VIAFLO SODIUM CHLORIDE 0.9% & POTASSIUM CHLORIDE 0.3% SOLUTION FOR INFUSION

2. What you need to know before you are given Viaflo Sodium Chloride 0.9% and Potassium Chloride 0.3%

Viaflo Sodium Chloride 0.9% and Potassium Chloride 0.3% 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 untreated 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 0.3% 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
• impaired kidney function

• adrenal 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, making breathing difficult (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 0.3%)
• 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 Other medicines and Viaflo Sodium Chloride 0.9% and Potassium Chloride 0.3%).

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 (especially if they are of childbearing age)
• people with 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 the blood and urine (your acid-base balance)
• the graph of your heart (ECG)

Your doctor will take into account if you are receiving parenteral nutrition (nutrition given by vein infusion). During prolonged treatment with Viaflo Sodium Chloride 0.9% and Potassium Chloride 0.3%, you may need to be given extra nutrition.

Other medicines and Viaflo Sodium Chloride 0.9% and Potassium Chloride 0.3%

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)
  • some anticancer 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.

• 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 0.3%.

Using Viaflo Sodium Chloride 0.9% and Potassium Chloride 0.3% 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 0.3% 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 0.3% does not affect your ability to drive or use machines.

3. How Viaflo Sodium Chloride 0.9% and Potassium Chloride 0.3% will be given to you

Viaflo Sodium Chloride 0.9% and Potassium Chloride 0.3% will be given to you by a doctor or nurse. Your doctor will decide the amount you need and when it will be given to you, depending on your age, weight, clinical 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.

You should not be given Viaflo Sodium Chloride 0.9% and Potassium Chloride 0.3% if there are particles floating in the solution or if the packaging is damaged in any way.

The infusion rate will be decided by your doctor.

If you need a large volume or rapid infusion of Viaflo Sodium Chloride 0.9% and Potassium Chloride 0.3%, your doctor may monitor your ECG (heart graph).

Generally, Viaflo Sodium Chloride 0.9% and Potassium Chloride 0.3% will be given to you through a plastic tube connected to a vein in your arm via a needle. However, your doctor may use another method to administer the medicine to you.

Before and during the infusion, your doctor will check:

• potassium
• the amount of fluid in your body
• the acidity of the 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 your kidney function is impaired, you will receive a lower dose.

Any unused portion of the solution should be discarded. You should NOT be given Viaflo Sodium Chloride 0.9% and Potassium Chloride 0.3% from a partially used bag.

If you are given too much Viaflo Sodium Chloride 0.9% and Potassium Chloride 0.3%

If you are given too much Viaflo Sodium Chloride 0.9% and Potassium Chloride 0.3% (overdose), the following symptoms may occur:

• increased levels of potassium in the blood (hyperkalemia)
• tingling in the arms and legs (paresthesia)
  • inability to breathe (respiratory paralysis)
  • nausea, vomiting, abdominal pain
  • decreased blood pressure

• muscle weakness
• irregular heartbeats (cardiac arrhythmias)
• heart block (very slow heartbeats)
• cardiac arrest (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 inform your doctor immediately. Your infusion will be stopped and you will be treated depending on the symptoms.

If a medicine has been added to Viaflo Sodium Chloride 0.9% and Potassium Chloride 0.3% 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 0.3%

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

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

4. Possible side effects

Like all medicines, Viaflo Sodium Chloride 0.9% and Potassium Chloride 0.3% can cause side effects, although not everybody gets them.

Side effects that may occur due to the administration technique include:

• fever (febrile response)
• infection at the administration site
• local pain or reaction (redness or swelling at the administration site)
• irritation and inflammation of the vein into which the solution is infused (phlebitis). This can cause redness, pain, or burning and swelling along the vein into which the solution is infused.
• formation of a blood clot (venous thrombosis) at the administration 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

• increased levels of potassium in the blood (hyperkalemia)
• low levels of sodium in the blood that can be acquired during hospitalization (nosocomial hyponatremia) and related neurological disorder (acute hyponatremic encephalopathy). Hyponatremia can cause irreversible brain damage and death due to brain inflammation (cerebral edema/inflammation) (see also section 2 “Warnings and precautions”)
• high levels of chloride in the blood or low levels of bicarbonate in the blood (hyperchloremic acidosis)
• cardiac arrest

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 will be stopped.

Reporting of 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 side effects directly through the Spanish Medicines Agency's website: 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 0.3%

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

Viaflo Sodium Chloride 0.9% and Potassium Chloride 0.3% does not require any 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 be given Viaflo Sodium Chloride 0.9% and Potassium Chloride 0.3% if there are particles floating in the solution or if the packaging is damaged in any way.

6. Contents of the pack and further information

Composition of Viaflo Sodium Chloride 0.9% and Potassium Chloride 0.3%

The active substances are:

• potassium chloride: 3 g per liter
• sodium chloride: 9 g per liter.

The only excipient is water for injections

Appearance of the product and pack contents

Viaflo Sodium Chloride 0.9% and Potassium Chloride 0.3% is a clear, particle-free solution. It is presented in polyolefin/polyamide (Viaflo) plastic bags. Each bag is packaged in a protective plastic overbag.

The bag sizes are:

• 500 ml
• 1000 ml

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

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

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Baxter S.L.

Pouet de Camilo, 2

Ribarroja del Turia (Valencia) 46394

Manufacturer:

Bieffe Medital S.A.

Ctra. Biescas-Senegüé s/n, 22666 Sabiñánigo (Huesca), Spain

Baxter SA

Boulevard René Branquart, 80

7860 Lessines, Belgium

Date of last revision of this leaflet: February 2019

Detailed and up-to-date information on this medicine 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 transparent, without 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 sterility of the product.

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

Medicines can be introduced before or during infusion through the injection port. When adding medicines, the isotonicity must be checked before parenteral administration. It is essential that the mixture of products is made under extreme asepsis conditions. Solutions containing medicines must 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 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 tab

• 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

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 section 5 "Incompatibilities of added medicines" below)

To Add Medication Before Administration

• Disinfect the injection port

• Using a syringe with a 19 G (1.10 mm) to 22 G (0.70 mm) needle, puncture the resealable injection port 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 port

• Using a syringe with a 19 G (1.10 mm) to 22 G (0.70 mm) needle, puncture the resealable injection port 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

• Put the container back in the operating position, reopen the clamp, and continue administration.

4.Expiry Date for Use (Added Medicines)

Before use, the physical and chemical stability of any additional medication must be established at the pH of the Viaflo Sodium Chloride 0.9% and Potassium Chloride 0.3% solution in the Viaflo container.

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

5-Incompatibilities of Added Medicines

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

In the absence of compatibility studies, this solution must not be mixed with other medicines.

It is the responsibility of the doctor to judge the incompatibility of the added medication to Viaflo Sodium Chloride 0.9% and Potassium Chloride 0.3% by examining any change in color and/or precipitate, insoluble complexes, or appearance of crystals. The prospectus of the medicine to be added must 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 0.3% solution (pH: 4.5 - 7.0).

Medicines that are known to be incompatible must not be added.