Glucose Vitulia 10% solution for infusion

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Suero Glucosado Vitulia 10% Infusion solution

Glucose

Read the entire leaflet carefully before you start using this 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 other people, even if they have the same symptoms as you, because it may harm them.
• If you think any of the side effects you experience is serious, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Leaflet contents:

1. What Suero Glucosado Vitulia 10% is and what it is used for
2. Before you use Suero Glucosado Vitulia 10%
3. How to use Suero Glucosado Vitulia 10%
4. Possible side effects
5. How to store Suero Glucosado Vitulia 10%
6. Further information

1. What Suero Glucosado Vitulia 10% is and what it is used for

Suero Glucosado Vitulia 10% is an infusion solution (administered intravenously via an infusion set) with a low concentration of glucose, used for:

• treatment of water loss (hypertonic dehydration) due to vomiting, diarrhea
• providing energy in parenteral nutrition when oral intake of food is limited
• carbohydrate metabolism disorders (glucose deficiency or hypoglycemia, insulin overdose coma, hepatic coma, vomiting)
• as a vehicle and diluent for other medications or electrolyte solutions (electrically charged substances such as sodium, potassium, and chlorides).

2. BEFORE USING Glucose Vitulia 10% Solution

Do not use Glucose Vitulia 10% Solution

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

Do not use if you have:

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

Take special care with Glucose Vitulia 10% Solution

Inform your doctor if you have:

• diabetes mellitus; may be used if appropriate insulin therapy has been initiated beforehand
• kidney insufficiency (impaired kidney function)
• increased intracranial pressure (hypertension intracraneal)
• acute ischemic attacks (reduced or absent blood flow in arteries)
• disturbances in acid-base balance (blood acidity disorders)
• malnutrition with vitamin B1 deficiency (thiamine, essential for glucose metabolism)
• conditions with inappropriate vasopressin release (antidiuretic hormone), e.g., in critical illness, pain, postoperative stress, infections, burns, and central nervous system (CNS) disorders, as well as in patients with heart, liver, or kidney disease. These patients are at higher risk of developing acute hyponatremia (low plasma sodium levels).

Glucose Vitulia 10% Solution must not be administered through the same infusion set (equipment used to deliver medications directly into the bloodstream), nor simultaneously, before, or after a blood transfusion, due to possible incompatibilities.

Your blood glucose levels, electrolyte levels, and fluid balance should be monitored regularly. Monitoring of serum sodium is particularly important, as Glucose Vitulia 10% Solution may become markedly hypotonic after administration due to glucose metabolism in the body, potentially causing hyponatremia in certain patients.

Potassium may be administered together with Glucose Vitulia 10% Solution to prevent hypokalemia (low blood potassium levels) that may occur during parenteral nutrition.

Thrombophlebitis (vein inflammation) may occur if administered continuously at the same infusion site.

Particular caution should be exercised in elderly patients, as they may have impaired liver and/or kidney function.

Do not administer by intramuscular route.

Use with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

It is important to inform your doctor if you are taking any of the following medicines:

• Insulin or oral antidiabetics (biguanides, sulfonylureas), used to treat diabetes: these drugs reduce the effect of glucose.
• Corticosteroids, used to treat inflammation or allergies: due to the risk of increased blood glucose levels or because these drugs may cause sodium and water retention.
• Digitalis glycosides (digoxin), used for heart failure (when the heart does not pump enough blood): if intravenous glucose is administered concurrently with digitalis glycosides (digoxin), there is a risk of developing toxicity from these drugs.
• Medications that stimulate vasopressin release; e.g.: chlorpropamide, clofibrate, carbamazepine, vincristine, selective serotonin reuptake inhibitors, 3,4-methylenedioxy-N-methamphetamine (MDMA), ifosfamide, antipsychotics, narcotics.
• Medications that enhance the action of vasopressin; e.g.: chlorpropamide, NSAIDs, cyclophosphamide.
• Vasopressin analogs; e.g.: desmopressin, oxytocin, vasopressin, terlipressin.

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

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

During pregnancy, your doctor will decide whether the use of 10% glucose solution is appropriate, as it should be used with caution in this situation. Intravenous glucose administration during pregnancy may increase glucose and insulin levels, as well as acid components, in fetal blood.

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

There is no evidence suggesting that 10% glucose may cause adverse effects in the neonate during breastfeeding. Nevertheless, caution is recommended during this period.

Driving and using machines

There is no indication that Glucose Vitulia 10% Solution may affect the ability to drive or operate machinery.

3. How to USE Glucose Vitulia 10% Solution

Follow exactly the administration instructions for Glucose Vitulia 10% Solution as indicated by your doctor.

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

The maximum infusion rate is approximately 2.5 ml per kg of body weight per hour, corresponding to 0.25 g per kg of body weight per hour.

In children, the infusion 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 determine the dose and frequency of administration based on your age, weight, and clinical condition.

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

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

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

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

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

4. Possible adverse effects

Like all medicines, Suero Glucosado Vitulia 10% can cause adverse effects, although not everyone will experience them.

Hyperglycemia, glycosuria, or disturbances in fluid or electrolyte balance may occur if the solution is administered too rapidly, 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 development of acute hyponatremic encephalopathy.

A local reaction at the injection site may occur.

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

Your doctor will assess whether or not it is appropriate to discontinue the treatment.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

5. Storage of Vitulia 10% Glucose Solution

Keep out of the reach and sight of children.

No special storage conditions are required.

Do not use Vitulia 10% Glucose Solution after the expiry date stated on the container. The expiry date refers to the last day of the month indicated.

Do not use Vitulia 10% Glucose Solution if the solution appears cloudy or shows sedimentation, or if the container shows visible signs of deterioration.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at a SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused containers and medicines. This way, you will help protect the environment.

6. ADDITIONAL INFORMATION

Composition

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

Theoretical osmolarity: 555 mOsm/L

Calories: 400 cal/L

Approximate pH: 4.5

The other components are: water for injections.

Appearance of the product and contents of the container:

Vitulia Glucose 10% infusion solution is supplied in plastic bottles: 1 bottle of 500 ml (standard pack) or 10 bottles of 500 ml (hospital pack).

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Laboratorios ERN, S.A.

Perú, 228

08020 Barcelona, Spain.

Manufacturer:

Laboratorios ERN, S.A.

Gorgs Lladó, 188

08210 Barberà del Vallès, Barcelona, Spain.

Or

Parenteral Solution Industry Vioser S.A.

9th km Trikala-Larisa Nt.Rd.

42100 Trikala, Greece.

This leaflet was last approved in May 2018.

This information is intended exclusively for healthcare professionals:

Monitoring of fluid balance, serum glucose, serum sodium, and other electrolytes may be required 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 treatment with vasopressin agonists due to the risk of hyponatremia.

Monitoring of serum sodium is particularly important when physiologically hypotonic solutions are administered. Vitulia Glucose 10% may become extremely hypotonic after administration due to the metabolism of glucose in the body.

Single-use containers. Discard any unused residual contents after infusion is complete.

The solution should only be used if the container closure is undamaged and the solution is clear.

Use a sterile administration set for administration.

Disposal of unused medicine and of all materials that have come into contact with it must be carried out in accordance with local regulations.

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