Glucose Vitulia 5% solution for infusion
SpainTable of Contents
Package leaflet: Information for the user
Introduction
PACKAGE LEAFLET: INFORMATION FOR THE USER
Suero Glucosado Vitulia 5% Infusion Solution
Glucose
Read all of this 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 you should not give it to others, even if they have the same symptoms, as it may harm them.
- If you think any of the side effects you experience is severe or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.
Contents of the leaflet:
- What Suero Glucosado Vitulia 5% is and what it is used for
- Before you use Suero Glucosado Vitulia 5%
- How to use Suero Glucosado Vitulia 5%
- Possible side effects
- How to store Suero Glucosado Vitulia 5%
- Further information
1. What Suero Glucosado Vitulia 5% is and what it is used for
Suero Glucosado Vitulia 5% is an intravenous infusion solution (administered intravenously via a drip) containing a low concentration of glucose, which is used:
- for the treatment of water loss (hypertonic dehydration) due to vomiting, diarrhea
- as an energy source 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 medicines or electrolyte solutions (electrically charged substances such as sodium, potassium, and chlorides).
2. BEFORE USING Suero Glucosado Vitulia 5%
Do not use Suero Glucosado Vitulia 5%
- if you are allergic (hypersensitive) to the active substances or to any of the other components of Suero Glucosado Vitulia 5%.
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 the blood)
- significant impairment of 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 Suero Glucosado Vitulia 5%
Inform your doctor if you have:
- diabetes mellitus; it may be used if appropriate insulin treatment is initiated beforehand
- kidney insufficiency (impaired kidney function)
- increased intracranial pressure (intracranial hypertension)
- acute ischemic events (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)
- patients with inappropriate vasopressin release (antidiuretic hormone), e.g., in critical conditions, pain, postoperative stress, infections, burns, and central nervous system (CNS) diseases, as well as patients with heart, liver, or kidney disease. These patients are at higher risk of developing acute hyponatremia (low sodium levels in plasma).
Suero Glucosado Vitulia 5% must not be administered using the same infusion equipment (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 Suero Glucosado Vitulia may become markedly hypotonic after administration due to glucose metabolism in the body, potentially causing hyponatremia in certain patients.
Potassium may be administered along with Suero Glucosado Vitulia to prevent hypokalemia (low potassium levels in blood), which may occur during parenteral nutrition.
Continuous administration at the same infusion site may lead to thrombophlebitis (vein inflammation).
Special caution should be exercised in elderly patients, as they may have impaired liver and/or kidney function.
Do not administer by intramuscular route.
Use of other medicines
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines, including those obtained without a prescription.
It is important that you inform your doctor if you are taking any of the following medicines:
- Insulin or oral antidiabetics (biguanides, sulfonylureas), used for the treatment of diabetes: these medicines reduce the effect of glucose.
- Corticosteroids, used to treat inflammation or allergies: due to the risk of increased blood glucose levels or because these medicines 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 medicines.
- Medicines that stimulate vasopressin release; e.g.: chlorpropamide, clofibrate, carbamazepine, vincristine, selective serotonin reuptake inhibitors, 3,4-methylenedioxymethamphetamine (MDMA), ifosfamide, antipsychotics, narcotics.
- Medicines that enhance the action of vasopressin; e.g.: chlorpropamide, NSAIDs, cyclophosphamide.
- Vasopressin analogs; e.g.: desmopressin, oxytocin, vasopressin, terlipressin.
In any case, the physician 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 5% 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 the fetal blood.
It should also be administered with caution during labor, especially if administered in combination with oxytocin, due to the risk of hyponatremia.
There is no evidence suggesting that 5% 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 Suero Glucosado Vitulia 5% solution may affect the ability to drive or operate machinery.
3. How to use Suero Glucosado Vitulia 5%
Follow exactly the administration instructions for Suero Glucosado Vitulia 5% as indicated by your doctor.
The maximum daily dose is 40 ml per kg of body weight.
The recommended infusion rate is approximately 5 ml per kg of body weight per hour, equivalent 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 generally should not exceed 10–18 mg of glucose per kg of body weight per minute.
Your doctor will determine the dose and frequency at which the solution will be administered, based on your age, weight, and clinical condition.
If you use more Suero Glucosado Vitulia 5% 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 depending on the severity of the situation, electrolytes, diuretic medications, or insulin should be administered.
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 5% can cause adverse effects, although not everybody 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 necessary 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 5% Glucose Infusion
Keep out of the reach and sight of children.
Special storage conditions are not required.
Do not use Vitulia 5% Glucose Infusion after the expiry date stated on the container. The expiry date refers to the last day of the month indicated.
Do not use Vitulia 5% Glucose Infusion if you notice cloudiness or sedimentation in the solution, or if the container shows visible signs of damage.
Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their containers to the SIGRE collection point at your pharmacy. If you are unsure, please ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.
6. ADDITIONAL INFORMATION
Composition
The active substance is: Glucose. 100 ml of product contain 5 g of glucose.
Theoretical osmolarity: 278 mOsm/L
Calories: 200 cal/L
Approximate pH: 4.5
The other components are: water for injections.
Appearance of the product and contents of the container:
Vitulia Glucose 5% is an infusion solution supplied in plastic bottles.
Standard pack: 1 bottle containing 50, 100, 500 or 1000 ml.
Clinical pack: 20 bottles of 50 ml, 20 bottles of 100 ml, 10 bottles of 500 ml or 10 bottles of 1000 ml.
Not all pack sizes may be marketed.
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 Barberá del Vallés, 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:
The water balance, serum glucose, serum sodium and other electrolytes may need to be monitored before and during administration, particularly 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 especially important when physiologically hypotonic solutions are administered. Vitulia Glucose Solution may become markedly hypotonic after administration due to the metabolism of glucose in the body.
Single-use containers. Any unused residual volume should be discarded after completion of the infusion.
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 been in contact with it should 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 of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/