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1. Glucosio Eurospital 5% solution for infusion, 10% solution for infusion, 20% solution for infusion
   1. What is Glucosio Eurospital and what is it used for
   2. What you need to know before using Glucosio Eurospital
   3. How to use Glucosio Eurospital
   4. Possible side effects
   5. How to store Glucosio Eurospital
   6. Package contents and other information

Glucosio Eurospital 5% solution for infusion, 10% solution for infusion, 20% solution for infusion

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 those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What is Glucosio Eurospital and what is it used for

Glucosio Eurospital contains the active ingredient glucose which belongs to the category of parenteral nutritional solutions.
Glucosio Eurospital is used for the treatment of conditions requiring restoration of hydration in association with a caloric intake, especially in patients who do not need salts or in whom these should be avoided. Restoration of blood glucose concentrations in case of hypoglycemia (low blood sugar level).
Consult your doctor if you do not feel better or if you feel worse.

2. What you need to know before using Glucosio Eurospital

Do not use Glucosio Eurospital

• if you are allergic to glucose or any of the other ingredients of this medicine (listed in section 6);
• If you suffer from a known allergy to wheat or wheat-derived products;
• If you suffer from anuria (absence or reduction of urine output);
• In case of spinal (inside the spinal column) or intracranial (inside the skull) hemorrhage;
• If you suffer from delirium tremens, a set of symptoms (e.g. hallucinations, tremors, fever, sweating) that can occur in chronic alcoholics in withdrawal (if you already have a state of dehydration);
• If you are severely dehydrated.
• In case of patients in hepatic coma.

Glucose solutions should not be administered to you through the same infusion catheter with whole blood due to the possible risk of pseudoagglutination (red blood cell aggregation) and hemolysis (red blood cell wall rupture).

Warnings and precautions
Consult your doctor or pharmacist before using Glucosio Eurospital.
Concentrated glucose solutions should not be administered subcutaneously or intramuscularly.
Do not administer if the solution is not clear and the container is not intact. One gram of glucose provides a caloric contribution equal to 3.74 Kcal (approximately 15.6 Kjoules).
The 5% solution is isotonic with blood (has the same osmotic pressure).
The 10%, 20% solutions are hypertonic with blood (have a higher osmotic pressure) and must be infused with caution and at a controlled infusion rate.
Glucose solutions should be administered with caution if you suffer from diagnosed or subclinical diabetes mellitus or if you have glucose intolerance of any kind. To minimize the risk of hyperglycemia (increased blood sugar concentration) and subsequent glycosuria (presence of sugar in the urine), it is necessary to monitor blood and urine glucose and, if necessary, administer insulin.
During prolonged use of concentrated glucose solutions, fluid overload (drawing water from tissues into the bloodstream), congestive state and electrolyte deficiency (reduction of certain elements in the blood), 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.
In addition, if necessary, vitamins and mineral salts can be administered.
It may be necessary to monitor electrolyte balance, serum glucose, serum sodium and other electrolytes before and during administration, especially if you suffer from the syndrome of inappropriate antidiuretic hormone secretion (SIADH) which involves an increase in non-osmotic vasopressin release and if you are undergoing concomitant therapy with vasopressin agonists, due to the risk of hyponatremia.
When the infusion of concentrated glucose needs to be suddenly stopped, it is advisable to continue with the administration of 5% - 10% glucose, in order to avoid rebound hypoglycemia.
Take particular care if you suffer from heart failure, severe kidney failure and if you experience clinical conditions associated with edema (tissue swelling) and hydrosaline retention (accumulation of water and salts in the body). If you are taking corticosteroids (cortisone) or corticotropin (a substance that stimulates the adrenal glands, which are glands located above the kidneys) (see section “Other medicines and Glucosio Eurospital”) particular attention must be paid when Glucosio Eurospital is administered to you.
In pediatric patients, especially in neonates and children with low body weight, 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.
Depending on the tonicity (concentration) of the solution, the volume and frequency of infusion and your clinical conditions, as well as your ability to metabolize glucose, intravenous administration of glucose may cause alterations in blood salt concentration, especially sodium (hypotonic or hyperosmotic hyponatremia).
If you suffer from: acute illnesses, pain, post-operative stress, infections, burns and diseases of the central nervous system (conditions that determine a non-osmotic release of a hormone called vasopressin), if you suffer from heart disease (cardiopathies), liver disease (hepatopathies) and kidney disease (nephropathies) and if you are being treated with vasopressin agonist drugs (see “Other medicines and Glucosio Eurospital”) you may be particularly at risk of sudden reduction in blood sodium concentration (acute hyponatremia) following infusion of hypotonic solutions.
Acute hyponatremia can cause acute hyponatremic encephalopathy (cerebral edema) characterized by headache, nausea, seizures, lethargy (drowsiness) and vomiting. Patients with cerebral edema are particularly at risk of severe, irreversible and life-threatening brain injury.
Children, women of childbearing potential 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.

Other medicines and Glucosio Eurospital
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Since corticosteroids and corticotropin are associated with decreased carbohydrate (sugar) tolerance and possible manifestation of latent (hidden) diabetes mellitus, careful monitoring of the patient is required in case of concomitant administration of glucose.

Glucose solutions for intravenous use are incompatible with:

• cyanocobalamin (vitamin B12)
• kanamycin sulfate (antibiotic)
• novobiocin sodium (antibiotic)
• warfarin sodium (anticoagulant)

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 stable in glucose solutions only for a short period.

Medicines that increase the effect of vasopressin
The following medicines increase the risk of hospital-acquired hyponatremia following treatment not adequately balanced with intravenous solutions (see “How to take Glucosio Eurospital”, “Warnings and precautions” and “Side effects”):

• Medicines stimulating vasopressin release, e.g.: Chlorpropamide, clofibrate, carbamazepine, vincristine, selective serotonin reuptake inhibitors, 3,4-methylenedioxymethamphetamine, ifosfamide, antipsychotics, narcotics
• Medicines that enhance the action of vasopressin, e.g.: Chlorpropamide, NSAIDs, cyclophosphamide
• Vasopressin analogues, e.g.: Desmopressin, oxytocin, vasopressin, terlipressin.

Other medicines that increase the risk of hyponatremia (reduction of sodium concentration in the blood) also include diuretics in general and antiepileptics such as oxcarbazepine.

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 this medicine is administered to you.
Pregnancy
This medicine should not be used during pregnancy unless absolutely necessary, for this reason your doctor will assess whether it is necessary to administer Glucosio Eurospital to you.
During labor, your doctor will assess whether it is necessary to administer this medicine to you, in particular if in association with oxytocin (a medicine used to stimulate uterine contractions), due to the risk of hyponatremia (see sections “Warnings and precautions”, “Other medicines and Glucosio Eurospital”, “Side effects”).
Breastfeeding
It is not known whether glucose alters the quantity and composition of breast milk. Until further data are available on the use of glucose during breastfeeding, it is important to take particular care when deciding to use glucose during breastfeeding. If you have doubts, ask your doctor.

Driving and using machines
Not applicable

3. How to use Glucosio Eurospital

This medicine must be administered to you always following the doctor's instructions exactly. If you have
any doubts, consult your doctor or pharmacist.
Glucose solutions are administered intravenously.
The 20% solution must be administered exclusively through a central venous catheter.
Should it 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 large-caliber vein in the arm. The infusion rate is generally 0.4 - 0.8 g/Kg/hour per kg of body weight.
Below are general guidelines for choosing the different glucose concentrations.

• 5% - 10% solutions - rehydration and calorie supplementation;
• 20% solution - calorie supplementation and limited rehydration;

Adults
The concentration of the glucose solution and the dose to be used depend on the characteristics of the
patient (age, weight, clinical conditions, hydro-electrolytic and acid-base balance).
Elderly
Clinical studies and clinical practice have not shown differences in response between elderly and younger
patients following glucose administration. As a general rule, caution is advised when
administering drugs to elderly patients.
Children
The dosage and rate of glucose administration must be chosen based on the patient's age, weight
and clinical condition. Generally, solutions with a concentration higher than 10% are not used. Particular caution is required in pediatric patients and especially in newborns or children
with low body weight (see section “Warnings and Precautions”).
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.

If you use more Glucosio Eurospital than you should
In case of prolonged glucose administration, hyperhydration (increased
amount of water in the tissues) and solute overload (increased amount of dissolved substances in the
tissues) may occur. In this case, the doctor will need to reassess your clinical condition and establish appropriate corrective measures.
In case of accidental ingestion/administration of an excessive dose of Glucosio Eurospital, immediately inform
your doctor or go to the nearest hospital.
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.
Some of the side effects listed below have occurred with incorrect administration of the
medicine, for example, administration that is too fast or by a route other than
intravenous.

• Infection at the site of administration
• Thrombosis at the site of administration (formation of a blood clot in the vein)
• Thrombophlebitis (inflammation of the vein with a blood clot)
• Fluid and/or solute overload with consequent dilution of serum electrolytes (hypokalaemia, i.e. low potassium levels in the blood, hypomagnesaemia i.e. low magnesium levels in the blood, hypophosphataemia, i.e. low phosphorus levels in the blood, hyperhydration increased amount of water in the blood)
• Increased metabolic rate (increased rate at which the body burns various substances to produce energy)
• Hyperglycaemia (increased blood sugar concentration)
• Hyperosmolarity (increased internal pressure of the blood due to dissolved substances)
• Hyponatraemia (reduction in blood sodium concentration) acquired in hospital, which can cause irreversible brain damage and death
• Hypervolaemia (increased circulating blood volume)
• Hypoglycaemia (reduced blood sugar concentration)
• Increased insulin level, which lowers blood sugar concentration
• Increased adrenaline level, which is a substance formed by the inner part of the adrenal glands
• Peripheral oedema (fluid accumulation in the tissues)
• Pulmonary oedema (water accumulation in the lung)
• Cerebral haemorrhage (rupture of a cerebral artery)
• Cerebral ischaemia (blockage of a cerebral artery)
• Hyponatraemic encephalopathy (brain damage caused by a reduction in blood sodium concentration)
• Extravasation (leakage of the solution from the vein into the surrounding tissues)
• Local pain
• Fever

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor, pharmacist or nurse. You can also report side effects directly through the
national reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-una-
sospetta-reazione-avversa.
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Glucosio Eurospital

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.
Store at room temperature (8-30°C).
Do not refrigerate.
Keep the container tightly closed.
After the first opening of the package, the medicine must be used immediately for a single and
uninterrupted administration.
Do not use this medicine if you notice that the packaging is damaged.
Do not use this medicine if you notice that the glucose 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 eliminate
medicines that you no longer use. This will help protect the environment.

6. Package contents and other information

What Glucosio Eurospital contains

Glucosio Eurospital 5% solution for infusion

• The active ingredient is glucose. 55 g/l of glucose monohydrate (corresponding to 50 g/l of anhydrous glucose), Osmolarity 278 mOsm/L, pH=3.5-6.5
• The other component is water for injections.

Glucosio Eurospital 10% solution for infusion

• The active ingredient is glucose. 110 g/l of glucose monohydrate (corresponding to 100 g/l of anhydrous glucose), Osmolarity 555 mOsm/L, pH=3.5-6.5
• The other component is water for injections.

Glucosio Eurospital 20% solution for infusion

• The active ingredient is glucose. 220 g/l of glucose monohydrate (corresponding to 200 g/l of anhydrous glucose), Osmolarity 1100 mOsm/L, pH=3.5-6.5
• The other component is water for injections.

Description of the appearance of Glucosio Eurospital and package contents
Solution for infusion in glass bottle.
Glucosio Eurospital 5% Solution for infusion –bottles of 100-250-500-1000 ml
Glucosio Eurospital 10% Solution for infusion – bottle of 500 ml
Glucosio Eurospital 20% Solution for infusion – bottle of 500 ml

Marketing authorisation holder
Eurospital S.p.A.
Via Flavia, 122
Trieste

Manufacturers
Industria Farmaceutica Galenica Senese S.r.l., Via Cassia Nord, 351 – 53014, Monteroni D'Arbia (SI)
Bieffe Medital S.p.A. – Via Nuova provinciale snc, 23034 Grosotto (SO), Italy
Laboratorios Grifols S.A., Pol. Ind. Autopista, Passeig Fluvial 24 - 08150 Parets del Vallès (Barcelona –
Spain)