Sodium chloride 0,9% baxter

PACKAGE LEAFLET: INFORMATION FOR THE USER

Natrium Chloratum 0,9% Baxter, solution for infusion
Active substance: sodium chloride
Please read carefully the entire leaflet before use, as it contains important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any questions, please consult your doctor or nurse.
• If the patient experiences any adverse reactions, including those not listed in this leaflet, inform your doctor or nurse immediately. See section 4.

Table of contents of the leaflet:

1. What Natrium Chloratum 0,9% Baxter is and what it is used for
2. Important information before using Natrium Chloratum 0,9% Baxter
3. How to use Natrium Chloratum 0,9% Baxter
4. Possible side effects
5. How to store Natrium Chloratum 0,9% Baxter
6. Contents of the pack and other information

1. WHAT NATRIUM CHLORATUM 0,9% BAXTER IS AND WHAT IT IS USED FOR

Natrium Chloratum 0,9% Baxter is a solution of sodium chloride in water. Sodium chloride is a chemical substance (commonly known as "salt") which is a component of blood.

The Natrium Chloratum 0,9% Baxter solution is used in the treatment of:

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

Loss of sodium chloride and water may occur in patients who experience:

• difficulty in eating or drinking due to illness or surgical procedure
• excessive sweating due to fever
• extensive skin loss, such as that occurring in severe burns.

Natrium Chloratum 0,9% Baxter may also be used for delivering or dissolving other drugs intended for infusion.

2. IMPORTANT INFORMATION BEFORE USING NATRIUM CHLORATUM 0,9% BAXTER

BAXTER
DO NOT use Natrium Chloratum 0,9% Baxter, infusion solution, if the patient has
any of the following conditions:

• elevated blood chloride levels compared to normal (hyperchloremia)
• elevated blood sodium levels compared to normal (hypernatremia)
  If another medicine has been added to Natrium Chloratum 0,9% Baxter, it is necessary to read the package leaflet of the added medicine to determine whether the solution can be administered to the patient.

Warnings and precautions
The patient should inform the doctor if any of the following conditions are present or have ever occurred:

• any type of heart disease or impaired heart function
• impaired kidney function
• acidic blood (acidosis)
• increased blood volume in blood vessels (hypervolemia)
• high blood pressure (hypertension)
• fluid accumulation under the skin, especially around the ankles (peripheral edema)
• fluid accumulation in the lungs (pulmonary edema)
• liver disease (e.g. cirrhosis)
• high blood pressure during pregnancy (pre-eclampsia)
• excessive production of the hormone called aldosterone (aldosteronism)
• any other conditions associated with sodium retention in the body (when the body retains excessive amounts of sodium), such as treatment with steroids (see also section "Other medicines and Natrium Chloratum 0,9% Baxter")
• condition that may cause high levels of vasopressin, a hormone regulating fluid balance in the body. Excessively high vasopressin levels in the body may be caused, for example, by:
  • sudden and serious illness;
  • pain;
  • surgery;
  • infection, burns, or brain disease;
  • diseases related to the heart, liver, kidneys, or central nervous system;
  • taking certain medicines (see also section "Other medicines and Natrium Chloratum 0,9% Baxter").
    This may increase the risk of low sodium levels in the blood and may cause headache, nausea, seizures, drowsiness, coma, cerebral edema, and death. Cerebral edema increases the risk of death and brain damage. Patients at higher risk of cerebral edema include:
  • children
  • women (especially those of childbearing age)
  • patients with problems related to cerebrospinal fluid levels, for example due to meningitis, intracranial hemorrhage, or brain injury.

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

• fluid levels in the body
• vital parameters
• levels of chemical substances such as sodium and potassium in the blood (plasma electrolytes). This is particularly important in children and newborns (preterm infants), as they may retain excessive amounts of sodium due to immature kidney function.

The doctor will consider whether the patient is receiving parenteral nutrition (nutrition
administered via intravenous infusion). During prolonged therapy with Natrium Chloratum
0,9% Baxter, additional nutritional support may be required.

Other medicines and Natrium Chloratum 0,9% Baxter solution
Inform the doctor or nurse about all medicines currently or recently taken, as well as any medicines the patient plans to take.
It is especially important to inform the doctor about the use of:

• corticosteroids (anti-inflammatory medicines)
  These medicines may cause sodium and water retention in the body, leading to tissue swelling due to fluid accumulation under the skin (edema) and high blood pressure (hypertension).
• lithium (used in the treatment of psychiatric disorders)
• certain medicines that may affect the level of the hormone vasopressin, including:
  • antidiabetic medicines (chlorpropamide)
  • cholesterol-lowering medicines (clofibrate)
  • certain anticancer medicines (vincristine, ifosfamide, cyclophosphamide)
  • selective serotonin reuptake inhibitors (used in the treatment of depression)
  • antipsychotic medicines
  • opioids used to relieve severe pain
  • painkillers 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 urine output), terlipressin (used to treat esophageal bleeding), and oxytocin (used to induce labor)
  • antiepileptic medicines (carbamazepine and oxcarbazepine)
  • diuretics (water pills).

Natrium Chloratum 0,9% Baxter with food and drink
Ask the doctor what the patient may eat or drink.

Pregnancy, breastfeeding, and effects on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or nurse before using this medicine.
Before adding any medicine to the Natrium Chloratum 0,9% Baxter solution used during pregnancy or breastfeeding, the following should be done:

• consult a doctor
• read the package leaflet of the medicine to be added.

Driving and operating machinery
Ask the doctor or nurse for advice before driving or operating machinery.

3. HOW TO USE NATRIUM CHLORATUM 0.9% BAXTER

Natrium Chloratum 0.9% Baxter is administered by a doctor or nurse. The dose and duration of administration are determined by the doctor and depend on the patient's age, body weight, clinical condition, reason for treatment, and whether the infusion is used to deliver or dilute another medicine or not.
Other medications the patient is receiving may also influence the dose.

Do not use Natrium Chloratum 0.9% Baxter if particles are visible in the solution or if the packaging is damaged in any way.

The infusion solution Natrium Chloratum 0.9% Baxter is usually administered through a plastic tube connected to a needle placed in a vein. Typically, the solution is infused into a vein in the arm; however, the doctor may choose a different route of administration for the patient.

Before and during the infusion, the doctor will monitor:

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

Any unused solution remnants must be discarded. Partially used bags of the medicine MUST NOT be reconnected.

Administration of a higher than recommended dose of Natrium Chloratum 0.9% Baxter
Intravenous administration of excessive amounts of solution (overinfusion) may cause:

• nausea
• vomiting
• diarrhea (loose stools)
• stomach cramps
• thirst
• dry mouth
• dry eyes
• sweating
• fever
• rapid heartbeat (tachycardia)
• increased blood pressure (hypertension)
• kidney failure (renal insufficiency)
• fluid accumulation in the lungs causing breathing difficulties (pulmonary edema)
• fluid accumulation under the skin, especially around the ankles (peripheral edema)
• respiratory arrest (cessation of breathing)
• headache
• dizziness
• restlessness
• irritability
• weakness
• muscle twitching and stiffness
• convulsions
• blood acidification (acidosis), causing fatigue, confusion, lethargy, and increased breathing rate
• elevated blood sodium levels (hypernatremia), which may lead to seizures, coma, cerebral edema, and death.

If any of the above symptoms occur, the doctor must be informed immediately. In such a case, the doctor will stop the infusion and initiate appropriate treatment depending on the symptoms.

If another medicine has been added to the Natrium Chloratum 0.9% Baxter infusion solution, it may also cause some of these symptoms. Please read the Package Leaflet of the added medicine to become familiar with possible side effects.

Discontinuation of Natrium Chloratum 0.9% Baxter
The decision to discontinue Natrium Chloratum 0.9% Baxter will be made by the doctor.

If you have any further doubts regarding the use of this medicine, please consult your doctor or nurse.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The frequency of the adverse reactions listed below is unknown:

• tremor
• low blood pressure
• urticaria
• rash
• itching (pruritus)

Low sodium levels in the blood, which may be associated with hospital treatment (hospital-acquired hyponatremia) and related neurological disorders (acute hyponatremic encephalopathy).
Hyponatremia may lead to irreversible brain damage and death due to swelling/edema of the brain (see also section 2 "Warnings and precautions").

Adverse reactions that may occur as a result of the administration technique include:

• infection at the site of administration,
• local pain or reaction (redness or swelling at the site of administration),
• irritation and inflammation of the vein into which the solution is infused (phlebitis). This may cause redness, pain, burning, and itching along the vein,
• formation of blood clots in veins at the infusion site (venous thrombosis), causing pain, swelling, or redness around the clot,
• leakage of solution into surrounding tissues (extravasation). This may damage tissues and lead to scarring,
• increased fluid volume in the blood vessels (hypervolemia),
• itching at the site of administration (urticaria),
• fever,
• chills.

Other adverse reactions reported with similar medicines (other sodium-containing solutions) include:

• higher than normal level of sodium in the blood (hypernatremia),
• lower than normal level of sodium in the blood (hyponatremia),
• blood acidification associated with higher than normal chloride concentration in the blood (metabolic acidosis with hyperchloremia).

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your 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
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.
If other adverse reactions occur, the infusion must be stopped.

5. HOW TO STORE NATRIUM CHLORATUM 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 instructions for this medicine.
Do not use this medicine after the expiry date stated on the label. The expiry date refers to the last day of the stated month.
Do not use this medicine if it contains visible particles or if the packaging is in any way damaged.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What Natrium Chloratum 0.9% Baxter contains
The active substance is sodium chloride: 9 g per litre.
The only other ingredient is water for injections.

What Natrium Chloratum 0.9% Baxter looks like and contents of the pack
Natrium Chloratum 0.9% Baxter, infusion solution, is a clear, particle-free solution. It is available in polyolefin/poliamide plastic bags (Viaflo).
Each bag is enclosed in a sealed, protective, outer plastic packaging.

Bag sizes:

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

Pack sizes:

• 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 Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Baxter Polska Sp. z o.o.
ul. Kruczkowskiego 8
00-380 Warszawa
Poland

Manufacturers:
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

Baxter and Viaflo are trademarks of Baxter International Inc.

The following information is intended exclusively for physicians or healthcare professionals:

Handling and Preparation
Use only if the solution is clear, free of visible particles, and the container is undamaged. Administer immediately after connecting the infusion set.
Do not remove the bag from its protective outer packaging until ready for use.
The inner bag ensures product sterility.

Do not connect plastic containers in series. Such use may result in air embolism due to residual air being drawn from the first container before the infusion from the second container is completed. Applying additional pressure to intravenous solutions contained in flexible plastic containers to increase the flow rate may cause air embolism if residual air is not completely removed from the container before administration.

The solution must be administered using sterile equipment and aseptic techniques. The infusion set should be pre-filled with the solution to prevent air from entering the system.

Additional medications may be added to the solution before or during infusion via the medication-addition self-sealing port.

If an additional component has been added, isotonicity must be confirmed prior to parenteral administration. After adding any medication, the solution must be thoroughly and gently mixed under aseptic conditions. Solutions containing added medications should be used immediately and not stored.

The addition of other drugs or improper administration techniques may lead to febrile reactions due to the potential introduction of pyrogens. In case of an adverse reaction, the infusion must be stopped immediately.

Discard after single use.
Discard any unused solution.
Do not re-use partially used bags.

1. Opening
   a. Remove the Viaflo bag from its protective packaging immediately before use.
   b. Squeeze the inner bag firmly to check for leakage. If leakage is detected, discard the bag, as the contents may no longer be sterile.
   c. Check that the solution is clear and free from insoluble particles. If the solution is not clear or contains insoluble particles, discard it.

2. Preparation for Administration
   Use sterile materials during preparation and administration.
   a. Hang the bag on an infusion stand.
   b. Remove the plastic cover from the administration port located at the bottom of the bag:

   • Hold the smaller winglet on the neck of the port with one hand
   • With the other hand, hold the larger winglet on the cap and twist
   • The cap will pop off.
     c. Use aseptic techniques when connecting the infusion set.
     d. Connect the infusion set, following the manufacturer's instructions for connection, priming, and administration of the solution.

3. Methods of Adding Additional Medications
   Note: Added medications may be incompatible (see section 5 below, "Incompatibilities of Added Medications").

   Adding medications before administration
   a. Disinfect the medication-addition port.
   b. Using a syringe with an appropriate needle, insert the needle into the self-sealing medication-addition port and inject the medication.
   c. Mix the solution thoroughly. For viscous preparations, such as potassium chloride, gently tap the ports with the bag held upright (ports upward) and mix.
   Note: Do not store bags containing added medications.

   Adding medications during administration
   a. Close the clamp on the infusion set.
   b. Disinfect the medication-addition port.
   c. Using a syringe with an appropriate needle, insert the needle into the self-sealing medication-addition port and inject the medication.
   d. Remove the bag from the stand and/or invert it so that the ports are facing upward.
   e. Clear both ports by gently tapping them while the bag is in the upright position (ports upward).
   f. Mix the solution thoroughly.
   g. Rehang the bag in its original position, reopen the clamp, and continue administration.

4. In-Use Stability (with added medications)
   For each added medication, its chemical and physical stability in Natrium Chloratum 0.9% Baxter at its pH, within a Viaflo-type bag, must be determined prior to use. From a microbiological standpoint, the diluted medication should be used immediately unless the dilution was carried out under controlled and validated aseptic conditions. If the solution is not used immediately, the user is responsible for the duration and conditions of storage.

5. Incompatibilities of Added Medications
   As with all parenteral solutions, the compatibility of any added medication with the solution in the Viaflo container must be assessed before administration. In the absence of compatibility studies, this solution should not be mixed with other medications. It is the physician's responsibility to evaluate the compatibility of the added medication with Natrium Chloratum 0.9% Baxter by checking for any possible change in colour and/or formation of precipitate, insoluble complexes, or crystals. The Summary of Product Characteristics of the added medication must be consulted. Prior to adding a medication, its solubility and/or stability in water within the pH range of Natrium Chloratum 0.9% Baxter should be verified. Substances known to be incompatible should not be used.

Baxter and Viaflo are trademarks of Baxter International Inc.