Potassium Hloride 0,15% + Glucose 5% B. Braun

Leaflet attached to the packaging: information for the user

Potassium Chloride 0.15% + Glucose 5% B. Braun, 1.5 g/l + 55.0 g/l, solution for infusion
Potassium Chloride 0.3% + Glucose 5% B. Braun, 3.0 g/l + 55.0 g/l, solution for infusion
Potassium chloride and glucose

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 questions.
• This medicine has been prescribed to you by a doctor. 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 undesirable effects, including any undesirable effects not mentioned in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What is Potassium Chloride 0.15% 0.3% + Glucose 5% B. Braun and what is it used for

used
This medicine contains a solution of potassium chloride and glucose. It is administered through a thin tube directly into a vein (intravenous infusion).
The medicine will be administered to maintain or restore potassium levels and to meet energy needs.

2. Important information before using Potassium Chloride 0.15% 0.3% + Glucose 5% B. Braun

When not to use Potassium Chloride 0.15% 0.3% + Glucose 5% B. Braun

• in case of abnormally high levels of potassium or chloride in the blood (hyperkalemia or hyperchloremia),
• in case of severe kidney disease,
• in case of head injury (within the first 24 hours after injury),
• in case of too much water in the body (overhydration),
• in case of too high a level of glucose in the blood (hyperglycemia),
• in case of a recent stroke.

Warnings and precautions

Patients taking this medicine and who are also in a state of severe stress, pain, post-operative stress, infection, burns, nervous system disorders, heart, liver or kidney disease, as well as patients taking medicines that enhance the action of vasopressin (a hormone responsible for regulating the amount of fluids in the body), are particularly at risk of low sodium levels in the blood (acute hyponatremia), which can lead to brain swelling (encephalopathy).
Children, women of childbearing age and patients with severe brain disorders, such as meningitis (infection of the membrane surrounding the brain) or patients with brain injuries are particularly at risk of severe and life-threatening brain swelling caused by a sudden drop in sodium levels in the blood.
Before starting to take Potassium Chloride 0.15% 0.3% + Glucose 5%, you should discuss it with your doctor.
Before or during the administration of this medicine, the doctor will pay particular attention to the following:

• Impaired kidney function. This medicine will be administered in a slow intravenous infusion, after the doctor has confirmed that the patient's kidneys are working properly. If kidney function disorders are detected during the infusion, potassium levels in the blood and ECG results 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.
• Swelling of the lower limbs or fluid accumulation in the lungs (pulmonary edema). When administering large volumes of this medicine to patients with one of the above conditions, particular caution should be exercised.
• Electrolyte (salt) levels in the blood
• Certain types of diabetes. This medicine should be administered with caution in the case of:
• diabetic patients,
• patients with carbohydrate metabolism disorders (when using this medicine, you should also consult the section "Other medicines and Potassium Chloride 0.15% 0.3% + Glucose 5% B. Braun"). Blood sugar levels should be monitored.
• Blood transfusions. This medicine should not be administered simultaneously, directly before or directly after blood transfusion through the same infusion set.
• Elevated potassium levels in the blood. This occurs when the patient has a condition characterized by elevated potassium levels in the blood, such as Addison's disease (adrenal cortex insufficiency).
• Burns. Caution should be exercised when administering this medicine to patients with burns.
• Dehydration. Caution should be exercised when administering this medicine to dehydrated patients.

During the administration of this medicine, ECG results, fluid and electrolyte balance, as well as blood glucose levels will be regularly monitored.
Particular attention should be paid to the condition of elderly patients and the dose should be adjusted during the administration of this medicine to elderly patients, as they are more prone to heart and kidney disorders.

Children and adolescents

When using this medicine in children and adolescents, particular caution should be exercised.
Fluid and electrolyte balance should be closely monitored.
This medicine should be administered to children and adolescents with caution, especially in cases of low electrolyte levels, especially sodium. The doctor will monitor electrolyte levels and fluid levels.

Potassium Chloride 0.15% 0.3% + Glucose 5% B. Braun and other medicines

You should inform your doctor, nurse or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take, especially:

• carbamazepine and oxcarbazepine used to treat epilepsy,
• vincristine and ifosfamide used in cancer therapy,
• cyclophosphamide used in cancer therapy and treatment of autoimmune diseases,
• selective serotonin reuptake inhibitors (SSRIs) used to treat depression,
• antipsychotic medicines used to treat mental disorders,
• opioid painkillers used to treat severe pain,
• non-steroidal anti-inflammatory medicines (NSAIDs) used to treat moderate to severe pain and inflammatory conditions,
• desmopressin used to treat diabetes insipidus (excessive thirst and production of large amounts of diluted urine),
• oxytocin used during childbirth,
• vasopressin and terlipressin used to treat "bleeding esophageal varices" (enlarged veins in the esophagus due to liver problems),
• diuretics or water tablets (medicines that increase urine production).

You should inform your doctor if you are taking digoxin or similar medicines that support heart function, as Potassium Chloride 0.15% 0.3% + Glucose 5% 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% + Glucose 5% B. Braun.
You should also inform your doctor if you are taking medicines that contain potassium or may increase potassium levels in the body:

• potassium-sparing medicines, such as spironolactone or triamterene (medicines that increase urine production),
• ACE inhibitors (medicines used to treat high blood pressure or heart disease),
• angiotensin II receptor antagonists (a type of medicine that lowers 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).

Particular caution should be exercised when using medicines that retain potassium,

as this may lead to heart problems (arrhythmias).When using certain medicines, such as corticosteroids, ACTH, and loop diuretics, potassium excretion by the kidneys may increase.

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% + Glucose 5% B. Braun does not affect the ability to drive and use machines.

3. How to use Potassium Chloride 0.15% 0.3% + Glucose 5% B. Braun

This medicine should always be used in accordance with the doctor's recommendations. In case of doubts, you should consult your doctor.
Dosage
The recommended dose will be determined by the doctor, depending on the patient's age, weight, and condition, in particular heart and kidney function. During the administration of this medicine, blood glucose and electrolyte levels, fluid balance, and ECG results 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 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 the case of 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 may 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% + Glucose 5% B. Braun

than recommended

Taking too much of this medicine is unlikely, as the dose is determined by the doctor.
The doctor will monitor the patient's chemical balance and fluid balance, glucose and electrolyte levels (including sodium) in the blood before and during treatment, especially in patients with vasopressin release disorders (hormone responsible for regulating the amount of fluids in the body) and patients taking medicines that enhance the action of vasopressin, due to the risk of low sodium levels in the blood (hyponatremia).
Overdose symptoms
In case of overdose of this medicine, disturbances of electrolyte, sugar, water, and acid-base balance may occur. It may also lead to fluid accumulation in the body and potassium poisoning.
In particular, potassium levels in the blood may rise significantly. Symptoms of such a situation may include:

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

In case of any further doubts related to 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.
It may lead to disturbances of fluid balance and some minerals in the patient's body. It may lead to low levels of sodium, potassium, phosphate, and magnesium in the blood. Low sodium levels in the blood may lead to a severe condition called hospital hyponatremia, which can lead to irreversible brain damage and death due to brain swelling (hyponatremic encephalopathy). Symptoms of brain swelling include: headaches, nausea, vomiting, seizures, feeling of fatigue and lack of energy.
Side effects should not be expected if this medicine is used in accordance with the recommendations.
You should inform your doctor if you experience pain or excessive sensitivity to touch or if you notice red blood clots at the injection site.

Reporting side effects

If you experience any side effects, including any side effects not mentioned in the leaflet, you should inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of 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 the medicine.

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

In the intact packaging: do not store at a temperature above 25°C.
The medicine should be stored in a place out of sight and reach of children.
Do not use this medicine 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 if there are color changes, if solid particles are visible in the solution, or if the packaging or closure is damaged.
The packaging is intended for single use only. The packaging and any remaining medicine should be discarded after use.
The medicine should be administered immediately. If the medicine is not administered immediately, the user is responsible for the period and conditions of storage. 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.

6. Contents of the packaging and other information

What does Potassium Chloride 0.15% 0.3% + Glucose 5% B. Braun contain

• The active substances of the medicine are potassium chloride and glucose. 1 ml of the solution for infusion contains 1.5 mg (3 mg) of potassium chloride and 50 mg of glucose. 1000 ml of the solution for infusion contains 20 mmol (40 mmol) of potassium and 20 (40) mmol of chloride.
• The other ingredients are water for injections.
• Energy 835 kJ/l ≈ 200 kcal/l Osmolality, theoretical 318 mOsm/l 358 mOsm/l pH approximately 3.5 - 6.5

What does Potassium Chloride 0.15% 0.3% + Glucose 5% B. Braun look like and what does the packaging contain

Potassium Chloride 0.15% 0.3% + Glucose 5% B. Braun, solution for infusion, is a clear, colorless to slightly straw-colored solution of potassium chloride and glucose in water.
It is available in polyethylene bottles with a capacity 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/glucose 0.15% 0.3% + 5% B. Braun
Estonia
Kalii chloridum/Glucosum B. Braun 1.5 mg/ml (3 mg/ml) + 50 mg/ml, infuusioneste, liuos / infusionsvätska, lösning / infusioonilahus
Spain
Cloruro Potásico 1.5 (3 mg/ml) mg/ml en Glucosa 50 mg/ml Prediluido B. Braun solución para perfusión
Finland
Kalii chloridum/Glucosum B. Braun 1.5 mg/ml (3 mg/ml) + 50 mg/ml infuusioneste, liuos / infusionsvätska, lösning / infusioonilahus
Ireland
Potassium Chloride 0.15% (0.3%) w/v and Glucose 5% w/v solution for infusion
Netherlands
Kaliumchloride 0,15% 0,3% - Glucose 5%, oplossing voor intraveneuze infusie
Poland
Potassium Chloride 0.15% 0.3% + Glucose 5% B. Braun
Portugal
Cloreto de Potássio 0.15% (0.3%) + Glucose 5% B.Braun
Slovakia
Kaliumchlorid/glucose 0,15% 0,3% + 5% B. Braun
United Kingdom
Potassium Chloride 0.15% (0.3%) w/v and Glucose 5% w/v solution for infusion

Date of last revision of the leaflet: 2018.07.20

Information intended exclusively for healthcare professionals:

Dosage
Adults:
The recommendations given below should be treated as general guidelines for potassium dosage, however, the obligatory 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 K level in serum ** - actual K level in serum [mmol/l])
* Indicates 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.
Maximum infusion rate:
Up to 5 ml/kg body weight per hour, which corresponds to 0.25 g glucose/kg body weight per hour.
Children and adolescents
Generally, the substitution rate should not exceed 0.5 mmol potassium/kg body weight per hour.
Maximum daily dose
The maximum recommended dose of potassium is 2 to 3 mmol/kg body weight per day. In no case should the daily fluid intake limit be exceeded.
Method of administration
As a rule, potassium infusions for replacement therapy should be administered using infusion pumps.
Special warnings
Solutions with low electrolyte content, in particular sodium, should be administered with caution to patients with hyponatremia.
Caution should be exercised to avoid a sudden drop in sodium levels in the blood, as this may be associated with the risk of osmotic damage to the central nervous system.
Children and adolescents
Infusion of hypotonic solutions with non-osmotic ADH release (in pain, post-operative phase, during nausea, vomiting) may lead to hyponatremia.
Treatment in case of overdose
Immediate discontinuation of the infusion, ECG monitoring, and if necessary, correction of urine output, and consequently fluid and electrolyte excretion, administration of sodium bicarbonate and insulin.
When administering insulin to increase cellular potassium uptake, glucose should be administered to avoid hypoglycemia. In case of persistent ECG abnormalities, calcium gluconate may be administered to counteract the cardiotoxic effect of potassium. Hemodialysis or peritoneal dialysis may be necessary in patients with renal failure.
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 period and conditions of storage. More information about this medicine can be found in the Summary of Product Characteristics.