Sodium chloride 0.9% Baxter: detailed information

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Sodium Chloride 0.9% Baxter infusion solution

Active substance: sodium chloride
Read 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 questions, ask your doctor or nurse.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or nurse. See section 4.
This medicine is called 'Sodium Chloride 0.9% Baxter infusion solution', but will be referred to as 'Sodium 0.9 for infusion' throughout the remainder of this leaflet.
Contents of this leaflet:

What Sodium 0.9 for infusion is and what it is used for
What you must know before Sodium 0.9 for infusion is administered to you
How Sodium 0.9 for infusion will be administered to you
Possible side effects
How to store Sodium 0.9 for infusion
Contents of the pack and other information

1. WHAT SODIO 0.9 FOR INFUSION IS AND WHAT IT IS USED FOR

Sodio 0.9 for infusion is a solution of sodium chloride in water. Sodium chloride is a chemical substance (often called "salt") that is naturally present in the blood.
Sodium chloride 0.9% infusion is used to treat:

Loss of water from the body (dehydration)
Loss of sodium from the body (sodium depletion)

Conditions that may cause loss of sodium chloride and water include:

Inability to drink or eat due to illness or following surgical procedures
Excessive sweating due to high fever
Extensive skin loss, as occurs in severe burns

Sodio 0.9 for infusion can also be used as a vehicle or diluent for other medicinal products administered by infusion.

2. WHAT YOU SHOULD KNOW BEFORE SODIUM 0.9% INFUSION IS ADMINISTERED TO YOU

INFUSION
Do not take Sodium 0.9% infusion if you have any of the following conditions:

elevated levels of chloride in the blood have been detected (hyperchloremia)
elevated levels of sodium in the blood have been detected (hypernatremia)
If a medicinal product is added to Sodium 0.9% infusion, please read the package leaflet of that medicine carefully to understand whether the solution can be administered.

Warnings and precautions
Please inform your doctor if you have or have ever had any of the following medical conditions:
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any heart disease or weakened cardiac function
impaired kidney function
acidification of the blood (acidosis)
increased blood volume in the blood vessels (hypervolemia)
high blood pressure (hypertension)
fluid accumulation under the skin, particularly in the ankles (peripheral edema)
fluid accumulation in the lungs (pulmonary edema)
liver diseases (e.g., cirrhosis)
high blood pressure during pregnancy (pre-eclampsia)
increased production of the hormone aldosterone (aldosteronism)
any condition associated with sodium retention (when the body retains too much sodium), such as treatment with steroids (also read “Sodium 0.9% infusion and other medicines”)
if you are in a condition that may cause high levels of vasopressin, a hormone that regulates fluids in your body. You may have excessive vasopressin in your body, for example, if:
- you have a sudden and serious illness
- you are experiencing pain
- you have recently undergone surgery
- you have infections, burns, or brain disorders
- you have diseases affecting your heart, liver, kidneys, or central nervous system
- you are taking certain medications (see also “Other medicines and Sodium 0.9% infusion”).
  This may increase the risk of low sodium levels in your blood and may lead to headache, seizures, lethargy, coma, cerebral edema, and death. Cerebral edema increases the risk of death and brain damage. People at higher risk of cerebral edema include:
- children
- women (especially those of childbearing age)
- individuals who have problems with their brain fluid levels, for example, due to meningitis, intracranial hemorrhage, or brain injury

When the infusion is administered, your doctor will take blood and urine samples to monitor:

fluid levels in your body
your vital signs
levels of chemical substances such as sodium and potassium in the blood (blood electrolytes)
This is particularly important for children and neonates (premature infants), as they may retain excessive sodium due to immature kidney function. Your doctor will consider whether you are receiving parenteral nutrition (nutrition administered via intravenous infusion). During long-term treatment with Sodium 0.9% infusion, you may require additional nutritional support.

Other medicines and Sodium 0.9% infusion
Inform your doctor or nurse if you are currently using, have recently used, or might use any other medicinal product.
It is especially important that you inform your doctor if you are taking:

corticosteroids (anti-inflammatory drugs) – these drugs may cause the body to retain sodium and water, leading to tissue swelling due to fluid accumulation under the skin (edema) and high blood pressure (hypertension)
lithium (used to treat psychiatric disorders)
Some medicines affect the hormone vasopressin. These may include:
- antidiabetic drugs (chlorpropamide)
- cholesterol-lowering drugs (clofibrate)
- certain anticancer drugs (vincristine, ifosfamide, cyclophosphamide)
- selective serotonin reuptake inhibitors (used to treat depression)
- antipsychotics
- opioids (used to treat severe pain)
- painkillers and/or anti-inflammatory drugs (also known as NSAIDs)
- drugs that mimic or enhance the effect of vasopressin, such as desmopressin (used to treat excessive thirst and urination), terlipressin (used to treat esophageal bleeding), and oxytocin (used to induce labor)
antiepileptic drugs (carbamazepine and oxcarbazepine)
diuretics (to promote urine production)

Sodium 0.9% infusion with food and drink
You should ask your doctor what you may drink or eat.

Pregnancy, breastfeeding, and fertility
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding, please consult your doctor or nurse before taking this medicine. In any case, if you are pregnant or breastfeeding and any drug is to be added to your infusion solution, you must:

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

Driving and using machines
Ask your doctor or nurse for advice before driving or operating machinery.

3. HOW SODIUM 0.9% FOR INFUSION WILL BE ADMINISTERED TO YOU

Sodium 0.9% for infusion will be administered to you by a doctor or nurse. Your doctor will decide how much medicine you need and when it will be administered. This will depend on your age, weight, medical condition, the reason for treatment, and whether the infusion is being used to administer or dilute another medicinal product.
The amount you receive will also depend on any other treatments you are undergoing.
Sodium 0.9% for infusion must NOT be administered to you if the solution contains
suspended particles or if the packaging is in any way damaged.
Sodium 0.9% for infusion is commonly administered intravenously through a plastic tube connected to a needle. Usually, a vein in your arm is used to administer the solution. However, your doctor may choose a different route of administration.
Before and during the infusion of Sodium 0.9% for infusion, your doctor will monitor:

the amount of fluid in your body
the acidity of your blood and urine 3 of 10
the level of electrolytes (particularly sodium, in patients with elevated levels of vasopressin hormone, or in those taking medications that enhance the effect of vasopressin).

Any unused solution must be discarded. YOU MUST NEVER BE GIVEN AN INFUSION OF SODIUM 0.9% FOR INFUSION FROM A PARTIALLY USED BAG.
If you are given more Sodium 0.9% for infusion than you should
If you receive too much Sodium 0.9% for infusion (over-infusion), this could lead to the following symptoms:

nausea (feeling of disgust)
vomiting
diarrhoea (loose stools)
abdominal cramps
thirst
dry mouth
dry eyes
sweating
fever
rapid heartbeat (tachycardia)
increased blood pressure (hypertension)
kidney failure (kidney disease)
fluid accumulation in the lungs leading to breathing difficulties (pulmonary oedema)
fluid accumulation under the skin, particularly in the ankles (peripheral oedema)
respiratory arrest (cessation of breathing)
headache
dizziness
restlessness
irritability
weakness
muscle twitching and stiffness
seizures
acidification of the blood (acidosis), resulting in fatigue, confusion, lethargy, and increased respiratory rate.
higher-than-normal levels of sodium in the blood (hypernatremia), which may lead to epileptic seizures, coma, brain swelling (cerebral oedema), and death.

If you develop any of these symptoms, you must inform your doctor immediately. Your infusion will be stopped and you will be given appropriate treatment depending on your symptoms.
If a medicinal product has been added to the Sodium 0.9% for infusion solution before the over-infusion, this added drug may also cause symptoms. You should read the package leaflet of the added medicine for a list of all possible side effects.
Stopping the Sodium 0.9% for infusion
Your doctor will decide when to stop administering the infusion to you.
If you have further questions about the use of this medicine, you may ask your doctor or nurse.
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4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them. The frequency of the side effects is unknown.

Tremor
Decreased blood pressure
Hives (urticaria)
Skin rash
Itching

Adverse reactions that may occur due to the administration technique include:

Infection at the infusion site
Localized pain or reaction (redness and/or swelling) at the infusion site
Irritation and inflammation of the vein used for infusion (phlebitis). This may cause redness, pain, burning, and swelling along the course of the vein where the solution was infused
Formation of a blood clot (venous thrombosis) at the infusion site, causing pain, swelling, or redness in the area of the clot
Leakage of the infused solution into the surrounding tissues (extravasation). This may damage tissues and lead to scarring
Excess fluid in the blood vessels (hypervolemia)
Itching at the infusion site (urticaria)
Fever (pyrexia)
Chills
Low sodium levels in the blood that may develop during hospitalization (nosocomial hyponatremia) and related neurological disorders (acute hyponatremic encephalopathy). Hyponatremia may cause irreversible brain damage and death due to the development of cerebral edema/swelling (see also section “Warnings and Precautions”)

Other side effects observed with similar products (other solutions containing sodium) include:

Higher than normal sodium levels in the blood (hypernatremia)
Lower than normal sodium levels in the blood (hyponatremia)
Blood acidification associated with higher than normal chloride levels in the blood (hyperchloremic metabolic acidosis)

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, please contact your doctor, pharmacist, or nurse. You may also report adverse reactions directly via the national reporting system at:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting adverse reactions, you can help provide more information on the safety of this medicine.
If any adverse reaction occurs, the infusion must be stopped.

5. HOW TO STORE SODIUM 0.9% FOR INFUSION

Keep this medicine out of the sight and reach of children.
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Bags of 50 and 100 ml: Do not store above 30°C.
Bags of 250, 500 and 1000 ml:
This medicine does not require any special storage conditions.
DO NOT use this medicine after the expiry date stated on the packaging after “Exp”. The expiry date refers to the last day of the month indicated.
DO NOT use this medicine if particles are present in the solution or if the packaging is damaged in any way.
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6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What Sodio 0,9 for infusion contains
The active substance is sodium chloride: 9 g per litre.
The only excipient is water for injections.

Description of the appearance of Sodio 0,9 for infusion and contents of the package
Sodio 0,9 for infusion is a clear solution, free from visible particles. It is supplied in plastic polyolefin/polyamide bags (Viaflo).
Each bag is enclosed in a sealed protective plastic overwrap.
The bag sizes are:

50 ml
100 ml
250 ml
500 ml
1000 ml

The bags are packed in cardboard boxes. Each box contains one of the following quantities:

50 bags of 50 ml
75 bags of 50 ml
50 bags of 100 ml
60 bags of 100 ml
30 bags of 250 ml
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, Italy

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
Baxter Healthcare S.A.
Moneen Road
Castlebar
County Mayo
Ireland
Bieffe Medital S.p.A.
Via Nuova Provinciale
23034 Grosotto (SO)
Italy

This Patient Information Leaflet was last reviewed on: ……………….

The following information is intended for healthcare professionals only:
Handling and Preparation
Use the medicinal product only if the solution is clear, free from visible particles, and the container is intact. Administer immediately after inserting the infusion set.
Do not remove the bag from its overwrap until immediately before use.
The inner bag maintains the sterility of the medicinal product.

Do not use plastic containers in series connection. This practice may result in gas embolism due to aspiration of residual air from the primary container before complete administration of fluid from the secondary container.

Pressurizing intravenous solutions contained in flexible plastic containers to increase flow rates may cause gas embolism if residual air in the container is not completely expelled prior to administration.

The solution must be administered using a sterile administration set and employing aseptic technique. The administration set must be primed with the solution to prevent air from entering the system.

Addition of medicinal products may be performed before or during infusion through the resealable outlet port.
When adding medicinal products, verify their isotonicity prior to parenteral administration.
Complete and thorough aseptic mixing is mandatory for any additive.
Solutions containing additives must be administered immediately and must not be stored.
The addition of medicinal products or incorrect administration technique may lead to the occurrence of febrile reactions due to possible introduction of pyrogens. In case of adverse reactions, the infusion must be immediately discontinued.
Dispose of the medicinal product after single use.
Discard any unused medicinal product remaining after use.
Do not reconnect partially used bags.
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1. Opening

a. Remove the Viaflo container from the outer wrapper 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. Check that the solution is clear and that no foreign particles are visible. Discard the solution if it is not clear or if it contains foreign particles.

2. Preparation for administration

Use sterile equipment for both preparation and administration.
a. Hang the container using the support hole.
b. Remove the plastic cap from the outlet port located at the bottom of the container:

firmly hold with one hand the small wing on the neck of the port,
with the other hand grasp the large wing on the cap and rotate,
the cap will open.
c. Use an aseptic method to perform the infusion.
d. Connect the administration set. Refer to the instructions provided with the administration set for connection, priming the device, and administering the solution.

3. Techniques for Injection of Other Medicinal Products

Warning: Added medicinal products may be incompatible (see section 5 "Incompatibility of Additives" below).

Addition of medicinal products prior to administration
a. Disinfect the medication injection port
b. Using a syringe with a 19 gauge (1.10 mm) to 22 gauge (0.70 mm) needle, puncture the resealable port and inject the drug.
c. Mix the solution and the medicinal product thoroughly. For high-density drugs, such as potassium chloride, gently tap the outlet ports while keeping the container in an upright position, and mix well.
Caution: Do not store bags containing added medicinal products.
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Addition of medicinal products during administration
a. Clamp and close the infusion set
b. Disinfect the medication injection port
c. Using a syringe with a 19 gauge (1.10 mm) to 22 gauge (0.70 mm) needle, puncture the resealable port and inject the drug.
d. Remove the container from the infusion device pole and/or invert it
e. Eliminate any residue from both outlet ports by gently tapping while the container is in an upright position
f. Mix the solution and added medicinal product thoroughly
g. Return the container to its correct upright position, reopen the clamp, and continue administration

4. Shelf Life During Use (Additives)
The chemical and physical stability of any medicinal product added to 0.9% Sodium Chloride Solution for infusion in Viaflo container at its pH must be evaluated before use. From a microbiological standpoint, the diluted medicinal product should be used immediately unless dilution has been carried out under controlled and validated aseptic conditions.
If the solution is not used immediately, the storage times and conditions are the responsibility of the user.

5. Incompatibility of Medicinal Product Additives
As with all parenteral solutions, incompatibility of added medicinal products with the solution in the Viaflo container must be assessed before addition.
In the absence of compatibility studies, this solution must not be mixed with other medicinal products.
It is the physician's responsibility to evaluate the incompatibility of any added medicinal product with 0.9% Sodium Chloride Solution for infusion, checking for possible changes in color and/or formation of precipitate, insoluble complexes, or crystals. The instructions for use of the medicinal product to be added must be consulted.
Before adding a drug, verify whether it is soluble and/or stable in water at the same pH as 0.9% Sodium Chloride Solution for infusion.
Medicinal products known to be incompatible must not be used.
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