GLUCOSE SOLUTION VITULIA 5%

Introduction

LEAFLET: INFORMATION FOR THE USER

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

1. What Vitulia 5% Glucose Serum is and what it is used for

Vitulia 5% 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 5% Glucose Serum

Do not use Vitulia 5% Glucose Serum

• if you are allergic (hypersensitive) to the active ingredients or to any of the other components of Vitulia 5% 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 5% 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).

Vitulia 5% Glucose Serum should not be administered with the same infusion equipment, nor at the same time, nor before or after a blood transfusion, as incompatibilities may occur.

Regular control of blood sugar, electrolyte levels, and water balance is required. Sodium serum monitoring is especially important, as Vitulia 5% Glucose Serum can become extremely hypotonic after administration due to glucose metabolism in the body, potentially causing hyponatremia in certain patients.

Potassium may be administered along with Vitulia 5% Glucose Serum to prevent hypokalemia (low potassium levels in the blood) that may occur during parenteral nutrition.

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

In elderly patients, special attention will be paid due to potential liver and/or kidney function impairment.

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 essential to 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 digoxin treatment, 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 whether to use 5% 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 5% 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 5% Glucose Serum may affect the ability to drive or use machines.

3. How to use Vitulia 5% Glucose Serum

Follow your doctor's instructions for administering Vitulia 5% Glucose Serum exactly.

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 infusion rate depends on the child's age and weight and 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, depending on your age, weight, and clinical situation.

If you use more Vitulia 5% Glucose Serum than you should

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

• excess hydration
• an imbalance in the levels of salts and acidic and basic substances in the body
• an increase in blood glucose 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 using this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Vitulia 5% 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 insufficiency.

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 administering other medicines, the nature of the added medicines will determine the likelihood of other adverse reactions.

Your doctor will assess whether it is necessary to discontinue 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 5% Glucose Serum

Keep out of the reach and sight of children.

No special storage conditions are required.

Do not use Vitulia 5% 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 5% 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 any unused medicines in the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Additional information

Composition

The active ingredient is: Glucose. 100 ml of the product contains 5 g of glucose.

Theoretical osmolality: 278 mOsm/l

Calories: 200 cal/L

Approximate pH: 4.5

The other components are: water for injectable preparations.

Appearance of the product and packaging content:

Vitulia 5% Glucose Serum is a solution for infusion that is packaged in plastic vials.

Standard packaging: 1 vial with 50, 100, 500, or 1000 ml.

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

Not all packaging sizes may be marketed.

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.

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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.

Sodium serum monitoring is especially important when administering physiologically hypotonic solutions. Vitulia 5% 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/