GLUCOSIO 5% Roztwór do infuzji

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1. Glucosio DIACO 5% infusion solution, 10% infusion solution
   1. What is Glucosio DIACO and what is it used for
   2. What you need to know before using Glucosio DIACO
   3. How to use Glucosio DIACO
   4. Possible side effects
   5. How to store Glucosio DIACO
   6. Package Contents and Other Information

Glucosio DIACO 5% infusion solution, 10% infusion solution

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

Contents of this leaflet:

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

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

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

2. What you need to know before using Glucosio DIACO

Do not use Glucosio DIACO

• If you are allergic to glucose or any of the other ingredients of this medicine (listed in section 6);
• If you suffer from anuria (absence or reduction of urine output);
• In case of spinal (inside the spinal column) or intracranial (inside the skull) haemorrhage;
• If you suffer from delirium tremens (hallucinations, tremors, fever, sweating) which can occur in chronic alcoholics in withdrawal in the presence of dehydration;
• If you are severely dehydrated.
• In case of hepatic coma.

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

Warnings and precautions
Consult your doctor or pharmacist before using Glucosio DIACO.
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.
The 5% solution is isotonic with blood (has the same osmotic pressure).
The 10% solution is hypertonic with blood (has a higher osmotic pressure) and must be infused with caution and at a controlled infusion rate.
This medicine must be administered with caution in the following cases:

• if you suffer from overt or subclinical diabetes mellitus or if you have glucose intolerance of any kind. To minimise the risk of hyperglycaemia (increased blood sugar concentration) and subsequent glycosuria (presence of sugar in the urine), it is necessary to monitor blood and urine glucose during administration and, if required, administer insulin.
• if you suffer from heart failure,
• if you suffer from severe renal insufficiency
• if you experience oedema (swelling of tissues) and hydrosaline retention (accumulation of water and salts in the body).
• if you are taking corticosteroids (cortisone) or corticotropin hormone (see section “Other medicines and Glucosio DIACO”).

This medicine must be administered with caution and under specific monitoring:

• if you suffer from “inappropriate secretion of antidiuretic hormone” (SIADH) syndrome, which involves an increase in the non-osmotic release of vasopressin (antidiuretic hormone),
• if you are undergoing therapy with vasopressin agonists,
• if you suffer from conditions that can cause high levels of vasopressin hormone (antidiuretic hormone):
• have an acute phase illness
• have pain
• have undergone surgery
• have infections, burns
• have brain diseases
• have heart, liver or kidney diseases.

This may increase the risk of low sodium levels in the blood (hyponatraemia).
Acute hyponatraemia can cause acute hyponatraemic encephalopathy (cerebral oedema) characterised by headache, nausea, seizures, drowsiness and vomiting, which can lead to death.
Acute hyponatraemia can cause serious brain damage, especially in children, women of childbearing age and patients with certain brain problems (reduced cerebral compliance).
During prolonged use with this medicine, fluid overload (accumulation of water in the body), congestion and a reduction in the concentration of mineral salts in the blood, particularly potassium and phosphate, may occur. Therefore, it is essential to monitor the concentration of mineral salts in the blood and, if necessary, correct imbalances in water and electrolyte balance.
In addition, if necessary, vitamins and mineral salts can be administered.
When the infusion of concentrated glucose needs to be stopped abruptly, it is recommended to continue with a 5% - 10% glucose administration, in order to avoid rebound hypoglycaemia.

Children
In children, especially in neonates and children with low body weight, the administration of glucose may increase the risk of increased blood sugar levels (hyperglycaemia). In addition, in children with low body weight, a rapid or excessive infusion may cause an increase in blood osmolarity and intracranial haemorrhage

Other medicines and Glucosio DIACO
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
If you are undergoing simultaneous administration of glucose with corticosteroids and corticotropin, you must be carefully monitored, as these medicines are associated with decreased carbohydrate (sugar) tolerance and possible manifestation of latent diabetes mellitus.
GLUCOSIO DIACO must be administered with caution if you are taking:
medicines that act on the vasopressin hormone 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 oxcarbazepine as they may increase the risk of hyponatraemia.
If you need to take these medicines, medical monitoring is necessary during treatment.
Glucose solutions may be incompatible with other infusion solutions.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
This medicine should not be used during pregnancy unless absolutely necessary.
If you are pregnant, this medicine must be administered with particular caution during labour due to the risk of hyponatraemia, especially if administered in association with a labour-inducing medicine (oxytocin).
Breastfeeding
Until data are available on the use of glucose during breastfeeding, it is important to exercise particular caution when deciding to use this medicine during breastfeeding.

Driving and operating machinery
Not applicable

3. How to use Glucosio DIACO

Use this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
5% and 10% glucose solutions are used for the replenishment of fluids and calories.
Glucose solutions are administered directly into a vein (intravenous infusion).
10% glucose solution must be infused with caution and at a controlled infusion rate.
If it should 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.
Adults
The concentration of the glucose solution and the dose to be used depend on age, weight,
your clinical condition and the levels of mineral salts and blood pH.
Elderly
No differences in response have been demonstrated between elderly and younger patients following
glucose administration. As a general rule, caution is advised when administering
medicines to the elderly.
Children
The dosage and rate of glucose administration must be chosen based on age,
weight and the patient's clinical condition. Particular caution is required in children and
especially in newborns or children with low birth weight (see section “Warnings and
Precautions”).
You must take all usual precautions to maintain sterility before and during intravenous
infusion.
Do not use this medicine if the packaging is damaged.
Do not use the glucose solution if it does not appear clear, colorless or slightly straw
yellow, or if it contains particles.

If you use more Glucosio DIACO than you should
In the case of prolonged glucose administration, hyperhydration may occur
(increased amount of water in the tissues) and solute overload (increased amount of
dissolved substances in the tissues). In this case, the doctor will need to reassess your clinical condition and
establish corrective therapy.
In case of accidental ingestion/administration of an excessive dose of Glucosio DIACO, 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 in cases of incorrect
administration of the medicine, for example, administration that is too fast or via a route other than
intravenous.
Not known (the frequency cannot be estimated based on the available data)

• Extravasation (leakage of the solution from the vein into the surrounding tissues)
• Local pain
• 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)
• Fever
• Fluid and/or solute overload with consequent decrease in potassium, magnesium, phosphate in the blood, and increase in the amount of water in the blood
• Increased metabolic rate (increase in the rate at which the body burns various substances to produce energy)
• Hyperglycemia (increased blood sugar concentration)
• Hyperosmolarity (increased internal pressure of the blood due to dissolved substances)
• Hypervolemia (increased circulating blood volume)
• Hypoglycemia (decreased blood sugar concentration)
• Hyponatremia (decreased sodium concentration in the blood) acquired in hospital, which can cause irreversible brain damage and death
• Increased insulin level
• Increased adrenaline level
• Peripheral edema (accumulation of fluid in the tissues)
• Cerebral hemorrhage
• Cerebral ischemia
• Pulmonary edema
• Hyponatremic encephalopathy (brain damage caused by a decrease in sodium concentration in the blood).

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
http://www.agenziafarmaco.gov.it/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 DIACO

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 after “EXP.”.
The expiry date refers to the last day of that month.
The expiry date refers to the medicine in intact packaging, correctly stored.
Do not refrigerate.
Keep the container tightly closed.
After the first opening of the package, use the medicine immediately for a single and
uninterrupted administration.
Do not use this medicine if you notice that the glucose solution is not clear, colorless 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
dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Glucosio DIACO contains

Glucosio DIACO 5% solution for infusion

• The active ingredient is glucose. 1000 ml of solution contains 55 g of glucose monohydrate (corresponding to 50 g/l of anhydrous glucose). Osmolarity 278 mOsmol/L, pH=3.5-6.5.
• The other component is water for injections.

Glucosio DIACO 10% solution for infusion

• The active ingredient is glucose. 1000 ml of solution contains 110 g of glucose monohydrate (corresponding to 100 g/l of anhydrous glucose). Osmolarity 555 mOsmol/L, pH=3.5-6.5.
• The other component is water for injections.

Description of the appearance of Glucosio DIACO and package contents
Glucosio DIACO is a sterile and apyrogenic solution for infusion available in glass bottles of
50-100-250-500-1000 ml.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Diaco Biofarmaceutici S.r.l.
Via Flavia 124 – 34147 Trieste

The following information is intended for healthcare professionals only
Incompatibilities
Glucose solutions for intravenous use are incompatible with:

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

In addition, there are conflicting opinions regarding the compatibility of glucose with the following
solutions:

• calcium chloride;
• magnesium chloride;
• potassium chloride;
• sodium chloride;
• sodium lactate;
• hetastarch (hydroxyethyl starch).

Glucose solutions that do not contain electrolytes should not be administered via the same
infusion catheter with whole blood due to the possible formation of aggregates and the risk of
hemolysis.
Ampicillin and amoxicillin are only stable in glucose solutions for a short period.

Overdose Treatment
In case of prolonged glucose administration, overhydration and solute overload may occur.
In such cases, the patient's clinical condition should be reassessed and appropriate corrective
measures should be instituted.