PATIENT INFORMATION LEAFLET

Sodium Chloride 0.9% and Potassium Chloride 0.15%, Infusion Solution

Active ingredients: sodium chloride and potassium 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, ask your doctor or nurse.
• If you experience any side effects, tell your doctor or nurse, even if they are not listed in this leaflet. See section 4.

This medicine is called “Viaflo Sodium Chloride 0.9% and Potassium Chloride 0.15%, Infusion Solution”, but it will be referred to as Viaflo Sodium Chloride 0.9% and Potassium Chloride 0.15% in the rest of this leaflet.

Viaflo Sodium Chloride 0.9% and Potassium Chloride 0.15% is a solution of sodium chloride and potassium chloride in water. Sodium chloride and potassium chloride are chemical substances (commonly called salts) that are found in the blood.

Viaflo Sodium Chloride 0.9% and Potassium Chloride 0.15% is used to treat and prevent:

• potassium loss from the body (potassium loss, for example, after treatment with certain diuretics [tablets to urinate])
• low potassium levels in the blood (hypokalemia)

In situations that may cause loss of water and sodium chloride, including:

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

You should not be administered Viaflo Chloride Sodic 0.9% and Potassium Chloride 0.15% if you have any of the following clinical situations:

• if you are allergic to sodium chloride and potassium chloride or to any of the other components of this medication (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 renal insufficiency (when your kidneys do not function well and require dialysis)
• if you have uncompensated heart failure. This is heart failure that does not receive adequate treatment and causes symptoms such as:
• difficulty breathing
• swelling of the ankles.
• Addison's disease (deteriorated function of the adrenal gland. This gland produces hormones that help control the concentrations of chemical substances in the body).

Warnings and precautions

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

Inform your doctor if you have or have had any of the following clinical situations:

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

This may increase the risk of having low sodium levels in the blood and may cause headache, nausea, convulsions, 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 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 administered this solution, your doctor may take blood and urine samples to control:

• 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)
• 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 through a vein). During prolonged treatment with Viaflo Chloride Sodic 0.9% and Potassium Chloride 0.15%, you may need to receive extra nutrition.

Other medications and Viaflo Chloride Sodic 0.9% and Potassium Chloride 0.15%

Inform your doctor or pharmacist if you are using or have used recently other medications, even those acquired without a prescription.

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

• cardiac glycosides (cardiotonics) such as digitals or digoxin, used to treat heart failure
• medications that increase the concentration of potassium in the blood such as:
• potassium-sparing diuretics (some tablets that help eliminate water, 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)
• ciclosporins (used to prevent transplant rejection)
• tacrolimus (used to prevent transplant rejection and treat skin disorders)
• medications that contain potassium (for example, potassium supplements or salt substitutes containing potassium)
• corticosteroids (anti-inflammatory medications)

• Some medications act on the vasopressin hormone. These may include:
• diabetes medications (chlorpropamide)
• cholesterol-lowering medications (clofibrate)
• some cancer medications (vincristine, ifosfamide, cyclophosphamide)
• selective serotonin reuptake inhibitors (used to treat depression)
• antipsychotics
• opioids for severe pain relief
• medications for pain and/or inflammation (also known as NSAIDs)

• medications that mimic or strengthen 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 (tablets that help urinate)

-Caution is recommended in patients treated with lithium. The elimination of chemical substances such as sodium and lithium by the kidneys may be increased during the administration of Viaflo Chloride Sodic 0.9% and Potassium Chloride 0.15%.

Use of Viaflo Chloride Sodic 0.9% and Potassium Chloride 0.15% with food and beverages

Ask your doctor about what you can eat or drink.

Fertility, pregnancy, and breastfeeding

Consult your doctor or pharmacist before using any medication. Inform your doctor if you are pregnant or breastfeeding.

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

If another medication is added to the infusion solution during pregnancy or breastfeeding, you should:

• Consult your doctor
• Read the prospectus of the medication to be added

Driving and operating machines

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

Sodium Chloride 0.9% and Potassium Chloride 0.15% will be administered by a doctor or nurse. Your doctor will decide how much you need and when it will be administered, depending on your age, weight, clinical and biological condition, and hydration status (the amount of water in your body). The amount you receive may also be influenced by other treatments you are receiving.

DO NOT receive 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 Sodium Chloride 0.9% and Potassium Chloride 0.15%, your doctor may monitor your ECG (heart graph).

Sodium Chloride 0.9% and Potassium Chloride 0.15% will usually be administered through a plastic tube connected to a vein in your arm, usually in your arm, but your doctor may use another method to administer the medication.

Before and during the infusion, your doctor will monitor:

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

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

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

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

If you receive an excessive amount of Sodium Chloride 0.9% and Potassium Chloride 0.15% (overdose), the following symptoms may occur:

-increased potassium levels 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)
• cardiac 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 observe 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 to Sodium Chloride 0.9% and Potassium Chloride 0.15% before the excessive administration, that medication may also cause symptoms. You should read the list of possible symptoms in the medication's package insert.

IF you interrupt the infusion of Sodium Chloride 0.9% and Potassium Chloride 0.15%

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

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

Like all medications, Viaflo Sodium Chloride 0.9% and Potassium Chloride 0.15% may cause adverse effects, although not everyone will experience them.

The adverse 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 administration site)
• irritation and inflammation of the vein through which the solution is infused (phlebitis). This may cause redness, pain, or burning and swelling along the vein through which the solution has been infused.
• formation of a blood clot (venous thrombosis), at the perfusion site, which causes pain, swelling, or redness in the area of the clot
• leakage of the perfusion solution into the tissues surrounding the vein (extravasation), which may damage the tissues and cause the formation of scars
• 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 may be acquired during hospitalization (nosocomial hyponatremia) and related neurological disorder (acute hyponatremic encephalopathy). Hyponatremia may cause brain damage and death due to swelling (cerebral edema/inflammation) (see also the "Warnings and Precautions" section).
• high levels of chloride in the blood or low levels of bicarbonate in the blood (hyperchloremic acidosis)
• cardiac arrest.

If a medication has been added to the perfusion solution, it may also cause adverse effects. These adverse effects will depend on the added medication. You should read the list of possible symptoms in the prospectus of the added medication.

Inform your doctor or nurse if you notice any of the listed adverse effects or any other. If any of them occur, the perfusion should be stopped.

Reporting Adverse Effects:

If you experience any type of adverse effect, consult your doctor or nurse, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep out of sight and reach of children.

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

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.

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

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

The active principles 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 contents of the package

Viaflo Sodium Chloride 0.9% and Potassium Chloride 0.15% is a transparent solution, free of visible particles. It is presented in polyolefin/polyamide (Viaflo) plastic bags. Each bag is packaged in a sealed protective plastic overbag.

The sizes of the bags 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

It may be that not all packages are marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder

Baxter S.L.

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

Responsible for manufacturing:

Baxter SA

Boulevard René Branquart, 80

7860 Lessines, Belgium

or

Bieffe Medital S.A.

Ctra. Biescas-Senegüé,

22666 Sabiñánigo (Huesca), Spain

Last review date of this leaflet: February 2019

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

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This information is intended solely for healthcare professionals

Handling and preparation

Use only if the solution is transparent, free of visible particles, and the package is not damaged. 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 product.

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

Medications may be introduced before or during infusion through the injection port. When adding medications, check isotonicity before parenteral administration. It is essential that the mixture of products be made in extreme asepsis conditions. Solutions containing added medications should be used immediately and not stored.

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 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, infusion should be interrupted immediately.

Dispose of after single use.

Dispose of unused remnants.

Do not reconnect partially used bags.

1. To open

1. Remove the Viaflo bag from the protective overbag immediately before use.
2. Check for small leaks by pressing the inner bag firmly. If you detect leaks, 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 hanger
2. 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 it.

- 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 auricle or ventricle to prevent localized hyperpotasemia, but should be administered in large or central peripheral veins to reduce the risk of sclerosis.

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

For adding 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, pierce the resellable injection port and inject.
3. 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.

For adding medication during administration

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

1. Expiration date 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% and Potassium Chloride 0.15% solution in the Viaflo container must be established.

From a microbiological point of view, the diluted product should 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.

1. Incompatibilities of added medications

As with all parenteral solutions, the incompatibility of added medications with the Viaflo solution in the 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 with Viaflo Sodium Chloride 0.9% and Potassium Chloride 0.15% by examining any eventual change in color and/or the occasional appearance of precipitates, 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 the Viaflo Sodium Chloride 0.9% and Potassium Chloride 0.15% solution (pH: 4.5 - 7.0).

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