GLUCOSIO 5% Roztwór do infuzji

Treść ulotki

1. GLUCOSIO B. BRAUN 5% Injectable Solution, 10% Injectable Solution, 20% Injectable Solution
   1. What is GLUCOSIO B. BRAUN and what is it 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
   7. What is GLUCOSIO B. BRAUN and what is it used for
   8. What you need to know before using GLUCOSIO B. BRAUN
   9. How to use GLUCOSIO B. BRAUN
   10. Possible side effects
   11. How to store GLUCOSIO B. BRAUN
   12. Package Contents and Other Information

GLUCOSIO B. BRAUN 5% Injectable Solution, 10% Injectable Solution, 20% Injectable Solution

Glucose monohydrate

Equivalent medicinal product

Read this leaflet carefully before using this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If any side effects occur, including any not listed in this leaflet, tell 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 you use GLUCOSIO B. BRAUN
• 3. How to use GLUCOSIO B. BRAUN
• 4. Possible side effects
• 5. How to store GLUCOSIO B. BRAUN
• 6. Contents of the pack and other information

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

GLUCOSIO B. BRAUN is a solution for administration both intravenously and intramuscularly, containing the active ingredient glucose, belonging to the class of parenteral nutritional solutions.
This medicine is indicated to provide the body with water and sugars suitable for providing a caloric intake
in emergency cases, especially in patients who do not require salts or in cases where these should be
avoided, and for the treatment of low blood sugar levels (hypoglycemia).
Concentrated glucose solutions can be mixed with other medicines to prepare
solutions for direct intravenous nutrition (Total Parenteral Nutrition).
Low-concentration glucose solutions can also be used to dilute other medicines 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 extracted)
• if you have problems with urination (anuria);
• if you have bleeding (hemorrhages) occurring at the spinal level or inside the skull with blood pouring into brain tissue (intracranial hemorrhage);
• if you suffer from hallucinations, tremors and sweating (delirium tremens) caused by excessive water loss from the body (dehydration);
• if you have low fluid levels in the body (dehydration);
• if you suffer from liver problems leading to loss of consciousness (hepatic coma).

Glucose solutions should not be administered through the same infusion catheter with whole blood due to the possible risk of red blood cell aggregation (pseudo-agglutination) or red blood cell rupture (hemolysis).

Warnings and precautions
Talk to your doctor, pharmacist or nurse before using GLUCOSIO B. BRAUN.
Use this medicine with cautionand inform your doctor in the following cases:

• if you suffer from diabetes or are intolerant to glucose. During administration, blood sugar (glycemia) and urine (glycosuria) levels should be carefully monitored to minimize the risk of them reaching high values; if necessary, insulin should be administered;
• 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 retention of mineral salts (edema with hydrosaline retention);
• if you are taking anti-inflammatory corticosteroid medicines;
• if you are taking certain hormonal medicines (corticotropin).
• if you are in one of the following conditions that can cause high levels of the 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 and kidney diseases. This can increase the risk of low sodium levels in the blood (hyponatremia) with headache, nausea, seizures, drowsiness, vomiting, cerebral edema which can lead to death. People with a higher risk of cerebral edema are:
• children
• women (especially of childbearing potential)
• people with altered fluid levels in the brain (e.g. due to meningitis, bleeding in the skull or brain contusion).

This medicine may contain traces of corn which can cause allergic reactions. Tell your doctor
if you suffer from corn allergies.
If you have low levels of vitamin B1, the administration of GLUCOSIO B. BRAUN can cause
Wernicke's encephalopathy (a serious brain disease). Your doctor may correct this deficiency before
administration of the medicine.

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

Other medicines and GLUCOSIO B. BRAUN
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.

• GLUCOSIO B. BRAUN must be administered with cautionif you are taking medicines. anti-inflammatory steroid medicines (corticosteroids) or hormonal medicines (corticotropin), because they may cause you to have an increase in blood sugar that could lead to latent diabetes mellitus;
• medicines that act on the vasopressin hormone e.g: chlorpropamide, clofibrate, carbamazepine, vincristine, selective serotonin reuptake inhibitors, 3,4-methylenedioxymethamphetamine, ifosfamide, antipsychotics, narcotics, NSAIDs, cyclophosphamide, desmopressin, oxytocin, vasopressin, terlipressin, diuretics in general and oxcarbazepine as they can increase the risk of hyponatremia. If you need to take these medicines, a check-up by your doctor is necessary during treatment.

Glucose solutions may be incompatible with other infusion solutions.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are 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 must be administered with particular caution during
labor due to the risk of hyponatremia, especially if administered in association with a
medicine that induces labor (oxytocin).
Breastfeeding
There are no data available to establish the effect of this medicine during breastfeeding, therefore take
particular care if you are breastfeeding.

Driving and operating machinery
There are no data available regarding the effects of the medicine on driving and operating
machinery.

3. How to use GLUCOSIO B. BRAUN

This medicine must be used following the doctor's instructions exactly. It may 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, the doctor will monitor your fluid levels in the body, glucose and salts, in particular sodium in the blood.
GLUCOSIO B.BRAUN 5% and 10% will be administered to you with caution directly into a vein (intravenous infusion) or into a muscle (intramuscular route) and at a controlled infusion rate.
GLUCOSIO B.BRAUN 20% must not be administeredby injection under the skin (subcutaneous route)
or into the muscle (intramuscular route), but exclusively by direct injection into a vein (central venous catheter).

Use in adults
The doctor will choose the concentration of glucose solution to be used based on age, weight and your health conditions and the levels of mineral salts and blood pH.

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

Use in children and adolescents
In children, especially in newborns or children with low body weight, this medicine must be administered with caution and at a controlled rate (See section Children). The dosage and administration rate must be chosen based on the age, weight and clinical condition of the child. Generally, solutions with a concentration higher than 10% are not used.

If you use more GLUCOSIO B. BRAUN than you should
If you think you have been given an excessive dose of GLUCOSIO B. BRAUN, inform your doctor immediately or go to the nearest hospital.
In case of prolonged administration of GLUCOSIO B. BRAUN, an increase in the amount of water and solutes in the body (hyperhydration and solute overload) may occur. In this case, the doctor or nurse must immediately stop administering the medicine and start corrective therapy.
If you have any doubts about the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some of the side effects listed below have occurred with incorrect
administration of the medicine, for example, administration that is too fast or via a route other than
intravenous.
The following side effects can occur with unknown frequency(the frequency of which cannot be
established based on available data):

• leakage of the medicine into the tissues around the injection site (extravasation);
• infection at the infusion site and local pain;
• circulation problems due to the formation of blood clots and inflammation of the veins in the infusion area (thrombosis and thrombophlebitis);
• increased body temperature (fever);
• increased metabolic rate;
• increased blood sugar (hyperglycemia);
• increased insulin level;
• increased adrenaline level;
• low levels of sodium in the blood (hospital-acquired hyponatremia)
• brain swelling (hyponatremic encephalopathy)
• fluid retention with swelling in the legs and ankles (peripheral edema);
• bleeding in the head (cerebral hemorrhage);
• brain damage caused by a blockage of blood supply (cerebral ischemia)
• hypersensitivity reactions, including a severe allergic reaction called anaphylaxis which can be fatal (in patients with corn allergy)

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

5. How to store GLUCOSIO B. BRAUN

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after “EXP.”.
The expiry date refers to the 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 does not appear clear, colourless or slightly straw-yellow, or if
it contains particles.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to eliminate
medicines that 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% injectable solution

• The active ingredient 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% injectable solution

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

GLUCOSIO B. BRAUN 20% injectable solution

• The active ingredient is glucose monohydrate. Each liter of solution contains 220 g of glucose monohydrate (200 g 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 contents of the pack
GLUCOSIO B. BRAUN 5% sterile and apyrogenic injectable solution
GLUCOSIO B. BRAUN 10% sterile and apyrogenic injectable solution
The packs contain 1 or 20 vials of 10 ml, 20 ml.
GLUCOSIO B. BRAUN 20% sterile and apyrogenic injectable solution
The packs contain 1 or 20 vials of 5 ml, 10 ml.

Marketing Authorisation 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 Rubí (Barcelona) - Spain

The following information is intended exclusively for doctors or healthcare professionals
Dosage and method of administration
5% and 10% Glucose solutions can be administered both intramuscularly and intravenously. Subcutaneous administration may cause irritation.
20% solutions should not be administered subcutaneously or intramuscularly, but must be administered exclusively via a central venous catheter.
If administration peripherally is necessary, for example in the emergency treatment of hypoglycemic crises, the solutions must be injected very slowly into a large-caliber vein in the arm.
It is recommended to adopt 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 characteristics of the patient (age, weight, clinical condition, water-electrolyte balance and acid-base balance).
Elderly
Clinical studies and clinical practice have not shown differences in response between elderly and younger patients following the administration of glucose. As a general rule, caution should be exercised when administering drugs to elderly patients.
Children
The dosage and rate of administration of glucose must be chosen according to the age, weight and clinical condition of the patient. Generally, solutions with a concentration higher than 10% are not administered. Particular caution is required in pediatric patients and especially in neonates or children with low body weight, as the administration of glucose may increase the risk of hyperglycemia. Furthermore, in children with low body weight, a rapid or excessive infusion may cause an increase in serum osmolarity and intracranial 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 a caloric contribution of approximately 3.74 Kcal (approximately 15.6 Kjoules).
Glucose solutions must be administered with caution in patients with diagnosed or subclinical diabetes mellitus or with glucose intolerance of any kind. To minimize the risk of hyperglycemia and subsequent glycosuria, blood and urine glucose must be monitored and, if necessary, insulin must be administered.
Particular caution is required in patients with heart failure, severe renal failure, clinical conditions associated with edema and hydrosaline retention, and in patients receiving corticosteroids or corticotropin.
It may be necessary to monitor electrolyte balance, serum glucose, serum sodium and other electrolytes before and during administration, particularly in patients with increased non-osmotic vasopressin release (syndrome of inappropriate antidiuretic hormone secretion, SIADH) and in patients undergoing 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 the metabolization of glucose in the body.
Intravenous glucose infusions are generally isotonic solutions. However, in the body, solutions containing glucose may become extremely hypotonic at a physiological level due to the rapid metabolization of glucose.
Depending on the tonicity of the solution, the volume and rate of infusion and the underlying clinical conditions of the patient, as well as the ability to metabolize glucose, intravenous administration of glucose may cause electrolyte disturbances and especially hypo- or hyperosmotic hyponatremia.
Hyponatremia:
Patients with non-osmotic vasopressin release (e.g. in the acute phase of the disease, surgical pain, infections, burns and diseases of the central nervous system), patients with heart disease, liver disease and kidney disease and patients treated with vasopressin agonists are particularly at risk of acute hyponatremia following infusion of hypotonic solutions.
Acute hyponatremia can 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 injury.
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 and life-threatening cerebral edema caused by acute hyponatremia.

Incompatibilities
Glucose solutions for intravenous use are incompatible with:
cyanocobalamin;
kanamycin sulfate;
novobiocin sodium;
warfarin sodium.
Furthermore, 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 that do not contain electrolytes should not be administered through the same infusion catheter with whole blood due to the possible formation of aggregates and the risk of hemolysis.
Ampicillin and amoxicillin are only stable in glucose solutions for a short period.

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

Special storage precautions
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.
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 derived from it must be disposed of in accordance with local regulations

For further information see the Summary of Product Characteristics.
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 pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
• If you get any side effects, talk to your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

• 1. What is GLUCOSIO B. BRAUN 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. Contents of the pack and other information

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

GLUCOSIO B. BRAUN is a solution to be administered directly into a vein (intravenous infusion) that
contains the active ingredient glucose belonging to the class of parenteral nutritional solutions.
This medicine is indicated to provide the body with water and sugars in emergency situations, especially
in patients who do not need salts or in cases where these should be avoided, and for the treatment of low blood sugar levels (hypoglycemia).

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 the glucose is extracted)
• if you have problems with urination (anuria);
• if you experience bleeding (hemorrhages) occurring at the spinal level or inside the skull (intracranial);
• if you suffer from hallucinations, tremors and sweating (delirium tremens) caused by excessive water loss from the body (dehydration);
• if you have low fluid levels in the body (dehydration);
• if you suffer from liver problems leading to loss of consciousness (hepatic coma).

Glucose solutions should not be administered through the same infusion catheter with whole blood due to the possible risk of red blood cell aggregation (pseudo-agglutination) or red blood cell rupture (hemolysis).

Warnings and precautions
Talk to your doctor, pharmacist or nurse before using GLUCOSIO B. BRAUN.
Use this medicine with cautionand inform your doctor in the following cases:

• if you suffer from diabetes or are intolerant to glucose. During the infusion, blood sugar levels (glycemia) and urine sugar levels (glycosuria) should be carefully monitored to minimize the risk of hyperglycemia and glycosuria; if necessary, insulin should be administered;
• if you suffer from severe heart problems (heart failure);
• if you suffer from severe kidney problems (severe renal insufficiency);
• if you experience swelling caused by fluid accumulation and retention of mineral salts (edema with hydrosaline retention);
• if you are taking anti-inflammatory corticosteroid medications;
• if you are taking certain hormonal medications (corticotropin);
• if you are in one of the following conditions that can cause high levels of the vasopressin hormone:
• you have an acute illness
• you are in pain
• you have undergone surgery
• you have infections, burns
• you have brain diseases
• you have liver, heart and kidney diseases. This can increase the risk of low sodium levels in the blood (hyponatremia) with headache, nausea, seizures, drowsiness, vomiting, cerebral edema which can lead to death. People with a higher risk of cerebral edema are:
• children
• women (especially of childbearing age)
• people with altered fluid levels in the brain (e.g. due to meningitis, intracranial bleeding or brain contusion).

This medicine may contain traces of corn which can cause allergic reactions. Inform your
doctor if you suffer from corn allergies.
During prolonged treatment with this medicine, an excess of water in the body
(fluid overload and congestion) and an excessive loss of mineral salts such as potassium and phosphate
(electrolyte deficiency) may occur; the doctor will periodically check the concentration of mineral salts
(electrolytes), correcting any excessive losses if necessary with the administration of mineral salts and
vitamins.
If you have low levels of vitamin B1, the administration of GLUCOSIO B. BRAUN may cause
Wernicke's encephalopathy (a serious brain disease). The doctor may correct this deficiency before
administration of the medicine.
Concentrated glucose solutions must NOT be administeredby subcutaneous injection (subcutaneously) or by intramuscular injection (intramuscularly).

Children
In children, particularly in newborns and children with low body weight, the administration of
glucose may increase the risk of a rise in blood glucose levels (hyperglycemia). Furthermore, in
children with low body weight, a rapid or excessive infusion may cause an increase in blood osmolarity
and intracranial hemorrhage (within the brain tissue).

Other medicines and GLUCOSIO B. BRAUN
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
GLUCOSIO B. BRAUN should be administered with cautionif you are taking medicines

• anti-inflammatory steroids (corticosteroids) or hormonal medicines (corticotropin), because they may cause you to have an increase in blood sugar that could lead to latent diabetes mellitus;
• medicines that act on 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 oxcarbazepine as they may increase the risk of hyponatremia. Glucose solutions may be incompatible with other infusion solutions.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning a pregnancy or are breastfeeding with breast
milk, ask your doctor or pharmacist for advice before this medicine is administered to you.
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
labor due to the risk of hyponatremia, especially if administered in association with a
medicine that induces labor (oxytocin).
Breastfeeding
There are no data available to establish the effect of this medicine during breastfeeding, therefore take
particular care if you are breastfeeding.

Driving and operating machinery
There are no data available regarding the effects of the medicine on driving and operating
machinery.

3. How to use GLUCOSIO B. BRAUN

This medicine will be administered to you by a doctor or other qualified medical personnel. If you have any doubts
consult your doctor, pharmacist or nurse.
Before and during administration, the doctor will monitor your fluid levels in the body, glucose and salts,
particularly sodium in the blood.
This medicine will be administered to you with caution and at a controlled rate directly into a vein
(intravenous infusion) by qualified medical personnel. This medicine should not be
administered subcutaneously or intramuscularly.
The infusion rate is generally 0.4 - 0.8 g/hour per kg of body weight.
The doctor will choose the concentration of glucose solution to be used based on age, weight and your
health conditions and the levels of mineral salts and blood pH.
Below are the general guidelines for choosing different glucose concentrations.

• 5% - or 10% solutions are used for replenishing fluids and calories;
• 20% solution is used for caloric replenishment and limited fluid replenishment.

Use in the elderly
No differences in response have been demonstrated between elderly patients and younger patients following
glucose administration.

Use in children and adolescents
In children, particularly in newborns and infants with low body weight, this medicine must
be administered with caution and at a controlled rate (See section Children). Dosage and
administration rate must be chosen based on age, weight and the patient's clinical condition. Generally, solutions with a concentration higher than 10% are not used.
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 if the glucose solution
is not clear.

If you use more GLUCOSIO B. BRAUN than you should
This medicine will be administered to you by a doctor or qualified personnel, it is unlikely that you
will be injected with an excessive dose. However, if you think you have been given an excessive dose of
GLUCOSIO 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 the concentration of water and solutes in the body (hyperhydration and solute overload) may occur. In
this case, the doctor or nurse must immediately stop administering the medicine
and start corrective therapy.

If you stop the treatment with GLUCOSIO B. BRAUN
If the infusion of concentrated glucose needs to be stopped suddenly, your doctor will gradually reduce
the dose by administering 5% or 10% glucose, in order to avoid a rapid drop
in blood sugar (rebound hypoglycemia).
If you have any doubts about the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur:

Not known(the frequency of which cannot be estimated based on the available data):

• leakage of the medicine into the tissues around the injection site (extravasation);
• infection at the infusion site and local pain;
• circulation problems due to the formation of blood clots and inflammation of the veins in the infusion area (thrombosis and thrombophlebitis);
• increased body temperature (fever);
• increased water in the body (hyperhydration) and decreased potassium (hypokalaemia), magnesium (hypomagnesaemia) and phosphate (hypophosphataemia);
• increased metabolic rate;
• increased blood sugar (hyperglycaemia);
• increased osmotic pressure of the blood (hyperosmolarity);
• increased blood volume in the body (hypervolaemia);
• decreased blood sugar (hypoglycaemia);
• increased insulin level;
• increased adrenaline level;
• low levels of sodium in the blood (hospital-acquired hyponatremia)
• brain edema (hyponatremic encephalopathy)
• fluid retention with swelling in the legs and ankles (peripheral edema);
• fluid accumulation in the lungs (pulmonary edema);
• bleeding in the head (cerebral haemorrhage);
• brain damage caused by a blockage of blood supply (cerebral ischaemia) ();
• hypersensitivity reactions, including a severe allergic reaction called anaphylaxis which can be fatal (in patients with corn allergy)

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

5. How to store GLUCOSIO B. BRAUN

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after “Exp”.
The expiry date refers to the last day of that month.
Keep the container tightly closed. Do not refrigerate.
After the first opening of the package, the medicine must be used immediately for a single and
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 in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

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

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

GLUCOSIO B. BRAUN 10% solution for infusion

• The active ingredient 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% solution for infusion

• The active ingredient 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 package contents
GLUCOSIO B. BRAUN 5% solution for infusion
The packs contain 1 or 20 vials of 50 ml, 100 ml, 250 ml, 500 ml, 1000 ml.
The packs contain 10 vials of 500 ml, 1000 ml.
The packs contain 1 bag of 100 ml, 250 ml, 500 ml, 1000 ml.

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

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

Marketing Authorisation 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 Rubí (Barcelona) – Spain.

The following information is intended exclusively for doctors or healthcare professionals:
Dosage and Administration
Glucose solutions are administered intravenously.
The 20% solution must be administered exclusively via a central venous catheter.
If it should be necessary to administer the solution peripherally, for example in the emergency treatment of hypoglycemic crises, the solution must be injected very slowly into a vein of large calibre in the arm.
The infusion rate is generally 0.4-0.8 g/hour per kg of body weight.
Below are general indications for choosing the different glucose concentrations.

• 5%-10% solutions: replenishment of fluids and calories;
• 20% solution: caloric replenishment and limited fluid replenishment. AdultsThe concentration of the glucose solution and the dose to be used depend on the characteristics of the patient (age, weight, clinical condition, water and electrolyte balance and acid-base balance). ElderlyClinical studies and clinical practice have not shown differences in response between elderly and younger patients following glucose administration. ChildrenThe dosage and rate of administration of glucose must be chosen according to the age, weight and clinical condition of the patient. Solutions with concentrations higher than 10% are generally not used. Particular caution is required in paediatric patients and especially in neonates or children with low body weight as the administration of glucose may increase the risk of hyperglycaemia. Furthermore, in children with low body weight, a rapid or excessive infusion may cause an increase in serum osmolarity and intracranial haemorrhage

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 infused with caution and at a controlled infusion rate.
One gram of glucose provides a caloric contribution equal to 3.74 Kcal (approximately 15.6 Kjoule).
Glucose solutions must be administered with caution in patients with diagnosed or subclinical diabetes mellitus or with glucose intolerance of any nature. To minimise the risk of hyperglycaemia and subsequent glycosuria, it is necessary to monitor glucose in the blood and urine and, if required, administer insulin.
During prolonged use of concentrated glucose solutions, fluid overload, congestive state and electrolyte deficiencies, particularly potassium and phosphate, may occur. Therefore, it is essential to monitor electrolytes in the blood and, if necessary, correct imbalances in water and electrolyte balance.
Furthermore, if necessary, vitamins and mineral salts can be administered.
When the infusion of concentrated glucose must be suddenly stopped, it is recommended to continue with the administration of 5%-10% glucose, in order to avoid rebound hypoglycaemia.
Particular caution is required especially in patients with heart failure, severe renal failure and in clinical conditions associated with oedema and fluid retention, and in patients receiving corticosteroids or corticotropin.
Concentrated glucose solutions must not be administered subcutaneously or intramuscularly.
It may be necessary to monitor electrolyte balance, serum glucose, serum sodium and other electrolytes before and during administration, particularly in patients with increased non-osmotic vasopressin release (syndrome of inappropriate antidiuretic hormone secretion, SIADH) and in patients undergoing 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 solution for infusion may become extremely hypotonic after administration, due to the metabolism of glucose in the body.
Intravenous infusions of glucose are generally isotonic solutions. However, in the body, solutions containing glucose may become extremely hypotonic at a physiological level due to the rapid metabolism of glucose.
Depending on the tonicity of the solution, the volume and frequency of infusion and the underlying clinical conditions of the patient, as well as the ability to metabolise glucose, the intravenous administration of glucose may cause electrolyte alterations and especially hypo or hyperosmotic hyponatraemia.
Hyponatraemia:
Patients with non-osmotic vasopressin release (e.g. in the acute phase of the disease, pain, post-operative stress, infections, burns and diseases of the central nervous system), patients with heart disease, liver disease and kidney disease and patients treated with vasopressin agonists are particularly at risk of acute hyponatraemia following infusion of hypotonic solutions.
Acute hyponatraemia can cause acute hyponatraemic encephalopathy (cerebral oedema) characterised by headache, nausea, seizures, lethargy and vomiting. Patients with cerebral oedema are particularly at risk of severe, irreversible and life-threatening brain injury.
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
Glucose solutions for intravenous use are incompatible with:

• cyanocobalamin;
• kanamycin sulphate;
• novobiocin sodium;
• warfarin sodium; Furthermore, 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 that do not contain electrolytes should not be administered through the same infusion catheter with 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 the first opening of the pack, the medicinal product must be used immediately for a single and uninterrupted administration.

Special Precautions for Storage and Handling
Store in tightly closed containers.
Do not use the glucose solution if it does not appear clear, colourless 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 medicinal product and waste material derived from it must be disposed of in accordance with local regulations.

For further information, consult the Summary of Product Characteristics.