Potassium chloride and sodium chloride Kabi

Package leaflet: Information for the user

Potassium chloride and Sodium chloride Kabi 0.3% w/v and 0.9% w/v infusion solution

Potassium chloride, sodium chloride
Please read all of this leaflet carefully before this medicine is administered to you because it contains important information for you.

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

Contents of this leaflet:

1. What Potassium chloride and sodium chloride Kabi 0.3% w/v and 0.9% w/v is and what it is used for
2. What you need to know before administration of Potassium chloride and sodium chloride Kabi 0.3% w/v and 0.9% w/v
3. How Potassium chloride and sodium chloride Kabi 0.3% w/v and 0.9% w/v is administered
4. Possible side effects
5. How to store Potassium chloride and sodium chloride Kabi 0.3% w/v and 0.9% w/v
6. Contents of the pack and other information

1. What Potassio cloruro e sodio cloruro Kabi 0.3% p/v and 0.9% p/v is and what it is used for

Potassio cloruro e sodio cloruro Kabi 0.3% p/v and 0.9% p/v is a solution of potassium chloride and sodium chloride in water. Potassium chloride and sodium chloride are chemical substances (often referred to as "salts") that occur naturally in the blood.
This medicine is used to prevent and treat:

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

2. What you should know before you are given Potassio cloruro e sodio cloruro Kabi 0.3% p/v and 0.9% p/v
   You will not be given Potassio cloruro e sodio cloruro Kabi 0.3% p/v and 0.9% p/v if:

• your blood potassium level is higher than normal (hyperkalaemia)
• your blood chloride level is higher than normal (hyperchloraemia)
• your blood sodium level is higher than normal (hypernatraemia)
• you have severe kidney function problems (you may produce little or no urine)
• you have untreated heart failure (decompensated heart failure) causing symptoms such as:
  • shortness of breath
  • swelling of the ankles
• you have a condition in which the adrenal glands do not function properly (Addison's disease)

Warnings and precautions
This medicine has a higher concentration (hypertonic solution) compared to blood. Your doctor will take this into account when calculating the dose.
Talk to your doctor or nurse before receiving Potassio cloruro e sodio cloruro Kabi 0.3% p/v and 0.9% p/v if:

• you have any type of heart disease or heart failure has reduced kidney function
• you have an adrenal gland disorder affecting the amount of steroid hormones in the body (adrenal insufficiency)
• you are severely dehydrated (loss of water from the body, e.g. due to vomiting or diarrhoea)
• you have a severe injury affecting a large area of skin, such as a burn
• you have high blood pressure
• you have swelling under the skin, especially around the ankles (peripheral oedema) or in the lungs (pulmonary oedema)
• you have high blood pressure during pregnancy (pre-eclampsia)
• you have any other condition in which the body retains too much sodium (sodium retention)

You will be closely monitored during administration of this medicine. Your doctor will take blood and urine samples to monitor your condition. Particular attention will be paid if you have heart or kidney problems.

Other medicines and Potassio cloruro e sodio cloruro Kabi 0.3% p/v and 0.9% p/v
Inform your doctor if you are taking, have recently taken, or might take any other medicines. In particular, inform your doctor if you are taking:

• cardiac glycosides used to treat heart failure (such as digoxin)
• antiarrhythmic drugs used to suppress abnormal heart rhythms (such as quinidine, hydroquinidine, procainamide)
• medicines that increase potassium levels in the blood such as:
  • potassium-sparing diuretics, known as "diuretics" (e.g. amiloride, spironolactone, triamterene)
  • ACE inhibitors (mainly used to treat high blood pressure)
  • angiotensin II receptor antagonists (used to treat high blood pressure)
  • ciclosporin (used to prevent transplant rejection)
  • tacrolimus (used to prevent transplant rejection and to treat certain skin diseases)
  • medicines containing potassium
• corticosteroids (anti-inflammatory drugs)

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor before taking this medicine.
This medicine may be used during pregnancy and breastfeeding. The amount of medicine you receive will be carefully monitored by your doctor. Your doctor will also perform blood tests to monitor the levels of chemicals in your blood. This is because changes in blood potassium levels may affect the function of your heart and that of your unborn baby.
Your doctor must closely monitor your blood pressure, as sodium chloride may increase it (risk of pre-eclampsia).

Driving and using machines
This medicine will not affect your ability to drive or operate machinery.

3. How Potassium Chloride and Sodium Chloride Kabi 0.3% w/v and 0.9% w/v is administered

This medicine will be administered by a doctor or nurse.
The doctor will decide how much medicine you need and when it will be given. This depends on your age,
weight, clinical and biological condition, and your hydration status (the amount of water in the body). The amount of
medication you receive may also be influenced by other treatments you are receiving.
Potassium Chloride and Sodium Chloride Kabi 0.3% w/v and 0.9% w/v is administered slowly into a vein
as an infusion. The duration of the infusion will be determined by the doctor. If you require a large volume or rapid infusion of the medicine, your doctor will monitor your ECG (heart activity).
While you are receiving Potassium Chloride and Sodium Chloride Kabi 0.3% w/v and 0.9% w/v, your doctor will perform blood tests to monitor your blood levels of potassium and other electrolytes (such as sodium and
chloride) normally present in the blood. Your doctor will also check that you are urinating normally (adequate urine output).
If you are given more Potassium Chloride and Sodium Chloride Kabi 0.3% w/v and 0.9% w/v than you should receive
If you have been given too much medicine, the following may occur: tingling and burning sensations in the arms and legs (paresthesia), muscle weakness, inability to move (paralysis), irregular heartbeat (arrhythmia), heart block (very slow heartbeat), cardiac arrest (heart stops beating), mental confusion, fluid accumulation in the lungs causing breathing difficulties (pulmonary edema), fluid accumulation under the skin, especially around the ankles (peripheral edema), acidification of the blood (acidosis) leading to fatigue, confusion, lethargy, and increased respiratory rate.
Inform your doctor immediately if any of these symptoms occur. The infusion will be stopped and you will receive treatment according to your symptoms.
If you have any doubts about the use of this medicine, consult your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
The following side effects have been reported during post-marketing use of the drug. The frequency of occurrence cannot be estimated from the available data. Side effects may occur due to the administration technique.

Inform your doctor or nurse if you experience any of the following side effects:

• Infection at the injection site
• Abnormal increase in blood volume (hypervolaemia)
• Leakage of solution into surrounding tissues (extravasation). This may damage tissues and lead to scarring.
• Irritation or pain at the injection site.
• Inflammation of the vein in which the solution is infused (phlebitis). This may cause redness, swelling, and pain or burning along the vein where the solution is administered.
• Blood clot at the injection site causing pain, swelling or redness in the area of the clot
• Fever

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, contact your doctor or nurse. You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Potassium chloride and sodium chloride Kabi 0.3% w/v and 0.9% w/v

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the vial. The expiry date refers to the last day of that month.
Do not use this medicine if the solution is not clear or contains visible particles. Do not use this medicine if the vial is in any way damaged.
From a microbiological standpoint, the product should be used immediately. If it is not used immediately, the in-use storage times and conditions prior to use are the responsibility of the user.
Do not dispose of any medicine via wastewater. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Potassio cloruro e sodio cloruro Kabi 0.3% p/v and 0.9% p/v contains

• The active substances are potassium chloride and sodium chloride. Each ml of solution contains 3 mg of potassium chloride and 9 mg of sodium chloride.
• Each 500 ml vial contains 1.50 g of potassium chloride and 4.5 g of sodium chloride.
• Each 1000 ml vial contains 3.00 g of potassium chloride and 9.00 g of sodium chloride.
• The other components are water for injections, and sodium hydroxide and hydrochloric acid used to adjust the pH.

Description of the appearance of Potassio cloruro e sodio cloruro Kabi 0.3% p/v and 0.9% p/v and package contents
Potassio cloruro e sodio cloruro Kabi 0.3% p/v and 0.9% p/v solution for infusion is a clear, colourless solution free from visible particles. It is available in polyethylene bottles of 500 ml and 1000 ml, closed with a polyolefin stopper containing a polyisoprene closure. It is supplied in packs of 10 bottles.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Fresenius Kabi Italia S.r.l.
Via Camagre, 41
37063 Isola della Scala, Verona
Italy

Manufacturer responsible for batch release
Fresenius Kabi Deutschland GmbH
Freseniusstraße 1, D-61169 Friedberg
Germany

This medicinal product is authorised in the European Economic Area countries under the following names:

The following information is intended exclusively for physicians or healthcare professionals:
Handling and Preparation
This product is for single use only. Any unused solution must be discarded.
Use only if the solution is clear, free from visible particles, and the container is intact.
Route of administration
Administration is performed intravenously using sterile and pyrogen-free equipment.
Intravenous potassium must be administered into a large peripheral or central vein to reduce the risk of causing phlebosclerosis. If infused through a central vein, ensure that the catheter is not positioned in the atrium or ventricle to avoid localized hyperkalemia.
Solutions containing potassium must be administered slowly.
Infusion rate
Since it is administered intravenously, potassium must not be infused at a rate exceeding 15–20 mmol/h to prevent dangerous hyperkalemia.
Under no circumstances should the dosage indicated in “general posology” be exceeded.
General posology
The recommended dosage for the treatment of isotonic fluid depletion (extracellular dehydration) using any intravenous solution is:

• For adults: from 500 ml to 3 litres/24 h
• For neonates and children: from 20 to 100 ml per 24 h per kg of body weight, depending on age and total body mass.

Dosage

• Adults, elderly and adolescents:

The typical potassium dosage for prevention of hypokalemia may be up to 50 mmol per day, and similar doses may be adequate in cases of mild potassium deficiency. When used for the treatment of hypokalemia, the recommended dosage is 20 mmol of potassium over 2–3 hours (i.e. 7–10 mmol/h) under ECG monitoring.

• Pediatric population:
  When used for the treatment of hypokalemia, the recommended dosage is 0.3–0.5 mmol/kg body weight/h. The dose should be adjusted based on frequently obtained laboratory values. The maximum recommended daily potassium dosage is 2–3 mmol/kg body weight/day.
• Renal impairment:
  Patients with renal impairment should receive reduced doses.

Potassium chloride and sodium chloride Kabi 0.3% w/v and 0.9% w/v is a hypertonic solution with an osmolarity of approximately 388 mOsm/l.
Administration must be carried out under regular and careful supervision. Regular monitoring of the clinical status, plasma electrolyte concentrations, plasma creatinine, blood urea nitrogen, acid-base balance, and ECG is essential, particularly in patients receiving potassium therapy who also have cardiac or renal impairment.
Adequate urine flow must be ensured and fluid balance must be monitored.
Potassium salts must be administered with great caution in patients with cardiac disease or conditions predisposing to hyperkalemia, such as renal or adrenal insufficiency, acute dehydration, or extensive tissue destruction, as occurs in severe burns. In patients receiving digitalis therapy, regular monitoring of plasma potassium levels is mandatory.
Sodium salts must be administered cautiously in patients with hypertension, cardiac failure, peripheral or pulmonary edema, renal impairment, pre-eclampsia, or other conditions associated with sodium retention.
In-use stability (Additives)
The chemical and physical stability of any additive medicinal product at the pH of Potassium chloride and sodium chloride Kabi 0.3% w/v and 0.9% w/v must be established prior to use.
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
It is the physician’s responsibility to assess the incompatibility of an additive drug with the Potassium chloride and sodium chloride Kabi 0.3% w/v and 0.9% w/v solution by checking for any change in color and/or formation of precipitate, insoluble complex, or crystals. Reference should also be made to the Summary of Product Characteristics accompanying the additive medicinal product. Incompatibility of the medicinal product to be added to Potassium chloride and sodium chloride Kabi 0.3% w/v and 0.9% w/v must be evaluated before addition.
Instructions for use of the additive medicinal product must be consulted. Before adding a medicinal product, verify that it is soluble and/or stable in water at the pH of Potassium chloride and sodium chloride Kabi 0.3% w/v and 0.9% w/v (pH: 4.5–7.0).
Medicinal products known to be incompatible must not be used.
From a microbiological standpoint, the product should be used immediately. If not used immediately, the in-use storage times and conditions prior to use are the responsibility of the user.