POTASSIO 0.3% W/V i 0.9% W/V Roztwór do infuzji

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1. Potassium chloride and Sodium chloride Kabi 0.3% w/v and 0.9% w/v solution for infusion
   1. What is Potassium chloride and Sodium chloride Kabi 0.3% w/v and 0.9% w/v and what is it used for
   2. How Potassio cloruro e sodio cloruro Kabi 0.3% p/v and 0.9% p/v is administered
   3. Possible side effects
   4. How to store Potassio cloruro e sodio cloruro Kabi 0.3% p/v and 0.9% p/v
   5. Package contents and other information

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

Potassium chloride, sodium chloride

Read this leaflet carefully before using this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your doctor or nurse.
• If any side effects occur, including any not listed in this leaflet, tell your doctor or nurse. See section 4.

Contents of this leaflet:

• 1. What is Potassium chloride and Sodium chloride Kabi 0.3% w/v and 0.9% w/v and what it is used for
• 2. What you need to know before Potassium chloride and Sodium chloride Kabi 0.3% w/v and 0.9% w/v is given to you
• 3. How Potassium chloride and Sodium chloride Kabi 0.3% w/v and 0.9% w/v is given
• 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 is Potassium chloride and Sodium chloride Kabi 0.3% w/v and 0.9% w/v and what is it used for

Potassium chloride and Sodium chloride Kabi 0.3% w/v and 0.9% w/v is a solution of potassium chloride and sodium chloride in water. Potassium chloride and sodium chloride are chemical substances (often called “salts”) that are naturally found in the blood.
The medicine is used to prevent and treat:

• the loss of potassium from the body (for example after treatment with some diuretics
• low levels of potassium in the blood (hypokalaemia) in situations that can cause the loss of potassium chloride and water, including
• when you cannot eat or drink, due to illness or after surgery
• profuse sweating due to high fever
• conditions of loss of sodium chloride and water
• 2.What you need to know before you are given Potassium chloride and Sodium chloride Kabi 0.3%w/v and 0.9% w/vYou will not be given Potassium chloride and Sodium chloride Kabi 0.3% w/v and 0.9% w/v :
• If the level of potassium in the blood is higher than normal (hyperkalaemia)
• If the level of chloride in the blood is higher than normal (hyperchloraemia)
• If the level of sodium in the blood is higher than normal (hypernatraemia)
• If you have severe problems with kidney function (you may produce little or no urine)
• If you suffer from heart failure that is not adequately treated (uncompensated heart failure) and causes symptoms such as:
• shortness of breath

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• swelling of the ankles
• if you suffer from 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) than blood. The doctor
will take this into account when calculating the dose.
Talk to your doctor or nurse before receiving Potassium chloride and Sodium chloride Kabi 0.3% w/v and
0.9% w/v if:

• you have any type of heart disease or heart failure has reduced kidney function
• you have a disease of the adrenal gland that affects the amount of steroid hormones in the body (adrenal insufficiency)
• you are very dehydrated (loss of water from the body, for example due to vomiting or diarrhea)
• you have a serious 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 edema) or in the lungs (pulmonary edema)
• 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 carefully monitored during the administration of this medicine. The 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 Potassium chloride and Sodium chloride Kabi 0.3% w/v and 0.9% w/v
Tell your doctor if you are taking, have recently taken or might take any other
medicines. In particular, tell your doctor if you are taking:

• cardiac glycosides used in the treatment of heart failure (such as digoxin)
• antiarrhythmic drugs used to suppress an irregular heartbeat (such as quinidine, hydroquinidine, procainamide)
• medicines that increase the concentration of potassium in the blood such as: potassium-sparing diuretics, known as "diuretics" (such as amiloride, spironolactone, triamterene) or ACE inhibitors (mainly used for the treatment of high blood pressure) or angiotensin II receptor antagonists (used to treat high blood pressure) or cyclosporine (used to prevent transplant rejection) or tacrolimus (used to prevent transplant rejection and the treatment of some skin diseases) or drugs that contain potassium
• corticosteroids (anti-inflammatory drugs)

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

Driving and using machines
This medicine will not affect your ability to drive vehicles or use machines.

3. How Potassio cloruro e sodio cloruro Kabi 0.3% p/v and 0.9% p/v is administered

This medicine will be administered by a doctor or a nurse.
The doctor will decide how much medicine you need and when you will be given it. This depends on your age,
weight, clinical and biological conditions and how hydrated you are (the amount of water in the body). The amount of
medicine you receive may also be affected by other treatments you are receiving.
Potassio cloruro e sodio cloruro Kabi 0.3% p/v and 0.9% p/v is administered slowly into a vein
as an infusion. The doctor will determine how long the infusion will take to be administered to you. If you
need a large volume or a rapid infusion of medicine, the doctor will check your ECG
(heart activity).
When you are administered Potassio cloruro e sodio cloruro Kabi 0.3% p/v and 0.9% p/v, the doctor will
perform blood tests to monitor your blood levels of potassium and other electrolytes (such as sodium and
chloride) that are normally in the blood. The doctor will also check that you are urinating normally
(adequate urine production).

If you are given too much Potassio cloruro e sodio cloruro Kabi 0.3% p/v and 0.9% p/v

If you have been given too much medicine, you may experience: tingling and burning in the arms and legs
(paresthesia), muscle weakness, inability to move (paralysis), irregular heartbeat (arrhythmia),
heart block (very slow heartbeat), cardiac arrest (the heart stops beating), mental confusion,
fluid buildup in the lungs that makes it difficult to breathe (pulmonary edema),
fluid buildup under the skin, especially around the ankles (peripheral edema), acidification of
the blood (acidosis) which leads to fatigue, confusion, lethargy and increased breathing rate.
Inform the doctor immediately if you experience any of these symptoms. The infusion will be
stopped and you will be given treatment based on your symptoms.
If you have any questions about the use of this medicine, ask your doctor or nurse.

4. Possible side effects

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

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

• Infection at the injection site
• Abnormal increase in blood volume (hypervolemia)
• Administration of solution into surrounding tissues (extravasation). This can damage tissues and cause scarring.
• Irritation or pain at the injection site.
• Inflammation of the vein into which the solution is infused (phlebitis). This can 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 get any side effects, even those not listed in this leaflet, tell your
doctor or nurse. You can also report side effects directly through 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 Potassio cloruro e sodio cloruro Kabi 0.3% p/v and 0.9% p/v

Keep this medicine out of the sight and reach of children.
This medicine does not require any particular storage conditions.
Do not use this medicine after the expiry date which is 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 has visible particles. Do not use this medicine
if the vial is in any way damaged.
From a microbiological point of view, the product must be used immediately. If not used
immediately, the storage times in use and the conditions before use are the responsibility
of the user.
Do not dispose of any medicine in wastewater. Ask your pharmacist how to dispose of medicines that
you no longer use. This will help protect the environment.

6. Package contents and other information

What contains Potassium chloride and sodium chloride Kabi 0.3% p/v and 0.9% p/v
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• The active ingredients 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 bottle contains 1.50 g of potassium chloride and 4.5 g of sodium chloride.
• Each 1000 ml bottle 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 to adjust the pH.

Description of the appearance of Potassium chloride and sodium chloride Kabi 0.3% p/v and 0.9% p/v
and package contents
Potassium chloride and Sodium Chloride Kabi 0.3% p/v and 0.9% p/v solution for infusion is a clear
and colorless 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

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

This medicinal product is authorised in the Member States of the European Economic Area with the following
names:

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The following information is intended only 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, without visible particles and if the container is intact.
Route of administration
Administration is done intravenously using sterile and
apyrogenic equipment.
Intravenous potassium must be administered in a large peripheral or central vein to
reduce the risk of causing sclerosis. If infused through a central vein, ensure that the
catheter is not in the atrium or ventricle to avoid localized hyperkalemia.
Solutions containing potassium must be administered slowly.

Rate of administration
Since it is administered intravenously, potassium should not be administered at an
infusion rate greater than 15-20 mmol/h to avoid dangerous hyperkalemia.
In any case, the dosage indicated in "general dosage" must not be exceeded.
General dosage
The recommended dosage for the treatment of isotonic fluid depletion (extracellular dehydration)
by any intravenous solution is:

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

Dosage

• Adults, elderly and adolescents:

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

• Paediatric population: When used in the treatment of hypokalemia, the recommended dosage is 0.3 - 0.5 mmol/kg body weight/h. The dose should be adjusted to frequently obtained laboratory values. The maximum recommended dose of potassium is 2-3 mmol/kg of body weight/day.
• Patients with renal insufficiency Patients with renal insufficiency should receive lower doses.

Potassium chloride and sodium chloride Kabi 0.3% p/v and 0.9% p/v is a hypertonic solution, with
an osmolarity of approximately 388 mOsm/l.
Administration must be carried out under regular and careful supervision. It is essential in
patients undergoing potassium therapy, especially those with heart failure or renal failure, regular
monitoring of clinical status, plasma electrolyte concentrations, plasma creatinine levels, blood urea level, acid-base balance and ECG.
Adequate urine flow must be ensured and fluid balance must be monitored.
Potassium salts must be administered with considerable caution to patients with heart disease
or conditions predisposing to hyperpotassemia, such as renal or adrenal insufficiency,
acute dehydration, or extensive tissue destruction, as occurs with severe burns. In patients in
therapy with digitalis, regular monitoring of plasma potassium levels is mandatory.
Sodium salts must be administered with caution in patients with hypertension, heart failure, peripheral or pulmonary edema, renal insufficiency, pre-eclampsia, or other conditions associated
with sodium retention.
Validity in use (Additives)
The chemical and physical stability of any medicinal additive to the pH of Potassium chloride and sodium chloride Kabi
0.3% p/v and 0.9% p/v must be established before use.
In the absence of compatibility studies, this medicine must not be mixed with other medicines.
It is the physician's responsibility to judge the incompatibility of an additive drug towards the solution of Potassium
chloride and sodium chloride Kabi 0.3% p/v and 0.9% p/v, checking for any change in color and/or
any formation of precipitate, insoluble complex or crystals. Also refer to the
Summary of Product Characteristics accompanying the additive medicine. The incompatibility of
the medicine to be added to Potassium chloride and sodium chloride Kabi 0.3% p/v and 0.9% p/v must be
evaluated before addition.
The instructions for use of the medicine to be added must be consulted. Before adding a
medicine, verify that it is soluble and/or stable in water at the pH of Potassium chloride and sodium chloride Kabi
0.3% p/v and 0.9% p/v (pH: from 4.5 to 7.0).
Additives known to be incompatible should not be used.
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From a microbiological point of view, the product must be used immediately. If not used
immediately, the storage times in use and the conditions before use are the responsibility
of the user
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