Label:information for theuser

Potassium Acetate B. Braun 1 mEq/ml

concentrate for infusion solution

Read this label carefully before starting to use the medication, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse
• This medication has been prescribed only for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this label.

This product belongs to the group of medications known as “Intravenous solution additives: Electrolyte solutions”.

Potassium Acetate B.Braun 1 mEq/mlis used for:

• Treatmentof potassium deficiency due to any cause
• Correcting the potassium level of other solutions administered directly into the blood.

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.

You have:

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

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

Inform your doctor if you are taking:

• Corticosteroids, mineralocorticoids, or corticotropin (ACTH),
• Laxatives. Chronic or excessive use of these promotes excessive potassium loss,
• Concomitant administration of medications containing potassium or salt substitutes,
• Angiotensin-converting enzyme inhibitors (ACE inhibitors) captopril or enalapril or angiotensin II receptor antagonists (candesartan, telmisartan, eprosartan, irbesartan, losartan), valsartan),
• Quinidine and digoxin (medications used for the treatment of heart rhythm disorders.

In case of doubt, consult your doctor or pharmacist.

Pregnancy and breastfeeding:

Consult your doctor or pharmacist before using a medication.

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

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

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

Your doctor will inform you of the duration of your treatment with Potassium Acetate B. Braun and will decide on 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/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, excess potassium in the blood (hyperkalemia), breathing difficulty, uncontrolled contraction of the heart muscle fibers (ventricular fibrillation), paralysis of voluntary muscles, heart stop, and death.

Upon the appearance 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 Toxicological Information Service (phone: 91.562 04 20) or consult your doctor or pharmacist. Bring this leaflet with you.

Like all medications, Acetate of Potassium B. Braun may produce adverse effects, although not everyone will experience them.

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

At the site of administration:

-pain at the injection site,

-cell death (necrosis) in the event of bleeding,

-phlebitis in the event of excessively high 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 theSpanish 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 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 the drains or in the trash. Ask your pharmacist how to dispose of the packaging and unused medicines. This will help protect the environment.

Potassium Acetate B. Braun 1 mEq/ml Composition

The other components are: Water for Injection.

Appearance of the product and contents of the package

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

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

B|BRAUN

B. Braun Medical, S.A.

Ctra. de Terrassa, 121

08191-Rubí (Barcelona)

Spain

Responsible for manufacturing:

B. 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.

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices. http//www.aemps.gob.es/

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This information is intended solely for doctors 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.

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

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

It is especially important to monitor the patient as it indicates after the first perfusion the subsequent perfusion rate required.

Normal doses in adults and adolescents:

The dose and perfusion rate are determined by the individual needs of each patient, up to the equivalent of 400 mEq of potassium per day (usually, not more than 3 mEq per body weight). In most cases, the maximum recommended concentration is 40 mEq of potassium per liter.

Do not administer more than 20 mmol of potassium per hour.

Pediatric doses:

No safety and efficacy have been established in pediatric patients.However, intravenous administration after dilution in an appropriate solution at a maximum concentration of 3 mmol of potassium per kg of body weight, or 40 mmol/m2of body surface area is recommended.

Visually inspect the solution 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.