PATIENT INFORMATION LEAFLET

Sucrose Glucose Vitulia 5% Solution 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 and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you think you are having any side effects, or if any of the following happens to you, tell your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Vitulia 5% Glucose Solutionis a perfusion solution (administered intravenously through an IV drip) 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 5%

- if you are allergic (hypersensitive) to the active principles or to any of the other components of Suero Glucosado Vitulia 5%.

If you have:

• edema due to accumulation of fluid in tissues
• high glucose levels in blood (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 5%

Inform your doctor if you suffer from:

• diabetes mellitus, it can be used if appropriate insulin treatment is initiated first
• kidney insufficiency (deficient 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 5% 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 because 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.

Administered continuously and in the same infusion site, it may cause thrombophlebitis (inflammation of veins).

Pay special attention 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 for diabetes treatment: these medications decrease the effect of glucose.
• Corticosteroids, used for inflammation and allergy treatment: due to the risk of increased blood glucose or the ability of these medications to retain sodium and water.
• Digoxin, used for 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 case of pregnancy, your doctor will decide whether to use 5% glucose solution, as it should be used with caution in this case. The administration of glucose by intravenous route during pregnancy may elevate glucose and insulin levels as well as acidic components in the blood of the fetus.

Similarly, it should 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 5% glucose 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 5% solution may affect the ability to drive or operate machinery.

Follow exactly the administration instructions for Vitulia 5% Dextrose Solution as indicated by your doctor.

The maximum daily dose is 40 ml per kg of body weight.

The recommended administration rate is approximately 5 ml per kg of body weight per hour, which corresponds to 1.7 drops per kg of body weight 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 you will be administered the solution, and it will depend on your age, weight, and clinical condition.

If you use more Vitulia 5% Dextrose 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 infusion 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 5% Solutionmay produce adverse effects, although not everyone will experience them.

Hyperglycemia, glycosuria, 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 site of injection.

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 discontinuing 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 reach and sight of children.

No special storage conditions are required.

Do not use Vitulia 5% 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 5% 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 5 g of glucose.

Theoretical osmolality:278 mOsm/l

Calories:200 cal/L

Approximate pH:4.5

The other components are: water for injection preparations.

Appearance of the product and contents of the packaging:

Serum Glucosado Vitulia 5%is a perfusion solution that is presented conditioned in plastic bottles.

Standard packaging: 1 bottle with50, 100, 500 or 1000 ml.

Clinical packaging:20 bottles with 50 ml, 20 bottles with 100 ml, 10 bottles with 500 ml or 10 bottles with 1000 ml.

It may not be marketed all packaging sizes.

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.

Or

Parenteral Solution Industry Vioser S.A.

9th km Trikala-Larisa Nt.Rd.

42100 Trikala. Greece.

This prospectus was approved in May 2018.

-------------------------------------------------------------------------------------------

This information is intended solely for doctors or healthcare professionals:

It may be necessary 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 (SIADH syndrome) 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 can 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 packaging seal 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/