Potassium chloride 0,15% + sodium chloride 0,9% b. braun

Package leaflet: 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
Please read all of this leaflet before use, as it contains important information for the patient.

• Keep this leaflet for future reference.
• Consult your doctor or pharmacist if you have any further questions.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including those not listed in this leaflet, inform a doctor or pharmacist immediately. See section 4.

Leaflet contents:

1. What Potassium Chloride 0.15% 0.3% + Sodium Chloride 0.9% B. Braun is and what it is 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 pack and other information

1. What Potassium Chloride 0.15% 0.3% + Sodium Chloride 0.9% B. Braun is and what it is 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).
This medicine is given to maintain or restore the balance of potassium, sodium, chloride, and fluid levels in the body when 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 excessively high sodium levels in the blood (severe hypernatremia),
• in case of severe kidney disease,
• in case of excessive amount of water in the body (overhydration).

Warnings and precautions
Before starting treatment with Potassium Chloride 0.15% 0.3% + Sodium Chloride 0.9%
B. Braun, you should discuss this with your doctor.
Before or during administration of this medicine, your doctor will pay special attention to the following:

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

Special caution is required when administering large volumes of this medicine to patients who have any of the above conditions.

• Impaired kidney or liver function
  This medicine will be administered as a slow intravenous infusion, after the doctor has confirmed normal kidney and liver function in the patient. If abnormalities in kidney or liver function are detected during the infusion, blood potassium levels and heart function will be monitored. If the patient's condition worsens, the infusion should be discontinued.
• Heart diseases
  Caution should be exercised when administering this medicine to patients with heart diseases.

The doctor will exercise particular caution during administration of this medicine if the patient has high levels of acidic substances in the blood.
The doctor will also exercise particular caution if the patient suffers from Addison’s disease (adrenal insufficiency), as in such cases blood potassium levels may rise excessively.
During administration of this medicine, heart function, fluid balance, electrolyte levels, and sodium chloride levels in the body should be monitored.
Since elderly patients may be more susceptible to heart or kidney diseases, the patient's condition should be closely monitored during infusion and the dose should be carefully adjusted.
Children and adolescents
Particular caution should be exercised when using this medicine in children and adolescents.
Water and electrolyte balance should be closely monitored.
Potassium Chloride 0.15% 0.3% + Sodium Chloride 0.9% B. Braun and other medicines
You should inform your doctor about all medicines currently taken or recently used, as well as any medicines the patient plans to take.
You should inform your doctor if digoxin or similar medicines used to support heart function are being taken, as Potassium Chloride 0.15% 0.3% + Sodium Chloride 0.9% B. Braun may affect their action. In such cases, adjustment of the dose of Potassium Chloride 0.15% 0.3% + Sodium Chloride 0.9% B. Braun may be necessary.
You should also inform your doctor if you are taking medicines containing potassium or that may increase potassium levels in the body:

• potassium-sparing agents, e.g. spironolactone or triamterene (medicines that increase urine excretion),
• ACE inhibitors (medicines used to treat hypertension or heart diseases),
• AT receptor antagonists (medicines used to treat hypertension),
• nonsteroidal anti-inflammatory drugs (used in acute or chronic pain and inflammatory conditions),
• cyclosporine, tacrolimus (medicines used after organ transplantation),
• suxamethonium (a medicine used during anesthesia).

Particular caution should be exercised when using potassium-retaining medicines, as this may lead to heart problems (cardiac arrhythmias).
Since the use of other potassium-retaining medicines may lead to fluid retention and edema, the doctor will exercise special caution.
When certain medicines such as corticosteroids (used to treat many diseases such as asthma, hay fever, urticaria, eczema, joint or muscle pain, muscle cramp-related pain, inflammatory bowel disease, lupus, multiple sclerosis), ACTH (used to treat many diseases such as seizures in infants and children, multiple sclerosis, arthritis, lupus, Stevens-Johnson syndrome), or loop diuretics (used to treat hypertension) are used, increased potassium excretion by the kidneys may occur.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor before using this medicine.
This medicine may be administered to pregnant women or women who are breastfeeding, if so decided by the doctor.
Driving and operating machinery
Potassium Chloride 0.15% 0.3% + Sodium Chloride 0.9% B. Braun has no influence on the ability to drive or operate machinery.

3. How to use Potassium Chloride 0.15% 0.3% + Sodium Chloride 0.9% B. Braun

This medicine should always be used exactly as directed by the doctor. If in doubt, consult your
doctor.
Dosage
The recommended dose will be determined by the doctor according to the patient's age, body weight, and condition, particularly heart and kidney function. During administration of this medicine, chloride and electrolyte (salt) concentrations, fluid balance, and heart function will be routinely monitored. The doctor will ensure adequate urine output.
The recommended maximum dose for adult patients is 40 ml/kg body weight/day. If higher potassium doses are required, the doctor will consider using other formulations.
This medicine may be administered as long as there is a need for energy, electrolytes, and fluids.
Elderly patients
Generally, the same dosage as in adult patients may be used. However, in elderly patients, dose adjustment may be necessary to eliminate the risk of circulatory and kidney disorders.
Children and adolescents
In children and adolescents, the dose will depend on individual requirements. Lower doses may be used.
Method of administration
This medicine will be administered through a tube inserted directly into a vein (intravenous infusion).
Use of a higher than recommended dose of Potassium Chloride 0.15% 0.3% + Sodium Chloride 0.9% B. Braun
Taking an excessive dose is unlikely, as the dose is determined by the doctor.
Symptoms of overdose
If too high a dose of this medicine is administered, disturbances in kidney function may occur, as well as imbalances in electrolytes, fluid, and acid-base equilibrium. Fluid accumulation in the body and potassium poisoning may also occur.
In case of a sudden increase in blood sodium concentration, brain damage (osmotic demyelination syndrome) may occur.
In particular, blood potassium levels may rise significantly. Symptoms of this may include:

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

If excessive amounts of chlorides are administered, loss of bicarbonate and increased levels of acidic substances in the blood may occur.
Treatment of overdose
In case of overdose, the infusion should be stopped immediately. The doctor may also administer medications to increase urine excretion. Heart rhythm should be monitored regularly. The doctor will decide whether other treatments, such as insulin, are necessary, or whether other measures should be taken to correct electrolyte, fluid, and acid-base imbalances.
If you have any further doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Adverse reactions are unlikely if this medicine is used as recommended.
You should inform your doctor if you experience pain, excessive tenderness to touch, or redness with blood clots at the injection site.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
e-mail: [email protected]

Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

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

B. Braun
Keep this medicine out of the 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 of the bottle and carton following EXP. The expiry date refers to the last day of the specified month.
Do not use the medicine if it is cloudy or discoloured, if solid particles are visible in the solution, or if the container or closure is damaged.
The packaging is intended for single use only. The container and any unused medicine must be discarded after use.
Do not re-connect partially used containers.
To eliminate the possibility of air entering the system, flush the infusion set before starting the infusion.
If adverse reactions occur, discontinue the infusion 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 must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.
Do not store above 25°C.

6. Contents of the pack and other information

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

• The active substances are potassium chloride and sodium chloride. 1 ml of infusion solution contains 1.5 mg/ml or 3 mg/ml of potassium chloride and 9 mg of sodium chloride. 1 litre of infusion solution contains 20 mmol or 40 mmol of potassium, 154 mmol of sodium and 174 to 194 mmol of chloride.
• The other component is water for injections.
• Theoretical osmolarity: 340 mOsm/l to 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 contents of the pack
Infusion solution.
Potassium Chloride 0.15% 0.3% + Sodium Chloride 0.9% B. Braun, infusion solution, is a clear, colourless solution of potassium chloride and sodium chloride in water.
It is supplied in polyethylene bottles with a capacity of 500 ml or 1000 ml, available in packs of 10 units.
Not all pack sizes may be marketed.

Marketing Authorisation 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 authorised in the European Economic Area countries 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 Potassium Chloride 0.15% (0.3%) + Sodium Chloride 0.9% B. Braun
Slovakia Potassium Chloride 0.15% 0.3% + Sodium Chloride 0.9% B. Braun
United Kingdom Potassium Chloride 0.15% (0.3%) w/v and Sodium Chloride 0.9% w/v solution for infusion

Information intended exclusively for healthcare professionals:

Dosage
Adults:
The recommendations below should be considered as general guidelines for potassium dosing; however, local guidelines should be followed.
Potassium
The amount of potassium required to correct mild deficiencies and to maintain adequate potassium levels can be calculated using the following formula:
required amount of K in mmol = (body weight [kg] × 0.2)* × 2 × (target serum K concentration** – current serum K concentration [mmol/L])
* Represents extracellular fluid volume.
** Should be 4.5 mmol/L.
The maximum recommended daily dose of potassium is 2 to 3 mmol/kg body weight/day.

Children and adolescents:
Generally, the potassium replacement rate should not exceed 0.5 mmol/kg body weight per hour. Continuous ECG monitoring is required during infusion.

Maximum daily dose
The maximum recommended dose of potassium is 3 mmol/kg body weight/day. Under no circumstances should the daily fluid intake limit be exceeded.

Infusion rate:
The infusion rate will depend on the patient's requirements (see section 4.4).
In patients with chronic hyponatremia, the infusion rate should be reduced to limit the increase in serum sodium concentration to a maximum of 0.35 mmol/L/hour.

Administration method
The maximum infusion rate for the medicinal product Potassium Chloride 0.15% 0.3% + Sodium Chloride 0.9% B. Braun, infusion solution, administered via peripheral veins, is 10 mmol potassium/hour. If a higher infusion rate is required, the product should be administered via a central vein.
In principle, infusion pumps should be used for potassium infusions as part of replacement therapy.

Contraindications

• Hyperkalemia,
• Severe renal failure with oliguria, anuria, or azotemia,
• Hyperchloremia and severe hypernatremia,
• Hypervolemia (overhydration).

Special warnings
Conditions requiring restriction of sodium intake include: heart failure, generalized edema, pulmonary edema, hypertension, pre-eclampsia, severe renal failure, and liver cirrhosis.
Sodium chloride supplementation should be administered slowly in patients with chronic hypernatremia, as overly rapid correction of serum sodium levels may, in rare cases, lead to osmotic adverse effects.

Children and adolescents
Due to immature renal function, premature infants and neonates may retain excess sodium. In this age group, prolonged sodium chloride infusion should only be initiated after prior determination of serum sodium concentration.

Incompatibilities
Due to lack of pharmaceutical compatibility data, this medicinal product should not be mixed with other medicinal products.

Shelf-life after first opening of the container
From a microbiological standpoint, solutions should be administered immediately after preparation. If not administered immediately, the responsibility for storage duration and conditions lies with the user.