PRODUCT INFORMATION FOR THE USER

SUERO RINGER LACTATO VITULIA solution for infusion

Sodium lactate, Sodium chloride, Potassium chloride, Calcium chloride dihydrate

Read this leaflet carefully before you start using the medicine.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for 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 side effects you are experiencing are serious or if you notice any side effects not mentioned in this leaflet, inform your doctor or pharmacist.

Suero Ringer Lactato Vitulia is a perfusion solution that belongs to the therapeutic group called Intravenous solutions that affect the electrolyte balance - Electrolites.

Suero Ringer Lactato Vitulia is presented in glass bottles of 500 milliliters (ml) and 1,000 ml.

Suero Ringer Lactato Vitulia is indicated in the following situations:

• Hydroelectrolytic repletion of extracellular fluid, such as in states of dehydration withlossof electrolytes or surgical interventions.
• Replenishment of plasma volume in the short term in states of hypovolemic shock (hemorrhages, burns and other problems that cause losses of the circulatory volume) or hypotension (decrease in blood pressure).
• Statesof mild or moderate metabolic acidosis (except lactic acidosis).
• Asvehiclefor the administration of compatible medications.

It is recommended to control the hydroelectrolyte balance.

Do not use Ringer Lactate Solution Vitulia.

• if you are allergic (hypersensitive) to sodium lactate, sodium chloride, potassium chloride, calcium chloride dihydrate, or any of the other components of Ringer Lactate Solution Vitulia
• extracellular hyperhydration or hypervolemia (excess of fluids in the body)
• severe renal insufficiency with oliguria or anuria (kidney failure with decreased or absence of urine)
• uncompensated heart failure
• if your blood contains high levels of potassium, sodium, calcium, or chlorides
• metabolic alkalosis
• severe metabolic acidosis
• lactic acidosis
• severe hepatocellular insufficiency (liver function failure) or lactate metabolism deteriorateddeteriorated
• general edema (excessive accumulation of liquids) or ascitic cirrhosis.

Do not use the medication in any of the above situations.

Be especially careful with Ringer Lactate Solution Vitulia

• If your kidneys, heart, and/or lungs do not function correctly. In these cases, the administration of large volumes of this solution should be performed under strict clinical control.
• It is recommended that, during the administration of this solution, regular clinical status controls and blood and urine analyses (electrolytes in blood and urine, acid-base balance, hematocrit) be performed. Blood potassium controls should be performed if you are at risk of developing hyperkalemia (high levels of potassium in blood). The vigilance of serum sodium is especially important with hypotonic solutions.

If you have any of the following diseases, this medication will be administered with special caution and it is likely that additional tests will be performed to determine if you can receive the medication:

• Due to the presence of sodium: If you have high blood pressure (hypertension), heart failure, pulmonary edema, or edema in the legs, feet, and ankles, preeclampsia (a condition that can occur during pregnancy or postpartum with an increase in blood pressure), aldosteronism (a disease associated with an increase in the secretion of a hormone called aldosterone) or have impaired renal function or other conditions associated with sodium retention.
• Due to the presence of potassium: If you have heart disease or other conditions that may cause high levels of potassium in the blood, such as renal insufficiency or adrenocortical insufficiency, acute dehydration, or massive tissue destruction, such as in severe burns.
• Due to the presence of calcium: If you have impaired renal function or if you have or have had kidney stones caused by calcium accumulation or diseases associated with high concentrations of vitamin D, such as sarcoidosis.
• Due to the presence of lactate ions: If Ringer Lactate Solution is administered in large quantities, it may cause metabolic alkalosis.
• If you have severe hypokalemia. Although Ringer Lactate Solution has a potassium concentration similar to that of plasma, it is insufficient to produce a beneficial effect in these situations.
• If your liver does not function correctly, Ringer Lactate Solution may not produce its effect, as lactate metabolism may be impaired.
• You should be administered Ringer Lactate Solution with caution if you are at risk of developing cerebral edema or intracranial hypertension.
• If you are being treated with corticosteroids, adrenocorticotropic hormone, or digitalis medications, the administration of Ringer Lactate Solution should be performed with caution (see Use of other medications).
• Patients with inadequate vasopressin release, e.g., in critical states, pain, postoperative stress, infections, burns, and central nervous system diseases, and patients with heart, liver, and kidney diseases. They have a higher risk of developing acute hyponatremia (low sodium levels in plasma).

You should pay special attention to patients of advanced age, as they may have impaired renal, hepatic, and/or cardiac function.

Administration should be avoided in the same place due to the risk of developing thrombophlebitis.

Use of other medications

Inform your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription.

Certain medications may interact with Ringer Lactate Solution Vitulia. In this case, it may be necessary to change the dose or discontinue treatment with one of the medications.

In general, it is recommended to avoid the concomitant administration of Ringer Lactate Solution with any medication that presents or may present renal toxicity, as it may cause fluid and electrolyte retention.

It is essential to inform your doctor if you use any of the following medications, as they may interact with one of the electrolytes present in Ringer Lactate Solution:

• Corticosteroids/steroids or adrenocorticotropic hormone.
• Lithium carbonate.
• Potassium-sparing diuretics (amiloride, spironolactone, triamterene) alone or in combination.
• Angiotensin-converting enzyme inhibitors (ACE inhibitors) (captopril, enalapril) or angiotensin II receptor antagonists (candesartan, telmisartan, eprosartan, irbesartan, losartan, valsartan).
• Tacrolimus and cyclosporine (medications with renal toxicity).
• Cardiotonic digitalis glycosides (digoxin, metildigoxin).
• Thiazide diuretics (hydrochlorothiazide, altizide, mebutizide, bendroflumethiazide) or vitamin D.
• Acidic medications such as salicylates and/or barbiturates.
• Alkaline medications such as sympathomimetics (ephedrine, pseudoephedrine) and/or stimulants (amphetamine, dexamphetamine).
• Medications that stimulate vasopressin release; e.g.: chlorpropamide, clofibrate, carbamazepine, vincristine, selective serotonin reuptake inhibitors, 3,4-methylenedioxymethamphetamine, ifosfamide, antipsychotics, narcotics.
• Medications that potentiate the action of vasopressin; e.g.: chlorpropamide, NSAIDs, cyclophosphamide.
• Vasopressin analogs; e.g.: desmopressin, oxytocin, vasopressin, terlipressin.

Pregnancy and Lactation

Consult your doctor or pharmacist before using any medication.

If Ringer Lactate Solution is administered correctly and under control, no adverse effects should be expected during pregnancy or lactation.

Ringer Lactate Solution should be administered with caution during delivery, especially if it is administered in combination with oxytocin, due to the risk of hyponatremia.

During pregnancy and lactation, the use of Ringer Lactate Solution as a vehicle to administer other medications should be evaluated based on the nature of these medications.

Driving and operating machines

There is no indication that Ringer Lactate Solution Vitulia may affect the ability to drive or operate machines.

Ringer's Lactate Solution will be presented in a solution form for intravenous administration.

Ringer's Lactate Solution will be used in a hospital by the corresponding healthcare personnel.

Your doctor will inform you of the duration of your treatment with Ringer's Lactate Solution.

The dose may be varied according to medical criteria.

The amount of solution needed to restore normal blood volume is 3-4 times the volume of blood lost.

Recommended daily dose:

-Adults: between 500 and 3000 ml per day.

-Children:

• up to 10 kg of weight: 100 ml per each kg of weight and day. between 10 and 20 kg of weight: 1000 ml + 50 ml additional per each kg that exceeds 10 kg of weight, per day.
• over 20 kg of weight: 1500 ml + 20 ml additional per each kg that exceeds 20 kg of weight, per day.

The infusion rate should be adjusted according to the patient's clinical needs based on age, weight, clinical condition, fluid balance, electrolytes, and acid-base balance.

When the solution is used as a vehicle to administer other medications, the dose and infusion rate will be defined by the nature and dosing regimen of the prescribed medication.

If you are administered more Ringer's Lactate Solution than you should

In case of overdose or too rapid administration, the following symptoms may appear:

• hyperhydration (edema, hypervolemia), disorders in electrolyte balance, and/or induction of metabolic alkalosis, especially in patients with impaired renal function. In these cases, the administration will be decreased or suspended, and symptomatic treatment will be used. If renal function is compromised, dialysis may be necessary.
• water and sodium overload with risk of edema, particularly when there is a defective renal excretion of sodium.

Excessive administration of potassium salts may lead to hyperkalemia (elevated potassium in the blood), especially in patients with impaired renal function. Symptoms include tingling, numbness, and/or burning sensation in hands and feet, muscle weakness, paralysis, cardiac arrhythmias, cardiac block, cardiac arrest, and mental confusion.

Excessive administration of calcium salts may lead to hypercalcemia (elevated calcium in the blood). Symptoms of hypercalcemia may include anorexia, nausea, vomiting, constipation, abdominal pain, muscle weakness, mental alteration, polydipsia (excessive thirst), polyuria (excessive urine volume), kidney stones, and, in severe cases, cardiac arrhythmias and coma, as well as a metallic taste, burning sensation, and peripheral vasodilation. Mild asymptomatic hypercalcemia will usually resolve by stopping calcium administration and using other contributing medications such as vitamin D. If hypercalcemia is severe, urgent treatment is required (such as diuretic cycles, hemodialysis, calcitonin, bisphosphonates, and edetate trisodium).

Excessive administration of sodium lactate may lead to hypokalemia (decreased potassium in the blood) and metabolic alkalosis. Symptoms may include change in behavior, fatigue, respiratory insufficiency, muscle weakness, and irregular heartbeats. Tetany (neuromuscular hyperexcitability) may develop, especially in hypocalcemic patients, along with muscle spasms and increased muscle tone. Treatment of metabolic alkalosis associated with bicarbonate overdose primarily involves correcting fluid and electrolyte balance.

In case of overdose related to medication added to the infused solution, signs and symptoms of overinfusion may be related to the nature of the added medication used. In case of accidental overdose, treatment should be interrupted, and the patient should be observed for symptoms and signs related to the administered medication. If necessary, symptomatic and supportive measures should be taken.

In case of overdose or accidental ingestion, consult the Toxicology Information Service. Phone: 915 620 420.

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

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

The most commonly described adverse effects are hyperhydration (edema) and electrolyte imbalances (mainly after administration of a significant volume of Ringer Lactate solution), as well as allergic reactions.

The possible adverse effects are:

• Electrolyte imbalances.
• Deep vein thrombosis (clots), phlebitis (vein inflammation) (associated with intravenous administration).
• Nasal congestion, cough, sneezing, difficulty breathing during solution administration, chest pain with altered heart rhythm.
• Allergic reactions such as urticaria, skin eruptions, skin redness, itching, swelling, fluid accumulation in tissues.
• Hyperhydration (edema).
• Fever, infection at the injection site, local reaction or local pain (associated with intravenous administration).
• Hospital-acquired hyponatremia can cause irreversible brain damage and death due to the onset of acute hyponatremic encephalopathy.

When using the Ringer Lactate solution as a vehicle to administer other medications, the adverse effects may be associated with the added medications in the solution.

In case of adverse effects appearance, the infusion should be interrupted.

If you consider that any of the adverse effects you are experiencing is severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Keep out of the reach and sight of children.

Do not useSUERO RINGER LACTATO VITULIAafter 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. Once the packaging is opened, the solution must be used immediately.

Do not useSUERO RINGER LACTATO VITULIAif you observe that the solution is not transparent and contains precipitates or lumps.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacisthow to dispose of packaging and medicines that you no longer need. In this way, you will help protect the environment.

Composition of Vitulia Ringer Lactate Solution

• The active principles are: sodium lactate, sodium chloride, potassium chloride, and calcium chloride dihydrate. Per 100 ml: 600 mg of sodium chloride, 312 mg of sodium lactate, 40 mg of potassium chloride, and 27 mg of calcium chloride dihydrate.
• The other components are: water for injections.

Electrolyte composition: Chloride 111.7 mEq/l, Lactate 27.8 mEq/l, Sodium 130.5 mEq/l, Potassium 5.4 mEq/l, and Calcium 3.7 mEq/l.

Osmolarity: 277 mOsm/l.

Approximate pH: 6.0.

Appearance of the product and contents of the container

Vitulia Ringer Lactate Solution is presented as an intravenous infusion solution.

Vitulia Ringer Lactate Solution is a transparent and colorless solution, without visible particles, sterile, and apyrogenic. It is presented in low-density polyethylene bottles and polyethylene caps with elastomeric membrane of 500 ml and 1,000 ml.

Only some sizes of containers may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Laboratorios ERN, S.A.

Perú, 228 - 08020 Barcelona, Spain.

Responsible for manufacturing

Laboratorios ERN, S.A.

Gorgs Lladó, 188 – 08210 - Barberá del Vallés. Barcelona. Spain

O

Parenteral Solution Industry Vioser S.A.

9th km Trikala-Larisa Nt.Rd. 42100 Trikala.Greece

This leaflet has been revised in October 2018.

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This information is intended solely for medical professionals or healthcare professionals

Vitulia Ringer Lactate Solution will be administered by infusion.

Monitor the water balance, serum electrolytes, and acid-base balance before and during administration, with special attention to serum sodium levels in patients with increased non-osmotic vasopressin release (SIADH syndrome) and in patients receiving concomitant medication with vasopressin agonists due to the risk of hospital-acquired hyponatremia. Serum sodium monitoring is especially important with hypotonic solutions.

Osmodality of Vitulia Ringer Lactate Solution: 277 mOsm/l.

The infusion rate and volume infused depend on age, weight, and clinical condition (e.g., burns, surgery, head injury, infections); the responsible physician, with experience in pediatric treatments with intravenous infusion solutions, must decide on the need for concomitant treatment.

When the solution is used as a vehicle for administering other medications, the dose and infusion rate will be defined by the nature and posological regimen of the prescribed medication.

The contents of each Vitulia Ringer Lactate Solution bottle are for a single infusion. Once the container is opened, the solution must be administered immediately and any unused portion discarded.

The solution must be transparent and not contain precipitates. Do not administer otherwise.

Administer the solution and, in the case of adding medications, maintain maximum asepsis. From a microbiological point of view, when the solution is used as a vehicle for other medications, it must be used immediately unless the dilution has been performed in controlled and validated aseptic conditions. If not used immediately, the storage conditions and duration during use are the responsibility of the user.

It is recommended to consult compatibility tables before adding medications to Ringer Lactate Solution or administering them simultaneously with other medications. It is recommended to consult the medication's leaflet, as well as verify if these are soluble and stable in aqueous solution at the pH of Ringer Lactate Solution (pH 5.0-7.0).

When compatible medication is added to Vitulia Ringer Lactate Solution, the solution must be administered immediately.

Do not use Ringer Lactate Solution as a vehicle for medications containing ions capable of causing the formation of insoluble calcium salts.

It is recommended not to mix or administer simultaneously in the same infusion set Ringer Lactate Solution with whole blood or with blood components preserved with an anticoagulant containing citrate (such as CPD), as the calcium ions present in this solution may exceed the chelating capacity of citrate, potentially causing the formation of clots. These clots may perfuse directly into the circulation and cause an embolism.