KABIPAC RINGER'S SOLUTION FOR INFUSION

Introduction

Package Leaflet: Information for the User

KabiPacRinger's Solution for Infusion

Sodium Chloride, Potassium Chloride, and Calcium Chloride

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.
• 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 Package Leaflet

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

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

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

KabiPac Ringer's Solution is administered by intravenous infusion (into a vein) and is indicated

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

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

KabiPac Ringer's Solution is a clear solution that is packaged in single-use KabiPacpolyethylene bottles. It is available in pack sizes of 250 ml, 500 ml, and 1000 ml.

2. What you need to know before you use KabiPac Ringer's Solution

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 components 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 heart failure.
• If you have liver disease (ascitic cirrhosis)
• If you have high levels of potassium, sodium, calcium, or chlorides in your blood
• If you are taking cardiac glycosides (digitalis)

Warnings and precautions

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

• If your kidneys, 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, you undergo regular checks of your clinical condition and blood and urine tests (electrolytes in blood and urine, acid-base balance, hematocrit). You should undergo potassium level checks in your blood if you are at risk of hyperkalemia (high potassium levels in your 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, fluid accumulation (edema) in the lungs or in the ankles, feet, and legs, preeclampsia (a disease that occurs during pregnancy or postpartum that is characterized by high blood pressure), aldosteronism (a disease associated with increased secretion of a hormone called aldosterone), or if you have impaired 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 an increase in potassium levels in your blood, such as renal 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 accumulation or diseases associated with elevated vitamin D levels, 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.

• This 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, the administration of Ringer's solution should be carried out with caution (see section on use with other medicines).

Special attention should be paid to elderly patients, as they may have impaired kidney, liver, or heart function.

Continuous administration at the same injection site should be avoided due to the risk of thrombophlebitis.

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

Using KabiPac Ringer's Solution with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

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

In general, it is recommended to avoid the simultaneous administration of Ringer's solution with any medicine that may have renal toxicity, as it may cause fluid and electrolyte retention.

It is essential that you inform your doctor if you use any of the following medicines, as they may interact with some 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)
• Digitalis cardiac glycosides (digoxin, methyldigoxin)
• -Thiazide diuretics (hydrochlorothiazide, altizide, mebutizide, bendroflumethiazide) or vitamin D.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine. The use of KabiPac Ringer's Solution is not considered to pose a risk during pregnancy or breastfeeding.

Driving and using machines

KabiPac Ringer's Solution does not affect the ability to drive or use machines.

3. How to use KabiPac Ringer's Solution

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

This medicine 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.

Your doctor will decide what dose is suitable for you to receive.

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

You will undergo blood tests to monitor electrolyte and fluid levels.

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

Use in children

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

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

If you use more KabiPac Ringer's Solution than you should

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

• Hyperhydration (edema, hypervolemia) and electrolyte imbalances. In these cases, administration will be reduced or discontinued, and symptomatic treatment will be initiated. If renal function is compromised, dialysis may be necessary.

• Fluid 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, 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 production), 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 discontinuing 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, disodium edetate).

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

4. Possible side effects

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

The very common side effects described are hyperhydration (edema) and electrolyte disturbances (mainly after administration of a large volume of Ringer's solution), as well as allergic reactions.

Possible side effects are:

• Electrolyte disturbances
• Venous thrombosis (clots) and phlebitis (inflammation of the vein), associated with intravenous administration.
• Hyperhydration (edema)
• Fever, infection at the injection site, local reaction, or local pain (associated with intravenous administration).
• Extravasation

When Ringer's solution is used as a vehicle to administer other medicines, side effects may be associated with the added medicines.

In case of side effects, the infusion should be discontinued.

If you think you have any side effects that are serious or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

Reporting side effects:

If you experience any side effects, talk to your doctor or nurse, even if they are 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's Solution

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

KabiPac Ringer's Solution does not require special storage conditions.

Do not use this medicine after the expiry date that appears on the packaging after EXP. The expiry date is the last day of the month indicated.

Use this medicine only if the solution is clear, free of particles, and the packaging is not damaged. Any unused solution should be discarded after treatment.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Contents of the pack and further information

Composition of KabiPac Ringer's Solution

The active ingredients 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 pack contents

KabiPac Ringer's Solution is a clear solution that is packaged in single-use KabiPacpolyethylene bottles. It is available in pack sizes of 250 ml, 500 ml, and 1000 ml.

Clinical packs are also available in the following presentations:

20 bottles of 250 ml

10 bottles of 500 ml

20 bottles of 500 ml

10 bottles of 1000 ml

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Fresenius Kabi España S.A.U.

Torre Mapfre – Vila Olímpica

C/ Marina 16-18

08005-Barcelona (Spain)

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 last revised in May 2016

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This information is intended only for healthcare professionals:

This medicine will always be administered by specialized personnel. It will be administered by infusion through a central vein.

The solution must be clear and free of precipitates. Do not administer otherwise.

The contents of each pack of KabiPac Ringer's Solution are for a single infusion. The unused fraction should be discarded.

Use an aseptic method to administer the solution and when preparing mixtures.

Before adding medicines to the solution or administering them simultaneously with other medicines, check for incompatibilities.