Cloruro de potasio braun 2 meq/ml concentrado para solucion para perfusion

Leaflet: information for the user

Potassium Chloride

concentrate for solution for infusion

Read this leaflet carefully before you start using the medicine

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others even if their symptoms are the same. It may harm them.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

1. What is Potassium Chloride Braun 2 mEq/ml and what is it used for

2. Before you start using Potassium Chloride Braun 2 mEq/ml

3. How to use Potassium Chloride Braun 2 mEq/ml

4. Possible side effects

5. Storage of Potassium Chloride Braun 2 mEq/ml

6. Additional information

This product belongs to the group of “Additives for intravenous solutions: Electrolyte solutions” and is dispensed with a medical prescription.

Potassium Chloride Braun 2 mEq/mlis indicated for the treatment of potassium deficits (prolonged treatments with potassium-depleting diuretics, digitalis intoxication, low potassium intake in the diet, vomiting and diarrhea, metabolic alkalosis, corticosteroid therapy, high renal excretion due to acidosis, and hemodialysis).

Do not use Potassium Chloride Braun 2 mEq/ml :

If you are allergic (hypersensitive) to potassium chloride or any of the other components of the medication.

If you have:

• kidney or adrenal cortex (glands located above the kidneys) abnormalities
• heart block and are being treated with cardiac stimulants (digitalis medications)
• decreased or eliminated urine formation (oliguria or anuria)
• excess acid in tissues and blood (metabolic acidosis)

Be especially careful withCloruro de Potasio Braun 2 mEq/ml:

The administration should be carried out slowly and under control of heart activity.

The dose should be programmed individually according to the patient's needs based on blood test results.

Pregnancy and breastfeeding :

Consult your doctor or pharmacist before using a medication.

The safety of the preparation during pregnancy and breastfeeding has not been established, so its administration should be evaluated in advance for the benefit/risk of therapy.

Driving and operating machines :

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

Use of other medications :

Inform your doctor or pharmacist if you are using or have recently used other medications, including those obtained without a prescription.

Potassium chloride is incompatible with::

• Amikacin, Amphotericin B, Dobutamine, 10% fat emulsions, 20-25% mannitol solutions, and Penicillin G sodium.

Non-recommended combinations ofCloruro de Potasio Braun with the following medications (except in case of low potassium in blood - hypokalemia):

-Diuretics that conserve potassium (such as amiloride, spironolactone, or triamterene) alone or in combination with other medications

-Angiotensin-converting enzyme inhibitors (ACE inhibitors) (captopril, enalapril) or angiotensin II receptor antagonists (candesartan, telmisartan, eprosartan, irbesartan, losartan, valsartan)

-Blood-derived products.

Combinations possible with special caution ::

• Quinidine and digoxin (medications used for the treatment of heart rhythm disorders)
• Thiazides(for the treatment of high blood pressure)
• Hormones such as adrenocorticoids,glucocorticoidsandmineralocorticoids
• Ionic exchange resins (replace potassium with sodium).

Your doctor will check the compatibility of this medication with others before using it.

Follow exactly the administration instructions for Braun Potassium Chloride 2 mEq/ml as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Braun Potassium Chloride 2 mEq/ml is administered intravenously.

Normal doses in adults and adolescents:

Administer only intravenously after dilution in an appropriate solution, up to a maximum concentration of 4 g/l of potassium chloride (or 50 mmol/l of potassium).

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

The normal daily intake is approximately 0.8 to 2 mmol of potassium per kilogram of body weight. The usual therapeutic dose is 20 mmol to 60 mmol, every 24 hours.

Doses for children:

The safety and efficacy of potassium chloride have not been fully established in pediatric patients.However, administration intravenously after dilution in an appropriate solution of a maximum concentration of 3 mmol of potassium per kilogram of body weight, or 40 mmol/m2of body surface area is recommended.

The normal infusion rate is 10 mmol/hour, although in severe cases it may reach 15 mmol/hour.

The maximum daily dose is 150 mmol in adults and 3 mmol/kg of body weight per day in children.

Your doctor will indicate the duration of treatment withBraun Potassium Chloride 2 mEq/ml.

If you estimate that the action ofBraun Potassium Chloride 2 mEq/mlis too strong or too weak, inform your doctor or pharmacist.

If you use more Braun Potassium Chloride 2 mEq/ml than you should

If you have used moreBraun Potassium Chloride 2 mEq/mlthan you should, consult your doctor or pharmacist immediately.

It is unlikely that this will happen since your doctor will determine the dose you need. However, if you receive more medication than you should, you may experience: slower heart rate (bradycardia), confusion, fatigue, diarrhea, difficulty swallowing (dysphagia), changes in the electrocardiogram, excessive potassium in the blood (hyperkalemia), respiratory difficulty, uncontrolled contraction of the heart muscle fibers (ventricular fibrillation), paralysis of voluntary muscles, heart arrest, and death.

In the event of any of these effects, the treatment should be stopped immediately and any potassium-containing elements removed from the diet and diuretic medications.

In case of overdose or accidental ingestion, consult the Toxicological Information Service (phone: 91.562 04 20) or consult your doctor or pharmacist. Bring this leaflet with you.

If you forgot to use Braun Potassium Chloride 2 mEq/ml:

Do not use a double dose to compensate for the missed doses.

Like all medications, Braun Potassium Chloride 2 mEq/ml may cause adverse effects, although not everyone will experience them.

The adverse reactions that may occur are those due to high levels of potassium in the blood, manifesting mainly through neuromuscular and heart alterations.

General disorders and changes at the administration site:

Unknown frequency:

• Pain at the injection site,
• Cell death in case of bleeding,
• Phlebitis in case of excessively high concentrations.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is about possible adverse effects that do not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep out of the reach and sight of children.

No special storage conditions are required.

Do not use Potassium Chloride Braun 2 mEq/ml after the expiration date appearing on the container. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medicines you no longer need. In this way, you will help protect the environment.

Keep Potassium Chloride Braun 2 mEq/ml out of the reach and sight of children.

Composition of Potassium Chloride Braun 2 mEq/ml:

The other components are: Water for Injection.

Appearance of the product and contents of the package

Potassium Chloride Braun 2 mEq/ml is available in the following formats: (not all sizes may be marketed).

Marketing Authorization Holder

B|BRAUN

B. Braun Medical, S.A.

Ctra. de Terrassa, 121

08191-Rubí (Barcelona)

Spain

Responsible for Manufacturing

B|BRAUN

B. Braun Medical, S.A.

Ctra. de Terrassa, 121

08191-Rubí (Barcelona)

Spain

or

B. Braun Melsungen AG

Carl Braun Str. 1

D- 34212 Melsungen

Germany

This leaflet was approved in March 2015

This information is intended solely for medical professionals or healthcare professionals:

Instructions for correct administration:

Administer exclusively diluted in an appropriate solution and by intravenous route.

The addition of the drug should be made by suitable personnel, never in a hanging position and taking into account the compatibility tables before adding or administering simultaneously with other medications. There may be incompatibility with amikacin, amphotericin B, dobutamine, fat emulsions at 10%, etc.

Once the vial is opened, the nozzle is adjusted to the Luer cone of a syringe, thus no needle is required for the extraction of the drug.

The solution should be visually inspected before use. The solution must be transparent, not contain precipitates, and the container must be intact. Do not administer otherwise.

Use an aseptic procedure to administer the solution and add medications if necessary.