Glucosum 20% Fresenius

Package Leaflet: Information for the User

GLUCOSUM 20% FRESENIUS, 200 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 those not listed in this package leaflet, or if you experience any unusual symptoms, tell your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Package Leaflet

• 1. What is GLUCOSUM 20% FRESENIUS and What is it Used For
• 2. Important Information Before Using GLUCOSUM 20% FRESENIUS
• 3. How to Use GLUCOSUM 20% FRESENIUS
• 4. Possible Side Effects
• 5. How to Store GLUCOSUM 20% FRESENIUS
• 6. Contents of the Package and Other Information

1. What is GLUCOSUM 20% FRESENIUS and What is it Used For

GLUCOSUM 20% FRESENIUS is a glucose solution 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:

• supplementation of energy deficiencies as a carbohydrate component in parenteral nutrition (when the patient does not receive food orally);
• treatment of hypoglycemia (decreased blood glucose levels).

2. Important Information Before Using GLUCOSUM 20% FRESENIUS

When Not to Use GLUCOSUM 20% FRESENIUS

Do not use GLUCOSUM 20% FRESENIUS:

• if you have hyperglycemia (increased blood glucose levels);
• if you have hypokalemia (decreased blood potassium levels);
• if you have acidosis (excessive accumulation of acidic substances in the blood);
• if you have fluid overload (excessive fluid in the body);
• if you are dehydrated (significant reduction in body water due to fluid loss or disease);
• if you have increased serum osmolality (increased concentration of substances in the blood confirmed by laboratory tests);
• if you have anuria (production of less than 100 ml of urine per day);
• if you have intracranial hemorrhage;
• if you have intramedullary hemorrhage.

Warnings and Precautions

• The medicinal product should be administered with caution if you have diabetes or carbohydrate intolerance (disorders of certain sugar absorption).
• The medicinal product may cause fluid overload, leading to decreased 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 20% FRESENIUS, your doctor will monitor fluid balance (the 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); your 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 20% FRESENIUS, tell your doctor or nurse if you have any condition that may cause increased vasopressin levels (a hormone that regulates water content in the body). Increased vasopressin levels 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 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 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 water regulation 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 life-threatening.

GLUCOSUM 20% 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.
It is especially important to inform your doctor if you are taking certain medicinal products that affect vasopressin action, including:

• antidiabetic medicinal products (chlorpropamide);
• cholesterol-lowering medicinal products (clofibrate);
• antiepileptic medicinal products (carbamazepine);
• medicinal products with a chemical structure similar to amphetamine (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 vasopressin action, such as desmopressin (used to treat increased thirst and urination), terlipressin (used to treat esophageal bleeding), 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 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 may be used in pregnant and breastfeeding women, provided that the recommendations and restrictions on dosage, contraindications, and general precautions for use are taken into account.
GLUCOSUM 20% FRESENIUS should be used with caution in pregnant women due to the possibility of fetal hyperglycemia, hyperinsulinemia (increased insulin levels in the blood), and acidosis, and subsequent 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

Not applicable.

3. How to Use GLUCOSUM 20% 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 your doctor individually for each patient, depending on age, body weight, and clinical condition.
Your doctor will monitor the amount of fluid in your body, 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 the infusion and during its administration.

Using a Higher Dose of GLUCOSUM 20% FRESENIUS Than Recommended

If a higher dose of the medicinal product is used, tell your doctor or nurse immediately.
Overdose of the medicinal product may cause:

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

If you have any further doubts about using this medicinal product, consult your doctor or nurse.

4. Possible Side Effects

Like all medicinal products, this medicinal product can cause side effects, although not everybody gets them.
The following side effects may occur:

• hyperglycemia (increased blood glucose levels);
• glycosuria (presence of glucose in the urine);
• phlebitis or thrombophlebitis at the injection 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 (excessive or insufficient fluid);
• acid-base balance disorders (changes in blood pH confirmed by laboratory tests);
• decreased electrolyte levels in the blood (e.g., potassium, magnesium, 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 those not listed in this package leaflet, or if you experience any unusual symptoms, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of 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.
By reporting side effects, you can help provide more information on the safety of this medicinal product.

5. How to Store GLUCOSUM 20% FRESENIUS

Keep the medicinal product out of the sight and reach of children.
Store in a temperature below 25°C. Do not freeze.
After opening, the package cannot be stored and used again. Unused medicinal product is not suitable for further use.
Do not use this medicinal product after the expiry date stated on the package. The expiry date refers to the last day of the month.
Do not use this medicinal product if it becomes contaminated, changes color, or if the package is damaged.
Do not dispose of medicinal products in the sewage system 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 20% FRESENIUS Contains

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

1000 ml of the solution contains 200 g of glucose in the form of glucose monohydrate (220 g) .

• The other ingredients are: water for injections.

The osmolality of the solution is 1114 mOsmol/l.

What GLUCOSUM 20% FRESENIUS Looks Like and What the Package Contains

The medicinal product is a clear and colorless solution.
The packages of the medicinal product are: polyethylene container KabiPac with a cap – 1 x 100 ml, 40 x 100 ml, 1 x 250 ml, 20 x 250 ml, 1 x 500 ml, 20 x 500 ml, 1 x 1000 ml, 10 x 1000 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.
Infusion Fluids Factory
ul. Sienkiewicza 25
99-300 Kutno
To obtain more detailed information, 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

The dosage is determined by your doctor individually for each patient, depending on age, body weight, and clinical condition.
If your doctor does not recommend otherwise, GLUCOSUM 20% FRESENIUS is administered according to the following scheme:
Maximum infusion rate (orientative values):
1.25 ml/kg body weight/h (87.5 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 (orientative values):
usually does not exceed a daily dose of 21 ml/kg body weight, which corresponds to 4.2 g of glucose/kg body weight.
The following glucose dosage restrictions must 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 dosage of carbohydrates and fluids must be observed.
GLUCOSUM 20% FRESENIUS should be administered into a central vein. In emergency situations, during the treatment of hypoglycemia, it can be administered by slow infusion into peripheral veins.
Children
The maximum daily dose must be adjusted to the maximum daily fluid requirement.
When used in newborns, the high osmolality of the solution must be taken into account.
Maximum daily doses:
Preterm infants
up to 18 g of glucose/kg body weight, which corresponds to up to 90 ml/kg body weight.
Newborns
up to 15 g of glucose/kg body weight, which corresponds to up to 75 ml/kg body weight.

• 1 – 2 years up to 15 g of glucose/kg body weight, which corresponds to up to 75 ml/kg body weight.
• 3 – 5 years up to 12 g of glucose/kg body weight, which corresponds to up to 60 ml/kg body weight.
• 6 – 10 years up to 10 g of glucose/kg body weight, which corresponds to up to 50 ml/kg body weight.
• 10 – 14 years up to 8 g of glucose/kg body weight, which corresponds to up to 40 ml/kg body weight.

When determining the dose, ensure that the total volume of fluid administered parenterally does not exceed the following values:
1 day of life

• 50 – 70 ml/kg body weight/day 2 days of life
• 70 – 90 ml/kg body weight/day 3 days of life
• 80 – 100 ml/kg body weight/day 4 days of life
• 100 – 120 ml/kg body weight/day from the 5th day of life
• 100 – 130 ml/kg body weight/day 1 year of life
• 100 – 140 ml/kg body weight/day 2 years
• 80 – 120 ml/kg body weight/day
• 3 – 5 years
• 80 – 100 ml/kg body weight/day
• 6 – 10 years 60 – 80 ml/kg body weight/day
• 11 – 14 years 50 – 70 ml/kg body weight/day

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 medicinal product, especially in patients with high vasopressin activity or patients taking other medicinal products that enhance vasopressin action.
Monitoring of sodium levels in the blood is particularly important during the administration of hypotonic fluids relative to physiological osmotic pressure. The GLUCOSUM 20% FRESENIUS medicinal product may become extremely hypotonic after administration due to glucose metabolism in the body.

Overdose

Hyperglycemia and glycosuria, if not recognized, may lead to disturbances of consciousness, hyperosmolar hyperglycemic coma, dehydration, and ultimately 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, the compatibility of other medicinal products added to the GLUCOSUM 20% FRESENIUS solution should be checked.
If other medicinal products are added to GLUCOSUM 20% FRESENIUS, the resulting solution should be administered immediately.
Vasopressin-enhancing medicinal products
The following medicinal products enhance vasopressin action, which can lead to increased 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, narcotics.
• Medicinal products that enhance vasopressin action, 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 medicinal products, such as oxcarbazepine.

Preparation of the Medicinal Product for Administration

Use only a clear solution.
Unused medicinal product is not suitable for further use.
Do not use this medicinal product if it becomes contaminated, changes color, or if the package is damaged.
Follow aseptic procedures.
Instructions for using the KabiPac container:

• 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 and/or previously used containers).

• 2. Preparation of the infusion: a) Place the KabiPac 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 neck of the container with the other hand.
• 3. Adding medicinal product to the package: a) Place the KabiPac container on a stable and flat surface. b) Remove the plastic cover/plug from the smaller port (injection port) with the arrow pointing inward, then insert the needle into the center of the injection port and add the medicinal product to the KabiPac container.

Note: The ports are sterile, no disinfection is required before first use.

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

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

Storage Conditions

Store in a temperature below 25°C. Do not freeze.
After opening, the package 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 package.

Disposal of Unused Medicinal Product

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