KABIPAC RINGER LACTATE SOLUTION FOR INFUSION

Introduction

Package Leaflet: Information for the User

KabiPac Ringer Lactate Solution for Infusion

Sodium Chloride/Potassium Chloride/Calcium Chloride Dihydrate/Sodium Lactate

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

1. What KabiPac Ringer Lactate is and what it is used for
2. What you need to know before you use KabiPac Ringer Lactate
3. How to use KabiPac Ringer Lactate
4. Possible side effects
5. Storage of KabiPac Ringer Lactate
6. Contents of the pack and further information

1. What KabiPac Ringer Lactate is and what it is used for

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

KabiPac Ringer Lactate is included in the group of intravenous medicines called infusion solutions.

This medicine 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 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 the case of hemorrhages, burns, shock, etc.
• During or after a surgical operation to prevent a drop in blood pressure.
• As a vehicle for administering other compatible medicines.

2. What you need to know before you use KabiPac Ringer Lactate

Do not use KabiPac Ringer Lactate

• if you are allergic to the active substances or to any of the other components of this medicine (listed in section 6).
• if you have been detected with an excess of fluids in the body (hyperhydration or hypervolemia) and if this causes swelling (edema)
• if you have high blood pressure problems.
• if you have an excess of potassium, sodium, calcium or chlorine in the body
• if the body fluids are too alkaline (metabolic alkalosis)
• if the body fluids are excessively acidic (severe metabolic acidosis)
• if you have been detected 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 undergoing prolonged treatment with steroids or with a hormone called ACTH.

Warnings and precautions

Consult your doctor or nurse before KabiPac Ringer Lactate is administered to you if your kidney, heart and/or lungs are not functioning properly. 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 checks of your clinical condition and blood and urine tests (electrolytes in blood and urine, acid-base balance, hematocrit) be performed. Potassium checks in the blood should be performed if you are at risk of hyperkalemia (high potassium levels in the blood).

If you have any of the following diseases, this medicine will be administered with special caution and it is likely that additional tests will be performed to determine if you can receive the medicine:

• 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 occurs during pregnancy or postpartum that is characterized by an increase in blood pressure), aldosteronism (a disease associated with an increase in the 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 suffer from heart diseases or other problems that can cause an increase in potassium 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 a accumulation of calcium or diseases associated with high concentrations of vitamin D such as sarcoidosis.
• Due to the presence of lactate ions: If KabiPac Ringer Lactate is administered in large quantities, it can cause metabolic alkalosis.
• If you have severe potassium deficiency. Although KabiPac Ringer Lactate 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, KabiPac Ringer Lactate may not produce its effect, since 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 KabiPac Ringer Lactate should be carried out with caution (see section "Use with other medicines").
• If you suffer from 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 medicine that increases the effect of vasopressin (a hormone that regulates water retention in the body) because this can increase the risk of acquired hyponatremia in the hospital (low sodium levels in the blood).

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.

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

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

Use of KabiPac Ringer Lactate with other medicines

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

Certain medicines may interact with KabiPac Ringer Lactate. In this case, it may be necessary to change the dose or interrupt treatment with one of the medicines.

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

It is important that you inform your doctor if you use any of the following medicines, as they may interact with any 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 (medicines with renal toxicity)
• Digitalis 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, dextroamphetamine).
• Medications that increase the effect of vasopressin (see also the "Warnings and precautions" section above), for example:

• Medications that stimulate the release of vasopressin (e.g., antipsychotics, narcotics)
• Medications that enhance the action of vasopressin (e.g., non-steroidal anti-inflammatory drugs)
• Medications that act as vasopressin, the so-called vasopressin analogs

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

Use of KabiPac Ringer Lactate with food and drinks

No interaction with food and drinks is known.

Pregnancy, breastfeeding and fertility

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

Provided that administration is correct and controlled, no adverse effects are expected during pregnancy or breastfeeding.

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

Driving and using machines

KabiPac Ringer Lactate does not affect the ability to drive or use machines.

3. How to use KabiPac Ringer Lactate

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

KabiPac Ringer Lactate will always be administered under the direct supervision of your doctor, who will closely control 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 disorder being treated.

The normal dose is 500-2500 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, 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 resorted to. 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, 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 changes, polydipsia (excessive thirst), polyuria (excessive urine volume), kidney stones and, in severe cases, cardiac arrhythmias and coma, as well as a taste of calcium, burning and peripheral vasodilation. Mild asymptomatic hypercalcemia will usually resolve by interrupting the administration of calcium 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 and metabolic alkalosis. Symptoms may include changes in character, fatigue, respiratory failure, muscle weakness and irregular heartbeats. There may be an increase in muscle tone, muscle spasms and tetany (neuromuscular hyperexcitability), especially in hypocalcemic patients. The treatment of metabolic alkalosis associated with bicarbonate overdose consists mainly in the proper correction of 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 used. In case of accidental overdose, treatment should be interrupted and the patient should be observed for the appearance of symptoms and signs related to the administered medication. If necessary, appropriate symptomatic and supportive measures should be taken.

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

4. Possible side effects

Like all medicines, KabiPac Ringer Lactate can cause side effects, although not everybody gets them.

The most commonly described side effects are hyperhydration (edema) and electrolyte disturbances (mainly after 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 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).
• 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 makes them swell. This results in increased pressure in the skull and causes hyponatremic encephalopathy.

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

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

If you think any of the side effects are serious or if you notice any side effects not mentioned in this leaflet, tell your doctor or pharmacist.

Reporting of side effects

If you experience any side effects, talk to your doctor or nurse, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of KabiPac Ringer Lactate

No special storage conditions are required.

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

Do not use KabiPac Ringer Lactate after the expiration date stated on the packaging after EXP. The expiration date is the last day of the month indicated.

Do not use this medicine if you notice that the solution is not transparent, free of particles or the packaging is damaged

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

6. Container Content and Additional Information

Composition of KabiPac Ringer Lactate

• The active ingredients are: sodium lactate, sodium chloride, potassium chloride, and calcium chloride dihydrate. 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 calcium chloride dihydrate (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 Container Content

KabiPac Ringer Lactate is an intravenous perfusion solution, transparent, colorless, and without visible particles, contained in polyethylene Kabipacvials.

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

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

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Fresenius Kabi España S.A.U.

Marina 16-18

08005 – Barcelona

Manufacturer

Fresenius Kabi Deutschland GmbH

Else-Kröner-Strasse, 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

Date of the Last Revision of this Prospectus December 2020.

Detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

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This information is intended only for doctors or healthcare professionals:

This medication is administered by perfusion.

The content of each vial is for a single perfusion. Once the container 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. It is recommended to disinfect the rubber stopper before puncturing 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 carried out in 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 5.5-7.0).

When compatible medication is added, 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.

Posology

General Advice:

Hydration balance, serum electrolytes, and acid-base balance may require monitoring 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 co-medicated with vasopressin agonist drugs, due to the risk of acquired hyponatremia in the hospital. Monitoring of serum sodium is particularly important for physiologically hypotonic fluids.

Pediatric Population

The dose and perfusion rate must be determined by a doctor expert in pediatric intravenous fluid therapy.