GLUCOSIO 4.27% + 0.18% Infusion solution

Зміст інструкції

1. GLUCOSIO CON SODIO CLORURO FRESENIUS KABI ITALIA 4.27%/0.18%
2. GLUCOSIO CON SODIO CLORURO FRESENIUS KABI ITALIA 5%/0.9%
   1. What is GLUCOSIO CON SODIO CLORURO FRESENIUS KABI ITALIA and what it is used for
   2. What you need to know before using GLUCOSIO CON SODIO CLORURO FRESENIUS KABI
   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. Package contents and other information
3. GLUCOSIO CON SODIO CLORURO FRESENIUS KABI ITALIA 2.5%/0.45%
   1. What is GLUCOSIO CON SODIO CLORURO FRESENIUS KABI ITALIA and what is it used for
   2. What you need to know before using GLUCOSIO CON SODIO CLORURO FRESENIUS KABI
   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. Package contents and other information

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
Equivalent Medicinal Product
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, ask your doctor, pharmacist or nurse.
• If any side effects occur, 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 you use 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 is GLUCOSIO CON SODIO CLORURO FRESENIUS KABI ITALIA and what it is used for

GLUCOSIO CON SODIO CLORURO FRESENIUS KABI ITALIA contains the active ingredients glucose
monohydrate and sodium chloride. The administration of glucose increases blood sugar levels
(glycemia), provides calories and water to the body. Glucose can reduce nitrogen losses, facilitate
the accumulation of energy reserves in the body (glycogen) and, if administered in sufficient quantities,
decrease or prevent a metabolic disorder (ketosis).
Sodium is important for maintaining a correct balance of fluids (osmolarity of fluids, acid-base balance), for the functioning of cells (transmembrane potential), for the functioning of the heart and
kidneys. Chloride is present mainly in red blood cells and in the tissue lining the stomach (gastric mucosa) and is absorbed together with sodium.
This medicine is indicated:

• to restore hydration of your body and promote a proper intake of mineral salts (sodium and chlorine) and calories;
• to restore blood sugar levels when they are low (hypoglycemia).

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

ITALY
Do not use GLUCOSIO CON SODIO CLORURO 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 with urination (anuria);
• if you experience bleeding (haemorrhages) that occurs at the spinal level or inside the skull (intracranial);
• if you experience hallucinations, tremors and sweating (delirium tremens) and already have excessive fluid loss from the body (dehydration);
• if you have low fluid levels 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 (hypernatremia, only for solution II); 1 of 16
• if you have an excessive amount of salts and fluids in the blood (hydrosaline plethora, only for solution II).

During blood transfusions, glucose solutions should not be administered through the same infusion catheter with whole blood due to the possible risk of red blood cell aggregation (pseudoagglutination) or red blood cell rupture (hemolysis).

Warnings and precautions
Consult your doctor, pharmacist or nurse before using GLUCOSIO CON SODIO CLORURO FRESENIUS KABI ITALY.
Use this medicine with cautionand inform your doctor in the following cases:

• if you suffer from diabetes or are intolerant to glucose. During the infusion, blood sugar levels (glycaemia) and urine (glycosuria) should be carefully monitored to minimize the risk of them reaching high values; if necessary, insulin should be administered;
• 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 suffer from a condition called pre-eclampsia, characterized by high blood pressure, swelling due to fluid accumulation and the presence of protein in the urine;
• if you experience peripheral or pulmonary edema;
• if you experience fluid accumulation and retention of mineral salts;
• if you are taking anti-inflammatory corticosteroid medications;
• if you are taking certain hormonal medications (corticotropin);
• if you suffer from other disorders associated with high levels of sodium (sodium retention).

During prolonged treatment with this medicine, an excess of water in the body (fluid overload and congestive state) and excessive loss of mineral salts (electrolyte deficit) may occur; the doctor should periodically check the concentration of mineral salts (electrolytes, plasma osmolarity, acid-base balance), correcting if necessary any excessive losses with the administration of mineral salts and vitamins.
Continuous administration without adding potassium can cause a reduction in potassium levels (hypokalaemia).
Due to the presence of sodium, use the medicine with caution if you suffer from heart problems (congestive heart failure), if you suffer from severe kidney problems (severe renal failure) and if you suffer from other disorders associated with fluid accumulation and swelling (edema with salt retention).
The solution must be clear, colorless and free of visible particles. Use immediately after opening the container. The container is for single and uninterrupted administration and any remaining medicine cannot be used.
GLUCOSIO CON SODIO CLORURO FRESENIUS KABI ITALIA 4.27%/0.18%, solution for infusion I
2 of 16

Children
In children, particularly in newborns and children with low body weight, the administration of glucose may increase the risk of increased blood sugar levels (hyperglycemia). Furthermore, in children with low body weight, rapid or excessive infusion may cause an increase in blood osmolarity and bleeding into brain tissue (intracerebral haemorrhage).

Other medicines and GLUCOSIO CON SODIO CLORURO FRESENIUS KABI ITALIA
Tell your doctor if you are taking, have recently taken or might take any other medicine..
Pay particular attention and consult your doctor if you are taking:

• anti-inflammatory steroid medicines (corticosteroids) or a hormonal medicine (corticotropin), because they can cause you to have an increase in blood sugar that can lead to manifestation of latent diabetes mellitus and decreased carbohydrate tolerance;
• corticosteroid medicines can cause fluid and sodium accumulation with consequent swelling (edema) and increased blood pressure (hypertension), therefore caution is necessary.

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

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are breastfeeding, ask your doctor for advice before using this medicine.
No data are available on possible adverse effects of the medicine when administered during pregnancy or breastfeeding or on fertility.
Do not use this medicine during pregnancy and breastfeeding unless absolutely necessary and only after your doctor has assessed the risks and benefits of treatment.
GLUCOSIO CON SODIO CLORURO FRESENIUS KABI ITALIA 4.27%/0.18%, solution for infusion I
(a hormone that is given to induce labor and control
bleeding)

Driving and operating machinery
The medicine does not impair the ability to drive vehicles or operate machinery.
3 of 16

3. How to use GLUCOSIO CON SODIO CLORURO FRESENIUS KABI ITALIA

This medicine will be administered to you by a doctor or other qualified medical personnel. If you have any doubts
consult your doctor, pharmacist or nurse.
This medicine will be administered to you with caution directly into a vein (intravenous infusion) and at a
controlled infusion rate.
The doctor will choose the concentration of glucose solution to be used based on your age, weight, your
health conditions and the levels of mineral salts (sodium deficit).

Use in the elderly
.

Use in Children
The safety and efficacy of this medicine in children are unknown.
The dosage and rate of administration of glucose must be chosen based on the patient's age, weight and
health conditions. Particular caution is required in children, especially in newborns or in
children with low body weight.

If you use more GLUCOSIO CON SODIO CLORURO FRESENIUS KABI ITALIA than you should
Because this medicine will be administered to you by a doctor or specialized personnel, it is unlikely that
you will be injected with an excessive dose. However, if you think you have been given an excessive dose of
GLUCOSIO CON SODIO CLORURO FRESENIUS KABI ITALIA, inform your doctor or
another healthcare professional immediately.
Symptoms
In case of prolonged administration of GLUCOSIO CON SODIO CLORURO FRESENIUS KABI
ITALIA, an increase in the concentration of water and solutes in the body (hyperhydration and
solute overload) may occur. In this case, the doctor or nurse must immediately stop the
administration of the medicine and start corrective therapy.
Administration of large amounts of Solution I can alter the levels of mineral salts in the blood
(plasma hypo-osmolality).
Administration of excessive doses of sodium chloride can lead to an increase in sodium levels in
the blood (hypernatremia) and/or a reduction in blood volume (hypervolemia).
The accumulation of chlorine causes an increase in blood acidity (acidosis).

If you forget to use GLUCOSIO CON SODIO CLORURO FRESENIUS KABI ITALIA
Because this medicine will be administered under close medical supervision, it is unlikely that
a dose may be forgotten. However, inform your doctor if you think a dose has been forgotten.
If you have any doubts about the use of this medicine, ask your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
4 of 16
The following side effects can occur. Some of the side effects have occurred in cases of inadequate administration, e.g. of administration that is too fast
(See section “Warnings and precautions”).
Below are the side effects of GLUCOSIO CON SODIO CLORURO FRESENIUS
KABI ITALIA. Insufficient data are available to establish the frequency of the individual effects listed.

Frequency not known(the frequency of which cannot be estimated on the basis of the available data):

Glucosio con Sodio Cloruro Fresenius Kabi Italia 4.27%/0.18%, solution for infusion I

• allergic-type reactions (hypersensitivity, urticaria);
• decreased levels of potassium, magnesium and phosphate in the blood;
• excessive levels of water in the body (hyperhydration);
• increase or decrease in sodium levels in the blood (hypernatremia/hyponatremia);
• increased levels of chlorine (hyperchloremia), which can cause increased blood acidity (acidosis);
• reduction of chlorine and sodium levels in the blood;
• increase or decrease in blood osmotic pressure (hyperosmolarity, hypoosmolarity);
• increased plasma volume circulating in the body (hypervolemia);
• increased metabolic rate;
• increased blood sugar (hyperglycemia);
• decreased blood sugar (hypoglycemia);
• increased insulin level;
• increased adrenaline level;
• increased heart rate (tachycardia);
• decrease or increase in blood pressure (hypotension, hypertension);
• fluid retention with swelling in the legs and ankles (peripheral edema);
• fluid accumulation in the lungs (pulmonary edema);
• difficult breathing (dyspnea), severe breathing problems (respiratory arrest);
• bleeding in the head (cerebral hemorrhage);
• poor blood circulation to the brain (cerebral ischemia);
• headache, dizziness;
• restlessness, irritability;
• muscle stiffness, weakness, convulsions;
• coma;
• death;
• drowsiness and confusion;
• thirst, reduced salivation;
• nausea, vomiting, diarrhea, abdominal pain;
• reduced tear production;
• kidney problems (renal failure);
• increased body temperature (fever);
• leakage of the medicine into the tissues around the injection site (extravasation);
• infection at the infusion site and local pain;
• circulation problems due to blood clot formation and inflammation of the veins in the infusion area (thrombosis and thrombophlebitis);
• hospital-acquired hyponatremia**;
• hyponatremic encephalopathy**.

**Hospital-acquired hyponatremia can cause irreversible brain damage and death, due to the
development of acute hyponatremic encephalopathy

Glucosio con Sodio Cloruro Fresenius Kabi Italia 5%/0.9%, solution for infusion 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 (hypernatremia);
• increased levels of chlorine (hyperchloremia), which can cause increased blood acidity (acidosis);
• increase or decrease in blood osmotic pressure (hyperosmolarity, hypoosmolarity);
• increased plasma volume circulating in the body (hypervolemia);
• increased metabolic rate;
• increased blood sugar (hyperglycemia);
• decreased blood sugar (hypoglycemia);
• increased insulin level;
• increased adrenaline level;
• increased heart rate (tachycardia);
• decrease or increase in blood pressure (hypotension, hypertension);
• fluid retention with swelling in the legs and ankles (peripheral edema);
• fluid accumulation in the lungs (pulmonary edema);
• difficult breathing (dyspnea), severe breathing problems (respiratory arrest);
• bleeding in the head (cerebral hemorrhage);
• poor blood circulation to the brain (cerebral ischemia);
• headache, dizziness;
• restlessness, irritability;
• muscle stiffness, weakness, convulsions;
• coma;
• death;
• drowsiness and confusion;
• thirst, reduced salivation;
• nausea, vomiting, diarrhea, abdominal pain;
• reduced tear production;
• kidney problems (renal failure);
• increased body temperature (fever);
• leakage of the medicine into the tissues around the injection site (extravasation);
• infection at the infusion site and local pain;
• circulation problems due to blood clot formation and inflammation of the veins in the infusion area (thrombosis and thrombophlebitis).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national
reporting system at
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 GLUCOSIO CON SODIO CLORURO FRESENIUS KABI ITALIA

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

6. Package contents 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 ingredients 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 ingredients are water for injections, hydrochloric acid and sodium hydroxide (as pH adjusters).

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

• The active ingredients 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 ingredients are water for injections, hydrochloric acid and sodium hydroxide (as pH adjusters).

Description of the appearance of GLUCOSIO CON SODIO CLORURO FRESENIUS KABI ITALIA and
package contents
Solution for infusion, sterile and apyrogenic.
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 bags 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, 24x250ml, 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)

Manufacturer:
Fresenius Kabi Italia S.r.l. - Via Camagre, 41 - 37063 Isola della Scala (VR)
7 of 16
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 doctors or healthcare professionals
Glucosio con Sodio Cloruro Fresenius Kabi Italia 4.27%/0.18%, solution for infusion 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 medicine must be administered at a rate not exceeding 0.4 - 0.8 g of glucose/hour per kg of
body weight.

Glucosio Con Sodio Cloruro Fresenius Kabi Italia 4.27%/0.18% solution for infusion I
Glucosio con Sodio Cloruro Fresenius Kabi Italia 4.27%/0.18%, solution for infusion I
Incompatibilities with GLUCOSIO CON SODIO CLORURO FRESENIUS KABI ITALIA
Due to the presence of glucose, the medicine is incompatible with:

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

In addition, there are conflicting opinions regarding the compatibility of glucose with hydroxyethyl starch
(hetastarch).
Glucose solutions that do not contain electrolytes should not be administered through the same
catheter as whole blood due to the possible formation of aggregates and the risk of hemolysis.
Ampicillin and amoxicillin are stable in glucose solutions only for a short period.
Unless otherwise indicated, it is not recommended to mix this medicine with other medicines.
After the first opening of the package, the medicine must be used immediately for a single and
uninterrupted administration and any residue cannot be used.
Do not use the medicine if the solution is not clear, colorless or if it contains particles.
Take all usual precautions to maintain sterility before and during intravenous infusion.

Overdosage
Treatment
Immediately stop the infusion and institute corrective therapy to reduce plasma levels of
glucose and excess ions and restore, if necessary, acid-base balance (see
Precautions for use).
8 of 16
The patient should be kept under observation to assess the appearance of any signs and symptoms
related to the administered drug, ensuring the patient with appropriate symptomatic and supportive measures
as needed.
In case of high natremia, loop diuretics can be used.
A natremia greater than 200 mmol/l may require dialysis.

For further information, see the Summary of Product Characteristics.
9 of 16

GLUCOSIO CON SODIO CLORURO FRESENIUS KABI ITALIA 2.5%/0.45%

INFUSION SOLUTION III
Generic Medicine
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, ask your doctor, pharmacist or nurse.
• If any side effects occur, 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

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

GLUCOSIO CON SODIO CLORURO FRESENIUS KABI ITALIA contains the active ingredients glucose
monohydrate and sodium chloride. The administration of glucose increases blood sugar
levels (glycemia), provides calories and water to the body.
Sodium is important for maintaining acid-base balance and a correct fluid balance
(osmolarity of fluids), for cell function (transmembrane potential) and for the correct
functioning of the heart, brain and kidneys. Chloride is present mainly in red blood cells and the tissue that
lines the stomach (gastric mucosa) and is absorbed together with sodium.
This medicine is indicated to restore your body's hydration and correct sodium levels
(blood sodium concentration) in association with a minimum intake of calories (through glucose
monohydrate).

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

ITALY
Do not use GLUCOSIO CON SODIO CLORURO 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 with urination (anuria);
• if you have bleeding inside the skull or spinal cord (intracranial or spinal hemorrhage);
• if you experience hallucinations, tremors and sweating (delirium tremens) and are already dehydrated (loss of water from the body);
• if you have low fluid levels in the body (severe dehydration);
• if you suffer from liver problems leading to loss of consciousness (hepatic coma);
• if you have an excessive amount of salts and fluids in the blood (hydrosaline plethora). Simultaneously with blood transfusions, glucose solutions should not be administered through the same infusion catheter with whole blood due to the possible risk of red blood cell aggregation (pseudoagglutination) or red blood cell rupture (hemolysis). 10 of 16

Warnings and precautions
Consult your doctor, pharmacist or nurse before using GLUCOSIO CON SODIO CLORURO
FRESENIUS KABI ITALY.
Use this medicine with cautionand inform your doctor in the following cases:

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

During prolonged treatment with this medicine, excessive accumulation of water
in the body (fluid overload and congestion) and excessive loss of mineral salts (electrolyte deficits) may occur; the doctor should periodically check the concentration of mineral salts (electrolytes and
plasma osmolarity), acid-base balance and the amount of fluids present in the body, correcting
if necessary any excessive losses with the administration of mineral salts and vitamins.
Continuous administration without the addition of potassium can cause a reduction in potassium levels
(hypokalemia).
Due to the presence of sodium, use with caution if you suffer from heart problems (congestive heart failure), if
you suffer from severe kidney problems (severe renal failure) and if you suffer from other disorders associated with fluid accumulation
and swelling (edema with salt retention).
The solution must be clear, colorless and free of visible particles. Use immediately after opening
the container. The container is for single and uninterrupted administration and any remaining medicine
cannot be used.
11 of 16

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

Other medicines and GLUCOSIO CON SODIO CLORURO FRESENIUS KABI ITALY
Tell your doctor if you are taking, have recently taken or might take any other medicines, including
in particular if you are taking:
Be particularly careful and consult your doctor if you are taking:

• anti-inflammatory steroid medicines (corticosteroids) or a hormonal medicine (corticotropin), because they can cause an increase in blood sugar that can lead to the manifestation of latent diabetes mellitus and decreased carbohydrate tolerance; if glucose is administered to you at the same time, your doctor will need to monitor you carefully;
• corticosteroid medicines, because if administered concurrently with sodium salts they can cause fluid and sodium accumulation with consequent swelling (edema) and increased blood pressure (hypertension).

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning to become pregnant or are breastfeeding, ask your doctor for advice before using this medicine.
There are no data on possible adverse effects of the medicine when administered during
pregnancy or breastfeeding or on fertility.
Do not use this medicine during pregnancy and breastfeeding unless absolutely necessary
and only after your doctor has assessed the risks and benefits of treatment.
(a hormone that is given to induce labor and control bleeding)

Driving and operating machinery
The medicine does not impair the ability to drive vehicles and operate machinery.

3. How to use GLUCOSIO CON SODIO CLORURO FRESENIUS KABI ITALIA

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

Use in the elderly
Use in children
The safety and efficacy of this medicine in children are unknown.
The dosage and rate of administration of glucose must be chosen based on the patient's age, weight and
health conditions. Particular caution is required especially in newborn or low birth weight infants, as an increase in blood glucose levels
(hyperglycemia) may occur.

If you use more GLUCOSIO CON SODIO CLORURO FRESENIUS KABI ITALIA than you should
In case of prolonged administration of GLUCOSIO CON SODIO CLORURO FRESENIUS KABI
ITALIA, an increase in the concentration of water and solutes in the body (hyperhydration and
solute overload) may occur. In this case, the doctor or nurse must immediately stop the
administration of the medicine and start corrective therapy to restore the levels of mineral salts
and glucose in the blood to normal, and re-establish the acid-base balance.
The accumulation of chloride ions causes an increase in blood acidity (acidosis) because it decreases the
concentration of bicarbonate ions.

If you forget to use GLUCOSIO CON SODIO CLORURO FRESENIUS KABI ITALIA
Since this medicine will be administered under close medical supervision, it is unlikely that a
dose may be forgotten. However, inform your doctor if you think a dose has been forgotten.
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.
GLUCOSIO CON SODIO CLORURO FRESENIUS KABI ITALIA (see section “Warnings and
precautions”).
+

Frequency not known(the frequency cannot be estimated from available data):

• allergic-type reactions (hypersensitivity), skin irritation (urticaria);
• decreased levels of potassium (hypokalaemia), magnesium (hypomagnesaemia) and phosphate (hypophosphataemia) in the blood;
• excessive levels of water in the body (hyperhydration);
• increase or decrease in blood sodium levels (hypernatraemia/ hyponatraemia);
• increase or decrease in blood osmotic pressure (hyperosmolarity, hyposmolarity);
• increased plasma volume (hypervolaemia);
• hyperchloraemia (which can cause increased blood acidity) 13 of 16
• increased metabolic rate;
• increased blood sugar (hyperglycaemia);
• decreased blood sugar (hypoglycaemia);
• increased insulin level;
• increased adrenaline level;
• increased heart rate (tachycardia);
• decrease or increase in blood pressure (hypotension, hypertension);
• fluid retention with swelling of the legs and ankles (peripheral oedema);
• fluid accumulation in the lungs (pulmonary oedema);
• breathing problems (dyspnoea, respiratory arrest);
• bleeding in the brain due to rupture of blood vessels (cerebral haemorrhage);
• poor blood supply to the brain (cerebral ischaemia);
• headache, 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 the tissues around the injection site (extravasation);
• infection at the infusion site and local pain;
• circulation problems due to blood clot formation and inflammation of the veins in the infusion area (thrombosis and thrombophlebitis);
• hospital-acquired hyponatraemia**;
• hyponatraemic encephalopathy**.

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

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system at
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 GLUCOSIO CON SODIO CLORURO FRESENIUS KABI ITALIA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after “EXP.”.
The expiry date refers to the product in intact packaging, correctly stored.
Store in the original packaging and in a tightly closed container. Do not refrigerate or freeze.
Caution: do not use the medicine after the expiry date stated on the packaging.
Do not use the medicine if the solution is not clear, colourless or if it contains particles. Use
immediately after opening the container. It is for single and uninterrupted administration and any
remaining solution cannot be used.
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Medicines should not be disposed of via drains or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What GLUCOSIO CON SODIO CLORURO FRESENIUS KABI ITALIA contains

• The active ingredients are glucose monohydrate and sodium chloride. Each litre of solution contains 27.5 g of glucose monohydrate (25 g of anhydrous glucose) and 4.5 g of sodium chloride. Each litre of solution contains 77 mEq of sodium, 77 mEq of chloride and 139 mmol of glucose. pH 3.5 - 6.5.
• The other ingredients are water for injections, hydrochloric acid and sodium hydroxide (as pH adjusters).

Description of the appearance of GLUCOSIO CON SODIO CLORURO FRESENIUS KABI ITALIA and
package contents
Solution for infusion, sterile and apyrogenic.
Bottle 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 bottle of 250 ml and 500 ml.
Freeflex bag of 50 ml and 100 ml with overpouch.
Freeflex bag of 250 ml, 500 ml, 1000 ml and 10x1000 ml.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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)

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The following information is intended exclusively for doctors or healthcare professionals
Dosage and administration
The solution is isotonic with blood and must be administered with caution for intravenous infusion and at a
controlled infusion rate. The medicinal product must be administered at a rate not exceeding 0.4

• 0.8 g of glucose/hour per kg of body weight.

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Incompatibilities with GLUCOSIO CON SODIO CLORURO FRESENIUS KABI ITALIA
Due to the presence of glucose, the medicinal product is incompatible with:

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

In addition, there are conflicting opinions regarding the compatibility of glucose with hydroxyethyl starch
(hetastarch).
Glucose solutions that do not contain electrolytes should not be administered through the same
catheter as whole blood due to the possible formation of aggregates and the risk of haemolysis.
Ampicillin and amoxicillin are stable in glucose solutions only for a short period.
Unless otherwise indicated, it is not recommended to mix this medicinal product with other medicinal products.
After the first opening of the package, the medicinal product must be used immediately for a single and
uninterrupted administration and any residue cannot be used.
Do not use the medicinal product if the solution is not clear, colourless or if it contains particles.
Take all usual precautions to maintain sterility before and during intravenous infusion.

Overdosage
Treatment
Immediately stop the infusion and initiate corrective therapy to reduce plasma glucose levels and the excess of
ions and restore, if necessary, the acid-base balance (see
Precautions for use).
The patient should be kept under observation to assess the appearance of any signs and symptoms
related to the administered drug, ensuring the patient receives appropriate symptomatic and supportive measures
as needed.
In case of high natremia, loop diuretics can be used.
A natremia greater than 200 mmol/l may require dialysis.

For further information, see the Summary of Product Characteristics.
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