Kabipac Ringer solution for infusion

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

KabiPac Ringer 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 as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• If you experience any adverse reactions, consult your doctor, pharmacist or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

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

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

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

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

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

2. What you need to know before using 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 excess fluid in the body (hyperhydration or hypervolemia)
• If you have kidney failure with reduced or absent urine output
• If you have a heart disorder
• 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 do not function properly. In such cases, administration of large volumes of this solution must be performed under strict clinical monitoring.

• It is advisable to have regular clinical check-ups and blood and urine tests (electrolytes in blood and urine, acid-base balance, hematocrit) during administration of this solution. 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 you may require additional tests to determine whether 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 ankles, feet, and legs, preeclampsia (a condition occurring during pregnancy or postpartum characterized by increased blood pressure), aldosteronism (a condition associated with increased secretion of a hormone called aldosterone), or if you have impaired kidney 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 elevated blood potassium levels, such as renal or adrenocortical insufficiency, acute dehydration, or massive tissue destruction, as occurs in severe burns.

• Due to the presence of calcium: If you have impaired kidney 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 contains potassium at a concentration similar to that in plasma, this concentration is insufficient to produce a beneficial effect in such situations.

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

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

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

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

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

Use of KabiPac Ringer's Solution with other medicines

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

Certain medicines may interact with Ringer's solution. In such cases, it may be necessary to adjust the dose or discontinue treatment with one of the medicines.

In general, concomitant administration of Ringer's solution with any medicine that has or may have renal toxicity should be avoided, as it may lead to fluid and electrolyte retention.

It is important that you inform your doctor if you are taking any of the following medicines, as they may interact with 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, 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 become pregnant, consult your doctor 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 operate machinery.

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 dose given.

This medicine is given by slow injection into a vein (intravenous infusion). The rate and amount administered will depend on your individual needs and the condition being treated.

Your doctor will decide the appropriate dose you should receive.

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

Blood tests will be performed to monitor your electrolyte and fluid levels.

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

Use in children

Children will receive lower doses, proportional to their body weight.

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

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

In case of overdose or administration that is too rapid, the following symptoms may occur:

• Fluid overload (edema, hypervolemia) and disturbances in electrolyte balance. In such cases, administration will be reduced or stopped, and symptomatic treatment will be initiated. If renal function is impaired, dialysis may be necessary.

• Water and sodium overload with risk of edema, particularly when renal sodium excretion is impaired.

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 the hands and feet, muscle weakness, paralysis, cardiac arrhythmias, heart block, cardiac arrest, and mental confusion.

Excessive administration of calcium salts may lead to hypercalcemia. Symptoms of hypercalcemia may include loss of appetite, nausea, vomiting, constipation, abdominal pain, muscle weakness, mental disturbances, polydipsia (excessive thirst), polyuria (excessive urine volume), kidney stones, and, in severe cases, cardiac arrhythmias and coma, as well as a sensation of calcium taste, burning, and peripheral vasodilation. Mild asymptomatic hypercalcemia usually resolves by discontinuing calcium administration and stopping other contributing medications such as vitamin D. If hypercalcemia is severe, urgent treatment is required (such as diuretic cycles, hemodialysis, calcitonin, bisphosphonates, trisodium edetate).

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

4. Possible adverse effects

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

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

The possible adverse effects are:

• Electrolyte disturbances
• Venous thrombosis (clots) and phlebitis (vein inflammation), associated with intravenous administration
• Fluid overload (oedema)
• Fever, infection at 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, the adverse effects may be related to the added medicines.

If any adverse effects occur, the infusion should be discontinued.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effect not listed in this leaflet, inform your doctor or pharmacist.

Reporting of 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 leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse 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 stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Use this medicine only if the solution is clear, free from particles, and the container is undamaged. Any remaining solution after treatment must be discarded.

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

6. Contents of the container and other information

Composition of KabiPac Ringer's Solution

The active substances 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 injections.

Appearance of the product and contents of the container

KabiPac Ringer's Solution is a clear solution packed in KabiPac polyethylene bottles. It is available in container sizes of 250 ml, 500 ml and 1000 ml.

Clinical pack presentations are also available in the following configurations:

20 bottles of 250 ml
10 bottles of 500 ml
20 bottles of 500 ml
10 bottles of 1000 ml

Not all container 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 reviewed in May 2016

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This information is intended for healthcare professionals only:

This medicine will always be administered by specialized personnel. It is administered by intravenous infusion via a central vein.

The solution must be clear and free from precipitates. Do not administer if this is not the case.

The contents of each KabiPac Ringer's Solution container are intended for single use only. Any unused portion must be discarded.

Use an aseptic technique when administering the solution and when preparing mixtures.

Before adding medications to the solution or administering it simultaneously with other medicinal products, compatibility must be verified to ensure that no incompatibilities exist.