GLUCOSE EUROSPITAL

Patient Information Leaflet

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

Generic medicine
Please read all of this leaflet carefully before you start 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 may be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact 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 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

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

Glucosio Eurospital contains the active substance glucose, which belongs to the category of parenteral nutritional solutions.
Glucosio Eurospital is used for the treatment of conditions requiring restoration of hydration status along with caloric intake, especially in patients who do not require electrolytes or in whom electrolytes should be avoided. It is also used for the restoration of blood glucose levels in cases of hypoglycaemia (low blood sugar levels).
Consult your doctor if you do not feel better or if you feel worse.

2. What you must know before using Glucosio Eurospital

Do not use Glucosio Eurospital

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

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

Warnings and precautions

Talk to your doctor or pharmacist before using Glucosio Eurospital.

Concentrated glucose solutions must not be administered subcutaneously or intramuscularly.
Do not administer if the solution is not clear or if the container is damaged. One gram of glucose provides approximately 3.74 kcal (about 15.6 kJ) of energy.

A 5% glucose solution is isotonic with blood (has the same osmotic pressure).
Solutions at 10% and 20% are hypertonic (have higher osmotic pressure than blood) and must be infused cautiously and at a controlled infusion rate.

Glucose solutions must be administered with caution if you have overt or subclinical diabetes mellitus or any form of glucose intolerance. To minimize the risk of hyperglycemia (increased blood sugar levels) and subsequent glycosuria (sugar in urine), blood and urine glucose levels should be monitored and insulin administered if required.

During prolonged use of concentrated glucose solutions, fluid overload (shift of water from tissues into the bloodstream), congestive states, and electrolyte imbalances (reduced concentration of certain elements in the blood), particularly potassium and phosphate, may occur. Therefore, monitoring of blood electrolytes is essential, and any imbalances in fluid and electrolyte levels should be corrected as needed.

Additionally, administration of vitamins and minerals may be necessary if required.

Electrolyte balance, serum glucose, serum sodium, and other electrolytes should be monitored before and during administration, especially if you have the syndrome of inappropriate antidiuretic hormone secretion (SIADH), which causes non-osmotic release of vasopressin, or if you are receiving concomitant treatment with vasopressin agonists, due to the risk of hyponatremia.

When concentrated glucose infusion must be abruptly discontinued, it is recommended to continue with a 5%–10% glucose infusion to prevent rebound hypoglycemia.

Exercise particular caution if you have heart failure, severe renal insufficiency, or clinical conditions associated with edema (tissue swelling) and hydro-saline retention (accumulation of water and salts in the body). Special attention is required if you are taking corticosteroids (e.g. cortisone) or corticotropin (a substance that stimulates the adrenal glands located above the kidneys) (see section “Other medicines and Glucosio Eurospital”) while receiving Glucosio Eurospital.

In pediatric patients, especially neonates and low-birth-weight infants, glucose administration may increase the risk of hyperglycemia. Moreover, in low-birth-weight infants, rapid or excessive infusion may lead to increased serum osmolarity and intracerebral hemorrhage.

Depending on the tonicity (concentration) of the solution, volume and frequency of infusion, your clinical condition, and your ability to metabolize glucose, intravenous glucose administration may cause changes in blood electrolyte concentrations, particularly sodium (hypo- or hyperosmolar hyponatremia).

If you suffer from acute illnesses, pain, postoperative stress, infections, burns, or diseases of the central nervous system (conditions causing non-osmotic release of the hormone vasopressin), or if you have heart disease (cardiopathy), liver disease (hepatopathy), kidney disease (nephropathy), or 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 may lead to acute hyponatremic encephalopathy (cerebral edema), characterized by headache, nausea, seizures, lethargy (drowsiness), and vomiting. Patients with cerebral edema are at particularly high risk of severe, irreversible, and life-threatening brain damage.

Children, women of childbearing age, and patients with reduced cerebral compliance (e.g. meningitis, intracranial bleeding, cerebral contusion) are especially at risk of severe and life-threatening cerebral edema caused by acute hyponatremia.

Other medicines and Glucosio Eurospital

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Since corticosteroids and corticotropin are associated with reduced carbohydrate tolerance and possible manifestation of latent (hidden) diabetes mellitus, careful monitoring is required when glucose is administered concomitantly.

Glucose solutions for intravenous use are incompatible with:

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

Moreover, 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 clumps and the risk of hemolysis.

Ampicillin and amoxicillin remain 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 due to inadequately balanced intravenous fluid therapy (see sections “How to take Glucosio Eurospital”, “Warnings and precautions”, and “Side effects”):

• Medicines that stimulate vasopressin release, e.g.: chlorpropamide, clofibrate, carbamazepine, vincristine, selective serotonin reuptake inhibitors, 3,4-methylenedioxy-N-methamphetamine, ifosfamide, antipsychotics, narcotics
• Medicines that enhance the action of vasopressin, e.g.: chlorpropamide, NSAIDs, cyclophosphamide
• Vasopressin analogs, e.g.: desmopressin, oxytocin, vasopressin, terlipressin

Other medicines that increase the risk of hyponatremia (reduced blood sodium concentration) include diuretics in general and antiepileptic drugs such as oxcarbazepine.

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, planning pregnancy, or breastfeeding, consult your doctor or pharmacist before receiving this medicine.

Pregnancy

This medicine should not be used during pregnancy unless absolutely necessary. Your doctor will assess whether administration of Glucosio Eurospital is required.

During labor, your doctor will evaluate whether administration of this medicine is necessary, particularly if used in combination 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 affects the quantity and composition of breast milk. Until further data on glucose use during breastfeeding become available, particular caution should be exercised when deciding to use glucose during lactation. If in doubt, consult your doctor.

Driving and using machines

Not applicable

3. How to use Glucosio Eurospital

This medicine must be administered to you exactly as prescribed by your doctor. If you have
any doubts, consult your doctor or pharmacist.
Glucose solutions are administered intravenously.
The 20% solution must be administered exclusively via a central venous catheter.
If peripheral administration is required, for example in the emergency treatment of hypoglycemic crises, the solution must be injected very slowly into a large-caliber vein of the arm. The usual infusion rate is 0.4 - 0.8 g/kg/hour per kg of body weight.
Below are general guidelines for selecting different glucose concentrations.

• 5% - 10% solutions: fluid and caloric replacement;
• 20% solution: caloric replacement with limited fluid replacement;

Adults
The concentration of the glucose solution and the dose to be used depend on the patient's characteristics (age, weight, clinical condition, fluid-electrolyte 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 required when administering medicines to elderly patients.
Children
The dosage and rate of glucose administration must be adjusted according to the patient's age, weight, and clinical condition. Solutions with a concentration higher than 10% are generally not used. Particular caution is required in pediatric patients, especially in neonates or children with low body weight (see section “Warnings and Precautions”).
Take 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, colorless or slightly straw-yellow, or if it contains particles.
If you use more Glucosio Eurospital than you should
Prolonged administration of glucose may lead to hyperhydration (increased water content in tissues) and solute overload (increased amount of dissolved substances in tissues). In such cases, the doctor should reassess your clinical condition and initiate appropriate corrective measures.
In case of accidental ingestion/overdose of Glucosio Eurospital, contact your doctor immediately 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 everyone experiences them.
Some of the side effects listed below have occurred in cases of incorrect administration of the drug, for example too rapid administration or administration by a route other than intravenous.

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

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your doctor, pharmacist or nurse. You can also report side effects directly via 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 stated on the container.
Store at room temperature (8–30°C).
Do not refrigerate.
Keep the container tightly closed.
After first opening 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 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 Eurospital contains
Glucosio Eurospital 5% solution for infusion

• The active substance is glucose. 55 g/l of glucose monohydrate (equivalent 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 substance is glucose. 110 g/l of glucose monohydrate (equivalent 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 substance is glucose. 220 g/l of glucose monohydrate (equivalent 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 contents of the pack
Solution for infusion in glass bottles.
Glucosio Eurospital 5% Solution for infusion – bottles of 100-250-500-1000 ml
Glucosio Eurospital 10% Solution for infusion – 500 ml bottle
Glucosio Eurospital 20% Solution for infusion – 500 ml bottle

Marketing Authorization Holder
Eurospital S.p.A.
Via Flavia, 122
Trieste, Italy

Manufacturers
Industria Farmaceutica Galenica Senese S.r.l., Via Cassia Nord, 351 – 53014, Monteroni D'Arbia (SI), Italy
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)