Label: Information for the User

Apiroserum Ringer's Solution for Infusion

Sodium Chloride, Potassium Chloride, and Dihydrated Calcium Chloride

Read this label carefully before starting to use this medication, as it contains important information for you.

• Keep this label as you may need to refer to it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this label. See section 4.

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

Apiroserum 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.

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

No use Apiroserum Solución Ringer:

• If you are allergic to sodium chloride, potassium chloride, or calcium chloride, or to any of the other components of this medication (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 medication.

• 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, regular clinical status checks and blood and urine analyses (electrolytes in blood and urine, acid-base balance, hematocrit) be performed. Blood potassium checks should be performed if you are at risk of developing hyperkalemia (high potassium levels in blood).

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

• 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 increased blood pressure), aldosteronism (a condition 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 the Ringer 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 the Ringer 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 the Ringer solution should be carried out with caution (see section Use of other medications).

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 injection site due to the risk of developing thrombophlebitis.

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

Use of Apiroserum Solución Ringer with other medications:

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

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

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

You should inform your doctor if you are using any of the following medications, as they may interact with one 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 (medications 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 or plan to become pregnant, consult your doctor before using this medication. The use of Apiroserum Solución Ringer is not considered to pose a risk to pregnancy or breastfeeding.

Driving and operating machinery:

Apiroserum Solución Ringer does not affect your ability to drive or operate machinery.

Apiroserum Ringer solution will be administered under the direct supervision of your doctor, who will closely monitor the administered dose.

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 per 24 hours, and the perfusion rate will normally be 40 ml/kg/24 h.

Blood tests will be performed 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 lower doses, proportional to their weight.

The recommended dosage in neonates and children is 20 to 100 ml per kilogram per 24 hours. In children, the perfusion 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 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 sensation 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 sensation, 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, Apiroserum Ringer Solution may produce 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, infection at the injection site, 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 that any of the adverse effects you are experiencing are 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 on the safety of this medication.

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

Store at a temperature below 25°C.

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 disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

Composition of Apiroserum Ringer Solution

The active principles are sodium chloride, potassium chloride, and anhydrous calcium chloride. 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 components are water for injectable preparations.

Appearance of the product and contents of the packaging

Apiroserum Ringer Solution is a transparent solution that is packaged in glass bottles. It is available in the following packaging sizes:

1 bottle of 250ml

1 bottle of 500ml

1 bottle of 1000ml

12 bottles of 500ml

Not all packaging sizes may be marketed.

Marketing Authorization Holder

Fresenius Kabi España S.A.U.

C/ Marina 16-18

08005-Barcelona (Spain)

Manufacturers Responsible

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 revised in September 2016

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

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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 Apiroserum 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.