Glucose B. Braun

Package leaflet: Information for the user

GLUCOSE B. BRAUN 5% Injection solution, 10% Injection solution, 20% Injection solution

Glucose monohydrate
Generic medicine
Please read all of this leaflet carefully before you start 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 their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

1. What GLUCOSE B. BRAUN is and what it is used for
2. What you need to know before you use GLUCOSE B. BRAUN
3. How to use GLUCOSE B. BRAUN
4. Possible side effects
5. How to store GLUCOSE B. BRAUN
6. Contents of the pack and other information

1. What GLUCOSIO B. BRAUN is and what it is used for

GLUCOSIO B. BRAUN is a solution for administration either intravenously or intramuscularly, containing the active substance glucose, which belongs to the class of parenteral nutritional solutions.
This medicinal product is indicated to provide water and sugars to the body, supplying caloric intake in emergency situations, especially in patients who do not require salts or in cases where salts should be avoided, and for the treatment of low blood sugar levels (hypoglycaemia).
Concentrated glucose solutions may be mixed with other medicinal products for the preparation of solutions used for direct intravenous nutrition (Total Parenteral Nutrition).
Low-concentration glucose solutions may also be used to dilute other medicinal products intended for direct intravenous injection.

2. What you need to know before using GLUCOSIO B. BRAUN

Do not use GLUCOSIO B. BRAUN

• if you are allergic to glucose or to any of the other ingredients of this medicine (listed in section 6), or if you are allergic to corn (from which glucose is derived);
• if you have problems urinating (anuria);
• if you have bleeding (haemorrhage) occurring in the spinal cord or within the skull with bleeding into brain tissue (intracranial haemorrhage);
• if you suffer from hallucinations, tremors, and sweating (delirium tremens) caused by excessive loss of body water (dehydration);
• if you have low levels of fluids in the body (dehydration);
• if you suffer from liver problems leading to loss of consciousness (hepatic coma).

Glucose solutions must not be administered through the same infusion catheter as whole blood due to the possible risk of red blood cell clumping (pseudo agglutination) or red blood cell breakdown (haemolysis).
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using GLUCOSIO B. BRAUN.
Use this medicine with caution and inform your doctor in the following cases:

• if you have diabetes or are glucose intolerant. During administration, blood sugar levels (glycaemia) and sugar in the urine (glycosuria) must be closely monitored to minimize the risk of elevated levels; insulin may need to be administered if necessary;
• if you suffer from severe heart problems (heart failure);
• if you suffer from severe kidney problems (severe renal failure);
• if you have swelling due to fluid accumulation and retention of mineral salts (oedema with hydro-saline retention);
• if you are taking corticosteroid anti-inflammatory medicines;
• if you are taking certain hormonal medicines (corticotrophin).
• if you are in any of the following conditions that may cause high levels of vasopressin hormone:
• you have an acute illness
• you have pain
• you have undergone surgery
• you have infections or burns
• you have brain diseases
• you have liver, heart, or kidney diseases. This may increase the risk of low sodium levels in the blood (hyponatraemia), leading to headache, nausea, seizures, drowsiness, vomiting, cerebral oedema, which may result in death. People at higher risk of cerebral oedema include:
• children
• women (especially those of childbearing age)
• individuals with altered fluid levels in the brain (e.g. due to meningitis, intracranial bleeding, or cerebral contusion).

This medicine may contain traces of corn which could cause allergic reactions. Inform your doctor
if you are allergic to corn.
If you have low levels of vitamin B1, administration of GLUCOSIO B. BRAUN may cause Wernicke's encephalopathy (a serious brain disorder). Your doctor may correct this deficiency before administering the medicine.
Children
In children, especially neonates and low-birth-weight infants, administration of glucose may increase the risk of elevated blood glucose levels (hyperglycaemia). Moreover, in low-birth-weight children, rapid or excessive infusion may increase blood osmolarity and cause intracerebral haemorrhage (within brain tissue).
Other medicines and GLUCOSIO B. BRAUN
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

• GLUCOSIO B. BRAUN should be administered with caution if you are taking corticosteroid anti-inflammatory medicines (corticosteroids) or hormonal medicines (corticotrophin), as they may increase your blood sugar levels, potentially unmasking latent diabetes mellitus;
• medicines affecting the vasopressin hormone, e.g.: chlorpropamide, clofibrate, carbamazepine, vincristine, selective serotonin reuptake inhibitors, 3,4-methylenedioxy-N-methamphetamine, ifosfamide, antipsychotics, narcotics, NSAIDs, cyclophosphamide, desmopressin, oxytocin, vasopressin, terlipressin, diuretics in general, and oxcarbamazepine, as they may increase the risk of hyponatraemia. If you need to take these medicines, medical monitoring during treatment is required.

Glucose solutions may be incompatible with other infusion solutions.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
Do not use this medicine during pregnancy unless absolutely necessary and always under strict medical supervision.
If you are pregnant, this medicine should be administered with particular caution during labour due to the risk of hyponatraemia, especially if administered concomitantly with a medicine inducing labour (oxytocin).
Breastfeeding
There are no available data on the effects of this medicine during breastfeeding; therefore, exercise particular caution if breastfeeding.
Driving and using machines
There are no data available on the effects of this medicine on the ability to drive or operate machinery.

3. How to use GLUCOSE B. BRAUN

This medicine must be used exactly as directed by your doctor and will be administered by a doctor or other qualified medical personnel. If you have any doubts, consult your doctor, pharmacist, or nurse.
Before and during administration, your doctor will monitor your body fluid levels, glucose levels, and electrolyte levels, particularly sodium in the blood.
GLUCOSE B. BRAUN 5% and 10% will be administered cautiously by direct intravenous infusion (intravenous route) or into a muscle (intramuscular route), and at a controlled infusion rate.
GLUCOSE B. BRAUN 20% must NOT be administered by subcutaneous injection (under the skin) or into the muscle (intramuscular route), but exclusively by direct intravenous injection (central venous catheter).

Use in adults
The doctor will select the appropriate glucose solution concentration based on your age, body weight, clinical condition, and blood electrolyte and pH levels.

Use in the elderly
No significant differences in response to glucose administration between elderly and younger patients have been demonstrated. As a general rule, if you are elderly, your doctor will adjust the dose and monitor you closely during treatment with this medicine.

Use in children and adolescents
In children, particularly in neonates or children with low body weight, this medicine must be administered cautiously and at a controlled rate (see section "Children"). Dosage and administration rate must be adjusted according to the child's age, weight, and clinical condition. Generally, solutions with a concentration higher than 10% are not used.

If you use more GLUCOSE B. BRAUN than you should
If you think you have been given an excessive dose of GLUCOSE B. BRAUN, inform your doctor immediately or go to the nearest hospital.
Prolonged administration of GLUCOSE B. BRAUN may lead to an increase in body water and accumulation of solutes (overhydration and solute overload). In such cases, the doctor or nurse must immediately stop administration of the medicine and initiate corrective therapy.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them. Some of the side effects listed below have occurred in cases of incorrect administration of the medicine, for example too rapid administration or administration by a route other than intravenous.

The following side effects may occur with unknown frequency (frequency cannot be estimated from the available data):

• Leakage of the medicine into the 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);
• Increased body temperature (fever);
• Increased metabolic rate;
• Increased blood sugar (hyperglycaemia);
• Increased insulin levels;
• Increased adrenaline levels;
• Low levels of sodium in the blood (hospital-acquired hyponatraemia);
• Cerebral oedema (hyponatraemic encephalopathy);
• Fluid accumulation causing swelling in the legs and ankles (peripheral oedema);
• Bleeding within the head (cerebral haemorrhage);
• Brain damage caused by blocked blood supply (cerebral ischaemia);
• Hypersensitivity reactions, including a severe allergic reaction called anaphylaxis which may be fatal (in patients allergic to maize).

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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store GLUCOSE B. BRAUN

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the container after “EXP.”.
The expiry date refers to the last day of that month.
Store in tightly closed containers.
Keep the container tightly closed. Do not refrigerate.
Do not use the glucose solution if it is not clear and colourless or slightly yellowish, or if it contains particles.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What GLUCOSIO B. BRAUN contains
GLUCOSIO B. BRAUN 5% solution for injection

• The active substance is glucose monohydrate. Each liter of solution contains 55 g of glucose monohydrate (50 g of anhydrous glucose) (278 mOsm/L, pH 3.5 - 6.5).
• The other component is water for injections.

GLUCOSIO B. BRAUN 10% solution for injection

• The active substance is glucose monohydrate. Each liter of solution contains 110 g of glucose monohydrate (100 g of anhydrous glucose) (555 mOsm/L, pH 3.5 - 6.5).
• The other component is water for injections.

GLUCOSIO B. BRAUN 20% solution for injection

• The active substance is glucose monohydrate. Each liter of solution contains 220 g of glucose monohydrate (200 g of anhydrous glucose) (1110 mOsm/L, pH 3.5 - 6.5).
• The other component is water for injections.

Description of the appearance of GLUCOSIO B. BRAUN and pack contents
GLUCOSIO B. BRAUN 5% sterile and pyrogen-free solution for injection
GLUCOSIO B. BRAUN 10% sterile and pyrogen-free solution for injection
Packs contain 1 or 20 vials of 10 ml, 20 ml.
GLUCOSIO B. BRAUN 20% sterile and pyrogen-free solution for injection
Packs contain 1 or 20 vials of 5 ml, 10 ml.

Marketing Authorization Holder
B. Braun Melsungen AG - Carl Braun Strasse, 1 - D-34212 Melsungen (Germany)

Manufacturer
B. Braun Melsungen AG - Mistelweg, 2 - 12357 – Berlin - Germany
B. Braun Medical SA - Carretera de Terrassa, 121 - 08191 Rubì (Barcelona) - Spain

The following information is intended exclusively for physicians or healthcare professionals
Dosage and method of administration
5% and 10% glucose solutions may be administered both intramuscularly and intravenously. Subcutaneous administration may cause irritation.
20% solutions must not be administered subcutaneously or intramuscularly, but must be administered exclusively via central venous catheter.
If peripheral administration is required, for example in the emergency treatment of hypoglycemic crises, the solutions must be injected very slowly into a large-caliber vein of the arm.
It is recommended to take all usual precautions to maintain sterility before and during intravenous infusion. Do not use if the packaging is damaged. Do not use the glucose solution if it is not clear, colorless or slightly straw-yellow, or if it contains particles.

Adults
The concentration of the glucose solution and the dose to be used depend on the patient's characteristics (age, weight, clinical condition, fluid and electrolyte balance, acid-base balance).

Elderly
Clinical studies and clinical practice have not shown differences in response between elderly and younger patients following glucose administration. As a general rule, caution is required when administering drugs to elderly patients.

Children
The dosage and rate of glucose administration must be selected according to the patient's age, weight, and clinical condition. Generally, solutions with concentrations exceeding 10% are not administered. Particular caution is required in pediatric patients, especially neonates or children with low body weight, as glucose administration may increase the risk of hyperglycemia. Furthermore, in children with low body weight, rapid or excessive infusion may cause an increase in serum osmolarity and intracerebral hemorrhage.

Special warnings and precautions for use
The 5% solution is isotonic with blood.
The 10% and 20% solutions are hypertonic with blood and must be administered with caution and at a controlled infusion rate.
One gram of glucose provides approximately 3.74 kcal (about 15.6 kJ) of caloric energy.
Glucose solutions must be administered with caution in patients with overt or subclinical diabetes mellitus or with any type of glucose intolerance. To minimize the risk of hyperglycemia and subsequent glycosuria, blood and urine glucose levels should be monitored, and insulin administered if required.
Particular caution is required in patients with heart failure, severe renal failure, clinical conditions associated with edema and water-salt retention, and in patients receiving corticosteroids or corticotropin.
Monitoring of electrolyte balance, serum glucose, serum sodium, and other electrolytes may be necessary before and during administration, particularly in patients with 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.
Glucosio B. Braun infusion solution may become extremely hypotonic after administration due to glucose metabolism in the body.
Intravenous glucose infusions are generally isotonic solutions. However, in the body, glucose-containing solutions may become extremely hypotonic physiologically due to the rapid metabolism of glucose.
Depending on the tonicity of the solution, volume and frequency of infusion, underlying clinical conditions of the patient, and the patient's capacity for glucose metabolism, intravenous administration of glucose may cause electrolyte disturbances, particularly hypo- or hyperosmolar hyponatremia.

Hyponatremia:
Patients with non-osmotic vasopressin release (e.g., in the acute phase of illness, postoperative pain, infections, burns, and central nervous system diseases), patients with cardiac, hepatic, or renal disorders, and patients treated with vasopressin agonists are particularly at risk of acute hyponatremia following infusion of hypotonic solutions.
Acute hyponatremia may cause acute hyponatremic encephalopathy (cerebral edema), characterized by headache, nausea, seizures, lethargy, and vomiting. Patients with cerebral edema are particularly at risk of severe, irreversible, and life-threatening brain damage.
Children, women of childbearing age, and patients with reduced cerebral compliance (e.g., meningitis, intracranial hemorrhage, and cerebral contusion) are particularly at risk of severe, life-threatening cerebral edema caused by acute hyponatremia.

Incompatibilities
Intravenous glucose solutions are incompatible with:
cyanocobalamin;
kanamycin sulfate;
sodium novobiote;
sodium warfarin.

Additionally, there are conflicting opinions regarding the compatibility of glucose with the following solutions:
calcium chloride;
magnesium chloride;
potassium chloride;
sodium chloride;
sodium lactate;
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 are stable in glucose solutions only for a short period.

Shelf life
36 months if the packaging is intact.
After first opening: After first opening of the packaging, the medicinal product must be used immediately for a single, uninterrupted administration; any remaining solution must be discarded.
Do not administer if the solution is not clear, colorless or slightly straw-yellow, or if it contains particles.

Special precautions for storage
Store in tightly closed containers.
Do not use the glucose solution if it is not clear, colorless or slightly straw-yellow, or if it contains particles.
Do not refrigerate.
Keep the container tightly closed.
Take all usual precautions to maintain sterility before and during administration.
Do not use if the packaging is damaged.
Unused medicine and waste derived from it must be disposed of in accordance with local regulations.

For further information, consult the Summary of Product Characteristics.
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, 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 could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

1. What GLUCOSIO B. BRAUN is and what it is used for
2. What you need to know before using GLUCOSIO B. BRAUN
3. How to use GLUCOSIO B. BRAUN
4. Possible side effects
5. How to store GLUCOSIO B. BRAUN
6. Package contents and other information

1. What GLUCOSIO B. BRAUN is and what it is used for

GLUCOSIO B. BRAUN is a solution for direct intravenous administration (intravenous infusion) containing the active substance glucose, belonging to the class of parenteral nutritional solutions.
This medicinal product is indicated to provide water and sugars to the body in emergency situations, especially in patients who do not require salts or in cases where salts should be avoided, and for the treatment of low blood sugar levels (hypoglycemia).

2. What you should know before using GLUCOSIO B. BRAUN

Do not use GLUCOSIO B. BRAUN

• if you are allergic to glucose or to any of the other ingredients of this medicine (listed in section 6), or if you are allergic to corn (from which glucose is derived);
• if you have problems urinating (anuria);
• if you have bleeding (haemorrhage) occurring in the spinal cord or within the skull (intracranial);
• if you suffer from hallucinations, tremors, and sweating (delirium tremens) caused by excessive loss of water from the body (dehydration);
• if you have low levels of fluids in the body (dehydration);
• if you suffer from liver problems leading to loss of consciousness (hepatic coma).

Glucose solutions must not be administered through the same infusion catheter as whole blood due to the possible risk of red blood cell clumping (pseudo-agglutination) or red blood cell breakdown (haemolysis).
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using GLUCOSIO B. BRAUN.
Use this medicine with caution and inform your doctor in the following cases:

• if you suffer from diabetes or are glucose intolerant. During infusion, blood sugar levels (glycaemia) and sugar in the urine (glycosuria) must be closely monitored to minimize the risks of hyperglycaemia and glycosuria; insulin should be administered if necessary;
• if you suffer from severe heart problems (heart failure);
• if you suffer from severe kidney problems (severe renal failure);
• if you have swelling caused by fluid accumulation and salt retention (oedema with hydro-saline retention);
• if you are taking corticosteroid anti-inflammatory medicines;
• if you are taking certain hormonal medicines (corticotrophin);
• if you are in any of the following conditions that may cause high levels of vasopressin hormone:
• you have an acute illness
• you have pain
• you have undergone surgery
• you have infections, burns
• you have brain diseases
• you have liver, heart, or kidney diseases
  This may increase the risk of low sodium levels in the blood (hyponatraemia), with symptoms such as headache, nausea, seizures, drowsiness, vomiting, cerebral oedema, which may lead to death. Individuals at higher risk of cerebral oedema include:
• children
• women (especially those of childbearing age)
• individuals with altered fluid levels in the brain (e.g. due to meningitis, intracranial bleeding, or cerebral contusion).

This medicine may contain traces of corn which may cause allergic reactions. Inform your doctor if you are allergic to corn.
During prolonged treatment with this medicine, excess water in the body (fluid overload and congestive state) and excessive loss of minerals such as potassium and phosphate (electrolyte deficiency) may occur; your doctor should periodically check electrolyte concentrations and correct any excessive losses by administering minerals and vitamins as needed.
If you have low levels of vitamin B1, administration of GLUCOSIO B. BRAUN may cause Wernicke's encephalopathy (a serious brain disorder). Your doctor may correct this deficiency before administering the medicine.
Concentrated glucose solutions must not be administered by subcutaneous injection or intramuscular injection.
Children
In children, particularly in neonates and low-birth-weight infants, glucose administration may increase the risk of elevated blood glucose levels (hyperglycaemia). Furthermore, in low-birth-weight children, rapid or excessive infusion may cause increased blood osmolarity and intracerebral haemorrhage (within brain tissue).
Other medicines and GLUCOSIO B. BRAUN
Inform your doctor or pharmacist if you are using, have recently used, or might use any other medicines.
GLUCOSIO B. BRAUN should be administered with caution if you are taking the following medicines:

• corticosteroid anti-inflammatory medicines (corticosteroids) or hormonal medicines (corticotrophin), as they may increase your blood sugar levels, potentially leading to latent diabetes mellitus;
• medicines affecting vasopressin hormone, e.g.: chlorpropamide, clofibrate, carbamazepine, vincristine, selective serotonin reuptake inhibitors, 3,4-methylenedioxy-N-methamphetamine, ifosfamide, antipsychotics, narcotics, NSAIDs, cyclophosphamide, desmopressin, oxytocin, vasopressin, terlipressin, diuretics in general, and oxcarbazepine, as they may increase the risk of hyponatraemia. Glucose solutions may be incompatible with other infusion solutions.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before this medicine is administered to you.
Pregnancy
Do not use this medicine during pregnancy unless absolutely necessary and only under strict medical supervision.
If you are pregnant, this medicine should be administered with particular caution during labour due to the risk of hyponatraemia, especially if administered in combination with a medicine inducing labour (oxytocin).
Breastfeeding
There are no available data on the effects of this medicine during breastfeeding; therefore, exercise particular caution if you are breastfeeding.
Driving and using machines
There are no available data on the effects of this medicine on driving or operating machinery.

3. How to use GLUCOSIO B. BRAUN

This medicine will be administered to you by a doctor or other specialized medical personnel. If you have any doubts,
please consult your doctor, pharmacist, or nurse.
Before and during administration, your doctor will monitor your body fluid levels, glucose, and electrolyte levels,
particularly sodium in the blood.
This medicine will be administered with caution and at a controlled rate directly into a vein
(intravenous infusion) by specialized medical personnel. This medicine must not be
administered subcutaneously or intramuscularly.
The usual infusion rate is 0.4 – 0.8 g/hour per kg of body weight.
The doctor will select the appropriate glucose solution concentration based on your age, weight, health condition, and
blood electrolyte and pH levels.
Below are general guidelines for selecting different glucose concentrations.

• 5% or 10% solutions are used for fluid and caloric replacement;
• 20% solution is used for caloric replacement with limited fluid replacement.

Use in the elderly
No differences in response between elderly and younger patients have been demonstrated following
glucose administration.
Use in children and adolescents
In children, particularly in neonates and children with low body weight, this medicine must be administered with caution and at a controlled rate (See section "Children"). Dosage and infusion rate must be determined according to the patient's age, weight, and clinical condition. Generally, solutions with a concentration higher than 10% are not used.
All standard precautions should be taken to maintain sterility before and during
intravenous infusion. Do not use if the packaging is damaged. Do not use if the glucose solution is not clear.
If you use more GLUCOSIO B. BRAUN than you should
This medicine will be administered by a doctor or specialized personnel; therefore, it is unlikely that you will receive an excessive dose. However, if you think that you have been given an excessive dose of GLUCOSIO B. BRAUN, inform your doctor immediately or go to the nearest hospital.
In case of accidental administration of excessive doses of GLUCOSIO B. BRAUN, 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.
If you stop treatment with GLUCOSIO B. BRAUN
If concentrated glucose infusion needs to be suddenly discontinued, the doctor will gradually reduce the dose by administering 5% or 10% glucose, in order to prevent a rapid drop in blood sugar (rebound hypoglycemia).
If you have any doubts about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
The following side effects may occur:
Not known (frequency cannot be estimated from the available data):

• leakage of the medicine into the 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);
• increased body temperature (fever);
• increased fluid in the body (hyperhydration) and decreased levels of potassium (hypokalaemia), magnesium (hypomagnesaemia), and phosphate (hypophosphataemia);
• increased metabolic rate;
• increased blood sugar (hyperglycaemia);
• increased blood osmotic pressure (hyperosmolarity);
• increased blood volume in the body (hypervolaemia);
• decreased blood sugar (hypoglycaemia);
• increased insulin levels;
• increased adrenaline levels;
• low sodium levels in the blood (hospital-acquired hyponatraemia);
• brain swelling (hyponatraemic encephalopathy);
• fluid accumulation causing swelling in the legs and ankles (peripheral oedema);
• fluid accumulation in the lungs (pulmonary oedema);
• bleeding in the brain (cerebral haemorrhage);
• brain damage caused by blocked blood supply (cerebral ischaemia);
• hypersensitivity reactions, including a severe allergic reaction called anaphylaxis which can be fatal (in patients with maize allergy).

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

5. How to store GLUCOSE B. BRAUN

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after “Exp”.
The expiry date refers to the last day of that month.
Keep the container tightly closed. Do not refrigerate.
After first opening of the container, the medicine must be used immediately for a single, uninterrupted
administration; any remaining solution must be discarded.
Do not administer if the solution is not clear, colourless, or slightly straw-yellow, or if it contains
particles.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of
medicines no longer required. This will help protect the environment.

6. Package Contents and Other Information

What GLUCOSIO B. BRAUN Contains
GLUCOSIO B. BRAUN 5% infusion solution

• The active substance is glucose. Each litre of solution contains 55 g of glucose monohydrate (50 g anhydrous glucose) (278 mOsmol/l, pH 3.5–6.5).
• The other component is water for injections.

GLUCOSIO B. BRAUN 10% infusion solution

• The active substance is glucose. Each litre of solution contains 110 g of glucose monohydrate (100 g anhydrous glucose) (555 mOsmol/l, pH 3.5–6.5).
• The other component is water for injections.

GLUCOSIO B. BRAUN 20% infusion solution

• The active substance is glucose. Each litre of solution contains 220 g of glucose monohydrate (200 g anhydrous glucose) (1110 mOsmol/l, pH 3.5–6.5).
• The other component is water for injections.

Description of the Appearance of GLUCOSIO B. BRAUN and Contents of the Package
GLUCOSIO B. BRAUN 5% infusion solution
Packages contain 1 or 20 vials of 50 ml, 100 ml, 250 ml, 500 ml, 1000 ml.
Packages contain 10 vials of 500 ml, 1000 ml.
Packages contain 1 bag of 100 ml, 250 ml, 500 ml, 1000 ml.

GLUCOSIO B. BRAUN 10% infusion solution
Packages contain 1 or 20 vials of 100 ml, 250 ml, 500 ml.
Packages contain 10 vials of 500 ml.
Packages contain 1 bag of 100 ml, 250 ml, 500 ml, 1000 ml.

GLUCOSIO B. BRAUN 20% infusion solution
Packages contain 1 or 20 vials of 100 ml, 250 ml, 500 ml, 1000 ml.
Packages contain 10 vials of 500 ml.

Marketing Authorization Holder
B. Braun Melsungen AG – Carl Braun Strasse, 1 – D-34212 Melsungen – Germany.

Manufacturer
B. Braun Melsungen AG – Carl-Braun Strasse, 1 – 34212 – Melsungen – Germany.
B. Braun Medical SA – Carretera de Terrassa, 121 – 08191 Rubì (Barcelona) – Spain.

The following information is intended exclusively for physicians or healthcare professionals:
Dosage and Method of Administration
Glucose solutions are administered intravenously.
The 20% solution must be administered exclusively via central venous catheter.
If peripheral administration is required, for example in emergency treatment of hypoglycaemic crises, the solution must be injected very slowly into a large-calibre vein of the arm.
The usual infusion rate is 0.4–0.8 g/hour per kg of body weight.
Below are general guidelines for selecting different glucose concentrations:

• 5%–10% solutions: fluid and caloric replacement;
• 20% solution: caloric replacement with limited fluid replacement.

Adults
The concentration of the glucose solution and the dose to be used depend on the patient's characteristics (age, weight, clinical condition, fluid-electrolyte and acid-base balance).

Elderly
Clinical studies and clinical practice have not shown differences in response between elderly and younger patients following glucose administration.

Children
The dosage and rate of glucose administration must be selected based on the child's age, weight, and clinical condition. Solutions with concentrations above 10% are generally not used. Particular caution is required in paediatric patients, especially neonates or children with low body weight, as glucose administration may increase the risk of hyperglycaemia. Furthermore, in children with low body weight, rapid or excessive infusion may lead to increased serum osmolarity and intracerebral haemorrhage.

Special Warnings and Precautions for Use
The 5% solution is isotonic with blood.
The 10% and 20% solutions are hypertonic with respect to blood and must be infused cautiously and at a controlled infusion rate.
One gram of glucose provides approximately 3.74 kcal (about 15.6 kJ) of energy.
Glucose solutions must be administered with caution in patients with overt or subclinical diabetes mellitus or with any form of glucose intolerance. To minimise the risk of hyperglycaemia and subsequent glycosuria, blood and urine glucose levels should be monitored, and insulin administered if required.
During prolonged use of concentrated glucose solutions, fluid overload, congestive state, and electrolyte deficits—particularly of potassium and phosphate—may occur. Therefore, it is essential to monitor blood electrolytes and to correct imbalances in fluid and electrolyte balance as necessary.
Additionally, vitamins and mineral salts may be administered if required.
When concentrated glucose infusion must be abruptly discontinued, it is advisable to continue with a 5%–10% glucose infusion to prevent rebound hypoglycaemia.
Particular caution is required especially in patients with cardiac failure, severe renal failure, clinical conditions associated with oedema and water-salt retention, and in patients receiving corticosteroids or corticotrophin.
Concentrated glucose solutions must not be administered subcutaneously or intramuscularly.
Monitoring of electrolyte balance, serum glucose, serum sodium, and other electrolytes may be necessary before and during administration, particularly in patients with 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 hyponatraemia.
Monitoring of serum sodium is particularly important for physiologically hypotonic solutions.
Glucosio B. Braun infusion solution may become extremely hypotonic after administration due to the metabolism of glucose in the body.
Intravenous glucose infusions are generally isotonic solutions. However, in the body, glucose-containing solutions may become physiologically extremely hypotonic due to the rapid metabolism of glucose.
Depending on the tonicity of the solution, volume and frequency of infusion, the patient's underlying clinical condition, and the capacity for glucose metabolism, intravenous administration of glucose may cause electrolyte disturbances, particularly hypo- or hyperosmolar hyponatraemia.

Hyponatraemia:
Patients with non-osmotic release of vasopressin (e.g., in the acute phase of illness, pain, postoperative stress, infections, burns, and central nervous system disorders), patients with cardiac, hepatic, or renal diseases, and patients treated with vasopressin agonists are particularly at risk of acute hyponatraemia following infusion of hypotonic solutions.
Acute hyponatraemia may cause acute hyponatraemic encephalopathy (cerebral oedema), characterised by headache, nausea, seizures, lethargy, and vomiting. Patients with cerebral oedema are at particular risk of severe, irreversible, and life-threatening brain damage.
Children, women of childbearing age, and patients with reduced cerebral compliance (e.g., meningitis, intracranial haemorrhage, and cerebral contusion) are particularly at risk of severe and life-threatening cerebral oedema caused by acute hyponatraemia.

Incompatibilities
Intravenous glucose solutions are incompatible with:

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

Additionally, there are conflicting opinions regarding the compatibility of glucose with the following solutions:

• calcium chloride;
• magnesium chloride;
• potassium chloride;
• sodium chloride;
• sodium lactate;
• 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 haemolysis.
Ampicillin and amoxicillin are stable in glucose solutions only for a short period.

Shelf Life
36 months.
After first opening: after first opening of the container, the medicinal product must be used immediately for a single, uninterrupted administration.

Special Precautions for Storage and Handling
Store in tightly closed containers.
Do not use the glucose solution if it is not clear, colourless, or slightly straw-yellow, or if it contains particles.
Do not refrigerate.
Keep the container tightly closed.
Adopt all usual precautions to maintain sterility before and during administration.
Do not use if the packaging is damaged.
Unused medicinal product and waste material must be disposed of in accordance with local regulations.

For further information, consult the Summary of Product Characteristics.