Glucosum 5% et Natrium hloratum 0,9% (2:1) Fresenius

Package Leaflet: Information for the User

GLUCOSUM 5% ET NATRIUM CHLORATUM 0,9% 2:1 FRESENIUS

(33.3 mg + 3.0 mg)/ml, solution for infusion
Glucose + Sodium chloride

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. 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, tell your doctor, pharmacist, or nurse. See section 4.

Contents of the Package Leaflet

• 1. What GLUCOSUM 5% ET NATRIUM CHLORATUM 0,9% 2:1 FRESENIUS is and what it is used for
• 2. Important information before using GLUCOSUM 5% ET NATRIUM CHLORATUM 0,9% 2:1 FRESENIUS
• 3. How to use GLUCOSUM 5% ET NATRIUM CHLORATUM 0,9% 2:1 FRESENIUS
• 4. Possible side effects
• 5. How to store GLUCOSUM 5% ET NATRIUM CHLORATUM 0,9% 2:1 FRESENIUS
• 6. Contents of the pack and other information

1. What GLUCOSUM 5% ET NATRIUM CHLORATUM 0,9% 2:1 FRESENIUS is and what it is used for

and what it is used for
GLUCOSUM 5% ET NATRIUM CHLORATUM 0,9% 2:1 FRESENIUS is a solution of glucose (simple sugar) and physiological saline. The medicine is used to cover the daily need for water, to balance electrolyte deficiencies, and to provide glucose that allows for the coverage of the body's minimum energy needs. The medicine is administered intravenously.
In adults, the average need for water is from 2 to 3 liters per day.
Glucose restores blood sugar levels and provides calories. One gram of glucose provides 16.8 kJ (4 kcal) of energy.
Sodium is responsible for water management in the body, regulates muscle contractions and relaxations, including the heart muscle. It is necessary for the functioning of various enzymes.
Chlorine is a component of digestive juices in the digestive tract (gastric juice and saliva), participates in the regulation of water management in the body, and acid-base balance.
Sodium, in combination with chlorine, is responsible for proper fluid management in the body and helps maintain proper acid-base balance.
Indications for use:

• hypertonic or isotonic dehydration;
• parenteral fluid, carbohydrate, and electrolyte (sodium, chloride) supplementation when administration of fluids by a route other than intravenous is not possible (especially in children);
• dilution and dissolution of electrolyte concentrates and medicines.

2. Important information before using GLUCOSUM 5% ET NATRIUM CHLORATUM 0,9% 2:1 FRESENIUS

When not to use GLUCOSUM 5% ET NATRIUM CHLORATUM 0,9% 2:1 FRESENIUS

Contraindications

Before administering this medicine, consider the contraindications for the substance being dissolved or diluted in the GLUCOSUM 5% ET NATRIUM CHLORATUM 0,9% 2:1 FRESENIUS.
Do not use the medicine if the patient:

• is allergic to the substance being dissolved or diluted in GLUCOSUM 5% ET NATRIUM CHLORATUM 0,9% 2:1 FRESENIUS;
• has fluid overload (excess fluid in the body);
• has too high sodium and chlorine levels in the blood;
• has too low potassium levels in the blood;
• has acidosis (excess of acidic substances in the blood);
• has hyperglycemia (elevated blood glucose levels);
• should limit sodium intake due to: heart failure, generalized edema, pulmonary edema, hypertension, pre-eclampsia (a cardiovascular disease that occurs in pregnant women) or severe renal failure.

Warnings and precautions

The medicine should be used with caution if the patient:

• has congestive heart failure;
• has severe renal failure; in patients with impaired renal function, the medicine may cause sodium retention in the body;
• has edema (caused by sodium retention in the body);
• is being treated with corticosteroids (also known as steroids, used to treat, among other things, rheumatic disease) or corticotropin (a pituitary hormone);
• has diabetes;
• receives large volumes of solutions that do not contain potassium, as this may lead to hypokalemia (significant decrease in potassium levels in the blood).

Before starting treatment with GLUCOSUM 5% ET NATRIUM CHLORATUM 0,9% 2:1 FRESENIUS, inform your doctor or nurse if the patient has a condition that may cause increased vasopressin levels (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 symptoms such as 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 disturbances in 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 antidiuretic hormone (ADH) secretion, infusion of low-sodium solutions (hypotonic solutions) may lead to low sodium levels in the blood (hyponatremia). This can cause symptoms such as 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.
The medicine may cause fluid overload, leading to a decrease in electrolyte levels in the blood 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% ET NATRIUM CHLORATUM 0,9% 2:1 FRESENIUS, the doctor will monitor the patient's condition and order blood tests (to check for fluid balance disturbances, electrolyte levels, and acid-base balance).
The medicine contains glucose, so it should not be mixed with the following medicines:

• 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 are planning to have a baby, ask your doctor for advice before taking this medicine.
Glucose solutions may be used in pregnant women and during breastfeeding, provided that the recommendations and restrictions on dosing, contraindications, and general precautions for use are taken into account.
GLUCOSUM 5% ET NATRIUM CHLORATUM 0,9% 2:1 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 prevent bleeding), due to the risk of hyponatremia.

Driving and using machines

Not applicable.

3. How to use GLUCOSUM 5% ET NATRIUM CHLORATUM 0,9% 2:1 FRESENIUS

This medicine is administered only by medical personnel. Do not use the medicine yourself.
In case of doubts, consult your doctor.
The dosage is determined by the doctor individually for each patient, depending on the 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 vasopressin activity), at the beginning of the infusion and during its administration.

Overdose of GLUCOSUM 5% ET NATRIUM CHLORATUM 0,9% 2:1 FRESENIUS

In case of overdose, tell your doctor or nurse immediately.
Overdose of the medicine may cause fluid overload or overload of the substances dissolved in the medicine.
In case of any further doubts about the use of this medicine, 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):

• increased body temperature;
• infection at the injection site;
• thrombophlebitis or vein inflammation spreading from the injection site (formation of inflammation and small blood clots, manifesting as palpable hardening of the vein, redness around it, pain, and tenderness);
• extravasation (leakage of the medicine outside the vein);
• hypervolemia (excessive blood volume in the blood vessels);
• hyperglycemia (elevated blood glucose levels) and glycosuria (presence of glucose in the urine), especially when the medicine is administered too quickly;
• exacerbation of heart failure symptoms and pulmonary edema (especially in patients with cardiovascular diseases);
• low sodium levels in the blood (hyponatremia) that can lead to brain damage and death due to brain edema (see section "Warnings and precautions").

Prolonged administration of the medicine may cause:

• fluid balance disturbances (excess or deficiency of fluids);
• acid-base balance disturbances (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).

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, tell 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. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store GLUCOSUM 5% ET NATRIUM CHLORATUM 0,9% 2:1 FRESENIUS

Storage

Polyethylene container KabiPac with cap:
Do not freeze.
Polypropylene container KabiClear with cap:
Store in a temperature below 25°C. Do not freeze.
Keep the medicine out of the sight and reach of children.
After opening, the packaging cannot be stored and used again.
Do not use this medicine 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 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. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What GLUCOSUM 5% ET NATRIUM CHLORATUM 0,9% 2:1 FRESENIUS contains

• The active substances of the medicine are: glucose in the form of glucose monohydrate, sodium chloride. 1000 ml of the solution contains:

Glucose (in the form of glucose monohydrate)
33.3 g (36.63 g)
Sodium chloride
3.0 g
Ions:
Na
51.3 mmol
Cl
51.3 mmol

• The other ingredient is water for injection.

The osmolality of the solution is 290 mOsmol/l, pH: 3.5 – 6.5.

What GLUCOSUM 5% ET NATRIUM CHLORATUM 0,9% 2:1 FRESENIUS looks like and contents of the pack

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.

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 about this medicine, 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 the basic daily needs, age, patient's condition, and fluid loss, as well as current electrolyte levels in the blood.
Maximum daily dose (orientative values):

• 0.5 g glucose/kg body weight/h

The medicine can be administered into peripheral veins. If administered into peripheral veins, a large vein of the arm should be chosen and the injection site changed daily.
Due to the risk of hyponatremia associated with hospital treatment, before and during administration of the medicine, it may be necessary to monitor fluid balance, blood glucose levels, and sodium and other electrolyte levels in the blood, especially in patients with non-osmotic stimulation of vasopressin secretion (syndrome of inappropriate antidiuretic hormone secretion - SIADH) and in patients receiving other medicines that enhance vasopressin activity.
Monitoring of sodium levels in the blood is particularly important during administration of hypotonic solutions relative to physiological osmotic pressure. GLUCOSUM 5% ET NATRIUM CHLORATUM 0,9% 2:1 FRESENIUS may become extremely hypotonic after administration due to glucose metabolism in the body.

Overdose

In case of fluid overload or overload of the substances dissolved in the medicine, assess the patient's clinical condition and provide appropriate treatment.

Interactions with other medicines and other types of interactions

As with all medicines administered parenterally, check the compatibility of other medicines added to GLUCOSUM 5% ET NATRIUM CHLORATUM 0,9% 2:1 FRESENIUS.
In case of adding other medicines to GLUCOSUM 5% ET NATRIUM CHLORATUM 0,9% 2:1 FRESENIUS, the resulting solution should be administered immediately.
Medicines that enhance vasopressin activity
The following medicines enhance vasopressin activity, which can lead to decreased excretion of water without electrolytes by the kidneys and may increase the risk of hyponatremia associated with hospital treatment after inadequately balanced fluid therapy.

• Medicines that stimulate the release of vasopressin, such as chlorpropamide, clofibrate, carbamazepine, vincristine, selective serotonin reuptake inhibitors, 3,4-methylenedioxymethamphetamine, ifosfamide, antipsychotic medicines, narcotics.
• Medicines that enhance vasopressin activity, such as chlorpropamide, non-steroidal anti-inflammatory medicines, cyclophosphamide.
• Vasopressin analogues, such as desmopressin, oxytocin, vasopressin, terlipressin.

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

Preparation of the medicine for administration

Use only a clear solution.
Unused remainder of the 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 aseptic procedures.
Instructions for use of 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 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 needle of the infusion set vertically into the infusion port, gently rotating the set with one hand, while holding the neck of the container 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, no disinfection is required 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

Due to the glucose content, the medicine is incompatible with:
aminophylline, soluble barbiturates, erythromycin, hydrocortisone, warfarin, kanamycin, soluble sulfonamides, vitamin B.

Storage

Polyethylene container KabiPac with cap: Do not freeze.
Polypropylene container KabiClear with cap: 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 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.