Potassium Kabiven 0.04 mEq/mL in sodium chloride 0.9% solution for infusion EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

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

potassium chloride and sodium chloride

Read all of this leaflet carefully before you start using this medicine, as 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 or nurse.
• If you experience any side effects, talk to your doctor or nurse, even if they are not listed in this leaflet. See section 4.

Leaflet contents:

1. What Potassium Kabi 0.04 mEq/ml in Sodium Chloride 0.9% is and what it is used for
2. What you need to know before you are given Potassium Kabi 0.04 mEq/ml in Sodium Chloride 0.9%
3. How you will be given Potassium Kabi 0.04 mEq/ml in Sodium Chloride 0.9%
4. Possible side effects
5. How to store Potassium Kabi 0.04 mEq/ml in Sodium Chloride 0.9%
6. Contents of the pack and other information

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

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

This medicine is used to treat and prevent:

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

conditions involving loss of sodium chloride and water

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

You should not be given Potassium Kabi 0.04 mEq/ml in Sodium Chloride 0.9% if you have any of the following clinical conditions:

• high levels of potassium in your blood above normal (hyperkalemia)
• high levels of chloride in your blood above normal (hyperchloremia)
• high levels of sodium in your blood above normal (hypernatremia)
• poor kidney function (producing little or no urine)
• uncompensated heart failure that is not adequately treated, causing symptoms such as:
  • difficulty breathing
  • swelling of the ankles
• a disease in which the adrenal glands do not function properly (Addison's disease).

Warnings and precautions

This medicine is more concentrated than blood (a hypertonic solution). Your doctor will take this into account when calculating the amount of solution to administer to you.

Consult your doctor or nurse before receiving Potassium Kabi 0.04 mEq/ml in Sodium Chloride 0.9% if:

• you have any type of heart disease or heart failure
• you have kidney failure
• you have an adrenal gland disorder affecting the amount of steroid hormones in the body (adrenocortical insufficiency)
• you are severely dehydrated (loss of body water, for example due to vomiting or diarrhea)
• you have severe extensive skin damage, 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)

While you are receiving this medicine, your doctor will take blood and urine samples to monitor your condition, especially if you have heart or kidney problems.

Use of Potassium Kabi 0.04 mEq/ml in Sodium Chloride 0.9% with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. It is particularly important that you inform your doctor if you are taking:

• cardiac glycosides used to treat heart failure (such as digoxin)

• antiarrhythmic medicines used to suppress abnormal heart rhythms (such as quinidine, hydroquinidine, procainamide)

• medicines that increase potassium levels in the blood, such as:

  • potassium-sparing diuretics, known as water tablets (such as amiloride, spironolactone, triamterene)
  • angiotensin-converting enzyme (ACE) inhibitors (mainly used to treat high blood pressure)
  • angiotensin II receptor antagonists (used to treat high blood pressure)
  • cyclosporine (used to prevent transplant rejection)
  • tacrolimus (used to prevent transplant rejection and to treat certain skin disorders)
  • medicines containing potassium

• corticosteroids (anti-inflammatory medicines)

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine.

This medicine may be administered during pregnancy and breastfeeding. The amount given to you will be carefully monitored by your doctor. Your doctor will perform blood tests to monitor the levels of chemicals in your blood. This is because changes in blood potassium levels may affect how both your heart and your unborn baby's heart function.

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

Driving and using machines

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

3. How Potassium Kabi 0.04 mEq/mL in 0.9% Sodium Chloride will be administered to you

This medicine will be administered to you by a doctor or a nurse.

Your doctor will decide how much you need and when it will be given, depending on your age, weight, clinical and biological condition, and your 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 0.9% Sodium Chloride is administered slowly into 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 medicine, your doctor will monitor your ECG (heart tracing).

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

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

If too much of the medicine is administered, you may experience: tingling or burning sensation in the 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, fluid accumulation in the lungs making breathing difficult (pulmonary edema), fluid accumulation under the skin, particularly around the ankles (peripheral edema), acidification of the blood (acidosis) leading to fatigue, confusion, lethargy, and increased breathing rate.

If you notice any of these symptoms, you must inform your doctor immediately. Administration of the medicine should be stopped and you will receive treatment depending on your symptoms.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

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

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

• infection at the injection site
• abnormal increase in blood volume (hypervolemia)
• administration of the solution into the surrounding tissues instead of the vein (extravasation), which may damage tissues and lead to scarring
• pain or irritation at the injection site
• inflammation of the vein where the solution was infused (phlebitis). This may cause redness, swelling, and pain or burning along the vein where the solution was administered
• formation of a blood clot at the injection site causing pain, swelling, or redness in the area of the clot
• fever

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 via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

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

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

This medicine requires no special storage conditions.

Do not use this medicine after the expiry date stated on the container. The expiry date is the last day of the month indicated.

Do not use this medicine if the solution is not clear or if it contains visible particles. Do not use this medicine if the container is damaged in any way.

From a microbiological standpoint, the product should be used immediately. If immediate use is not possible, the duration and conditions of storage during use are the responsibility of the user.

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

6. Pack contents and other information

Composition of Potassium Kabi 0.04 mEq/ml in 0.9% Sodium Chloride

• The active substances 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 vial contains 1.50 g of potassium chloride and 4.5 g of sodium chloride.

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

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

Appearance of the product and pack contents

Potassium Kabi 0.04 mEq/ml in 0.9% Sodium Chloride is a clear, colourless solution free from 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 certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Fresenius Kabi España, S.A.U.

C/ Marina 16-18,

08005-Barcelona

Spain

Manufacturer

Fresenius Kabi Deutschland GmbH

Else-Kröner-Straße 1,

61352 Bad Homburg v.d.H.

Germany

or

Labesfal – Laboratórios 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:

Date of the most recent review of this summary: April 2015

Up-to-date detailed information on this medicine is available on the website of the Spanish Agency for Medicinal Products and Medical Devices (AEMPS) http://www.aemps.gob.es/.

This information is intended exclusively for healthcare professionals:

Handling and Preparation

This medicine is for single use only. Discard any unused contents.

Use only if the solution is clear, free from visible particles, and if the container is undamaged.

Route of administration

Administration is performed by intravenous infusion using a sterile, pyrogen-free set.

Intravenous potassium must be administered through a large peripheral vein or central vein to reduce the risk of phlebitis. If infused via a central vein, ensure that the catheter tip is not located in the atrium or ventricle to avoid localized hyperkalemia.

Solutions containing potassium must be administered slowly.

Rate of administration

Potassium must not be administered intravenously at a rate exceeding 15 to 20 mmol per hour to avoid dangerous hyperkalemia.

In any case, the dose indicated in the section “General Dosage” must not be exceeded.

General Dosage

The recommended dosage for treatment of isotonic fluid depletion (extracellular dehydration) using any intravenous solution is:

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

Dosage

• Adults, elderly patients and adolescents:

Typical potassium doses for prevention of hypokalemia may be up to 50 mmol daily, and similar doses may be appropriate in mild potassium deficiency. When used for treatment of hypokalemia, the recommended dose is 20 mmol of potassium over 2 to 3 hours (i.e. 7–10 mmol/h) under continuous electrocardiographic (ECG) monitoring.

• Paediatric population

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

The maximum recommended daily potassium dose is 2 to 3 mmol/kg body weight/day.

• Patients with renal impairment

Patients with renal impairment should receive reduced doses.

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

Administration must be carried out under continuous and careful supervision. Continuous monitoring of clinical status, plasma electrolyte concentrations, plasma creatinine, BUN levels, acid-base balance, and ECG is essential in patients receiving potassium therapy, particularly those with renal or cardiac dysfunction.

Maintaining adequate urine flow and monitoring fluid balance is essential.

Potassium salts must be administered with caution in patients with cardiac disease or conditions predisposing to hyperkalemia, such as renal or adrenocortical insufficiency, acute dehydration, or massive tissue destruction, as occurs in extensive burns. Constant monitoring of plasma potassium levels is mandatory in patients receiving digitalis therapy.

Sodium salts must be administered with caution in patients with hypertension, cardiac failure, peripheral or pulmonary edema, renal dysfunction, preeclampsia, or other conditions associated with sodium retention.

In-use shelf life (Additives)

Prior to use, the physical and chemical stability of any added medicinal product must be established at the pH of the 0.04 mEq/ml potassium chloride solution in 0.9% sodium chloride.

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

It is the physician's responsibility to assess incompatibility of any added medication with the 0.04 mEq/ml potassium chloride solution in 0.9% sodium chloride, checking for possible colour change and/or formation of precipitate, insoluble complexes, or crystals. The summary of product characteristics of the added medicinal product should also be consulted.

Incompatibility of medicinal products added to Potassium Kabi 0.04 mEq/ml in 0.9% Sodium Chloride must be checked before addition.

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

Do not use additives known to be incompatible.

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