Potassium chloride Meinsol 2 mEq/ml concentrate for infusion solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Potassium chloride Meinsol 2 mEq/ml, concentrate for solution for infusion Potassium chloride

Read the entire 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people,
  even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet:

1. What Potassium chloride Meinsol is and what it is used for
2. What you need to know before using Potassium chloride Meinsol
3. How to use Potassium chloride Meinsol
4. Possible adverse effects
5. How to store Potassium chloride Meinsol
6. Contents of the pack and other information

1. What Cloruro de potasio Meinsol is and what it is used for

This product belongs to the group of "Additives for intravenous solutions: Electrolyte solutions" and is dispensed by prescription.

Cloruro de potasio Meinsol is indicated for the treatment of potassium deficiency in patients for whom dietary measures or oral medication are inadequate.

You should consult a doctor if you worsen or do not improve.

2. What you need to know before starting to use Potassium Chloride Meinsol

Do not use Potassium Chloride Meinsol

• If you have excess potassium in the blood (hyperkalemia).

Warnings and precautions

Consult your doctor before starting to use Potassium Chloride Meinsol.

Administration must be performed by your doctor or under their direct supervision, who will pay careful attention to the following conditions:

• Direct injection of concentrated potassium chloride without proper dilution may cause immediate death.
• Administration must be carried out slowly (usually 10 mEq/h, not exceeding 20 mEq/h), and cardiac activity must be monitored.
• Adequate urine flow must be ensured and therefore must be monitored.
• Serum electrolyte levels and the patient's acid-base balance must be monitored, and the dose adjusted according to the patient's needs.
• Close monitoring is required in patients with heart disease, acute fluid deficiency (acute dehydration), heat cramps, massive tissue destruction as occurs in severe burns, and in elderly patients, since renal function may be impaired or other conditions may predispose to the development of hyperkalemia.
• Initial potassium replacement therapy should not involve glucose infusion, as glucose may cause a further decrease in plasma potassium concentrations.
• If signs of renal failure appear, intravenous administration of potassium-containing solutions must be discontinued.

Your doctor may need to take special precautions and will decide whether you can use potassium chloride if you have:

• Decompensated heart failure, are being treated with digitalis (medications used for the treatment of heart diseases), or suffer from severe or complete cardiac block.
• Conditions frequently associated with excess potassium in the blood (hyperkalemia): episodic adynamia (a type of periodic paralysis), sickle cell anemia, impaired adrenal gland function (adrenal insufficiency), reduced kidney function (renal failure), low urine output after surgery (postoperative oliguria), shock with destruction of red blood cells and/or body fluid deficiency (shock with hemolytic reaction and/or dehydration), metabolic acidosis (a type of blood acidosis), treatment with potassium-sparing diuretics (medications used to increase urinary excretion that retain potassium in the blood), excess chloride in the blood (hyperchloremia).

Your doctor must be cautious during intravenous administration, as leakage of the infused fluid outside the vessel (extravasation) may cause tissue death (necrotic tissue lesions).

Children: The safety and efficacy of potassium chloride have not been clearly established in pediatric patients.

Use of Potassium Chloride Meinsol with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Combinations not recommended (except in cases of severe potassium deficiency):

• Potassium-sparing diuretics (medications used to increase urine excretion that retain potassium in the blood), alone or in combination such as: amiloride, spironolactone, triamterene, potassium canrenoate, eplerenone; risk of potentially fatal excess potassium (hyperkalemia), particularly in patients with renal failure (additive effects increasing potassium).

• Angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor antagonists, non-steroidal anti-inflammatory drugs (NSAIDs), cyclosporine, tacrolimus, suxamethonium: potentially fatal excess potassium in the blood (hyperkalemia), particularly in patients with renal failure (additive effects increasing potassium).

• Blood products, potassium salts of penicillin: potential risk of excess potassium in the blood (hyperkalemia) due to the amount of potassium present in these products.

Combinations possible with special precautions in use:

• Quinidine: potassium may enhance the antiarrhythmic effects of quinidine.

• Thiazides, adrenocorticoids, glucocorticoids, mineralocorticoids: potential reduction in the effects of potassium supplementation.

• Digoxin: excess potassium in the blood (hyperkalemia) can be dangerous if you are taking digitalis medications for the treatment of heart diseases.

• Ion-exchange resins: reduce serum potassium levels by replacing potassium with sodium.

In the absence of compatibility studies, this medicine must not be mixed with other medicines.

However, the 2 mEq/ml concentrated solution for infusion of potassium chloride is physically incompatible with the following medicinal substances: amikacin, amphotericin B, dobutamine, fat emulsions, 20-25% mannitol solutions, and sodium penicillin G.

Pregnancy, breastfeeding, and fertility

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

There are no data or data are limited regarding the use of potassium chloride in pregnant women.

The use of Potassium Chloride 2 mEq/ml, concentrated solution for infusion, may be considered during pregnancy in cases where it is clinically indicated.

Potassium chloride is excreted in breast milk in amounts expected to have an effect on newborns/infants.

Risk to newborns/infants cannot be excluded.

Your doctor will decide whether it is necessary to interrupt breastfeeding or discontinue treatment, taking into account the benefit of breastfeeding for the child and the benefit of treatment for the mother.

Driving and using machines

There is no evidence that this medicine may affect the ability to drive vehicles or operate complex machinery.

3. How to use Potassium Chloride Meinsol

Potassium chloride will be administered to you by your doctor, or under their direct supervision, who will closely monitor the appropriate amount of potassium chloride.

Your doctor will decide the correct dose you should receive.

Recommended dose in adults and adolescents:

Administration only by intravenous route after dilution in an appropriate solution, to a maximum concentration of 3 g/L of potassium chloride (or 40 mEq/L of potassium). For the treatment of severe hypokalemia or diabetic ketoacidosis, higher concentrations may be required; in such cases, the infusion should be administered into a vein with high blood flow, and continuous ECG monitoring is recommended.

1 g of potassium chloride corresponds to 13.4 mEq or 524 mg of potassium.

The dose depends on serum electrolyte levels and acid-base balance. The potassium deficit should be calculated using the following formula:

Potassium deficit (mEq) = body weight in kg x 0.2 x 2 x (4.5 mEq/L – serum potassium). (Extracellular volume is calculated as body weight in kg x 0.2).

Normal daily intake is approximately 0.8 to 2 mEq of potassium per kilogram of body weight. Normally, the maximum daily dose in adults should not exceed 150 mEq per day.

Use in children:

Intravenous administration after dilution in an appropriate solution is recommended, with a maximum dose of 3 mEq of potassium per kg of body weight, or 40 mEq/m² of body surface area. For children with a body weight of 25 kg or more, refer to adult dosing.

The maximum daily dose in children is 3 mEq/kg of body weight. In patients with renal insufficiency, the dose should be reduced.

Method of administration:

The diluted medication will be administered to you by intravenous infusion (intravenous drip). The infusion rate should be slow, and the amount of potassium chloride will depend on your specific needs.

A rate of 10 mEq/hour is considered safe. As a general rule, the infusion rate should not exceed 20 mEq/hour.

Infusion by means of an infusion pump is recommended, especially for solutions with higher concentrations.

Your doctor will advise you on the duration of treatment with Potassium Chloride Meinsol.

If you feel that the effect of Potassium Chloride Meinsol is too strong or too weak, inform your doctor or pharmacist.

If you use more Potassium Chloride Meinsol than you should:

Overdose resulting from excess potassium in the blood may cause ECG abnormalities, decreased heart rate (bradycardia), irregular heart rhythm with very rapid and uncoordinated beats in the lower chambers of the heart (ventricular fibrillation), other disturbances in heart rhythm (arrhythmias), including cardiac arrest, confusion, fatigue, diarrhea, difficulty swallowing, abnormal skin sensations in arms and legs (paresthesia of the extremities), breathing difficulties, paralysis of voluntary muscles, and death.

If any of these effects occur, stop treatment immediately and eliminate any potassium-containing food from the diet, as well as potassium-sparing diuretics (medications used to increase urine excretion that retain potassium in the blood).

In case of overdose or accidental ingestion, go immediately to a medical center, or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and the amount ingested.

If you experience any of these symptoms or think you may have received too much potassium chloride, inform your doctor or healthcare professional immediately.

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

4. Possible adverse effects

Like all medicines, this medicine may produce adverse effects, although not everyone will experience them.

Excessive intake of potassium may lead to excess potassium in the blood (hyperkalaemia), which could cause neuromuscular and cardiac disturbances, especially cardiac rhythm disorders and even cardiac arrest.

Other adverse reactions:

Metabolism and nutrition disorders:

• acidic blood (acidosis)
• excess chloride in the blood (hyperchloraemia)

Vascular disorders:

• blood clot in a blood vessel (venous thrombosis)

General disorders and administration site conditions:

• nausea
• pain at the injection site
• cell death in cases of leakage of the perfusion fluid outside the vessel (extravasation)
• inflammation of the veins in cases of locally too high concentrations.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, 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 Medicines: http://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Potassium Chloride Meinsol

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

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

This medicine does not require any special storage conditions.

Do not use this medicine if the solution is cloudy, contains visible particles, or shows discoloration.

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

6. Contents of the container and other information

Composition of Potassium Chloride Meinsol

The active substance is potassium chloride (INN).

The only excipient is water for injections.

Each 1 ml of solution contains 150 mg of potassium chloride (15% w/v), equivalent to 2 mEq of potassium ions.

Each 5 ml of solution contains 750 mg of potassium chloride (15% w/v), equivalent to 10 mEq of potassium ions.

Each 10 ml of solution contains 1500 mg of potassium chloride (15% w/v), equivalent to 20 mEq of potassium ions.

Each 20 ml of solution contains 3000 mg of potassium chloride (15% w/v), equivalent to 40 mEq of potassium ions.

Ionic content: K+ 2000 mEq/ml or 2000 mmol/l
Cl– 2000 mEq/ml or 2000 mmol/l

Theoretical osmolarity: 4000 mOsm/l

Appearance of the product and contents of the container

Potassium Chloride Meinsol is a clear, colourless solution. Potassium Chloride Meinsol is available in the following pack sizes:

• Pack of 20 ampoules of 5 ml
• Pack of 50 ampoules of 5 ml
• Pack of 20 ampoules of 10 ml
• Pack of 50 ampoules of 10 ml
• Pack of 20 ampoules of 20 ml

Only certain pack sizes may be marketed.

Instructions for correct administration:

Potassium Chloride Meinsol is a sterile potassium chloride solution for intravenous infusion. It must be diluted in at least 50 times its volume of 0.9% sodium chloride isotonic solution for infusion or another suitable infusion solution.

Compatibility of potassium chloride with any other infusion solution must be established before dilution.

To avoid inadequate mixing of the diluted solution, the concentrated potassium chloride solution must not be added to an infusion bottle/bag while it is hanging. After adding the concentrated solution to the infusion bottle/bag, the product must be thoroughly mixed before use. Therefore, gently agitate the infusion bottle/bag with 3–5 slow movements to ensure adequate homogenization. Then, hang the infusion bottle/bag and begin the infusion process.

For single use only. Always use diluted!

How to open:

To separate one ampoule from the strip, rotate one ampoule on itself away from the rest of the strip without touching the head and neck of the ampoules (1). Tap the ampoule once as shown in the picture to remove any liquid from the neck (2). To open the ampoule, twist the body and the head in opposite directions until the neck breaks (3). Attach the Luer or Luer-lock syringe as shown in the picture (4).

Thus, there is no need to use a needle to withdraw the solution. Withdraw the liquid.

Marketing Authorization Holder and Manufacturer

FRESENIUS KABI ESPAÑA, S.A.U
C/ Marina 16 – 18,
08005 Barcelona (Spain)

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

Belgium: Kaliumchloride Fresenius Kabi 150 mg/ml concentrate for solution for infusion
Spain: Cloruro de potasio Meinsol 2 mEq/ml, concentrate for solution for infusion
Estonia: Potassium chloride Kabi 150 mg/ml
Greece: Potassium Chloride/Fresenius, Πυκνό διάλυμα για την Παρασκευή διαλύματος προς έγχυση, 2M.
Ireland: Potassium Chloride 15% w/v concentrate for solution for infusion
Latvia: Potassium chloride Kabi 150 mg/ml koncentrats infūziju šķīduma pagatavošanai
Lithuania: Potassium chloride Kabi 150 mg/ml koncentratas infuziniam tirpalui
Poland: Kalium chloratum 15% Kabi
Portugal: Cloreto de Potássio Kabi
Romania: Clorura de potasiu Kabi 150 mg/ml, concentrat pentru solutie perfuzabila
United Kingdom: Potassium Chloride 15% w/v concentrate for solution for infusion

This summary of product characteristics was approved in January 2015