Kalii chloridum 0,15% + glucosum 5% kabi

Package leaflet: Information for the user

Kalii chloridum 0,15% + Glucosum 5% Kabi, (1.5 mg + 50 mg)/ml, infusion solution
Kalii chloridum + Glucosum
Please read this leaflet carefully before using this medicine, because it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or nurse.
• If you experience any side effects, including any not listed in this leaflet, please inform your doctor or nurse. See section 4.

Leaflet contents

1. What Kalii chloridum 0,15% + Glucosum 5% Kabi is and what it is used for
2. Important information before using Kalii chloridum 0,15% + Glucosum 5% Kabi
3. How to use Kalii chloridum 0,15% + Glucosum 5% Kabi
4. Possible side effects
5. How to store Kalii chloridum 0,15% + Glucosum 5% Kabi
6. Contents of the pack and other information

1. What Kalii chloridum 0,15% + Glucosum 5% Kabi is and what it is used for

Kalii chloridum 0,15% + Glucosum 5% Kabi is an aqueous solution of potassium chloride and glucose.
Potassium chloride is a chemical compound (a type of salt) naturally present in blood. Glucose is
one of the body's sources of energy. This infusion solution provides 200 kilocalories per litre.
This medicine is used as a source of carbohydrates (sugars) in the prevention and treatment of:

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

2. Information before using Kalii chloridum 0,15% + Glucosum 5% Kabi

When not to use Kalii chloridum 0,15% + Glucosum 5% Kabi:

• if the patient has increased potassium levels in the blood (hyperkalemia);
• if the patient has increased chloride levels in the blood (hyperchloremia);
• if the patient has severe kidney disease (reduced or no urine output);
• if the patient has heart failure that is not properly treated (decompensated heart failure) and causes symptoms such as:
  • shortness of breath;
  • ankle swelling;
• if the patient has adrenal gland disorders (Addison's disease);
• if the patient has diabetes that is not properly controlled and leads to elevated blood sugar levels (uncontrolled diabetes);
• if the patient has another type of glucose intolerance, for example:
  • metabolic stress (a condition in which the patient's metabolism does not function properly, e.g. due to a severe illness);
  • hyperosmolar coma (loss of consciousness); this is a type of coma that may occur in patients with diabetes who are not receiving adequate medication;
  • increased blood sugar levels (hyperglycemia);
  • increased lactate levels in the blood (hyperlactatemia).

Warnings and precautions
This medicine has a higher concentration than blood (a hypertonic solution). The doctor will take this into account when
determining the dose for the patient.
Before starting treatment with Kalii chloridum 0,15% + Glucosum 5% Kabi, inform the 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 any of the above conditions are present);
• if the patient has an adrenal gland disorder (a gland located on top of the kidney) affecting steroid hormone levels in the body (adrenal insufficiency);
• if the patient is dehydrated (excessive fluid loss, e.g. due to vomiting or diarrhea);
• if the patient has severe wounds with extensive skin damage, e.g. after burns;
• if the patient has had a head injury within the last 24 hours;
• if the patient has increased intracranial pressure (intracranial hypertension);
• if the patient has recently had a stroke;
• if the patient is allergic to corn (Kalii chloridum 0,15% + Glucosum 5% Kabi contains sugar derived from corn);
• if the patient has a condition that may cause increased vasopressin levels (a hormone regulating water content in the body). Elevated vasopressin levels may occur:
  • if the patient has had an acute or serious illness;
  • if the patient is in pain;
  • if the patient has undergone surgery;
  • if the patient has an infection, burn, or central nervous system disorder;
  • if the patient has diseases affecting heart, liver, or kidney function;
  • if the patient is taking certain medications. This may increase the risk of low sodium levels in the blood, which can lead to headache, nausea, seizures, lethargy, coma, brain swelling, and death. Brain swelling increases the risk of death and brain damage. Increased risk of brain swelling occurs in:
• children;
• women (especially those of reproductive age);
• patients with disorders affecting cerebrospinal fluid levels, which may be caused by meningitis, intracranial hemorrhage, or brain injury.

The doctor will closely monitor the patient's condition during administration of this medicine. The doctor will take
blood and urine samples to assess the patient's condition. Special care should be taken in patients
with heart or kidney disease.
The doctor will consider whether the patient is receiving parenteral nutrition (nutrition delivered intravenously via infusion).
In cases of prolonged administration of Kalii chloridum 0,15% + Glucosum 5% Kabi, the patient may
require additional nutritional support.
Kalii chloridum 0,15% + Glucosum 5% Kabi contains sugar (glucose), which may cause increased
blood sugar levels (hyperglycemia). In such cases, the doctor may:

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

This is particularly important in diabetic patients.
Patients should be closely monitored. In cases where proper regulation of blood water content is impaired due to increased secretion of antidiuretic hormone (ADH), infusion of fluids with low salt concentration (hypotonic solutions) may lead to low sodium levels in the blood (hyponatremia). This may result in headache, nausea, seizures, lethargy, coma, brain swelling, and death. Therefore, the occurrence of these symptoms (severe symptomatic encephalopathy with hyponatremia) is considered life-threatening.

Children and adolescents
Kalii chloridum 0,15% + Glucosum 5% Kabi must be administered with particular caution in children.
Newborns, especially those born prematurely and with low birth weight, are more susceptible to
abnormally low or high blood glucose levels (hypo- or hyperglycemia) during
intravenous administration of glucose solutions.

• Low blood glucose levels in newborns may lead to prolonged seizures, coma, and brain damage.
• High blood glucose levels are associated with intracranial hemorrhage, delayed bacterial and fungal infections, gastrointestinal infection (necrotizing enterocolitis), visual impairment (retinopathy of prematurity), lung disorders (bronchopulmonary dysplasia), prolonged hospital stay, and death.

Kalii chloridum 0,15% + Glucosum 5% Kabi and other medicines
Inform the doctor or nurse about all medicines currently used or recently used by the patient, as well as any medicines the patient plans to use. It is especially important to inform the doctor if the patient is taking:

• cardiac glycosides used in heart diseases (e.g. digoxin);
• antiarrhythmic drugs used to treat irregular heart rhythms (e.g. quinidine, hydroquinidine, procainamide);
• medicines that increase potassium levels in the blood, such as:
  • potassium-sparing diuretics, i.e. drugs that increase urine excretion (e.g. amiloride, spironolactone, triamterene);
  • angiotensin-converting enzyme inhibitors (used mainly 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 medicines (e.g. potassium supplements, potassium-containing salt substitutes).
• certain medicines affecting vasopressin hormone activity, including:
  • antidiabetic drugs (chlorpropamide);
  • cholesterol-lowering drugs (clofibrate);
  • antiepileptic drugs (carbamazepine);
  • drugs with a chemical structure similar to amphetamine (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 non-steroidal anti-inflammatory drugs, NSAIDs);
  • drugs mimicking or enhancing vasopressin action, such as desmopressin (used to treat excessive thirst and urination), terlipressin (used to treat esophageal bleeding), and oxytocin (used to induce labor).
• other drugs increasing the risk of hyponatremia, including all diuretics and anticonvulsant drugs such as oxcarbazepine.

Do not administer Kalii chloridum 0,15% + Glucosum 5% Kabi through the same needle used for
blood transfusion. This may cause breakdown or clumping of red blood cells.

Kalii chloridum 0,15% + Glucosum 5% Kabi with food and drink
Consult the doctor regarding the use of Kalii chloridum 0,15% + Glucosum 5% Kabi
with food and drink.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult a doctor or nurse before using this medicine.
This medicine may be used in pregnant women and during breastfeeding. The doctor will closely
monitor the amount of medicine administered to the patient. The doctor will order blood tests to monitor
chemical substance levels in the blood, as changes in blood potassium levels may affect the heart function of both the mother and the fetus.
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 reduce bleeding), due to the risk of hyponatremia.

Driving and operating machinery
This medicine does not affect the ability to drive or operate machinery.

3. How to use Kalii chloridum 0.15% + Glucosum 5% Kabi

This medicine is administered by a doctor or nurse.
The doctor will determine the dose and method of administration depending on the patient's age, body weight, clinical and biological condition, hydration status (amount of water in the body), and the reason for treatment. The dose also depends on other medicines the patient is taking.
The doctor will monitor fluid levels in the body, blood pH, urine output, and blood electrolyte concentrations (particularly sodium), both at the beginning of the infusion and during its administration, especially in patients with high levels of vasopressin hormone or those taking other medicines that enhance vasopressin activity.
The doctor will determine the infusion rate.
If the patient requires a large volume or rapid infusion, the doctor will perform an ECG (electrocardiogram) to monitor heart activity.
While receiving Kalii chloridum 0.15% + Glucosum 5% Kabi, the doctor will order regular blood tests to monitor the levels of:

• potassium;
• other electrolytes (such as sodium or chlorides), and other blood components such as creatinine (a breakdown product of muscle metabolism).

If the patient has impaired kidney function, the doctor may reduce the dose of the medicine.

Administration of a higher than recommended dose of Kalii chloridum 0.15% + Glucosum 5% Kabi
If too much of the medicine is infused, the following may occur:

• tingling and burning sensations in the hands and feet (paresthesia);
• muscle weakness;
• difficulty moving (paralysis);
• irregular heartbeat (arrhythmia);
• heart block (very slow heartbeat);
• cardiac arrest (heart stops beating, life-threatening condition);
• confusion;
• blood acidification (acidosis), leading to feelings of weakness, disorientation, coma, and increased breathing rate.

If any of these symptoms occur, inform the doctor immediately. The infusion will be stopped, and the patient will receive appropriate treatment depending on the symptoms present.

If you have any further questions about the use of this medicine, consult your doctor or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The frequency of adverse reactions is not known.
You must immediately inform the doctor or nurse if the patient experiences any of the following adverse reactions:

• increased blood volume (hypervolemia);
• hypersensitivity reactions, including severe allergic reaction called anaphylactic reaction (possible clinical sign of allergy to corn);
• fever;
• chills.

Adverse reactions resulting from the method of administration:

• infection at the site of administration;
• irritation or pain at the site of administration (redness or swelling);
• irritation and inflammation of the vein into which the solution was administered (phlebitis). This may cause redness, pain, burning sensation, and swelling along the vein;
• blood clot at the site of administration (venous thrombosis), causing pain, swelling, or redness in the area of the clot;
• low sodium concentration in the blood (hyponatremia). Low sodium levels may lead to brain damage and death due to cerebral edema (see section “Warnings and precautions”).

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, you should inform the doctor 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
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Email: [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 Kalii chloridum 0,15% + Glucosum 5% Kabi

Keep this medicine out of the sight and reach of children.
No special storage conditions are required for this medicine.
Do not use this medicine after the expiry date stated on the bottle. The expiry date refers to the last day of the stated month.
Do not use this medicine if the solution is not clear or if visible particles are present. Do not use this medicine if the bottle is damaged.

6. Contents of the pack and other information

What Kalii chloridum 0,15% + Glucosum 5% Kabi contains

• The active substances are potassium chloride and glucose (as glucose monohydrate). 1 ml of solution contains 1.50 mg of potassium chloride and 50 mg of glucose. Each 500 ml bottle contains 0.75 g of potassium chloride and 25 g of glucose. Each 1000 ml bottle contains 1.50 g of potassium chloride and 50 g of glucose.
• Other ingredients: water for injections, sodium hydroxide (for pH adjustment), and concentrated hydrochloric acid (for pH adjustment).

What Kalii chloridum 0,15% + Glucosum 5% Kabi looks like and contents of the pack
Kalii chloridum 0,15% + Glucosum 5% Kabi is a clear, transparent solution free from visible solid particles. It is available in 500 ml or 1000 ml LDPE bottles (KabiPac) with a polyisoprene stopper and a polyolefin cap. Pack size: 10 bottles in a cardboard box.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw, Poland

Manufacturer
Labesfal – Laboratórios Almiro, S.A.
Zona Industrial do Lagedo
3465 – 157 Santiago de Besteiros
Portugal

For further information, please contact the Marketing Authorisation Holder:
Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw, Poland
Tel.: +48 22 345 67 89

This medicinal product is authorised for sale in the European Economic Area under the following names:
Belgium    Kalii chloride 0.15% + Glucose 5% Fresenius Kabi
Bulgaria    Калиев хлорид + Глюкоза Каби 1,5 mg/ml + 50 mg/ml инфузионен разтвор
Estonia    Potassium Chloride/Glucose Fresenius 1,5 mg/50 mg/ml
France     Chlorure de potassium 0,15% et glucose 5% Kabi, solution pour perfusion
Spain      Cloruro de potasio Kabi 20 mEq/l en Glucosa 5% solución para perfusion EFG
Netherlands Kaliichloride 0.15% + Glucose 5% Fresenius Kabi
Ireland    Potassium Chloride 0.15% w/v & Glucose 5% w/v Solution for Infusion
Lithuania   Potassium Chloride/ Glucose Fresenius 1,5 mg/50 mg/ml infuzinis tirpalas
Latvia      Potassium Chloride/Glucose Fresenius 1,5 mg/50 mg/ml šķīdums infūzijām
Poland     Kalii chloridum 0,15% + Glucosum 5% Kabi
Portugal   Cloreto de Potássio 0,15% p/v e Glucose 5% p/v Kabi
Slovenia   Kalijev klorid/Glukoza Kabi 1,5 mg/50 mg v 1 ml raztopina za infundiranje
United Kingdom Potassium Chloride 0.15% w/v & Glucose 5% w/v Solution for Infusion

Information intended solely for medical professionals:

Administration and preparation of the solution
The medicinal product is for single use only. Any unused portions of the solution must be discarded.
Only a clear solution free from visible solid particles and contained in undamaged packaging should be used.

Route of administration
Intravenous administration using sterile, pyrogen-free equipment.
Potassium should be administered into a large peripheral vein or central vein to reduce the risk of phlebitis. When administered via a central venous catheter, ensure that the tip is not positioned within the atrium or ventricle of the heart to avoid the risk of local hyperkalemia.

Solutions containing potassium must be administered slowly.

SPEED OF INFUSION
To avoid the occurrence of dangerous hyperkalemia, the infusion rate during potassium administration should not exceed 15 to 20 mmol/hour.
Under no circumstances should the recommendations in the section "Dosage regimen" be exceeded.

DOSING
General principles
Due to the risk of hyponatremia, monitoring of fluid balance, serum glucose concentration, and serum concentrations of sodium and other electrolytes may be necessary before and during administration of the product, particularly in patients with non-osmotic stimulation of vasopressin secretion (syndrome of inappropriate antidiuretic hormone secretion) and in patients receiving concomitant treatment with vasopressin agonists.
Monitoring of serum sodium concentration is especially important during administration of fluids that are hypotonic relative to physiological osmotic pressure. Kalii chloridum 0,15% + Glucosum 5% Kabi may become markedly hypotonic after administration due to glucose metabolism in the body.

Dosage regimen
Recommended dosing for treatment of carbohydrate and fluid deficiency:

• 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 for prevention of hypokalemia is up to 50 mmol per day, and similar doses may be appropriate for mild potassium deficiency. The maximum recommended dose of potassium is 2 to 3 mmol/kg body weight per day.
For treatment of hypokalemia, the recommended dose is 20 mmol of potassium administered over 2 to 3 hours (e.g., 7–10 mmol/hour), with continuous monitoring of ECG recordings.
The maximum infusion rate should not exceed 15 to 20 mmol/hour.
Patients with impaired renal function should receive reduced doses.
Under no circumstances should the recommendations in the section "Dosage regimen" be exceeded.

Children
For treatment of hypokalemia, the recommended dosage is 0.3–0.5 mmol/kg body weight/hour. The dose should be adjusted based on frequent laboratory test results.
The maximum recommended dose of potassium is 2 to 3 mmol/kg body weight/day.
Infusion rate and volume depend on age, body weight, clinical condition, metabolism, and concomitant therapy, and must be determined in consultation with a physician experienced in intravenous fluid therapy in children.

Shelf-life after first opening
The stability of the medicinal product after first opening has not been established; therefore, the product should be used immediately after first opening.

Shelf-life of ready-to-use solution (added medicinal products)
Prior to use, the chemical and physical stability of each added medicinal product at the pH of Kalii chloridum 0,15% + Glucosum 5% Kabi must be established.
Incompatibilities should be checked before adding any medicinal product to Kalii chloridum 0,15% + Glucosum 5% Kabi.
In the absence of compatibility studies, this medicinal product should not be mixed with other medicinal products.
The physician is responsible for assessing incompatibility of added medicinal products by checking for possible changes in color and/or precipitation, formation of insoluble compounds or crystals. The package leaflet of the added medicinal product should be consulted.
Before adding a medicinal product, its solubility and/or stability in water at the pH of Kalii chloridum 0,15% + Glucosum 5% Kabi (pH: 3.5 – 6.0) should be confirmed.

According to guidelines, the following medicinal products are known to be incompatible with Kalii chloridum 0,15% + Glucosum 5% Kabi (incomplete list):

• amphotericin B;
• dobutamine.

Medicinal products known to be incompatible should not be added.

From a microbiological standpoint, this medicinal product, once mixed with added medicinal products, should be used immediately unless mixing was performed under controlled and validated aseptic conditions. If not used immediately, the responsibility for storage duration and conditions of the prepared solution lies with the user.