Glucose Bioindustria L.I.M

Package leaflet: Information for the user

GLUCOSIO Bioindustria L.I.M. 5% solution for infusion, 10% solution for infusion, 20% solution for infusion, 33% solution for infusion

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 they have the same symptoms as yours, because it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

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

GLUCOSIO Bioindustria L.I.M. is a solution for direct intravenous administration (intravenous infusion) containing the active substance glucose monohydrate, belonging to the class of parenteral nutritional solutions.
This medicinal product is indicated to provide the body with water and sugars capable of 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 should know before using GLUCOSIO Bioindustria L.I.M.

Do not use GLUCOSIO Bioindustria L.I.M.

• if you are allergic to glucose or to any of the other ingredients of this medicine (listed in section 6);
• if you have problems urinating (anuria);
• if you have bleeding occurring at the spinal level (spinal hemorrhage) or within the skull with blood leakage into brain tissue (intracranial hemorrhage);
• if you experience hallucinations, tremors, and sweating (delirium tremens) associated with 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).

Glucose solutions must not be administered through the same infusion catheter as whole blood due to the possible risk of red blood cell clumping (pseudoagglutination) or red blood cell breakdown (hemolysis).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using GLUCOSIO Bioindustria L.I.M.

Use this medicine with caution and inform your doctor in the following cases:

• if you have diabetes 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 levels; 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 (edema with hydro-saline retention);
• if you are taking corticosteroid anti-inflammatory medicines;
• if you are taking certain hormonal medicines (corticotropin).

Children
In children, especially newborns and children with low body weight, administration of glucose may increase the risk of elevated blood glucose levels (hyperglycemia). Moreover, 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).

Other medicines and GLUCOSIO Bioindustria L.I.M.
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other medicine.

GLUCOSIO Bioindustria L.I.M. should be administered with caution if you are taking steroid anti-inflammatory medicines (corticosteroids) or hormonal medicines (corticotropin), as they may increase your blood sugar levels, potentially unmasking latent diabetes mellitus. Medical monitoring is required during treatment if you need to take these medicines.

Glucose solutions may be incompatible with other infusion solutions.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.

Do not use this medicine during pregnancy unless absolutely necessary and always under strict medical supervision.

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 regarding the effects of this medicine on the ability to drive or use machinery.

3. How to use GLUCOSIO Bioindustria L.I.M.

This medicine will be administered to you by a doctor or trained healthcare professional. If you have any doubts, consult your doctor, pharmacist, or nurse.
GLUCOSIO Bioindustria L.I.M. 5% and 10% will be administered cautiously directly into a vein (intravenous infusion) or into a muscle (intramuscular route) at a controlled infusion rate. It must not be administered subcutaneously, as it may cause irritation.
GLUCOSIO Bioindustria L.I.M. 20% and 33% must not be administered by subcutaneous or intramuscular injection, but exclusively by direct intravenous injection (via central venous catheter).

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

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

Use in children and adolescents
In 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 patient's age, weight, and clinical condition. Generally, solutions with a concentration exceeding 10% are not used.

If you use more GLUCOSIO Bioindustria L.I.M. 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 you have been given too much GLUCOSIO Bioindustria L.I.M., inform your doctor immediately or go to the nearest hospital.
In case of accidental administration of an excessive dose of GLUCOSIO Bioindustria L.I.M., an increase in body water and an increase in solutes in the body (hyperhydration and solute overload) may occur. In such cases, the doctor or nurse must immediately stop administering the medicine and initiate corrective therapy.

If you have any questions 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 everybody gets them.
The following side effects may occur:

• 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;
• fluid retention causing swelling in the legs and ankles (peripheral oedema);
• bleeding in the brain (cerebral haemorrhage);
• brain damage caused by poor blood circulation to the brain (cerebral ischaemia).

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 the website
http://www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store GLUCOSIO Bioindustria L.I.M.

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.
Do not use the glucose solution if it is not clear, colourless or slightly yellowish, or if it contains particles.
Keep the container tightly closed. Do not refrigerate.
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 Bioindustria L.I.M. contains
GLUCOSIO BIOINDUSTRIA L.I.M. 5% injectable solution

• The active substance is glucose monohydrate. Each litre 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 BIOINDUSTRIA L.I.M. 10% injectable solution

• The active substance is glucose monohydrate. Each litre 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 BIOINDUSTRIA L.I.M. 20% injectable solution

• The active substance is glucose monohydrate. Each litre 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.

GLUCOSIO BIOINDUSTRIA L.I.M. 33% injectable solution

• The active substance is glucose monohydrate. Each litre of solution contains 363 g of glucose monohydrate (330 g of anhydrous glucose) (1832 mOsm/L, pH 3.5 - 6.5).
• The other component is water for injections.

Description of the appearance of GLUCOSIO Bioindustria L.I.M. and contents of the pack
Injectable solution.
Packaging: 10 vials of 5 ml;
Packaging: 10 vials of 10 ml;
Packaging: 5 vials of 20 ml.
Marketing Authorization Holder and Manufacturer
BIOINDUSTRIA Laboratorio Italiano Medicinali S.p.A. - Via De Ambrosiis, 2 - 15067 Novi Ligure (AL)

Package leaflet: information for the physician
The following information is intended exclusively for physicians or healthcare professionals
Special warnings and precautions for use
The 5% solution is isotonic with blood.
The 10%, 20%, and 33% solutions are hypertonic with respect to blood and must be administered with caution and at a controlled infusion rate.
Dosage and method of administration
If peripheral administration is required, for example in the emergency treatment of hypoglycemic crises, the solutions must be injected very slowly into a large vein of the arm.
It is recommended to take all the 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, colourless or slightly yellowish, or if it contains particles.
Incompatibilities
Glucose solutions for intravenous use are incompatible with:

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

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 not containing 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.

For further information, consult the Summary of Product Characteristics.
Package leaflet: information for the user

GLUCOSE Bioindustria L.I.M. 5% solution for infusion, L.I.M. 10% solution for infusion, L.I.M. 20% solution for infusion, L.I.M. 33% solution for infusion, L.I.M. 50% solution for infusion

Glucose monohydrate
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, 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 side effect, including those not listed in this leaflet, contact your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

1. What GLUCOSE Bioindustria L.I.M. is and what it is used for
2. What you need to know before using GLUCOSE Bioindustria L.I.M.
3. How to use GLUCOSE Bioindustria L.I.M.
4. Possible side effects
5. How to store GLUCOSE Bioindustria L.I.M.
6. Package contents and other information

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

GLUCOSIO Bioindustria L.I.M. 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 (hypoglycaemia).

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

Do not use GLUCOSIO Bioindustria L.I.M.

• if you are allergic to glucose or to any of the other ingredients of this medicine (listed in section 6);
• if you have problems urinating (anuria);
• if you have bleeding (haemorrhage) occurring in the spinal area or within the skull (intracranial);
• if you suffer from hallucinations, tremors, and sweating (delirium tremens) associated with 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 (pseudoagglutination) or red blood cell breakdown (haemolysis).
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using GLUCOSIO Bioindustria L.I.M.
Use this medicine with caution and inform your doctor in the following cases:

• if you have 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; 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 salt retention (oedema with hydro-saline retention);
• if you are taking corticosteroid anti-inflammatory medicines;
• if you are taking certain hormonal medicines (corticotrophin).

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 deficit) may occur. Your doctor should periodically check the concentration of minerals (electrolytes) and correct any excessive losses by administering mineral salts and vitamins, if necessary.
Concentrated glucose solutions must not be administered by subcutaneous injection (subcutaneous route) or by intramuscular injection (intramuscular route).
Children
In children, particularly in newborns and children with low body weight, administration of glucose may increase the risk of elevated blood glucose levels (hyperglycaemia). Furthermore, in children with low body weight, rapid or excessive infusion may cause an increase in the concentration of substances in the blood (osmolarity) and bleeding within the brain tissue due to rupture of a blood vessel (intracerebral haemorrhage).
Other medicines and GLUCOSIO Bioindustria L.I.M.
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
GLUCOSIO Bioindustria L.I.M. should be administered with caution if you are taking steroid anti-inflammatory medicines (corticosteroids) or hormonal medicines (corticotrophin), as they may cause an increase in blood sugar levels, potentially leading to latent diabetes mellitus.
Glucose solutions may be incompatible with other infusion solutions.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before administration of this medicine.
Do not use this medicine during pregnancy unless absolutely necessary and always under strict medical supervision.
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 regarding the effects of this medicine on driving or operating machinery.

3. How to use GLUCOSIO Bioindustria L.I.M.

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 by direct intravenous infusion at a carefully controlled rate. Concentrated glucose solutions must NOT be administered by subcutaneous injection (subcutaneous route) or intramuscular injection (intramuscular route), but exclusively by intravenous route.
The usual infusion rate is 0.4 - 0.8 g/hour per kg of body weight.
Your doctor will select the appropriate glucose solution concentration based on your age, body weight, clinical condition, and blood electrolyte and pH levels.
Below are general guidelines for selecting different glucose concentrations:

• 5%-10% solutions are used for fluid and caloric replenishment;
• 20%-33% solutions are used for caloric replenishment with limited fluid replacement;
• 50% solutions are used for treatment of low blood glucose levels (hypoglycemia) due to excessive insulin production (hyperinsulinemia) or other causes.

Use in children and adolescents
In children with low body weight, this medicine must be administered cautiously and at a controlled rate (see section "Children"). Dosage and infusion rate must be adjusted according to the patient's age, weight, and clinical condition. Generally, solutions with concentrations higher than 10% are not used.
Standard precautions should be taken 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, colourless, or slightly yellowish, or if it contains particles.

Use in the elderly
There appear to be no significant differences in response between elderly and younger patients following glucose administration. As a general rule, caution should be exercised when administering medicines to elderly patients.

If you use more GLUCOSIO Bioindustria L.I.M. than you should
Since this medicine is administered by a doctor or trained medical personnel, it is unlikely that you will receive an excessive dose. However, if you think that an overdose of GLUCOSIO Bioindustria L.I.M. has been administered, inform your doctor immediately or go to the nearest hospital.
In case of accidental administration of excessive doses of GLUCOSIO Bioindustria L.I.M., an increase in water and solute concentration in the body (overhydration and solute overload) may occur. In such cases, the doctor or nurse must immediately stop administration of the medicine and initiate corrective therapy.

If you stop treatment with GLUCOSIO Bioindustria L.I.M.
If an infusion of concentrated glucose must be suddenly discontinued, it is recommended to 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 questions 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 everybody gets them.
The following side effects may occur:

• 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 osmotic pressure of the blood (hyperosmolarity);
• Increased blood volume in the body (hypervolaemia);
• Decreased blood sugar (hypoglycaemia);
• Increased insulin levels;
• Increased adrenaline levels;
• 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 poor blood circulation to the brain (cerebral ischaemia).

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
http://www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store GLUCOSIO Bioindustria L.I.M.

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 freeze. Do not refrigerate.
After first opening the package, the medicine must be used immediately for a single, uninterrupted administration; any remaining solution must be discarded.
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 Bioindustria L.I.M. contains
GLUCOSIO Bioindustria L.I.M. 5% solution for infusion

• The active substance 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 Bioindustria L.I.M. 10% solution for infusion

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

GLUCOSIO Bioindustria L.I.M. 20% solution for infusion

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

GLUCOSIO Bioindustria L.I.M. 33% solution for infusion

• The active substance is glucose. Each litre of solution contains 363 g of glucose monohydrate (330 g of anhydrous glucose) (1832 mOsmol/L, pH 3.5 - 6.5).
• The other component is water for injections.

GLUCOSIO Bioindustria L.I.M. 50% solution for infusion

• The active substance is glucose. Each litre of solution contains 550 g of glucose monohydrate (500 g of anhydrous glucose) (2775 mOsmol/L, pH 3.5 - 6.5).
• The other component is water for injections.

Description of the appearance of GLUCOSIO Bioindustria L.I.M. and contents of the pack
Solution for infusion
1 vial 50 ml;
1 vial 100 ml;
1 vial 250 ml;
1 vial 500 ml;
50 ml in 100 ml vial;
100 ml in 250 ml vial;
250 ml in 500 ml vial.

Marketing Authorisation Holder and Manufacturer
BIOINDUSTRIA Laboratorio Italiano Medicinali S.p.A.
Via De Ambrosiis, 2
15067 Novi Ligure (AL)
Italy

The following information is intended exclusively for doctors or healthcare professionals

GLUCOSE Bioindustria L.I.M. 5%, 10%, 20%, 33%, 50% solution for infusion
CLINICAL INFORMATION
Glucose solutions are administered intravenously.
The 5% solution is isotonic with blood.
The 10%, 20%, 30%, 33%, and 50% solutions are hypertonic with blood and must be infused with caution and at a controlled infusion rate.
The 20%, 30%, 33%, and 50% solutions must be administered exclusively via central venous catheter.
If peripheral administration becomes necessary, for example in emergency treatment of hypoglycemic crises, the solutions must be injected very slowly into a large-bore vein of the arm.
One gram of glucose provides a caloric contribution of 3.74 kcal (approximately 15.6 kJ).

Incompatibilities
Intravenous glucose solutions are incompatible with:

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

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 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.

For further information, consult the Summary of Product Characteristics.