Leaflet: information for the user

Sodium Chloride 3.6%/0.3% Glucose Solution for Infusion

Glucose Monohydrate, Sodium Chloride

Read this leaflet carefully before you start using this medicine because it contains important information for you.

- Keep this leaflet, as you may need to read it again.

- If you have any questions, consult your doctor or nurse.

- If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

Vitulia Glucosaline Solution is a perfusion solution containing glucose and sodium chloride, and it belongs to the pharmacotherapeutic group of solutions affecting electrolyte balance – electrolytes with carbohydrate hydrates.

Vitulia Glucosaline Solution is indicated for:

• States of dehydration (loss of body water) accompanied by moderate losses of electrolytes.
• States of acidosis: uremic coma, diabetic coma (with insulin administration).
• Mild states of alkalosis.
• Acute abdomen syndrome: peritonitis, hepatic colic, intestinal invagination, mesenteric thrombosis.
• Acetone vomiting.
• As a vehicle to administer other medications or electrolytes along with a light energy supply.

Do not use Glucose Saline Solution:

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

Warnings and precautions:

Consult with your doctor or nurse before using Glucose Saline Solution.

• Frequent and massive administration of glucose solutions can cause fluid overload (hyperhydration), acid-base balance alterations, and significant ionic depletions, including hypomagnesemia (low levels of magnesium in the blood), hypokalemia (low levels of potassium in the blood), and hypophosphatemia (low levels of phosphates in the blood). In these cases, you may need to receive electrolyte supplements. For this reason, it is recommended that you undergo regular checks of your blood glucose levels, serum electrolytes, water balance, and acid-base balance.
• To avoid hypokalemia produced during prolonged infusions with glucose solutions, it is recommended to add potassium to the solution as a safety measure.
• Your blood glucose levels must be closely monitored during episodes of intracranial hypertension.
• You should be especially careful if you have suffered acute ischemic attacks (decrease or absence of circulation in arteries), as hyperglycemia has been related to an increase in ischemic brain damage and difficulty in recovery.
• Be especially careful if you have any of the following diseases: hypertension, heart failure, peripheral or pulmonary edema, renal dysfunction, preeclampsia (symptoms that precede seizures and blood pressure drop in pregnant women), or other problems associated with sodium retention.
• The administration of solutions containing glucose may cause vitamin B1 deficiency, especially in cases of malnutrition.
• In cases of diabetes mellitus, glucose solutions can be used as long as you receive the initial appropriate treatment (insulin). Additionally, these solutions should be used with caution if you have Addison's disease or carbohydrate intolerance.
• You should be especially careful if you are administered continuously in the same injection site, due to the risk of developing thrombophlebitis.
• This medication should be used with caution if your heart, liver, and/or kidneys do not function correctly, especially if you are elderly.
• Do not administer Glucose Saline Solution with the same infusion equipment, or at the same time, or before or after a blood transfusion, as there may be incompatibilities.

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

Depending on the tonicity of the solution, the volume, and the speed of perfusion, and the initial clinical condition of the patient and their ability to metabolize glucose, the intravenous administration of glucose can cause electrolyte alterations, the most important of which is hypotonic hyperosmolar hyponatremia.

Hypotonic hyponatremia:

Patients with non-osmotic vasopressin release (e.g., in the presence of critical states, pain, postoperative stress, infections, burns, and central nervous system diseases), patients with heart, liver, and kidney diseases, and patients exposed to vasopressin agonists have a special risk of experiencing acute hyponatremia after perfusion with 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 severe and irreversible brain damage, potentially leading to death.

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

Children

Glucose Saline Solution should be administered with caution to premature infants and full-term newborns, due to immature renal function, to avoid excessive sodium retention.

Other medications and Glucose Saline Solution

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

Certain medications may interact with Glucose Saline Solution. In this case, you may need to change the dose or discontinue treatment with one of the medications.

It is essential to inform your doctor if you use any of the following medications:

• Systemic corticosteroids with glucocorticoid activity (cortisol), diuretics, diphenylhydantoin, chlorpromazine increase blood glucose levels. As for corticosteroids with mineralocorticoid activity, they should be administered with caution due to their ability to retain water and sodium.
• Insulin or oral antidiabetic agents (biguanides, sulfonylureas) may lead to a reduction in the therapeutic efficacy of these agents (antagonistic action). Additionally, oral antidiabetic agents may cause modifications in electrolyte balance.
• Digitalis glycosides (digoxin), there is an increased risk of developing digitalis toxicity.
• Lithium carbonate, as the administration of sodium chloride accelerates renal excretion of lithium, leading to a decrease in the therapeutic effect of this agent.

Medications that potentiate the effect of vasopressin

The following medications increase the effect of vasopressin, which reduces renal water excretion without electrolytes and increases the risk of hospital hyponatremia after an unbalanced treatment with intravenous perfusion solutions:

• Medications that stimulate vasopressin release; e.g., chlorpropamide, clofibrate, carbamazepine, vincristine, selective serotonin reuptake inhibitors, 3,4-methylenedioxy-N-methamphetamine, ifosfamide, antipsychotics, narcotics.
• Medications that potentiate the action of vasopressin; e.g., chlorpropamide, nonsteroidal anti-inflammatory drugs, cyclophosphamide.
• Vasopressin analogs; e.g., desmopressin, oxytocin, vasopressin, terlipressin.

Other medications that are known to increase the risk of hyponatremia are also diuretics in general and antiepileptic drugs such as oxcarbazepine.

Pregnancy, lactation, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or nurse before using this medication.

Pregnancy

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

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

Glucose Saline Solution should be administered with special caution in pregnant women during delivery, especially if it is administered in combination with oxytocin, due to the risk of hyponatremia.

Lactation

There is no evidence to suggest that Glucose Saline Solution may cause adverse effects during the lactation period in the newborn. However, it is recommended to use with caution during this period.

Driving and operating machinery

There is no indication that the administration of Glucose Saline Solution may affect your ability to drive or operate machinery.

This medication will be used in a hospital or healthcare center by the responsible healthcare staff.

Your doctor will decide the dose, frequency, and average infusion rate at which the solution will be administered to you, which will depend on your age, weight, clinical condition (particularly your hydration status), blood glucose levels, electrolyte 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 per 24 hours.

For infants and children:

- 0 to 10 kg body weight: 100 mL/kg/24 h.

- 10 to 20 kg body weight: 1,000 mL + 50 mL/kg/24 h for weight above 10 kg.

- > 20 kg body weight: 1,500 mL + 20 mL/kg/24 h for weight above 20 kg.

If you are administered more Glucosaline Solution than you should

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

- excessive hydration,

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

- an increase in blood sugar concentration.

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

- medications that increase the elimination of water and salts (diuretics),

- electrolytes (such as sodium, calcium, chlorides…), or

- insulin.

If you have any other questions about the use of this medication, ask your doctor or nurse.

Like all medications, Glucosaline Solution may produce adverse effects, although not everyone will experience them.

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

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

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

In case of adverse reactions, discontinue the infusion.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Human Medicines Pharmacovigilance System:www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

Do not use Vitulia Glucosaline Solution after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Composition of Vitulia Glucosaline Solution

• 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 injection preparations.

Aspect of the product and content of the packaging

Vitulia Glucosaline Solution is a perfusion solution that is presented in low-density polyethylene bottles with 500 mL of solution. The clinical packaging contains 10 bottles.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Laboratorios ERN, S.A.

C/Perú, 228

08020 Barcelona, Spain

Responsible for manufacturing:

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

Last review date of this leaflet: November 2023.

The detailed and updated information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.

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This information is intended solely for doctors or healthcare professionals:

It may be necessary to monitor the water balance, serum 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 hypotonic physiological solutions. Vitulia Glucosaline Solution can 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 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 contents of each package are for a single perfusion. The unused portion should be discarded.

The solution for perfusion 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 add medications if necessary.

Before adding medications to the solution or administering simultaneously with other medications, check that there are no incompatibilities.

These solutions should not be administered through the same infusion equipment used, used, or to 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 of 0.3% is incompatible with mitomycin due to the low pH of this solution.

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

On the other hand, incompatibility samples have been described when some medications are diluted in solutions containing glucose, including: ampicillin sodium, amrinone lactate, amoxicillin sodium/clavulanic acid, interferon alfa-2b, and procainamide hydrochloride. However, amrinone lactate or amoxicillin sodium/clavulanic acid may be injected directly into the injection site 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.