Leaflet: information for theuser

Viaflo Sodium Chloride 0.9% solution for infusion

Active ingredient: sodium chloride

Read this leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or nurse.
• If you experienceside effects, consultyour doctor or nurse,even if they are not listed in this leaflet. See section 4.

This medicine is called “ Viaflo Sodium Chloride 0.9% solution for infusion”, but it is referred to as Viaflo Sodium Chloride 0.9% in the rest of this leaflet.

1.What is Viaflo Sodium Chloride 0.9% and what it is used for

2.What you need to know before you are given Viaflo Sodium Chloride 0.9%

3.How you will be given Viaflo Sodium Chloride 0.9%

4.Possible side effects

5.Storage of Viaflo Sodium Chloride 0.9%

6.Contents of the pack and additional information

Viaflo Sodium Chloride 0.9% is a sodium chloride solution in water. Sodium chloride is a chemical substance (commonly called salt) that is found in the blood.

Viaflo Sodium Chloride 0.9% is used to treat:

• body water loss (dehydration),
• body sodium loss (sodium depletion),

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

• when unable to eat or drink due to illness or after surgery,
• excessive sweating caused by high fever,
• abundant skin loss, such as in severe burns.

Viaflo Sodium Chloride 0.9% may also be used to administer or dilute other medications for infusion.

You should not be given Viaflo Cloruro sódico 0,9% if you have any of the following medical conditions:

• If your blood contains high levels of chloride above the normal range (hyperchloremia).
• If your blood contains high levels of sodium above the normal range (hypernatremia).

If another medicine has been added to Viaflo Cloruro sódico 0,9%, you should consult your leaflet to determine if you can or cannot receive the solution.

Warnings and precautions

Inform your doctor if you have or have had any of the following medical conditions:

• Any type of heart disease or heart function impairment.
• Impaired kidney function.
• Blood acidification (acidosis).
• When the blood volume in the blood vessels is greater than it should be (hypervolemia).
• High blood pressure (hypertension).
• Accumulation of fluid under the skin, particularly under the ankles (peripheral edema).
• Fluid accumulation in the lungs (pulmonary edema).
• Liver disease (cirrhosis).
• High blood pressure during pregnancy (preeclampsia).
• Increased production of the aldosterone hormone (aldosteronism).
• Any other condition associated with sodium retention (when the body retains too much sodium), such as steroid treatment (see also Other medicines and Viaflo Cloruro sódico 0,9%).
• If you have a condition that could cause high levels of vasopressin, a hormone that regulates the fluid in your body. You may have too much vasopressin in your body because, for example:
• You have had a sudden and severe illness,
• You are in pain,
• You have had surgery,
• You have infections, burns, or brain injury
• You have diseases related to your heart, liver, kidneys, or central nervous system,
• You are taking certain medicines (see below Other medicines and Viaflo Cloruro sódico 0,9%).

This may increase the risk of having low sodium levels in the blood and can cause headaches, nausea, convulsions, drowsiness, coma, brain inflammation, and death. Brain inflammation increases the risk of death and brain damage. People at higher risk of brain inflammation are:

• Children
• Women (particularly if you are of childbearing age)
• People who have problems with their cerebrospinal fluid levels, for example, due to meningitis, bleeding in the skull, or brain injury.

When you are being given this solution, your doctor may take blood and urine samples to monitor:

• The amount of fluid in your body.
• Your vital signs.
• The amount of chemicals such as sodium and potassium in your body (your plasma electrolytes).

This is especially important in children and premature babies, as they may retain too much sodium due to their immature renal function.

Your doctor will take into account if you are receiving parenteral nutrition (nutrition given by intravenous infusion). During prolonged treatment with Viaflo Cloruro sódico 0,9%, you may need to receive extra nutrition.

Other medicines and Viaflo Cloruro sódico 0,9%

Inform your doctor or nurse if you are using, have used recently, or may need to use any other medicine.

It is especially important to inform your doctor if you are taking:

• Corticosteroids (anti-inflammatory medicines).

These medicines can cause the body to accumulate sodium and water, leading to inflammation of the tissue due to fluid accumulation under the skin (edema) and high blood pressure (hypertension).

• Lithium (used to treat psychiatric diseases).
• Some medicines act on the vasopressin hormone. These may include:
• Diabetes medication (chlorpropamide)
• Cholesterol-lowering medication (clofibrate)
• Some cancer medications (vincristine, ifosfamide, cyclophosphamide)
• Selective serotonin reuptake inhibitors (used to treat depression)
• Antipsychotics
• Opioids for severe pain relief
• Medicines for pain and/or inflammation (also known as NSAIDs)
• Medicines that mimic or enhance the effects 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 medications (carbamazepine and oxcarbazepine)
• Diuretics

Use of Viaflo Cloruro sódico 0,9% with food and drinks

Ask your doctor about what you can eat or drink.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or nurse.

However, if another medicine is added to the infusion solution during pregnancy or breastfeeding, you should:

• Consult your doctor.
• Read the leaflet of the medicine that will be added.

Driving and operating machinery

Ask your doctor or nurse for advice before driving or operating machinery.

Sodium Chloride 0.9% Viaflo will be administered by a doctor or nurse. Your doctor will decide how much you need and when it will be administered. This will depend on your age, weight, medical condition, the reason for your treatment, and whether the infusion is used to administer or dilute another medication.

The amount you receive may also be influenced by other treatments you are receiving.

You should not receive Sodium Chloride 0.9% Viaflo if there are particles floating in the solution or if the container is damaged in any way.

Sodium Chloride 0.9% Viaflo will usually be administered through a plastic tube connected to a vein in your arm using a needle. However, your doctor may use another method to administer the medication.

Before and during the infusion, your doctor will monitor:

• the amount of fluid in your body
• the acidity of your blood and urine
• the amount of electrolytes in your body (particularly sodium, in patients with high levels of vasopressin, or those taking other medications that increase the effect of vasopressin).

Any unused solution should be discarded. You should not receive Sodium Chloride 0.9% Viaflo from a bag that has been used partially.

If you receive more Sodium Chloride 0.9% Viaflo than you should

If you are given too muchSodium Chloride 0.9% Viaflo(overdose), the following symptoms may occur:

• Nausea (discomfort).
• Vomiting.
• Diarrhea (loss of stool).
• Abdominal cramps.
• Thirst.
• Dry mouth.
• Dry eyes.
• Sweating.
• Fever.
• Fast heart rate (tachycardia).
• Increased blood pressure (hypertension).
• Failure of the kidneys (renal failure).
• Accumulation of fluid in the lungs, making it difficult to breathe (pulmonary edema).
• Accumulationof fluid under the skin, particularly under the ankles (peripheral edema).
• Labored breathing (respiratory arrest).
• Headache.
• Dizziness.
• Restlessness.
• Irritability.
• Weakness.
• Muscle twitching and numbness.
• Seizures.
• Acidification of the blood (acidosis) leading to fatigue, confusion, lethargy, and increased respiratory rate.
• High levels of sodium in your blood (hypernatremia), which may cause seizures, coma,brain inflammation (cerebral edema) and death.

If you notice any of these symptoms, you should inform your doctor immediately. Your infusion will be stopped and you will be treated depending on the symptoms.

If a medication has been added toSodium Chloride 0.9% Viaflobefore the excessive administration,that medication may also cause symptoms. You shouldread the list of possible symptoms in the prospectus of the added medication.

If you interruptthe infusion ofSodium Chloride 0.9% Viaflo

Your doctor will decide ifyou should stop receiving this infusion.

If you have any other questions about the use of this product, ask your doctor or nurse.

In case of overdose or accidental ingestion, consult the Toxicological Information Service. Phone 915.620.420

Like all medicines, this medicine can cause side effects, although not everyone will experience them. The frequency of these side effects is unknown.

• Tremors,
• Decreased blood pressure (hypotension),
• Hives (urticaria),
• Skin rash,
• Itching (pruritus).

Low sodium levels in the blood that may occur during hospitalization (nosocomial hyponatremia) and related neurological disorder (acute hyponatremic encephalopathy).

- Hyponatremia can cause irreversible brain damage and death due to cerebral edema/inflammation (see also section 2 “Warnings and precautions”).

The side effects that may occur due to the administration technique include:

• Infection at the injection site,
• Local pain or reaction (redness or swelling at the administration site),
• Irritation and inflammation of the vein through which the solution is perfused (phlebitis). This may cause redness, pain, or burning and swelling along the vein through which the solution has been perfused,
• Formation of a blood clot (thrombosis) in the perfusion site, causing pain, swelling, or redness in the area of the clot,
• Leakage of the perfusion solution into the surrounding tissues (extravasation), which may damage the tissues and cause scarring,
• Excess fluid in the blood vessels (hypervolemia),
• Itching at the perfusion site (urticaria),
• Fever (pyrexia),
• Chills.

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

• Higher than normal sodium levels in the blood (hypernatremia),
• Lower than normal sodium levels in the blood (hyponatremia),
• Metabolic acidosis related to higher than normal chloride levels in the blood (hyperchloremic metabolic acidosis).

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through theSpanish System for the Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es.

By reporting side effects, you can contribute to providing more information on the safety of this medicine.

If any of these occur, the infusion should be stopped.

Keep this medication out of the sight and reach of children.

Bags of 50 and 100 ml:Do not store at a temperature above 30°C.

Bags of 250, 500, and 1000 ml:No special storage conditions are required.

Do not use this medication after the expiration date that appears on the bag after CAD. The expiration date is the last day of the month indicated.

Do not use this medication if there are particles floating in the solution or if the container is damaged in any way.

Composition ofViaflo Sodium Chloride 0.9%

The active ingredient is sodium chloride: 9 g per liter.

The only excipient is water for injectable preparations.

Appearance of the product and contents of the package

Viaflo Sodium Chloride 0.9% is a transparent, particle-free solution. It is presented in polyolefin/polyamide plastic bags (Viaflo). Each bag is packaged in a sealed plastic protective overbag.

The bag sizes are:

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

The presentations are:

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

Only some sizes of packaging may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Baxter S.L.

Pouet de Camilo 2, 46394 Ribarroja del Turia (Valencia)

Responsible 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

Last review date of thisleaflet: October 2023

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/

This information is intended solely for healthcare professionals

Handling and preparation

Use only if the solution is transparent, particle-free and the package is intact. Administer immediately after connecting the infusion equipment.

Do not remove the bag from its protective overbag until it is ready for use.

The inner bag maintains the sterility of the solution.

Do not connect in series plastic containers. This type of use may cause gas embolism due to residual air carried from the primary container before the secondary container is completed.

The pressurization of intravenous solutions in flexible plastic containers to increase flow rates may cause gas embolism if the residual air in the container is not completely evacuated before administration.

The solution must be administered with sterile equipment using an aseptic technique. The equipment must be primed with the solution to prevent air from entering the system.

When adding medications, verify isotonicity before parenteral administration. A complete and careful aseptic mixing of any medication is required. Solutions containing medications must be used immediately and not stored.

The addition of other medications or the use of an incorrect administration technique may cause the appearance of fever reactions due to the possible introduction of pyrogens. In case of an adverse reaction, the infusion must be interrupted immediately.

Dispose of after single use.

Dispose of any remaining portion.

Do not reconnect partially used bags.

1-To open

a.Remove the Viaflo bag from the protective overbag immediately before use.

b.Check for small leaks by pressing the inner bag firmly. If you detect leaks, discard the solution, as it may not be sterile.

c.Check the transparency of the solution and the absence of foreign particles. Discard the solution if it is not transparent or contains foreign particles.

2-Preparation for administration

Use sterile material for preparation and administration.

a.Hang the container by the hanger.

b.Remove the plastic protector from the outlet in the lower part of the container.

-Hold one hand on the small handle of the outlet tube.

-Hold the other hand on the large handle of the closure cap and turn.

-The cap will come off.

c.Use an aseptic technique to prepare the infusion.

d.Connect the administration equipment. Consult the instructions accompanying the equipment for its connection, priming, and administration of the solution.

3-Techniques for injecting added medication

Warning: Added medications may be incompatible. (See below the section 5 "incompatibilities of added medications")

To add medication before administration

a.Disinfect the injection site.

b.Using a syringe with an appropriate gauge needle, puncture the resellable injection site and inject.

c.Mix the medication and solution carefully. For high-density medications, such as potassium chloride, gently move the tubes while in the vertical position and mix.

Caution: Do not store bags with added medication.

To add medication during administration

a.Close the clamp of the equipment.

b.Disinfect the injection site.

c.Using a syringe with an appropriate gauge needle, puncture the resellable injection site and inject.

d.Remove the container from the intravenous support and/or turn it to a vertical position.

e.Empty both tubes by gently tapping them while the container is in the vertical position.

f.Mix the solution and medication carefully.

g.Place the container back in the use position, reopen the clamp, and continue administration.

4.Expiry in use (added medications)

Before use, the physical and chemical stability of any additional medication to the pH of the Viaflo Sodium Chloride 0.9% solution in the Viaflo bag must be established.

From a microbiological point of view, the diluted product must be used immediately unless the addition of medications has been carried out in validated and aseptic conditions. If not used immediately, the conditions and storage times used before use are the responsibility of the user.

5-Incompatibilities of added medications

As with all parenteral solutions, the incompatibility of added medications to the solution in the Viaflo bag must be verified before addition.

In the absence of compatibility studies, this solution should not be mixed with other medications.

It is the responsibility of the doctor to judge the incompatibility of the added medication to Viaflo Sodium Chloride 0.9% by examining any eventual change in color and/or precipitation, appearance of insoluble complexes or crystals. The medication's prospectus should be consulted.

Before adding a medication, verify that it is soluble and stable in water at the pH of Viaflo Sodium Chloride 0.9%.

Medications that are known to be incompatible should not be used.