POTASSIUM ACETATE B.BRAUN 1 mEq/ml CONCENTRATE FOR INFUSION SOLUTION

Introduction

Leaflet:information for theuser

Potassium Acetate B. Braun 1 mEq/ml

withconcentrate for solution for infusion

Read the entire leaflet carefully before starting to use the 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, pharmacist, or nurse.
• This medicine has been prescribed to 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 side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this leaflet.

Contents of the leaflet:

1. What is Potassium Acetate B. Braun 1 mEq/ml and what is it used for
2. What you need to know before starting to use Potassium Acetate B. Braun 1 mEq/ml
3. How to use Potassium Acetate B. Braun 1 mEq/ml
4. Possible side effects
5. Storage of Potassium Acetate B. Braun 1 mEq/ml
6. Package contents and additional information

1. What is Potassium Acetate B. Braun 1 mEq/ml and what is it used for

This product belongs to the group of medicines called "Additives for intravenous solutions: Electrolyte solutions".

Potassium Acetate B.Braun 1 mEq/ml is used for:

• treatment of potassium deficiency for any reason
• to correct the amount of potassium in other solutions that are administered directly into the blood.

2. What you need to know before starting to use Potassium Acetate B. Braun 1 mEq/ml

Do not use Potassium Acetate B. Braun 1 mEq/ml:

If you are allergic (hypersensitive) to any of the components of Potassium Acetate B. Braun.

If you have:

• excess acid in the tissues and blood (metabolic acidosis),
• untreated Addison's disease
• kidney or adrenal cortex disorders (glands located above the kidneys)
• heart block and are being treated with digitalis medications (heart stimulants)
• medical problems related to trauma: severe burns, traumatic injuries, external infections, major surgery in the 24 hours prior to administration, or hemodialysis (a technique used to remove waste products from the blood such as potassium or urea)
• decreased or absent urine formation (oliguria or anuria)

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Potassium Acetate B. Braun.

Potassium supplements should be administered with caution in elderly patients or those with impaired kidney function.

Your doctor will assess whether it is recommended to administer adequate amounts of sodium chloride.

Use of Potassium Acetate B. Braun with other medicines:

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

Tell your doctor if you are taking:

• Corticosteroids, mineralocorticoids, or corticotropin (ACTH),
• Laxative medications. Chronic or excessive use of these promotes excessive potassium loss,
• The concomitant administration of medications containing potassium or salt substitutes,
• Angiotensin-converting enzyme inhibitors (ACE inhibitors) such as captopril or enalapril, or angiotensin II receptor antagonists (such as candesartan, telmisartan, eprosartan, irbesartan, losartan), valsartan),
• Quinidine and digoxin (medicines used to treat heart disorders.

In case of doubt, consult your doctor or pharmacist.

Pregnancy and breastfeeding:

Consult your doctor or pharmacist before using a medicine.

The safety of the medicine during pregnancy and breastfeeding has not been established, so your doctor will need to assess the benefit/risk of therapy before administration.

3. How to use Potassium Acetate B. Braun 1 mEq/ml

This medicine is administered directly into a vein, always in a hospital, and will be administered by healthcare personnel.

Potassium Acetate B. Braun cannot be injected alone and must be diluted with other solutions before use.

Your doctor will indicate the duration of your treatment with Potassium Acetate B. Braun and decide the most suitable dose for you.

If you use more Potassium Acetate B.Braun 1 mEq/ml than you should

If you have used more Potassium Acetate B.Braun 1 mEq/ml than 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 medicine than you should, you may experience: slower heart rate (bradycardia), confusion, fatigue, diarrhea, difficulty swallowing (dysphagia), changes in the electrocardiogram, excess potassium in the blood (hyperkalemia), breathing difficulties, uncontrolled contraction of the heart muscle fibers (ventricular fibrillation), paralysis of the voluntary muscles, heart stoppage, and death.

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

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

4. Possible side effects

Like all medicines, Potassium Acetate B. Braun can cause side effects, although not everyone will experience them.

The adverse reactions that may occur are those due to high levels of potassium. The signs and symptoms are those described in the previous section, and hypotension and even cardiac arrest may occur.

At the administration site:

• pain at the injection site,
• cell death (necrosis) in case of bleeding,
• inflammation of the veins in case of too high concentrations (phlebitis).

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that is not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Potassium Acetate B. Braun 1 mEq/ml

Keep out of sight and reach of children.

No special storage conditions are required.

Do not use Potassium Acetate B. Braun after the expiration date indicated on the packaging. The expiration date is the last day of the month indicated.

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

6. Package contents and additional information

Composition of Potassium Acetate B. Braun 1 mEq/ml

The other ingredients are: water for injectable preparations.

Appearance of the product and package contents

Potassium Acetate B. Braun 1 mEq/ml is available in the following formats: (not all sizes may be marketed).

Marketing authorization holder and manufacturer

Marketing authorization holder:

B|BRAUN

• Braun Medical, S.A.

Ctra. de Terrassa, 121

08191-Rubí (Barcelona)

Spain

Manufacturer:

• Braun Medical, S.A.

Ronda de los Olivares, Parcela 11

Polígono Industrial Los Olivares

23009-Jaén (Jaén)

Spain

This leaflet was approved in February 2015.

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products. http//www.aemps.gob.es/

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This information is intended only for doctors or healthcare professionals:

Instructions for correct administration:

Administer exclusively diluted in a suitable solution and by intravenous route.

The addition of the drug should be done by suitable personnel, never in a hanging position, and taking into account the compatibility tables before adding or administering simultaneously with other medicines.

Since hypokalemia may be associated with hypochloremic alkalosis, it may be recommended to administer adequate amounts of sodium chloride, along with potassium.

Administration should be done slowly and under control of heart activity.

It is especially important to monitor the patient, as indicated after the first perfusion, the subsequent required perfusion speed.

Normal doses in adults and adolescents:

The dose and perfusion speed are determined by the individual needs of each patient, up to the equivalent of 400 mEq of potassium per day (normally, no more than 3 mEq per kilogram of body weight). In most cases, the maximum recommended concentration is 40 mEq of potassium per liter.

No more than 20 mmol of potassium should be administered per hour.

Pediatric doses:

The safety and effectiveness in pediatric patients have not been fully established. However, it is recommended to administer intravenously after dilution in a suitable solution at a maximum concentration of 3 mmol of potassium/kg of body weight, or 40 mmol/m2 of body surface area.

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

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