Glucose Diaco

Package leaflet: Information for the patient

Glucosio DIACO 5% solution for infusion, 10% solution for infusion

Please read this leaflet carefully before 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 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, talk to 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 Glucosio DIACO is and what it is used for

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

2. What you should know before using Glucosio DIACO

Do not use Glucosio DIACO

• If you are allergic to glucose or to any of the other ingredients of this medicine (listed in section 6);
• 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 (hallucinations, tremors, fever, sweating), which may occur in chronic alcoholics during withdrawal, especially when dehydration is present;
• If you are severely dehydrated;
• In case of 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 DIACO.

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 of energy.

The 5% solution is isotonic with blood (has the same osmotic pressure).

The 10% solution is hypertonic compared to blood (has higher osmotic pressure) and must be infused cautiously and at a controlled infusion rate.

This medicine should be administered with caution in the following cases:

• If you have overt or subclinical diabetes mellitus or any type of glucose intolerance. To minimize the risk of hyperglycemia (increased blood sugar concentration) and subsequent glycosuria (sugar in urine), blood and urine glucose levels should be monitored during administration, and insulin should be administered if required.
• If you have heart failure,
• If you have severe renal failure,
• If you have edema (tissue swelling) or hydro-saline retention (accumulation of water and salts in the body),
• If you are taking corticosteroids (corticosteroids) or corticotropin hormone (see section "Other medicines and Glucosio DIACO").

This medicine should be administered with caution and under specific monitoring conditions:

• If you have the "syndrome of inappropriate antidiuretic hormone secretion" (SIADH), which causes non-osmotic release of vasopressin (antidiuretic hormone),
• If you are receiving treatment with vasopressin agonists,
• If you have conditions that may cause elevated levels of vasopressin (antidiuretic hormone):
  • acute illness
  • pain
  • recent surgery
  • infections, burns
  • cerebral diseases
  • heart, liver, or kidney diseases.

These conditions may increase the risk of low sodium levels in the blood (hyponatremia).

Acute hyponatremia may cause acute hyponatremic encephalopathy (cerebral edema), characterized by headache, nausea, seizures, drowsiness, and vomiting, which may lead to death.

Acute hyponatremia may cause severe brain damage, especially in children, women of childbearing age, and patients with certain brain conditions (reduced cerebral compliance).

Prolonged use of this medicine may lead to fluid overload (accumulation of water in the body), circulatory congestion, and decreased concentrations of electrolytes in the blood, particularly potassium and phosphate. Therefore, it is essential to monitor blood electrolyte levels and correct any imbalances in fluid and electrolyte equilibrium as needed.

Additionally, if necessary, vitamins and minerals may be administered.

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

Children

In children, especially neonates and those with low body weight, administration of glucose may increase the risk of elevated blood sugar levels (hyperglycemia). Furthermore, in low-weight children, rapid or excessive infusion may increase blood osmolarity and lead to intracerebral hemorrhage.

Other medicines and Glucosio DIACO

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

If you are receiving glucose together with corticosteroids and corticotropin, close monitoring is required, as these medicines are associated with reduced carbohydrate (sugar) tolerance and possible manifestation of latent diabetes mellitus.

GLUCOSIO DIACO should be administered with caution if you are taking:

medicines affecting 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 hyponatremia.

If you need to take any of these medicines, medical supervision during treatment is necessary.

Glucose solutions may be incompatible with other infusion solutions.

Pregnancy and breastfeeding

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

Pregnancy

This medicine should not be used during pregnancy unless absolutely necessary.

If you are pregnant, this medicine should be administered with particular caution during labor due to the risk of hyponatremia, especially if administered in combination with a labor-inducing medicine (oxytocin).

Breastfeeding

Until data on the use of glucose during breastfeeding become available, particular caution should be exercised when deciding to use this medicine during breastfeeding.

Driving and using machines

Not applicable

3. How to use Glucosio DIACO

Use this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Glucose 5% and 10% solutions are used for fluid and calorie replacement.
Glucose solutions are administered directly into a vein (intravenous infusion).
The 10% glucose solution must be infused with caution and at a controlled infusion rate.
If peripheral administration is necessary, 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 usual infusion rate is 0.4 – 0.8 g/kg/hour based on body weight.

Adults
The concentration of the glucose solution and the dose to be used depend on age, body weight, clinical condition, and blood electrolyte and pH levels.

Elderly
No differences in response to glucose administration have been demonstrated between elderly and younger patients. However, as a general rule, caution should be exercised when administering medicines to elderly patients.

Children
The dosage and rate of glucose administration must be adjusted according to the patient's age, body weight, and clinical condition. Particular caution is required in children, especially in neonates or children with low body weight (see section "Warnings and Precautions").

You must take all standard 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 is not clear and colourless or slightly yellowish, or if it contains particles.

If you use more Glucosio DIACO than you should
Prolonged administration of glucose may lead to hyperhydration (increased water content in tissues) and solute overload (increased concentration of dissolved substances in tissues). In such cases, your doctor will need to reassess your clinical condition and initiate corrective therapy.
In case of accidental ingestion/overdose of Glucosio DIACO, inform your doctor immediately or go to the nearest hospital.

If you have any doubts about how to use 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 too rapid administration or administration by a route other than intravenous.

Not known (frequency cannot be estimated from 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 clot in the vein)
• Thrombophlebitis (inflammation of the vein with clot formation)
• Fever
• Fluid and/or solute overload leading to decreased potassium, magnesium, and phosphate levels in the blood, and increased water content in the blood
• Increased metabolic rate (increase in the rate at which the body burns various substances to produce energy)
• Hyperglycaemia (increased blood sugar concentration)
• Hyperosmolarity (increased internal blood pressure due to dissolved substances)
• Hypervolaemia (increased volume of circulating blood)
• Hypoglycaemia (reduced blood sugar concentration)
• Hospital-acquired hyponatraemia (reduced sodium concentration in the blood), which may cause irreversible brain damage and death
• Increased insulin levels
• Increased adrenaline levels
• Peripheral oedema (fluid accumulation in tissues)
• Cerebral haemorrhage
• Cerebral ischaemia
• Pulmonary oedema
• Hyponatraemic encephalopathy (brain damage caused by reduced sodium concentration in the blood)

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. You can also report side effects directly via 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 stated on the packaging after “EXP.”.
The expiry date refers to the last day of that month.
The expiry date refers to the medicine kept in its original, undamaged packaging and stored correctly.
Do not refrigerate.
Keep the container tightly closed.
After first opening the container, use the medicine immediately for a single, uninterrupted administration.
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 via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Glucosio DIACO contains
Glucosio DIACO 5% infusion solution

• The active substance is glucose. 1000 ml of solution contain 55 g of glucose monohydrate (equivalent 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% infusion solution

• The active substance is glucose. 1000 ml of solution contain 110 g of glucose monohydrate (equivalent 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 contents of the pack
Glucosio DIACO is a sterile, pyrogen-free infusion solution available in glass bottles of
50-100-250-500-1000 ml.
Not all pack sizes may be marketed.

Marketing Authorization 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)
• sodium novobiocin (antibiotic)
• sodium warfarin (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 (hydroxyethyl starch).

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.

Management of overdose
Prolonged administration of glucose may lead to hyperhydration and solute overload. In such cases, the patient's clinical condition should be re-evaluated and appropriate corrective measures instituted.