Leaflet: information for the user

KabiPac Ringer Lactate solution for infusion

Sodium chloride/Potassium chloride/Dihydrated calcium chloride/Lactic acid sodium

Read this leaflet carefully before you start using the medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist or nurse.
• This medicine has been prescribedonlyfor you, and you must not give it to others even iftheyhavethe same symptomsas you,as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4

KabiPac Ringer Lactate is an intravenous infusion solution that provides a mineral salt and water supplement for hydration.

KabiPac Ringer Lactate is included within the group of intravenous medications known as infusion solutions.

This medication will be administered intravenously by specialized personnel and is indicated in the following cases:

• When there is dehydration with high losses of salts and water, such as occurs when there are vomiting, diarrhea, fistulas, or severe burns.
• When the body fluids are too acidic (mild or moderate metabolic acidosis).
• When there is a significant decrease in blood volume, in cases of hemorrhage, burns, shock, etc.
• During or after surgery to prevent a drop in blood pressure.
• As a vehicle to administer other compatible medications.

No use KabiPac Ringer Lactato

• If you are allergic to the active ingredients or any of the other components of this medication (listed in section 6).
• If you have been diagnosed with excess fluid in the body (hyperhydration or hyper-volemia) and if this causes swelling (edema).
• If you have high blood pressure.
• If you have an excess of potassium, sodium, calcium, or chloride in the body.
• If the fluids in your body are too alkaline (metabolic alkalosis).
• If the fluids in your body are excessively acidic (severe metabolic acidosis).
• If you have been diagnosed with high levels of lactic acid in the blood.
• If you have severe kidney or liver disease.
• If you have severe heart disease.
• If you are being treated with long-term steroids or with a hormone called ACTH.

Warnings and Precautions

Consult your doctor or nurse before administering KabiPac Ringer Lactato if the kidneys, heart, and/or lungs do not function correctly. In these cases, the administration of large volumes of this solution should be carried out under strict clinical control.

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. Blood potassium checks should be performed if there is a risk of hyperkalemia (high levels of potassium 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 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 adrenal 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 KabiPac Ringer Lactato is administered in large quantities, metabolic alkalosis may occur.
• If you have severe potassium deficiency. Although KabiPac Ringer Lactato 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, KabiPac Ringer Lactato may not produce its effect, as the metabolism of lactate may be impaired.
• KabiPac Ringer Lactato 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 KabiPac Ringer Lactato should be carried out with caution (see section "Use of other medications").
• If you have acute disease, pain, postoperative stress, infections, burns, or central nervous system diseases.
• If you have any type of liver, heart, or kidney disease.
• If you have been treated with a medication that increases the effect of vasopressin (a hormone that regulates water retention in the body) because this may increase the risk of acquired hyponatremia in the hospital (low sodium levels in the blood).

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

The administration of the solution should be avoided in the same location due to the risk of thrombophlebitis.

All patients should be closely monitored. In cases where the normal regulation of blood water content is altered due to an increase in the secretion of antidiuretic hormone (ADH), the infusion of fluids with a low concentration of sodium chloride (hypotonic fluids) may result in low sodium levels in the blood (hyponatremia). This may cause headache, nausea, convulsions, lethargy, coma, cerebral edema, and death; therefore, these symptoms (acute symptomatic hyponatremic encephalopathy) are considered a medical emergency.

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

Use of KabiPac Ringer Lactato with other medications

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

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

Generally, the concurrent 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 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
• 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)
• 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)
• Medications that increase the effect of vasopressin (see also the section "Warnings and Precautions" above), 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 as vasopressin, called vasopressin analogs

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

Use of KabiPac Ringer Lactato with foods and beverages

No interactions with foods and beverages are known.

Pregnancy, lactation, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist.

As long as the administration is correct and controlled, no adverse effects should be expected during pregnancy or lactation.

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

Driving and operating machinery

KabiPac Ringer Lactato does not affect the ability to drive or operate machinery.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor again.

KabiPac Ringer Lactate will be administered always under the direct supervision of your doctor, who will closely monitor the administered dose.

KabiPac Ringer Lactate is administered by slow injection into a vein (intravenous infusion).The speed and amount administered will depend on your needs and the condition being treated.

The normal dose is 500-2,500 ml/day, at a rate of 40-60 drops/minute.Your doctor will indicate the duration of treatment with KabiPac Ringer Lactate.

Use in children

Children will be administered lower doses, proportional to their weight.

If you use more KabiPac Ringer Lactate than you should

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

• hyperhydration (edema, hyperolemia), disorders in electrolyte balance and/orinduction of a 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.

• 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, especially in patients with impaired renal function. Symptoms include tingling, numbness, and/or burning sensations 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. 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, and peripheral vasodilation. Mild asymptomatic hypercalcemia will usually resolve by stopping calcium administration and with 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 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 increased muscle tone and muscle spasms. Treatment of metabolic alkalosis associated with bicarbonate overdose consists mainly of correcting fluid and electrolyte balance.

In cases of overdose related to medication added to the perfused 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.

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

Like all medications, KabiPac Ringer Lactate may cause 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 Lactate Ringer solution), as well as allergic reactions.

The possible adverse effects are:

• Electrolyte imbalances
• Thrombosis (clots), phlebitis (vein inflammation) (associated with intravenous administration)
• 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).
• Headache, nausea, convulsions, lethargy. This can be caused by low sodium levels in the blood. When sodium levels in the blood drop, water enters the brain cells and causes them to swell. This results in increased pressure in the skull and causes hyponatremic encephalopathy.

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

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

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

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 Medications for Human Use: https://www.notificaram.es.By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

No special storage conditions are required.

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

Do not use KabiPac Ringer Lactate after the expiration date that appears on thecontainer after CAD.The expiration date is the last day of the month indicated.

Do not use this medication if you observe that the solution is not transparent, free of particles or the container is damaged

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medicines that you do not need. In thisway, you will help protect the environment.

KabiPac Ringer Lactate Composition

• The active principles are: sodium lactate, sodium chloride, potassium chloride, and dihydrate calcium chloride.Each 100 ml of solution contains 317 mg of sodium lactate, 600 mg of sodium chloride, 40 mg of potassium chloride, and 27 mg of dihydrate calcium chloride (electrolytes: Ca2+3.7 mEq/l, K+5.4 mEq/l, Na+130.8 mEq/l, Lactate-28.3 mEq/l, Cl-109.75 mEq/l).

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

Product Appearance and Packaging Contents

KabiPac Ringer Lactate is a transparent, colorless, and particle-free intravenous infusion solution contained in polyethyleneKabipacbottles.

Clinical packaging of 10 bottles of 500ml and 1000 ml.

Clinical packaging of 20 bottles of 100ml and 250 ml.

Marketing Authorization Holder and Responsible Manufacturer

Marketing Authorization Holder

Fresenius Kabi España S.A.U.

Marina 16-18

08005 – Barcelona

Responsible Manufacturer

Fresenius Kabi Deutschland GmbH

Else-KrönerStrasse, 1

D-61346 Bad Homburg

Germany

Fresenius Kabi España, S.A.U.

Marina, 16-18 - 17

08005 Barcelona – Spain

Fresenius Kabi Italia S.r.l.

Via Camagre, 41

I - 37063 Isola della Scala - Verona

Italy

Labesfal - Laboratórios Almiro, S.A.

Zona Industrial do Lagedo

3465 157 Santiago de Besteiros

Portugal

Fresenius Kabi Polska Sp. Z.o.o.

Infusion Liquid Plant

P-99-300 Kutno, ul. Sienkiewicza, 25–

Poland

Last Review Date of this Leaflet December 2020.

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

------------------------------------------------------------------------------------------------------------------

This information is intended solely for medical professionals or healthcare professionals:

This medicine is administered by infusion.

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

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

To administer the solution and in the event of adding medications, maximum asepsis must be maintained. It is recommended to disinfect the rubber stopper before piercing it with the injection equipment. 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 them simultaneously with other medications. It is recommended to consult the medication's leaflet, as well as verify if they are soluble and stable in aqueous solution at the pH of the Ringer Lactate solution (pH 5.5-7.0).

When adding compatible medication, the solution must be administered immediately.

The Ringer Lactate solution must not be used as a vehicle for medications containing ions capable of forming insoluble calcium salts.

It is recommended not to mix or administer simultaneously in the same infusion equipment Ringer Lactate solution with total blood or with conserved blood components containing an anticoagulant that contains citrate (such as CPD), due to the fact that the calcium ions present in this solution may exceed the chelating capacity of the citrate, potentially producing the formation of clots. These clots may perfuse directly into the circulation and cause an embolism.

Posology

General advice:

Hydration balance, serum electrolytes, and acid-base balance may require monitoring before and during administration, with special attention to serum sodium levels in patients with increased non-osmotic vasopressin release (SIADH syndrome) and in patients co-medicated with vasopressin agonists, due to the risk of acquired hyponatremia in the hospital. Serum sodium monitoring is particularly important for physiologically hypotonic fluids.

Pediatric population

The dose and infusion rate must be determined by an expert pediatrician in intravenous fluid therapy.