Glucose Monico

Package leaflet: Information for the user

GLUCOSIO MONICO

5% injectable solution
10% injectable solution
20% injectable solution
33% injectable solution
Glucose monohydrate
Generic medicine

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

Contents of this leaflet:

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

1. What GLUCOSIO MONICO is and what it is used for

GLUCOSIO MONICO 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 the body with water and sugars suitable to ensure a caloric intake in emergency situations, especially in patients who do not require salts or when these 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 intravenous injection.

2. What you should know before using GLUCOSE MONICO

Do not use GLUCOSE MONICO

• 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 in the spinal area (spinal haemorrhage) or in 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 (pseudoagglutination) or red blood cell breakdown (haemolysis).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using GLUCOSE MONICO.
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 levels in urine (glycosuria) must be closely monitored to minimize the risk of elevated levels; insulin may be administered if necessary;
• if you have heart problems (heart failure);
• if you have 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 steroid anti-inflammatory medicines (corticosteroids);
• if you are taking certain hormonal medicines (corticotrophin).

The 5% solution is isotonic with blood.
The 10%, 20%, and 33% solutions are hypertonic with blood and must be infused with caution and at a controlled infusion rate.
One gram of glucose provides approximately 3.74 kcal (about 15.6 kJoules) of caloric energy.
Children
In children, particularly in newborns and low-body-weight children, administration of glucose may increase the risk of elevated blood glucose levels (hyperglycaemia). Moreover, in low-body-weight children, rapid or excessive infusion may cause increased blood osmolarity and bleeding within brain tissue due to rupture of a blood vessel (intracerebral haemorrhage).
Other medicines and GLUCOSE MONICO
Inform your doctor or pharmacist if you are using, have recently used, or might use any other medicines.
GLUCOSE MONICO should be administered with caution if you are taking steroid anti-inflammatory medicines (corticosteroids) or hormonal medicines (corticotrophin), as they may increase your blood sugar levels, potentially unmasking latent diabetes mellitus. Medical monitoring is necessary if you are taking these medicines during treatment.
Glucose solutions may be incompatible with other infusion solutions.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning a pregnancy, 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 driving or operating machinery.

3. How to use GLUCOSIO MONICO

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.
GLUCOSIO MONICO 5% and 10% will be administered carefully directly into a vein (intravenous infusion) or into a muscle (intramuscular route) at a controlled infusion rate, and not by subcutaneous route as it may cause irritation.
GLUCOSIO MONICO 20% and 33% must NOT be administered by subcutaneous or intramuscular injection, but exclusively by direct intravenous injection (central venous catheter).
If administration through peripheral arm veins is required, for example in emergency treatment of low blood glucose levels (hypoglycemic crises), the solutions must be injected very slowly into a large-caliber vein of the arm.

Use in adults
The doctor will select the glucose solution concentration based on your age, weight, health condition, 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 with caution and at a controlled rate (See section “Children”). Dosage and administration 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.

If you use more GLUCOSIO MONICO than you should
Since this medicine will be administered by a doctor or trained medical personnel, it is unlikely that you will receive an excessive dose. However, if you think that you have been given an excessive dose of GLUCOSIO MONICO, inform your doctor immediately or go to the nearest hospital.
In case of accidental administration of excessive doses of GLUCOSIO MONICO, an increase in body water and solute levels (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 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 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 (hyperglycemia);
• Increased insulin levels;
• Increased adrenaline levels;
• Fluid accumulation causing swelling in the legs and ankles (peripheral edema);
• Bleeding into brain tissue (cerebral hemorrhage);
• Brain damage caused by impaired blood flow to the brain (cerebral ischemia).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist. You may 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 MONICO

Keep this medicine out of the reach and sight 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 or freeze.
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 MONICO contains
GLUCOSIO MONICO 5% injectable solution

• The active substance is glucose monohydrate. Each litre of solution contains 55 g of glucose monohydrate, equivalent to 278 mmol/litre. pH 3.5 ÷ 6.5.
• The other component is water for injections.

GLUCOSIO MONICO 10% injectable solution

• The active substance is glucose monohydrate. Each litre of solution contains 110 g of glucose monohydrate, equivalent to 555 mmol/litre. pH 3.5 ÷ 6.5.
• The other component is water for injections.

GLUCOSIO MONICO 20% injectable solution

• The active substance is glucose monohydrate. Each litre of solution contains 220 g of glucose monohydrate, equivalent to 1110 mmol/litre. pH 3.5 ÷ 6.5.
• The other component is water for injections.

GLUCOSIO MONICO 33% injectable solution

• The active substance is glucose monohydrate. Each litre of solution contains 363 g of glucose monohydrate, equivalent to 1832 mmol/litre. pH 3.5 ÷ 6.5.
• The other component is water for injections.

Description of the appearance of GLUCOSIO MONICO and package contents
GLUCOSIO MONICO 5% injectable solution
Carton pack containing 1 or 10 glass vials of 10 ml.
GLUCOSIO MONICO 10% injectable solution
Carton pack containing 1 or 10 glass vials of 10 ml.
GLUCOSIO MONICO 20% injectable solution
Carton pack containing 1 or 10 glass vials of 10 ml.
GLUCOSIO MONICO 33% injectable solution
Carton pack containing 1 or 10 glass vials of 10 ml.

Marketing Authorisation Holder and Manufacturer
MONICO SPA – Via Ponte di Pietra 7, 30173 – VENEZIA/MESTRE – Italy

PATIENT INFORMATION LEAFLET: INFORMATION FOR THE USER

MONOHYDRIC GLUCOSE

5%, 10%, 20%, 33%, 50%, 70% - Solution for infusion
Glucose monohydrate
Generic medicinal product
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 other people, 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, talk to your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What GLUCOSIO MONICO is and what it is used for

GLUCOSIO MONICO 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 whom salts should be avoided, and for the treatment of low blood sugar levels (hypoglycaemia).

2. What you need to know before using GLUCOSE MONICO

Do not use GLUCOSE MONICO

• if you are allergic to glucose or to any of the other ingredients of this medicine (listed in section 6);
• if you have problems with urination (anuria);
• if you have bleeding (haemorrhage) occurring in the spinal area (spinal haemorrhage) or within the skull (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 body fluids (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 GLUCOSE MONICO.
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 urine (glycosuria) must be closely monitored to minimize the risk of hyperglycaemia and glycosuria; insulin should be administered if necessary;
• if you have heart problems (heart failure);
• if you have severe kidney problems (severe renal failure);
• if you have swelling due to 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 (corticotropin).

The 5% solution is isotonic with blood.
Solutions at 10%, 20%, 33%, 50%, and 70% are hypertonic with respect to blood and must be infused with caution and at a controlled infusion rate.
One gram of glucose provides approximately 3.74 kcal (about 15.6 kJoules) of energy.
During prolonged treatment with this medicine, fluid accumulation 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 monitor mineral (electrolyte) concentrations and correct any imbalances in fluid and electrolyte equilibrium if necessary.
If required, vitamins and minerals may be administered.
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 in 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 increased blood osmolarity and bleeding within brain tissue due to rupture of a blood vessel (intracerebral haemorrhage).
Other medicines and GLUCOSE MONICO
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
GLUCOSE MONICO should be administered with caution if you are taking steroid anti-inflammatory medicines (corticosteroids) or hormonal medicines (corticotropin), as they may cause an increase in blood sugar levels which could lead to latent diabetes mellitus.
Glucose solutions may be incompatible with other infusion solutions.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Do not use this medicine during pregnancy or breastfeeding unless absolutely necessary and always under strict medical supervision.
Driving and using machines
There are no data available regarding the effects of this medicine on the ability to drive vehicles or operate machinery.

3. How to use GLUCOSIO MONICO

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 with caution directly into a vein (intravenous infusion) at a carefully controlled infusion rate. Concentrated glucose solutions must not be administered by subcutaneous injection (under the skin) or into the muscle (intramuscular route), but exclusively by intravenous route.
If administration through peripheral veins (e.g., in the arms) is required, for example in the emergency treatment of low blood glucose levels (hypoglycemic crises), the solutions must be injected very slowly into a large-caliber vein in the arm.
The usual infusion rate is 0.4–0.8 g of glucose per kilogram of body weight per hour.
The 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 replacement;
• 20%–33% solutions are used for caloric replacement with limited fluid replacement;
• 50%–70% solutions are used for the 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 with caution and at a controlled rate (see section “Children”). Dosage and infusion rate should be adjusted according to the patient’s age, weight, and clinical condition. Generally, solutions with a concentration higher than 10% are not used.
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.
All standard precautions should be followed 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 yellowish, or if it contains particles.
If you use more GLUCOSIO MONICO than you should
Since this medicine will be administered by a doctor or trained medical personnel, it is unlikely that you will receive an excessive dose. However, if you think you have been given too much GLUCOSIO MONICO, inform your doctor immediately or go to the nearest hospital.
In case of accidental administration of excessive doses of GLUCOSIO MONICO, 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 MONICO
If glucose infusion is to be discontinued abruptly, it is recommended to gradually reduce the dose by administering 5% or 10% glucose solution, 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 water retention in the body (hyperhydration) and decreased levels of potassium (hypokalemia), magnesium (hypomagnesemia), and phosphate (hypophosphatemia);
• increased metabolic rate;
• increased blood sugar (hyperglycemia);
• increased osmotic pressure of the blood (hyperosmolarity);
• increased blood volume circulating in the body (hypervolemia);
• reduced glucose levels in the blood (hypoglycemia);
• increased insulin levels;
• increased adrenaline levels;
• fluid accumulation causing swelling in the legs and ankles (peripheral edema);
• fluid accumulation in the lungs (pulmonary edema);
• bleeding into the tissues of the brain (cerebral hemorrhage);
• brain damage caused by poor blood circulation to the brain (cerebral ischemia).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist. You may also report side effects directly through 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 MONICO

Keep this medicine out of the reach and sight 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 or freeze.
After first opening of the container, the medicine must be used immediately for a single, uninterrupted administration, and any remaining solution must be discarded.
Do not administer if the solution is not clear, 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 MONICO contains
GLUCOSIO MONICO 5% solution for infusion

• The active substance is glucose monohydrate. 1000 ml of solution contain 55 g of glucose monohydrate. Each litre of solution contains 278 mmol of glucose monohydrate. pH: 3.5 - 6.5.
• The other component is water for injections.

GLUCOSIO MONICO 10% solution for infusion

• The active substance is glucose monohydrate. 1000 ml of solution contain 110 g of glucose monohydrate. Each litre of solution contains 555 mmol of glucose monohydrate. pH: 3.5 - 6.5.
• The other component is water for injections.

GLUCOSIO MONICO 20% solution for infusion

• The active substance is glucose monohydrate. 1000 ml of solution contain 220 g of glucose monohydrate. Each litre of solution contains 1110 mmol of glucose monohydrate. pH: 3.5 - 6.5.
• The other component is water for injections.

GLUCOSIO MONICO 33% solution for infusion

• The active substance is glucose monohydrate. 1000 ml of solution contain 363 g of glucose monohydrate. Each litre of solution contains 1832 mmol of glucose monohydrate. pH: 3.5 - 6.5.
• The other component is water for injections.

GLUCOSIO MONICO 50% solution for infusion

• The active substance is glucose monohydrate. 1000 ml of solution contain 550 g of glucose monohydrate. Each litre of solution contains 2775 mmol of glucose monohydrate. pH: 3.5 - 6.5.
• The other component is water for injections.

GLUCOSIO MONICO 70% solution for infusion

• The active substance is glucose monohydrate. 1000 ml of solution contain 770 g of glucose monohydrate. Each litre of solution contains 3885 mmol of glucose monohydrate. pH: 3.5 - 6.5.
• The other component is water for injections.

Description of the appearance of GLUCOSIO MONICO and contents of the pack
Solution for infusion.
Glass vials of 50, 100, 250, 500, 1000 ml.
Plastic bags of 50, 100, 250, 500, 1000, 2000 ml.
Marketing Authorization Holder and Manufacturer
MONICO SPA – Via Ponte di Pietra 7, 30173 – VENEZIA/MESTRE – Italy.

The following information is intended exclusively for healthcare professionals

Warnings and precautions
Due to the risk of hyponatremia, monitoring of electrolyte balance, serum glucose, serum sodium, and other electrolytes before and during administration is necessary, particularly in patients with syndrome of inappropriate antidiuretic hormone secretion (SIADH) and in patients receiving concomitant therapy with vasopressin agonists.
Monitoring of serum sodium is especially important for physiologically hypotonic solutions. GLUCOSIO MONICO may become extremely hypotonic after administration due to metabolism of glucose in the body.
Patients with non-osmotic vasopressin release (e.g., during acute illness, pain, postoperative stress, infections, burns, and central nervous system disorders), patients with cardiac, hepatic, or renal disease, 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 at particular 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.

Interactions
Medicinal products that may reduce renal electrolyte-free water excretion and increase the risk of hospital-acquired hyponatremia following inadequately balanced intravenous fluid therapy include:

• medications stimulating vasopressin release; e.g., chlorpropamide, clofibrate, carbamazepine, vincristine, selective serotonin reuptake inhibitors, 3,4-methylenedioxy-N-methamphetamine, ifosfamide, antipsychotics, narcotics;
• medications enhancing the action of vasopressin; e.g., chlorpropamide, NSAIDs, cyclophosphamide;
• vasopressin analogs: desmopressin, oxytocin, vasopressin, terlipressin.

Other medications that increase the risk of hyponatremia also include diuretics in general and antiepileptic drugs such as oxcarbazepine.

Pregnancy
GLUCOSIO MONICO should be administered with particular caution to pregnant women during labor, especially if administered concomitantly with oxytocin, due to the risk of hyponatremia.