Viaflo sodium chloride 0.9% and potassium chloride 0.3% solution for infusion

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Viaflo Sodium Chloride 0.9% and Potassium Chloride 0.3% solution for infusion

Active substances: sodium chloride and potassium chloride

Read the entire 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 adverse reactions, inform 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 0.3% solution for infusion", but will be referred to as "Viaflo Sodium Chloride 0.9% and Potassium Chloride 0.3%" throughout the rest of this leaflet.

Leaflet contents:

1. What Viaflo Sodium Chloride 0.9% and Potassium Chloride 0.3% is and what it is used for
2. What you need to know before being administered Viaflo Sodium Chloride 0.9% and Potassium Chloride 0.3%
3. How Viaflo Sodium Chloride 0.9% and Potassium Chloride 0.3% will be administered
4. Possible side effects
5. Storage of Viaflo Sodium Chloride 0.9% and Potassium Chloride 0.3%

Pack contents and other information

1. What Viaflo Sodium Chloride 0.9% and Potassium Chloride 0.3% is and what it is used for

Viaflo Sodium Chloride 0.9% and Potassium Chloride 0.3% is a solution of sodium chloride and potassium chloride in water. Sodium chloride and potassium chloride are chemical substances (commonly known as salts) normally present in the blood.

Viaflo Sodium Chloride 0.9% and Potassium Chloride 0.3% is used to treat and prevent:

• loss of potassium from the body (potassium depletion, for example, after treatment with certain diuretics [water tablets])
• low blood potassium levels (hypokalaemia)

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

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

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

DO NOT administer Viaflo Sodium Chloride 0.9% and Potassium Chloride 0.3% if you have any of the following clinical conditions:

• if you are allergic to sodium chloride and potassium chloride or to any of the other ingredients of this medicine (listed in section 6).

• if your blood has abnormally high levels of potassium (hyperkalemia)

• if your blood has abnormally high levels of chloride (hyperchloremia)

• if your blood has abnormally high levels of sodium (hypernatremia)

• severe renal insufficiency (when your kidneys do not function properly and you require dialysis)

• if you have uncompensated heart failure. This is heart failure that is not receiving adequate treatment and causes symptoms such as:

• shortness of breath

• swelling of the ankles.

• Addison's disease (impaired function of the adrenal gland. This gland produces hormones that help regulate chemical concentrations in the body).

Warnings and precautions

Viaflo Sodium Chloride 0.9% and Potassium Chloride 0.3% 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 conditions:

• any type of heart disease or heart failure
• impaired kidney function
• adrenocortical insufficiency (a disease of the adrenal glands affecting hormones that regulate the concentration of chemicals in the body)
• acute dehydration (loss of body water, for example due to vomiting or diarrhoea)
• extensive tissue damage (such as occurs in severe burns)
• if you are receiving cardiac glycosides (cardiotonics) used to treat heart failure, such as digitalis or digoxin. Regular monitoring of potassium levels in your blood will be performed.
• high blood pressure (hypertension)
• fluid accumulation under the skin, particularly around the ankles (peripheral oedema)
• fluid accumulation in the lungs (pulmonary oedema)
• 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 elevated levels of vasopressin, a hormone that regulates your body's fluid balance. You may have excess vasopressin in your body due, for example, to:
  • a sudden and serious illness
  • pain
  • recent surgery
  • infections, burns, or brain injury
  • diseases affecting your heart, liver, kidneys, or central nervous system
  • taking certain medicines (see below: 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 may cause headache, nausea, seizures, lethargy, coma, brain swelling, and death. Brain swelling increases the risk of death and brain damage. People at higher risk of brain swelling include:

• children
• women (particularly if of childbearing age)
• individuals who have problems with their cerebral fluid levels, for example due to meningitis, bleeding in the skull, or brain injury.

While you are receiving this solution, your doctor may take blood and urine samples to monitor:

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

Your doctor will consider whether you are receiving parenteral nutrition (nutrition delivered by intravenous infusion). During prolonged treatment with Viaflo Sodium Chloride 0.9% and Potassium Chloride 0.3%, you may require additional nutritional support.

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

Inform 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 inform your doctor if you are taking:

• cardiac glycosides (cardiotonic agents) such as digitalis or digoxin, used to treat heart failure

• medicines that increase potassium concentration 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)
  • cyclosporine (used to prevent transplant rejection)
  • tacrolimus (used to prevent transplant rejection and to treat skin disorders)
  • medicines containing potassium (e.g. potassium supplements or potassium-containing salt substitutes)
  • corticosteroids (anti-inflammatory medicines)

• Some medicines act on the hormone vasopressin. These may include:

  • antidiabetic medication (chlorpropamide)
  • cholesterol-lowering medicines (clofibrate)
  • some anticancer medicines (vincristine, ifosfamide, cyclophosphamide)
  • selective serotonin reuptake inhibitors (used to treat depression)
  • antipsychotics
  • opioids for relief of severe pain
  • 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 medicines (carbamazepine and oxcarbazepine)

• diuretics

• Caution is recommended in patients treated with lithium. The elimination of chemicals such as sodium and lithium through the kidneys may be increased during administration of Viaflo Sodium Chloride 0.9% and Potassium Chloride 0.3%.

Use of Viaflo Sodium Chloride 0.9% and Potassium Chloride 0.3% with food and drink

Ask your doctor about what you may eat or drink.

Fertility, pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

Inform your doctor if you are pregnant or breastfeeding.

Viaflo Sodium chloride 0.9% and potassium chloride 0.3% may be used during pregnancy. The amount administered will be carefully controlled by your doctor.

If another medicine is added to the infusion solution during pregnancy or breastfeeding, you must:

• 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 administered to you

Viaflo Sodium Chloride 0.9% and Potassium Chloride 0.3% will be administered to you by a doctor or a nurse. Your doctor will decide how much you need and when it will be given, depending on your age, weight, clinical and biological condition, and your hydration status (the amount of water in your body). The amount you receive may also be influenced by other treatments you are receiving.

You must not receive Viaflo Sodium Chloride 0.9% and Potassium Chloride 0.3% if there are particles floating in the solution or if the container is damaged in any way.

The infusion rate will be determined by your doctor.

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

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

Before and during the infusion, your doctor will monitor:

• potassium levels
• fluid volume 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 enhance the effect of vasopressin).

If you have impaired kidney function, you will receive a lower dose.

Any unused portion of the solution must be discarded. You must NOT receive Viaflo Sodium Chloride 0.9% and Potassium Chloride 0.3% from a bag that has been partially used.

If you receive more Viaflo Sodium Chloride 0.9% and Potassium Chloride 0.3% than you should

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 (hyperkalaemia)

• tingling in the arms and legs (paraesthesia)

  • inability to breathe (respiratory paralysis)
  • nausea, vomiting, abdominal pain
  • decrease in blood pressure

• muscle weakness

• irregular heartbeats (cardiac arrhythmias)

• heart block (very slow heartbeats)

• cardiac arrest (the heart stops beating and life is at risk)

• accumulation of fluid in the lungs making breathing difficult (pulmonary oedema)

• accumulation of fluid under the skin, particularly under the ankles (peripheral oedema)

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

If any medicine has been added to Viaflo Sodium Chloride 0.9% and Potassium Chloride 0.3% 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 the infusion of Viaflo Sodium Chloride 0.9% and Potassium Chloride 0.3% is interrupted

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 adverse effects

Like all medicines, Viaflo Sodium Chloride 0.9% and Potassium Chloride 0.3% can cause adverse effects, although not everyone will experience them.

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

• fever (febrile reaction)
• 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 may cause redness, pain or burning, and swelling along the vein where the solution has been infused.
• formation of a blood clot (venous thrombosis) at the administration site, causing pain, swelling or redness in the area of the clot
• leakage of the infusion solution into the surrounding tissues (extravasation), which may damage tissues and lead to 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 may develop during hospitalization (hospital-acquired hyponatremia) and associated neurological disorder (acute hyponatremic encephalopathy). Hyponatremia may cause irreversible brain damage and death due to brain swelling (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 adverse effects. These adverse effects will depend on the added medicine. You should read the list of possible symptoms in the package leaflet of the added medicine.

Inform your doctor or nurse if you notice any of the listed adverse effects or any others. If any of these occur, the infusion should be stopped.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist or nurse, even if they are adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaRAM.es. By reporting adverse 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 stated on the bag after EXP. The expiry date refers to the last day of the month indicated.

Do not administer Viaflo Sodium Chloride 0.9% and Potassium Chloride 0.3% if there are particles floating in the solution or if the container is damaged in any way.

6. Contents of the container and Additional Information

Composition of Viaflo Sodium chloride 0.9% and potassium chloride 0.3%

The active substances are:

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

The only excipient is water for injections.

Appearance of the product and contents of the pack

Viaflo Sodium Chloride 0.9% and Potassium Chloride 0.3% is a clear solution, free from visible particles. It is supplied in plastic bags made of polyolefin/polyamide (Viaflo). Each bag is contained within a sealed protective plastic overpouch.

The bag sizes are:

• 500 ml
• 1000 ml

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

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

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturing Responsible Person

Title

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 the most recent review of this leaflet: February 2019

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/

This information is intended for healthcare professionals only

Handling and Preparation

Use only if the solution is clear, free of visible particles, and if the container is undamaged. Administer immediately after connecting the infusion set.

Do not remove the bag from its overpouch until ready for use.

The inner bag maintains the sterility of the product.

Do not connect plastic containers in series. This type of use may result in gas embolism due to residual air being displaced from the primary container before completion of administration of the fluid in the secondary container.

The solution must be administered using a sterile set and employing aseptic technique. The administration set should be primed with the solution to prevent air from entering the system.

Medications may be added before or during infusion through the injection port. When adding medications, isotonicity must be verified prior to parenteral administration. It is essential that mixing of products be performed under strict aseptic conditions. Solutions containing added medications should be used immediately and not stored.

After adding medications, 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 drugs or the use of incorrect administration techniques may lead to febrile reactions due to the possible introduction of pyrogens. In the event of an adverse reaction, the infusion must be stopped immediately.

Discard after single use.

Dispose of any unused portions.

Do not reconnect partially used bags.

1- To open

• Remove the Viaflo bag from the overpouch immediately before use.

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

• Check the solution for clarity and absence of foreign particles. Discard the solution if it is not clear or contains foreign particles.

2-Preparation for Administration

Use sterile materials 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 with one hand the small fin on the neck of the outlet tube.
  • Hold with the other hand the large fin on the closure cap and twist.
  • The cap will detach.

• Use an aseptic technique to prepare the infusion

• Connect the administration set. Refer to the instructions provided with the set for connection, priming, and administration of the solution.

3-Techniques for injection of added medication

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

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

To add medication prior to 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 the medication.

• Carefully mix the medication and solution. For high-density medications, such as potassium chloride, gently invert the bags while in an upright position and mix.

Caution: Do not store bags with added medication.

To add medication during administration

• Close the clamp of the administration set

• 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 the medication.

• Remove the container from the intravenous support and/or rotate it to place it in an upright position.

• Empty both tubes by gently tapping them while the container is in an upright position.

• Carefully mix the solution and medication.

• Return the container to the upright position for use, reopen the clamp, and continue administration.

4. In-use expiry (added medications)

Prior to use, the physical and chemical stability of any additional medication added 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 standpoint, the diluted product should be used immediately unless the addition of medications has been carried out under validated aseptic conditions. If not used immediately, the storage conditions and duration before use are the responsibility of the user.

5- Incompatibilities of added medications

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

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

It is the physician's responsibility to assess the incompatibility of any medication added to Viaflo Sodium Chloride 0.9% and Potassium Chloride 0.3% by examining for potential changes in color and/or precipitation, formation of insoluble complexes, or appearance of crystals. The package leaflet of the medication to be added must 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 0.3% solution (pH: 4.5 – 7.0).

Medicinal products known to be incompatible must not be added.