Glucosum 10% Fresenius

Leaflet attached to the packaging: information for the user

GLUCOSUM 10% FRESENIUS, 100 mg/ml, solution for infusion

Glucosum

Please read carefully the contents of the leaflet before using the medicine, as it contains important information for the patient.

• Please keep this leaflet, so that you can read it again if you need to.
• In case of any doubts, please consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is GLUCOSUM 10% FRESENIUS and what is it used for
• 2. Important information before using GLUCOSUM 10% FRESENIUS
• 3. How to use GLUCOSUM 10% FRESENIUS
• 4. Possible side effects
• 5. How to store GLUCOSUM 10% FRESENIUS
• 6. Contents of the packaging and other information

1. What is GLUCOSUM 10% FRESENIUS and what is it used for

GLUCOSUM 10% 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 medicine is administered intravenously.
Indications for use:

• supplementation of energy deficiencies as a carbohydrate component in parenteral nutrition (when the patient does not take food orally);
• treatment of hypoglycemia (decreased blood glucose levels);
• dilution and dissolution of electrolyte concentrates and medicines.

2. Important information before using GLUCOSUM 10% FRESENIUS

When not to use GLUCOSUM 10% FRESENIUS

Do not use GLUCOSUM 10% 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 is overhydrated (excess fluid in the body);
• if the patient is dehydrated (significant reduction in the amount of water in the body due to fluid loss or disease);
• if the patient has elevated serum osmolality (increased amount of components in the blood serum confirmed by laboratory tests);
• if the patient has anuria (production of less than 100 ml of urine per day);
• if the patient has intracranial hemorrhage;
• if the patient has intraspinal hemorrhage.

Warnings and precautions

• The medicine should be administered with caution if the patient has diabetes or carbohydrate intolerance (disorders of absorption of certain sugars).
• The medicine 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 10% FRESENIUS, the doctor will monitor fluid balance (amount of fluids taken and excreted), blood electrolyte levels, and whether there is a disturbance in acid-base balance.
• Excessive infusion rate or metabolic disorders may cause hyperglycemia and glycosuria (see "Possible side effects"), and the doctor will order regular blood sugar and urine tests.
• Glucose solutions should not be administered with blood through the same infusion set.
• The medicine should be used with caution in newborns whose mothers have diabetes.

Before starting treatment with GLUCOSUM 10% FRESENIUS, the patient should inform their doctor or nurse if they have a condition that may cause increased levels of vasopressin (a hormone that regulates water content in the body). Increased vasopressin levels in the body may occur:

• if the patient has had a sudden or severe illness;
• if the patient is experiencing severe pain;
• if the patient has undergone surgery;
• if the patient has an infection, burn, or central nervous system disease;
• if the patient has heart, liver, or kidney disease;
• if the patient is taking certain medications. 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 increased risk of brain edema occurs in:
• children;
• women (especially of childbearing age);
• patients with disorders of cerebrospinal fluid volume, 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 disturbed due to increased secretion of antidiuretic hormone (ADH), 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 encephalopathy with hyponatremia) is considered a life-threatening condition.

GLUCOSUM 10% FRESENIUS and other medicines

Please tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.
It is especially important to inform your doctor if you are taking certain medicines that affect the action of vasopressin, including:

• antidiabetic medicines (chlorpropamide);
• cholesterol-lowering medicines (clofibrate);
• antiepileptic medicines (carbamazepine);
• medicines with an amphetamine-like chemical structure (including MDMA);
• certain anticancer medicines (vincristine, ifosfamide, cyclophosphamide);
• selective serotonin reuptake inhibitors (used to treat depression);
• antipsychotic medicines;
• opioids used to treat severe pain;
• analgesic and/or anti-inflammatory medicines (also known as nonsteroidal anti-inflammatory drugs, NSAIDs);
• medicines 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 medicines that increase the risk of hyponatremia, including all diuretics and antiepileptic medicines such as oxcarbazepine.

The following medicines should not be added to the glucose solution:

• aminophylline (a medicine used to treat asthma);
• soluble barbiturates (medicines used to treat insomnia and epilepsy);
• erythromycin (an antibiotic used to treat bacterial infections);
• hydrocortisone (a steroid medicine used to treat, among other things, atopic dermatitis);
• warfarin (an anticoagulant medicine used to reduce blood clotting);
• kanamycin (a strong antibiotic used to treat bacterial infections, such as sepsis);
• soluble sulfonamides (medicines 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, please consult your doctor or pharmacist before using this medicine.
Glucose solutions may be used in pregnant and breastfeeding women if the recommendations and restrictions on dosing, contraindications, and general precautions for use are taken into account.
GLUCOSUM 10% 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, and subsequent hypoglycemia in the newborn.
Particular caution should be exercised when administering this medicine 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

Not applicable.

3. How to use GLUCOSUM 10% FRESENIUS

This medicine is administered only by medical personnel. Do not use the medicine yourself.
In case of doubts, please consult a doctor.
The dosage is determined by the doctor individually for each patient, depending on age, body weight, and clinical condition.
The doctor will monitor the amount of fluid in the body, blood acidity, urine flow, and electrolyte levels (especially sodium) in the blood (mainly in patients with high vasopressin activity or patients taking other medicines that enhance the action of vasopressin), at the beginning of the infusion and during its administration.

Using a higher dose of GLUCOSUM 10% FRESENIUS than recommended

In case of using a higher dose of the medicine, please inform your doctor or nurse immediately.
Overdose of the medicine may cause:

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

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

4. Possible side effects

Like all medicines, this medicine 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 injection site (formation of inflammation and small blood clots, manifesting as 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);
• deficiency of vitamin B group;
• low sodium levels in the blood (hyponatremia) that can lead to brain damage and death due to brain edema (see "Warnings and precautions").

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, please inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Medical Devices, and Biocidal Products
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 the medicine.

5. How to store GLUCOSUM 10% FRESENIUS

Polyethylene container KabiPac with cap:
Do not freeze.
Polypropylene container KabiClear with cap, polypropylene bag of " freeflex" or " freeflex+ " type:
Store at a temperature below 25°C. Do not freeze.
The medicine should be stored out of sight and reach of children.
Once opened, the packaging cannot be stored and used again. Unused remaining medicine is not suitable for further use.
Do not use this medicine after the expiry date stated on the packaging: EXP.
The expiry date refers to the last day of the specified month. The labeling on the packaging is: EXP - expiry date, Lot - batch number.
Do not use this medicine if there are any signs of contamination, color change, or if the packaging is damaged.
Medicines should not be disposed of via wastewater or household waste. Please ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What GLUCOSUM 10% FRESENIUS contains

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

1000 ml of the solution contains 100 g of glucose in the form of glucose monohydrate (110 g).

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

The osmolality of the solution is 557 mOsmol/l.

What GLUCOSUM 10% FRESENIUS looks like and contents of the packaging

The medicine is a colorless and clear solution.
Packaging of the medicine:

• polyethylene container KabiPac with cap - 100 ml, 250 ml, 500 ml, 1000 ml;
• polyethylene container KabiPac with cap - 40 x 100 ml, 20 x 250 ml, 10 x 500 ml, 20 x 500 ml, 10 x 1000 ml, in a cardboard box;
• polypropylene container KabiClear with cap - 100 ml, 250 ml, 500 ml, 1000 ml;
• polypropylene container KabiClear with cap - 40 x 100 ml, 20 x 250 ml, 10 x 500 ml, 20 x 500 ml, 10 x 1000 ml, in a cardboard box;
• polypropylene bag of " freeflex" or " freeflex+ " type (with a needle-free port) - 250 ml, 500 ml, 1000 ml;
• polypropylene bag of " freeflex" or " freeflex+ " type (with a needle-free port) - 30 x 250 ml, 20 x 500 ml, 10 x 1000 ml, in a cardboard box.

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.
Infusion Fluids Factory
ul. Sienkiewicza 25
99-300 Kutno
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
To obtain 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 update of the leaflet:

Information intended only for healthcare professionals:

Dosage and administration

The dosage is determined by the doctor individually for each patient, depending on age, body weight, and clinical condition.
If the doctor does not recommend otherwise, GLUCOSUM 10% FRESENIUS is administered according to the following scheme:
Maximum infusion rate (guideline values):
2.5 ml/kg body weight/h (175 ml/h for a patient with a body weight of 70 kg, which corresponds to 17.5 g of glucose/h for a patient with a body weight of 70 kg).
Maximum daily dose (guideline values):
40 ml/kg body weight, which corresponds to 4.0 g of glucose/kg body weight.
The following restrictions on glucose dosing should be strictly observed in adult patients:
0.5 g/kg body weight/h and up to 6.0 g/kg body weight/day.
General recommendations for the use and dosing of carbohydrates and fluids should be followed.
GLUCOSUM 10% FRESENIUS can be administered into peripheral veins. A large vein of the arm should be chosen and the infusion site changed daily. Due to the fact that GLUCOSUM 10% FRESENIUS is a hypertonic solution, the preferred route of administration is central venous.
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 before and during administration of the medicine, especially in patients with non-osmotic stimulation of vasopressin release (syndrome of inappropriate antidiuretic hormone secretion - SIADH) and in patients receiving other medicines that enhance the action of vasopressin.

Overdose

Hyperglycemia and glycosuria, if left undiagnosed, may lead to disturbances of consciousness, hyperosmolar hyperglycemic 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 medicines and other types of interactions

As with all parenterally administered medicines, the compatibility of other medicines added to GLUCOSUM 10% FRESENIUS should be checked.
In case of adding other medicines to GLUCOSUM 10% FRESENIUS, the resulting solution should be administered immediately.
Medicines that enhance the action of vasopressin
The following medicines enhance the action of vasopressin, which can lead to decreased excretion of water without electrolytes by the kidneys and increase the risk of hyponatremia associated with hospital treatment.

• Medicines that stimulate the release of vasopressin, such as chlorpropamide, clofibrate, carbamazepine, vincristine, selective serotonin reuptake inhibitors, 3,4-methylenedioxymethamphetamine, ifosfamide, antipsychotic medicines, opioids.
• Medicines that enhance the action of vasopressin, such as chlorpropamide, NSAIDs, cyclophosphamide.
• Vasopressin analogs, such as desmopressin, oxytocin, vasopressin, terlipressin.

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

Preparation of the medicine for use

Use only a clear solution.
Unused remaining medicine is not suitable for further use.
Do not use this medicine if there are any signs of contamination, color change, or if the packaging is damaged.
Follow the principles of asepsis.
Instructions for use of the " freeflex" and " freeflex+ " polypropylene bag:

• 1. Before use, check the appearance of the bag and the solution - the solution should be clear, without contamination (do not use damaged and/or previously used bags).
• 2. Preparation of the infusion: a) Remove the bag from the outer packaging. b) Remove the plastic cover/plug from the larger dark blue port (infusion port) with the arrow pointing outward. c) Connect the infusion set.
• 3. Adding medicine to the packaging: a) Remove the bag from the outer packaging. b) Remove the plastic cover/plug from the smaller port for injections (white in the case of the " freeflex" bag, light blue in the case of the " freeflex+ " bag) with the arrow pointing inward, and then add the medicine:
• to the " freeflex" bag via a syringe with a needle.
• to the " freeflex+ " bag via a luer lock syringe, screwing it directly into the injection port, or via a standard syringe with a needle.
• using the freeflex+ transfer adapter device intended for direct addition of medicine from a vial to the packaging.

Note: The ports are sterile, do not require disinfection before first use.

Medical devices intended for administration and addition of the medicine should be used in accordance with their instructions for use. The solution resulting from the addition of the medicine 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, without contamination (do not use damaged and/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/plug 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 medicine to the packaging: a) Place the KabiPac/KabiClear container on a stable and flat surface. b) Remove the plastic cover/plug 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 medicine to the KabiPac/KabiClear container.

Note: The ports are sterile, do not require disinfection before first use.

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

Incompatibilities

Incompatibilities with the glucose solution are shown by:
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 " freeflex" or " freeflex+ " type: Store at a temperature below 25°C. Do not freeze.
Once opened, the packaging cannot be stored and used again. From a microbiological point of view, the medicine should be used immediately. Otherwise, the user is responsible for the storage conditions and storage time of the remaining medicine in the packaging.

Disposal of unused medicine

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