Glucose 5% and sodium chloride 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
Glucosum + Natrii chloridum
Please read all of this leaflet carefully before using this medicine, because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Contents of the 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

GLUCOSUM 5% ET NATRIUM CHLORATUM 0,9% (2:1) FRESENIUS is a solution containing glucose
(a simple sugar) and physiological saline. This medicine is used to meet daily water requirements, correct electrolyte deficiencies, and provide glucose to cover the body's minimal energy needs. The medicine is administered intravenously.
In adults, average daily water requirement ranges from 2 to 3 litres.
Glucose restores blood sugar levels and provides calories. One gram of glucose provides 16.8 kJ (4 kcal) of energy.
Sodium plays a key role in the body's water balance, regulates muscle contractions and relaxations, including those of the heart muscle, and is essential for the function of various enzymes.
Chloride is a component of digestive fluids in the gastrointestinal tract (gastric juice and saliva), participates in regulating the body's water balance, and contributes to acid-base equilibrium.
Sodium in combination with chloride maintains proper fluid balance in the body and helps sustain appropriate acid-base balance.

Indications:

• Hypertonic or isotonic dehydration;
• Parenteral replenishment of fluids, carbohydrates, and electrolytes (sodium, chloride), when administration by routes other than intravenous is not feasible (especially in children);
• Dilution and dissolution of electrolyte concentrates and medicinal products.

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

Before administering this medicinal product, contraindications related to the substance being dissolved or diluted and administered to the patient must be considered.

Do not use this medicine if the patient:

• is allergic to the substance being dissolved or diluted in GLUCOSUM 5% ET NATRIUM CHLORATUM 0.9% (2:1) FRESENIUS;
• is overhydrated (excess fluid in the body);
• has abnormally high levels of sodium and chloride in the blood;
• has abnormally low potassium levels in the blood;
• has acidosis (accumulation in the blood of excessive amounts of acidic substances);
• has hyperglycaemia (increased glucose concentration in the blood);
• must restrict sodium intake due to: heart failure, generalized oedema, pulmonary oedema, arterial hypertension, eclampsia (a circulatory disorder occurring in pregnant women), or severe renal insufficiency.

Warnings and precautions

Use this medicine with caution if the patient:

• has congestive heart failure;
• has severe renal insufficiency; in patients with impaired kidney function, the medicine may cause sodium retention;
• has oedema (caused by sodium retention);
• is being treated with corticosteroids (also known as steroids, used in the treatment of, among others, rheumatic diseases) or corticotropin (a pituitary hormone);
• has diabetes;
• is receiving large volumes of solutions that do not contain potassium, as this may lead to hypokalaemia (marked decrease in potassium concentration in the blood).

Before starting treatment with GLUCOSUM 5% ET NATRIUM CHLORATUM 0.9% (2:1) FRESENIUS, inform the doctor or nurse if the patient has a condition that may cause increased vasopressin levels (a hormone regulating water content in the body). Elevated vasopressin levels may occur:

• if the patient has experienced an acute or serious 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 disorder;
• if the patient has diseases affecting heart, liver, or kidney function;
• if the patient is taking certain medicines.

This may increase the risk of low sodium levels in the blood, which may lead to headache, nausea, seizures, lethargy, coma, cerebral oedema, and death. Cerebral oedema increases the risk of death and brain damage. Increased risk of cerebral oedema occurs in:

• children;
• women (particularly of childbearing age);
• patients with disorders of cerebrospinal fluid volume, which may be caused by meningitis, intracranial haemorrhage, or brain injury.

Patients should be closely monitored. In cases where proper regulation of blood water content is impaired due to increased secretion of antidiuretic hormone (ADH), infusion of low-salt concentration fluids (hypotonic fluids) may lead to low sodium levels in the blood (hyponatraemia). This may result in headache, nausea, seizures, drowsiness, coma, cerebral oedema, and death. Therefore, the occurrence of these symptoms (severe symptomatic encephalopathy with hyponatraemia) is considered life-threatening.

This medicine may cause fluid overload, leading to decreased electrolyte concentrations in the blood and risk of peripheral oedema (swelling around ankles and feet) and pulmonary oedema (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 disturbances in fluid balance, electrolyte concentrations, and acid-base balance).

This medicine contains glucose and must not be administered simultaneously with blood through the same infusion set.

GLUCOSUM 5% ET NATRIUM CHLORATUM 0.9% (2:1) FRESENIUS and other medicines

Inform the doctor or pharmacist about all medicines currently used, recently used, or planned for use by the patient.

It is particularly important to inform the doctor if the patient is taking certain medicines affecting vasopressin hormone activity, including:

• antidiabetic medicines (chlorpropamide);
• cholesterol-lowering medicines (clofibrate);
• antiepileptic medicines (carbamazepine);
• medicines chemically similar to amphetamines (e.g. MDMA);
• certain anticancer medicines (vincristine, ifosfamide, cyclophosphamide);
• selective serotonin reuptake inhibitors (used in the treatment of depression);
• antipsychotic medicines;
• opioids used to treat severe pain;
• analgesic and/or anti-inflammatory medicines (also known as non-steroidal anti-inflammatory drugs, NSAIDs);
• medicines mimicking or enhancing vasopressin action, such as desmopressin (used to treat excessive thirst and urination), terlipressin (used to treat oesophageal bleeding), and oxytocin (used to induce labour);
• other medicines increasing the risk of hyponatraemia, including all diuretics and anticonvulsant medicines such as oxcarbazepine.

This medicine contains glucose; therefore, the following medicines must 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, among others, in the treatment of atopic dermatitis);
• warfarin (an anticoagulant medicine used to reduce blood coagulability);
• kanamycin (a potent antibiotic used to treat bacterial infections, e.g. sepsis);
• soluble sulfonamides (medicines used to treat bacterial infections);
• vitamin B.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor before using this medicine.

Glucose solutions may be used in pregnant and breastfeeding women, provided dosage recommendations and limitations, contraindications, and general precautions for use are observed.

GLUCOSUM 5% ET NATRIUM CHLORATUM 0.9% (2:1) FRESENIUS should be used with caution in pregnant women due to the risk of fetal hyperglycaemia, hyperinsulinaemia (increased insulin concentration in the blood), and acidosis, followed by neonatal hypoglycaemia.

Particular caution is required when administering this medicine to pregnant women during labour, especially in combination with oxytocin (a hormone used to induce uterine contractions and reduce bleeding), due to the risk of hyponatraemia.

Driving and operating machinery

Not applicable.

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

This medicine is administered exclusively by medical personnel.
You must not use this medicine on your own.
If in doubt, consult your doctor.
The dosage is determined individually by the doctor for each patient, depending on the clinical condition.
The doctor will monitor fluid levels in the body, blood pH, urine output, and blood electrolyte concentrations (particularly sodium), especially in patients with high vasopressin hormone activity or in patients taking other medicines that enhance vasopressin activity, both at the beginning and during the infusion.
Use of a higher than recommended dose of GLUCOSUM 5% ET NATRIUM CHLORATUM 0,9% 2:1 FRESENIUS
If a higher dose than recommended is administered, inform the doctor or nurse immediately.
Overdose may lead to overhydration or overload with substances dissolved in the medicine.
If you have any further doubts regarding the use of this medicine, consult your doctor or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Frequency unknown (frequency cannot be estimated from the available data):

• increased body temperature;
• infection at the site of administration;
• thrombosis or phlebitis spreading from the injection site (inflammation and small blood clots characterized by palpable vein hardening, redness around the vein, pain, and tenderness);
• extravasation (leakage of the medicine outside the vein);
• hypervolemia (excessively high blood volume in the blood vessels);
• hyperglycemia (increased glucose concentration in the blood) and glycosuria (presence of glucose in urine), especially when the medicine is administered too rapidly;
• worsening of heart failure symptoms and pulmonary edema (particularly in patients with cardiovascular diseases);
• low sodium concentration in blood (hyponatremia), which may lead to brain damage and death due to cerebral edema (see section “Warnings and precautions”).

Prolonged administration of the medicine may cause:

• disturbances in fluid balance (excess or deficiency of fluids);
• disturbances in acid-base balance (changes in blood pH confirmed by laboratory tests);
• decreased concentration of electrolytes in blood (e.g. potassium, magnesium, and phosphorus);
• peripheral edema (swelling in the ankles and feet).

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

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

FRESENIUS
Polyethylene container KabiPac with closure:
Do not freeze.
Polypropylene container KabiClear with closure:
Store below 25°C. Do not freeze.
Keep the medicine out of the sight and reach of children.
The container must not be reused after opening.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month. The packaging is labelled as follows: EXP – expiry date, Lot – batch number.
Do not use this medicine if particulate matter is present, if discoloration occurs, or if the packaging is damaged.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the package 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 monohydrate glucose, sodium chloride.

1000 ml of solution contains:
Glucose (as monohydrate glucose) 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 injections.

The osmolarity 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 package
The medicine is a colourless and clear solution.
Packaging:

• 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 Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warszawa
For further information about this medicine, please contact the Marketing Authorisation Holder:
Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warszawa
Tel.: +48 22 345 67 89

Manufacturer
Fresenius Kabi Polska Sp. z o.o.
Infusion Solutions Manufacturing Plant
ul. Sienkiewicza 25
99-300 Kutno

Information intended exclusively for healthcare professionals:

Dosage and method of administration
The dosage is determined individually by a physician for each patient, depending on the patient's basic daily requirements, age, clinical condition, fluid losses, and current serum electrolyte concentrations.
Maximum daily dose (approximate values):

• 0.5 g glucose/kg body weight/hour

The medicinal product may be administered into peripheral veins. When administered into peripheral veins, a large vein of the arm should be selected, and the infusion site should be changed daily.
Due to the risk of hospital-acquired hyponatremia, monitoring of fluid balance, serum glucose concentration, and serum sodium and other electrolyte concentrations may be necessary before and during administration of the medicinal product, especially in patients with non-osmotic stimulation of vasopressin release (syndrome of inappropriate antidiuretic hormone secretion – SIADH) and in patients receiving concomitant treatment with vasopressin agonists.
Monitoring of serum sodium concentration is particularly important during administration of fluids that are hypotonic relative to physiological osmotic pressure. GLUCOSUM 5% ET NATRIUM CHLORATUM 0,9% 2:1 FRESENIUS may become markedly hypotonic after administration due to glucose metabolism in the body.

Overdose
In case of overhydration or solute overload, the patient's clinical status should be assessed and appropriate treatment initiated.

Interactions with other medicinal products and other forms of interaction
As with all parenterally administered medicinal products, compatibility with other medicinal products added to GLUCOSUM 5% ET NATRIUM CHLORATUM 0,9% 2:1 FRESENIUS must be verified.
When other medicinal products are added to GLUCOSUM 5% ET NATRIUM CHLORATUM 0,9% 2:1 FRESENIUS, the resulting solution should be administered immediately.

Medicinal products enhancing vasopressin effects
The following medicinal products enhance vasopressin effects, leading to reduced renal excretion of electrolyte-free water and may increase the risk of hospital-acquired hyponatremia during inadequately balanced infusion therapy:

• Medicinal products stimulating vasopressin release, e.g. chlorpropamide, clofibrate, carbamazepine, vincristine, selective serotonin reuptake inhibitors, 3,4-methylenedioxy-N-methamphetamine, ifosfamide, antipsychotics, narcotics.
• Medicinal products enhancing vasopressin action, e.g. chlorpropamide, NSAIDs, cyclophosphamide.
• Vasopressin analogues, e.g. desmopressin, oxytocin, vasopressin, terlipressin.

Other medicinal products associated with increased risk of hyponatremia include all diuretics and antiepileptic medicinal products such as oxcarbazepine.

Preparation of the medicinal product for administration
Use only clear solutions.
Unused medicinal product residue must not be reused.
Do not use this medicinal product if contamination or discoloration occurs, or if the packaging is damaged.
Follow aseptic procedures.
Instructions for use of KabiPac and KabiClear container types:

1. Before use, inspect the container and solution visually – the solution should be clear and free from particulate matter (do not use damaged or previously used containers).
2. Preparing the infusion: a) Place the KabiPac/KabiClear container on a stable, flat surface. b) Remove the plastic cover/cap from the larger port (infusion port) with the arrow pointing outward from the packaging. c) Insert the infusion set spike vertically into the infusion port, rotating the set slightly with one hand while holding the container neck with the other hand.
3. Adding medicinal product to the container: a) Place the KabiPac/KabiClear container on a stable, flat surface. b) Remove the plastic cover/cap from the smaller port (injection port) with the arrow pointing inward toward the packaging, then insert the needle into the center of the injection port and add the medicinal product to the KabiPac/KabiClear container.

Note: Ports are sterile and do not require disinfection before first use.
Medical devices intended for administration and addition of medicinal products must be used according to their instructions for use. The solution formed after adding a medicinal product should be thoroughly mixed, and it should be ensured that no precipitate has formed.

Pharmaceutical incompatibilities
Due to its glucose content, the medicinal product 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 below 25°C.
Do not freeze.
After opening, the packaging must not be stored or reused. From a microbiological point of view, the medicinal product should be used immediately. Otherwise, the user is responsible for storage conditions and duration of the remaining medicinal product in the container.

Disposal of unused medicinal product
Any unused residues of the medicinal product or waste materials must be disposed of in accordance with local regulations.