 g of glucose in the form of glucose monohydrate (55 g).

• Other ingredients are: water for injections, sodium hydroxide (for pH adjustment), and hydrochloric acid (for pH adjustment).

The osmolality of the solution is 278 mOsmol/l.

What GLUCOSUM 5% FRESENIUS Looks Like and Contents of the Package

Packaging of the medicinal product:

• Polyethylene container KabiPac with cap - 100 ml, 250 ml, 500 ml, 1000 ml;
• Polypropylene container KabiClear with cap - 100 ml, 250 ml, 500 ml, 1000 ml;
• Polypropylene bag of "free flex" and "free flex +" type (with a needle-free port) - 50 ml, 100 ml, 250 ml, 500 ml, 1000 ml;
• Polypropylene bag of "free flex ProDapt" type (with a needle-free port) - 60 x 50 ml, 50 x 100 ml, 30 x 250 ml, in a cardboard box;
• Glass bottle - 250 ml, 500 ml.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Fresenius Kabi Polska Sp. z o.o., Al. Jerozolimskie 134, 02-305 Warsaw

Manufacturer

Fresenius Kabi Polska Sp. z o.o., Wytwórnia Płynów Infuzyjnych, ul. Sienkiewicza 25, 99-300 Kutno

Fresenius Kabi Italia S.r.l., Via Camagre 41, 37063 Isola della Scala VR, Italy

Fresenius Kabi France, 6, Rue du Rempart, B.P. 611, 27400 Louviers Cedex, France

Fresenius Kabi Deutschland GmbH, Werk Friedberg, Freseniusstraße 1, D-61169 Friedberg, Germany

For more detailed information, please contact the marketing authorization holder: Fresenius Kabi Polska Sp. z o.o., Al. Jerozolimskie 134, 02-305 Warsaw, tel.: +48 22 345 67 89

Date of Last Revision of the Package Leaflet

Information Intended for Healthcare Professionals Only

Dosage and Administration

Dosage is determined by the doctor individually for each patient, depending on age, body weight, and clinical condition.

If the doctor does not prescribe otherwise, GLUCOSUM 5% FRESENIUS is administered according to the following scheme:

Maximum infusion rate (guideline values):

• 3 ml/kg body weight/h (210 ml/h for a patient with a body weight of 70 kg, which corresponds to 10.5 g glucose/h for a patient with a body weight of 70 kg).

Maximum daily dose (guideline values):

• 30 - 40 ml/kg body weight, which corresponds to 1.5 - 2.0 g glucose/kg body weight.

Strictly follow the recommended dosage restrictions for glucose in adult patients:

• 0.5 g/kg body weight/h and up to 6.0 g/kg body weight/day.

Follow the general recommendations for the administration and dosage of carbohydrates and fluids.

GLUCOSUM 5% FRESENIUS can be administered into peripheral veins. Choose a large vein in the arm and change the infusion site daily.

Due to the risk of hyponatremia associated with hospital treatment, it may be necessary to monitor fluid balance, blood glucose levels, and sodium and other electrolyte levels in the blood, especially in patients with high vasopressin activity or patients taking other medicinal products that enhance vasopressin action, before and during infusion.

Overdose

Hyperglycemia and glycosuria, if left undiagnosed, may lead to disturbances of consciousness, hyperosmolar coma, dehydration, and eventually death.

Appropriate treatment should be initiated, which may include reducing the glucose infusion rate and administering insulin.

Fluid overload and electrolyte disturbances caused by overdose of the glucose solution should be treated with appropriate corrective measures.

Interactions with Other Medicinal Products and Other Types of Interactions

As with all parenterally administered medicinal products, check the compatibility of other medicinal products added to GLUCOSUM 5% FRESENIUS.

In case of adding other medicinal products to GLUCOSUM 5% FRESENIUS, the resulting solution should be administered immediately.

Medicinal products that enhance vasopressin action

The following medicinal products enhance vasopressin action, which can lead to decreased renal excretion of water without electrolytes and increase the risk of hyponatremia associated with hospital treatment due to improperly balanced fluid therapy.

• Medicinal products that stimulate the release of vasopressin, such as chlorpropamide, clofibrate, carbamazepine, vincristine, selective serotonin reuptake inhibitors, 3,4-methylenedioxymethamphetamine, ifosfamide, antipsychotic medicinal products, and opioids.
• Medicinal products that enhance vasopressin action, such as chlorpropamide, nonsteroidal anti-inflammatory drugs (NSAIDs), and cyclophosphamide.
• Vasopressin analogs, such as desmopressin, oxytocin, vasopressin, and terlipressin.

Other medicinal products that increase the risk of hyponatremia include all diuretics and antiepileptic medicinal products, such as oxcarbazepine.

Preparation of the Medicinal Product for Administration

Use only a clear solution.

Unused remainder of the medicinal product is not suitable for further use.

Do not use the medicinal product if it is contaminated, discolored, or if the packaging is damaged.

Follow aseptic procedures.

Instructions for use of the "free flex" and "free flex +" polypropylene bag:

• 1. Before use, check the appearance of the bag and the solution - the solution should be clear and free of contaminants (do not use damaged or previously used bags).
• 2. Preparation of the infusion: a) Remove the bag from the outer packaging. b) Remove the plastic cover/cap from the larger dark blue port (infusion port) with the arrow pointing outward. c) Connect the infusion set.
• 3. Adding the medicinal product to the packaging: a) Remove the bag from the outer packaging. b) Remove the plastic cover/cap from the smaller white port (injection port) with the arrow pointing inward, and then add the medicinal product to the bag:
• to the "free flex" bag via a syringe with a needle;
• to the "free flex +" bag via a luer lock syringe by screwing it directly into the injection port or via a standard syringe with a needle;
• using the freeflex+ transfer adapter designed for direct addition of the medicinal product from a vial to the packaging.

Ports are sterile and do not require disinfection before first use.

Medical devices intended for administration and addition of the medicinal product should be used in accordance with their instructions for use. The solution resulting from the addition of the medicinal product should be carefully mixed and checked for precipitation.

Instructions for use of the KabiPac and KabiClear containers:

• 1. Before use, check the appearance of the container and the solution - the solution should be clear and free of contaminants (do not use damaged or previously used containers).

• 2. Preparation of the infusion: a) Place the KabiPac/KabiClear container on a stable and flat surface. b) Remove the plastic cover/cap from the larger port (infusion port) with the arrow pointing outward. c) Insert the infusion set needle into the infusion port, gently rotating the set with one hand while holding the container neck with the other hand.
• 3. Adding the medicinal product to the packaging: a) Place the KabiPac/KabiClear container on a stable and flat surface. b) Remove the plastic cover/cap from the smaller port (injection port) with the arrow pointing inward, and then insert the needle into the center of the injection port and add the medicinal product to the KabiPac/KabiClear container.

Ports are sterile and do not require disinfection before first use.

Medical devices intended for administration and addition of the medicinal product should be used in accordance with their instructions for use. The solution resulting from the addition of the medicinal product should be carefully mixed and checked for precipitation.

Incompatibilities

The following medicinal products are incompatible with the glucose solution:

aminophylline, soluble barbiturates, erythromycin, hydrocortisone, warfarin, kanamycin, soluble sulfonamides, vitamin B.

Storage Conditions

Polyethylene container KabiPac with cap: Do not freeze.

Polypropylene container KabiClear with cap, polypropylene bag of "free flex", "free flex +", or "free flex ProDapt" type, or glass bottle: Store in a temperature below 25°C. Do not freeze.

After opening, the packaging cannot be stored and used again. From a microbiological point of view, the medicinal product should be used immediately. Otherwise, the user is responsible for the storage conditions and storage time of the remaining medicinal product in the packaging.

Disposal of Unused Medicinal Product

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