SUERO GLUCOSALINO VITULIA 3.6%/0.3% SOLUTION FOR INFUSION

2. What you need to know before you use Vitulia Glucosaline Serum

Do not use Vitulia Glucosaline Serum:

• If you are allergic to the active substances or to any of the other components of this medicine (listed in section 6).
• If you have states of hyperhydration (excess fluid in the body).
• In situations of generalized edema (fluid accumulation in body tissues) or ascitic cirrhosis (chronic progressive liver disease with fluid accumulation).
• If you have hyperglycemia (high blood glucose levels).
• If you have hypernatremia (high sodium levels in the blood).
• If you have hyperchloremia (high chloride levels in the blood).
• In states of hyperosmolar coma (loss of consciousness due to an increase in blood salt concentration).
• In states of hyperlactacidemia (presence of lactic acid in the blood).
• In severe cases of cardiac, hepatic, or renal insufficiency (heart, liver, or kidney failure).
• In the first 24 hours after a cranial trauma.

Warnings and precautions:

Consult your doctor or nurse before using Vitulia Glucosaline Serum.

• Frequent and massive administration of glucosaline solutions can cause fluid overload (hyperhydration), acid-base balance disorders, and significant ionic depletions, including hypomagnesemia (low magnesium levels in the blood), hypokalemia (low potassium levels in the blood), and hypophosphatemia (low phosphate levels in the blood). In these cases, it will be necessary to administer electrolyte supplements. For this reason, it is recommended that regular checks of blood glucose, serum electrolytes, water balance, and acid-base balance be performed.
• To avoid hypokalemia produced during prolonged infusions with glucosaline solutions, it is recommended to add potassium to the solution as a safety measure.
• Blood glucose levels should be carefully monitored during episodes of intracranial hypertension.
• Special caution should be exercised in case of having suffered acute ischemic attacks (decreased or absent circulation in arteries), as hyperglycemia has been linked to an increase in cerebral ischemic damage and difficulty in recovery.
• Be careful if you have any of the following diseases: hypertension, heart failure, peripheral or pulmonary edema, renal dysfunction, preeclampsia (symptoms preceding convulsions and blood pressure drop in pregnant women), or other problems associated with sodium retention.
• The administration of solutions containing glucose can cause a deficiency of vitamin B1, especially in cases of malnutrition.
• In case of diabetes mellitus, solutions containing glucose can be used as long as you receive initial treatment (insulin). Similarly, these solutions should be used with caution if you have Addison's disease or carbohydrate intolerance.
• Special caution should be exercised if you are administered continuously in the same injection site, due to the risk of suffering from thrombophlebitis.
• This medicine should be used with caution if your heart, liver, or kidneys are not functioning properly, especially if you are elderly.
• Vitulia Glucosaline Serum should not be administered with the same infusion equipment, or at the same time, or before or after a blood transfusion, as incompatibilities may occur.

Glucosated solutions for intravenous infusion are generally isotonic. However, in the body, glucosated solutions can become extremely hypotonic physiologically due to the rapid metabolism of glucose.

Depending on the tonicity of the solution, the volume and rate of infusion, and the patient's initial clinical condition and ability to metabolize glucose, intravenous glucose administration can cause electrolyte disturbances, the most important of which is hyperosmotic hyponatremia.

Hyponatremia:

Patients with non-osmotic release of vasopressin (e.g., in critical states, pain, postoperative stress, infections, burns, and CNS diseases), patients with heart, liver, and kidney diseases, and patients exposed to vasopressin agonists have a special risk of experiencing acute hyponatremia after infusion of hypotonic solutions.

Acute hyponatremia can cause acute hyponatremic encephalopathy (cerebral edema) characterized by headache, nausea, seizures, lethargy, and vomiting. Patients with cerebral edema have a special risk of suffering from severe, irreversible, and potentially fatal brain damage.

Children, women of childbearing age, and patients with reduced cerebral distensibility (e.g., in case of meningitis, intracranial hemorrhage, and cerebral contusion) have a special risk of suffering from severe and potentially fatal cerebral edema caused by acute hyponatremia.

Children

Vitulia Glucosaline Serum will be administered with caution to premature and full-term infants, due to immature renal function, to avoid excessive sodium retention.

Other medicines and Vitulia Glucosaline Serum

Tell your doctor or nurse if you are using or have recently used or may need to use any other medicine.

Certain medicines may interact with Vitulia Glucosaline Serum. In this case, it may be necessary to change the dose or interrupt treatment with one of the medicines.

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

• Systemic corticosteroids with glucocorticoid activity (cortisol), diuretics, diphenylhydantoin, chlorpromazine increase blood glucose levels. Regarding corticosteroids with mineralocorticoid activity, they should be administered with caution due to their ability to retain water and sodium.
• Insulin or oral antidiabetics (biguanides, sulfonylureas) may lead to a reduction in the therapeutic efficacy of these latter (antagonistic action). Additionally, oral antidiabetics can produce changes in the electrolyte balance.
• Digitalis glycosides (digoxin), may produce an increase in digitalis activity, with the risk of developing intoxication with these medicines.
• Lithium carbonate, since the administration of sodium chloride accelerates the renal excretion of lithium, leading to a decrease in the therapeutic effect of the latter.

Medicines that potentiate the effect of vasopressin

The following medicines increase the effect of vasopressin, which reduces the renal excretion of water without electrolytes and increases the risk of hospital hyponatremia after inadequately balanced treatment with intravenous infusion solutions:

• 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.

Other medicines that are known to increase the risk of hyponatremia are also diuretics in general and antiepileptics such as oxcarbazepine.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or nurse before using this medicine.

Pregnancy

In case of pregnancy, your doctor will decide whether to use glucosaline solution, as it should be used with caution.

Excessive administration of solutions containing glucose during pregnancy can cause hyperglycemia, hyperinsulinemia, and fetal acidosis, and may be harmful to the newborn.

Vitulia Glucosaline Serum should be administered with special caution in pregnant women during labor, especially if administered in combination with oxytocin, due to the risk of hyponatremia.

Breastfeeding

There is no evidence to suggest that Vitulia Glucosaline Serum may cause adverse effects during the breastfeeding period in the neonate. However, it is recommended to use with caution during this period.

Driving and using machines

There is no indication that the administration of Vitulia Glucosaline Serum may affect the ability to drive or use machines.

3. How to use Vitulia Glucosaline Serum

This medicine will be used in a hospital or healthcare center by the responsible healthcare personnel.

Your doctor will decide the dose, frequency, and average infusion rate at which the solution will be administered, which will depend on your age, weight, clinical situation (particularly the state of hydration), blood glucose, hydroelectrolytic and acid-base balance, and the nature of any medication that may have been added to the solution.

The recommended dose is:

For adults: 500 mL to 3,000 mL every 24 hours.

For infants and children:

• From 0 to 10 kg of body weight: 100 mL/kg/24 h.
• From 10 to 20 kg of body weight: 1,000 mL + 50 mL/kg/24 h for weight above 10 kg.
• > 20 kg of body weight: 1,500 mL + 20 mL/kg/24 h for weight above 20 kg.

If you are given more Vitulia Glucosaline Serum than you should

If the administration of Vitulia Glucosaline Serum is not performed correctly and under control, some of the following signs of overdose may appear:

• excess hydration,
• an imbalance of electrolyte levels (substances with electric charge in the blood and other body fluids such as: sodium, calcium, chlorides) and acid-base balance (loss of balance in the levels of acidic and basic substances in the body, which must always be kept constant),
• an increase in blood sugar levels.

If this happens, treatment should be discontinued immediately and, depending on the severity, the following may be administered:

• medicines that increase water and salt elimination (diuretics),
• electrolytes (such as sodium, calcium, chlorides...) or
• insulin.

If you have any further questions on the use of this medicine, ask your doctor or nurse.

4. Possible side effects

Like all medicines, Vitulia Glucosaline Serum can cause side effects, although not everybody gets them.

Adverse reactions can occur associated with the administration technique, including fever, infection at the injection site, local reaction or pain, venous irritation, venous thrombosis or phlebitis extending from the injection site, extravasation, and hypervolemia. To avoid the risk of suffering from thrombophlebitis (inflammation of a vein due to a blood clot), it is recommended to vary the insertion site of the catheter (every 24-48 hours).

Hospital hyponatremia can cause irreversible brain damage and death due to the onset of acute hyponatremic encephalopathy.

Adverse reactions can be associated with the medications added to the solution; the nature of the added medications will determine the possibility of any other undesirable effect.

In case of adverse reactions, the infusion should be discontinued.

Reporting of side effects

If you experience any side effect, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report them directly through the Human Medicines Pharmacovigilance System: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Vitulia Glucosaline Serum

Keep this medicine out of the sight and reach of children.

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

No special storage conditions are required.

6. Container Contents and Additional Information

Composition of Suero Glucosalino Vitulia

• The active principles per 100 mL of solution are: glucose (as monohydrate) 3.6 g, sodium chloride 0.3 g.
• The other components are: water for injectable preparations.

Appearance of the Product and Container Contents

Suero Glucosalino Vitulia is a solution for perfusion that is presented in low-density polyethylene bottles with 500 mL of solution. The clinical container contains 10 bottles.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Laboratorios ERN, S.A.

C/Perú, 228

08020 Barcelona, Spain

Manufacturer:

C/Gorgs Lladó, 188

Pol. Ind. Can Salvatella

08210 Barberá del Vallés (Barcelona), Spain

or

Parenteral Solution Industry Vioser S.A.

9th km Trikala-Larisa Nt.Rd.

42100 Trikala

Greece

Date of the Last Revision of this Prospectus: November 2023.

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

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This information is intended only for doctors or healthcare professionals:

It may be necessary to monitor the fluid balance, serum glucose, serum sodium, and other electrolytes 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 medication with vasopressin agonists due to the risk of hyponatremia.

Monitoring of serum sodium is especially important when administering physiologically hypotonic solutions. Suero Glucosalino Vitulia may become extremely hypotonic after administration due to the metabolism of glucose in the body.

Administration Rate:

The perfusion rate is normally 40 mL/kg/24 h in adults.

In pediatric patients, the perfusion rate is 5 mL/kg/h on average, but this value varies with weight:

• From 0 to 10 kg of body weight: 6-8 mL/kg/h.
• From 10 to 20 kg of body weight: 4-6 mL/kg/h.
• > 20 kg of body weight: 2-4 mL/kg/h.

The perfusion rate should not exceed the patient's glucose oxidation capacity in order to avoid hyperglycemia. Therefore, the maximum dose ranges from 5 mg/kg/min for adults to 10-18 mg/kg/min for infants and children depending on age and total body mass.

The content of each container is for a single perfusion. The unused fraction should be discarded.

The perfusion solution should be visually inspected before use. The solution should be transparent, not contain precipitates, and the container should be intact. Do not administer otherwise.

Use an aseptic procedure to administer the solution and the addition of medications if necessary.

Before adding medications to the solution or administering simultaneously with other medications, it should be checked that there are no incompatibilities.

These solutions should not be administered through the same perfusion equipment that is being used, has been used, or will be used for the administration of blood, as there is a possibility of pseudoagglutination.

It has been described that the glucosaline solution with a glucose content of 3.6% and sodium chloride content of 0.3% is incompatible with mitomycin, due to the low pH of this solution.

Similarly, samples of incompatibility have been observed for different isotonic glucosaline solutions with: sodium amoxicillin, sodium heparin, sodium imipenem-cilastatin, and meropenem. However, these medications may be compatible with this type of solution depending on different factors such as the concentration of the medication (sodium heparin) or the time that elapses between dissolution and administration (sodium amoxicillin, sodium imipenem-cilastatin, and meropenem).

On the other hand, samples of incompatibility have been described when some medications are diluted in solutions that contain glucose, including: sodium ampicillin, amrinone lactate, sodium amoxicillin/acid clavulanic, interferon alfa-2b, procainamide hydrochloride. However, amrinone lactate or sodium amoxicillin/acid clavulanic can be injected directly into the injection point while these perfusion solutions are being administered.

The elimination of unused medication and all materials that have come into contact with it will be carried out in accordance with local regulations.