B. Braun

Concentrate for solution for infusion 1 mmol / ml 
(clear, colorless liquid)

Read all of this leaflet carefully before you start using this medicine.

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet you will find information about: 
1. What is Addens-Potassium Chloride B. Braun and what it is used for 
2. What you need to know before using Addens-Potassium Chloride B. Braun 
3. How to use Addens-Potassium Chloride B. Braun 
4 . Possible side effects 
5. How to store Addens’ Potassium Chloride B. Braun 
6. Contents of the pack and other information 

1. What Addens-Potassium Chloride B. Braun is and what it is used for

Addens-Potassium Chloride B. Braun is a concentrated solution containing potassium chloride.

It is used for potassium supply:

  • if you have a potassium deficiency, especially if it is accompanied by an excess base and abnormally low chloride content in the blood (hypochloremic alkalosis )
  • as part of parenteral nutrition ( intravenous ) if you can not eat food in the usual way.

2. What you need to know before you use Addens-Potassium Chloride B. Braun

Do not use Addens-Potassium Chloride B. Braun

  • if you have abnormally high levels of potassium or chloride in your blood (hyperkalemia, hyperchloraemia ).

Warnings and cautions

Talk to your doctor before using Addens-Potassium Chloride B. Braun.

Particular care should be taken with Addens-Potassium Chloride B. Braun

  • if you have heart problems
  • if you have a disease that is often associated with decreased urinary potassium excretion, such as renal impairment, Addison’s disease (a disease of the adrenal glands), or sickle cell anemia (a hereditary disease of the red blood cells ). If you have severe renal impairment or receive dialysis treatment, your doctor will consult a kidney specialist before you receive this medicine.
  • if you are taking or receiving medicines that reduce the excretion of potassium in your urine. This applies, for example:
    • certain drugs that increase urinary excretion ( diuretics )
    • certain blood pressure medicines ( angiotensin II receptor antagonists, ACE inhibitors )
  • if you are taking or receiving medicines that may affect your kidney function (for example, certain anti-inflammatory drugs)
  • if you suffer from shock (an acute medical condition accompanied by a drop in blood pressure, cold skin, rapid heartbeat, and irregular breathing and which may occur if you have lost a lot of blood, suffered severe burns, or an allergic reaction )
  • if you have extensive tissue damage (eg burns)
  • if you have a disease that causes muscle weakness and in some cases abnormally high potassium levels in the blood (hyperkalemic familial periodic paralysis).

Your doctor will consider these points before and during treatment with this medicine.

If you are taking this medicine due to a lack of potassium, you will not be given glucose infusions at the same time, as glucose may cause a further reduction in potassium levels.

During treatment, the electrolyte content in your blood and acid-base balance will be monitored. This is done to ensure that your values ​​are normal. In addition, ECG monitoring can be performed.

The person giving the solution to you makes sure that it is given in a vein, as the solution can cause tissue damage if given outside a vein.

If you are taking this medicine due to a lack of potassium, your doctor will usually give it to you using an infusion pump

Elderly patients have an increased tendency for heart and kidney problems and will therefore be closely monitored during treatment. In these patients, dose one will be carefully adjusted.

If you are very malnourished, ie have not received enough food, there is a risk that you will suffer from a condition called rebirth syndrome. Your doctor will monitor you closely and increase your nutritional intake slowly.

Other medicines and Addens-Potassium chloride B. Braun

Tell your doctor if you are taking, have recently taken, or might take any other medicines.

It is especially important for your doctor to know if you are using:

  • Drugs used to treat heart failure (cardiac glycosides, eg digoxin ): The effect of these drugs becomes weaker as the potassium concentration in the blood increases. The effect of these drugs becomes stronger (and may possibly cause irregular heartbeat) as the potassium concentration in the blood decreases.
  • Drugs that reduce the excretion of potassium in the urine: These include
    • certain drugs that increase urine production (potassium-sparing diuretics such as triamterene, amiloride, spironolactone )
    • certain medicines for high blood pressure ( angiotensin II receptor antagonists, ACE inhibitors )
    • drugs that inhibit the immune system (tacrolimus, ciclosporin)
    • certain medicines to treat pain or inflammation (non-steroidal anti-inflammatory drugs)
    • blood thinners ( heparin )
      Concomitant treatment with potassium and these drugs can lead to very high potassium levels in the blood. This can affect heart rhythm.
  • Drugs that increase the excretion of potassium in the urine: The following medicines may increase the excretion of potassium in the urine:
    • a certain hormone (adrenocorticotropic hormone ie ACTH)
    • certain medicines used to treat inflammation ( corticosteroids )
    • certain drugs that increase urinary excretion (loop diuretics)
      Concomitant treatment with potassium and these drugs can lead to you getting the wrong dose of potassium because the potassium you get disappears from the body faster than normal.
  • Suxamethone (a muscle relaxant used in connection with anesthesia): Concomitant treatment with potassium and suxamethonium can lead to very high potassium levels in the blood. This can affect heart rhythm.

Pregnancy and breastfeeding

Pregnancy

If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine. Your doctor will decide if you can use Addens-Potassium Chloride B.Braun.

Breast-feeding

Addens-Potassium chloride B. Braun can be used during breast-feeding.

Driving and using machines

Addens-Potassium chloride B. Braun has no effect on the ability to drive and use machines.

3. How to use Addens-Potassium Chloride B. Braun

Addens-Potassium Chloride. B. Braun is given to you after dilution with a suitable solution. It is given via a cannula or a small tube into a vein ( intravenous infusion ).

Dosage

Your doctor will calculate the appropriate amount based on the electrolyte concentration in your blood, your acid-base balance, age, and your individual needs.

If you use too much Addens’ Potassium Chloride B. Braun

It is unlikely that you would receive too much of the medicine. The doctor or healthcare professional monitors the treatment.

Overdose can cause abnormally high levels of potassium, which can cause side effects (see section 4).

If you have any further questions on the use of this product, ask your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects may be serious, contact your doctor immediately if you get any of the following side effects:

  • irregular heartbeat ( cardiac arrhythmia, caused by the drug being given too fast) (occurs in an unknown number of users)

Overdose can cause hyperkalemia (too high a potassium level in your blood). Symptoms may include slow heart rate or even cardiac arrest, electrocardiogram ( ECG ) changes, drop in blood pressure, redistribution of circulating blood from arms and legs to head and torso, weakness, fatigue, confusion, heaviness in arms and legs, muscle twitching, loss of sensation, loss of sensation.

Other side effects are

  • the accumulation of acidic substances in the blood ( acidosis ) (occurs in an unknown number of users).
  • the abnormally high chloride content in the blood ( hyperchloraemia ) (occurs in an unknown number of users).
  • nausea (affects an unknown number of users)
  • injection site reactions including local pain, irritation, or inflammation of the veins ( thrombophlebitis ) and leakage of fluid into the surrounding tissue(extravasation) (occurs in an unknown number of users).

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

5. How to store Addens’ Potassium Chloride B. Braun

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The expiration date is the last day of the specified month.

No special storage instructions.

May only be used if the solution is clear and colorless and if the container and its closure are undamaged.

The container is for single use only. Any unused product or waste material should be disposed of in accordance with local requirements.

6. Contents of the packaging and other information

Content declaration

  • The active substance is potassium chloride.1 ml of concentrate for solution for infusion contains 74.5 mg of potassium chloride corresponding to 1 mmol of potassium and 1 mmol of chloride.
    One 20 ml ampoule contains 1.49 g of potassium chloride. One 50 ml bottle contains 3.73 g of potassium chloride.
  • The other ingredients are water for injections.

What the medicine looks like and the contents of the pack

Addens-Potassium Chloride B. Braun is a clear, colorless aqueous solution.

pH 4.5 – 7.5

Packaging:

Mini Plasco plastic ampoule made of polyethylene, 20×20 ml

Mini Plasco Connect plastic ampoule made of polyethylene, 20×20 ml

Glass bottle with a stopper of halobutyl rubber, 20×50 ml

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

B. Braun Melsungen AG

34209 Melsungen

Germany

Manufacturer

B. Braun Melsungen AG

Carl-Braun-Strasse 1

34212 Melsungen

Germany

or

B. Braun Medical SA

Terrace Carrier 121

08191 Rubi, Barcelona

Spain

Further information on this medicine can be obtained from the representative of the marketing authorization holder:

B. Braun Medical AB

Box 110 
SE-182 12 Danderyd

This leaflet was last modified on 03/05/2018

The following information is intended for healthcare professionals only:

Instructions for use, handling, and disposal:

Intravenous use.

May only be given as an infusion after dilution with a suitable infusion solution.

80 ml (equivalent to 80 mmol = 4 ampoules ) can be added to 1000 ml of most common infusion fluids such as amino acid solutions, glucose, glucose – electrolyte – and electrolyte solutions. Addition of Addens-Potassium Chloride B. Braun should be performed aseptically just before the start of the infusion.

The potassium concentration in the infusion solution should not normally exceed 40 mmol per liter.

If the serum potassium concentration in adults is below 2 mmol per liter, the potassium concentration in the infusion solution may be up to 80 mmol per liter.

In principle, an infusion of potassium should be given using an infusion pump to correct the potassium concentration.

The container is for single use only. Any unused product or waste material should be disposed of in accordance with local requirements.

Shelf life after first opening the container: From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to administration are the responsibility of the user and would normally not be longer than 24 hours at 2 – 8 ° C, unless dilution has taken place under controlled and validated aseptic conditions.

Muhammad Nadeem

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