Cloruro de potasio braun 1 meq/ml concentrado para solucion para perfusion

Package Insert: Information for the User

Potassium Chloride Braun 1 mEq/ml Concentrate for Infusion Solution

Read this package insert carefully before starting to receive this medication, because it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• If you experience any adverse effects,consult your doctor or pharmacist,evenifthey are not listed in this package insert. See section 4

1. What isCloruro dePotasio Braun 1 mEq/mland how it is used

2. What you need to knowbefore starting to useCloruro dePotasio Braun 1 mEq/ml

3. How to useCloruro dePotasio Braun 1 mEq/ml

4. Possible adverse effects

5. Storage ofCloruro dePotasio Braun 1 mEq/ml

6. Contents of the package and additional information

Potassium Chloride 1is a concentrated solution of potassium chloride.

It is used to provide potassium:

• whenyouhave a potassium deficiency, especially if this is accompanied by an excess of alkalinity and abnormally low levels of chloride in the blood (hypochloremic alkalosis)
• as part of parenteral nutrition, when you cannot take food normally

No use Cloruro de Potasio Braun 1 mEq/ml :

If you have an abnormally high level of potassium or chloride in your blood (hyperkalemia, hyperchloremia)

Warnings and precautions

Consult your doctor before starting to use Potassium Chloride 1 mEq/ml.

Special care is required with Potassium Chloride 1 mEq/ml:

? If you have heart problems

?If you have a disease in which potassium is often excreted in the urine is reduced, such as kidney dysfunction, Addison's disease (a specific adrenal gland disease) or hereditary anemia (a hereditary disease of red blood cells) if your kidney function is severely impaired or if you are on dialysis, your doctor will consult a kidney specialist before administering this medication

?If you are taking or receiving medications that reduce potassium excretion in the urine; for example, if you are taking:

– Certain medications that increase urine flow (diuretics)

– Certain medications for high blood pressure (angiotensin II receptor antagonists, ACE inhibitors)

?If you are taking or receiving medications that can affect kidney function (e.g., certain medications that suppress inflammatory processes)

?If you are experiencing shock (an acute clinical condition accompanied by a drop in blood pressure, cold skin, rapid heartbeat, and irregular breathing that may occur, for example, after losing a large amount of blood, suffering severe burns, or having an allergic reaction)

? If you have severe tissue damage, for example, severe burns

? If you have a disorder that causes muscle weakness and sometimes higher-than-normal potassium levels in the blood (periodic familial paralytic hyperkalemia)

Your doctor will take these points into account before and during your treatment with this medication.

If you receive this medication because you are deficient in potassium, you will not initially receive any glucose infusion at the same time because glucose can further reduce potassium levels.

While receiving this medication, your potassium and acid-base balance levels in the blood will be monitored to ensure they are normal. Additionally, your ECG may be monitored.

It will be ensured with absolute certainty that the solution is administered through a vein to avoid tissue damage.

If you receive this medication because you are deficient in potassium, your doctor will administer it to you through a pump infusion.

Patients of advanced age, who have a higher probability of suffering from heart and kidney problems, will be closely monitored during treatment, and the dosage will be carefully adjusted.

If you are severely malnourished, i.e., you have not received enough food, there is a possibility that you may develop a condition called "Refeeding Syndrome". Your doctor will closely monitor you and gradually increase your nutrient administration.

Use of Potassium Chloride 1 mEq/ml with other medications

Inform your doctor if you are taking, have taken recently, or may need to take any other medication.

In particular, your doctor will pay attention to:

?Medications for the treatment of heart failure (cardiac glycosides, e.g., digoxin):

The effects of these medications decrease when the potassium level in the blood increases. They increase (possibly with an irregular heartbeat) when the potassium level in the blood decreases.

? Medications that reduce potassium excretion in the urine:

This group of medications includes:

– Some medications that increase urine flow (potassium-sparing diuretics such as triamterene, amiloride, and spironolactone)

– Certain medications for high blood pressure (angiotensin II receptor antagonists and ACE inhibitors)

– Medications that suppress the immune system (tacrolimus, cyclosporine)

– Certain medications used to treat pain or to treat inflammation (nonsteroidal anti-inflammatory drugs)

– Anticoagulant medications (heparin)

The administration of potassium with these medications can lead to very high levels of potassium in the blood. This could affect the heart rhythm.

?Medications that increase potassium excretion in the urine:

The following medications can increase potassium excretion in the urine:

– A specific hormone (corticotropin [ACTH])

– Certain medications to treat inflammation (corticosteroids)

– Some medications that increase urine flow (loop diuretics)

The administration of potassium with these medications can lead to a lower-than-normal dose of potassium because the potassium administered will be eliminated from your body more quickly than normal

? Suxamethonium (a muscle relaxant used in general anesthesia):

The administration of potassium with these medications can also lead to very high levels of potassium in the blood. This could affect the heart rhythm.

Pregnancy and lactation

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

Pregnancy

No adverse effects or risks have been reported so far regarding the use of this medication in pregnant women.

Your doctor will administer potassium chloride with caution and only when clearly necessary.

Lactation

Potassium chloride concentrates for infusion can be used during breastfeeding

Driving and operating machinery

This medication does not affect your ability to drive and operate machinery.

Potassium Chloride 1mEq/ml is administered after diluting it in an appropriate solution. It is administered through a small cannula or tube into a vein (intravenous infusion).

Dosage

The amount you will receive will be calculated by your doctor based on your blood electrolyte levels, acid-base balance, age, and individual needs.

If you use more Potassium Chloride Braun 1 mEq/ml Braun than you should

It is unlikely that you will ever receive an excessive amount of the medication. Your doctor or healthcare professional will monitor the administration.

Side Effects

Overdose may lead to abnormally high levels of potassium, with the following adverse effects. You are more likely to experience adverse effects if you have a blood deviation to the acidic side (acidosis) or kidney disorders.

Heart and Circulation:

? slow or even heart stoppage

? changes in the electrocardiogram

? decrease in blood pressure

? redistribution of circulating blood to the head and trunk

Muscles and Nervous System:

? weakness

? fatigue

? confusional states

? heaviness in the limbs

? muscle spasms

? numbness

? paralysis

Treatment

If an overdose occurs, the infusion will be stopped immediately, and your doctor will provide the necessary treatment.

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

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

The following adverse effects may be serious. If you experience any of the following adverse effects, consult your doctor immediately.

?Accumulation of acidic substances in the blood (acidosis) (unknown frequency)

?Abnormally high levels of chloride in the blood (hyperchloremia) (unknown frequency)

?Irregular heartbeat (cardiac arrhythmia, consequence of abnormally high administration rates) (unknown frequency)

Other Adverse Effects

? Nausea (unknown frequency)

?Reactions at the injection site, such as local pain, irritation, or inflammation of the veins (thrombophlebitis) and leakage ofliquid into the tissue (extravasation) (unknown frequency)

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 Medicinal Products for Human Use:www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on 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 label and the box. The expiration date is the last day of the month indicated.

No special storage conditions are required.

It should only be used if the solution is transparent, colorless, and free of particles, and if the container and its closure are intact.

The containers are valid for single use. The container and unused contents should be discarded after use.

Composition of Potassium Chloride Braun 1 mEq/ml:

The active ingredient is potassium chloride.

1 ml of solution contains 74.5 mg of potassium chloride,

which corresponds to 1 mmol of potassium and 1 mmol of chloride

One vial of 10 ml contains 745 mg of potassium chloride

One vial of 20 ml contains 1.49 g of potassium chloride

The other components are: water for injectable preparations.

Appearance of the product and content of the container

Potassium Chloride Braun 1 mEq/ml is a concentrate for the preparation of a solution for infusion. It must be diluted before use and is administered by intravenous drip.

It is a transparent and colorless aqueous solution.

Potassium Chloride Braun 1 mEq/ml is available in:

Plastic polyethylene vials; content: 10 ml, 20 ml

Container sizes:

1 x 10 ml, 20 x 10 ml, 100 x 10 ml

1 x 20 ml, 20 x 20 ml, 100 x 20 ml

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 November 2017

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

This information is intended solely for doctors or healthcare professionals:

To view the complete information about this medicine, consult the Technical Data Sheet or Summary of Product Characteristics.