APIROSERUM RINGER'S SOLUTION FOR INFUSION

Introduction

Package Leaflet: Information for the User

Apiroserum Ringer Solution for Infusion

Sodium Chloride, Potassium Chloride, and Calcium Chloride Dihydrate

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 pack:

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

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

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

Apiroserum Ringer 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.

Apiroserum Ringer Solution is a clear solution that is packaged in single-use glass vials. It is available in pack sizes of 250 ml, 500 ml, and 1000 ml.

2. What you need to know before you use Apiroserum Ringer Solution

Do not use Apiroserum Ringer 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 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 performed 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 you may need to undergo additional tests to determine if you can receive the medicine:

• Due to the presence of sodium: If you have high blood pressure, heart failure, fluid accumulation 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 kidney function or other conditions associated with sodium retention.

• Due to the presence of potassium: If you have heart disease or other problems that can cause an increase in potassium levels in your blood, such as kidney or adrenal 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 high levels of vitamin D, such as sarcoidosis.

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

• The Ringer 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 the Ringer solution should be performed with caution (see section "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.

Use of Apiroserum Ringer 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 the Ringer solution. 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 solution with any medicine that has or may have renal toxicity should be avoided, as it can 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 any of the electrolytes present in the Ringer 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 have a baby, ask your doctor for advice before using this medicine. The use of Apiroserum Ringer Solution is not considered to pose a risk during pregnancy or breastfeeding.

Driving and using machines

Apiroserum Ringer Solution does not affect your ability to drive or use machines.

3. How to use Apiroserum Ringer Solution

Apiroserum Ringer 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 dosage 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 Apiroserum Ringer Solution than you should

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

• Hyperhydration (edema, hypervolemia) and electrolyte imbalance. In these cases, administration will be decreased or suspended, and symptomatic treatment will be used. If kidney 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 kidney 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 production), 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 discontinuing calcium administration and other contributing medicines, 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, Apiroserum Ringer 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 solution), as well as allergic reactions.

The 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 the Ringer 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 any of the side effects are serious or if you notice any side effects not listed 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 possible side effects not listed in this leaflet. You can also report side effects 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 Apiroserum Ringer Solution

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

Store at a temperature below 25°C.

Do not use this medicine after the expiry date which is stated on the pack after EXP. The expiry date is the last day of the month stated.

Use this medicine only if the solution is clear, free of particles, and the pack 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 medicines no longer required. This will help protect the environment.

6. Contents of the pack and further information

Composition of Apiroserum Ringer Solution

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

The other ingredients are water for injectable preparations.

Appearance and pack size

Apiroserum Ringer Solution is a clear solution that is packaged in glass vials. It is available in the following pack sizes:

1 vial of 250 ml

1 vial of 500 ml

1 vial of 1000 ml

12 vials of 500 ml

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Fresenius Kabi España S.A.U.

C/ Marina 16-18

08005-Barcelona (Spain)

Manufacturers

Fresenius Kabi España, S.A.

C/ Marina, 16-18

08005 Barcelona (Spain)

Fresenius Kabi Italia S.R.L.

Via Camagre, 41/43

37063 Isola della Scala (VR) (Italy)

This leaflet was last revised in September 2016

Detailed and up-to-date information on this medicine 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 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 Apiroserum Ringer Solution are for single infusion only. 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.