Label: information for the user

Ringer Lactated Grifols Solution for infusion

Read this label carefully before starting to use this medication, because it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or nurse.

-If you experience any adverse effects, consult your doctor or nurse, even if they are not listed in this label.

Ringer Lactado Grifols belongs to the group of medications known as Intravenous Solutions that affect the electrolyte balance – Electrolytes(used to maintain the body's fluid balance in correct equilibrium).

Ringer Lactado Grifols is indicated in the following situations:

-Hydroelectrolytic replenishment of extracellular fluid, such as in states of dehydration with electrolyte loss or surgical interventions.

-Short-term replenishment of plasma volume in states of hypovolemic shock (hemorrhages, burns, and other problems that cause circulatory volume loss) or hypotension (a decrease in blood pressure).

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

-As a vehicle for the administration of compatible medications.

No use Ringer Lactado Grifols

• if you are allergic to the active ingredients or any of the other components of this medication (listed in section 6)

-in states of extracellular hyperhydration or hypervolemia (excess of fluids in the body)

-if you have severe renal insufficiency with oliguria or anuria (kidney failure with decreased or absent urine production)

-in case of uncompensated heart failure

-if your blood contains high levels of potassium, sodium, calcium, or chloride

-if you have metabolic alkalosis

-in case of severe metabolic acidosis

-if you have lactic acidosis

-if you have severe hepatocellular insufficiency (liver function failure) or impaired lactate metabolism

-in situations of general edema (excessive accumulation of liquids) or ascitic cirrhosis.

Warnings and precautions

Consult your doctor or nurse before starting to use Ringer Lactado Grifols.

-If the kidney, heart, and/or lungs do not function correctly, the administration of large volumes of this solution should be performed under strict clinical control.The administration of large volumes will also require special monitoring if you are a patient with non-osmotic vasopressin release (including the syndrome of inappropriate antidiuretic hormone secretion, SIADH), due to the risk of hospital-acquired hyponatremia (low sodium levels in the blood during hospitalization).

Hypotremia:

If you are a patient with non-osmotic vasopressin release (e.g., in the presence of critical states, pain, postoperative stress, infections, burns, and central nervous system diseases), if you have heart, liver, and kidney diseases, and if you are exposed to vasopressin agonists (see next subsection), you have a special risk of suffering acute hyponatremia after administration of hypotonic solutions.

Acute hyponatremia can cause acute hyponatremic encephalopathy (brain edema) characterized by headache, nausea, seizures, lethargy, and vomiting. Patients with brain edema have a special risk of suffering severe, irreversible, and potentially fatal brain damage.

Children, fertile 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 brain edema caused by acute hyponatremia.

-It is recommended that, during the administration of this solution, regular clinical status checks and blood and urine analyses (electrolytes in blood and urine, acid-base balance, hematocrit) be performed.You should have blood potassium checks if you are at risk of hyperkalemia (high potassium levels in the blood).

If you have any of the following conditions, 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 occurs during pregnancy or postpartum with increased blood pressure), aldosteronism (a disease associated with increased secretion of a hormone called aldosterone) or have impaired renal function or other conditions associated with sodium retention.

-Due to the presence of potassium: Ifyou have heart diseases or other conditions that may cause high potassium levels 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 accumulationor diseases associated with elevated concentrations of vitamin D such as sarcoidosis.

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

-If you have severe potassium deficiency. Although the Ringer Lactado solution has a potassium concentration similar to that of plasma, it is insufficient to produce a beneficial effect in these situations.

• If the liver does not function correctly, the Ringer Lactado solution may not produce its effect, as the lactate metabolism may be impaired.

• You should be administered the Ringer Lactado solution 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 Lactado 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 impaired renal, hepatic, and/or cardiac function.

The administration should be avoided in the same place of injection due to the risk of thrombophlebitis.

Other medications and Ringer Lactado Grifols

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

Certain medications may interact with Ringer Lactado Grifols. 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 the Ringer Lactado 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:

-Medications thatmay interact with one of the electrolytes present in the Ringer Lactado 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) (captopril, enalapril) or angiotensin II receptor antagonists (candesartan, telmisartan, eprosartan, irbesartan, losartan, valsartan)

-Tacrolimus and cyclosporine (medications with renal toxicity)

-Digitalis cardiotonic glucosides (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, dextroamphetamine)

-Medications that increase the effect of antidiuretic hormone (such as chlorpropamide, clofibrate, carbamazepine, vincristine, selective serotonin reuptake inhibitors, 3,4-methylenedioxy-N-methamphetamine, ifosfamide, antipsychotics, narcotics, NSAIDs, cyclophosphamide, desmopressin, oxytocin, vasopressin, terlipressin). These medications reduce water excretion in urine and increase the risk of hospital-acquired hyponatremia after receiving an insufficiently balanced treatment with intravenous infusion solutions (see previous subsection and sections 3 and 4)

-Diuretics in general and antiepileptic medications such as oxcarbazepine, which increase the risk of hyponatremia.

Pregnancy and lactation

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

If the Ringer Lactado solution is administered correctly and under control, no adverse effects are expected during pregnancy or lactation.

This medicationshould be administered with special caution in pregnant women during delivery and special monitoring of serum sodium levels will be required if it is administered in combination with oxytocin (see previous subsections and section 4).

During pregnancy and lactation, the use of the Ringer Lactado solution as a vehicle for administering other medications should be evaluated based on the nature of these medications.

Driving and operating machines

There isnoindication thatthis medicationmay affect the ability to drive or operate machines.

This medicationis presented in the form of a solution for intravenous administration.

Ringer Lactado Grifolswill be used in a hospital by the corresponding healthcare personnel.

Your doctor will inform you of the duration of your treatment withRinger Lactado Grifols.

The dose may be varied according to medical criteria.Either the volume or the speed of administrationshould be adjusted to the clinical needs of each patient based on age, weight, clinical picture (e.g., burns, surgery, head injury, infections),fluid balance, electrolytes, and acid-base balance.

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

Recommended daily dose:

-Adults:between500 and 3000 ml per day.

-Children: -up to 10 kg of weight: 100 ml per kilogram of weight per day.

- between 10 and 20 kg of weight: 1000 ml + 50 ml additional per kilogram that exceeds 10 kg of weight per day.

-over 20 kg of weight: 1500 ml + 20 ml additional per kilogram that exceeds 20 kg of weight per day.

You may need to monitor fluid balance, serum electrolytes, and acid-base balance before and during administration, with special attention to serum sodium if you have an increase in non-osmotic vasopressin release (SIADH) and if you are receiving simultaneous medication with vasopressin agonists, due to the risk of hospital-acquired hyponatremia (see sections 2 and 4). Monitoring of serum sodium is especially important with hypotonic solutions (this medication is considered slightly hypotonic).

Your doctor will decide on the need for simultaneous treatment (see sections 2 and 4).

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

If you receive more Ringer Lactado Grifols 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 discontinued, and symptomatic treatment will be used. 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 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, heart 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.Asymptomatic mild hypercalcemia will usually resolve by stopping 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, and edetate trisodium).

Excessive administration of sodium lactate can lead to hypokalemia and metabolic alkalosis. Symptoms may include changes 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.

When overdose is 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, 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 medication, ask your doctor or nurse.

Like all medications,this medicationcan produce adverse effects, although not all people will experience them.

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

In patients with non-osmotic vasopressin release, in patients with heart, liver, and kidney diseases, and in patients treated with vasopressin agonists, the risk of acute hyponatremia increases after administration of hypotonic solutions. Hospital-acquired hyponatremia can cause irreversible brain damage and death due to the onset of cerebral edema (see sections 2 and 3).

The possible adverse effects are:

-Electrolyte imbalances, hospital-acquired hyponatremia

- Cerebral edema

-Thrombophlebitis (clots), 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, injection site infection, local reaction or local pain (associated with intravenous administration).

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

In case of adverse effect appearance, the perfusion should be interrupted.

Reporting Adverse Effects

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

No requires special conditions for conservation.

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

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

Do not usethis medicationafter the expiration date that appears on the container.

Do not use this medication if the solution is nottransparent or if precipitates are observed.

Medications should not be thrown into the drains or trash. Dispose of the containers and medications you do not need at the SIGRE collection point (SIGRE symbol) at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you do not need. In this way, you will help protect the environment.

Composition ofRinger Lactated Grifols

The active principles are sodium chloride, potassium chloride, calcium chloride, and sodium lactate. Each 100 ml of solution contains 600 mg of sodium chloride, 40 mg of potassium chloride, 20.4 mg of calcium chloride (as dihydrate) and 305 mg of sodium lactate (as 50% solution).

The other components (excipients) are:hydrochloric acid or sodium hydroxide (for pH adjustment) and water for injectable preparations.

Appearance of the product and contents of the package

Ringer Lactated Grifolsis a transparent and colorless infusion solution, which is presented in glass bottles of 500 and 1000 ml; and in flexible polypropylene bags (Fleboflex) of 500 and 1000 ml.

Holder of the marketing authorization

LABORATORIOS GRIFOLS, S.A.

Can Guasch, 2

08150 Parets del Vallès, Barcelona (SPAIN)

Responsible for manufacturing

LABORATORIOS GRIFOLS, S.A.

Polígono Industrial Autopista. Passeig Fluvial, 24

08150 Parets del Vallès, Barcelona (SPAIN)

LABORATORIOS GRIFOLS, S.A.

Polígono Industrial Los Llanos. C/ Marte, 4

30565 Las Torres de Cotillas, Murcia (SPAIN)

Date of the last review of this leaflet:June 2018

Other sources of information

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

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This information is intended solely for healthcare professionals:

Ringer Lactated Grifols will be administered by infusion.

The contents of each package of this medicine are for a single infusion. Once the package is opened, the solution must be administered immediately and the unused portion must be discarded.

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

Fleboflex Bag:

-Check for the absence of small leaks by pressing firmly on the bag. If leaks are detected, discard the product.

-To connect the infusion equipment, separate the protective tongue from the infusion port, leaving the access membrane to the bag exposed.

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

When compatible medication is added to Ringer Lactated Grifols, the solution must be administered immediately.

The Ringer Lactated 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 equipment Ringer Lactated solution with total blood or with conserved blood components 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.