Glucose 5% fresenius

Package leaflet: Information for the user

GLUCOSUM 5% FRESENIUS, 50 mg/ml, infusion solution
Glucosum
Please read carefully all the information in this leaflet before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any doubts, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not give it to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform the doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

1. What GLUCOSUM 5% FRESENIUS is and what it is used for

GLUCOSUM 5% FRESENIUS is a glucose solution (simple sugar) used by the body as a source of energy. One gram of glucose provides 16.8 kJ (4 kcal) of energy. The medicine is administered intravenously.
Indications:

• Parenteral fluid and carbohydrate supplementation (when the patient is not receiving oral nutrition);
• Dilution and dissolution of electrolyte concentrates and medicines.

2. Important information before using GLUCOSUM 5% FRESENIUS

When not to use GLUCOSUM 5% FRESENIUS
Do not use GLUCOSUM 5% FRESENIUS:

• if the patient has hyperglycemia (increased blood glucose concentration);
• if the patient has hypokalemia (reduced potassium concentration in the blood);
• if the patient has acidosis (accumulation in the blood of excessive amounts of acidic substances);
• if the patient is overhydrated (excess fluid in the body);
• if the patient is dehydrated (significant reduction in body water content due to fluid loss).

Warnings and precautions

• The medicinal product should be administered with caution if the patient has diabetes or carbohydrate intolerance (impaired absorption of certain sugars).
• The medicinal product may cause fluid overload, leading to decreased electrolyte concentrations in the blood and risk of peripheral edema (swelling around ankles and feet) and pulmonary edema (causing severe shortness of breath).
• During prolonged administration of GLUCOSUM 5% FRESENIUS, the physician will monitor fluid balance (amount of fluids taken in and excreted), blood electrolyte concentrations, and possible disturbances in acid-base equilibrium.
• Excessively rapid infusion rate or metabolic disorders may cause hyperglycemia and glycosuria (see section: Possible side effects); the physician will order regular monitoring of blood and urine glucose levels.
• Glucose solutions should not be administered simultaneously with blood through the same infusion set.
• The medicinal product should be used with caution in neonates whose mothers have diabetes.

Before starting treatment with GLUCOSUM 5% FRESENIUS, inform the physician or nurse if the patient has a condition that may cause increased vasopressin levels (a hormone regulating body water content). Elevated vasopressin levels may occur:

• if the patient has experienced 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 edema, and death. Cerebral edema increases the risk of death and brain damage. Increased risk of cerebral edema occurs in:
  • children;
  • women (particularly of childbearing age);
  • patients with disorders of cerebrospinal fluid volume, which may be caused by meningitis, intracranial hemorrhage, or brain injury.

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

GLUCOSUM 5% FRESENIUS with 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 particularly important to inform the physician if the patient is taking certain medicines affecting vasopressin hormone activity, including:

• antidiabetic agents (chlorpropamide);
• cholesterol-lowering agents (clofibrate);
• antiepileptic drugs (carbamazepine);
• amphetamine-like drugs (including MDMA);
• certain anticancer drugs (vincristine, ifosfamide, cyclophosphamide);
• selective serotonin reuptake inhibitors (used in the treatment of depression);
• antipsychotic drugs;
• opioids used to treat severe pain;
• analgesic and/or anti-inflammatory drugs (also known as non-steroidal anti-inflammatory drugs, NSAIDs);
• drugs mimicking or enhancing vasopressin action, such as desmopressin (used to treat excessive thirst and urine output), terlipressin (used to treat esophageal bleeding), and oxytocin (used to induce labor);
• other drugs increasing the risk of hyponatremia, including all diuretics and anticonvulsant drugs such as oxcarbazepine.

The following drugs should not be added to glucose solution:

• 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, to treat 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 or pharmacist before using this medicine.
Glucose solutions may be used in pregnant and breastfeeding women, provided dosage recommendations and restrictions, contraindications, and general precautions for use are observed.
GLUCOSUM 5% FRESENIUS should be used with caution in pregnant women due to possible occurrence of fetal hyperglycemia, hyperinsulinemia (increased insulin concentration in the blood), and acidosis, followed by neonatal hypoglycemia.
Particular caution is required when administering this medicine to women in labor, especially in combination with oxytocin (a hormone used to induce labor and reduce bleeding), due to the risk of hyponatremia.

Driving and operating machinery
Not applicable.

3. How to use GLUCOSUM 5% FRESENIUS

This medicine is administered only by medical personnel.
Do not use the medicine yourself.
If in doubt, consult your doctor.
The dosage is determined individually by the doctor for each patient depending on age, body weight,
and clinical condition.
The doctor will monitor fluid levels in the body, blood acidity, urine flow, and electrolyte concentrations
(in particular sodium) in the blood (especially in patients with high vasopressin hormone activity or
in patients taking other medicines that enhance the effect of vasopressin), both at the beginning
of the infusion and during its administration.
Use of a higher than recommended dose of GLUCOSUM 5% FRESENIUS
If a higher dose is administered, inform the doctor or nurse immediately.
Overdose may cause:

• hyperglycaemia and glycosuria, which, if not recognized, may lead to disturbances in consciousness, coma, dehydration, and ultimately death;
• fluid overload;
• disturbances in electrolyte concentrations in the blood.

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 will experience them.
Unknown frequency (frequency cannot be estimated from the available data):

• hyperglycaemia (increased blood glucose concentration);
• glucosuria (presence of sugar in urine);
• phlebitis or thrombophlebitis at the site of administration (inflammation or blood clots causing a palpable hardening of the vein, redness around it, pain and tenderness);
• fluid balance disorders (excess or deficiency of fluids);
• acid-base balance disorders (changes in blood pH confirmed by laboratory tests);
• decreased concentration of electrolytes in blood (e.g. potassium, magnesium and phosphorus);
• peripheral oedema (swelling in the ankles and feet);
• deficiency of vitamin B complex;
• low sodium concentration in blood (hyponatraemia), which may lead to brain damage and death due to cerebral oedema (see section "Warnings and precautions").

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 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
tel.: +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 authorisation holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store GLUCOSUM 5% FRESENIUS

Polyethylene container KabiPac with cap:
Do not freeze.
Polypropylene container KabiClear with cap, polypropylene bag type " free flex ", " free flex +",
" free flex ProDapt", or glass bottle:
Store below 25°C. Do not freeze.
Keep this medicine out of the sight and reach of children.
The container must not be stored or reused after opening. Any unused residue
of the medicine is not suitable for further use.
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 the medicine if contamination occurs, if there is a change in colour, 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 in use. Such measures will help protect
the environment.

6. Contents of the pack and other information

What GLUCOSUM 5% FRESENIUS contains
The medicine is a colourless and clear solution.

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

1000 ml of solution contains 50 g of glucose in the form of monohydrate glucose (55 g).

• Other components: water for injections, sodium hydroxide (for pH adjustment), and hydrochloric acid (for pH adjustment).

The osmolarity of the solution is 278 mOsmol/l.

What GLUCOSUM 5% FRESENIUS looks like and contents of the pack
Packaging of the medicine:

• Polyethylene container KabiPac with cap – 100 ml, 250 ml, 500 ml, 1000 ml;
• Polypropylene container KabiClear with cap – 100 ml, 250 ml, 500 ml, 1000 ml;
• Polypropylene bag type "free*flex*" and "free*flex* +" (with needle-free port) – 50 ml, 100 ml, 250 ml, 500 ml, 1000 ml;
• Polypropylene bag type "free*flex* ProDapt" (with needle-free port) – 60 x 50 ml, 50 x 100 ml, 30 x 250 ml, in a cardboard box;
• Glass bottle – 250 ml, 500 ml.

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 Solutions Production Plant
ul. Sienkiewicza 25
99-300 Kutno
Fresenius Kabi Italia S.r.l.
Via Camagre 41
37063 Isola della Scala VR
Italy
Fresenius Kabi France
6, Rue du Rempart
B.P. 611
27400 Louviers Cedex
France
Fresenius Kabi Deutschland GmbH
Werk Friedberg
Freseniusstraße 1
D-61169 Friedberg
Germany

For further information, 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 medical professionals:

Dosage and administration
Dosage must be individually determined by a physician for each patient depending on age, body weight, and clinical condition.
If not otherwise directed by a physician, GLUCOSUM 5% FRESENIUS should be administered according to the following scheme:
Maximum infusion rate (guideline values):
3 ml/kg body weight/hour (210 ml/hour for a patient weighing 70 kg, corresponding to 10.5 g glucose/hour for a 70 kg patient).
Maximum daily dose (guideline values):
30–40 ml/kg body weight, corresponding to 1.5–2.0 g glucose/kg body weight.
The following glucose dosage limitations in adult patients must be strictly observed:
0.5 g/kg body weight/hour and up to 6.0 g/kg body weight/day.
General recommendations regarding carbohydrate and fluid administration must be followed.
GLUCOSUM 5% FRESENIUS may be administered via peripheral veins. A large vein in 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, particularly in patients with non-osmotic stimulation of vasopressin secretion (syndrome of inappropriate antidiuretic hormone secretion – SIADH) and in patients concurrently receiving drugs belonging to the vasopressin agonist group.
Monitoring of serum sodium concentration is particularly important during administration of fluids hypotonic relative to physiological osmotic pressure. GLUCOSUM 5% FRESENIUS may become markedly hypotonic after administration due to glucose metabolism in the body.

Overdose
Hyperglycemia and glycosuria, if not recognized, may lead to disturbances of consciousness, hyperosmolar 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 imbalances caused by glucose solution overdose should be treated with appropriate corrective measures.

Interactions with other medicinal products and other forms of interactions
As with all parenterally administered drugs, compatibility with other medicinal products added to GLUCOSUM 5% FRESENIUS must be verified.
When other medicinal products are added to GLUCOSUM 5% FRESENIUS, the resulting solution should be administered immediately.

Drugs enhancing vasopressor effects
The following drugs enhance vasopressor effects, leading to reduced renal excretion of electrolyte-free water and may increase the risk of hospital-acquired hyponatremia due to inappropriately balanced infusion therapy:

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

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

Preparation of the medicinal product for administration
Use only clear, particle-free solution.
Any unused portion of the medicinal product must not be reused.
Do not use this medicinal product if contamination, discoloration, or package damage occurs.
Follow aseptic principles.

Instructions for use of the polypropylene bag type "freeflex" and "freeflex+":

1. Before use, inspect the bag and solution visually – the solution should be clear and free from particles (do not use damaged and/or previously used bags).
2. Preparing for infusion:
   a) Remove the bag from the outer packaging.
   b) Remove the plastic cover/cap from the larger dark blue port (infusion port) with the arrow pointing outward from the packaging.
   c) Connect the infusion set.
3. Adding medicinal product to the container:
   a) Remove the bag from the outer packaging.
   b) Remove the plastic cover/cap from the smaller port for injection (white for "freeflex" bag, light blue for "freeflex+" bag) with the arrow pointing inward toward the packaging, then add the medicinal product:
   • Into the "freeflex" bag using a syringe with a needle.
   • Into the "freeflex+" bag using a luer lock syringe screwed directly onto the injection port or using a standard syringe with a needle.
   • Using the freeflex+ transfer adapter device designed for direct addition of drug from a vial into the 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 adding a medicinal product must be thoroughly mixed, and it must be ensured that no precipitation has occurred.

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 particles (do not use damaged and/or previously used containers).
2. Preparing for 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 spike of the infusion set vertically into the infusion port, rotating the set slightly with one hand while holding the neck of the container 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 into 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 adding a medicinal product must be thoroughly mixed, and it must be ensured that no precipitation has occurred.

Pharmaceutical incompatibilities
The following substances are incompatible with glucose solution:
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, polypropylene bag type "freeflex", "freeflex+", or "freeflex ProDapt", glass bottle: Store below 25°C. Do not freeze.
Once opened, the container must not be stored and reused. From a microbiological standpoint, the medicinal product should be used immediately. Otherwise, the responsibility for storage conditions and duration of the remaining medicinal product in the container lies with the user.

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