Patient Information

Meinsol Potassium Chloride 2 mEq/ml, Concentrate for Perfusion Solution
Potassium Chloride

Read this entire 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, consult your doctor or pharmacist.

-This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

This product belongs to the group of “Intravenous Solution Additives: Electrolyte Solutions” and is dispensed with a medical prescription.

Potassium Chloride Meinsol is indicated for the treatment of potassium deficits in patients for whom dietary measures or oral medication are inadequate.

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

No use Cloruro de potasio Meinsol

-If you have an excess of potassium in your blood (hyperkalemia).

Warnings and precautions:

Consult your doctor before starting to use Potassium Chloride.

The administration should be performed by your doctor or under their direct supervision who will take care of the following situations:

-Direct injection of potassium chloride concentrates without proper dilution may cause instant death.

-The administration should be performed slowly (usually 10 mEq/h, not exceeding 20 mEq/h) and cardiac activity should be monitored.

-Adequate urine flow should be ensured and therefore monitoring is required.

-Patients' serum electrolyte levels and acid-base balance should be monitored and the dose should be adjusted according to the patient's needs.

-Patients with heart disease, acute fluid deficiency (dehydration), heat cramps, massive tissue destruction as occurs in severe burns, and the elderly should be closely monitored since renal function may be impaired or other conditions may predispose to hyperkalemia.

-The initial potassium replacement therapy should not involve the perfusion of glucose as glucose may cause an additional decrease in plasma potassium concentrations.

-If signs of renal insufficiency appear, intravenous administration of potassium-containing solutions should be discontinued.

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

-decompensated heart failure, are being treated with digitalis (medicines used to treat heart diseases) or have severe or complete heart block.

-conditions frequently associated with an excess of potassium in the blood (hyperkalemia): episodic hypokalemic paralysis (a type of periodic paralysis), sickle cell anemia, impaired adrenal gland function (adrenal insufficiency), decreased renal function (renal insufficiency), oliguria post-surgery, shock with red blood cell destruction and/or fluid deficiency, metabolic acidosis (a type of acidosis in the blood), treatment with potassium-sparing diuretics (medicines used to increase urine excretion that retain potassium in the blood), excess chloride in the blood (hyperchloremia).

Your doctor should be careful with intravenous administration as the leakage of the perfusion fluid outside the vein (extravasation) may cause tissue death (necrotic lesions in the tissue).

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

Use of Potassium Chloride Meinsol with other medicines:

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

Non-recommended combinations (except in case of severe potassium deficiency):

+ Potassium-sparing diuretics (medicines 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 lethal potassium excess (hyperkalemia), particularly in patients with renal insufficiency (addition of effects that increase potassium).

+ Angiotensin-converting enzyme inhibitors (ACE inhibitors), angiotensin II receptor antagonists, non-steroidal anti-inflammatory drugs (NSAIDs), cyclosporine, tacrolimus: suxamethonium: potentially lethal potassium excess in the blood (hyperkalemia), particularly in patients with renal insufficiency (addition of effects that increase potassium).

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

Combinations possible with special precautions:

+ Quinidine: potassium may increase the anti-arrhythmic effects of quinidine.

+ Thiazides, adrenocorticoids, glucocorticoids, mineralocorticoids: potential decrease in the effects of potassium supplementation.

+Digoxin: an excess of potassium in the blood (hyperkalemia) may be hazardous if you use digitalis medicines to treat heart diseases,

+ Ion exchange resins: serum potassium levels are reduced by the substitution of potassium with sodium.

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

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

Pregnancy, lactation, and fertility:

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using a medicine.

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

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

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

The risk in newborns/infants cannot be ruled out.

Your doctor will decide if breastfeeding or treatment should be interrupted after considering the benefits of breastfeeding for the child and the benefits of treatment for the mother.

Driving and operating machinery:

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

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

Your doctor will decide on the correct dose you should receive.

The recommended dose in adults and adolescents is:

Administration only via intravenous route after dilution in an appropriate solution, up 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 necessary; in this case, the infusion should be in 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 the results of serum electrolyte levels and acid-base balance. The

potassium deficit must be calculated with the following formula:

Deficit of potassium (mEq) = body weight in kg x 0.2 x 2 x (4.5 mEq/l – serum potassium). (The extracellular volume is calculated from body weight in kg x 0.2).

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

Use in children:

Administration via intravenous route after dilution in an appropriate solution of a maximum dose of 3 mEq of potassium/kg of body weight, or 40 mEq/m2of body surface area. For children with a body weight of 25 kg or more, see adult doses.

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

Administration method:

The medication will be administered diluted through infusion in the vein (intravenous drip). The infusion rate should be slow, the amount of potassium chloride will depend on your specific needs.

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

Administration via a perfusion pump is recommended, especially in solutions with higher concentrations.

Your doctor will indicate the duration of treatment with Potassium chloride Meinsol.

If you estimate that the action 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 excessive potassium in the blood can produce ECG abnormalities, decreased heart rate (bradycardia), irregular heart rhythm with very rapid and disorganized contractions in the lower chambers of the heart (ventricular fibrillation), other heart rhythm disorders (arrhythmias) including cardiac arrest, confusion, fatigue, diarrhea, swallowing disorders, abnormal sensations in the skin of arms and legs (paresthesia of the extremities), respiratory difficulty, paralysis of voluntary muscle, and death.

In the event of any of these effects, discontinue treatment immediately and eliminate any potassium-containing foods from the diet and diuretics that retain potassium (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 tel. 91 562 04 20, indicating the medication and the amount ingested.

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

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

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

Excessive potassium intake could cause an excess of potassium in the blood (hyperkalemia) that could cause neuromuscular and cardiac alterations, especially cardiac rhythm disorders and even cardiac arrest.

Other adverse reactions:

Metabolism and nutrition disorders:

-acidic blood (acidosis)

-excess of chloride in the blood (hyperchloremia)

Vascular disorders

-blood clot in a blood vessel (venous thrombosis)

General disorders and changes at the administration site:

- nausea

-pain at the injection site,

-cell death in cases of leakage of perfusion fluid outside the vein (extravasation)

-inflammation of the veins in case of excessively high local concentrations.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use, http: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.

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.

This medication does not require special conservation conditions.

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

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 Potassium Chloride Meinsol

The active ingredient is Potassium Chloride (DCI).

The only excipient is Water for Injection.

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

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

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

Each 20 ml of solution contains 3000mg 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 osmolality: 4000 mosm/l

Appearance of the product and contents of the package

Potassium Chloride Meinsol is a transparent and colorless solution. Potassium Chloride Meinsol is presented in the following formats:

Package with 20 ampoules of 5 ml Package with 50 ampoules of 5 ml Package with 20 ampoules of 10 ml Package with 50 ampoules of 10 ml Package with 20 ampoules of 20 ml

Only some package sizes may be marketedInstructions for correct administration:

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

The compatibility of potassium chloride with any other infusion solution

must be established before its dilution.

To avoid poor homogenization of the diluted solution, the concentrated potassium chloride solution should not be added to an infusion bag in a hanging position. Once the concentrated solution is added to the infusion bag, the product must be mixed well before use, therefore gently agitate the infusion bag with 3-5 slow movements to obtain a good homogenization of the product. Then, hang the infusion bag and start the infusion process.

For single use. Always use diluted!

To open:

To separate a vial from the rest, rotate a vial around itself against the rest of the vials in the strip without touching the head and neck of the vials (1). Shake the vial with a single movement as shown in the drawing to remove any liquid that may be in the stopper (2). To open the vial, rotate the body and head of the vial in opposite directions until it breaks at the neck (3). Connect the Luer or Luer-lock syringe as shown in the drawing (4).

It is not necessary to use a needle to extract the solution. Extract the liquid.

Holder of the marketing authorization and responsible for manufacturing

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 with the following names:

BelgiumKaliumchloride Fresenius Kabi 150 mg/ml concentrate for solution forinfusion

SpainCloruro de potasio Meinsol 2 mEq/ml, concentrated for solution for infusion

EstoniaPotassium chloride Kabi 150 mg/ml

GreecePotassium Chloride/Fresenius, Πυκν? δι?λυμα για την Παρασκευ? διαλ?ματος

προς?γχυση, 2M.

IrelandPotassium Chloride 15% w/v concentrate for solution for infusion

LatviaPotassium chloride Kabi 150 mg/ml koncentrats infuziju škiduma pagatavošanai

LithuaniaPotassium chloride Kabi 150 mg/ml koncentratas infuziniam tirpalui

PolandKalium chloratum 15% Kabi

PortugalCloreto de Potássio Kabi

RomaniaClorurade potasiu Kabi 150 mg/ml, concentrat pentru solutie perfuzabila

United KingdomPotassium Chloride 15% w/v concentrate for solution for infusion

This leaflet was approved in January 2015