GLUCOSE SOLUTION VITULIA 10%

Introduction

LEAFLET: INFORMATION FOR THE USER

Vitulia 10% Glucose Serum Solution for infusion

Glucose

Read the entire leaflet carefully before starting to use the medicine

• Keep this leaflet as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed to you and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you consider that any of the adverse effects you are suffering from is serious or if you notice any adverse effect not mentioned in this leaflet, inform your doctor or pharmacist.

Contents of the leaflet:

1. What Vitulia 10% Glucose Serum is and what it is used for
2. Before using Vitulia 10% Glucose Serum
3. How to use Vitulia 10% Glucose Serum
4. Possible side effects
5. Storage of Vitulia 10% Glucose Serum
6. Additional information

1. What is Vitulia 10% Glucose Serum and what is it used for

Vitulia 10% Glucose Serum is a solution for infusion (administered intravenously through a drip) with a low concentration of glucose that is used:

• for the treatment of water loss (hypertonic dehydration) due to vomiting, diarrhea
• as an energy supplement in parenteral nutrition when oral food intake is limited
• for alterations in carbohydrate metabolism (glucose deficit or hypoglycemia, insulin coma, hepatic coma, vomiting)
• as a vehicle and diluent for other medicines or solutions with electrolytes (electrically charged substances such as sodium, potassium, and chlorides).

2. BEFORE USING Vitulia 10% Glucose Serum

Do not use Vitulia 10% Glucose Serum

• if you are allergic (hypersensitive) to the active ingredients or to any of the other components of Vitulia 10% Glucose Serum.

If you have:

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

Be careful with Vitulia 10% Glucose Serum

Tell your doctor if you have:

• diabetes mellitus, it can be used if adequate insulin treatment is initiated beforehand
• kidney failure (poor kidney function)
• intracranial hypertension
• acute ischemic attacks (reduced or absent blood circulation in arteries)
• acid-base balance disorders (blood acidity disorders)
• 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 the higher risk of suffering from acute hyponatremia (low sodium levels in plasma).

Do not administer Vitulia 10% Glucose Serum with the same infusion equipment (equipment used to administer medicines directly into the blood), either at the same time, before, or after a blood transfusion, as incompatibilities may occur.

Regularly check blood sugar levels, electrolyte levels, and water balance. Also, monitoring of serum sodium is especially important, as Vitulia 10% Glucose Serum can become extremely hypotonic after administration due to glucose metabolism in the body, potentially causing hyponatremia in certain patients.

Along with Vitulia 10% Glucose Serum, potassium may be administered to prevent hypokalemia (low potassium levels in the blood) that may occur during parenteral nutrition.

Continuous administration and in the same infusion site can cause thrombophlebitis (inflammation of the veins).

In elderly patients, special attention will be paid, as they may have impaired liver and/or kidney function.

Do not administer intramuscularly.

Use of other medicines

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

It is important that you inform your doctor if you are using any of the following medicines:

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

In any case, the doctor should check the compatibility of the added medicines.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

In case of pregnancy, your doctor will decide on the convenience of using a 10% glucose solution, as it should be used with caution in this case. The administration of glucose intravenously during pregnancy may increase glucose and insulin levels as well as acidic components in the fetus's blood.

Similarly, it should be administered with caution during childbirth, especially if administered in combination with oxytocin, due to the risk of hyponatremia.

There is no evidence to suggest that 10% Glucose can cause adverse effects during the breastfeeding period in the newborn. However, it is recommended to use with caution during this period.

Driving and using machines

There is no indication that Vitulia 10% Glucose Serum may affect the ability to drive or use machines.

3. HOW TO USE Vitulia 10% Glucose Serum

Follow exactly the administration instructions of Vitulia 10% Glucose Serum indicated by your doctor.

The maximum daily dose is 20 ml per kg of body weight.

The maximum administration rate is approximately 2.5 ml per kg of body weight per hour, which corresponds to 0.25 g per kg of body weight per hour.

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 on the dose and frequency with which the solution will be administered, depending on your age, weight, and clinical situation.

If you use more Vitulia 10% Glucose Serum than you should

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

• excess hydration
• an imbalance in salt and acid-base levels in the body
• an increase in blood sugar levels (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 medicines, or insulin should be administered.

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

4. Possible side effects

Like all medicines, Vitulia 10% Glucose Serum can cause side effects, although not everyone will 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 failure.

Hospital hyponatremia can 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 medicines, the nature of the added medicines will determine the likelihood of other adverse reactions.

Your doctor will assess the need to suspend the medication.

If you consider that any of the side effects you are suffering from is serious or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

5. Storage of Vitulia 10% Glucose Serum

Keep out of the reach and sight of children.

No special storage conditions are required.

Do not use Vitulia 10% Glucose Serum after the expiration date stated on the packaging. The expiration date is the last day of the month indicated.

Do not use Vitulia 10% Glucose Serum if you notice that the solution is cloudy or has sediment or if the packaging shows visible signs of deterioration.

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and unused medicines in the pharmacy's SIGRE point. In case of doubt, ask your pharmacist how to dispose of the packaging and unused medicines. This will help protect the environment.

6. ADDITIONAL INFORMATION

Composition

The active ingredient is: Glucose. 100 ml of the product contain 10 g of glucose.

Theoretical osmolality: 555 mOsm/l

Calories: 400 cal/L

Approximate pH: 4.5

The other components are: water for injectable preparations.

Appearance of the product and packaging content:

Vitulia 10% Glucose Serum is a solution for infusion that is presented in plastic bottles: 1 bottle with 500 ml (standard packaging) or 10 bottles with 500 ml (clinical packaging).

Marketing authorization holder and manufacturer

Marketing authorization holder:

ERN Laboratories, S.A.

Peru, 228

08020 Barcelona, Spain.

Manufacturer:

ERN Laboratories, 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 leaflet was approved in May 2018.

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

This information is intended only for doctors or healthcare professionals:

It may be necessary to monitor water balance, blood glucose, serum sodium, and other electrolytes before and during administration, especially in patients with increased non-osmotic vasopressin release (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 physiologically hypotonic solutions. Vitulia 10% Glucose Serum can become extremely hypotonic after administration due to glucose metabolism in the body.

Single-use packaging. Discard any unused contents after completing the infusion.

The solution should only be used if the packaging is not damaged and the solution is clear.

Use the sterile administration set for administration.

Disposal of unused medicines and all materials that have come into contact with them will be carried out in accordance with local regulations.

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