Leaflet: information for the user

KabiPacRinger Solution for infusion

Sodium chloride, Potassium chloride and Calcium chloride

Read this leaflet carefully before you start using this 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.
• If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

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

2. What you need to know before you start using KabiPac Ringer Solution

3. How to use KabiPac Ringer Solution

4. Possible side effects

5. Storage of KabiPac Ringer Solution

6. Contents of the pack and additional information

KabiPac Ringer Solution is a transparent solution of sodium chloride, potassium chloride, and calcium chloride in water for injectable preparations.

KabiPac Ringer Solution is administered via intravenous infusion (into the vein) and is indicated

-as a replacement in cases of dehydration caused by loss of water and liquids.

-to establish the electrolyte balance caused by the loss of ions (sodium, potassium, calcium, and chlorides) for the treatment of isotonic dehydration.

KabiPac Ringer Solution is a transparent solution that is packaged in polyethylene KabiPac bottles for single use. It is available in the packaging sizes of 250 ml, 500 ml, and 1000 ml.

Do not use KabiPac Ringer's Solution:

• If you are allergic to sodium chloride, potassium chloride, or calcium chloride or to any of the other ingredients of this medicine (listed in section 6).
• If you have severe high blood pressure.
• If you have excessive fluid accumulation (edema).
• If you have been diagnosed with excessive fluid in the body (hyperhydration or hypervolemia).
• If you have kidney failure with decreased or absent urine production.
• If you have a heart condition.
• If you have liver disease (ascitic cirrhosis).
• If you have high levels of potassium, sodium, calcium, or chloride in your blood.
• If you are taking cardiac glycosides (digitals).

Warnings and precautions:

Consult your doctor or nurse before starting to take this medicine.

• If your kidneys, heart, and/or lungs do not function 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, your clinical status and blood and urine tests (electrolytes in blood and urine, acid-base balance, hematocrit) should be regularly monitored. Blood potassium levels should be monitored if you are at risk of hyperkalemia (high potassium levels in blood).

If you have any of the following conditions, 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, fluid accumulation (edema) in the lungs or in the ankles, feet, and legs, 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 potassium levels 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.

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

• You should be administered Ringer's solution with caution if you are at risk of cerebral edema or intracranial hypertension.

• If you are being treated with corticosteroids, adrenocorticotropic hormone, the administration of Ringer's solution should be carried out with caution (see section Use of other medicines).

You should pay special attention to patients of advanced age, as they may have impaired kidney, liver, or heart function.

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

Your doctor or healthcare professional should check before use that the solution is transparent and free of particles.

Use of KabiPac Ringer's Solution with other medicines:

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

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

In general, the administration of Ringer's Solution with any medicine 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 medicines, as they may interact with one of the electrolytes present in Ringer's 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).
• Cardiac glycosides (digoxin, metildigoxin).
• -Thiazide diuretics (hydrochlorothiazide, altizide, mebutizide, bendroflumethiazide) or vitamin D.

Pregnancy, lactation, and fertility:

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor before using this medicine. The use of KabiPac Ringer's Solution is not considered to pose a risk to pregnancy or breastfeeding.

Driving and operating machinery:

KabiPac Ringer's Solution does not affect the ability to drive or operate machinery.

KabiPacRinger Solution will be administered under the direct supervision of your doctor, who will closely monitor the dose administered.

This medication is administered through a slow injection into a vein (intravenous perfusion). The speed and amount administered will depend on your needs and the condition being treated.

Your doctor will decide what is the appropriate dose you should receive.

The recommended dose in adults, elderly, and adolescents is 500 ml to 3 liters every 24 hours, and the perfusion rate will normally be 40 ml/kg/24 h.

You will have blood tests to control the levels of electrolytes and fluid.

Consult your doctor or pharmacist if you have any further doubts about the use of this product.

Use in children

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

The recommended dosage in neonates and children is 20 to 100 ml per kilogram every 24 hours. In children, the perfusion rate is 5 ml/kg/h on average.

If you use more KabiPac Ringer Solution than you should

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

• hyperhydration (edema, hypervolemia) and disorders in the electrolyte balance. In these cases, the 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 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 sensations 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, and peripheral vasodilation. Mild asymptomatic hypercalcemia will usually resolve by interrupting 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).

If you have any other doubts about the use of this medication, ask your doctor or nurse

Like all medications, KabiPac Solution Ringer may cause adverse effects, although not everyone will experience them.

The very frequent adverse effects described are hyperhydration (edema) and electrolyte imbalances (mainly after administration of a significant volume of Ringer's solution), as well as allergic reactions.

The possible adverse effects are:

• Electrolyte imbalances
• Thrombophlebitis (clots) and phlebitis (vein inflammation), associated with intravenous administration.
• Hyperhydration (edema)
• Fever, injection site infection, local reaction, or local pain (associated with intravenous administration).
• Extravasation

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

In case of adverse effects appearing, 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.

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 the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

KabiPac Ringer's Solutiondoes not require special conditions for conservation.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Use this medication only if the solution is transparent, free of particles, and the packaging is not damaged. Any remaining solution must be discarded after treatment.

Medications should not be thrown into the drains or trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. This will help protect the environment.

Composition of KabiPac Ringer Solution

The active principles are sodium chloride, potassium chloride, and calcium chloride. Each 100 ml of solution contains 860 mg of sodium chloride, 30 mg of potassium chloride, and 33 mg of calcium chloride.

The excipient is water for injectable preparations.

Appearance of the product and contents of the packaging

KabiPac Ringer Solution is a transparent solution that is packaged in polyethylene flasksKabiPacIt is available in packaging sizes of 250 ml, 500 ml, and 1000 ml.

Additionally, the clinical packaging is available in the following presentations:

20 flasks with 250 ml

10 flasks with 500 ml

20 flasks with 500 ml

10 flasks with 1000 ml

Not all packaging sizes may be marketed.

Holder of the marketing authorization and responsible manufacturer

Holder:

Fresenius Kabi España S.A.U.

Torre Mapfre – Vila Olímpica

C/ Marina 16-18

08005-Barcelona (Spain)

Responsible manufacturer:

LABESFAL – Laboratórios Almiro, S.A.

Zona industrial do Lagedo

P-3465-157 Santiago de Besteiros Portugal

or

Fresenius Kabi España S.A.U.

C/ Dr. Ferran 12

08339 Vilassar de Dalt - Spain

This leaflet was revised in May 2016

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

This medication will be administered only by specialized personnel. It will be administered by infusion through a central vein.

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

The contents of each package of KabiPac Ringer Solution are for a single infusion. Discard any unused portion.

Use an aseptic method to administer the solution and in the event of preparation of mixtures.

Before adding medications to the solution or administering simultaneously with other medications, check for any incompatibilities.