Glucose with sodium chloride Galenica Senese: detailed information

Package leaflet: Information for the patient

GLUCOSIO CON SODIO CLORURO GALENICA SENESE 4.27%/0.18% infusion solution I, 5%/0.9% infusion solution II

Glucose monohydrate and sodium chloride
Generic medicine
Please read all of this leaflet carefully before you start 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.
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 may be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or nurse. See section 4.

Contents of this leaflet:

What GLUCOSIO CON SODIO CLORURO GALENICA SENESE is and what it is used for
What you need to know before using GLUCOSIO CON SODIO CLORURO GALENICA SENESE
How to use GLUCOSIO CON SODIO CLORURO GALENICA SENESE
Possible side effects
How to store GLUCOSIO CON SODIO CLORURO GALENICA SENESE
Contents of the pack and other information

1. What GLUCOSIO CON SODIO CLORURO GALENICA SENESE is and what it is used for

GLUCOSIO CON SODIO CLORURO GALENICA SENESE 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 cell 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:

to correct hydration of your body and support an adequate intake of mineral salts (through sodium chloride) and calories (through glucose monohydrate);
to correct blood sugar levels when they are low (hypoglycaemia).

2. What you should know before using GLUCOSIO CON SODIO CLORURO GALENICA SENESE

Do not use GLUCOSIO CON SODIO CLORURO GALENICA SENESE

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 into the tissues of the brain or spinal cord (intracranial or spinal hemorrhage);
if you suffer from hallucinations, tremors, and sweating (delirium tremens) caused by excessive loss of body water (dehydration);
if you have low fluid levels in the body (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 excessive amounts of salts and fluids in the blood (hypersaline hypervolemia, only for solutions II and III).

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 destruction (hemolysis).
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using GLUCOSIO CON SODIO CLORURO
GALENICA SENESE.
Intravenous glucose infusions are generally isotonic solutions. However, in the body, glucose-containing solutions may become physiologically highly hypotonic due to the rapid metabolism of glucose (see below).
Depending on the tonicity of the solution, volume and frequency of infusion, the patient's underlying clinical condition, and the ability to metabolize glucose, intravenous administration of glucose may cause electrolyte imbalances, particularly low levels of sodium in the blood (hypo- or hyperosmolar states).
Special caution is required in:

Patients affected by a condition called syndrome of inappropriate antidiuretic hormone secretion, SIADH (e.g. in the acute phase of illness, pain, postoperative stress, infections, burns, and diseases of the central nervous system);
patients with heart (cardiac), liver (hepatic), or kidney (renal) disorders, and patients treated with drugs that increase the activity of a hormone called vasopressin (vasopressin agonists) (see section 2);

if you suffer from diabetes mellitus or are glucose intolerant. During infusion, blood sugar levels (glycemia) and sugar in the urine (glycosuria) must be closely monitored to minimize the risk of elevated values; 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 suffer from a condition called pre-eclampsia, characterized by high blood pressure, swelling due to fluid accumulation, and protein in the urine;
if you have swelling caused by fluid accumulation and salt retention (peripheral or pulmonary edema);
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 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 (electrolytes and plasma osmolarity), acid-base balance, and body fluid volume, correcting any excessive losses as needed with administration of minerals and vitamins.
Monitoring of mineral balance (electrolytes), blood glucose (serum glucose), blood sodium (serum sodium), and other minerals (electrolytes) may be necessary before and during administration, with particular attention to serum sodium levels in patients with syndrome of inappropriate antidiuretic hormone secretion (SIADH) and in patients taking medicines that enhance the action of a hormone called vasopressin (vasopressin agonists), due to the risk of decreased sodium levels in the blood.
Continuous administration without potassium supplementation may lead to reduced potassium levels (hypokalemia).
Due to the presence of sodium, use 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 (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.
Children and adolescents
In children, especially neonates and low-body-weight infants, glucose administration may increase the risk of elevated blood sugar levels (hyperglycemia). Furthermore, in children with low body weight, rapid or excessive infusion may cause increased blood osmolarity and bleeding within brain tissue due to rupture of a blood vessel (intracerebral hemorrhage).
Children are particularly at risk of severe and life-threatening cerebral fluid accumulation (cerebral edema) caused by low sodium levels in the blood (acute hyponatremia).
Other medicines and GLUCOSIO CON SODIO CLORURO GALENICA SENESE
Inform your doctor if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.
The following medicines may increase the risk of low sodium levels in the blood (hospital-acquired hyponatremia) following inadequate balancing with intravenous solutions during hospitalization:

medicines that stimulate the release of a hormone called vasopressin (chlorpropamide, clofibrate, carbamazepine, vincristine, selective serotonin reuptake inhibitors, 3,4-methylenedioxy-N-methamphetamine, ifosfamide, antipsychotics, narcotics);
medicines that potentiate the effect of a hormone called vasopressin (chlorpropamide, NSAIDs, cyclophosphamide);
medicines similar to a hormone called vasopressin (desmopressin, oxytocin, vasopressin, terlipressin);

Other medicines that increase the risk of reduced sodium levels in the blood (hyponatremia) also include medicines that increase urine production (diuretics in general) and antiepileptic medicines such as oxcarbazepine.
Exercise particular caution and consult your doctor if you are taking:

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

Fertility, pregnancy, and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or 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 careful evaluation of the risks and benefits of treatment.
Glucosio con sodio cloruro Galenica Senese should be administered with particular caution to pregnant women during labor, especially regarding serum sodium levels, when administered in association with a hormone called oxytocin (see sections 2 and 4).
Driving and using machines
This medicine does not affect the ability to drive or use machinery.

3. How to use GLUCOSIO CON SODIO CLORURO GALENICA SENESE

This medicine will be administered to you by a doctor or other trained medical personnel. If you have any doubts, consult your doctor, pharmacist, or nurse.
This medicine will be administered cautiously directly into a vein (intravenous infusion) and at a controlled infusion rate.
Your doctor will choose the appropriate glucose solution concentration based on your age, weight, clinical condition (e.g., burns, surgical procedures, head injuries, infections), and electrolyte levels—particularly sodium levels (electrolyte profile, theoretical osmolarity, and sodium deficit).

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

Children
The safety and efficacy of this medicine in children have not been established.
The dose, frequency, infusion volume, and rate of glucose administration must be determined according to the child's age, weight, and clinical condition (e.g., burns, surgical procedures, head injuries, infections). Particular caution is required, 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 GALENICA SENESE than you should
Since this medicine is administered by a doctor or trained healthcare professional, it is unlikely that you will receive an excessive dose. However, if you think an overdose has occurred, inform your doctor or another healthcare provider immediately.
In case of accidental administration of excessive doses of GLUCOSIO CON SODIO CLORURO GALENICA SENESE, an increase in water and solute concentration in the body may occur (overhydration and solute overload). In such cases, the doctor or nurse must immediately stop the administration of the medicine and initiate corrective therapy to restore normal levels of electrolytes and blood glucose (re-establish acid-base balance and reduce plasma glucose levels).
Administration of large volumes of Solution I may alter electrolyte levels in the blood (plasma hypoosmolarity).
Excessive administration of sodium chloride may lead to increased sodium levels in the blood (hypernatremia) and/or increased blood volume (hypervolemia).
Accumulation of chloride ions may cause increased blood acidity (acidosis) due to decreased bicarbonate ion concentration.

If you forget to use GLUCOSIO CON SODIO CLORURO GALENICA SENESE
Since this medicine is administered under strict medical supervision, it is unlikely that a dose will be missed. However, inform your doctor if you believe a dose has been omitted.

If you have any questions about how to use this medicine, consult your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
If GLUCOSE WITH SODIUM CHLORIDE GALENICA SENESESE is administered incorrectly or too rapidly, the following side effects may occur (see section “Warnings and precautions”).
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 water in the body (hyperhydration);
increased levels of sodium (hypernatraemia) and chloride (hyperchloraemia) following administration of solution II, leading to increased blood acidity (acidosis);
decreased levels of chloride (hypochloraemia) and sodium (hyponatraemia) in the blood following administration of solution I;
increased or decreased blood osmotic pressure (hyperosmolarity, hypoosmolarity);
increased blood volume in circulation (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);
breathing problems (dyspnoea, respiratory arrest);
bleeding in the brain due to rupture of blood vessels (cerebral haemorrhage);
brain damage caused by poor cerebral blood circulation (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 vein inflammation at the infusion site (thrombosis and thrombophlebitis);
decreased sodium levels in the blood following hospitalisation, known as hospital-acquired hyponatraemia*;
a brain disorder called acute hyponatraemic encephalopathy*.

*Reduced sodium levels in the blood following hospitalisation (hospital-acquired hyponatraemia) may cause irreversible brain damage and death due to the development of acute hyponatraemic encephalopathy, with frequency not known (see sections 3 and 2).
Following the instructions provided in this leaflet reduces the risk of side effects.
If any of the side effects worsens, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.
Reporting of side effects
If you experience any side effects, 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 http://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 GALENICA SENESE

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.
Bags: store at a temperature not exceeding 30°C.
Warning: do not use the medicine after the expiry date printed 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 continuous administration only; any
remaining residue must not be used.
Do not dispose of medicines 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 GALENICA SENESE contains
GLUCOSIO CON SODIO CLORURO GALENICA SENESE 4.27%/0.18% - infusion solution I

The active substances are monohydrate glucose and sodium chloride. 100 ml of solution contain 47 g of monohydrate glucose (42.7 g of anhydrous glucose) and 1.8 g of sodium chloride. One litre of solution contains 31 mEq of sodium, 31 mEq of chloride and 277 mmol of monohydrate glucose (pH 3.5 - 6.5).
The other component is water for injections.

GLUCOSIO CON SODIO CLORURO GALENICA SENESE 5%/0.9% - infusion solution II

The active substances are monohydrate glucose and sodium chloride. 1000 ml of solution contain 55 g of monohydrate glucose (equivalent to 50 g of anhydrous glucose) and 9.0 g of sodium chloride. One litre 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 GALENICA SENESE and contents of the package
Sterile, pyrogen-free infusion solution.
Glass vial of 50 ml, 100 ml, 250 ml, 500 ml and 1000 ml.
Plastic bag of 50 ml, 100 ml, 250 ml, 500 ml and 1000 ml.

Marketing Authorization Holder and Manufacturer
Industria Farmaceutica Galenica Senese S.r.l.
Via Cassia Nord, 351
53014 Monteroni D’Arbia (SI)
Italy

The following information is intended exclusively for doctors 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 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.

Incompatibilities with Glucosio con sodio cloruro Galenica Senese
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 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 packaging, the medicinal product must be used immediately for a single, uninterrupted administration, and any remaining solution must not be reused.
Do not use the medicinal product if the solution is not clear, colourless, or contains particles.
All standard 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, 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 drug, providing 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, consult the Summary of Product Characteristics.

Package leaflet: information for the patient

GLUCOSE WITH SODIUM CHLORIDE GALENICA SENESE 2.5%/0.45% infusion solution III

Glucose monohydrate and sodium chloride
Equivalent 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.
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 may be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or nurse. See section 4.

Contents of this leaflet:

What GLUCOSE WITH SODIUM CHLORIDE GALENICA SENESE is and what it is used for
What you need to know before using GLUCOSE WITH SODIUM CHLORIDE GALENICA SENESE
How to use GLUCOSE WITH SODIUM CHLORIDE GALENICA SENESE
Possible side effects
How to store GLUCOSE WITH SODIUM CHLORIDE GALENICA SENESE
Contents of the pack and other information

2. What GLUCOSIO CON SODIO CLORURO GALENICA SENESE is and what it is used for

GLUCOSIO CON SODIO CLORURO GALENICA SENESE 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 (osmolarity of body fluids), for normal cell 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 to correct your body's hydration and to support an adequate intake of mineral salts (through sodium chloride) and calories (through glucose monohydrate).

2. What you should know before using GLUCOSE WITH SODIUM CHLORIDE GALENICA SENESE

Do not use GLUCOSE WITH SODIUM CHLORIDE GALENICA SENESE

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 into the tissues of the brain or spinal cord (intracranial or spinal hemorrhage);
if you are experiencing hallucinations, tremors, and sweating (delirium tremens) caused by excessive loss of body water (dehydration);
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.

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 clumping (pseudoagglutination) or red blood cell destruction (hemolysis).
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using GLUCOSE WITH SODIUM CHLORIDE
GALENICA SENESE.
Use this medicine with caution and inform your doctor in the following cases:

if you have diabetes mellitus or glucose intolerance. During infusion, blood sugar levels (glycemia) and sugar in the urine (glycosuria) must be closely monitored to minimize the risk of elevated 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 have 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 proteins in the urine;
if you have swelling caused by fluid accumulation and salt retention (peripheral or pulmonary edema);
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 sodium levels (sodium retention).

Intravenous glucose infusions are generally isotonic solutions. However, in the body,
glucose-containing solutions may become physiologically highly hypotonic due to the
rapid metabolism of glucose (see below).
Depending on the tonicity of the solution, volume and frequency of infusion, the patient's underlying
clinical condition, and glucose metabolism capacity, intravenous administration of glucose may cause
electrolyte imbalances, particularly low sodium levels in the blood (hypo- or hyperosmolar state).
Special attention must be paid in:

Patients affected by a condition called syndrome of inappropriate antidiuretic hormone secretion, SIADH (e.g., during the acute phase of illness, pain, postoperative stress, infections, burns, and central nervous system disorders);
patients with heart conditions (cardiopathies), liver conditions (hepatopathies), and kidney conditions (nephropathies), and patients treated with medicines that increase the activity of a hormone called vasopressin (vasopressin agonists) (see section 2);

These patients are particularly at risk of developing low sodium levels in the blood
(acute hyponatremia) following infusion of hypotonic solutions.
An acute reduction in blood sodium levels (acute hyponatremia) may cause a condition called
acute hyponatremic encephalopathy, which involves an increase in brain fluid (cerebral edema) and is
characterized by headache, nausea, seizures, drowsiness, and vomiting. These patients are particularly
at risk of severe, irreversible, and life-threatening brain damage.
Children, women of childbearing age, and patients with impaired brain function (e.g., meningitis,
bleeding (hemorrhage) within the skull, contusion (trauma), and cerebral edema) are
particularly at risk of severe and life-threatening cerebral fluid accumulation (cerebral edema) caused by
low sodium levels in the blood (acute hyponatremia).
During prolonged treatment with this medicine, excessive accumulation of water
in the body (water overload and congestive state) and excessive loss of minerals (electrolyte deficit) may occur; your doctor should periodically check the concentration of minerals (electrolytes and
plasma osmolarity), acid-base balance, and fluid volume in the body, correcting
any excessive losses as needed by administering minerals and vitamins.
Monitoring of electrolyte balance (electrolytes), blood glucose
(serum glucose), serum sodium (serum sodium), and other electrolytes may be necessary before and during
administration, with particular attention to serum sodium levels in patients affected
by syndrome of inappropriate antidiuretic hormone secretion (SIADH) and in
patients taking medicines that enhance the action of a hormone called vasopressin (vasopressin agonists), due to the risk of decreased sodium levels in the blood.
Continuous administration without potassium supplementation may lead to reduced 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 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 intended for single, uninterrupted administration and any residual medicine
must not be used.
Children and adolescents
In children, particularly in neonates and low-birth-weight infants, administration of
glucose may increase the risk of elevated blood sugar levels (hyperglycemia). In addition,
in low-birth-weight children, rapid or excessive infusion may increase blood osmolarity and cause bleeding within brain tissue due to rupture of a blood vessel (intracerebral hemorrhage).
Children are particularly at risk of severe and life-threatening cerebral fluid accumulation (cerebral edema) caused by low sodium levels in the blood (acute hyponatremia).
Other medicines and GLUCOSE WITH SODIUM CHLORIDE GALENICA SENESE
Inform your doctor if you are taking, have recently taken, or might take any other medicines, including
those not requiring a prescription.
The following medicines may increase the risk of low sodium levels in the blood during hospitalization (hospital-acquired hyponatremia) following inadequately balanced intravenous fluid therapy:

medicines that stimulate the release of a hormone called vasopressin (chlorpropamide, clofibrate, carbamazepine, vincristine, selective serotonin reuptake inhibitors, 3,4-methylenedioxymethamphetamine, ifosfamide, antipsychotics, narcotics);
medicines that enhance the effect of a hormone called vasopressin (chlorpropamide, NSAIDs, cyclophosphamide);
medicines similar to a hormone called vasopressin (desmopressin, oxytocin, vasopressin, terlipressin);

Other medicines that increase the risk of reduced sodium levels in the blood (hyponatremia)
also include medicines that increase urine production (diuretics in general) and antiepileptic medicines such as oxcarbazepine.
Exercise particular caution and consult your doctor if you are taking:

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

Fertility, pregnancy, and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or 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 careful evaluation of the risks and benefits of treatment.
Glucose with sodium chloride Galenica Senese infusion solution III must be administered with
particular caution in pregnant women during labor, especially regarding serum sodium levels (serum sodium), when administered in combination with a hormone called oxytocin (see
sections 2 and 4).
Driving and using machines
This medicine does not affect the ability to drive or use machinery.

3. How to use GLUCOSIO CON SODIO CLORURO GALENICA SENESE

This medicine will be administered to you by a doctor or other medical specialist. If you have any doubts,
consult your doctor, pharmacist, or nurse.
This medicine will be administered cautiously directly into a vein (intravenous infusion) and at a controlled
infusion rate.
The medicine must be administered at a rate not exceeding 0.4–0.8 g of glucose/hour per kg of body weight.
Your doctor will select the appropriate glucose solution concentration based on your age, weight, your health
condition (e.g. burns, surgical procedures, head injuries, infections), and your electrolyte levels, particularly
sodium levels (electrolyte profile, theoretical osmolarity, and sodium deficit).

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

Use in children
The safety and efficacy of this medicine in children have not been established.
The dose, frequency, infusion volume, and rate of glucose administration must be determined according to
the child's age, weight, and health status (e.g. burns, surgical procedures, head injuries, infections). Particular
caution is required, especially in neonates or children with low body weight, as blood glucose levels may rise
(hyperglycaemia).

If you use more GLUCOSIO CON SODIO CLORURO GALENICA SENESE than you should
Since this medicine will be administered by a doctor or trained healthcare professional, it is unlikely that you
will receive an excessive dose. However, if you think you have been given too much GLUCOSIO CON SODIO
CLORURO GALENICA SENESE, inform your doctor or another healthcare provider immediately.
In case of accidental administration of excessive doses of GLUCOSIO CON SODIO CLORURO GALENICA
SENESE, an increase in water and solute concentration in the body may occur (overhydration and solute
overload). In such cases, the doctor or nurse must immediately stop administration of the medicine and start
corrective therapy to restore normal levels of electrolytes and glucose in the blood (restore acid-base balance
and reduce plasma glucose levels).
Accumulation of chloride ions may lead to increased blood acidity (acidosis) due to decreased bicarbonate ion
concentration.

If you forget to use GLUCOSIO CON SODIO CLORURO GALENICA SENESE
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 using 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.
If GLUCOSIO CON SODIO CLORURO GALENICA SENESE is administered improperly or too rapidly, the following side effects may occur (see section “Warnings and precautions”).
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 levels of water in the body (overhydration);
increased levels of sodium (hypernatraemia) and chloride (hyperchloraemia);
increase or decrease in blood osmotic pressure (hyperosmolarity, hypoosmolarity);
increased blood volume circulating 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);
breathing problems (dyspnoea, respiratory arrest);
bleeding in the brain due to rupture of blood vessels (cerebral haemorrhage);
brain damage caused by 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;
circulatory problems due to blood clot formation and inflammation of the veins at the infusion site (thrombosis and thrombophlebitis);
reduced sodium levels in the blood following hospitalisation, known as hospital-acquired hyponatraemia*;
a brain disorder called acute hyponatraemic encephalopathy*.

*Reduced sodium levels in the blood following hospitalisation (hospital-acquired hyponatraemia) may cause irreversible brain damage and death due to the development of acute hyponatraemic encephalopathy, with frequency not known (see sections 3 and 2).
Following the instructions provided in this leaflet reduces the risk of side effects.
If any of the side effects worsens, or if you notice any side effect not listed in this leaflet, inform your doctor or pharmacist.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please consult your doctor or pharmacist. You may also report side effects directly via the national reporting system at http://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 GALENICA SENESE

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, undamaged packaging and properly stored.
Store in the original packaging and in a tightly closed container. Do not refrigerate or freeze.
Bags: store at a temperature not exceeding 30°C.
Warning: do not use the medicine after the expiry date printed 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 only; any
remaining residue must not be used.
Do not dispose of medicines 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 GALENICA SENESE infusion solution contains
III

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 GALENICA SENESE and contents of the package
Infusion solution, sterile and pyrogen-free.
Glass vial of 50 ml, 100 ml, 250 ml, 500 ml, and 1000 ml.
Plastic bag of 50 ml, 100 ml, 250 ml, 500 ml, and 1000 ml.
Marketing Authorization Holder and Manufacturer
Industria Farmaceutica Galenica Senese S.r.l.
Via Cassia Nord, 351
53014 Monteroni D’Arbia (SI)
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 and 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 Galenica Senese
Due to the presence of glucose, the 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 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, mixing this medicinal product with other medicinal products is not recommended.
After first opening, 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 and colourless or if it contains particles.
Adopt all usual precautions 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, if necessary, 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 drug, providing appropriate symptomatic and supportive measures as needed.
In cases of marked hypernatremia, loop diuretics may be used.
A serum sodium level exceeding 200 mmol/l may require dialysis.

For further information, please consult the Summary of Product Characteristics.