Kalii chloridum 0.3% + glucosum 5% kabi

Package leaflet: Information for the user

Kalii chloridum 0,3% + Glucosum 5% Kabi, (3 mg + 50 mg)/ml, infusion solution
Kalii chloridum + Glucosum
Please read all of this leaflet carefully before the medicine is administered, as it contains
important information for the patient.

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

1. What Kalii chloridum 0,3% + Glucosum 5% Kabi is and what it is used for

Kalii chloridum 0,3% + Glucosum 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 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 (medicines that increase urine production));
• low blood potassium levels (hypokalaemia) in situations 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. Important information before using Kalii chloridum 0.3% + Glucosum 5% Kabi

When not to use Kalii chloridum 0.3% + 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 severe illness);
  • hyperosmolar coma (loss of consciousness); 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 0.3% + 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 above the kidney) affecting steroid hormone levels in the body (adrenal cortex 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 0.3% + 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 suffering from 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 (hyponatremia), which can lead to headache, nausea, seizures, lethargy, coma, brain edema, and death. Brain edema increases the risk of death and brain damage. The risk of brain edema is increased in:
• children;
• women (particularly those of childbearing 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. Blood and urine samples will be taken to assess the patient's status. Particular care should be taken in patients with heart or kidney disease.
The doctor will consider whether the patient is receiving intravenous nutrition (nutrition delivered via intravenous infusion).
With prolonged administration of Kalii chloridum 0.3% + Glucosum 5% Kabi, the patient may require additional nutritional support.
Kalii chloridum 0.3% + 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 glucose levels.

This is particularly important for patients with diabetes.
Patients should be closely monitored. In cases where proper regulation of blood water content is disturbed due to increased antidiuretic hormone (ADH) secretion, 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, drowsiness, coma, brain edema, and death. Therefore, the occurrence of these symptoms (severe symptomatic encephalopathy with hyponatremia) is considered life-threatening.

Children and adolescents
Kalii chloridum 0.3% + 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 disease (bronchopulmonary dysplasia), prolonged hospitalization, and death.

Kalii chloridum 0.3% + 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 (e.g. MDMA);
  • certain anticancer drugs (vincristine, ifosfamide, cyclophosphamide);
  • selective serotonin reuptake inhibitors (used to treat depression);
  • antipsychotic drugs;
  • opioids used to treat severe pain;
  • painkillers 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 urine output), 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 0.3% + Glucosum 5% Kabi through the same needle used for blood transfusion.
This may cause red blood cell destruction or clumping.

Kalii chloridum 0.3% + Glucosum 5% Kabi with food and drink
Consult the doctor regarding the use of Kalii chloridum 0.3% + 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 have a child, 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. Blood tests will be ordered to monitor chemical levels in the blood, as changes in potassium levels may affect the heart function of both mother and fetus.
Particular caution is required 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 0.3% + 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 the patient's fluid balance, blood pH, urine output, and blood electrolyte levels (particularly sodium), both at the beginning and during the infusion, especially in patients with high vasopressin hormone levels 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 check the ECG recording (heart activity).
During treatment with Kalii chloridum 0.3% + Glucosum 5% Kabi, the doctor will order blood tests to monitor levels of:

• potassium;
• other electrolytes (such as sodium or chlorides) and other blood substances such as creatinine (a breakdown product of muscles).

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

Use of a higher than recommended dose of Kalii chloridum 0.3% + Glucosum 5% Kabi
If too large a quantity 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 situation);
• confusion;
• blood acidification (acidosis), leading to feelings of weakness, disorientation, coma, and increased breathing rate.

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

If you have any further questions regarding 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 everybody will experience them.
The frequency of adverse reactions is unknown.
Immediately inform a 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 (clinical sign of allergy to maize may occur);
• 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 or 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 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, inform a 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
Tel: +48 22 49 21 301
Fax: +48 22 49 21 309
E-mail: [email protected]
Adverse reactions can also be reported to the responsible entity.
Reporting adverse reactions enables further information on the safety of the medicine to be collected.

5. How to store Kalii chloridum 0.3% + Glucosum 5% Kabi

Keep the medicine out of the sight and reach of children.
No special storage instructions 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 solid particles are visible. Do not use this medicine if the bottle is damaged.

6. Contents of the packaging and other information

What Kalii chloridum 0,3% + Glucosum 5% Kabi contains

• The active substances are potassium chloride and glucose (in the form of monohydrate glucose). 1 ml of 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.
• Other components are: water for injections, sodium hydroxide (for pH adjustment) and concentrated hydrochloric acid (for pH adjustment).

What Kalii chloridum 0,3% + Glucosum 5% Kabi looks like and contents of the pack

Kalii chloridum 0,3% + 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
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
Tel.: +48 22 345 67 89

This medicinal product is authorised for sale in the European Economic Area countries under the following names:
Belgium: Kaliumchloride 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: Kaliumchloride 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

Information intended exclusively for healthcare 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 particles and from undamaged packaging should be used.

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

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

Dosage
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 vasopressin agonists.
Monitoring of serum sodium concentration is especially important during administration of fluids hypotonic relative to physiological osmotic pressure. Kalii chloridum 0,3% + 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 litres 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
Adults, 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 in mild potassium deficiency. The maximum recommended dose of potassium is 2 to 3 mmol/kg body weight per day.
For treatment of hypokalemia, a recommended dose is 20 mmol of potassium administered over 2 to 3 hours (e.g., 7–10 mmol/hour), with monitoring of ECG.
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 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 monitoring.
The maximum recommended dose of potassium is 2 to 3 mmol/kg body weight/day.
The rate and volume of infusion depend on the patient's age, body weight, clinical condition, metabolism, and concomitant therapy, and should 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 compatibility of each added medicinal product at the pH of Kalii chloridum 0,3% + Glucosum 5% Kabi must be established.
Compatibility should be checked before adding any medicinal product to Kalii chloridum 0,3% + Glucosum 5% Kabi.
In the absence of compatibility studies confirming compatibility, 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 changes in color and/or precipitation, formation of insoluble complexes 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 0,3% + Glucosum 5% Kabi (pH: 3.5–6.0) should be confirmed.
According to guidelines, the following medicinal products are incompatible with Kalii chloridum 0,3% + 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, when mixed with added medicinal products, should be used immediately unless mixing was performed under controlled and validated aseptic conditions. If the product is not used immediately, the user is responsible for the storage duration and conditions of the prepared solution.