GLUCOSE MONICO

PACKAGE LEAFLET: INFORMATION FOR THE USER

GLUCOSE MONOHYDRATE

5%, 10%, 20%, 33%, 50%, 70% - 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 other people, even if their symptoms are the same 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 GLUCOSE MONOHYDRATE is and what it is used for
2. What you need to know before using GLUCOSE MONOHYDRATE
3. How to use GLUCOSE MONOHYDRATE
4. Possible side effects
5. How to store GLUCOSE MONOHYDRATE
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 cases where 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 urinating (anuria);
• if you have bleeding (haemorrhages) occurring in the spinal area (spinal haemorrhages) or within the skull (intracranial haemorrhages);
• 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 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; if necessary, insulin should be administered;
• if you suffer from 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 (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 caloric energy.
During prolonged treatment with this medicine, accumulation of water in the body (fluid overload and congestive state) and excessive loss of mineral salts such as potassium and phosphate (electrolyte deficit) may occur; your doctor should periodically check the concentration of mineral salts (electrolytes) and correct, if necessary, any imbalance in fluid and electrolyte equilibrium.
If required, vitamins and mineral salts may be administered.
Concentrated glucose solutions must not be administered by subcutaneous injection or intramuscular injection.
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). 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 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, suspect you may be pregnant, planning a pregnancy, or breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
Do not use this medicine during pregnancy and 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 or operate machinery.

3. How to use GLUCOSIO MONICO

This medicine will be administered to you by a doctor or other specialized medical personnel. If you have any doubts, consult your doctor, pharmacist, or nurse.
This medicine will be administered carefully directly into a vein (intravenous infusion) at a strictly controlled infusion rate. Concentrated glucose solutions must not be administered by injection under the skin (subcutaneous route) or into the muscle (intramuscular route), but exclusively by intravenous route.
If administration through the veins in the arms (peripherally) 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 choose the appropriate glucose solution concentration based on your age, weight, health condition, and blood electrolyte levels and pH.
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 carefully 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. Solutions with concentrations higher than 10% are generally 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 is required when administering medicines to elderly patients.
It is recommended to follow all standard 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 and 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 specialized personnel, it is unlikely that you will receive an excessive dose. However, if you think 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 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 MONICO
If glucose infusion is suddenly discontinued, 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 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 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 (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 contact 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 MONICO

Keep this medicine out of the reach and sight of children.
Do not use this medicine after the expiry date stated on the packaging after "EXP.".
The expiry date refers to the last day of that month.
Keep the container tightly closed. Do not refrigerate or freeze.
After the 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 ml, 100 ml, 250 ml, 500 ml, 1000 ml.
Plastic bags of 50 ml, 100 ml, 250 ml, 500 ml, 1000 ml, 2000 ml.
Marketing Authorisation 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 the 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 markedly hypotonic after administration due to glucose metabolism in the body.
Patients with non-osmotic vasopressin release (e.g., during 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 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 reproductive 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:

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

Other medicinal products 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.