Glucose 5% and sodium chloride 0,9% 1:1 fresenius

Package leaflet: Information for the user

GLUCOSUM 5% ET NATRIUM CHLORATUM 0.9% 1:1 FRESENIUS
(25 mg + 4.5 mg)/ml, solution for infusion
Glucosum + Natrii chloridum
Please read all of this leaflet carefully before this medicine is administered because it contains
important information for the patient.

• Keep this leaflet as 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 the patient experiences any adverse reactions, including any not listed in this leaflet, please inform your doctor, pharmacist or nurse. See section 4.

Contents of the leaflet

1. What GLUCOSUM 5% ET NATRIUM CHLORATUM 0.9% 1:1 FRESENIUS is and what it is used for
2. Important information before administration of 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 adverse effects
5. How to store GLUCOSUM 5% ET NATRIUM CHLORATUM 0.9% 1:1 FRESENIUS
6. Contents of the pack and other information

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

and what it is used for
GLUCOSUM 5% ET NATRIUM CHLORATUM 0.9% 1:1 FRESENIUS is a solution of glucose
(simple sugar) and physiological saline. The 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 concentration and provides calories. One gram of glucose provides 16.8 kJ (4 kcal) of energy.
Sodium is responsible for the body's water balance, regulates muscle contractions and relaxations, including those of the heart muscle. It is essential for the function of various enzymes.
Chloride is a component of digestive juices in the gastrointestinal tract (gastric juice and saliva), participates in regulating the body's water balance, and acid-base equilibrium.
Sodium in combination with chloride maintains proper fluid balance in the body and helps maintain appropriate acid-base balance.

Indications:

• Parenteral supplementation of fluids, carbohydrates and electrolytes (sodium, chloride);
• Dilution and dissolution of electrolyte concentrates and medicinal products.

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 medicinal product, contraindications related to the substance being dissolved or diluted in the patient should be considered.

Do not use GLUCOSUM 5% ET NATRIUM CHLORATUM 0,9% 1:1 FRESENIUS if the patient:

• is allergic to the substance being dissolved or diluted in GLUCOSUM 5% ET NATRIUM CHLORATUM 0,9% 1:1 FRESENIUS;
• is overhydrated (excess fluid in the body);
• has elevated blood levels of sodium and chloride;
• has low blood potassium levels;
• has acidosis (accumulation in the blood of excessive amounts of acidic substances);
• has hyperglycaemia (increased blood glucose concentration);
• 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 failure.

Warnings and precautions

Use this medicinal product with caution if the patient:

• has congestive heart failure;
• has severe renal failure; in patients with impaired renal function, the product may cause sodium retention;
• has oedema (caused by sodium retention);
• is being treated with corticosteroids (also known as steroids, used e.g. in the treatment of rheumatic disease) 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 blood potassium concentration).

Before starting treatment with GLUCOSUM 5% ET NATRIUM CHLORATUM 0,9% 1:1 FRESENIUS, inform the physician or nurse if the patient has a condition that may cause increased vasopressin levels (a hormone regulating water content in the body). Increased vasopressin levels may occur:

• if the patient has had 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 medications.

This may increase the risk of low blood sodium levels, which can 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 normal regulation of blood water content is disturbed due to increased secretion of antidiuretic hormone (ADH), infusion of low-salt concentration fluids (hypotonic fluids) may lead to low blood sodium levels (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.

The product may cause fluid overload, leading to decreased blood electrolyte concentrations and risk of peripheral oedema (swelling in the ankles and feet) and pulmonary oedema (causing severe shortness of breath).

During prolonged administration of GLUCOSUM 5% ET NATRIUM CHLORATUM 0,9% 1:1 FRESENIUS, the physician will monitor the patient’s condition and order blood tests (to check for disturbances in fluid balance, electrolyte concentrations, and acid-base balance).

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

GLUCOSUM 5% ET NATRIUM CHLORATUM 0,9% 1:1 FRESENIUS and other medicines

Inform the physician or pharmacist about all medicines currently or recently taken by the patient, as well as any medicines the patient plans to use.

It is especially important to inform the physician if the patient is taking certain medicines that affect vasopressin hormone activity, including:

• antidiabetic medicines (chlorpropamide);
• cholesterol-lowering medicines (clofibrate);
• antiepileptic medicines (carbamazepine);
• medicines chemically similar to amphetamine (including 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 urine production), 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.

The product 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 e.g. in the treatment of atopic dermatitis);
• warfarin (an anticoagulant used to reduce blood clotting);
• 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 plans to become pregnant, she should consult a physician before using this medicinal product.

Glucose solutions may be used in pregnant and breastfeeding women, provided dosage recommendations, 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 risk of fetal hyperglycaemia, hyperinsulinaemia (increased blood insulin concentration), and acidosis, followed by neonatal hypoglycaemia.

Particular caution is required when administering this product to women in labour, especially when used concomitantly with oxytocin (a hormone used to induce labour 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% 1:1 FRESENIUS

This medicine is administered exclusively by medical personnel.
Do 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 volume in the body, blood pH, urine output, and blood electrolyte levels
(in particular sodium), both at the beginning of the infusion and during its administration, especially
in patients with high vasopressin hormone activity or in patients taking other medicines that enhance
the effect of vasopressin.
USE OF A HIGHER THAN RECOMMENDED DOSE OF GLUCOSUM 5% ET NATRIUM
CHLORATUM 0,9% 1:1 FRESENIUS
If a higher dose of the medicine 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 everybody gets them.
Frequency unknown (frequency cannot be estimated from the available data):

• increased body temperature;
• infection at the site of administration;
• thrombophlebitis or phlebitis spreading from the injection site (inflammation and small blood clots characterized by a palpable vein hardening, redness around the vein, pain and tenderness);
• extravasation (leakage of the medicine out of the blood vessel);
• hypervolemia (excessively high blood volume in the blood vessels);
• hyperglycemia (elevated blood glucose levels) 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 blood sodium levels (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:

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

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can also be reported directly to the Department of Monitoring of Adverse Drug Reactions, 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 may 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% 1:1

FRESENIUS
Polyethylene container KabiPac with cap:
Do not freeze.
Polypropylene container KabiClear with cap:
Store below 25°C. Do not freeze.
The medicine should be stored out of sight and reach of children.
The container must not be reused or re-stored once opened.
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 labelling on the packaging indicates:
EXP – expiry date, Lot – batch number.
Do not use this medicine if contamination occurs, if there is a change in colour, or if the packaging is damaged.
Medicines must not be disposed of via the sewage system or in household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures 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 are: glucose in the form of monohydrated glucose, sodium chloride.

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

The osmolarity 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 contents of the pack

The medicine is a clear, colourless 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 Warsaw
Manufacturer
Fresenius Kabi Polska Sp. z o.o.
Infusion Fluids Manufacturing Plant
ul. Sienkiewicza 25
99-300 Kutno

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

Information intended exclusively for healthcare professionals:

Dosage and method of administration
The dosage must be 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 (guideline values):

• 0.5 g glucose/kg body weight/hour

The medicinal product may be administered into peripheral veins. If 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 electrolytes may be necessary before and during administration of the medicinal product, particularly in patients with non-osmotic stimulation of vasopressin secretion (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% 1:1 FRESENIUS may become markedly hypotonic after administration due to glucose metabolism in the body.

Overdose
In cases of dehydration or fluid overload with solutes, the patient's clinical condition should be assessed and appropriate treatment initiated.

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

Medicinal products enhancing vasopressor effects
The following medicinal products enhance vasopressor effects, leading to reduced renal excretion of electrolyte-free water and may increase the risk of hospital-acquired hyponatremia associated with inadequately balanced intravenous fluid 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 effects, e.g. chlorpropamide, NSAIDs, cyclophosphamide.
• Vasopressin analogues, e.g. desmopressin, oxytocin, vasopressin, terlipressin.

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

Preparation of the medicinal product for use
Use only clear, particle-free solutions.
Any unused portion of the medicinal product must not be reused.
Do not use the medicinal product if particulate matter is present, if discoloration occurs, or if the container is damaged.
Follow aseptic techniques.

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/plug from the larger port (infusion port) with the arrow pointing outward from the container.
   c) Insert the infusion set spike vertically into the infusion port, gently rotating the set with one hand while holding the container neck with the other.
3. Adding medicinal product to the container:
   a) Place the KabiPac/KabiClear container on a stable, flat surface.
   b) Remove the plastic cover/plug from the smaller port (injection port) with the arrow pointing inward toward the container, 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 resulting from the addition of medicinal products should be thoroughly mixed, and it must be ensured that no precipitate has formed.

Pharmaceutical incompatibilities
Due to its glucose content, this 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 container must not be stored or reused. From a microbiological standpoint, the product should be used immediately. Otherwise, the user is responsible for the conditions and duration of storage of any remaining medicinal product in the container.

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