Natrium hloratum 0,9% Baxter

1. WHAT IS SODIUM CHLORIDE 0.9% BAXTER AND WHAT IS IT USED FOR

Sodium Chloride 0.9% Baxter is a solution of sodium chloride in water. Sodium chloride is a chemical substance (commonly known as "salt") that is a component of blood.
The Sodium Chloride 0.9% Baxter solution is used to treat:

• loss of water from the body (dehydration)
• loss of sodium from the body (excessive loss of sodium from the body).

Sodium and water loss can occur if the patient has:

• difficulty eating and drinking due to illness or surgery
• excessive sweating due to fever
• extensive skin loss, which can occur as a result of severe burns. The Sodium Chloride 0.9% Baxter solution can also be used to administer or dissolve other medicines for infusion.

2. IMPORTANT INFORMATION BEFORE USING SODIUM CHLORIDE 0.9% BAXTER

DO NOT USE Sodium Chloride 0.9% Baxter, solution for infusion, if the patient has any of the following conditions:

• chloride levels in the blood are higher than normal (hyperchloremia)
• sodium levels in the blood are higher than normal (hypernatremia) If another medicine has been added to Sodium Chloride 0.9% Baxter, it is necessary to read the leaflet included in the packaging of the added medicine to assess whether the given solution can be used in the patient.

Warnings and precautions

The patient should inform their doctor if they have or have ever had any of the following conditions:

• any type of heart disease or weakened heart function
• impaired kidney function
• acidosis (acidic blood)
• higher than normal blood volume in the blood vessels (hypervolemia)
• high blood pressure (hypertension)
• fluid accumulation under the skin, especially in the ankles (peripheral edema)
• fluid accumulation in the lungs (pulmonary edema)
• liver disease (e.g. liver cirrhosis)
• high blood pressure during pregnancy (pre-eclampsia)
• increased production of a hormone called aldosterone (aldosteronism)
• any other conditions related to sodium retention in the body (when the body retains too much sodium), such as: steroid treatment (see also section "Other medicines and Sodium Chloride 0.9% Baxter")
• a condition that can cause high levels of vasopressin, a hormone that regulates the amount of fluid in the body. Excessive vasopressin levels in the body can be caused by, for example:
• -sudden and severe illness;
• -pain;
• -surgery;
• -infection, burns, or brain disease;
• -heart, liver, kidney, or central nervous system diseases;
• -taking certain medications (see also section "Other medicines and Sodium Chloride 0.9% Baxter"). This may increase the risk of low sodium levels in the blood and cause headache, nausea, seizures, lethargy, coma, brain swelling, and death. Brain swelling increases the risk of death and brain damage. Patients at higher risk of brain swelling are:
• -children
• -women (especially of childbearing age)
• -patients with problems with cerebrospinal fluid levels, for example, due to meningitis, intracranial hemorrhage, or brain damage.

During infusion of the solution, the doctor will take blood and urine samples to examine:

• the amount of fluid in the body
• vital signs
• the amount of chemical substances such as sodium and potassium in the blood (electrolytes in serum). This is especially important in children and newborns (premature babies), as they may retain too much sodium in the body due to kidney immaturity.

The doctor will consider whether the patient is receiving parenteral nutrition (nutrition administered through a vein). During long-term therapy with Sodium Chloride 0.9% Baxter solution, additional nutrition may be necessary.

Other medicines and Sodium Chloride 0.9% Baxter

Tell your doctor or nurse about all medicines the patient is taking or has recently taken, as well as any medicines the patient plans to take.
It is especially important to inform the doctor about taking:

• corticosteroids (anti-inflammatory medicines) These medicines can cause sodium and water retention, leading to tissue swelling due to fluid accumulation under the skin (edema) and high blood pressure (hypertension).
• lithium (used to treat mental illnesses)
• certain medicines that may affect vasopressin hormone levels. These include:
• antidiabetic medicines (chlorpropamide)
• cholesterol-lowering medicines (clofibrate)
• certain anticancer medicines (vincristine, ifosfamide, cyclophosphamide)
• selective serotonin reuptake inhibitors (used to treat depression)
• antipsychotic medicines
• opioids used to relieve severe pain
• pain relievers and/or anti-inflammatory medicines (also known as NSAIDs)
• medicines that mimic or enhance the action of vasopressin, such as desmopressin (used to treat excessive thirst and urination), terlipressin (used to treat bleeding from the esophagus), and oxytocin (used to induce labor)
• antiepileptic medicines (carbamazepine and oxcarbazepine)
• diuretics (diuretics).

Sodium Chloride 0.9% Baxter with food and drink

Ask your doctor what the patient can eat or drink.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or nurse before using this medicine.
Before adding any medicine to the Sodium Chloride 0.9% Baxter solution used during pregnancy or breastfeeding, the patient should:

• consult a doctor
• read the leaflet included in the packaging of the medicine to be added.

Driving and using machines

Ask your doctor or nurse for advice before driving or using machines.

3. HOW TO USE SODIUM CHLORIDE 0.9% BAXTER

Sodium Chloride 0.9% Baxter is administered by a doctor or nurse. The dose of the medicine and the duration of administration are determined by the doctor. This will depend on the patient's age, weight, condition, reason for treatment, and whether the infusion is used to administer or dilute another medicine or not.
The dose may also be influenced by other medicines the patient is taking.

DO NOT USE Sodium Chloride 0.9% Baxter if the solution contains visible particles or if the packaging is damaged in any way.

The Sodium Chloride 0.9% Baxter solution for infusion is usually administered through a plastic tube connected to a needle inserted into a vein. The solution is usually administered through a vein in the arm; however, the doctor may use a different method to administer the medicine to the patient.
Before and during infusion, the doctor will monitor:

• the amount of fluid in the body
• blood and urine acidity
• electrolyte levels in the body (especially sodium, in patients with high vasopressin hormone levels or taking other medicines that increase the effect of vasopressin).

Remove any unused remains of the solution. Partially used bags of the medicine MUST NOT be reconnected.

Using more than the recommended dose of Sodium Chloride 0.9% Baxter

Intravenous administration of too much solution (over-infusion) may cause:

• nausea (nausea)
• vomiting
• diarrhea (loose stools)
• stomach cramps
• thirst
• dry mouth
• dry eyes
• sweating
• fever
• rapid heartbeat (tachycardia)
• high blood pressure (hypertension)
• kidney failure (renal failure)
• fluid accumulation in the lungs causing breathing difficulties (pulmonary edema)
• fluid accumulation under the skin, especially in the ankles (peripheral edema)
• respiratory arrest (respiratory arrest)
• headache
• dizziness
• restlessness
• irritability
• weakness
• muscle tremors and stiffness
• seizures
• acidic blood (acidosis), causing fatigue, confusion, lethargy, and rapid breathing
• higher than normal sodium levels in the blood (hypernatremia), which can lead to seizures, coma, brain swelling, and death.

If any of the above symptoms occur, the patient should immediately inform their doctor.
In such a situation, the doctor will stop the infusion and administer appropriate treatment, depending on the symptoms.
If another medicine has been added to the Sodium Chloride 0.9% Baxter solution, it may also cause symptoms. The patient should read the leaflet included in the packaging of the added medicine to learn about possible symptoms.

Stopping the use of Sodium Chloride 0.9% Baxter

The decision to stop using Sodium Chloride 0.9% Baxter is made by the doctor.
In case of any further doubts about the use of this medicine, the patient should consult their doctor or nurse.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The frequency of the following side effects is unknown:

• tremors
• low blood pressure
• hives
• rash
• itching (pruritus)

Low sodium levels in the blood, which can be associated with hospital treatment (hospital-acquired hyponatremia) and related neurological disorders (acute hyponatremic encephalopathy).
Hyponatremia can lead to irreversible brain damage and death due to brain swelling (see also section 2 "Warnings and precautions").
Side effects that may occur due to the administration technique used include:

• infection at the injection site,
• local pain or reaction (redness or swelling at the injection site),
• irritation and inflammation of the vein into which the solution is administered (phlebitis). This can cause redness, pain, or burning and itching along the vein into which the solution is administered.
• blood clots in the veins (thrombophlebitis) at the infusion site, causing pain, swelling, or redness in the area of the clot,
• leakage of the solution into the tissue around the blood vessel (extravasation). This can damage tissues and lead to scarring.
• increased fluid volume in the blood vessels (hypervolemia),
• itching at the injection site (hives),
• fever,
• chills.

Other side effects reported for similar medicines (other sodium-containing solutions) include:

• higher than normal sodium levels in the blood (hypernatremia),
• lower than normal sodium levels in the blood (hyponatremia),
• acidic blood due to higher than normal chloride levels (metabolic acidosis with hyperchloremia).

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.
In case of other side effects, the infusion must be stopped.

5. HOW TO STORE SODIUM CHLORIDE 0.9% BAXTER

Keep the medicine out of the sight and reach of children.
Bags of 50 ml and 100 ml: do not store above 30°C.
Bags of 250 ml, 500 ml, and 1000 ml: no special storage precautions.
Do not use this medicine after the expiry date stated on the label. The expiry date refers to the last day of the given month.
Do not use this medicine if it contains visible particles or if the packaging is damaged in any way.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Sodium Chloride 0.9% Baxter contains

The active substance is sodium chloride: 9 g per liter.
The only other ingredient is water for injections.

What Sodium Chloride 0.9% Baxter looks like and what the pack contains

Sodium Chloride 0.9% Baxter, solution for infusion, is a clear solution free from visible particles. It is available in polyolefin/polyamide plastic bags (Viaflo).
Each bag is placed in a closed, protective, outer plastic packaging.
Sizes of bags:

• -50 ml
• -100 ml
• -250 ml
• -500 ml
• -1000 ml

Sizes of packs:

• 50 bags of 50 ml in a cardboard box
• 75 bags of 50 ml in a cardboard box
• 1 bag of 50 ml
• 50 bags of 100 ml in a cardboard box
• 60 bags of 100 ml in a cardboard box
• 1 bag of 100 ml
• 30 bags of 250 ml in a cardboard box
• 1 bag of 250 ml
• 20 bags of 500 ml in a cardboard box
• 1 bag of 500 ml
• 10 bags of 1000 ml in a cardboard box
• 12 bags of 1000 ml in a cardboard box
• 1 bag of 1000 ml

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:
Baxter Polska Sp. z o.o.
ul. Kruczkowskiego 8
00-380 Warsaw
Manufacturer:
Baxter S.A.
Boulevard René Branquart, 80
7860 Lessines
Belgium
Bieffe Medital S.A.
Ctra de Biescas, Senegüé
22666 Sabiñanigo (Huesca)
Spain
Vantive Manufacturing Limited Moneen Road
Castlebar
County Mayo
Ireland
Bieffe Medital S.P.A.
Via Nuova Provinciale
23034 Grosotto (SO)
Italy
Date of last revision of the leaflet:April 2025
Baxter and Viaflo are trademarks of Baxter International Inc.
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The following information is intended for healthcare professionals only:

Method of handling and preparation

Use only if the solution is clear, free from visible particles, and the container is undamaged. Administer immediately after connecting the infusion set.
Do not remove the bag from the protective packaging until use.
The inner bag ensures the sterility of the product.
Plastic containers should not be connected in series. Such use could cause an air embolism due to residual air drawn into the first container before the infusion of the fluid from the second container is completed. Applying additional pressure on intravenous solutions contained in flexible plastic containers to increase the flow rate may cause an air embolism if the container is not completely emptied of air before administration. The solution should be administered using sterile equipment and aseptic technique. The infusion equipment should be primed with the solution before use to prevent air from entering the system. Additional medicines can be added to the solution before or during infusion through the self-sealing port for adding medicines.

• 1. Opening
• a. Remove the Viaflo bag from the protective packaging immediately before use.
• b. Squeezing the inner bag firmly, check for leaks. If a leak is found, discard the bag, as the contents may not be sterile.
• c. Check if the solution is clear and free from visible particles. If the solution is not clear or contains visible particles, discard it.
• 2. Preparation for administration During preparation and administration, use sterile materials.
• a. Hang the bag on a stand.
• b. Remove the plastic cover from the transfer port located at the bottom of the bag:
• hold one side of the smaller wing on the neck of the port
• with the other hand, hold the larger wing on the plug and twist
• the plug will come off.
• c. When connecting the infusion set, follow aseptic technique.
• d. Connect the infusion set according to the instructions provided with the set regarding connection, priming, and administration of the solution.
• 3. Methods of adding other medicines Note: Added medicines may be incompatible (see below, section 5 "Incompatibility of added medicines").

Adding medicines before administration

• a. Disinfect the medicine addition port.

• b. Using a syringe with a suitable needle, insert the needle into the self-sealing medicine addition port and inject the medicine.
• c. Mix the solution with the added medicine thoroughly. For preparations with high density, such as potassium chloride, gently tap the ports with the bag in an upright position and mix.

Note: Do not store bags containing added medicines.
Adding medicines during administration

• a. Close the infusion set clamp.
• b. Disinfect the medicine addition port.
• c. Using a syringe with a suitable needle, insert the needle into the self-sealing medicine addition port and inject the medicine.
• d. Remove the bag from the stand and/or turn it upside down.
• e. Empty both ports by gently tapping in an upright position.
• f. Mix the solution with the added medicine thoroughly.
• g. Hang the bag in its previous position, reopen the clamp, and continue administration.
• 4. Shelf life during use (added medicines) For each added medicine, its chemical and physical stability in the pH of Sodium Chloride 0.9% Baxter, in a Viaflo bag, should be determined before use. From a microbiological point of view, the diluted medicine should be used immediately, unless the solution was prepared in controlled and validated aseptic conditions. If the solution is not used immediately, the user is responsible for the storage time and conditions.
• 5. Incompatibility of added medicines As with all solutions for intravenous administration, before adding other medicines, their compatibility with the solution in the Viaflo container should be assessed. In the absence of compatibility studies, this solution should not be mixed with other medicines. It is the doctor's responsibility to assess the incompatibility of the added medicine with Sodium Chloride 0.9% Baxter by checking for any change in color and/or the appearance of a precipitate, insoluble complexes, or crystals. It is mandatory to check the instructions for use of the added medicine. Before adding a medicine, its solubility and/or stability in water within the pH range of the Sodium Chloride 0.9% Baxter solution should be checked. Substances known to be incompatible should not be used.

Baxter and Viaflo are trademarks of Baxter International Inc.