VIAFLO GLUCOSA 5% & POTASSIUM CHLORIDE 0.15%, SOLUTION FOR INFUSION

Introduction

Package Leaflet: Information for the User

Viaflo Glucose 5% and Potassium Chloride 0.15%, Solution for Infusion

Active substance: glucose monohydrate and potassium chloride

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or nurse.
• If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Throughout this leaflet, Viaflo Glucose 5% and Potassium Chloride 0.15% Solution for Infusion is referred to as Viaflo Glucose 5% and Potassium Chloride 0.15%.

Contents of the pack and other information:

1. What Viaflo Glucose 5% and Potassium Chloride 0.15% is and what it is used for
2. What you need to know before you are given Viaflo Glucose 5% and Potassium Chloride 0.15%
3. How Viaflo Glucose 5% and Potassium Chloride 0.15% will be given to you
4. Possible side effects
5. Storage of Viaflo Glucose 5% and Potassium Chloride 0.15%
6. Contents of the pack and other information

1. What Viaflo Glucose 5% and Potassium Chloride 0.15% is and what it is used for

Viaflo Glucose 5% and Potassium Chloride 0.15% is a solution of glucose and potassium chloride in water. Potassium chloride is a chemical substance (commonly called "a salt") that is found in the blood.

Glucose is one of the body's sources of energy. This infusion solution provides 200 kilocalories per liter.

Viaflo Glucose 5% and Potassium Chloride 0.15% is used as a source of carbohydrates (sugar) in the prevention and treatment of:

• a loss of potassium from the body (potassium loss, for example, after treatment with certain diuretics)
• low levels of potassium in the blood (hypokalemia) in situations that may cause loss of water and potassium chloride, including:
• when you cannot eat or drink, due to illness or after surgery
• excessive sweating caused by high fever
• extensive skin loss, such as in severe burns

2. What you need to know before you are given Viaflo Glucose 5% and Potassium Chloride 0.15%

Viaflo Glucose 5% and Potassium Chloride 0.15% must not be given to you if you have any of the following conditions:

• 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 sugar above normal (hyperglycemia)
• 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 causes 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 concentration of chemical substances in the body).
• if you have diabetes that is not receiving proper treatment, so that the blood glucose concentration is above normal (uncontrolled diabetes)
• if you have situations of glucose intolerance, for example:
• metabolic stress (when the body's metabolism is not working correctly, for example, due to serious illness)
• hyperosmolar coma (loss of consciousness). This is a type of coma that can occur if you have diabetes and are not receiving proper medication.
• high levels of lactate in the blood (hyperlactatemia)
• if you are allergic to potassium chloride and glucose monohydrate or to any of the other components of this medicine (listed in section 6).

Warnings and precautions

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

• changes in the concentrations of chemical substances in the blood (electrolyte disorders)
• excess fluid in the blood vessels (hypervolemia)
• fluid accumulation under the skin, affecting all parts of the body (generalized edema), around the ankles (peripheral edema), or in the lungs (pulmonary edema)

Infusion may cause:

• high levels of sugar in the blood (hyperglycemia), especially with states of glucose intolerance, for example:
• • diabetes that is not being treated properly, allowing blood sugar levels to rise above normal (diabetes mellitus)
  • a head injury in the last 24 hours
  • metabolic stress (when the body's metabolism is not working correctly; for example, due to serious illness)

• high levels of potassium in the blood (hyperkalemia), especially with:

• burns and injuries

• heart failure
• extreme muscle weakness or paralysis

• muscle weakness in children (congenital paramyotonia)
• adrenocortical insufficiency. This is a disease that affects the hormones that control the concentration of chemical substances in the body.
• a disorder in which the blood becomes too alkaline (metabolic alkalosis)
• muscle weakness and periodic paralysis due to low thyroid activity (thyrotoxic periodic paralysis)
• rapid loss of body water, for example, due to vomiting or diarrhea
• being on a low-potassium diet for a long time
• aldosteronism (a disease that causes high levels of a hormone called aldosterone)
• allergy, particularly to corn (Viaflo Glucose 5% and Potassium Chloride 0.15% contains corn-derived sugar)

• If you have a condition that could cause high levels of vasopressin, a hormone that regulates body fluid. 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 medications (see "Other medicines and Viaflo Glucose 5% and Potassium Chloride 0.15%").

This may increase the risk of low sodium levels in the blood and can cause headache, nausea, seizures, lethargy, coma, brain swelling (cerebral edema), and death. Brain swelling increases the risk of death and brain damage. People at higher risk of brain swelling 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 check:

• the amount of fluid in your body
• the amount of sugar (glucose)
• your vital signs
• the amount of chemical substances such as sodium and potassium in your body (your plasma electrolytes)

• the concentration in the blood of a substance called creatinine (your plasma creatinine)
• the concentration in the blood of a substance called urea (your BUN levels)
• the acidity of the blood and urine (your acid-base balance)
• the graph of your heart (ECG)

Your doctor will consider whether you are receiving parenteral nutrition (nutrition given by vein infusion). During prolonged treatment with Viaflo Glucose 5% and Potassium Chloride 0.15%, you may need to be given extra nutrition.

Children

Viaflo Glucose 5% and Potassium Chloride 0.15% should be given with special care in children.

Newborns - especially premature and low birth weight babies - are at higher risk of developing low or high blood glucose levels (hypo or hyperglycemia) due to glucose solution infusion. Low blood sugar levels in newborns can cause prolonged seizures, coma, and brain damage. High blood sugar levels can cause brain hemorrhage, bacterial or fungal infections, intestinal infections (necrotizing enterocolitis), eye damage (retinopathy of prematurity), lung problems (bronchopulmonary dysplasia), prolonged hospital stay, and death.

The pediatric population should be closely monitored. In cases where normal water regulation in the blood is disturbed due to an increase in the secretion of antidiuretic hormone (ADH), infusion of fluids with low sodium chloride concentration (hypotonic fluids) can cause low sodium levels in the blood (hyponatremia). This can cause headache, nausea, seizures, lethargy, coma, brain swelling (cerebral edema), and death; therefore, these symptoms (acute symptomatic hyponatremic encephalopathy) are considered a medical emergency.

Other medicines and Viaflo Glucose 5% and Potassium Chloride 0.15%

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

It is particularly important that you tell your doctor if you are taking medicines that increase potassium levels in the blood, such as:

• potassium-sparing diuretics (certain water pills like amiloride, spironolactone, triamterene)
• angiotensin-converting enzyme inhibitors (ACE inhibitors) (used to treat high blood pressure)
• corticosteroids (anti-inflammatory medicines)
• 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)

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

• antidiabetic medication (chlorpropamide)
• cholesterol medication (clofibrate)
• certain cancer medicines (vincristine, ifosfamide, cyclophosphamide)
• selective serotonin reuptake inhibitors (used to treat depression)
• antipsychotics or 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.

Viaflo Glucose 5% and Potassium Chloride 0.15% must not be added to or administered with the same needle used with anticoagulated/conserved blood with citrate. Red blood cells may be damaged or clumped.

Using Viaflo Glucose 5% and Potassium Chloride 0.15% with food and drinks

Ask your doctor about what you can eat or drink.

Pregnancy, breastfeeding, and fertility

Consult your doctor or nurse before using this medicine. If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or nurse before using this medicine.

If you are given Viaflo Glucose 5% and Potassium Chloride 0.15% during labor, there is a small chance that glucose may affect the fetus, causing:

• hyperglycemia (high blood sugar levels, causing intense thirst, dry mouth, and frequent urination)
• hyperinsulinemia (high insulin levels, the hormone that regulates blood sugar. Blood sugar levels may become too low.)
• acidosis (a biochemical imbalance in the blood) that can cause low blood sugar levels and jaundice (yellowing of the skin or whites of the eyes)

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 to be added.

Driving and using machines

Viaflo Glucose 5% and Potassium Chloride 0.15% does not affect your ability to drive or use machines.

3. How you will be given Viaflo Glucose 5% and Potassium Chloride 0.15%

A doctor or nurse will give you the infusion. Your doctor will decide how much you need and when you will be given it, depending on your age, weight, condition, hydration status (the amount of water in your body), and the reason for treatment. The amount you receive may also be influenced by other treatments you are receiving.

You must not be given Viaflo Glucose 5% 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 need a high volume or rapid infusion of Viaflo Glucose 5% and Potassium Chloride 0.15%, your doctor may monitor your ECG (heart graph).

It 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 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 the vasopressin hormone, 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 must not be given Viaflo Glucose 5% and Potassium Chloride 0.15% from a bag that has been partially used.

If you are given too much Viaflo Glucose 5% and Potassium Chloride 0.15%

If you are given too much Viaflo Glucose 5% and Potassium Chloride 0.15% (overdose), or if it is infused too quickly, the following symptoms may occur:

• high levels of sugar in the blood (hyperglycemia), causing intense thirst, dry mouth, and frequent urination.
• low levels of sodium in the blood (hyponatremia). Hyponatremia can cause headache, nausea, seizures, lethargy, coma, brain swelling (cerebral edema), and death
• fluid accumulation under the skin (peripheral edema), particularly around the ankles
• high levels of potassium (hyperkalemia), symptoms include:
• tingling in the arms and legs (paresthesia)
• respiratory paralysis (difficulty breathing)
• gastrointestinal symptoms (obstructive intestinal pain, nausea, vomiting, abdominal pain)
• low blood pressure (hypotension)
• muscle weakness
• inability to move (paralysis)
• irregular heartbeats (cardiac arrhythmias)
• heart block (very slow heartbeats)
• cardiac arrest (the heart stops beating, and life is at risk)

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 Glucose 5% and Potassium Chloride 0.15% 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.

Stopping treatment with Viaflo Glucose 5% and Potassium Chloride 0.15%

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Side effects:

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

• irritation and inflammation of the vein through which the infusion is given (phlebitis). This can cause redness, pain, or burning and swelling of the vein
• itching of the skin (pruritus)
• fever (pyrexia)
• infection at the injection site
• local pain or reaction (redness or swelling at the injection site)
• blisters at the injection site
• feeling of cold (chills)
• formation of a blood clot in the injected vein (venous thrombosis), causing pain, swelling, or redness
• leakage of the infusion solution into the tissues surrounding the vein (extravasation). This can damage the tissues and cause scarring
• allergic reactions, including a serious allergic reaction called anaphylaxis (potential manifestation in patients with corn allergy)
• high levels of potassium in the blood (hyperkalemia)
• low levels of potassium in the blood (hypokalemia)
• cardiac arrest
• sweating
• excess fluid in the blood vessels (hypervolemia)
• low sodium levels in the blood that can be acquired during hospitalization (nosocomial hyponatremia) and related neurological disorder (acute symptomatic hyponatremic encephalopathy). Hyponatremia can cause irreversible brain damage and death due to brain swelling (cerebral edema) (see also section 2 "Warnings and precautions").

If another 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.

Reporting 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 them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Viaflo Glucose 5% and Potassium Chloride 0.15%

Keep this medication out of sight and reach of children.

No special storage conditions are required.

Do not use this medication after the expiration date shown on the bag after CAD. The expiration date is the last day of the month indicated.

You should not receive this medication if you notice that there are particles floating in the solution or if the container is damaged in any way.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Viaflo Glucose 5% and Potassium Chloride 0.15%

The active ingredients are:

• potassium chloride: 1.5 g per liter
• glucose monohydrate: 50 g per liter.

The other ingredients are:

• concentrated hydrochloric acid
• water for injectable preparations

Appearance of the Product and Package Contents

Viaflo Glucose 5% 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 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

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:

Bieffe Medital S.A.

Ctra. Biescas-Senegüé, 22666 Sabiñánigo

(Huesca), Spain

Baxter SA

Boulevard René Branquart, 80

7860 Lessines, Belgium

Date of Last Revision of this Leaflet: August 2020

Detailed and updated information on this medication 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 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 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 use of an intravenous administration set with a ventilation filter in the open position could cause a gas embolism. This type of intravenous administration set with the ventilation filter in the open position should not be used with flexible plastic containers.

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

Added medications can be introduced before or during infusion through the resealable medication addition port.

Medications that are known or determined to be incompatible should not be added.

Before adding a medication, verify that it is soluble and/or stable in Viaflo Glucose 5% and Potassium Chloride 0.15% and that the pH range of Viaflo Glucose 5% and Potassium Chloride 0.15% is appropriate.

You should read the leaflet of the added medication or other relevant documentation.

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.

Mix the solution completely when adding medications.

Do not store solutions containing added medications.

For single use only.

Discard any unused portion.

When medications are added, the isotonicity should be checked before parenteral administration. It is essential that the mixing of products is done under extreme asepsis conditions. Solutions containing added medications should be used immediately and not stored unless the addition of medications has been carried out under aseptic and validated conditions.

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.

Pediatric Population

In order to avoid a potentially fatal overdose during the infusion of intravenous solutions to newborns, special attention should be paid to the method of administration. When using a syringe pump to administer fluids or medications intravenously to newborns, a solution bag should not be left connected to the syringe.

When using an infusion pump, all clamps on the intravenous administration equipment should be closed before removing the administration equipment from the pump or disconnecting the pump. This is required regardless of whether the administration equipment has an anti-free flow device.

The intravenous infusion device and administration equipment should be frequently supervised.

Discard after a single use.

Discard 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 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 handle.
2. 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.

1. Use an aseptic technique to prepare the infusion.
2. Connect the administration equipment. Consult the instructions accompanying the equipment for connection, purging, and administration of the solution.

1. Techniques for Injecting Added Medication

To avoid localized hyperkalemia, the solution should not be administered in the atrium or ventricle; it should be administered through a central vein or a large peripheral vein to reduce the risk of sclerosis.

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

To Add Medication Before Administration

1. Disinfect the medication addition port.
2. Using a syringe with a 19-gauge (1.10 mm) to 22-gauge (0.70 mm) needle, puncture the resealable medication addition 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 clamp on the equipment.
2. Disinfect the medication addition port.
3. Using a syringe with a 19-gauge (1.10 mm) to 22-gauge (0.70 mm) needle, puncture the resealable medication addition port and inject.
4. Remove the container from the intravenous support and/or turn 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 position of use, reopen the clamp, and continue administration.

1. Expiry Date for Use (Added Medications)

Before use, the physical and chemical stability of any added medication in the pH of the glucose 5% and potassium chloride 0.15% solution in the Viaflo container should be established.

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

1. Incompatibilities of Added Medications

As with all parenteral solutions, before adding medications, their compatibility with the solution in the Viaflo container should be evaluated.

In the absence of compatibility studies, this solution should not be mixed with other medications.

Before adding a medication, verify that it is soluble and stable in water at the pH of the Viaflo Glucose 5% and Potassium Chloride 0.15% solution (pH: 3.5 – 6.5).

The following list of medications incompatible with Viaflo Glucose 5% and Potassium Chloride 0.15% serves as a guide (non-exhaustive list):

• Amphotericin B
• Dobutamine

Glucose should not be administered through the same infusion equipment as whole blood, as hemolysis and clot formation may occur.

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