PATIENT INFORMATION LEAFLET

Apiroserum Ringer Lactate infusion solution

Sodium lactate, Sodium chloride, Potassium chloride, Dihydrated calcium chloride

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

Apiroserum Ringer Lactato is presented in glass bottles of 250 ml, 500 ml and 1000 ml.

Apiroserum Ringer Lactato is indicated in the following situations:

-Replenishment of hydroelectrolytic fluid of the extracellular fluid, such as in states of dehydration with loss of

electrolytes or surgical interventions.

-Replenishment of plasma volume in the short term in states of hypovolemic shock (bleeding, burns and other problems that cause loss of circulatory volume) or hypotension (decrease in blood pressure).

-Mild or moderate metabolic acidosis (except lactic acidosis).

-As a vehicle for the administration of compatible medications.

Monitor the hydroelectrolyte balance.

Do not use Apiroserum Ringer Lactato in the following cases:

-Allergy to the active principles or to any of the other components of Apiroserum Ringer Lactato.

-Extracellular hyperhydration or hypervolemia (excess of fluids in the body).

-Severe renal insufficiency with oliguria or anuria (kidney failure with decreased or absent urine production).

-Uncompensated heart failure.

-If your blood contains high levels of potassium, sodium, calcium, or chloride.
-Metabolic alkalosis.

-Severe metabolic acidosis.

-Lactic acidosis.

-Severe hepatocellular insufficiency (liver function failure) or deteriorated lactate metabolism.

-Generalized edema (excessive accumulation of liquids) or ascitic cirrhosis.

Warnings and precautions

Be especially careful with Apiroserum Ringer Lactato

-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, your clinical status and blood and urine analyses (electrolytes in blood and urine, acid-base balance, hematocrit) be regularly monitored. You should have potassium blood controls if you are at risk of developing hyperkalemia (high potassium levels in blood).

If you have any of the following diseases, this medication will be administered to you 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 ankles, feet, and legs, preeclampsia (a disease that occurs 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 deteriorated renal function or other conditions associated with sodium retention.

-Due to the presence of potassium: If you have heart diseases or other problems that may cause high potassium levels in 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 deteriorated renal function or if you have or have had kidney stones produced by a calcium accumulation or diseases associated with high concentrations of vitamin D such as sarcoidosis.

-Due to the presence of lactate ions: If the Ringer Lactate solution is administered in large quantities, it can cause metabolic alkalosis.

-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 does not function correctly, the Ringer Lactate solution may not produce its effect, as lactate metabolism may be deteriorated.

-You should be administered the 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 the Ringer Lactate solution should be performed with caution (see section Use of other medications).

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

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

Be especially careful:

• If you suffer from critical states, pain, postoperative stress, infections, burns, or central nervous system diseases

• You have any type of heart, liver, and kidney disease and are being treated with a medication that increases the effect of vasopressin (a hormone that regulates water retention in the body) because it may increase the risk of developing hyponatremia (low sodium levels in blood) in the hospital. (see section Other medications and Apiroserum Ringer Lactato)

All patients must be closely monitored. In cases where the normal regulation of blood water content is altered due to the increase in vasopressin secretion, also known as Antidiuretic Hormone (ADH), the infusion of fluids with a low concentration of sodium chloride (hypotonic fluids) may result in low sodium levels in blood (hyponatremia). This can cause headache, nausea, convulsions, lethargy, coma, cerebral edema, and death; therefore, these symptoms (acute symptomatic hyponatremic encephalopathy) are considered a medical emergency. (See section 4. Possible side effects)

Children, fertile women, and patients with brain diseases such as meningitis, cerebral hemorrhage, cerebral contusion, and cerebral edema have a special risk of developing severe and potentially fatal brain inflammation caused by acute hyponatremia.

Children and adolescents

Children are at particular risk of developing severe and potentially fatal brain inflammation due to acute hyponatremia.

Other medications and Apiroserum Ringer Lactato

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

Certain medications may interact with Apiroserum Ringer Lactato. In this case, it may be necessary to change the dose or interrupt the treatment of one of the medications.

In general, it is recommended to avoid the concomitant administration of the 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 are using any of the following medications, as they may interact with one of the electrolytes present in the Ringer Lactate solution:

-Corticosteroids/steroids or adrenocorticotropic hormone

-Lithium carbonate

-Diuretics that spare potassium (amiloride, spironolactone, triamterene) alone or in combination

-Inhibitors of the angiotensin-converting enzyme (ACE inhibitors) (captopril, enalapril) or angiotensin II receptor antagonists (candesartan, telmisartan, eprosartan, irbesartan, losartan, valsartan)

-Tacrolimus and cyclosporine (medications with renal toxicity)
-Digitalis cardiotonic glucosides (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).

Inform your doctor if you are taking:

Medications that increase the effect of vasopressin (see section Warnings and precautions), for example:

• Medications that stimulate the release of vasopressin (e.g., antipsychotics, narcotics)
• Medications that potentiate the action of vasopressin (e.g., nonsteroidal anti-inflammatory drugs)

• Medications that act like vasopressin, called vasopressin analogs

• Other medications that increase the risk of hyponatremia, including diuretics in general and antiepileptic medications.

Pregnancy and lactation

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 should be expected during pregnancy or lactation.

During pregnancy and lactation, the use of the Ringer Lactate solution as a vehicle to administer other medications should be evaluated in accordance with the nature of these medications.

This medication should be administered with special caution in pregnant women during delivery, especially if it is administered in combination with oxytocin (a hormone that can be administered to induce delivery and control bleeding) due to the risk of hyponatremia.

Driving and operating machines

There is no indication that Apiroserum Ringer Lactato may affect the ability to drive or operate machines.

Apiroserum Ringer Lactato is presented in the form of a solution for intravenous administration. Apiroserum Ringer Lactato will be used in a hospital by the corresponding healthcare personnel.

Your doctor will inform you of the duration of your treatment with Apiroserum Ringer Lactato.

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.

- more than 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, taking into account their 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 Apiroserum Ringer Lactato 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, administration will be reduced or suspended and symptomatic treatment will be sought. If renal function is compromised, dialysis may be necessary.

-excessive water and sodium loading with risk of edema, particularly when there is a defective renal excretion of sodium.

Excessive administration of potassium salts can lead to hyperkalemia, 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. 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 can lead to hypokalemia 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 consists mainly of 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 observed for symptoms and signs related to the administered medication. If necessary, take appropriate symptomatic and supportive measures.

In case of overdose or accidental ingestion, consult the Toxicological 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, Apiroserum Ringer Lactate may produce adverse effects,

although not everyone will experience them.

The most commonly described adverse effects are hyperhydration (edema) and electrolyte alterations

(primarily after administration of a significant volume of Ringer Lactate solution), as well as allergic reactions.

The possible adverse effects are:

-Electrolyte alterations

-Thrombophlebitis (clotting), phlebitis (vein inflammation) (associated with intravenous administration)

-Nasal congestion, cough, sneezing, respiratory difficulty 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).

Headache, nausea, convulsions, lethargy. This may be caused by low sodium levels in the blood. When sodium levels in the blood drop significantly, water enters the brain cells and causes inflammation. This results in increased intracranial pressure and causes hyponatremic encephalopathy.

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

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

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

No special conservation conditions are required.

Once the container is opened, the solution must be used immediately.

Keep out of the reach and sight of children.

Do not use Apiroserum Ringer Lactato after the expiration date that appears on the container.

Do not use Apiroserum Ringer Lactato if the solution is not transparent and contains precipitates.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of containers and medicines that you no longer need. This will help protect the environment.

Composition of Apiroserum Ringer Lactate

The active principles are:

Per 100ml, Sodium lactate 310 mg, Sodium chloride 600 mg, Potassium chloride 30 mg, Calcium chloride (dihydrate) 21.9 mg.

The other components (excipients) are: water for injections.

Clear and colorless solution, without visible particles, sterile and apyrogenic.

The electrolytic composition per 1000 ml is:

Calcium 1.5 mmol/l, 3.0 meq/l; Potassium 4.0 mmol/l, 4.0 meq/l; Sodium 130 mmol/l, 130 meq/l; Lactate 27 mmol/l, 27 meq/l; Chloride 110 mmol/l, 110 meq/l.

Theoretical osmolality: 273 mosm/l. pH: 5.0-7.0

Appearance of the product and contents of the package

Apiroserum Ringer Lactate is a clear and colorless solution, without visible particles. It is presented in glass bottles of 250 ml, 500 ml and 1000 ml.

Holder of the marketing authorization

Fresenius Kabi España S.A.

C/ Marina 16-18, 17th floor

08005-Barcelona (Spain)

Manufacturers responsible

Fresenius Kabi España, S.A.

C/ Marina, 16-18

08005 Barcelona (Spain)

Fresenius Kabi Italia S.R.L.

Via Camagre, 41/43

37063 Isola della Scala (VR) (Italy)

This leaflet has been revised in

August 2018

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This information is intended solely for doctors or healthcare professionalsApiroserum Ringer Lactate will be administered by infusion.

The contents of each bottle of Apiroserum Ringer Lactate are for a single infusion. Once the package is opened, the solution must be administered immediately and the unused portion 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 in controlled and validated aseptic conditions. If 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 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 the Ringer Lactate solution (pH 5.0-7.0).

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

The Ringer Lactate solution must not be used 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), due to 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.

General advice

Hydration 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 vasopressin release (SIADH syndrome) and in patients receiving concomitant medication with vasopressin agonists due to the risk of hospital-acquired hyponatremia.

Monitoring of serum sodium is especially important with hypotonic physiological solutions.

The dose and administration rate for pediatric patients must be determined by an experienced pediatric intravenous fluid therapy physician.