VIAFLO Sodium Chloride 0.9% & Potassium Chloride 0.15%, Solution for Infusion

2. What you need to know before you are given Viaflo Sodium Chloride 0.9% and Potassium Chloride 0.15%

Viaflo Sodium Chloride 0.9% and Potassium Chloride 0.15% should not be given to you if you have any of the following conditions:

• if you are allergic to sodium chloride and potassium chloride or any of the other ingredients of this medicine (listed in section 6).
• if your blood contains high levels of potassium above normal (hyperkalemia)
• if your blood contains high levels of chloride above normal (hyperchloremia)
• if your blood contains high levels of sodium above normal (hypernatremia)
• severe kidney failure (when your kidneys do not work well and you need dialysis)
• if you have uncompensated heart failure. This is heart failure that is not receiving proper treatment and is causing symptoms such as:
• breathing difficulties
• swelling of the ankles.
• Addison's disease (impaired function of the adrenal gland. This gland produces hormones that help control the concentrations of substances in the body).

Warnings and precautions

Viaflo Sodium Chloride 0.9% and Potassium Chloride 0.15% is a hypertonic solution (concentrated). Your doctor will take this into account when calculating the amount of solution to be given to you.

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

• any type of heart disease or heart failure
• kidney failure
• adrenocortical insufficiency (a disease of the adrenal glands that affects the hormones that control the concentration of substances in the body)
• acute dehydration (a loss of water from the body, for example, due to vomiting or diarrhea)
• extensive tissue damage (such as in severe burns)
• if you are receiving cardiac glycosides (cardiotonics) used to treat heart failure, such as digitalis or digoxin. Regular checks of the potassium level in your blood will be performed.
• high blood pressure (hypertension)
• fluid accumulation under the skin, particularly under the ankles (peripheral edema)
• fluid accumulation in the lungs (pulmonary edema)
• high blood pressure during pregnancy (pre-eclampsia)
• 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% and Potassium Chloride 0.15%)
• 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 been operated on,
• you have infections, burns, or head injury
• you have diseases related to your heart, liver, kidneys, or central nervous system,
• you are taking certain medications (see below Other medicines and Viaflo Sodium Chloride 0.9% and Potassium Chloride 0.15%).

This may increase the risk of low sodium levels in the blood and may 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 a head injury.

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

• the amount of fluid in your body
• your vital signs
• the amount of substances such as sodium and potassium in your body (your plasma electrolytes)
• the acidity of your blood and urine (your acid-base balance)
• your heart graph (ECG)

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% and Potassium Chloride 0.15%, you may need to be given extra nutrition.

Other medicines and Viaflo Sodium Chloride 0.9% and Potassium Chloride 0.15%

Tell your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription.

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

• cardiac glycosides (cardiotonics) such as digitalis or digoxin, used to treat heart failure
• medicines that increase the concentration of potassium in the blood, such as:
• potassium-sparing diuretics (some water pills, e.g., amiloride, spironolactone, triamterene)
• angiotensin-converting enzyme inhibitors (ACE inhibitors) used to treat high blood pressure
• angiotensin II receptor antagonists (used to treat high blood pressure)
• cyclosporins (used to prevent transplant rejection)
• tacrolimus (used to prevent transplant rejection and treat skin disorders)
• medicines that contain potassium (e.g., potassium supplements or salt substitutes with potassium)
• corticosteroids (anti-inflammatory medicines)

• Some medicines act on the vasopressin hormone. These may include:
• antidiabetic medication (chlorpropamide)
• cholesterol medication (clofibrate)
• certain 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 increased thirst and urination), terlipressin (used to treat bleeding from the esophagus), and oxytocin (used to induce labor)
• antiepileptic medicines (carbamazepine and oxcarbazepine)
• diuretics (water pills)

• Caution is recommended in patients treated with lithium. The elimination of substances such as sodium and lithium by the kidneys may increase during administration of Viaflo Sodium Chloride 0.9% and Potassium Chloride 0.15%.

Using Viaflo Sodium Chloride 0.9% and Potassium Chloride 0.15% with food and drink

Ask your doctor about what you can eat or drink.

Fertility, pregnancy, and breastfeeding

Consult your doctor or pharmacist before using any medicine. Tell your doctor if you are pregnant or breastfeeding.

Viaflo Sodium Chloride 0.9% and Potassium Chloride 0.15% can be used during pregnancy. The amount given to you will be carefully controlled by your doctor.

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 to be added

Driving and using machines

Viaflo Sodium Chloride 0.9% and Potassium Chloride 0.15% does not affect your ability to drive or use machines.

3. How to use Viaflo Sodium Chloride 0.9% and Potassium Chloride 0.15%

Viaflo Sodium Chloride 0.9% and Potassium Chloride 0.15% 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, depending on your age, weight, medical condition, and biological condition, and your state of hydration (the amount of water in your body). The amount you receive may also be influenced by other treatments you are receiving.

DO NOT receive Viaflo Sodium Chloride 0.9% and Potassium Chloride 0.15% if there are particles floating in the solution or if the container is damaged in any way.

The infusion rate will be decided by your doctor.

If you require a large volume or rapid infusion of Viaflo Sodium Chloride 0.9% and Potassium Chloride 0.15%, your doctor may monitor your ECG (heart graph).

Generally, Viaflo Sodium Chloride 0.9% and Potassium Chloride 0.15% will 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 check:

• potassium
• 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).

If you have kidney failure, you will receive a lower dose.

Any unused solution should be discarded. You should NOT receive Viaflo Sodium Chloride 0.9% and Potassium Chloride 0.15% from a bag that has been partially used.

If you receive more Viaflo Sodium Chloride 0.9% and Potassium Chloride 0.15% than you should

If you are given too much Viaflo Sodium Chloride 0.9% and Potassium Chloride 0.15% (overdose), the following symptoms may occur:

• increase in potassium levels in the blood (hyperkalemia)
  • tingling in the arms and legs (paresthesia)
  • inability to breathe (respiratory paralysis)
  • nausea, vomiting, abdominal pain
  • decrease in blood pressure
  • muscle weakness
  • irregular heartbeats (cardiac arrhythmias)
  • heart block (very slow heartbeats)
  • heart stoppage (the heart stops beating and life is at risk)

• fluid accumulation in the lungs, making breathing difficult (pulmonary edema)
• fluid accumulation under the skin, particularly under the ankles (peripheral edema)

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 a medicine has been added to the infusion solution before the overdose, this medicine may also cause symptoms. You should read the list of possible symptoms in the package leaflet of the added medicine.

If you stop the infusion of Viaflo Sodium Chloride 0.9% and Potassium Chloride 0.15%

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

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

4. Possible side effects

Like all medicines, Viaflo Sodium Chloride 0.9% and Potassium Chloride 0.15% can cause side effects, although not everybody gets them.

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

• fever (febrile response)
• infection at the injection site
• local pain or reaction (redness or swelling at the injection 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)
• any allergic reaction
• increase in potassium levels in the blood (hyperkalemia)
• low sodium levels in the blood that can be acquired during hospitalization (nosocomial hyponatremia) and related neurological disorder (acute hyponatremic encephalopathy). Hyponatremia can cause brain damage and death due to swelling (cerebral edema/inflammation) (see also the section "Warnings and precautions").
• high chloride levels in the blood or low bicarbonate levels in the blood (hyperchloremic acidosis)
• heart stoppage.

If a medicine has been added to the infusion solution, it may also cause side effects. These side effects will depend on the added medicine. You should read the list of possible symptoms in the package leaflet of the added medicine.

Tell your doctor or nurse if you notice any of the side effects listed or any other. If any of these occur, the infusion should be stopped.

Reporting of side effects:

If you experience any side effects, talk to your doctor or nurse, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Viaflo Sodium Chloride 0.9% and Potassium Chloride 0.15%

Keep out of the sight and reach of children.

Viaflo Sodium Chloride 0.9% and Potassium Chloride 0.15% does not require special storage conditions.

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.

You should not receive Viaflo Sodium Chloride 0.9% and Potassium Chloride 0.15% if there are particles floating in the solution or if the container is damaged in any way.

6. Container Contents and Additional Information

Composition of Viaflo Sodium Chloride 0.9% and Potassium Chloride 0.15%

The active ingredients are:

• potassium chloride: 1.5 g per liter
• 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% and Potassium Chloride 0.15% is a clear, particle-free solution. It is presented in polyolefin/polyamide (Viaflo) plastic bags. Each bag is packaged in a sealed protective plastic overbag.

The bag sizes are:

• 500 ml
• 1000 ml

The bags are delivered in boxes, each containing the following quantities:

• 20 bags of 500 ml
• 10 or 12 bags of 1000 ml

Not all packaging sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Holder

Baxter S.L.

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

Manufacturer:

Baxter SA

Boulevard René Branquart, 80

7860 Lessines, Belgium

or

Bieffe Medital S.A.

Ctra. Biescas-Senegüé,

22666 Sabiñánigo (Huesca), Spain

Date of Last Revision of this Leaflet: February 2019

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/

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This information is intended only for healthcare professionals

Handling and Preparation

Use only if the solution is clear, free of visible particles, and if the container is not damaged. 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 product's sterility.

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

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.

Medicines can be introduced before or during infusion through the injection point. When adding medicines, it is essential to check isotonicity before parenteral administration. It is crucial that the mixing of products is done under extreme asepsis conditions. Solutions containing added medicines should be used immediately and not stored.

After adding medicines, do not use the solution if there is a change in color and/or the appearance of precipitates, insoluble complexes, or crystals.

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

Discard after a single use.

Discard unused remains.

Do not reconnect half-used bags.

1. To open

1. Remove the Viaflo bag from the protective overbag immediately before use.
2. 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.
3. Check the transparency of the solution and the absence of foreign particles. Discard the solution if it is not transparent or contains foreign particles.

1. Preparation for Administration

Use sterile material for preparation and administration.

1. Hang the container by the tab
2. Remove the plastic protector from the outlet in the lower part of the container.

• Hold the small wing of the neck of the outlet tube with one hand.
• Hold the large wing of the closure cap with the other hand and turn.
• The cap will come off.
  1. Use an aseptic technique to prepare the infusion
  2. Connect the administration equipment. Consult the instructions accompanying the equipment for connection, priming, and administration of the solution.

1. Techniques for Injecting Added Medication

The solution should not be administered in the atrium or ventricle to prevent localized hyperkalemia but should be administered in large peripheral or central veins to reduce the risk of sclerosis.

Warning: Added medicines may be incompatible. (See the section below "Incompatibilities of Added Medicines")

To Add Medication Before Administration

1. Disinfect the injection port
2. Using a syringe with a 19 G (1.10 mm) to 22 G (0.70 mm) needle, puncture the resealable injection port and inject.
3. 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

1. Close the equipment clamp
2. Disinfect the injection port
3. Using a syringe with a 19 G (1.10 mm) to 22 G (0.70 mm) needle, puncture the resealable injection port and inject.
4. Remove the container from the intravenous support and/or turn it to put it in a vertical position.
5. Empty both tubes by gently tapping them while the container is in a vertical position
6. Mix the solution and medication carefully
7. Put the container back in the operating position, reopen the clamp, and continue administration.

1. Expiry Date for Use (Added Medicines)

Before use, the physical and chemical stability of any additional medication in the pH of the Viaflo Sodium Chloride 0.9% and Potassium Chloride 0.15% solution in the Viaflo container must be established.

From a microbiological point of view, the diluted product must be used immediately unless the addition of medicines 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

1. Incompatibilities of Added Medicines

As with all parenteral solutions, the incompatibility of added medicines with 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 medicines.

It is the responsibility of the physician to judge the incompatibility of the added medication to Viaflo Sodium Chloride 0.9% and Potassium Chloride 0.15% by examining any eventual change in color and/or occasional appearance of precipitate, insoluble complexes, or crystals. The leaflet of the medicine to be added should be consulted.

Before adding a medicine, verify that it is soluble and stable in water at the pH of the Viaflo Sodium Chloride 0.9% and Potassium Chloride 0.15% solution (pH: 4.5 – 7.0).

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