SODIO KLORURO 0,9% KON POTASSIO KLORURO 0,3% BAXTER 500 ml Infusion solution

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1. Sodio Cloruro 0,9% con Potassio Cloruro 0,3% Baxter, solution for infusion
   1. WHAT IS SODIO 0,9 & POTASSIO 0,3 FOR INFUSION AND WHAT IS IT USED FOR
   2. BEFORE USING SODIUM 0.9% & POTASSIUM CHLORIDE 0.3% FOR INFUSION
   3. HOW TO ADMINISTER SODIUM CHLORIDE 0.9% & POTASSIUM CHLORIDE 0.3% FOR
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE SODIO 0,9 & POTASSIO 0,3 BAXTER
   6. FURTHER INFORMATION
   7. Opening
   8. Preparation for administration
   9. Techniques for Adding Medication Additives

Sodio Cloruro 0,9% con Potassio Cloruro 0,3% Baxter, solution for infusion

Active ingredients: potassium chloride and sodium chloride

Read this leaflet carefully before you start using this medicine

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Never give it to others. In fact, for other individuals this medicine could be dangerous, even if their symptoms are the same as yours.
• If any of the side effects gets worse, or if you notice any unwanted effect not listed in this leaflet, tell your doctor or pharmacist. This medicine is called “Sodio cloruro 0.9% con Potassio cloruro 0.3% Baxter solution for infusion”, but will be called “Sodio 0.9 & Potassio 0.3 for infusion” in the rest of this leaflet.

Contents of this leaflet:

• 1. What Sodio 0.9 & Potassio 0.3 for infusion is and what it is used for
• 2. What you need to know before you use Sodio 0,9& Potassio 0,3 for infusion
• 3. How to administer Sodio 0,9 & Potassio 0,3 for infusion
• 4. Possible side effects
• 5. How to store Sodio 0,9 & Potassio 0,3 for infusion
• 6. Contents of the pack and other information

1. WHAT IS SODIO 0,9 & POTASSIO 0,3 FOR INFUSION AND WHAT IS IT USED FOR

Sodio 0,9 & Potassio 0,3 for infusion is a solution of potassium chloride and sodium chloride in water.
Potassium chloride and sodium chloride are chemical substances (often called “salts”) that are found
in the blood.
The infusion of Sodio 0,9 & Potassio 0,3 for infusion is used to prevent and treat:

• a loss of potassium from the body (potassium depletion, for example after treatment with certain diuretics [water tablets])
• a low level of potassium in the blood (hypokalemia) in situations that can cause loss of sodium chloride and water including:
• when unable to eat or drink, due to illness or after surgery
• excessive sweating due to high fever
• extensive skin loss, as can happen in severe burns

2. BEFORE USING SODIUM 0.9% & POTASSIUM CHLORIDE 0.3% FOR INFUSION

You must not receive an infusion of Sodium 0.9% & Potassium 0.3% for infusion if you
suffer from any of the following conditions:

• levels of potassium in the blood higher than normal (hyperkalemia)
• levels of chlorides in the blood higher than normal (hyperchloremia) 1 of 10
• levels of sodium in the blood higher than normal (hypernatremia)
• severe kidney failure (when your kidneys do not function well and you need dialysis)
• decompensated heart failure. This is heart failure that is not adequately treated and causes symptoms such as:
• shortness of breath
• swelling of the ankles
• Addison's disease (weak functioning of the adrenal gland. The adrenal gland produces hormones that help control the concentrations of chemicals in the body)

Take particular care when taking Sodium 0.9% & Potassium 0.3% for infusion
Sodium 0.9% & Potassium 0.3% for infusion is a hypertonic solution (concentrated). Your doctor
will take this into account when calculating how much solution to administer to you.
Tell your doctor if you have or have had any of the following medical conditions

• any heart disease or weak heart function
• reduced kidney function
• adrenocortical insufficiency (this disease of the adrenal gland affects the hormones that control the concentration of chemicals in the body)
• a loss of water from the body (acute dehydration, for example from vomiting or diarrhea)
• extensive tissue damage (as can happen in severe burns)
• if you are being treated with cardiac glycosides (also called cardiotonics), such as digitalis or digoxin. These drugs are used to treat heart disease. Regular monitoring of blood potassium levels must be performed.
• high blood pressure (hypertension)
• accumulation of fluid under the skin, and especially at the level of the ankles (peripheral edema)
• accumulation of fluid at the lung level (pulmonary edema)
• high blood pressure during pregnancy (pre-eclampsia)
• any condition associated with sodium retention (when the body retains too much sodium), such as in the treatment with steroids (see also “Taking other medicines”).
• if you are in a condition that can cause high levels of vasopressin, a hormone that regulates fluids in your body. You may have too much vasopressin in your body because, for example:
• you have a sudden and severe illness
• you are in pain
• you have undergone surgery
• you have infections, burns, or brain diseases
• you have diseases related to your heart, liver, kidneys, or central nervous system
• because you are taking certain medications (see also below “Taking other medicines ”)This can increase the risk of low sodium levels in your blood and can lead to headache, nausea, seizures, lethargy, coma, cerebral edema, and death. Cerebral edema increases the risk of death and brain damage. People who are at higher risk of cerebral edema are:
• children
• women (especially if of childbearing age)

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• people who have problems with their levels of cerebrospinal fluid, for example, due to meningitis, intracranial bleeding, or brain damage

When you are given the infusion, your doctor will take blood and urine samples from you
to check:

• the amount of fluid in your body
• your vital signs
• the amount of compounds such as sodium and potassium in your blood (your plasma electrolytes)
• the concentration in the blood of a substance called creatinine (your plasma creatinine)
• the concentration in the blood of a substance called urea (your BUN levels)
• the acidity of your blood and urine (your acid-base balance)
• your heart tracing (ECG)

Your doctor will consider whether you are receiving parenteral nutrition (nutrition administered
by infusion into a vein).
During long-term treatment with Sodium Chloride 0.9% with Potassium Chloride 0.3% for
infusion, you may need to be given extra nutrition

Taking other medicines
Tell your doctor or pharmacist if you are taking or have recently taken any other
medicines, including those available without a prescription.
It is particularly important that you inform your doctor if you are taking:

• cardiac glycosides (cardiotonics) used to treat heart failure, such as digitalis or digoxin
• medicines that increase the concentration of potassium in the blood, such as:
• potassium-sparing diuretics (certain water tablets, for example amiloride, spironolactone, triamterene)
• angiotensin-converting enzyme (ACE) inhibitors (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 to treat some skin diseases)
• medicines that contain potassium (for example, potassium supplements, salt substitutes that contain potassium)
• corticosteroids (anti-inflammatory drugs)

Some drugs affect the hormone vasopressin. These may include:

• antidiabetic drugs (chlorpropamide)
• cholesterol drugs (clofibrate)
• some cancer drugs (vincristine, ifosfamide, cyclophosphamide)
• selective serotonin reuptake inhibitors (used to treat depression)
• antipsychotics
• opioids, for relief from severe pain
• pain relievers and/or anti-inflammatory drugs (also known as NSAIDs)

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• drugs that reproduce or enhance the effect of vasopressin such as desmopressin (used to treat thirst and increased urination), terlipressin (for treating esophageal bleeding) and oxytocin (used to induce labor).
• Antiepileptic drugs (carbamazepine and oxcarbazepine)
• Diuretics (water pills).
• .

Taking Sodium 0.9% & Potassium 0.3% for infusion with food and drink
You should ask your doctor what you can drink or eat.

Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
Tell your doctor if you are pregnant or if you are breastfeeding.
Changes in potassium levels in your blood can affect the functioning of your heart
and the baby you are expecting. Your doctor will therefore carefully monitor the levels of chemicals
in your blood.
Sodium 0.9% & Potassium 0.3% for infusioncan be used during pregnancy. The amount that
can be administered to you must be carefully controlled by your doctor
In any case, if you are pregnant or breastfeeding and any drug needs to be added to your
infusion solution, you should:

• consult your doctor
• read the leaflet of the medicine being added carefully

Driving and using machines
Sodium Chloride 0.9% with Potassium Chloride 0.3% Baxter does not affect your ability to drive
or use machines.

3. HOW TO ADMINISTER SODIUM CHLORIDE 0.9% & POTASSIUM CHLORIDE 0.3% FOR

INFUSION
Sodium 0.9% & Potassium 0.3% for infusionwill be administered to you by a doctor or nurse.
Your doctor will decide how much product you need and when it will be administered to you. This will depend
on your age, weight, clinical/biological condition and hydration status (amount of water in your
body). The quantity that will be administered to you will also depend on other treatments you are undergoing.

You should not be administered Sodium 0.9% & Potassium 0.3% for infusion if there are
particles in suspension in the solution or if the packaging is damaged in any
way.
The infusion rate will be decided by your doctor.
If you require a large volume or a rapid infusion of Sodium chloride 0.9% with Potassium
Chloride 0.3% Baxter, your doctor may monitor your ECG (cardiac tracing).
Sodium 0.9% & Potassium 0.3% for infusion is commonly administered intravenously through a
plastic tube connected to a needle. Usually, a vein in your arm is used for the
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administration of the solution. However, your doctor may choose a different route of
administration.
Before and during the infusion your doctor will monitor:

• potassium
• the amount of fluids in your body
• the acidity of blood and urine
• the amount of electrolytes (in particular sodium, in patients with high levels of vasopressin hormone, or those who take drugs that increase the effect of vasopressin).

If you suffer from reduced kidney function, you may receive a lower dose.
Any unused solution must be discarded. NEVER administer an infusion of
Sodium 0.9% & Potassium 0.3% for infusion from a partially used bag.

If you are administered more Sodium 0.9% & Potassium 0.3% for infusion than you should
If you are administered too much Sodium 0.9% & Potassium 0.3% for infusion (overinfusion), this
could lead to the following symptoms:

• tingling in the arms and legs (paresthesia)
• muscle weakness
• inability to move (paralysis)
• irregular heartbeat (cardiac arrhythmias)
• heart block (a very slow heartbeat)
• cardiac arrest (the heart stops beating; a life-threatening situation)
• confusion
• fluid accumulation in the lungs with resulting difficulty breathing (pulmonary edema)
• fluid accumulation under the skin, especially at the ankles (peripheral edema)
• acidification of the blood (acidosis) with resulting fatigue, confusion, lethargy and increased respiratory rate.

If you develop any of these symptoms, you should immediately inform your doctor. Your
infusion will be suspended and you will be given treatment depending on the symptoms. If a drug
has been added to the Sodium 0.9% & Potassium 0.3% for infusion solution before the overinfusion,
added to the list of all possible symptoms.

Discontinuation of Sodium 0.9% & Potassium 0.3% for infusion
Your doctor will decide when to stop administering the infusion.
If you have further questions about the use of this product, please consult your doctor.

4. POSSIBLE SIDE EFFECTS

Like all medicines, the infusion of Sodium 0.9 & Potassium 0.3 for infusion may cause side
effects, although not everybody gets them.

• Low levels of sodium in the blood that can be acquired during hospitalization (hospital-acquired hyponatremia) and related neurological disorders (acute hyponatremic encephalopathy). Hyponatremia can cause irreversible brain damage and death, due to the

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development of cerebral edema/ swelling (see also the paragraph “Pay particular
attention when taking Sodium 0.9 & Potassium 0.3 for infusion”)
Side effects that may occur due to the method of administration include:

• Fever (febrile response)
• Infection at the infusion site
• Pain or local reaction (redness or swelling at the infusion site)
• Irritation and inflammation of the vein into which the infusion was performed (phlebitis). This can cause redness, pain, burning and swelling along the path of the vein into which the solution was infused
• Formation of a blood clot (venous thrombosis) at the infusion site, which causes pain, swelling or redness in the area of the clot
• Leakage of the infused solution into the tissues around the vein (extravasation). This can damage the tissues and cause scarring
• Excess fluid in the blood vessels (hypervolemia)

If a drug has been added to the infusion solution, the added drug may also cause
all possible symptoms.
If any of the side effects gets worse, or if you notice any effect
If any side effect occurs, the infusion must be stopped.

5. HOW TO STORE SODIO 0,9 & POTASSIO 0,3 BAXTER

Keep this medicine out of the reach and sight of children.
Sodium 0.9% & Potassium 0.3% for infusion does not require special storage conditions.
DO NOT administer Sodium 0.9% & Potassium 0.3% for infusion after the expiry date stated on the packaging. The expiry date refers to the last day of the month indicated.
DO NOT administer Sodium 0.9% & Potassium 0.3% for infusion if particles in suspension are present in the solution or if the packaging is damaged in any way.

6. FURTHER INFORMATION

What Sodio 0,9 & Potassio 0,3 for infusion contains
The active ingredients are:

• potassium chloride: 3 g per litre
• sodium chloride: 9 g per litre

The only excipient is water for injections.
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Description of the appearance of Sodio cloruro Sodio 0,9 & Potassio 0,3 for infusion and contents
of the pack
Sodio 0,9 & Potassio 0,3 for infusion is a clear solution, free from visible particles. It is
dispensed in polyolefin/polyamide plastic bags (Viaflo).
Each bag is wrapped in a sealed protective covering of plastic material.
The sizes of the bags are:

• 500 ml
• 1000 ml The bags are placed inside cardboard boxes. Each carton contains one of the following quantities:
• 20 bags of 500 ml
• 10 bags of 1000 ml Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturers
Marketing Authorisation Holder:
Baxter S.p.A., Piazzale dell’Industria 20, 00144 Roma
Manufacturers:
Baxter S.A.
Boulevard Rene Branquart, 80
B–7860 Lessines, Belgium
Baxter Healthcare Ltd.
Caxton Way,
Thetford Norfolk IP24 3SE
United Kingdom
Bieffe Medital Sabiñanigo
Ctra de Biescas, Senegüé
22666 Sabiñanigo(Huesca)
Spain
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The following information is intended exclusively for doctors and healthcare professionals:
Handling and Preparation
Use the product only if the solution is clear, free from visible particles and if the container is
intact. Administer immediately after inserting the infusion set.
Do not remove the bag from its wrapper until the time of use.
The inner bag preserves the sterility of the product
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Do not use plastic containers for series connections. This use could determine
gaseous embolism due to aspiration of residual air from the primary container before the
administration of fluid from the secondary container is completed.
The solution must be administered using sterile equipment and by aseptic technique. The device must be filled with the solution to prevent air from entering the
system.
Medicinal additions can be made before or during the infusion through the resealable access point
When making medicinal additions, check the tonicity before
parenteral administration.
Complete and accurate aseptic mixing of any addition is mandatory.
Solutions containing additions must be administered immediately and not
stored.
The addition of medicines or an incorrect administration technique may lead to the appearance
of febrile reactions due to the possible introduction of pyrogens. In case of adverse reactions
the infusion must be immediately stopped.

Dispose of the product after each single use.
Discard any unused product residue.
Do not reconnect partially used bags.

1. Opening

• a. Remove the Viaflo container from the outer packaging immediately before use
• b. Check for any small leaks by firmly compressing the inner bag. If any leaks are detected, discard the solution as sterility may be compromised.
• c. Verify that the solution is clear and that no foreign particles are visible. Discard the solution if foreign material and/or turbidity is visible.

2. Preparation for administration

Use sterile material for both preparation and administration.

• a. Hang the container using the support hole
• b. Remove the plastic cap from the outlet located at the bottom of the container:
• hold firmly with one hand the small flap located on the neck of the outlet,
• with the other hand grasp the large flap located on the cap and rotate,
• the cap will open
• c. Use an aseptic method to prepare the infusion

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• d. Connect the infusion set. Consult the instructions included with the set for connection, device filling, and solution administration.

3. Techniques for Adding Medication Additives

The solution should not be administered into the atrium or ventricle to avoid localized hyperkalemia
but in a large peripheral or central vein to decrease the risk of causing
sclerosis.

Warning: additives may be incompatible (see the following paragraph 5

“Incompatibilities of Additives”).

Adding Medications Before Administration

• a. Disinfect the entry point for the dressing
• b. Using a syringe with a 19 (1.10 mm) to 22 gauge (0.70 mm) needle, puncture the entry point for the resealable dressing and inject the drug.
• c. Mix the solution and medication thoroughly. For drugs with high density, such as potassium chloride, gently tap the entry points while keeping them in a vertical position and mix. Caution: do not store bags that contain medication additives.

Adding Medications During Administration

• a. Close a clamp on the infusion set
• b. Disinfect the entry point of the dressing
• c. Using a syringe with a 19 (1.10 mm) to 22 gauge (0.70 mm) needle, puncture the entry point for the resealable dressing and inject the drug.
• d. Remove the container from the pole of the infusion device and turn it upside down
• e. Eliminate any residual medication and solution from both entry points by gently tapping while the container is in a vertical position
• f. Mix the solution and added medication thoroughly
• g. Return the container to the correct position for use, reopen the clamp and continue administration

4Validity During Use (Additives)
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The chemical and physical stability of each medication added to the pH of Sodium 0.9 &
Potassium 0.3 solution for infusion in the Viaflo container must be evaluated before use. From a
microbiological point of view, the diluted product must be used immediately unless
the dilution has occurred under validated and controlled aseptic conditions.
If the solution is not used immediately, the storage times and conditions are
the responsibility of the user.

5Incompatibilities of Medication Additives
As with all parenteral solutions, the incompatibility of medication additives with the
solution in the Viaflo container must be evaluated before addition.
In the absence of compatibility studies, this solution should not be mixed with other medicinal products.
It is the physician's responsibility to judge the incompatibility of a medication additive with the
Sodium 0.9 & Potassium 0.3 solution for infusion, checking for any color change
and/or the possible appearance of a precipitate, insoluble complexes or crystals. The instructions for
use of the medication to be added must be consulted.
Before adding a drug, verify if it is soluble and/or stable in water at the same pH as the
Sodium 0.9 & Potassium 0.3 solution for infusion (pH: 4.5-7.0)
Additives known to be incompatible should not be used.
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