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

Leaflet attached to the packaging: information for the user

GLUCOSUM 5% ET NATRIUM CHLORATUM 0.9% 1:1 FRESENIUS

(25 mg + 4.5 mg)/ml, solution for infusion
Glucose + Sodium chloride

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, 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.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is GLUCOSUM 5% ET NATRIUM CHLORATUM 0.9% 1:1 FRESENIUS and what is it used for
• 2. Important information before using GLUCOSUM 5% ET NATRIUM CHLORATUM 0.9% 1:1 FRESENIUS
• 3. How to use GLUCOSUM 5% ET NATRIUM CHLORATUM 0.9% 1:1 FRESENIUS
• 4. Possible side effects
• 5. How to store GLUCOSUM 5% ET NATRIUM CHLORATUM 0.9% 1:1 FRESENIUS
• 6. Contents of the packaging and other information

1. What is GLUCOSUM 5% ET NATRIUM CHLORATUM 0.9% 1:1 FRESENIUS

and what is it used for
GLUCOSUM 5% ET NATRIUM CHLORATUM 0.9% 1:1 FRESENIUS is a solution of glucose
(simple sugar) and physiological salt. The medicine is used to cover the daily need for water, balance electrolyte deficiencies, and provide glucose to meet the body's minimum energy needs. The medicine is administered intravenously.
In adults, the average daily water requirement 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 essential for the functioning of various enzymes.
Chlorine is a component of digestive juices in the gastrointestinal 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:

• extraintestinal fluid, carbohydrate, and electrolyte supplementation (sodium, chlorides);
• dilution and dissolution of electrolyte and drug concentrates.

2. Important information before using GLUCOSUM 5% ET NATRIUM

CHLORATUM 0.9% 1:1 FRESENIUS

When not to use GLUCOSUM 5% ET NATRIUM CHLORATUM 0.9% 1:1

FRESENIUS

Before administering this medicine, consider the contraindications for the substance being dissolved or diluted in the GLUCOSUM 5% ET NATRIUM CHLORATUM 0.9% 1:1 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% 1:1 FRESENIUS;
• has fluid overload (excess fluid in the body);
• has too high a concentration of sodium and chlorine in the blood;
• has too low a concentration of potassium in the blood;
• has acidosis (accumulation of excessive amounts 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, preeclampsia (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 (a significant decrease in potassium levels in the blood).

Before starting treatment with GLUCOSUM 5% ET NATRIUM CHLORATUM 0.9% 1:1 FRESENIUS, the doctor or nurse should be informed if the patient has 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 headaches, nausea, seizures, lethargy, coma, brain swelling, and death. Brain swelling increases the risk of death and brain damage. The risk of brain swelling 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 secretion of antidiuretic hormone (ADH), infusion of low-sodium solutions (hypotonic solutions) may lead to low sodium levels in the blood (hyponatremia). This can cause headaches, nausea, seizures, lethargy, coma, brain swelling, 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 blood electrolyte levels and the possibility of peripheral edema (edema in the ankles and feet) and pulmonary edema (causing severe shortness of breath).
During prolonged administration of GLUCOSUM 5% ET NATRIUM CHLORATUM 0.9% 1:1 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 and should not be administered with blood through the same infusion set.

GLUCOSUM 5% ET NATRIUM CHLORATUM 0.9% 1:1 FRESENIUS and other medicines

Tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
It is especially important to inform the doctor if the patient is taking certain medicines that affect the action of vasopressin, including:

• antidiabetic medicines (chlorpropamide);
• cholesterol-lowering medicines (clofibrate);
• antiepileptic medicines (carbamazepine);
• medicines with a chemical structure similar to amphetamine (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 excessive 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 medicine contains glucose, so the following medicines should not be added to it:

• 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 potent antibiotic used to treat bacterial infections, such as sepsis);
• soluble sulfonamides (medicines used to treat bacterial infections);
• vitamin B.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor before using this medicine.
Glucose solutions may be used in pregnant and breastfeeding women, provided that the recommendations and restrictions on dosing, contraindications, and general precautions for use are observed.
GLUCOSUM 5% ET NATRIUM CHLORATUM 0.9% 1:1 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 reduce bleeding), due to the risk of hyponatremia.

Driving and using machines

Not applicable.

3. How to use GLUCOSUM 5% ET NATRIUM CHLORATUM 0.9% 1:1 FRESENIUS

This medicine is administered only by medical personnel. The medicine should not be used by the patient themselves.
In case of doubts, consult a doctor.
The dosage is determined by the doctor individually for each patient, depending on their clinical condition.
The doctor will monitor the patient's fluid levels, 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 start of infusion and during its administration.

Using a higher dose of GLUCOSUM 5% ET NATRIUM

CHLORATUM 0.9% 1:1 FRESENIUS

In case of overdose, tell the doctor or nurse immediately.
Overdose of the medicine may cause fluid overload or overload of substances dissolved in the medicine.
In case of further doubts about the use of this medicine, consult a 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 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;
• worsening 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 swelling (see "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 (edema in the ankles and feet).

Reporting side effects

If side effects occur, including any side effects not listed in this leaflet, tell the doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the 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.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store GLUCOSUM 5% ET NATRIUM CHLORATUM 0.9% 1:1

FRESENIUS

Polyethylene container KabiPac with cap:
Do not freeze.
Polypropylene container KabiClear with cap:
Store at a temperature below 25°C. Do not freeze.
Keep the medicine out of the sight and reach of children.
Once opened, 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 specified month. The labeling on the packaging includes:
EXP - expiry date, Lot - batch number.
Do not use this medicine if it becomes contaminated, changes color, or if the packaging is damaged.
Do not throw away medicines 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 packaging and other information

What GLUCOSUM 5% ET NATRIUM CHLORATUM 0.9% 1:1 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)
25 g (27.5 g)
Sodium chloride
4.5 g
Ions:
Na
76.9 mmol
Cl
76.9 mmol

• The other ingredient is water for injection.

The osmolality of the solution is 293 mOsmol/l, pH: 3.5 – 6.5.

What GLUCOSUM 5% ET NATRIUM CHLORATUM 0.9% 1:1 FRESENIUS looks like and what the packaging contains

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 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 loss of fluids, as well as the 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, 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 secretion (syndrome of inappropriate antidiuretic hormone secretion, SIADH) and in patients receiving other medicines that enhance the action of vasopressin.
Monitoring of sodium levels in the blood is especially important during administration of hypotonic solutions relative to physiological osmotic pressure. GLUCOSUM 5% ET NATRIUM CHLORATUM 0.9% 1:1 FRESENIUS may become extremely hypotonic after administration due to glucose metabolism in the body.

Overdose

In case of fluid overload or overload of substances dissolved in the medicine, the patient's clinical condition should be assessed and appropriate treatment initiated.

Interactions with other medicines and other types of interactions

As with all parenterally administered medicines, the compatibility of other medicines added to GLUCOSUM 5% ET NATRIUM CHLORATUM 0.9% 1:1 FRESENIUS should be checked.
When adding other medicines to GLUCOSUM 5% ET NATRIUM CHLORATUM 0.9% 1:1 FRESENIUS, the resulting solution should be administered immediately.
Medicines that enhance vasopressin action
The following medicines enhance vasopressin action, leading to decreased renal excretion of water without electrolytes 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, opioids.
• Medicines that enhance the action of vasopressin, such as chlorpropamide, NSAIDs, cyclophosphamide.
• Vasopressin analogs, such as desmopressin, oxytocin, vasopressin, terlipressin.

Other medicines 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 remnants of the medicine are not suitable for further use.
Do not use the medicine if it becomes contaminated, changes color, 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 contaminants (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 infusion set needle 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, 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 conditions

Polyethylene container KabiPac with cap: Do not freeze.
Polypropylene container KabiClear with cap: 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 remnants of the medicine or its waste should be disposed of in accordance with local regulations.