RINGER'S LACTATE SOLUTION FOR INFUSION VITULIA

2. Before using Vitulia Ringer Lactate

It is recommended to monitor the hydroelectrolytic balance.

Do not use Vitulia Ringer Lactate

• extracellular hyperhydration or hypervolemia (excess fluid in the body)
• severe renal failure with oliguria or anuria (kidney failure with decreased or absent urine production)
• uncompensated heart failure
• metabolic alkalosis
• severe metabolic acidosis
• lactic acidosis
• severe hepatocellular failure (liver failure) or impaired lactate metabolism
• generalized edema (excessive fluid accumulation) or ascitic cirrhosis.

In any of the above situations, do not use the medication.

Be especially careful with Vitulia Ringer Lactate

• If your kidneys, heart, and/or lungs are not functioning properly. 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, you undergo regular checks of your clinical condition and blood and urine tests (electrolytes in blood and urine, acid-base balance, hematocrit). Potassium levels in the blood should be monitored if you are at risk of hyperkalemia (high potassium levels in the blood). Sodium serum monitoring is also 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, edema in the lungs or in the ankles, feet, and legs, preeclampsia (a disease that can occur during pregnancy or postpartum that is characterized by high blood pressure), aldosteronism (a disease associated with increased secretion of a hormone called aldosterone), or you have impaired renal function or other conditions associated with sodium retention.
• Due to the presence of potassium: If you have heart diseases or other problems that can cause an increase in potassium levels in the blood, such as renal or adrenocortical insufficiency, acute dehydration, or massive tissue destruction, as occurs in large burns.
• Due to the presence of calcium: If you have impaired renal function or if you have or have had kidney stones produced by calcium accumulation or diseases associated with high levels of vitamin D, such as sarcoidosis.
• Due to the presence of lactate ions: If the Ringer Lactate solution is administered in large quantities, metabolic alkalosis may occur.
• If you have severe potassium deficiency. Although the 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 is not functioning properly, the Ringer Lactate solution may not produce its effect, as lactate metabolism may be impaired.
• The Ringer Lactate solution should be administered with caution if you are at risk of cerebral edema or intracranial hypertension.
• If you are being treated with corticosteroids, adrenocorticotropic hormone, or digitalis medications, the administration of the Ringer Lactate solution should be performed with caution (see section on Use of other medications).
• Patient with inadequate release of vasopressin (antidiuretic hormone); e.g., in the presence of critical states, pain, postoperative stress, infections, burns, and central nervous system diseases, and patients with heart, liver, and kidney diseases. Due to the higher risk of suffering from acute hyponatremia (low sodium levels in plasma).

Special attention should be paid to elderly patients, as they may have impaired renal, hepatic, and/or cardiac function.

Continuous administration at the same injection site should be avoided due to the risk of thrombophlebitis.

Use of other medications

Tell 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 Vitulia Ringer Lactate. In this case, it may be necessary to change the dose or interrupt treatment with one of the medications.

In general, the concomitant administration of the Ringer Lactate solution with any medication that presents or may present renal toxicity should be avoided, 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 some of the electrolytes present in the 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).
• Cardiac glycosides (digoxin, methyldigoxin).
• 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 the release of vasopressin; 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, nonsteroidal anti-inflammatory drugs, cyclophosphamide.
• Vasopressin analogs; e.g., desmopressin, oxytocin, vasopressin, terlipressin.

Pregnancy and Breastfeeding

Consult your doctor or pharmacist before using any medication.

If the administration of the Ringer Lactate solution is performed correctly and under control, no adverse effects are expected during pregnancy or breastfeeding.

Vitulia Ringer Lactate should be administered with caution during childbirth, especially if administered in combination with oxytocin, due to the risk of hyponatremia.

During pregnancy and breastfeeding, the use of the Ringer Lactate solution as a vehicle for administering other medications should be assessed based on the nature of the medications.

Driving and using machines

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

3. How to use VITULIA RINGER LACTATE

Vitulia Ringer Lactate is presented as a solution for intravenous administration.

Vitulia Ringer Lactate will be used in a hospital by the corresponding healthcare personnel.

Your doctor will indicate the duration of your treatment with Vitulia Ringer Lactate.

The dose may vary 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 kg of weight and day.
  • between 10 and 20 kg of weight: 1000 ml + 50 ml additional per kg that exceeds 10 kg of weight, per day.
  • over 20 kg of weight: 1500 ml + 20 ml additional per 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 Ringer Lactate solution is used as a vehicle for administering other medications, the dose and infusion rate will be determined by the nature and dosage regimen of the prescribed medication.

If you are given more VITULIA RINGER LACTATE than you should

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

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

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

Excessive administration of sodium lactate can lead to hypokalemia (decreased potassium in the blood) and metabolic alkalosis (blood alkalinity). Symptoms can include changes in character, fatigue, respiratory failure, muscle weakness, and irregular heartbeats. Tetany (neuromuscular hyperexcitability) and muscle spasms may develop, especially in hypocalcemic patients. Treatment of metabolic alkalosis associated with bicarbonate overdose consists mainly of correcting fluid and electrolyte balance.

When the overdose is related to the medication added to the perfused solution, the signs and symptoms of overperfusion may be related to the nature of the added medication. In case of accidental overdose, treatment should be interrupted, and the patient should be monitored 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 further questions about the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, Vitulia Ringer Lactate can cause side effects, although not everyone will experience them.

The most commonly described side effects are hyperhydration (edema) and electrolyte disturbances (mainly after the administration of a large volume of Ringer Lactate solution), as well as allergic reactions.

Possible side effects are:

• Electrolyte disturbances.
• Venous thrombosis (clots), phlebitis (inflammation of the vein) (associated with intravenous administration).
• Nasal congestion, cough, sneezing, difficulty breathing during the administration of the solution, chest pain with altered heart rhythm.
• Allergic reactions such as urticaria, skin rashes, 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 hyponatremia can cause irreversible brain damage and death due to the onset of acute hyponatremic encephalopathy.

When the Ringer Lactate solution is used as a vehicle for administering other medications, side effects may be associated with the added medications.

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

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

5. Storage of VITULIA RINGER LACTATE

Keep out of the reach and sight of children.

Do not use Vitulia Ringer Lactate 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. Once the packaging is opened, the solution should be used immediately.

Do not use Vitulia Ringer Lactate if you observe that the solution is not transparent and contains precipitates or particles.

Medications should not be disposed of through wastewater or household waste. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. ADDITIONAL INFORMATION

Composition of Suero Ringer Lactato Vitulia

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

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.

Osmolality: 277 mOsm/l.

Approximate pH: 6.0.

Appearance of the product and packaging content

Suero Ringer Lactato Vitulia is presented as a solution for intravenous perfusion.

Suero Ringer Lactato Vitulia is a clear and colorless solution, without visible particles, sterile and apyrogenic. It is presented in low-density polyethylene bottles with a polyethylene cap and an elastomeric membrane of 500 ml and 1,000 ml.

Only some packaging 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 prospectus was revised in October 2018.

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This information is intended only for doctors or healthcare professionals

Suero Ringer Lactato Vitulia will be administered by perfusion.

The hydrological balance, serum electrolytes, and acid-base balance must be monitored before and during administration, with special attention to serum sodium in patients with increased non-osmotic release of vasopressin (syndrome of inappropriate secretion of antidiuretic hormone, SIADH) and in patients receiving concomitant medication with vasopressin agonists due to the risk of hospital hyponatremia. Serum sodium monitoring is especially important with hypotonic solutions.

Tonicity of Suero Ringer Lactato Vitulia: 277 mOsm/l.

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

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

The content of each vial of Suero Ringer Lactato Vitulia is for single perfusion. Once the packaging is opened, the solution must be administered immediately and the unused fraction must be discarded.

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

To administer the solution and in case of addition of medications, maximum asepsis must be maintained. 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 under controlled and validated aseptic conditions. If it is not used immediately, the conditions and periods of conservation during use are the responsibility of the user.

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

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

The Ringer Lactate solution should not be used as a vehicle for medications that contain ions capable of causing the formation of insoluble calcium salts.

It is recommended not to mix or administer simultaneously in the same perfusion equipment Ringer Lactate solution with whole blood or with blood components preserved with an anticoagulant that contains citrate (such as CPD), since the calcium ions present in this solution may exceed the chelating capacity of citrate, potentially producing clot formation. These clots could be perfused directly into the circulation and cause an embolism.