KALII 3 mg/50 mg Solution

Contents of the leaflet

1. Leaflet attached to the packaging: information for the user
2. Potassium Chloride 0.3% + Glucose 5% Kabi, (3 mg + 50 mg)/ml, solution for infusion
   1. You should carefully 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. What is Potassium Chloride 0.3% + Glucose 5% Kabi and what is it used for
4. Important information before using Potassium Chloride 0.3% + Glucose 5% Kabi
   1. When not to use Potassium Chloride 0.3% + Glucose 5% Kabi:
   2. Warnings and precautions
   3. Children and adolescents
   4. Potassium Chloride 0.3% + Glucose 5% Kabi and other medicines
   5. Potassium Chloride 0.3% + Glucose 5% Kabi with food and drink
   6. Pregnancy and breastfeeding
   7. Driving and using machines
5. How to use Potassium Chloride 0.3% + Glucose 5% Kabi
   1. Using more than the recommended dose of Potassium Chloride 0.3% + Glucose 5% Kabi
6. Possible side effects
   1. You should immediately inform your doctor or nurse if you experience any of the following side effects:
   2. Side effects related to the method of administration of the medicine:
   3. Reporting side effects
7. How to store Potassium Chloride 0.3% + Glucose 5% Kabi
8. Contents of the packaging and other information
   1. What Potassium Chloride 0.3% + Glucose 5% Kabi contains
   2. What Potassium Chloride 0.3% + Glucose 5% Kabi looks like and what the pack contains
   3. Marketing authorization holder and manufacturer
   4. Marketing authorization holder
   5. Manufacturer
   6. This medicinal product is authorized in the Member States of the European Economic Area under the following names:
   7. Method of handling and preparation of the solution

Leaflet attached to the packaging: information for the user

Potassium Chloride 0.3% + Glucose 5% Kabi, (3 mg + 50 mg)/ml, solution for infusion

Potassium Chloride + Glucose

You should carefully 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 you need to.
• If you have any doubts, you should consult a doctor or nurse.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or nurse. See section 4.

Table of contents of the leaflet

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

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

Potassium Chloride 0.3% + Glucose 5% Kabi is an aqueous solution of potassium chloride and glucose.
Potassium chloride is a chemical compound (a type of salt) that occurs naturally in the blood. Glucose is
one of the sources of energy for the body. This infusion solution provides 200 kilocalories per liter.
This medicine is used as a source of carbohydrates (sugars) in the prevention and treatment of:

• potassium loss from the body (e.g. after treatment with certain diuretics (tablets that increase urine production));
• low potassium levels in the blood (hypokalemia) in situations that may cause potassium and water loss:
• when the patient cannot eat or drink due to illness or after surgery;
• when the patient has excessive sweating due to high fever.

2. Important information before using Potassium Chloride 0.3% + Glucose 5% Kabi

When not to use Potassium Chloride 0.3% + Glucose 5% Kabi:

• if the patient has high potassium levels in the blood (hyperkalemia);
• if the patient has high chloride levels in the blood (hyperchloremia);
• if the patient has severe kidney disease (reduced or absent urine production);
• if the patient has heart failure that is not properly treated (uncompensated heart failure) and causes symptoms such as:
• shortness of breath;
• swelling of the ankles;
• if the patient has adrenal gland disorders (Addison's disease);
• if the patient has diabetes that is not properly treated and causes high blood sugar levels (uncontrolled diabetes);
• if the patient has other types of glucose intolerance, such as:
• metabolic stress (a condition in which the patient's metabolism does not work properly, e.g. due to severe illness);
• hyperosmolar coma (loss of consciousness); this is a type of coma that can occur in diabetic patients who do not receive enough medication;
• high blood sugar levels (hyperglycemia);
• high lactate levels in the blood (hyperlactatemia).

Warnings and precautions

This medicine has a higher concentration than blood (hypertonic solution). The doctor will take this into account when determining the dose for the patient.
Before starting treatment with Potassium Chloride 0.3% + Glucose 5% Kabi, you should inform your doctor or nurse:

• if the patient has any heart disease or heart failure;
• if the patient has respiratory failure (lung disease);
• if the patient has impaired kidney function (the patient may require special monitoring if they have any of the above-mentioned diseases);
• if the patient has adrenal gland disease (a gland located on top of the kidney) that affects the level of steroid hormones in the body (adrenal insufficiency);
• if the patient is dehydrated (excessive water loss, e.g. due to vomiting or diarrhea);
• if the patient has severe burns with extensive skin damage, e.g. after a burn;
• if the patient has had a head injury in the last 24 hours;
• if the patient has high blood pressure in the skull (intracranial hypertension);
• if the patient has recently had a stroke;
• if the patient is allergic to corn (Potassium Chloride 0.3% + Glucose 5% Kabi contains sugar derived from corn);
• if the patient has a condition that may cause increased levels of vasopressin (a hormone that regulates water content in the body). Increased vasopressin levels in the body may occur: if the patient has had a sudden or severe illness; if the patient is in pain; if the patient has had surgery; if the patient has an infection, burn, or central nervous system disease; if the patient has heart, liver, or kidney disease; if the patient is taking certain medications. This may increase the risk of low sodium levels in the blood, which can lead to symptoms such as headache, nausea, seizures, lethargy, coma, brain swelling, and death. Brain swelling increases the risk of death and brain damage. The increased risk of brain swelling occurs in:
• children;
• women (especially of childbearing age);
• patients with disorders of cerebrospinal fluid levels, which may be caused by meningitis, intracranial hemorrhage, or brain damage.

The doctor will closely monitor the patient's condition during treatment with this medicine. The doctor will take blood and urine samples to determine the patient's condition. Patients with heart or kidney disease should be monitored closely.
The doctor will consider whether the patient is receiving intravenous nutrition (nutrition administered through a drip into a vein).
In the case of long-term administration of Potassium Chloride 0.3% + Glucose 5% Kabi, the patient may require additional nutrition.
Potassium Chloride 0.3% + Glucose 5% Kabi contains sugar (glucose), which may cause high blood sugar levels (hyperglycemia). In such a situation, the doctor may:

• adjust the infusion rate;
• administer insulin to reduce blood sugar levels.

This is especially important in the case of diabetic patients.
Patients should be closely monitored. In cases where proper regulation of water content in the blood is disrupted due to increased secretion of antidiuretic hormone (ADH),
infusion of low-sodium fluids (hypotonic fluids) may lead to low sodium levels in the blood (hyponatremia). This can cause symptoms such as headache, nausea, seizures, drowsiness,
coma, brain swelling, and death, so the occurrence of these symptoms (severe symptomatic encephalopathy with hyponatremia) is considered a life-threatening condition.

Children and adolescents

Potassium Chloride 0.3% + Glucose 5% Kabi should be administered with particular caution in children.
Newborns, especially premature and low-birth-weight infants, are more susceptible to low or high blood sugar levels(hypo- or hyperglycemia) during intravenous administration of glucose solutions.

• Low blood sugar levelsin newborns can cause prolonged seizures, coma, and brain damage.
• High blood sugar levelsare associated with an increased risk of brain hemorrhage, delayed bacterial and fungal infections, gastrointestinal infection (necrotizing enterocolitis), vision damage (retinopathy of prematurity), lung disease (bronchopulmonary dysplasia), prolonged hospital stay, and death.

Potassium Chloride 0.3% + Glucose 5% Kabi and other medicines

You should tell your doctor or nurse about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take. It is especially important to inform your doctor if you are taking:

• cardiac glycosides used in heart disease (e.g. digoxin);
• anti-arrhythmic drugs used to treat irregular heart rhythm (e.g. quinidine, hydroquinidine, procainamide);
• drugs that increase potassium levels in the blood, such as:
• potassium-sparing diuretics (e.g. amiloride, spironolactone, triamterene);
• angiotensin-converting enzyme inhibitors (mainly used to treat high blood pressure);
• angiotensin II receptor antagonists (used to treat high blood pressure);
• cyclosporine (used to prevent transplant rejection);
• tacrolimus (used to prevent transplant rejection and treat certain skin diseases);
• potassium-containing drugs (e.g. potassium supplements, salt substitutes containing potassium).
• certain drugs that affect the action of vasopressin, including:
• antidiabetic drugs (chlorpropamide);
• cholesterol-lowering drugs (clofibrate);
• antiepileptic drugs (carbamazepine);
• drugs with an amphetamine-like structure (including MDMA);
• certain anticancer drugs (vincristine, ifosfamide, cyclophosphamide);
• selective serotonin reuptake inhibitors (used to treat depression);
• antipsychotic drugs;
• opioids used to treat severe pain;
• analgesic and/or anti-inflammatory drugs (also known as nonsteroidal anti-inflammatory drugs, NSAIDs);
• drugs that mimic or enhance the action of vasopressin, such as desmopressin (used to treat excessive thirst and urination), terlipressin (used to treat bleeding from the esophagus), and oxytocin (used to induce labor).
• other drugs that increase the risk of hyponatremia, including all diuretics and antiepileptic drugs such as oxcarbazepine.

Potassium Chloride 0.3% + Glucose 5% Kabi should not be administered through the same needle as a blood transfusion.
This may cause red blood cells to break down or clump together.

Potassium Chloride 0.3% + Glucose 5% Kabi with food and drink

You should consult your doctor about using Potassium Chloride 0.3% + Glucose 5% Kabi with food and drink.

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 or nurse before using this medicine.
This medicine may be used in pregnant and breastfeeding women. The doctor will closely monitor the amount of medicine administered to the patient. The doctor will order blood tests to monitor the levels of substances in the blood, as changes in potassium levels can affect the mother's and fetus's heart function.
Particular caution should be exercised when administering this medicine to pregnant women during labor, especially in combination with oxytocin (a hormone used to induce labor and prevent bleeding), due to the risk of hyponatremia.

Driving and using machines

This medicine does not affect the ability to drive or use machines.

3. How to use Potassium Chloride 0.3% + Glucose 5% Kabi

This medicine is administered by a doctor or nurse.
The doctor will determine the dose and method of administration based on the patient's age, weight, clinical and biological condition, hydration status, and reason for treatment. The dose of the medicine also depends on other medicines the patient is taking.
The doctor will monitor the patient's fluid levels, blood acidity, urine flow, and electrolyte levels (especially sodium) in the blood (mainly in patients with high vasopressin levels or patients taking other drugs that enhance vasopressin action), at the start of the infusion and during its administration.
The doctor will determine the infusion rate.
If the patient needs a large volume or rapid infusion, the doctor will monitor the ECG (heart function) recording.
During treatment with Potassium Chloride 0.3% + Glucose 5% Kabi, the doctor will order blood tests to monitor the levels of:

• potassium;
• other electrolytes (such as sodium or chlorides) and other substances in the blood, such as creatinine (a product of muscle breakdown). If the patient has impaired kidney function, the doctor may reduce the dose of the medicine.

Using more than the recommended dose of Potassium Chloride 0.3% + Glucose 5% Kabi

In case of administration of too much medicine (in infusion), the following may occur:

• tingling and burning sensation in the hands and feet (paresthesia);
• muscle weakness;
• difficulty moving (paralysis);
• irregular heart rhythm (arrhythmia);
• heart block (very slow heart rhythm);
• cardiac arrest (the heart stops working, a life-threatening situation);
• confusion;
• acidosis of the blood (leading to feelings of weakness, disorientation, coma, and increased breathing rate). You should immediately inform your doctor if you experience any of these symptoms. The infusion will be stopped and the patient will receive treatment depending on the symptoms that occur.

If you have any further doubts about using this medicine, you should consult your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The frequency of side effects is not known.

You should immediately inform your doctor or nurse if you experience any of the following side effects:

• increased blood volume (hyperolemia);
• allergic reactions, including a severe allergic reaction known as anaphylactic reaction (a possible clinical symptom of corn allergy);
• fever;
• chills.

Side effects related to the method of administration of the medicine:

• infection at the injection site;
• irritation or pain at the injection site (redness or swelling);
• irritation and inflammation of the vein into which the solution was administered (phlebitis). This can cause redness, pain, or burning sensation and swelling along the vein into which the solution was administered;
• blood clot at the injection site (thrombophlebitis), causing pain, swelling, or redness in the area where the clot occurred;
• low sodium levels in the blood (hyponatremia). Low sodium levels can lead to brain damage and death caused by brain swelling (see "Warnings and precautions").

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, you should inform your doctor or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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]
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Potassium Chloride 0.3% + Glucose 5% Kabi

The medicine should be stored out of sight and reach of children.
There are no special storage instructions for the medicine.
Do not use this medicine after the expiry date stated on the bottle. The expiry date refers to the last day of the month.
Do not use this medicine if the solution is not clear or if there are visible solid particles. Do not use this medicine if the bottle is damaged.

6. Contents of the packaging and other information

What Potassium Chloride 0.3% + Glucose 5% Kabi contains

• The active substances of the medicine are potassium chloride and glucose (in the form of glucose monohydrate). 1 ml of the solution contains 3 mg of potassium chloride and 50 mg of glucose. Each 500 ml bottle contains 1.50 g of potassium chloride and 25 g of glucose. Each 1000 ml bottle contains 3.00 g of potassium chloride and 50 g of glucose.
• The other ingredients are: water for injections, sodium hydroxide (to adjust pH), and concentrated hydrochloric acid (to adjust pH).

What Potassium Chloride 0.3% + Glucose 5% Kabi looks like and what the pack contains

Potassium Chloride 0.3% + Glucose 5% Kabi is a clear solution, free from visible solid particles.
It is available in 500 ml or 1000 ml LDPE (KabiPac) bottles with a polyisoprene plug and a polyolefin cap.
Pack size: 10 bottles in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw

Manufacturer

Labesfal – Laboratórios Almiro, S.A.
Zona Industrial do Lagedo

• 3465 – 157 Santiago de Besteiros Portugal

To obtain more detailed information, you should contact the marketing authorization holder:
Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw
tel.: +48 22 345 67 89

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

Belgium
Potassium Chloride 0.3% + Glucose 5% Fresenius Kabi
Bulgaria
Калиев хлорид + Глюкоза Каби 3 mg/ml + 50 mg/ml инфузионен разтвор
Estonia
Potassium Chloride/Glucose Fresenius 3 mg/50 mg/ml
France
Chlorure de potassium 0,3% et glucose 5% Kabi, solution pour perfusion
Spain
Cloruro de potasio Kabi 40 mEq/l en Glucosa 5% solución para perfusion EFG
Netherlands
Potassium Chloride 0.3% + Glucose 5% Fresenius Kabi
Ireland
Potassium Chloride 0.3% w/v & Glucose 5% w/v Solution for Infusion
Lithuania
Potassium Chloride/ Glucose Fresenius 3 mg/50 mg/ml infuzinis tirpalas
Latvia
Potassium Chloride/Glucose Fresenius 3 mg/50 mg/ml šķīdums infūzijām
Poland
Kalii chloridum 0,3% + Glucosum 5% Kabi
Portugal
Cloreto de Potássio 0,3% p/v e Glucose 5% p/v Kabi
Slovenia
Kalijev klorid/Glukoza Kabi 3 mg/50 mg v 1 ml raztopina za infundiranje
United Kingdom
Potassium Chloride 0.3% w/v & Glucose 5% w/v Solution for Infusion
Date of last revision of the leaflet:29.06.2018
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Information intended for healthcare professionals only:

Method of handling and preparation of the solution

The medicine is for single use only. Any unused solution should be discarded.
Only a clear solution, free from visible solid particles and with undamaged packaging, should be used.
Route of administration
Intravenous administration using sterile equipment free from pyrogens.
Intravenous administration of potassium should be performed into a large peripheral vein or central vein, in order to reduce the risk of vein hardening. When administering into a central vein, it should be ensured that the catheter is not located in the atrium or ventricle of the heart, in order to avoid local hyperkalemia.
Solutions containing potassium should be administered slowly.
Infusion rate
To avoid the risk of dangerous hyperkalemia, the infusion rate during potassium administration should not exceed 15 to 20 mmol/hour.
In no case should the recommendations in the "Dosage regimen" section be exceeded.
Dosage
General principles
Due to the risk of hyponatremia, before and during administration of the product, it may be necessary to monitor fluid balance, blood glucose levels, and sodium and other electrolyte levels in the blood, especially in patients with non-osmotic stimulation of vasopressin secretion (syndrome of inappropriate antidiuretic hormone secretion) and in patients receiving agonist drugs of vasopressin.
Monitoring of sodium levels in the blood is particularly important during administration of low-sodium fluids (hypotonic fluids) relative to physiological osmotic pressure. Potassium Chloride 0.3% + Glucose 5% Kabi may become extremely hypotonic after administration due to glucose metabolism in the body.
Dosage regimen
Recommended dosage for the treatment of carbohydrate and fluid deficiencies:

• adult patients: 500 ml to 3 liters per day;
• infants and children:
• 0-10 kg body weight: 100 ml/kg body weight per day,
• 10-20 kg body weight: 1000 ml + (50 ml/kg body weight above 10 kg) per day,
• >20 kg body weight: 1500 ml + (20 ml/kg body weight above 20 kg) per day.

Prevention and treatment of potassium deficiency
Adult patients, elderly patients, and adolescents
The usual dose of potassium used to prevent hypokalemia is up to 50 mmol per day, and similar doses may be suitable for use in mild potassium deficiency. The maximum recommended dose of potassium is 2 to 3 mmol/kg body weight per day.
In the treatment of hypokalemia, the recommended dose is 20 mmol of potassium over a period of 2 to 3 hours (e.g. 7-10 mmol/hour) while monitoring the ECG recording.
The maximum infusion rate should not exceed 15 to 20 mmol/hour.
Patients with impaired kidney function should receive smaller doses.
In no case should the recommendations in the "Dosage regimen" section be exceeded.
Children
In the treatment of hypokalemia, the recommended dosage is 0.3-0.5 mmol/kg body weight/hour. The dose should be determined based on frequent laboratory tests.
The maximum recommended dose of potassium is 2 to 3 mmol/kg body weight per day.
The rate and volume of infusion depend on the patient's age, weight, clinical condition, and metabolism, as well as any concomitant treatment, and should be determined after consultation with a doctor experienced in intravenous fluid therapy in children.
Shelf life of the medicine after first opening
The stability of the medicine after first opening has not been established, so the medicine should be used immediately after first opening.
Shelf life of the ready-to-use medicine (added drugs)
Before use, the chemical and physical stability of each added drug in the pH of Potassium Chloride 0.3% + Glucose 5% Kabi should be established.
Any incompatibilities should be checked before adding any drug to Potassium Chloride 0.3% + Glucose 5% Kabi.
In the absence of compatibility studies, this medicine should not be mixed with other medicines.
The doctor is responsible for assessing the incompatibility of the added drug with Potassium Chloride 0.3% + Glucose 5% Kabi by checking for any change in color and/or precipitation, formation of insoluble compounds or crystals. The instructions for use of the added drug should be consulted.
Before adding the drug, its solubility and/or stability in water at the pH of Potassium Chloride 0.3% + Glucose 5% Kabi (pH: 3.5 - 6.0) should be confirmed.
In accordance with the guidelines, incompatibilities with Potassium Chloride 0.3% + Glucose 5% Kabi have been reported (non-exhaustive list):

• amphotericin B;
• dobutamine.

Drugs with known incompatibilities should not be added.
From a microbiological point of view, this medicine mixed with added drugs should be used immediately, unless mixing is performed in controlled and validated aseptic conditions. If the medicine is not used immediately, the user is responsible for the storage time and conditions of the prepared solution.