Prospecto: Information for the user

Potasio Kabi 0.04 mEq/ml in Sodium Chloride 0.9% solution for infusion EFG

Potassium chloride and sodium chloride

Read this prospect carefully before starting to use this medicine because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or nurse.
• If you experience adverse effects,consult your doctor or nurse, eveniftheydo not appear in this prospect. See section 4.

1.What is Potasio Kabi 0.04 mEq/ml in Sodium Chloride 0.9% and for what it is used

2.What you need to know before Potasio Kabi 0.04 mEq/ml in Sodium Chloride 0.9% is administered to you

3.How you will be administered Potasio Kabi 0.04 mEq/ml in Sodium Chloride 0.9%

4.Possible adverse effects

5.Storage of Potasio Kabi 0.04 mEq/ml in Sodium Chloride 0.9%

6.Contents of the package and additional information

Potasio Kabi 0.04 mEq/ml in Sodium Chloride 0.9% is a solution of potassium chloride and sodium chloride in water. Potassium chloride and sodium chloride are chemical substances (commonly called salts) that are found in the blood.

This medication is used to treat and prevent:

• potassium loss from the body (for example, after treatment with certain diuretics)
• low levels of potassium in the blood (hypokalemia), in situations that may cause loss of water and potassium chloride including:
• when unable to eat or drink, due to an illness or after a surgical intervention
• excessive sweating caused by high fever

conditions of sodium chloride and water loss

You should not be administered Potasio Kabi 0.04 mEq/ml in Sodium Chloride 0.9%if you have any of the following clinical situations:

• if your blood contains high levels of potassium above normal (hyperkalemia)
• if your blood contains high levels of chloride above normal (hyperchloremia)
• if your blood contains high levels of sodium above normal (hypernatremia)
• if your kidneys do not function well (producing little urine or no urine)
• if you have untreated heart failure (uncompensated heart failure) that causes symptoms such as:
• difficulty breathing
• swelling of the ankles
• if you have a disease in which the adrenal glands do not function correctly (Addison's disease).

Warnings and precautions

This medication has a higher concentration than blood (hypertonic solution). Your doctor will take this into account when calculating the amount of solution to be administered.

Consult your doctor or nurse before being administered Potasio Kabi 0.04 mEq/ml in Sodium Chloride 0.9% if:

• you have any type of heart disease or heart failure
• you have kidney insufficiency

• you have a disease of the adrenal glands that affects the amount of steroid hormones in the body (adrenocortical insufficiency)
• you are severely dehydrated (a loss of water from the body, for example, vomiting or diarrhea)
• you have severely damaged a large area of skin, such as in burns
• you have high blood pressure
• you have swelling under the skin, particularly around the ankles (peripheral edema) or in the lungs (pulmonary edema)
• you have high blood pressure during pregnancy (preeclampsia)
• you have any other condition in which the body retains too much sodium (sodium retention)

When you are being administered this medication, your doctor will take blood and urine samples to monitor your condition, especially if you have heart or kidney problems.

Use of Potasio Kabi 0.04 mEq/ml in Sodium Chloride 0.9% with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication. It is particularly important to inform your doctor if you are taking:

• cardiac glycosides used in the treatment of heart failure (such as digoxin)
• antiarrhythmic medications used to suppress abnormal heart rhythm (such as quinidine, hydroquinidine, procainamide)
• medications that increase the concentration of potassium in the blood, such as:

• potassium-sparing diuretics, known as tablets that help eliminate water (such as amiloride, spironolactone, triamterene)
• angiotensin-converting enzyme inhibitors (ACE inhibitors) (mainly used to treat high blood pressure)
• angiotensin II receptor antagonists (used to treat high blood pressure)
• ciclosporins (used to prevent transplant rejection)
• tacrolimus (used to prevent transplant rejection and to treat some skin conditions)
• medications containing potassium

• corticosteroids (anti-inflammatory medications)

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor before using this medication.

This medication can be administered during pregnancy and breastfeeding. The amount of medication to be administered will be carefully controlled by your doctor. Your doctor will take blood samples to monitor the levels of chemical substances in your blood. This is because changes in potassium levels in the blood can affect the way both your heart and your unborn baby work.

Your doctor will carefully monitor your blood pressure as sodium chloride can increase it (risk of preeclampsia).

Driving and operating machinery

This medication does not affect your ability to drive or operate machinery.

This medication will be administered by a doctor or a nurse.

Your doctor will decide how much you need and when it will be administered, depending on your age, weight, clinical and biological condition, and hydration status (amount of water in your body). The amount you receive may also be influenced by other treatments you are receiving.

Potassium Kabi 0.04 mEq/mL in Sodium Chloride 0.9% is administered slowly through a vein as an infusion. The infusion rate will be determined by your doctor. If you require a large volume or a rapid infusion of the medication, your doctor will monitor your ECG (heart graph).

When you are administered Potassium Kabi 0.04 mEq/mL in Sodium Chloride 0.9%, your doctor may perform blood tests to monitor your blood levels of potassium and other electrolytes (such as sodium or chloride) that are normally present in the blood. Your doctor will also monitor if you are urinating normally (adequate urine production).

If you receive more Potassium Kabi 0.04 mEq/mL in Sodium Chloride 0.9% than you should

If you are given too much of the medication, you may experience: tingling or burning sensation in your arms and legs (paresthesia), muscle weakness, inability to move (paralysis), irregular heartbeat (arrhythmia), heart block (very slow heartbeats), cardiac arrest (heart stops beating), mental confusion, accumulation of fluid in the lungs making it difficult to breathe (pulmonary edema), accumulation of fluid under the skin, particularly around the ankles (peripheral edema), blood acidification (acidosis) leading to fatigue, confusion, lethargy, and increased respiratory rate.

If you observe any of these symptoms, you should inform your doctor immediately. You will be stopped from receiving the medication and receive treatment depending on the symptoms.

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

Like all medications, this medication may produce adverse effects, although not all people may experience them..

The following adverse reactions have been reported during post-marketing use of the medication. The frequency of the event cannot be estimated from the available data.Adverse effects may be associated with the administration technique..

Inform your doctor or nurse if you observe any of the following adverse effects:

• Infection at the injection site
• Abnormal increase in blood volume (hypervolemia)
• Administration of the solution into the tissues surrounding the vein (extravasation), which may damage the tissues and cause scarring
• Pain or irritation at the injection site
• Inflammation of the vein into which the solution has been perfused (phlebitis). This may cause redness, swelling, and pain or burning along the vein into which the solution has been administered
• Formation of a clot at the injection site that causes pain, swelling, or redness in the area of the clot
• Fever

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or nurse, even if it is a possible adverse effect that does not appear in this prospectus. You may 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.

This medication does not require special storage conditions.

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

Do not use this medication if the solution is not transparent or has visible particles. Do not use this medication if the packaging is damaged in any way.

From a microbiological point of view, the product should be used immediately. If not used immediately, the time and storage conditions during use are the responsibility of the user.

Medications should not be disposed of through drains or trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. In this way, you will help protect the environment.

Potassium Kabi 0.04 mEq/ml in Sodium Chloride 0.9%

• The active ingredients are potassium chloride and sodium chloride.Each ml contains 3.00 mg of potassium chloride and 9.00 mg of sodium chloride.

Each 500 ml bottle contains 1.50 g of potassium chloride and 4.5 g of sodium chloride.

Each 1000 ml bottle contains 3.00 g of potassium chloride and 9.00 g of sodium chloride.

• The other components are water for injection, sodium hydroxide, and hydrochloric acid for pH adjustment.

Appearance of the product and contents of the container

Potassium Kabi 0.04 mEq/ml in Sodium Chloride 0.9%is a transparent and colorless solution, without visible particles..It is available in 500 ml and 1000 ml polyethylene bottles, closed with a polyolefin cap containing a polyisoprene rubber stopper. It is supplied in packs of 10 bottles.

Only some pack sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Fresenius Kabi España, S.A.U.

C/ Marina 16-18,

08005-Barcelona

Spain

Responsible for manufacturing

Fresenius Kabi Deutschland GmbH

Else-Kröner-Straße 1,

61352 Bad Homburg v.d.H.

Germany

or

Labesfal –Laborarios Almiro S.A.

Zona Industrial do Lagedo,

Santiago de Besteiros, 3465 – 157

Portugal

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Last review date of thissummary of product characteristics: April2015

The detailed and updated information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.

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This information is intended solely for healthcare professionals:

Handling and preparation

This medicinal product is for single use only.Dispose of any unused content.

Use only if the solution is transparent, without visible particles, and if the container is not damaged.

Route of administration

The administration is carried out by intravenous infusion using a sterile and apyrogenic equipment.

Potassium administered intravenously should be administered through a large peripheral vein or central vein to reduce the risk of sclerosis. If administered through a central vein, ensure that the catheter is not in the atrium or ventricle to avoid localized hyperkalemia.

Solutions containing potassium should be administered slowly.

Administration rate

Potassium should not be administered intravenously at a rate greater than 15 to 20 mmoles per hour to avoid a potentially life-threatening hyperkalemia.

Under no circumstances should the dose indicated in the "Posology" section be exceeded.

Posology

The recommended dosage for the treatment of isotonic dehydration (extracellular dehydration) by any intravenous solution is:

• for adults: 500 ml to 3 liters per 24 hours
• for infants and children: 20 to 100 ml per 24 hours and per kilogram of body weight, depending on age and total body mass.

Posology

• Adults, elderly and adolescents:

The typical potassium doses for the prevention of hypokalemia can be up to 50 mmoles per day and similar doses may be suitable for mild potassium deficiencies. When used for the treatment of hypokalemia, the recommended dose is 20 mmoles of potassium in 2 or 3 hours (i.e. 7-10 mmol/h) under electrocardiographic (ECG) control.

• Pediatric population

When used for the treatment of hypokalemia, the recommended dose is 0.3 – 0.5 mmoles/kg of body weight/hour. The dose should be adjusted according to laboratory values obtained regularly.

The maximum recommended dose of potassium is 2 to 3 mmoles/kg of body weight/day.

• Patients with renal insufficiency

Patients with renal insufficiency should receive lower doses.

Potassium Kabi 0.04 mEq/ml in Sodium Chloride 0.9%is a hypertonic solution, with an osmolarity of approximately 388 mOsm/l.

The administration should be carried out under continuous and careful supervision. It is essential to monitor the patient's clinical status, plasma electrolyte concentrations, plasma creatinine levels, BUN levels, acid-base balance, and ECG in patients receiving potassium therapy, particularly those with renal or cardiac dysfunction.

It is essential to maintain an adequate urine flow and monitor fluid balance.

Potassium salts should be administered with caution to patients with cardiac disease or conditions predisposing to hyperkalemia, such as renal insufficiency or adrenal insufficiency, acute dehydration, or massive tissue destruction, as occurs in severe burns. Continuous monitoring of plasma potassium levels is mandatory in patients treated with digitals.

Sodium salts should be administered with caution to patients with hypertension, heart failure, peripheral or pulmonary edema, renal dysfunction, preeclampsia, or other conditions associated with sodium retention.

Validity period during use (Additives)

Before use, the physical and chemical stability of any added medication should be established at the pH of the potassium chloride 0.04 mEq/ml in sodium chloride 0.9%solution.

In the absence of compatibility studies, this medicinal product should not be mixed with other medicinal products.

It is the responsibility of the physician to evaluate the incompatibility of any added medication with the potassium chloride 0.04 mEq/ml in sodium chloride 0.9%solution, checking for possible color change and/or formation of a precipitate, insoluble complexes, or appearance of crystals. The technical data sheet of the added medication should also be consulted.

The incompatibility of added medications withPotassium Kabi 0.04 mEq/ml in Sodium Chloride 0.9%should be checked before its addition.

The instructions for use of the medication to be added should be consulted. Before adding a medication, verify if it is soluble and/or stable in water at the pH of the potassium chloride 0.04 mEq/ml in sodium chloride 0.9%solution (pH: 4.5 to 7.0).

Do not use additives known to be incompatible.

From a microbiological point of view, the product should be used immediately. If not used immediately, the time and conditions of storage during use are the responsibility of the user.