Glucose Bioindustria L.I.M.

Package leaflet: Information for the user

GLUCOSIO 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
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 others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact 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, 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 when 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 with urination (anuria);
• if you have bleeding (haemorrhage) occurring in the spinal cord or within the skull (intracranial);
• if you suffer from hallucinations, tremors, and sweating (delirium tremens) 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 suffer from diabetes or glucose intolerance. During the infusion, blood sugar levels (glycaemia) and sugar in the urine (glycosuria) must be closely monitored to minimize the risk 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);
• if you are in any of the following conditions that may cause high levels of the hormone vasopressin:
• you have an acute illness
• you have pain
• you have undergone surgery
• you have infections, burns
• you have brain diseases
• you have liver, heart, or kidney diseases

This may increase the risk of low sodium levels in the blood (hyponatraemia), with symptoms such as headache, nausea, seizures, drowsiness, vomiting, cerebral oedema, which may lead to death. People at higher risk of cerebral oedema include:

• children
• women (especially those of childbearing age)
• people with altered fluid levels in the brain (e.g. due to meningitis, intracranial bleeding, or cerebral contusion).

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 depletion) may occur; your doctor should periodically monitor mineral concentrations (electrolytes) and correct any excessive losses by administering minerals and vitamins if necessary.
Concentrated glucose solutions must not be administered by subcutaneous injection or intramuscular injection.
Children
In children, especially 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 increased concentration of substances in the blood (osmolarity) and bleeding within 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 increase your blood sugar levels, potentially unmasking latent diabetes mellitus;
• medicines affecting the hormone vasopressin, e.g.: chlorpropamide, clofibrate, carbamazepine, vincristine, selective serotonin reuptake inhibitors, 3,4-methylenedioxy-N-methamphetamine, ifosfamide, antipsychotics, narcotics, NSAIDs, cyclophosphamide, desmopressin, oxytocin, vasopressin, terlipressin, diuretics in general, and oxcarbamazepine, as they may increase the risk of hyponatraemia.

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

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

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.
Before and during administration, your doctor will monitor your body fluid levels, glucose levels, and electrolyte levels, particularly sodium in the blood.
This medicine will be administered carefully by intravenous infusion at a strictly controlled infusion rate. Concentrated glucose solutions must not be administered by subcutaneous injection or intramuscular injection, 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 replacement;
• 20%-33% solutions are used for caloric replacement with limited fluid replacement;
• 50% 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.
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 and colorless 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 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 excessive doses of GLUCOSIO Bioindustria L.I.M., an increase in body water and solute concentration (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 the infusion of concentrated glucose needs to be suddenly discontinued, it is recommended to gradually reduce the dose by administering 5% or 10% glucose solution, in order to prevent 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 will experience them.
The following side effects may occur:

• leakage of the medicine into the tissues around the injection site (extravasation);
• infection at the infusion site and local pain;
• circulation problems due to blood clot formation and inflammation of the veins at the infusion site (thrombosis and thrombophlebitis);
• increased body temperature (fever);
• fluid retention 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;
• low sodium levels in the blood (hospital-acquired hyponatraemia**);
• brain swelling (hyponatraemic encephalopathy**);
• fluid accumulation causing swelling in the legs and ankles (peripheral oedema);
• fluid accumulation in the lungs (pulmonary oedema);
• bleeding in the brain (cerebral haemorrhage);
• brain damage caused by poor blood circulation to the brain (cerebral ischaemia).

** Hospital-acquired hyponatraemia can lead to irreversible brain damage and death due to the development of acute hyponatraemic encephalopathy.
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 following address:
http://www.agenziafarmaco.gov.it/content/come-segnalare-una-reazione-avversa. 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 sight and reach of children.
Do not use this medicine after the expiry date stated on the pack 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 you no longer use. This will help protect the environment.

6. Pack 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 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 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 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 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 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 pack contents
Solution for infusion
1 vial of 50 ml;
1 vial of 100 ml;
1 vial of 250 ml;
1 vial of 500 ml;
50 ml in a 100 ml vial;
100 ml in a 250 ml vial;
250 ml in a 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 physicians or healthcare professionals

GLUCOSE Bioindustria L.I.M. 5%, 10%, 20%, 33%, 50% infusion solution
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 cautiously and at a controlled infusion rate.
The 20%, 30%, 33%, and 50% solutions must be administered exclusively via central venous catheter.
If peripheral administration is required, for example in emergency treatment of hypoglycemic crises, the solutions must be injected very slowly into a large-caliber vein of the arm.
One gram of glucose provides approximately 3.74 kcal (about 15.6 kJoule) of caloric energy.
Monitoring of electrolyte balance, serum glucose, serum sodium, and other electrolytes may be necessary before and during administration, particularly in patients with non-osmotic vasopressin release (syndrome of inappropriate antidiuretic hormone secretion, SIADH) and in patients receiving concomitant therapy with vasopressin agonists, due to the risk of hyponatremia.
Monitoring of serum sodium is particularly important for physiologically hypotonic solutions. Glucose Bioindustria L.I.M. infusion solution may become extremely hypotonic after administration due to the metabolism of glucose in the body. Intravenous glucose infusions are generally isotonic solutions. However, in the body, glucose-containing solutions may become extremely hypotonic at a physiological level due to the rapid metabolism of glucose.
Depending on the tonicity of the solution, volume and frequency of infusion, underlying clinical conditions of the patient, and the patient's ability to metabolize glucose, intravenous administration of glucose may cause electrolyte disturbances, particularly hypo- or hyperosmolar hyponatremia.

Hyponatremia:
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 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 damage.
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.

Incompatibilities
Intravenous glucose solutions are incompatible with:

• cyanocobalamin;
• kanamycin sulfate;
• sodium novobiocinate;
• 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 without added electrolytes should not be administered through the same infusion catheter as whole blood due to the possible formation of aggregates and the risk of hemolysis.
Ampicillin and amoxicillin are stable in glucose solutions only for a short period.

For further information, consult the Summary of Product Characteristics.