PATIENT INFORMATION LEAFLET

Sucrose Glucose Solution 20% for Infusion

Glucose

Read this leaflet carefully before you start using the medicine

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others even if their symptoms are the same.
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Vitulia 20% Glucose Solutionis a perfusion solution (administered intravenously through an infusion set) with a low concentration of glucose that is used:

• fortreatment of excessive water loss (hypertonic dehydration) due to vomiting, diarrhea
• as an energy supplement in parenteral nutrition when oral food intake is limited
• carbohydrate metabolism disorders (glucose deficiency or hypoglycemia, insulin excess coma, hepatic coma, vomiting)
• as a vehicle and diluent for other medications or electrolyte solutions (substances with electric charge such as sodium, potassium and chlorides).

No use Suero Glucosado Vitulia 20%

- if you are allergic (hypersensitive) to the active principles or to any of the other components of Suero Glucosado Vitulia 20%.

If you have:

• edema due to accumulation of fluid in tissues
• high blood glucose levels (hyperglycemia)
• low potassium levels (hypokalemia)
• hyperlactacidemia (accumulation of lactic acid in blood)
• significant alteration of glucose tolerance
• excessive water (hyperhydration)
• hypotonic dehydration (greater loss of salts than water)
• within the first 24 hours after a head trauma.

Be especially careful with Suero Glucosado Vitulia 20%

Inform your doctor if you suffer from:

• diabetes mellitus, it can be used if appropriate insulin treatment is initiated first
• kidney insufficiency (defective kidney function)
• intracranial hypertension
• acute ischemic attacks (decrease or absence of blood circulation in arteries)
• acid-base balance alterations (acid-base disorders in blood)
• malnutrition with vitamin B1 deficiency (essential for glucose metabolism)
• patients with inadequate vasopressin release, e.g., in critical states, pain, postoperative stress, infections, burns, and CNS diseases, and patients with heart, liver, and kidney diseases. Due to a higher risk of acute hyponatremia(low sodium level in plasma).

Do not administer Suero Glucosado Vitulia 20% with the same infusion equipment (equipment used to administer medications directly into the blood), nor at the same time, nor before or after a blood transfusion, as incompatibilities may occur.

Regularly monitor your blood sugar levels, electrolyte levels, and water balance.Also, serum sodium monitoring is especially important, as Suero Glucosado Vitulia may become extremely hypotonic after administration due to glucose metabolism in the body, potentially causing hyponatremia in certain patients.

In addition to Suero Glucosado Vitulia, potassium may be administered to prevent hypokalemia (low potassium levels in blood) that may occur during parenteral nutrition.

Continued administration in the same infusion site may cause thrombophlebitis (inflammation of veins).

Special attention will be given to elderly patients, as they may have impaired liver and/or kidney function.

Do not administer by intramuscular route.

Use of other medications

Inform your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription.

It is essential to inform your doctor if you use any of the following medications:

• Insulin or oral antidiabetic medications (biguanides, sulfonylureas), used to treat diabetes: these medications decrease the effect of glucose.
• Corticosteroids, used to treat inflammation and allergies: due to the risk of increased blood glucose or the ability of these medications to retain sodium and water.
• Digoxin, used to treat heart failure (the heart does not pump enough blood): If intravenous glucose administration coincides with digoxin treatment, there is a risk of developing digoxin toxicity.
• Medications that stimulate vasopressin release; e.g.: chlorpropamide, clofibrate, carbamazepine, vincristine, selective serotonin reuptake inhibitors, 3,4-methylenedioxy-N-methamphetamine, ifosfamide, antipsychotics, narcotics.
• Medications that potentiate the action of vasopressin; e.g.: chlorpropamide, NSAIDs, cyclophosphamide.
• Vasopressin analogs; e.g.: desmopressin, oxytocin, vasopressin, terlipressin.

In any case, the doctor must check the compatibility of the added medications.

Pregnancy and lactation

Consult your doctor or pharmacist before using any medication.

In the case of pregnancy, your doctor will decide whether to use 20% glucose solution, as it should be used with caution in this case. The administration of glucose by intravenous route during pregnancy may elevate blood glucose and insulin levels, as well as acidic components in the fetus's blood.

It should also be administered with caution during delivery, especially if administered in combination with oxytocin, due to the risk of hyponatremia.

There is no evidence to suggest that 20% glucose solution may cause adverse effects during the lactation period in the neonate. However, it is recommended to use with caution during this period.

Driving and operating machinery

There is no indication that the Suero Glucosado Vitulia 20% solution may affect the ability to drive or operate machinery.

Follow exactly the administration instructions for Glucose 20% Solution as indicated by your doctor.

The dosage will be established according to medical criteria. In general, 250 – 1,500 ml per day is recommended, at a rate of 20-40 drops per minute. It should not exceed 100 drops per minute.

In children, the perfusion rate depends on the child's age and weight, and generally should not exceed 10-18 mg of glucose per kg of body weight per minute.

Your doctor will decide the dose and frequency at which the solution will be administered to you, and it will depend on your age, weight, and clinical condition.

If you use more Glucose 20% Solution than you should

This is unlikely to happen since your doctor will determine your daily doses. However, if you receive an overdose, this could cause:

• excessive hydration
• imbalance in the levels of salts and acidic and basic substances in the body
• an increase in blood sugar concentration (hyperglycemia) and glucose in urine (glucosuria).

If this happens, the perfusion should be stopped immediately and, depending on the severity of the situation, electrolytes, diuretic medications, or insulin should be administered.

If you have any other questions about the use of this product, ask your doctor or pharmacist.

Like all medications, Glucose Solution Vitulia 20% may produce adverse effects, although not all people may experience them.

Hyperglycemia, glucosuria, or alterations in fluid or electrolyte balance may occur if administered too quickly or if the fluid volume is excessive, or in cases of metabolic insufficiency.

Hospital-acquired hyponatremia may cause irreversible brain damage and death due to the onset of acute hyponatremic encephalopathy.

A local reaction may occur at the injection site.

If used as a vehicle for the administration of other medications, the nature of the added medications will determine the likelihood of other adverse reactions.

Your doctor will assess the advisability of suspending the medication.

If you consider any of the adverse effects you are experiencing to be severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Keep out of the reach and sight of children.

No special storage conditions are required.

Do not use Vitulia 20% Dextrose Solution after the expiration date shown on the container. The expiration date is the last day of the month indicated.

Do not use Vitulia 20% Dextrose Solution if you observe that the solution is cloudy or has sedimentation or if the container shows visible signs of deterioration.

Medicines should not be disposed of through drains or in the trash. Dispose of empty containers and unused medicines at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of empty containers and unused medicines. By doing so, you will help protect the environment.

Composition

The active principle is:Glucose. 100 ml of the product contain 20 g of glucose.

Theoretical osmolality:1.110 mOsm/l

Calories:800 cal/L

Approximate pH:4 - 4.5

The other components are: water for injection preparations.

Appearance of the product and contents of the container:

Serum Glucosado Vitulia 20%is a solution for perfusion that is presented conditioned in plastic bottles: 1 bottle with 250 or 1 bottle with 500 ml (normal containers) or 10 bottles with 500 ml (clinical container).

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Laboratorios ERN, S.A.

Perú, 228

08020 Barcelona. Spain.

Responsible for manufacturing:

Laboratorios ERN, S.A.

Gorgs Lladó, 188

08210 Barberá del Vallés, Barcelona. Spain.

O

Parenteral Solution Industry Vioser S.A.

9th km Trikala-Larisa Nt.Rd.

42100 Trikala. Greece.

This leaflet was approved in May 2018.

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This information is intended solely for doctors or healthcare professionals:

You may need to monitor the water balance, serum glucose, serum sodium, and other electrolytes before and during administration, especially in patients with increased non-osmotic release of vasopressin (syndrome of inappropriate antidiuretic hormone secretion, SIADH) and in patients receiving concomitant medication with vasopressin agonists due to the risk of hyponatremia.

Monitoring of serum sodium is especially important when administering hypotonic physiological solutions. Serum Glucosado Vitulia may become extremely hypotonic after administration due to the metabolism of glucose in the body.

Single-use containers. Dispose of any remaining unused content after completing the perfusion.

Only use the solution if the container closure is not damaged and the solution is clear.

Use the sterile administration set for administration.

The elimination of unused medication and all materials that have come into contact with it will be carried out in accordance with local regulations.

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/