Ringer's lactate Vitulia solution for infusion

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

SUERO RINGER LACTATO VITULIA infusion solution

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

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 should not be given to other people, even if they have the same symptoms, as it may harm them.
• If you consider any of the side effects you experience to be serious, or if you notice any side effects not listed in this leaflet, please inform your doctor or pharmacist.

Leaflet contents:

1. What Suero Ringer Lactato Vitulia is and what it is used for
2. Before you use Suero Ringer Lactato Vitulia
3. How to use Suero Ringer Lactato Vitulia
4. Possible side effects
5. How to store Suero Ringer Lactato Vitulia
6. Further information

1. What SUERO RINGER LACTATO VITULIA is and what it is used for

Suero Ringer Lactato Vitulia is an infusion solution belonging to the therapeutic group known as Intravenous solutions affecting electrolyte balance – Electrolytes.

Suero Ringer Lactato Vitulia is supplied in 500 millilitre (ml) and 1,000 ml glass bottles.

Suero Ringer Lactato Vitulia is indicated in the following situations:

• Hydroelectrolytic reposition of extracellular fluid, such as in states of dehydration with electrolyte loss or surgical interventions.
• Short-term reposition of plasma volume in states of hypovolemic shock (haemorrhage, burns and other conditions causing loss of circulatory volume) or hypotension (decreased blood pressure).
• Mild or moderate metabolic acidosis (except lactic acidosis).
• As a vehicle for administration of compatible medications.

2. Before using Suero Ringer Lactato Vitulia

Monitoring of fluid and electrolyte balance is recommended.

Do not use Suero Ringer Lactato Vitulia

• if you are allergic (hypersensitive) to sodium lactate, sodium chloride, potassium chloride, calcium chloride dihydrate, or to any of the other components of Suero Ringer Lactato Vitulia
• extracellular hyperhydration or hypervolemia (excess fluid in the body)
• severe renal insufficiency with oliguria or anuria (kidney failure with reduced or absent urine output)
• uncompensated cardiac failure
• if your blood contains high levels of potassium, sodium, calcium, or chlorides
• metabolic alkalosis
• severe metabolic acidosis
• lactic acidosis
• severe hepatocellular insufficiency (liver failure) or impaired lactate metabolism
• generalized edema (excessive fluid accumulation) or ascitic cirrhosis.

Do not use this medicine in any of the above situations.

Take special care with Suero Ringer Lactato Vitulia

• If your kidneys, heart, and/or lungs are not functioning properly. In these cases, administration of large volumes of this solution must be carried out under strict clinical supervision.
• It is advisable to have regular monitoring of your clinical condition and blood and urine tests (blood and urine electrolytes, acid-base balance, hematocrit) during administration of this solution. Blood potassium levels should be monitored if you are at risk of hyperkalemia (high blood potassium levels). Monitoring of serum sodium is particularly important with hypotonic solutions.

If you have any of the following conditions, this medicine should be administered with special caution and you may require additional tests to determine whether you can receive the medicine:

• Due to the presence of sodium: If you have high blood pressure (hypertension), heart failure, pulmonary or ankle, foot, and leg edema, preeclampsia (a condition that may occur during pregnancy or postpartum and is characterized by increased blood pressure), aldosteronism (a condition associated with increased secretion of a hormone called aldosterone), or impaired kidney 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 elevated blood potassium levels, such as renal or adrenocortical insufficiency, acute dehydration, or massive tissue destruction, as occurs in extensive burns.
• Due to the presence of calcium: If you have impaired kidney function or have or have had kidney stones caused by calcium accumulation, or diseases associated with elevated vitamin D levels such as sarcoidosis.
• Due to the presence of lactate ions: If Ringer Lactate solution is administered in large amounts, metabolic alkalosis may occur.
• If you have severe potassium deficiency. Although Ringer Lactate solution has a potassium concentration similar to that of plasma, this is insufficient to produce a beneficial effect in these situations.
• If your liver is not functioning properly, Ringer Lactate solution may not produce its intended effect, as lactate metabolism may be impaired.
• Ringer Lactate solution should be administered with caution if you are at risk of cerebral edema or increased intracranial pressure.
• If you are being treated with corticosteroids, adrenocorticotropic hormone, or digitalis medications, administration of Ringer Lactate solution should be done with caution (see section "Use with other medicines").
• Patients with inappropriate vasopressin release (antidiuretic hormone), e.g., in critical conditions, pain, postoperative stress, infections, burns, and central nervous system diseases, and patients with heart, liver, or kidney disease. These patients are at higher risk of developing acute hyponatremia (low plasma sodium levels).

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

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

Use with other medicines

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

Certain medicines may interact with Suero Ringer Lactato Vitulia. In such cases, it may be necessary to adjust the dose or discontinue treatment with one of the medicines.

In general, concomitant administration of Ringer Lactate solution with any medicine that has or may have renal toxicity should be avoided, as it may cause fluid and electrolyte retention.

It is important that you inform your doctor if you are taking any of the following medicines, as they may interact with 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 (medicines with renal toxicity).
• Cardiotonic digitalis glycosides (digoxin, methyldigoxin).
• Thiazide diuretics (hydrochlorothiazide, altizide, mebutizide, bendroflumethiazide) or vitamin D.
• Acidic medicines such as salicylates and/or barbiturates.
• Alkaline medicines such as sympathomimetics (ephedrine, pseudoephedrine) and/or stimulants (amphetamine, dexamphetamine).
• Medicines that stimulate vasopressin release; e.g.: chlorpropamide, clofibrate, carbamazepine, vincristine, selective serotonin reuptake inhibitors, 3,4-methylenedioxy-N-methamphetamine, ifosfamide, antipsychotics, narcotics.
• Medicines that potentiate the action of vasopressin; e.g.: chlorpropamide, NSAIDs, cyclophosphamide.
• Vasopressin analogues; e.g.: desmopressin, oxytocin, vasopressin, terlipressin.

Pregnancy and Lactation

Consult your doctor or pharmacist before using any medicine.

If Ringer Lactate solution is administered correctly and under control, adverse effects are not expected during pregnancy or lactation.

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

During pregnancy and lactation, the use of Ringer Lactate solution as a vehicle for administering other medicines should be evaluated based on the nature of those medicines.

Driving and using machines

There is no evidence that Suero Ringer Lactato Vitulia may affect the ability to drive or use machines.

3. HOW TO USE RINGER LACTATE SOLUTION VITULIA

Ringer Lactate Solution Vitulia is provided as a solution for intravenous administration.

Ringer Lactate Solution Vitulia will be administered in a hospital setting by qualified healthcare personnel.

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

The dose may be adjusted at the physician's discretion.

The volume of solution required to restore normal blood volume is 3 to 4 times the volume of blood lost.

Recommended daily dose:

• Adults: between 500 and 3000 ml per day.
• Children:
  • Up to 10 kg body weight: 100 ml per kg of body weight per day.
  • Between 10 and 20 kg body weight: 1000 ml + an additional 50 ml for each kg exceeding 10 kg body weight, per day.
  • Over 20 kg body weight: 1500 ml + an additional 20 ml for each kg exceeding 20 kg body weight, per day.

The infusion rate must be adjusted according to the patient's clinical needs, taking into account age, weight, clinical condition, fluid balance, electrolyte levels, and acid-base balance.

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

If you are given more Ringer Lactate Solution Vitulia than you should

In case of overdose or excessively rapid administration, the following symptoms may occur:

• Hyperhydration (edema, hypervolemia), disturbances in electrolyte balance, and/or induction of metabolic alkalosis, especially in patients with impaired renal function. In such cases, administration should be reduced or discontinued, and symptomatic treatment initiated. If renal function is compromised, dialysis may be necessary.
• Water and sodium overload with risk of edema, particularly when renal sodium excretion is impaired.

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

Excessive administration of calcium salts may lead to hypercalcemia (elevated calcium levels in blood). Symptoms of hypercalcemia may include anorexia, nausea, vomiting, constipation, abdominal pain, muscle weakness, mental disturbances, polydipsia (excessive thirst), polyuria (excessive urine volume), kidney stones, and, in severe cases, cardiac arrhythmias and coma, as well as sensations of calcium taste, burning, and peripheral vasodilation. Mild asymptomatic hypercalcemia usually resolves by discontinuing calcium administration and withholding contributing medications such as vitamin D. In cases of severe hypercalcemia, urgent treatment is required (e.g., diuretic cycles, hemodialysis, calcitonin, bisphosphonates, trisodium edetate).

Excessive administration of sodium lactate may lead to hypokalemia (decreased potassium levels in blood) and metabolic alkalosis (increased blood alkalinity). Symptoms may include changes in mental status, fatigue, respiratory insufficiency, muscle weakness, and irregular heartbeats. In particular, in patients with hypocalcemia, increased muscle tone, muscle spasms, and tetany (neuromuscular hyperexcitability) may develop. Treatment of metabolic alkalosis associated with bicarbonate overdose primarily involves appropriate correction of fluid and electrolyte balance.

When overdose is related to medication added to the infused solution, signs and symptoms of over-infusion may reflect the nature of the added medication. In case of accidental overdose, treatment should be discontinued and the patient monitored for symptoms and signs related to the administered medication. If necessary, appropriate symptomatic and supportive measures should be taken.

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

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

4. Possible adverse effects

Like all medicines, Suero Ringer Lactato Vitulia may cause adverse effects, although not everyone will experience them.

The most commonly reported adverse effects are hyperhydration (oedema) and electrolyte disturbances (mainly after administration of a large volume of Ringer Lactate solution), as well as allergic reactions.

Possible adverse effects include:

• Electrolyte disturbances.
• Venous thrombosis (blood clots), phlebitis (vein inflammation) (associated with intravenous administration).
• Nasal congestion, cough, sneezing, difficulty breathing during administration of the solution, chest pain with alteration of heart rhythm.
• Allergic reactions such as urticaria, skin rashes, skin redness, itching, swelling, fluid accumulation in tissues.
• Hyperhydration (oedema).
• Fever, infection at injection site, local reaction or local pain (associated with intravenous administration).
• Hospital-acquired hyponatraemia may cause irreversible brain damage and death due to the development of acute hyponatraemic encephalopathy.

When Ringer Lactate solution is used as a vehicle to administer other medicines, adverse effects may be related to the added medicines.

If any adverse effects occur, the infusion should be stopped.

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 RINGER LACTATE SODIUM VITULIA

Keep out of the reach and sight of children.

Do not use Ringer Lactate Sodium Vitulia after the expiry date stated on the container following EXP. The expiry date refers to the last day of the month indicated.

No special storage conditions are required. Once the container has been opened, the solution must be used immediately.

Do not use Ringer Lactate Sodium Vitulia if you notice that the solution is not clear or contains precipitates or clumps.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. ADDITIONAL INFORMATION

Composition of Suero Ringer Lactato Vitulia

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

Electrolytic 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

Suero Ringer Lactato Vitulia is supplied as a solution for intravenous infusion.

Suero Ringer Lactato Vitulia is a clear, colorless, sterile and pyrogen-free solution, free from visible particles. It is available in low-density polyethylene bottles with a polyethylene cap and elastomeric membrane, in 500 ml and 1,000 ml sizes.

Only certain container sizes may be commercially available.

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 - Barberà del Vallès. Barcelona. Spain

Or

Parenteral Solution Industry Vioser S.A.

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

This leaflet was last reviewed in October 2018.

This information is intended for healthcare professionals only

Suero Ringer Lactato Vitulia is administered by intravenous infusion.

Water balance, serum electrolytes, and acid-base balance must be monitored before and during administration, with special attention to serum sodium levels in patients with non-osmotic increased release of vasopressin (syndrome of inappropriate antidiuretic hormone secretion, SIADH) and in patients receiving concomitant treatment with vasopressin agonists due to the risk of hospital-acquired hyponatremia. Monitoring of serum sodium is particularly important when using hypotonic solutions.

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

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

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

The contents of each bottle of Suero Ringer Lactato Vitulia are intended for single use only. Once the container is opened, the solution must be administered immediately, and any unused portion must be discarded.

The solution must be clear and free from precipitates. Do not administer if otherwise.

The solution should be administered under maximum aseptic conditions, especially when adding medications. From a microbiological standpoint, when the solution is used as a vehicle for other drugs, it should be used immediately unless dilution has been performed under controlled and validated aseptic conditions. If not used immediately, the conditions and duration of storage during use are the responsibility of the user.

Compatibility tables should be consulted before adding medications to Ringer Lactate solution or administering it simultaneously with other drugs. The package leaflets of added medications should be reviewed, and their solubility and stability in aqueous solution at the pH of Ringer Lactate solution (pH 5.0–7.0) should be verified.

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

Ringer Lactate solution should not be used as a vehicle for drugs containing ions capable of causing the formation of insoluble calcium salts.

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