Glucose 20% fresenius

Package leaflet: Information for the user

GLUCOSUM 20% FRESENIUS, 200 mg/ml, solution for infusion
Glucosum
Please read all of this leaflet carefully before using this medicine, because it contains
important information for the patient.

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

Table of contents

1. What GLUCOSUM 20% FRESENIUS is and what it is used for
2. Important information before using GLUCOSUM 20% FRESENIUS
3. How to use GLUCOSUM 20% FRESENIUS
4. Possible side effects
5. How to store GLUCOSUM 20% FRESENIUS
6. Contents of the pack and other information

1. What GLUCOSUM 20% FRESENIUS is and what it is used for

GLUCOSUM 20% 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. This medicine is administered intravenously.
Indications:

• supplementation of energy deficits as a carbohydrate component in parenteral nutrition (when the patient is not receiving food orally);
• treatment of hypoglycaemia (low blood glucose concentration).

2. Important information before using GLUCOSUM 20% FRESENIUS

When not to use GLUCOSUM 20% FRESENIUS
Do not use GLUCOSUM 20% FRESENIUS:

• if the patient has hyperglycaemia (increased blood glucose concentration);
• if the patient has hypokalaemia (decreased potassium concentration in the blood);
• if the patient has acidosis (accumulation of excessive amounts of acidic substances in the blood);
• if the patient is overhydrated (excess fluid in the body);
• if the patient is dehydrated (significant reduction in body water due to fluid loss or in alcohol-related disease);
• if the patient has increased serum osmolality (increased concentration of substances in blood serum confirmed by laboratory test);
• if the patient has anuria (kidneys producing less than 100 ml of urine per day);
• if the patient has intracranial haemorrhage;
• if the patient has intramedullary haemorrhage.

Warnings and precautions

• The medicine should be administered with caution if the patient has diabetes or carbohydrate intolerance (disorders in the absorption of certain sugars).
• The 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 20% FRESENIUS, the doctor will monitor fluid balance (amount of fluids taken in and excreted), blood electrolyte concentrations, and whether acid-base imbalance has occurred.
• Excessively rapid infusion rate or metabolic disorders may cause hyperglycaemia and glycosuria (see section: Possible side effects); the doctor will order regular monitoring of blood and urine glucose levels.
• Glucose solutions should not be administered together with blood through the same infusion set.
• The medicine should be used with caution in newborns whose mothers have diabetes.

Before starting treatment with GLUCOSUM 20% FRESENIUS, inform the doctor 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 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, burns, or a 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 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 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.

GLUCOSUM 20% FRESENIUS and other medicines
Inform the doctor or pharmacist about all medicines currently used or recently taken, as well as any medicines the patient plans to use.
It is particularly important to inform the doctor if the patient is taking certain medicines affecting vasopressin hormone activity, including:

• antidiabetic agents (chlorpropamide);
• cholesterol-lowering agents (clofibrate);
• antiepileptic drugs (carbamazepine);
• amphetamine-like substances (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 the action of vasopressin, such as desmopressin (used to treat excessive thirst and urination), terlipressin (used to treat oesophageal bleeding), and oxytocin (used to induce labour);
• other drugs increasing the risk of hyponatraemia, including all diuretics and anticonvulsants such as oxcarbazepine.

The following medicines should not be added to the 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, 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 is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Glucose solutions may be used in women during pregnancy and breastfeeding, provided dosage recommendations, contraindications, and general precautions for use are observed.
GLUCOSUM 20% 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 labour and reduce bleeding), due to the risk of hyponatraemia.

Driving and operating machinery
Not applicable.

3. How to use GLUCOSUM 20% FRESENIUS

This medicine is administered exclusively by medical personnel. Do not use the medicine yourself.
If in doubt, consult a 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), at the beginning of the infusion and during its administration.
Administration of a higher than recommended dose of GLUCOSUM 20% FRESENIUS
If a higher dose of the medicine is administered, inform the doctor or nurse immediately.
Overdose of the medicine may cause:

• hyperglycemia and glycosuria, which, if unrecognized, may lead to disturbances of consciousness, coma, dehydration, and ultimately death;
• fluid overload;
• disturbances in blood electrolyte concentrations.

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.
The following adverse reactions may occur:

• hyperglycaemia (increased glucose concentration in blood);
• glycosuria (presence of sugar in urine);
• phlebitis or thrombophosis at the site of administration (inflammation and small blood clots characterised by palpable hardening of the vein, redness around it, pain and tenderness);
• fluid balance disorders (excess or deficiency of fluids);
• acid-base balance disturbances (changes in blood pH confirmed by laboratory tests);
• decreased concentration of electrolytes in blood (e.g. potassium, magnesium, phosphorus);
• peripheral oedema (swelling around ankles and feet);
• deficiency of vitamin B complex;
• low sodium concentration in blood (hyponatraemia) which may lead to brain damage and death caused by 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 of Adverse Drug Reactions, 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 provide more information on the safety of the medicine.

5. How to store GLUCOSUM 20% FRESENIUS

Keep the medicine out of the sight and reach of children.
Store below 25°C. Do not freeze.
The container must not be stored or reused after opening. Unused portions of the medicine are not suitable for further use.
Do not use this medicine after the expiry date stated on the container. The expiry date refers to the last day of the stated month.
Do not use this medicine if contamination occurs, if there is a change in colour, or if the container is damaged.
Medicines must not be disposed of via the sewage system or household waste. Ask a 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 20% FRESENIUS contains

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

1000 ml of solution contains 200 g of glucose in the form of monohydrate glucose (220 g).

• Other components: water for injections.

The osmolarity of the solution is 1114 mOsmol/l.
What GLUCOSUM 20% FRESENIUS looks like and contents of the pack
The medicine is a colourless and clear solution.
Packaging of the medicine: polyethylene container KabiPac with closure – 1 x 100 ml, 40 x 100 ml, 1 x 250 ml, 20 x 250 ml, 1 x 500 ml, 20 x 500 ml, 1 x 1000 ml, 10 x 1000 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 Fluids Manufacturing Plant
ul. Sienkiewicza 25
99-300 Kutno
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 healthcare professionals:

Dosage and method of administration
The physician must determine the dosage individually for each patient according to age, body weight, and clinical condition.
Unless otherwise directed by a physician, GLUCOSUM 20% FRESENIUS should be administered according to the following regimen:

Maximum infusion rate (guideline values):
1.25 ml/kg body weight/h (87.5 ml/h for a patient weighing 70 kg, corresponding to 17.5 g glucose/h for a 70 kg patient).

Maximum daily dose (guideline values):
The daily dose usually should not exceed 21 ml/kg body weight, corresponding to 4.2 g glucose/kg body weight.

The following glucose dosage limits must be strictly observed in adult patients:
0.5 g/kg body weight/h and up to 6.0 g/kg body weight/day.

General recommendations regarding the use and dosing of carbohydrates and fluids must be observed.

GLUCOSUM 20% FRESENIUS should be administered via a central vein. In emergency treatment of hypoglycemia, slow peripheral intravenous infusion may be used.

Children
The maximum daily dose must be adjusted according to the maximum daily fluid requirements.
When used in newborns, the high osmolarity of the solution should be taken into account.

Maximum daily doses:
Preterm infants up to 18 g glucose/kg body weight, corresponding to up to 90 ml/kg body weight.
Newborns up to 15 g glucose/kg body weight, corresponding to up to 75 ml/kg body weight.
1 – 2 years up to 15 g glucose/kg body weight, corresponding to up to 75 ml/kg body weight.
3 – 5 years up to 12 g glucose/kg body weight, corresponding to up to 60 ml/kg body weight.
6 – 10 years up to 10 g glucose/kg body weight, corresponding to up to 50 ml/kg body weight.
10 – 14 years up to 8 g glucose/kg body weight, corresponding to up to 40 ml/kg body weight.

When determining dosage, care must be taken that the total volume of parenterally administered fluid does not exceed the following values:
Day 1 of life: 50 – 70 ml/kg body weight/day
Day 2 of life: 70 – 90 ml/kg body weight/day
Day 3 of life: 80 – 100 ml/kg body weight/day
Day 4 of life: 100 – 120 ml/kg body weight/day
From day 5 of life: 100 – 130 ml/kg body weight/day
1 year of life: 100 – 140 ml/kg body weight/day
2 years: 80 – 120 ml/kg body weight/day
3 – 5 years: 80 – 100 ml/kg body weight/day
6 – 10 years: 60 – 80 ml/kg body weight/day
11 – 14 years: 50 – 70 ml/kg body weight/day

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, especially in patients with non-osmotic stimulation of vasopressin secretion (syndrome of inappropriate antidiuretic hormone secretion - SIADH) and in patients receiving vasopressin agonists concurrently.

Monitoring of serum sodium concentration is particularly important during administration of fluids hypotonic relative to physiological osmotic pressure. The medicinal product GLUCOSUM 20% 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 hyperglycemic 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 managed with appropriate corrective measures.

Interactions with other medicinal products and other types of interactions
As with all parenterally administered medicinal products, compatibility with other drugs added to the GLUCOSUM 20% FRESENIUS solution must be verified.

When other drugs are added to GLUCOSUM 20% 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 during inadequately 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 the effect of vasopressin, 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.
Unused medicinal product residue is not suitable for further use.
Do not use this medicinal product if cloudiness, discoloration, or contamination occurs, or if the container is damaged.
Follow aseptic procedures.

Instructions for use of KabiPac container type:

1. Before use, inspect the container and solution – the solution should be clear and free from particles (do not use damaged or previously used containers).
2. Preparing the infusion:
   a) Place the KabiPac 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, slightly rotating the set with one hand while holding the neck of the container with the other.
3. Adding medication to the container:
   a) Place the KabiPac 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 container.

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

Pharmaceutical incompatibilities
The following have been shown to be incompatible with glucose solution:
aminophylline, soluble barbiturates, erythromycin, hydrocortisone, warfarin, kanamycin, soluble sulfonamides, vitamin B.

Storage conditions
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 storage conditions and duration of the remaining product in the container.

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