VIAFLO SODIUM CHLORIDE 0.9% SOLUTION FOR INFUSION

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

Viaflo Sodium Chloride 0.9% will not be given to you if you have any of the following medical conditions:

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

If another medicine has been added to Viaflo Sodium Chloride 0.9%, you should consult the package leaflet of that medicine to determine if you can receive the solution.

Warnings and precautions

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

• Any type of heart disease or impaired heart function.
• Impaired kidney function.
• Acidification of the blood (acidosis).
• When the blood volume in the blood vessels is higher than it should be (hypervolemia).
• High blood pressure (hypertension).
• Fluid accumulation under the skin, particularly under the ankles (peripheral edema).
• Fluid accumulation in the lungs making breathing difficult (pulmonary edema).
• Liver disease (cirrhosis).
• High blood pressure during pregnancy (preeclampsia).
• Increased production of the hormone aldosterone (aldosteronism).
• Any other condition associated with sodium retention (when the body retains too much sodium), such as treatment with steroids (see also Other medicines and Viaflo Sodium Chloride 0.9%).
• If you have a condition that could cause high levels of vasopressin, a hormone that regulates 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 head 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 Sodium Chloride 0.9%).

This may increase the risk of low sodium levels in the blood and can cause headache, nausea, seizures, lethargy, 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 they are of childbearing age)
• people who have problems with their brain fluid levels, for example, due to meningitis, bleeding in the skull, or head 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 chemical substances such as sodium and potassium in your body (your plasma electrolytes).

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

Your doctor will take into account if you are receiving parenteral nutrition (nutrition given by infusion into a vein). During prolonged treatment with Viaflo Sodium Chloride 0.9%, you may need to be given extra nutrition.

Other medicines and Viaflo Sodium Chloride 0.9%

Tell your doctor or nurse if you are using, have recently used, or might use any other medicines.

It is especially important that you tell your doctor if you are taking:

• Corticosteroids (anti-inflammatory medicines).

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

• Lithium (used to treat psychiatric diseases).
• Certain medicines that act on the hormone vasopressin. These may include:
• antidiabetic medication (chlorpropamide)
• cholesterol medication (clofibrate)
• certain anticancer medicines (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 increased thirst and urination), terlipressin (used to treat esophageal bleeding), and oxytocin (used to induce labor)
• antiepileptic medicines (carbamazepine and oxcarbazepine)
• diuretics

Using Viaflo Sodium Chloride 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, think you may be pregnant, or plan to become 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 package leaflet of the medicine that is being added.

Driving and using machines

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

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

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

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

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

Viaflo Sodium Chloride 0.9% will usually be given to you through a plastic tube connected to a needle in a vein, usually in your arm. However, your doctor may use another method to give you the medicine.

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 medicines that increase the effect of vasopressin).

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

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

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

• Nausea (discomfort).
• Vomiting.
• Diarrhea (loss of bowel movements).
• Stomach cramps.
• Thirst.
• Dry mouth.
• Dry eyes.
• Sweating.
• Fever.
• Fast heart rate (tachycardia).
• High blood pressure (hypertension).
• Kidney failure (renal failure).
• Fluid accumulation in the lungs making breathing difficult (pulmonary edema).
• Fluid accumulation under the skin, particularly under the ankles (peripheral edema).
• Shortness of breath (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 sodium levels in your blood, which can cause seizures, coma, brain inflammation (cerebral edema), and death.

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

If another medicine has been added to Viaflo Sodium Chloride 0.9% before the overdose, that medicine may also cause symptoms. You should read the list of possible symptoms in the package leaflet of the added medicine.

If you stop receiving Viaflo Sodium Chloride 0.9%

Your doctor will decide if you should stop receiving this infusion.

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

In case of overdose or accidental ingestion, contact the Toxicology Information Service. Telephone 915.620.420

4. Possible side effects

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

• Tremor,
• low blood pressure (hypotension),
• hives (urticaria),
• skin rash,
• itching (pruritus).

Low sodium levels in the blood that can be acquired during hospitalization (hospital-acquired hyponatremia) and related neurological disorder (acute hyponatremic encephalopathy).

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

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 in which the solution is infused (phlebitis). This can cause redness, pain, or burning and swelling along the vein in which the solution is infused,
• formation of a blood clot (thrombosis) at the infusion site, which can cause pain, swelling, or redness in the area of the clot,
• leakage of the infusion solution into the tissues surrounding the vein (extravasation), which can damage the tissues and cause scarring,
• excess fluid in the blood vessels (hypervolemia),
• itching at the infusion site (urticaria),
• fever (pyrexia),
• chills.

Other side effects that have been reported with similar products (other solutions containing sodium) include:

• High sodium levels in the blood (hypernatremia),
• low sodium levels in the blood (hyponatremia),
• acidification of the blood related to high chloride levels in the blood (metabolic acidosis with hyperchloremia).

Reporting side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines Agency's online platform: www.notificaRAM.es.

By reporting side effects, you can help provide more information on the safety of this medicine.

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

5. Storage of Viaflo Sodium Chloride 0.9%

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

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

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

Do not use this medicine after the expiry date which is stated on the bag after EXP. The expiry date is the last day of the month shown.

Do not receive this medicine if there are particles floating in the solution or if the packaging is damaged in any way.

6. Container Contents and Additional Information

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 Container Contents

Viaflo Sodium Chloride 0.9% is a clear solution, free from visible particles. It is presented in polyolefin/polyamide plastic bags (Viaflo). Each bag is packaged in a sealed protective overbag.

The bag sizes are:

• 50 ml
• 100 ml
• 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 package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Holder

Baxter S.L.

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

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 the Last Revision of thisProspectus: October 2023

Detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

This information is intended only for healthcare professionals

Handling and Preparation

Use only if the solution is clear, free from visible particles, and the container is intact. Administer immediately after connecting the infusion equipment.

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

The inner bag maintains the sterility of the solution.

Do not connect plastic containers in series. This type of use can produce gas embolisms due to residual air dragged from the primary container before the administration of the liquid contained in the secondary container is completed.

The pressurization of intravenous solutions in flexible plastic containers to increase flow rates can lead to a gas embolism if the residual air in the container is not fully 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 mixture of any medication is necessary. Solutions containing medications should be used immediately and not stored.

The addition of other medications or the use of an incorrect administration technique can cause the appearance of febrile reactions due to the possible introduction of pyrogens. In the event of an adverse reaction, the infusion should be interrupted immediately.

Discard after a single use.

Discard any remaining portion.

Do not reconnect partially used bags.

1- To Open

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

• Check for the absence of small leaks by squeezing the inner bag firmly. If leaks are detected, discard the solution, as it may not be sterile.

• 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.

• Hang the container by the handle

• Remove the plastic protector from the outlet port at the bottom of the container.
  • Hold the small wing of the outlet tube neck with one hand.
  • Hold the large wing of the closure cap with the other hand and turn.
  • The cap will come off.

• Use an aseptic technique to prepare the infusion

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

3- Techniques for Injecting Added Medication

Warning: Added medications may be incompatible. (See section 5 "Incompatibilities of Added Medications" below)

To Add Medication Before Administration

• Disinfect the injection point

• Using a syringe with a suitable caliber needle, puncture the resealable injection point and inject.

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

Precaution: Do not store bags with added medication.

To Add Medication During Administration

• Close the equipment clamp.

• Disinfect the injection point.

• Using a syringe with a suitable caliber needle, puncture the resealable injection point and inject.

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

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

• Mix the solution and medication carefully.

• Return the container to the operating position, reopen the clamp, and continue administration.

1. Expiry Date for Use (Added Medications)

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

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

5- Incompatibilities of Added Medications

As with all parenteral solutions, the incompatibility of medications added 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 physician to judge the incompatibility of the added medication to Viaflo Sodium Chloride 0.9% by examining any eventual color change and/or precipitation, appearance of insoluble complexes or crystals. The prospectus of the medication to be added 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 known to be incompatible should not be used.