POTASSIUM 1.5 g/l + 9 g/l Solution

Contents of the leaflet

1. Leaflet accompanying the packaging: information for the user
   1. You should read the contents of the leaflet before using the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet:
3. Important information before using Potassium Chloride 0.15% 0.3% + Sodium Chloride 0.9% B. Braun
   1. When not to use Potassium Chloride 0.15% 0.3% + Sodium Chloride 0.9% B. Braun
   2. Warnings and precautions
   3. Pregnancy and breastfeeding
   4. Driving and using machines
4. 1. Using a higher dose of Potassium Chloride 0.15% 0.3% + Sodium Chloride 0.9% B. Braun than recommended
5. Possible side effects
   1. Reporting side effects
6. How to store Potassium Chloride 0.15% 0.3% + Sodium Chloride 0.9% B. Braun
7. Contents of the packaging and other information
   1. Marketing authorization holder:
   2. Manufacturer:
   3. This medicinal product is authorized in the Member States of the European Economic Area under the following names:
   5. Date of last revision of the leaflet: 2017-04-02
   6. Information intended for healthcare professionals only:

Leaflet accompanying the packaging: information for the user

Potassium Chloride 0.15% + Sodium Chloride 0.9% B. Braun, 1.5 g/l + 9.0 g/l, solution for infusion
Potassium Chloride 0.3% + Sodium Chloride 0.9% B. Braun, 3.0 g/l + 9.0 g/l, solution for infusion
Potassium chloride and sodium chloride

You should read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• -You should keep this leaflet, so that you can read it again if necessary.
• -You should consult a doctor or pharmacist if you have any further doubts.
• -This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• -If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Potassium Chloride 0.15% 0.3% + Sodium Chloride 0.9% B. Braun and what is it used for
• 2. Important information before using Potassium Chloride 0.15% 0.3% + Sodium Chloride 0.9% B. Braun
• 3. How to use Potassium Chloride 0.15% 0.3% + Sodium Chloride 0.9% B. Braun
• 4. Possible side effects
• 5. How to store Potassium Chloride 0.15% 0.3% + Sodium Chloride 0.9% B. Braun
• 6. Contents of the packaging and other information

1.

What is Potassium Chloride 0.15% 0.3% + Sodium Chloride 0.9% B. Braun and what is it used for

This medicine contains a solution of potassium chloride and sodium chloride. It is administered through a thin tube directly into a vein (intravenous infusion).
The medicine will be administered to maintain or restore the balance of potassium, sodium, chloride, and fluid levels if these levels are too low.

2. Important information before using Potassium Chloride 0.15% 0.3% + Sodium Chloride 0.9% B. Braun

When not to use Potassium Chloride 0.15% 0.3% + Sodium Chloride 0.9% B. Braun

• in case of abnormally high levels of potassium (hyperkalemia) or chloride (hyperchloremia) or too high levels of sodium in the blood (severe hypernatremia),
• in case of severe kidney disease,
• in case of too much water in the body (overhydration).

Warnings and precautions

Before starting to take Potassium Chloride 0.15% 0.3% + Sodium Chloride 0.9% B. Braun, you should discuss it with your doctor.

• B. Braun, the doctor will pay special attention to the following things:

Before or during the administration of this medicine, the doctor will pay special attention to the following things:

• High levels of sodium in the blood (hypernatremia).
• Swelling of the lower limbs or fluid accumulation in the lungs (pulmonary edema)

In case of administration of large volumes of this medicine to patients with one of the above conditions, special caution should be exercised.

• Abnormal kidney or liver function The medicine will be administered in slow intravenous infusion, after the doctor has confirmed that the patient's kidneys and liver are working properly. In case of abnormalities in kidney or liver function during the infusion, the levels of potassium in the blood and heart function will be monitored. If the patient's condition worsens, the infusion should be discontinued.
• Heart disease Caution should be exercised when administering this medicine to patients with heart disease.

The doctor will exercise special caution when administering this medicine in case of high levels of acidic substances in the patient's blood.
The doctor will exercise special caution when the patient has Addison's disease (adrenal insufficiency), as the levels of potassium in the blood may increase excessively.
During the administration of this medicine, the heart function, fluid balance, electrolyte levels, and sodium chloride levels in the body will be monitored.
As elderly patients may be more prone to heart or kidney disease, their condition should be closely monitored during the infusion and the dose should be carefully adjusted.
Children and adolescents
When using this medicine in children and adolescents, special caution should be exercised.
The fluid and electrolyte balance should be closely monitored.
Potassium Chloride 0.15% 0.3% + Sodium Chloride 0.9% B. Braun and other medicines
You should tell your doctor about all the medicines you are taking or have recently taken, as well as any medicines you plan to take.
You should inform your doctor if you are taking digoxin or similar medicines that support heart function, as Potassium Chloride 0.15% 0.3% + Sodium Chloride 0.9% B. Braun may affect their action. In such a case, it may be necessary to adjust the dose of Potassium Chloride 0.15% 0.3% + Sodium Chloride 0.9% B. Braun.

• You should also inform your doctor if you are taking medicines that contain potassium or may increase the level of potassium in the body:

You should also inform your doctor if you are taking medicines that contain potassium or may increase the level of potassium in the body:

• potassium-sparing medicines, such as spironolactone or triamterene (diuretics),
• ACE inhibitors (medicines used to treat high blood pressure or heart disease),
• angiotensin II receptor antagonists (medicines used to treat high blood pressure),
• non-steroidal anti-inflammatory medicines (used to treat acute or chronic pain and inflammatory conditions),
• cyclosporine, tacrolimus (medicines used after organ transplants),
• suxamethonium (a medicine used during anesthesia).

Special caution should be exercised when using medicines that retain potassium, as this may lead to heart problems (arrhythmias).
As the use of other potassium-retaining medicines may lead to the formation of edema due to water retention, the doctor will exercise special caution.
In case of the use of certain medicines, such as corticosteroids (used to treat many diseases, such as asthma, hay fever, hives, eczema, joint or muscle pain, or menstrual cramps), ACTH (used to treat many diseases, such as infantile spasms, multiple sclerosis, arthritis, lupus, or Stevens-Johnson syndrome), and loop diuretics (used to treat high blood pressure), there may be an increased excretion of potassium by the kidneys.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor before using this medicine.
This medicine may be administered to pregnant or breastfeeding women if the doctor decides so.

Driving and using machines

Potassium Chloride 0.15% 0.3% + Sodium Chloride 0.9% B. Braun does not affect the ability to drive or use machines.

3.

How to use Potassium Chloride 0.15% 0.3% + Sodium Chloride 0.9% B. Braun
This medicine should always be used according to the doctor's recommendations. In case of doubts, you should consult your doctor.
Dosage
The recommended dose will be determined by the doctor based on the patient's age, weight, and condition, particularly heart and kidney function. During the administration of this medicine, the levels of chloride, electrolytes, fluid balance, and heart function will be routinely monitored. The doctor will ensure adequate urine output.
The recommended maximum dose for an adult patient is 40 ml/kg body weight/day. If it is necessary to use a larger amount of potassium, the doctor will also consider using other strengths.
This medicine may be administered for as long as there are indications for the administration of energy, electrolytes, and fluids.
Elderly patients
Generally, the same dosage as for adult patients can be used. However, in elderly patients, it may be necessary to adjust the dose to eliminate the risk of circulatory and kidney disorders.
Children and adolescents
In children and adolescents, the dose will depend on individual needs. Smaller doses can be used.
Method of administration
This medicine will be administered through a tube inserted directly into a vein (intravenous infusion).

Using a higher dose of Potassium Chloride 0.15% 0.3% + Sodium Chloride 0.9% B. Braun than recommended

It is unlikely that an overdose of the medicine will occur, as the dose is determined by the doctor.
Overdose symptoms
In case of an overdose of this medicine, kidney function may be impaired, and there may be disturbances in electrolyte, fluid, and acid-base balance. There may also be an accumulation of water in the body and potassium poisoning.
In case of a sudden increase in sodium levels in the blood, there may be brain damage (osmotic demyelination syndrome).
In particular, the levels of potassium in the blood may increase significantly. The symptoms of such a situation may include:

• low blood pressure (hypotension),
• irregular heartbeat or cardiac arrest,
• general weakness and apathy,
• muscle weakness, inability to move,
• numbness, weakness, or heaviness in the legs,
• feeling of disorientation.

In case of an overdose of chloride, there may be a loss of bicarbonate and an increase in the levels of acidic substances in the blood.
Treatment of overdose
In case of an overdose, the infusion should be stopped immediately. The doctor may also administer medicines that increase urine production. The heart rhythm should be monitored regularly. The doctor will decide whether it is necessary to administer other medicines, such as insulin, or take other actions to balance the levels of electrolytes, fluid, and acid-base.
In case of any further doubts about the use of this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
You should not expect side effects to occur if this medicine is used according to the recommendations.
You should inform your doctor if you experience pain or excessive sensitivity to touch or red blood clots at the injection site.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
e-mail: [email protected]
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Potassium Chloride 0.15% 0.3% + Sodium Chloride 0.9% B. Braun

The medicine should be stored out of sight and reach of children.
Do not use Potassium Chloride 0.15% 0.3% + Sodium Chloride 0.9% B. Braun after the expiry date stated on the labels on the bottle and carton after EXP. The expiry date refers to the last day of the given month.
Do not use the medicine if it is cloudy or discolored, if there are visible solid particles, or if the packaging or closure is damaged.
The packaging is for single use only. The packaging and any remaining medicine should be discarded after use.
Do not reconnect partially used containers.
To prevent air from entering the system, the infusion set should be flushed before starting the infusion.
In case of side effects, the infusion should be stopped immediately.
The product should be administered immediately. If the medicine is not administered immediately, the user is responsible for the storage period and conditions. Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.
Do not store above 25°C.

6. Contents of the packaging and other information

What contains Potassium Chloride 0.15% 0.3% + Sodium Chloride 0.9% B. Braun

• The active substances of the medicine are potassium chloride and sodium chloride. 1 ml of the solution for infusion contains 1.5 mg/ml (3 mg/ml) of potassium chloride and 9 mg of sodium chloride. 1 liter of the solution for infusion contains 20 mmol (40 mmol) of potassium, 154 mmol of sodium, and 174-194 mmol of chloride
• The other ingredients are water for injections.
• Theoretical osmolality 340 mOsm/l 380 mOsm/l pH (approximately) 4.5 - 7.0

What Potassium Chloride 0.15% 0.3% + Sodium Chloride 0.9% B. Braun looks like and what the packaging contains
Solution for infusion.
Potassium Chloride 0.15% 0.3% + Sodium Chloride 0.9% B. Braun, solution for infusion, is a clear, colorless solution of potassium chloride and sodium chloride in water.
It is supplied in polyethylene bottles of 500 ml or 1000 ml, available in packs of 10.
Not all pack sizes may be marketed.

Marketing authorization holder:

• B. Braun Melsungen AG Carl-Braun-Strasse 1 34212 Melsungen Germany

Manufacturer:

• B. Braun Melsungen AG Carl-Braun-Strasse 1

34212 Melsungen
Germany
and

• B. Braun Medical S.A. Carretera de Terrassa 121, 08191 Rubi, Barcelona Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Czech Republic
Kaliumchlorid/natriumchlorid 0.15% 0.3% + 0.9% B. Braun
Estonia
Kalii chloridum/Natrii chloridum B. Braun 1.5 mg/ml (3 mg/ml) + 9 mg/ml, infuusioneste, liuos / infusionsvätska, lösning / infusioonilahus
Spain
Cloruro Potásico 1.5 mg/ml (3 mg/ml) en Fisiológico 9 mg/ml Prediluido B.
Braun solución para perfusión
Finland
Kalii chloridum/Natrii chloridum B. Braun 1.5 mg/ml (3 mg/ml) + 9 mg/ml infuusioneste, liuos / infusionsvätska, lösning / infusioonilahus
Ireland
Potassium Chloride 0.15 % (0.3 %)w/v and Sodium Chloride 0.9 % w/v solution for infusion
Netherlands
Kaliumchloride 0,15% 0,3% - Natriumchloride 0,9%, oplossing voor intraveneuze infusie
Poland
Potassium Chloride 0.15% 0.3% + Sodium Chloride 0.9% B. Braun
Portugal
Cloreto de Potássio 0.15% (0.3%)+ Cloreto de Sódio 0.9% B.Braun
Slovakia
Kaliumchlorid/natriumchlorid 0.15% 0.3% + 0.9% B. Braun
United Kingdom
Potassium Chloride 0.15% (0.3%)w/v and Sodium Chloride 0.9 % w/v solution for infusion

Date of last revision of the leaflet: 2017-04-02

Information intended for healthcare professionals only:

Dosage
Adults:
The recommendations given below should be treated as general guidelines for potassium dosage; however, local guidelines should be followed.
Potassium
The amount of potassium required to correct moderate deficiencies and to maintain adequate potassium levels can be calculated using the following formula:
required amount of mmol K = (body weight [kg] x 0.2)* x 2 x (target serum K concentration** - actual serum K concentration [mmol/l])
* Represents the extracellular fluid volume.
** Should be 4.5 mmol/l.
The maximum recommended dose of potassium is 2 to 3 mmol/kg body weight/day.
Children and adolescents:
Generally, the substitution rate should not exceed 0.5 mmol potassium/kg body weight/hour. During the infusion, continuous ECG monitoring should be performed.

Maximum daily dose
The maximum recommended dose of potassium is 3 mmol/kg body weight/day. In no case should the daily limit of fluid intake be exceeded.
Infusion rate:
The infusion rate will depend on the patient's needs (see section 4.4).
The infusion rate in patients with chronic hyponatremia should be lower, to limit the increase in sodium levels in the blood to a maximum of 0.35 mmol/l/hour.
Method of administration
The maximum infusion rate of Potassium Chloride 0.15% 0.3% + Sodium Chloride 0.9% B. Braun, solution for infusion, administered into peripheral veins, is 10 mmol potassium/hour. If a higher infusion rate is required, the product should be administered into a central vein.
As a rule, infusion pumps should be used for potassium infusion as part of replacement therapy.
Contraindications

• hyperkalemia,
• severe renal failure with oliguria, anuria, or azotemia,
• hyperchloremia and severe hypernatremia,
• overhydration.

Special warnings
Situations in which sodium intake should be restricted, such as heart failure, generalized edema, pulmonary edema, hypertension, pre-eclampsia, severe renal failure, or liver cirrhosis.
Sodium chloride supplementation should be performed slowly in patients with chronic hypernatremia, as rapid correction of sodium levels in the blood may, in rare cases, lead to osmotic adverse reactions.
Children and adolescents
Due to immature kidney function, premature infants and newborns may retain excess sodium. In this age group, prolonged infusion of sodium chloride can only be performed after determining the sodium level in the blood.
Incompatibilities
Due to the lack of pharmaceutical compatibility studies, this medicinal product should not be mixed with other medicinal products.
Shelf life after first opening of the packaging
From a microbiological point of view, mixtures should be administered immediately after preparation.
If the mixture is not administered immediately, the user is responsible for the storage period and conditions.