Glucose with sodium chloride FKI

Italy
Brand name Glucose with sodium chloride FKI
Form solution for infusion
Active substance / Dosage
ANHYDROUS GLUCOSE (DEXTROSE)
SODIUM CHLORIDE
Prescription type Prescription only
ATC code
B05BB02
Registration number 031386
Manufacturer FRESENIUS KABI ITALIA S.R.L.

Table of Contents

Package leaflet: Information for the user

GLUCOSIO CON SODIO CLORURO FRESENIUS KABI ITALIA 4.27%/0.18%

infusion solution I
GLUCOSIO CON SODIO CLORURO FRESENIUS KABI ITALIA 5%/0.9%
infusion solution II
Generic Medicine
Read 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 questions, ask your doctor, pharmacist, or nurse.
  • If you experience any side effects, including those not listed in this leaflet, tell your doctor or nurse. See section 4.

Contents of this leaflet:

  1. What GLUCOSIO CON SODIO CLORURO FRESENIUS KABI ITALIA is and what it is used for
  2. What you need to know before using GLUCOSIO CON SODIO CLORURO FRESENIUS KABI ITALIA
  3. How to use GLUCOSIO CON SODIO CLORURO FRESENIUS KABI ITALIA
  4. Possible side effects
  5. How to store GLUCOSIO CON SODIO CLORURO FRESENIUS KABI ITALIA
  6. Contents of the pack and other information

1. What GLUCOSE WITH SODIUM CHLORIDE FRESENIUS KABI ITALIA is and what it is used for

GLUCOSE WITH SODIUM CHLORIDE FRESENIUS KABI ITALIA contains the active substances glucose monohydrate and sodium chloride. Administration of glucose increases blood sugar levels (glycaemia), provides calories and water to the body. Glucose may reduce nitrogen losses, promote the storage of energy reserves in the body (glycogen), and, when administered in sufficient amounts, reduce or prevent a metabolic disorder (ketosis).
Sodium is important for maintaining proper fluid balance (fluid osmolarity, acid-base balance), for cell function (transmembrane potential), and for the proper functioning of the heart and kidneys. Chloride is found mainly in red blood cells and in the tissue lining the stomach (gastric mucosa) and is absorbed together with sodium.
This medicinal product is indicated:

  • to restore hydration and support an adequate intake of minerals (sodium and chloride) and calories;
  • to restore blood sugar levels when they are low (hypoglycaemia).

2. What you should know before using GLUCOSIO CON SODIO CLORURO FRESENIUS KABI

ITALY
Do not use GLUCOSIO CON SODIO CLORURO FRESENIUS KABI ITALIA

  • if you are allergic to glucose or sodium chloride or to any of the other ingredients of this medicine (listed in section 6);
  • if you have problems with urination (anuria);
  • if you have bleeding (haemorrhage) occurring in the spinal cord or within the skull (intracranial);
  • if you are experiencing hallucinations, tremors, and sweating (delirium tremens) and already have excessive loss of water from the body (dehydration);
  • if you have very low levels of fluids in the body (severe dehydration);
  • if you suffer from liver problems leading to loss of consciousness (hepatic coma);
  • if you have high levels of sodium in the blood (hypernatraemia, only for solution II); 1 of 16
  • if you have excessive amounts of salts and fluids in the blood (hypersaline hypervolaemia, only for solution II).

During blood transfusions, glucose solutions must not be administered through the same infusion catheter as whole blood due to the possible risk of red blood cell clumping (pseudoagglutination) or red blood cell breakdown (haemolysis).
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using GLUCOSIO CON SODIO CLORURO FRESENIUS KABI ITALIA.
Use this medicine with caution and inform your doctor in the following cases:

  • if you have diabetes or are glucose intolerant. Blood sugar levels (glycaemia) and sugar in the urine (glycosuria) should be closely monitored during infusion to minimize the risk of elevated levels; insulin should be administered if necessary;
  • if you have high blood pressure (hypertension);
  • if you suffer from serious heart problems (heart failure);
  • if you suffer from kidney problems (reduced renal function);
  • if you are pregnant and suffer from a condition called pre-eclampsia, characterized by high blood pressure, swelling due to fluid accumulation, and presence of protein in the urine;
  • if you have peripheral or pulmonary oedema;
  • if you have fluid accumulation and retention of mineral salts;
  • if you are taking corticosteroid anti-inflammatory medicines;
  • if you are taking certain hormonal medicines (corticotropin);
  • if you suffer from other disorders associated with high levels of sodium (sodium retention).

During prolonged treatment with this medicine, excess water in the body (fluid overload and congestive state) and excessive loss of mineral salts (electrolyte deficit) may occur; your doctor should periodically monitor the concentration of mineral salts (electrolytes, plasma osmolarity, acid-base balance), correcting any excessive losses as needed by administering mineral salts and vitamins.
Continuous administration without potassium supplementation may lead to reduced potassium levels (hypokalaemia).
Due to the presence of sodium, use the medicine with caution if you suffer from heart problems (congestive heart failure), severe kidney problems (severe renal failure), or other disorders associated with fluid accumulation and swelling (oedema with salt retention).
The solution must be clear, colourless, and free from visible particles. Use immediately after opening the container. The container is intended for single, uninterrupted administration and any remaining medicine must not be used.
GLUCOSIO CON SODIO CLORURO FRESENIUS KABI ITALIA 4.27%/0.18%, infusion solution I
2 of 16
Children
In children, especially in neonates and low-birth-weight infants, administration of glucose may increase the risk of elevated blood sugar levels (hyperglycaemia). Furthermore, in low-birth-weight children, rapid or excessive infusion may cause increased blood osmolarity and bleeding within brain tissue (intracerebral haemorrhage).
Other medicines and GLUCOSIO CON SODIO CLORURO FRESENIUS KABI ITALIA
Inform your doctor if you are taking, have recently taken, or might take any other medicines.
Pay particular attention and consult your doctor if you are taking:

  • corticosteroid anti-inflammatory medicines (corticosteroids) or a hormonal medicine (corticotropin), as these may increase your blood sugar levels, potentially unmasking latent diabetes mellitus and reducing glucose tolerance;
  • corticosteroids may cause water and sodium retention, leading to swelling (oedema) and increased blood pressure (hypertension); therefore, caution is required.

GLUCOSIO CON SODIO CLORURO FRESENIUS KABI ITALIA 4.27%/0.18%, infusion solution I
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor before using this medicine.
There are no data available on possible adverse effects of the medicine when administered during pregnancy or breastfeeding or on fertility.
Do not use this medicine during pregnancy or breastfeeding unless absolutely necessary and only after your doctor has evaluated the risks and benefits of treatment.
GLUCOSIO CON SODIO CLORURO FRESENIUS KABI ITALIA 4.27%/0.18%, infusion solution I
(a hormone given to induce labour and control bleeding)
Driving and use of machinery
This medicine does not impair the ability to drive vehicles or operate machinery.
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3. How to use GLUCOSE WITH SODIUM CHLORIDE FRESENIUS KABI ITALIA

This medicine will be administered to you by a doctor or other specialized medical personnel. If you have any doubts, consult your doctor, pharmacist, or nurse.
This medicine will be administered carefully directly into a vein (intravenous infusion) and at a controlled infusion rate.
The doctor will select the glucose solution concentration based on your age, weight, health condition, and mineral salt levels (sodium deficiency).

Use in the elderly
.

Use in Children
The safety and efficacy of this medicine in children are unknown.
The dosage and rate of glucose administration must be determined according to the patient's age, weight, and health condition. Particular caution is required in children, especially in neonates or children with low body weight.

If you use more GLUCOSE WITH SODIUM CHLORIDE FRESENIUS KABI ITALIA than you should
Since this medicine will be administered by a doctor or specialized personnel, it is unlikely that you will receive an excessive dose. However, if you think that you have been given too much GLUCOSE WITH SODIUM CHLORIDE FRESENIUS KABI ITALIA, inform your doctor or another healthcare professional immediately.

Symptoms
Prolonged administration of GLUCOSE WITH SODIUM CHLORIDE FRESENIUS KABI ITALIA may lead to an increase in water and solute concentration in the body (hyperhydration and solute overload). In such cases, the doctor or nurse must immediately stop administration of the medicine and initiate corrective therapy.
High-volume administration of Solution I may alter mineral salt levels in the blood (plasma hypoosmolality).
Excessive administration of sodium chloride may lead to increased sodium levels in the blood (hypernatremia) and/or to an increase in blood volume (hypervolemia).
Chloride accumulation causes increased blood acidity (acidosis).

If you forget to use GLUCOSE WITH SODIUM CHLORIDE FRESENIUS KABI ITALIA
Since this medicine will be administered under close medical supervision, it is unlikely that a dose will be missed. However, inform your doctor if you think a dose has been missed.
If you have any doubts about the use of this medicine, consult your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
4 of 16
The following side effects may occur. Some of these side effects have been observed in cases of inappropriate administration, e.g. too rapid administration
(See section “Warnings and precautions”).
Below are listed the side effects of GLUCOSIO CON SODIO CLORURO FRESENIUS KABI ITALIA. There are insufficient data available to determine the frequency of the individual side effects listed.
Frequency not known (frequency cannot be estimated from the available data):
Glucose with Sodium Chloride Fresenius Kabi Italia 4.27%/0.18%, infusion solution I

  • allergic-type reactions (hypersensitivity, urticaria);
  • decreased levels of potassium, magnesium and phosphate in the blood;
  • excessive levels of water in the body (hyperhydration);
  • increased or decreased levels of sodium in the blood (hypernatraemia/hyponatraemia);
  • increased levels of chloride (hyperchloraemia), which may cause increased blood acidity (acidosis);
  • decreased levels of chloride and sodium in the blood;
  • increased or decreased blood osmotic pressure (hyperosmolarity, hypoosmolarity);
  • increased circulating plasma volume in the body (hypervolaemia);
  • increased metabolic rate;
  • increased blood sugar (hyperglycaemia);
  • decreased blood sugar (hypoglycaemia);
  • increased insulin levels;
  • increased adrenaline levels;
  • increased heart rate (tachycardia);
  • decreased or increased blood pressure (hypotension, hypertension);
  • fluid accumulation causing swelling in the legs and ankles (peripheral oedema);
  • fluid accumulation in the lungs (pulmonary oedema);
  • difficulty breathing (dyspnoea), severe breathing problems (respiratory arrest);
  • bleeding in the brain (cerebral haemorrhage);
  • poor blood circulation to the brain (cerebral ischaemia);
  • headache (cephalalgia), dizziness;
  • restlessness, irritability;
  • muscle stiffness, weakness, convulsions;
  • coma;
  • death;
  • drowsiness and confusion;
  • thirst, reduced salivation;
  • nausea, vomiting, diarrhoea, abdominal pain;
  • reduced tear production;
  • kidney problems (renal failure);
  • increased body temperature (fever);
  • leakage of the medicine into surrounding tissues at the injection site (extravasation);
  • infection at the infusion site and local pain;
  • circulation problems due to blood clot formation and inflammation of the veins at the infusion site (thrombosis and thrombophlebitis);
  • hospital-acquired hyponatraemia**;
  • hyponatraemic encephalopathy**.

**Hospital-acquired hyponatraemia may cause irreversible brain damage and death due to the development of acute hyponatraemic encephalopathy.
Glucose with Sodium Chloride Fresenius Kabi Italia 5%/0.9%, infusion solution II

  • allergic-type reactions (hypersensitivity), skin irritation (urticaria); 5 of 16
  • decreased levels of potassium, magnesium and phosphate in the blood;
  • excessive levels of water in the body (hyperhydration);
  • increased levels of sodium (hypernatraemia);
  • increased levels of chloride (hyperchloraemia), which may cause increased blood acidity (acidosis);
  • increased or decreased blood osmotic pressure (hyperosmolarity, hypoosmolarity);
  • increased circulating plasma volume in the body (hypervolaemia);
  • increased metabolic rate;
  • increased blood sugar (hyperglycaemia);
  • decreased blood sugar (hypoglycaemia);
  • increased insulin levels;
  • increased adrenaline levels;
  • increased heart rate (tachycardia);
  • decreased or increased blood pressure (hypotension, hypertension);
  • fluid accumulation causing swelling in the legs and ankles (peripheral oedema);
  • fluid accumulation in the lungs (pulmonary oedema);
  • difficulty breathing (dyspnoea), severe breathing problems (respiratory arrest);
  • bleeding in the brain (cerebral haemorrhage);
  • poor blood circulation to the brain (cerebral ischaemia);
  • headache (cephalalgia), dizziness;
  • restlessness, irritability;
  • muscle stiffness, weakness, convulsions;
  • coma;
  • death;
  • drowsiness and confusion;
  • thirst, reduced salivation;
  • nausea, vomiting, diarrhoea, abdominal pain;
  • reduced tear production;
  • kidney problems (renal failure);
  • increased body temperature (fever);
  • leakage of the medicine into surrounding tissues at the injection site (extravasation);
  • infection at the infusion site and local pain;
  • circulation problems due to blood clot formation and inflammation of the veins at the infusion site (thrombosis and thrombophlebitis).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the website
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store GLUCOSE WITH SODIUM CHLORIDE FRESENIUS KABI ITALIA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label. The expiry date refers to the last day
of that month.
The expiry date applies to the product in its original packaging, stored correctly.
Store in the original packaging and in a tightly closed container.
6 of 16
Warning: do not use the medicine after the expiry date shown on the packaging.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What GLUCOSIO CON SODIO CLORURO FRESENIUS KABI ITALIA contains
GLUCOSIO CON SODIO CLORURO FRESENIUS KABI ITALIA 4.27%/0.18% solution for infusion I

  • The active substances are glucose monohydrate and sodium chloride. Each liter of solution contains 47 g of glucose monohydrate (42.7 g of anhydrous glucose) and 1.8 g of sodium chloride. Each liter of solution contains 31 mEq of sodium, 31 mEq of chloride, and 237 mmol of glucose. pH 3.5 - 6.5.
  • The other components are water for injections, hydrochloric acid, and sodium hydroxide (used as pH regulators).

GLUCOSIO CON SODIO CLORURO FRESENIUS KABI ITALIA 5%/0.9% solution for infusion II

  • The active substances are glucose monohydrate and sodium chloride. Each liter of solution contains 55 g of glucose monohydrate (50 g of anhydrous glucose) and 9 g of sodium chloride. Each liter of solution contains 154 mEq of sodium, 154 mEq of chloride, and 277 mmol of glucose. pH 3.5 - 6.5.
  • The other components are water for injections, hydrochloric acid, and sodium hydroxide (used as pH regulators).

Description of the appearance of GLUCOSIO CON SODIO CLORURO FRESENIUS KABI ITALIA and contents of the pack
Solution for infusion, sterile and pyrogen-free.
GLUCOSIO CON SODIO CLORURO FRESENIUS KABI ITALIA 4.27%/0.18% solution for infusion I
Vial of 50 ml, 100 ml, 250 ml, 500 ml, and 1000 ml.
Flexible bag of 100 ml, 250 ml, 500 ml, and 1000 ml.
Plastic vial of 250 ml and 500 ml.
GLUCOSIO CON SODIO CLORURO FRESENIUS KABI ITALIA 5%/0.9% solution for infusion II
Vial of 50 ml, 100 ml, 250 ml, 24x250 ml, 500 ml, 20x500 ml, and 1000 ml.
Plastic vial of 250 ml and 500 ml.
Flexible bag of 100 ml, 250 ml, 500 ml, and 1000 ml.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Fresenius Kabi Italia S.r.l. - Via Camagre, 41 - 37063 Isola della Scala (VR)
Manufacturers:
Fresenius Kabi Italia S.r.l. - Via Camagre, 41 - 37063 Isola della Scala (VR)
Fresenius Kabi France – 6, rue du Rempart BP 611 – 27400 Louviers Cedex (France)
S.M. Farmaceutici S.r.l. – Zona Industriale – 85050 Tito (PZ)
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The following information is intended exclusively for physicians or healthcare professionals

Glucose with Sodium Chloride Fresenius Kabi Italia 4.27%/0.18%, infusion solution I
Dosage and method of administration
The 4.27% glucose solution (solution I) is isotonic with blood. The 5% glucose solution (solution II) is hypertonic with blood.
The medicinal product must be administered at a rate not exceeding 0.4–0.8 g of glucose/hour per kg of body weight.

Glucose with Sodium Chloride Fresenius Kabi Italia 4.27%/0.18% infusion solution I
Glucose with Sodium Chloride Fresenius Kabi Italia 4.27%/0.18%, infusion solution I

Incompatibilities with GLUCOSE WITH SODIUM CHLORIDE FRESENIUS KABI ITALIA
Due to the presence of glucose, this medicinal product is incompatible with:

  • cyanocobalamin;
  • kanamycin sulfate;
  • sodium novobiocin;
  • sodium warfarin.

Moreover, there are conflicting opinions regarding the compatibility of glucose with hydroxyethyl starch (hetastarch).
Glucose solutions without added electrolytes should not be administered through the same infusion catheter as whole blood due to the possible formation of clumps and the risk of hemolysis.
Ampicillin and amoxicillin remain stable in glucose solutions only for a short period.
Unless otherwise indicated, it is advised not to mix this medicinal product with other medicinal products.
After the first opening of the packaging, the medicinal product must be used immediately for a single, uninterrupted administration, and any unused portion must not be retained.
Do not use the medicinal product if the solution is not clear and colorless, or if it contains particles.
All standard precautions should be observed to maintain sterility before and during intravenous infusion.

Overdose
Treatment
Immediately discontinue the infusion and initiate corrective therapy to reduce plasma levels of glucose and excess ions, and restore acid-base balance if necessary (see Precautions for use).
The patient should be closely monitored for the appearance of any signs and symptoms related to the administered drug, ensuring appropriate symptomatic and supportive measures as needed.
In cases of severe hypernatremia, loop diuretics may be used.
A serum sodium concentration exceeding 200 mmol/L may require dialysis.

For further information, consult the Summary of Product Characteristics.
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Package leaflet: information for the user

GLUCOSE WITH SODIUM CHLORIDE FRESENIUS KABI ITALIA 2.5%/0.45%

INFUSION SOLUTION III
Generic Medicine
Please read this leaflet carefully before using this medicine as it contains important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any questions, consult your doctor, pharmacist, or nurse.
  • If you experience any side effects, including those not listed in this leaflet, please contact your doctor or nurse. See section 4.

Contents of this leaflet:

  1. What GLUCOSE WITH SODIUM CHLORIDE FRESENIUS KABI ITALIA is and what it is used for
  2. What you need to know before using GLUCOSE WITH SODIUM CHLORIDE FRESENIUS KABI ITALIA
  3. How to use GLUCOSE WITH SODIUM CHLORIDE FRESENIUS KABI ITALIA
  4. Possible side effects
  5. How to store GLUCOSE WITH SODIUM CHLORIDE FRESENIUS KABI ITALIA
  6. Contents of the pack and other information

2. What GLUCOSIO CON SODIO CLORURO FRESENIUS KABI ITALIA is and what it is used for

GLUCOSIO CON SODIO CLORURO FRESENIUS KABI ITALIA contains the active substances glucose monohydrate and sodium chloride. Administration of glucose increases blood sugar levels (glycaemia), provides calories and water to the body.
Sodium is important for maintaining acid-base balance and proper fluid balance (fluid osmolarity), for cellular function (transmembrane potential), and for the proper functioning of the heart, brain, and kidneys. Chloride is mainly present in red blood cells and in the tissue lining the stomach (gastric mucosa) and is absorbed together with sodium.
This medicinal product is indicated for restoring hydration and correcting serum sodium levels (blood sodium concentration), in association with a minimal caloric intake (through glucose monohydrate).

2. What you should know before using GLUCOSE WITH SODIUM CHLORIDE FRESENIUS KABI

ITALY
Do not use GLUCOSE WITH SODIUM CHLORIDE FRESENIUS KABI ITALY

  • if you are allergic to glucose or sodium chloride or to any of the other ingredients of this medicine (listed in section 6);
  • if you have problems urinating (anuria);
  • if you have bleeding within the skull or spinal cord (intracranial or spinal hemorrhage);
  • if you experience hallucinations, tremors, and sweating (delirium tremens) and are already dehydrated (loss of body water);
  • if you have severely low fluid levels in the body (severe dehydration);
  • if you suffer from liver problems leading to loss of consciousness (hepatic coma);
  • if you have excessive amounts of salts and fluids in the blood (hypervolemia). During blood transfusions, glucose solutions must not be administered through the same infusion catheter as whole blood due to the potential risk of red blood cell clumping (pseudoagglutination) or red blood cell breakdown (hemolysis). 10 of 16

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using GLUCOSE WITH SODIUM CHLORIDE FRESENIUS KABI ITALY.
Use this medicine with caution and inform your doctor in the following cases:

  • if you have diabetes mellitus or are glucose intolerant. Blood sugar levels (glycemia) and sugar in the urine (glycosuria) should be closely monitored during infusion to minimize the risk of high levels; insulin should be administered if necessary;
  • if you have high blood pressure (hypertension);
  • if you suffer from severe heart problems (heart failure);
  • if you suffer from kidney problems (reduced renal function);
  • if you are pregnant and have a condition called pre-eclampsia, characterized by high blood pressure, swelling due to fluid accumulation, and presence of protein in the urine;
  • if you have peripheral or pulmonary edema;
  • if you have fluid accumulation and salt retention;
  • if you are taking corticosteroid anti-inflammatory medicines;
  • if you are taking certain hormonal medicines (corticotropin);
  • if you suffer from other conditions associated with high sodium levels (sodium retention).

During prolonged treatment with this medicine, excessive accumulation of water in the body (fluid overload and congestive state) and excessive loss of minerals (electrolyte deficit) may occur. Your doctor should periodically check the concentration of minerals in the blood (electrolytes and plasma osmolarity), acid-base balance, and body fluid levels, correcting any excessive losses as needed by administering minerals and vitamins.
Continuous administration without potassium supplementation may lead to decreased potassium levels (hypokalemia).
Due to the presence of sodium, use with caution if you have heart problems (congestive heart failure), severe kidney problems (severe renal failure), or other conditions associated with fluid accumulation and swelling (edema with salt retention).
The solution must be clear, colorless, and free from visible particles. Use immediately after opening the container. The container is intended for single, uninterrupted administration and any remaining medicine must not be reused.
11 of 16

Children
In children, especially in newborns and children with low body weight, administration of glucose may increase the risk of elevated blood sugar levels (hyperglycemia). Furthermore, in low-weight children, rapid or excessive infusion may increase blood osmolarity and cause bleeding within brain tissue (intracerebral hemorrhage).

Other medicines and GLUCOSE WITH SODIUM CHLORIDE FRESENIUS KABI ITALY
Inform your doctor if you are taking, have recently taken, or might take any other medicines, especially if you are taking:
Exercise particular caution and consult your doctor if you are using:

  • corticosteroid anti-inflammatory medicines (corticosteroids) or a hormonal medicine (corticotropin), as they may increase your blood sugar levels, potentially revealing latent diabetes mellitus or reducing carbohydrate tolerance; if glucose is administered simultaneously, your doctor must monitor you closely;
  • corticosteroid medicines, because when administered together with sodium salts they may cause accumulation of water and sodium, resulting in swelling (edema) and increased blood pressure (hypertension).

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor before using this medicine.
There are no data available on potential adverse effects of the medicine when administered during pregnancy or breastfeeding or on fertility.
Do not use this medicine during pregnancy or breastfeeding unless absolutely necessary and only after your doctor has evaluated the risks and benefits of treatment.
(a hormone given to induce labor and control bleeding)

Driving and using machines
This medicine does not affect the ability to drive or operate machinery.

3. How to use GLUCOSE WITH SODIUM CHLORIDE FRESENIUS KABI ITALIA

This medicine will be administered to you by a doctor or other specialized medical personnel. If you have any doubts, consult your doctor, pharmacist, or nurse.
This medicine will be administered with caution directly into a vein (intravenous infusion) and at a controlled infusion rate.
The doctor will choose the glucose solution concentration based on your age, weight, health condition, and electrolyte levels, particularly sodium levels (electrolyte profile, theoretical osmolarity, and sodium deficit).
12 of 16

Use in the elderly
Use in children
The safety and efficacy of this medicine in children have not been established.
The dosage and rate of glucose administration must be selected according to the patient's age, weight, and health condition. Particular caution is required, especially in neonatal patients or children with low body weight, as increased blood glucose levels (hyperglycemia) may occur.

If you use more GLUCOSE WITH SODIUM CHLORIDE FRESENIUS KABI ITALIA than you should
Prolonged administration of GLUCOSE WITH SODIUM CHLORIDE FRESENIUS KABI ITALIA may lead to an increase in water and solute concentration in the body (overhydration and solute overload). In such cases, the doctor or nurse must immediately discontinue administration of the medicine and initiate corrective therapy to normalize blood electrolyte and glucose levels and restore acid-base balance.
An accumulation of chloride ions causes increased blood acidity (acidosis) due to a decrease in bicarbonate ion concentration.

If you forget to use GLUCOSE WITH SODIUM CHLORIDE FRESENIUS KABI ITALIA
Since this medicine will be administered under strict medical supervision, it is unlikely that a dose will be missed. However, inform your doctor if you think a dose has been missed.
If you have any doubts about the use of this medicine, consult your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
GLUCOSE WITH SODIUM CHLORIDE FRESENIUS KABI ITALIA (see section “Warnings and precautions”).
+
Frequency not known (frequency cannot be estimated from the available data):

  • allergic reactions (hypersensitivity), skin irritation (urticaria);
  • decreased levels of potassium (hypokalaemia), magnesium (hypomagnesaemia), and phosphate (hypophosphataemia) in the blood;
  • excessive water accumulation in the body (overhydration);
  • increased or decreased levels of sodium in the blood (hypernatraemia / hyponatraemia);
  • increased or decreased osmotic pressure of the blood (hyperosmolarity, hypoosmolarity);
  • increased plasma volume (hypervolaemia);
  • hyperchloraemia (which may cause increased blood acidity);
  • increased metabolic rate;
  • increased blood sugar (hyperglycaemia);
  • decreased blood sugar (hypoglycaemia);
  • increased insulin levels;
  • increased adrenaline levels;
  • increased heart rate (tachycardia);
  • decreased or increased blood pressure (hypotension, hypertension);
  • fluid accumulation causing swelling in legs and ankles (peripheral oedema);
  • fluid accumulation in the lungs (pulmonary oedema);
  • breathing difficulties (dyspnoea, respiratory arrest);
  • bleeding into the brain due to rupture of blood vessels (cerebral haemorrhage);
  • reduced blood flow to the brain (cerebral ischaemia);
  • headache (cephalalgia), dizziness;
  • restlessness, irritability;
  • muscle stiffness, weakness, seizures;
  • coma;
  • death;
  • drowsiness and confusion;
  • thirst, reduced salivation;
  • nausea, vomiting, diarrhoea, abdominal pain;
  • reduced tear production;
  • kidney problems (renal failure);
  • increased body temperature (fever);
  • leakage of medicine into surrounding tissues at the injection site (extravasation);
  • infection at the infusion site and local pain;
  • circulatory problems due to blood clot formation and inflammation of veins at the infusion site (thrombosis and thrombophlebitis);
  • hospital-acquired hyponatraemia**;
  • hyponatraemic encephalopathy**.

**Hospital-acquired hyponatraemia may cause irreversible brain damage and death due to the development of acute hyponatraemic encephalopathy.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. You may also report side effects directly via the national reporting system at the following website:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store GLUCOSE WITH SODIUM CHLORIDE FRESENIUS KABI ITALIA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "EXP.".
The expiry date refers to the product kept in its original, undamaged packaging and stored correctly.
Store in the original packaging and in a tightly closed container. Do not refrigerate or freeze.
Warning: do not use the medicine after the expiry date indicated on the packaging.
Do not use the medicine if the solution is not clear and colourless or if it contains particles. Use
immediately after opening the container. Intended for single and uninterrupted administration; any
remaining solution must not be used.
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Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What GLUCOSIO CON SODIO CLORURO FRESENIUS KABI ITALIA contains

  • The active substances are glucose monohydrate and sodium chloride. Each liter of solution contains 27.5 g of glucose monohydrate (25 g of anhydrous glucose) and 4.5 g of sodium chloride. Each liter of solution contains 77 mEq of sodium, 77 mEq of chloride, and 139 mmol of glucose. pH 3.5 – 6.5.
  • The other components are water for injections, hydrochloric acid, and sodium hydroxide (used as pH regulators).

Description of the appearance of GLUCOSIO CON SODIO CLORURO FRESENIUS KABI ITALIA and
contents of the pack
Sterile, pyrogen-free infusion solution.
50 ml, 100 ml, 250 ml, 500 ml, and 1000 ml vials.
Flexible bags of 100 ml, 250 ml, 500 ml, and 1000 ml.
Plastic vials of 250 ml and 500 ml.
Freeflex bags of 50 ml and 100 ml with overpouch.
Freeflex bags of 250 ml, 500 ml, 1000 ml, and 10x1000 ml.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Fresenius Kabi Italia S.r.l. - Via Camagre, 41 - 37063 Isola della Scala (VR)
Manufacturer
Fresenius Kabi Italia S.r.l. - Via Camagre, 41 - 37063 Isola della Scala (VR)
Fresenius Kabi Deutschland GmbH – Freseniusstrasse 1 – 61169 Friedberg (Germany)
Fresenius Kabi France – 6, rue du Rempart BP 611 – 27400 Louviers Cedex (France)
S.M. Farmaceutici S.r.l. – Zona Industriale – 85050 Tito (PZ)

The following information is intended exclusively for physicians or healthcare professionals

Posology and method of administration
The solution is isotonic with blood and must be administered with caution by intravenous infusion at a controlled infusion rate. The medicinal product should be administered at a rate not exceeding 0.4–0.8 g of glucose per hour per kg of body weight.

Incompatibilities with GLUCOSE WITH SODIUM CHLORIDE FRESENIUS KABI ITALIA
Due to the presence of glucose, the medicinal product is incompatible with:

  • cyanocobalamin;
  • kanamycin sulfate;
  • sodium novobiocin;
  • sodium warfarin.

Furthermore, there are conflicting opinions regarding the compatibility of glucose with hydroxyethyl starch (hetastarch).
Glucose solutions without added electrolytes should not be administered through the same infusion catheter as whole blood due to the possible formation of clumps and the risk of hemolysis.
Ampicillin and amoxicillin remain stable in glucose solutions only for a short period.
Unless otherwise indicated, it is advisable not to mix this medicinal product with other medicinal products.
After the first opening of the container, the medicinal product must be used immediately for a single, uninterrupted administration; any remaining solution must not be reused.
Do not use the medicinal product if the solution is not clear, colorless, or contains particulate matter.
All usual precautions should be taken to maintain sterility before and during intravenous infusion.

Overdose
Treatment
Immediately discontinue the infusion and initiate corrective therapy to reduce plasma levels of glucose and excess ions, and restore acid-base balance if necessary (see Precautions for use).
The patient should be closely monitored for the appearance of any signs and symptoms related to the administered drug, providing appropriate symptomatic and supportive measures as needed.
In case of severe hypernatremia, loop diuretics may be used.
A serum sodium level exceeding 200 mmol/L may require dialysis.

For further information, please refer to the Summary of Product Characteristics.