Glucose with sodium chloride Bioindustria L.I.M.

Package leaflet: Information for the user

GLUCOSIO CON SODIO CLORURO Bioindustria L.I.M. 2.5% / 0.45% infusion solution III

Glucose monohydrate and sodium chloride
Generic medicine
Read all of 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.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or nurse. See section 4.

Contents of this leaflet:

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

1. What GLUCOSIO CON SODIO CLORURO Bioindustria L.I.M. is and what it is used for

GLUCOSIO CON SODIO CLORURO Bioindustria L.I.M. contains the active substances glucose monohydrate and sodium chloride, which provide calories and help maintain proper fluid balance in the body.
This medicine is indicated:

• to restore hydration and correct sodium levels in the body, along with an adequate intake of calories.

2. What you should know before using GLUCOSIO CON SODIO CLORURO Bioindustria L.I.M.

Do not use GLUCOSIO CON SODIO CLORURO Bioindustria L.I.M.

• 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 occurring within the skull or spinal cord (intracranial or spinal hemorrhage);
• if you experience hallucinations, tremors, and sweating (delirium tremens) associated with a dehydrated state;
• 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 (hydrosaline plethora). 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 (hemolysis).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using GLUCOSIO CON SODIO CLORURO Bioindustria L.I.M.
Use this medicine with caution and inform your doctor in the following cases:

• if you have diabetes mellitus or glucose intolerance. To minimize the risk of high blood sugar levels (hyperglycemia) and presence of sugar in the urine (glycosuria), it is necessary to monitor blood and urine glucose levels during administration, and insulin should be administered if required;
• if you have high blood pressure (hypertension);
• if you suffer from severe heart problems (heart failure, congestive cardiac failure);
• if you have kidney problems (reduced renal function, severe renal failure);
• 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 swelling caused by fluid accumulation and salt retention (peripheral or pulmonary edema, edema with salt retention);
• if you are taking anti-inflammatory medicines (corticosteroids);
• if you are taking corticotropin hormone;
• 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), congestion, and excessive loss of electrolytes (electrolyte deficit) may occur. Your doctor must periodically monitor plasma electrolyte concentrations and osmolarity, especially in patients with non-osmotic vasopressin release and in patients receiving concomitant therapy with vasopressin agonists, acid-base balance, and body fluid volume, correcting any excessive losses with administration of electrolytes and vitamins if necessary.
Continuous administration without addition of potassium and sodium may lead to reduced potassium levels (hypokalemia) and sodium levels (hyponatremia).
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 used.

Children
In children, especially in neonates and low-body-weight infants, glucose administration may increase the risk of elevated blood sugar levels (hyperglycemia) or lead to low sodium levels in the blood (hypotonic hyponatremia), potentially resulting in cerebral edema (hyponatremic encephalopathy). Furthermore, in low-body-weight children, rapid or excessive infusion may increase blood osmolarity and cause intracerebral hemorrhage.

Other medicines and GLUCOSIO CON SODIO CLORURO Bioindustria L.I.M.
Inform your doctor if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.
Pay particular attention and consult your doctor if you are taking:

• corticosteroids (steroidal anti-inflammatory drugs) or corticotropin, as they may reduce glucose tolerance and possibly unmask latent diabetes mellitus; if glucose is administered concomitantly, your doctor must monitor you closely. Additionally, corticosteroids, when administered together with sodium salts, may cause water and sodium retention, leading to swelling (edema) and increased blood pressure (hypertension);
• medicines that increase the effect of antidiuretic hormone (vasopressin), e.g., chlorpropamide, clofibrate, carbamazepine, vincristine, selective serotonin reuptake inhibitors, 3,4-methylenedioxy-N-methamphetamine, ifosfamide, antipsychotics, narcotics, NSAIDs, cyclophosphamide, desmopressin, oxytocin, terlipressin, as they may increase the risk of low sodium levels in the blood (hyponatremia).

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor before using this medicine.
Do not use this medicine during pregnancy or breastfeeding unless absolutely necessary and only after careful assessment of treatment risks and benefits.
If you are pregnant, this medicine will be administered with particular caution during labor due to the risk of hyponatremia, especially if administered in combination with a labor-inducing medicine (oxytocin).

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

3. How to use GLUCOSIO CON SODIO CLORURO Bioindustria L.I.M.

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).

Use in the elderly
If you are elderly, your doctor will closely monitor you during treatment with this medicine.

Children
The safety and efficacy of this medicine in children have not been established.
The dosage and rate of glucose administration must be determined according to the child's age, weight, and health status. Particular caution is required in children, especially in neonates or children with low body weight, as increased blood glucose levels (hyperglycemia) may occur.

If you use more GLUCOSIO CON SODIO CLORURO Bioindustria L.I.M. 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 an excessive dose of GLUCOSIO CON SODIO CLORURO Bioindustria L.I.M. has been administered, inform your doctor or another healthcare professional immediately.
In case of accidental administration of excessive doses of GLUCOSIO CON SODIO CLORURO Bioindustria L.I.M., an increase in water and solute concentration in the body (hyperhydration and solute overload) may occur. In such cases, the doctor or nurse must immediately stop administration of the medicine and initiate corrective therapy to restore normal levels of electrolytes and blood glucose (restore acid-base balance and reduce plasma glucose levels).

If you forget to use GLUCOSIO CON SODIO CLORURO Bioindustria L.I.M.
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 how to use 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.
If GLUCOSIO CON SODIO CLORURO Bioindustria L.I.M. is administered improperly or too rapidly, the following adverse reactions may occur:
Not known (frequency cannot be estimated from the available data):

• allergic-type reactions (hypersensitivity), skin irritation (urticaria);
• decreased levels of potassium (hypokalaemia), magnesium (hypomagnesaemia), and phosphate (hypophosphataemia) in the blood;
• excessive water accumulation in the body (hyperhydration);
• increased levels of sodium (hypernatraemia) and chloride (hyperchloraemia), leading to increased blood acidity (acidosis);
• increased or decreased internal blood pressure due to dissolved substances (hyperosmolarity, hypoosmolarity);
• increased blood volume (hypervolaemia);
• increased metabolic rate (the rate at which substances are metabolized in the body);
• increased blood sugar (hyperglycaemia);
• decreased blood sugar (hypoglycaemia);
• increased insulin levels;
• increased adrenaline levels;
• hospital-acquired hyponatraemia, which may cause irreversible brain damage and death due to the development of acute hyponatraemic encephalopathy;
• 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);
• cerebral haemorrhage;
• brain damage (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 disorders (renal failure);
• fever;
• leakage of the medicine into surrounding tissues at the injection site (extravasation);
• infection at the infusion site and local pain;
• blood clot formation and inflammation of veins at the infusion site (thrombosis and thrombophlebitis).

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

5. How to store GLUCOSIO CON SODIO CLORURO Bioindustria L.I.M.

Keep this medicine out of the reach and sight of children.
Do not use this medicine after the expiry date stated on the packaging after "EXP.".
The expiry date refers to the product stored in its original, undamaged packaging under proper conditions.
Store in the original packaging and in a tightly closed container. Do not refrigerate or freeze.
Do not use the medicine if the solution is not clear and colourless or if it contains particles. Use immediately after opening the container.
It is intended for single and uninterrupted administration; any remaining solution must not be used.
Medicines must not be disposed of via 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 Bioindustria L.I.M. infusion solution III contains

• The active substances are glucose monohydrate and sodium chloride. 1000 ml of solution contain 27.5 g of glucose monohydrate (25 g of anhydrous glucose) and 4.5 g of sodium chloride. One litre of solution contains 77 mEq of sodium, 77 mEq of chloride, and 139 mmol of glucose monohydrate (pH 3.5 - 6.5).
• The other component is water for injections.

Description of the appearance of GLUCOSIO CON SODIO CLORURO Bioindustria L.I.M. and package contents
Infusion solution, sterile and pyrogen-free.
Vials of 50 ml, 100 ml, 250 ml, and 500 ml.
50 ml in a 100 ml vial;
100 ml in a 250 ml vial;
250 ml in a 500 ml vial.

Marketing Authorization Holder and Manufacturer
BIOINDUSTRIA Laboratorio Italiano Medicinali S.p.A.
Via De Ambrosiis, 2 - Novi Ligure (AL) - Italy

The following information is intended exclusively for doctors or healthcare professionals

Dosage, method and duration 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.
Electrolyte balance, serum glucose, serum sodium and other electrolytes may need to be monitored before and during administration, particularly in patients with increased non-osmotic release of vasopressin (syndrome of inappropriate antidiuretic hormone secretion, SIADH) and in patients receiving concomitant therapy with vasopressin agonists, due to the risk of hyponatremia.
Monitoring of serum sodium is particularly important for physiologically hypotonic solutions. Glucose with Sodium Chloride Bioindustria L.I.M. may become extremely hypotonic after administration due to the metabolism of glucose in the body (see sections 4.4, 4.5 and 4.8 of the Summary of Product Characteristics).

Incompatibilities with GLUCOSE WITH SODIUM CHLORIDE Bioindustria L.I.M.
If used to dilute medicinal products, consult a pharmacist, if available, before adding any medicinal additives; always consider the characteristics of the products to be added; use aseptic techniques.
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 electrolytes should not be administered through the same infusion catheter as whole blood due to the possible formation of clumps and the risk of haemolysis.
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.

Special precautions for disposal and handling
Adopt all standard precautions to maintain sterility before and during intravenous infusion.

Overdose
Symptoms
Prolonged administration of glucose may lead to hyperhydration and solute overload. In such cases, the patient's clinical condition should be reassessed and appropriate corrective measures initiated.
Accumulation of chloride ions leads to a reduction in bicarbonate ion concentration, resulting in acidosis.

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 Warnings and precautions for use).
The patient should be closely monitored for the appearance of any signs and symptoms related to the administered medicinal product, ensuring appropriate symptomatic and supportive measures as required.
In cases of severe hypernatremia, loop diuretics may be used.
A serum sodium concentration exceeding 200 mmol/l may require dialysis.

For further information, refer to the Summary of Product Characteristics.
Package leaflet: Information for the user

GLUCOSE WITH SODIUM CHLORIDE Bioindustria L.I.M. 4.27%/0.18% infusion solution I, 5%/0.9% infusion solution II

Glucose monohydrate and sodium chloride
Generic medicine
Please 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, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or nurse. See section 4.

Contents of this leaflet:

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

2. What GLUCOSIO CON SODIO CLORURO Bioindustria L.I.M. is and what it is used for

GLUCOSIO CON SODIO CLORURO Bioindustria L.I.M. contains the active substances glucose monohydrate and sodium chloride, which provide calories and help maintain proper fluid balance in the body.
This medicine is indicated:

• To restore hydration of the body, in association with an adequate intake of electrolytes and calories
• To restore blood sugar levels when they are low (hypoglycemia).

2. What you should know before using GLUCOSIO CON SODIO CLORURO Bioindustria L.I.M.

Do not use GLUCOSIO CON SODIO CLORURO Bioindustria L.I.M.

• 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 occurring inside the skull or spinal cord (intracranial or spinal hemorrhage);
• if you experience hallucinations, tremors, and sweating (delirium tremens) in the presence of a dehydrated state;
• 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);
• if you have an excessive amount of salts and fluids in the blood (hypersaline hypervolemia, only for Solution II).

Glucose solutions must not be administered simultaneously with blood transfusions
through the same infusion catheter as whole blood due to the possible risk of red blood cell aggregation (pseudoagglutination) or red blood cell breakdown (hemolysis).
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using GLUCOSIO CON SODIO CLORURO
Bioindustria L.I.M.
Use this medicine with caution and inform your doctor in the following cases:

• if you have diabetes mellitus or glucose intolerance. To minimize the risk of high blood sugar levels (hyperglycemia) and presence of sugar in urine (glycosuria), it is necessary to monitor blood and urine glucose during administration, and insulin should be administered if needed;
• if you have high blood pressure (hypertension);
• if you suffer from severe heart problems (heart failure, congestive heart failure) and are taking medicines to treat this condition (positive inotropic agents);
• if you have kidney problems (reduced renal function, severe renal failure);
• 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 swelling caused by fluid accumulation and salt retention (peripheral or pulmonary edema, edema with salt retention);
• if you are taking anti-inflammatory medicines (corticosteroids);
• if you are taking the hormone 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), congestion, and excessive loss of mineral salts (electrolyte deficit) may occur; your doctor should periodically check the concentration of mineral salts (electrolytes and
plasma osmolarity), especially in patients with non-osmotic vasopressin release and in patients receiving concomitant therapy with vasopressin agonists, as well as acid-base balance and body fluid volume, correcting any excessive losses if necessary by administering mineral salts and vitamins.
Continuous administration without potassium supplementation may lead to reduced potassium levels
(hypokalemia). Continuous administration without sodium supplementation may lead to reduced sodium levels (hyponatremia), following administration of Solution I.
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 used.
Children
In children, particularly in neonates and low-birth-weight infants, administration of
glucose may increase the risk of elevated blood sugar levels (hyperglycemia) or lead
to low sodium levels in the blood (hypotonic hyponatremia), resulting in cerebral edema (hyponatremic encephalopathy). Furthermore, in low-birth-weight children, rapid or excessive infusion may cause increased blood osmolarity and intracerebral hemorrhage.
Other medicines and GLUCOSIO CON SODIO CLORURO Bioindustria L.I.M.
Inform your doctor if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.
Exercise particular caution and consult your doctor if you are taking:

• corticosteroids (steroidal anti-inflammatory drugs) or corticotropin, as they may reduce your glucose tolerance and possibly unmask latent diabetes mellitus; if glucose is administered concomitantly, your doctor should monitor you closely; additionally, corticosteroids, when administered together with sodium salts, may cause water and sodium retention leading to swelling (edema) and increased blood pressure (hypertension);
• medicines that increase the effect of antidiuretic hormone (vasopressin), e.g., chlorpropamide, clofibrate, carbamazepine, vincristine, selective serotonin reuptake inhibitors, 3,4-methylenedioxy-N-methamphetamine, ifosfamide, antipsychotics, narcotics, NSAIDs, cyclophosphamide, desmopressin, oxytocin, terlipressin, as they may increase the risk of low sodium levels in the blood (hyponatremia).

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding,
ask your doctor for advice before using this medicine.
Do not use this medicine during pregnancy or breastfeeding unless absolutely necessary
and only after careful assessment of treatment risks and benefits.
If you are pregnant, this medicine will be administered with particular caution during labor due to the risk of hyponatremia, especially if administered in combination with a labor-inducing medicine (oxytocin).
Driving and using machines
This medicine does not affect the ability to drive or operate machinery.

3. How to use GLUCOSIO CON SODIO CLORURO Bioindustria L.I.M.

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, your health condition, and mineral salt levels, particularly sodium levels (electrolyte profile, theoretical osmolarity, and sodium deficit).

Use in the elderly
If you are elderly, the doctor will closely monitor you during treatment with this medicine.

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 determined according to the child's age, weight, and health status. Particular caution is required in children, especially in neonates or children with low body weight, as increased blood glucose levels (hyperglycemia) may occur.

If you use more GLUCOSIO CON SODIO CLORURO Bioindustria L.I.M. 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 you have been given too much GLUCOSIO CON SODIO CLORURO Bioindustria L.I.M., inform your doctor or another healthcare professional immediately.
In case of accidental administration of excessive doses of GLUCOSIO CON SODIO CLORURO Bioindustria L.I.M., an increase in water and solute concentration in the body (overhydration and solute overload) may occur. In such cases, the doctor or nurse must immediately stop administration of the medicine and initiate corrective therapy to restore normal mineral salt and blood glucose levels (restore acid-base balance and reduce plasma glucose levels).

If you forget to use GLUCOSIO CON SODIO CLORURO Bioindustria L.I.M.
Since this medicine will be administered under close medical supervision, it is unlikely that a dose will be missed. However, inform the doctor if you think a dose has been missed.

If you have any questions about 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.
If GLUCOSIO CON SODIO CLORURO Bioindustria L.I.M. is administered incorrectly or too rapidly, the following adverse reactions may occur:
Frequency not known (frequency cannot be estimated from the available data):

• allergic-type reactions (hypersensitivity), skin irritation (urticaria);
• decreased levels of potassium (hypokalaemia), magnesium (hypomagnesaemia), and phosphate (hypophosphataemia) in the blood;
• excessive accumulation of water in the body (overhydration);
• increased levels of sodium (hypernatraemia), increased levels of chloride (hyperchloraemia) leading to increased blood acidity (acidosis);
• reduced levels of chloride (hypochloraemia) and sodium (hyponatraemia) in the blood following administration of Solution I;
• increased or decreased blood osmotic pressure due to dissolved substances (hyperosmolarity, hypoosmolarity);
• increased blood volume (hypervolaemia);
• increased metabolic rate (rate at which substances are metabolized in the body);
• increased blood sugar levels (hyperglycaemia);
• decreased blood sugar levels (hypoglycaemia);
• increased insulin levels;
• increased adrenaline levels;
• hospital-acquired hyponatraemia, which may cause irreversible brain damage and death due to acute hyponatraemic encephalopathy;
• increased heart rate (tachycardia);
• decreased or increased blood pressure (hypotension, hypertension);
• fluid accumulation with swelling in the legs and ankles (peripheral oedema);
• fluid accumulation in the lungs (pulmonary oedema);
• breathing difficulties (dyspnoea, respiratory arrest);
• cerebral haemorrhage;
• brain damage (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);
• fever;
• leakage of the medicine into surrounding tissues at the injection site (extravasation);
• infection at the infusion site and local pain;
• formation of blood clots and inflammation of the veins at the infusion site (thrombosis and thrombophlebitis).

Following the instructions provided in this leaflet reduces the risk of adverse reactions.
Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, please contact your doctor or pharmacist. You may also report adverse reactions directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. How to store GLUCOSIO CON SODIO CLORURO Bioindustria L.I.M.

Keep this medicine out of the reach and sight of children.
Do not use this medicine after the expiry date stated on the packaging after "EXP.".
The expiry date refers to the product in its original intact packaging, correctly stored.
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 stated 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. It is intended for single and uninterrupted administration, and any
remaining solution must not be used.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What GLUCOSIO CON SODIO CLORURO Bioindustria L.I.M. contains
Glucosio con sodio cloruro Bioindustria L.I.M. 4.7%/0.18% infusion solution I

• The active substances are monohydrate glucose and sodium chloride. Each liter of solution contains 47 g of monohydrate glucose (42.7 g of anhydrous glucose) and 1.8 g of sodium chloride. One liter of solution contains 31 mEq of sodium, 31 mEq of chloride, and 237 mmol of monohydrate glucose (pH 3.5 - 6.5).
• The other component is water for injections.

Glucosio con sodio cloruro Bioindustria L.I.M. 5%/0.9% infusion solution II

• The active substances are monohydrate glucose and sodium chloride. Each liter of solution contains 55 g of monohydrate glucose (50 g of anhydrous glucose) and 9 g of sodium chloride. One liter of solution contains 154 mEq of sodium, 154 mEq of chloride, and 277 mmol of monohydrate glucose (pH 3.5 - 6.5). The other component is water for injections.

Description of the appearance of GLUCOSIO CON SODIO CLORURO Bioindustria L.I.M. and package contents
Infusion solution, sterile and pyrogen-free.
Glass vials of 50 ml, 100 ml, 250 ml, and 500 ml.
50 ml of solution in a 100 ml vial.
100 ml of solution in a 250 ml vial.
250 ml of solution in a 500 ml vial.

Marketing Authorization Holder and Manufacturer
BIOINDUSTRIA Laboratorio Italiano Medicinali S.p.A.
Via De Ambrosiis, 2
Novi Ligure (AL) - Italy

The following information is intended exclusively for physicians or healthcare professionals

Dosage, method and duration of administration
The 4.27% glucose solution (solution I) is isotonic with blood. The 5% glucose solution (solution II) is hypertonic with respect to blood.
The medicinal product must be administered at a rate not exceeding 0.4–0.8 g of glucose per hour per kg of body weight.
Monitoring of electrolyte balance, serum glucose, serum sodium and other electrolytes before and during administration may be necessary, particularly in patients with increased non-osmotic release of vasopressin (syndrome of inappropriate antidiuretic hormone secretion, SIADH) and in patients receiving concomitant therapy with vasopressin agonists, due to the risk of hyponatremia.
Monitoring of serum sodium is particularly important for physiologically hypotonic solutions. Glucose with sodium chloride Bioindustria L.I.M. may become markedly hypotonic after administration due to in vivo metabolism of glucose (see sections 4.4, 4.5 and 4.8 of the Summary of Product Characteristics).

Incompatibilities with Glucose with Sodium Chloride Bioindustria L.I.M.
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 aggregates 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.

Special precautions for disposal and handling
All standard precautions should be taken to maintain sterility before and during intravenous infusion.

Overdose
Symptoms
Prolonged administration of glucose may lead to hyperhydration and solute overload. In such cases, the patient's clinical condition should be re-evaluated and appropriate corrective measures instituted.
Prolonged administration of large amounts of Solution I may result in plasma hypoosmolality.
Excessive administration of sodium chloride may lead, depending on the patient's clinical condition, to hypernatremia and/or hypervolemia.
Accumulation of chloride ions leads to a reduction in bicarbonate ion concentration, resulting in acidosis.

Treatment
Immediately discontinue the infusion and initiate corrective therapy to reduce plasma levels of glucose and excess ions, and, if necessary, restore acid-base balance (see Precautions for use).
The patient should be closely monitored for the appearance of any signs and symptoms related to the administered medicinal product, providing 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.