VIAFLO GLUCOSALINE POTASSIUM 4%, 0.18%, 0.15% SOLUTION FOR INFUSION

Introduction

Package Leaflet: Information for the User

Viaflo Glucosalino Potásico 4%, 0.18%, 0.15%, Solution for Infusion

Active Substances: Glucose Monohydrate, Sodium Chloride, 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.

In this leaflet, Viaflo Glucosalino Potásico 4%, 0.18%, 0.15%, Solution for Infusion will be referred to as Viaflo Glucosalino Potásico.

Contents of the Package Leaflet:

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

1. What is Viaflo Glucosalino Potásico and what is it used for

Viaflo Glucosalino Potásico is a solution of glucose monohydrate, sodium chloride, and potassium chloride in water. Sodium chloride and potassium chloride are chemical substances (often referred to as "salts") that are found in the blood.

It is used to prevent and treat the following disorders:

• Insufficient levels of potassium, sodium, and chloride in the blood. This can occur when gastrointestinal fluid (stomach) is lost. It can be caused by:

• vomiting
• diarrhea
• drainage of a wound after surgery (by collecting body fluid in a bag)
• gastric suction (stomach) to empty the stomach contents
• diversion of part of the digestive system that prevents food from passing through the small intestine. This procedure is called intestinal bypass
• perforation in the small intestine (small intestine fistula)
  • excessive ingestion of laxatives (medicines to empty the intestines)
  • development of malabsorption syndrome (not enough nutrients are absorbed)
  • tumor in the small intestine that produces mucus (mucous villous adenoma)
  • kidney problems that can cause excessive loss of salts
  • excessive ingestion of diuretics (pills that increase urine production)

inability to ingest food, which implies the need to obtain energy from another source

2. What you need to know before you are given Viaflo Glucosalino Potásico

You will not be given Viaflo Glucosalino Potásicoin the following cases:

• high levels of potassium in the blood (hyperkalemia)
• high levels of chloride in the blood (hyperchloremia)
• severe kidney failure (when the kidneys do not work well and dialysis is needed)
• decompensated heart failure. This is a heart failure that is not conveniently treated and causes symptoms such as:

• Difficulty breathing
• Swelling of the ankles
  • Addison's disease (deficient functioning of the adrenal gland that is responsible for producing hormones that help control the concentrations of chemical substances in the body)
  • untreated diabetes that allows blood sugar levels to be higher than normal (uncompensated diabetes)
  • states of glucose intolerance, such as:

• metabolic stress (when the body's metabolism does not work correctly, for example due to a serious illness)
• hyperosmolar coma (unconsciousness). This is a type of coma that can occur if you have diabetes and do not receive enough medication.
• if you have a higher than normal amount of sugar in the blood (hyperglycemia)
• a higher than normal amount of lactate in the blood (hyperlactacidemia)
  • recent cerebral infarction
  • cranioencephalic trauma in the last 24 hours
  • If you are allergic to potassium chloride, sodium chloride, and glucose monohydrate or to any of the other components of this medicine (included in section 6).

Your doctor should be especially careful when administering Viaflo Glucosalino Potásico to you

Viaflo Glucosalino Potásico is a hypertonic solution (concentrated). When it is administered, the solution will become hypotonic due to its low sodium content. Your doctor will take this into account when calculating the amount to be administered to you.

Warnings and Precautions

If you develop or have developed any of the following medical conditions, inform your doctor:

• 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 serious illness,
• you are in pain,
• you have been operated on,
• you have infections, burns, or brain damage
• you have diseases related to your heart, liver, kidneys, or central nervous system,
• you are taking certain medications (see Other Medicines and Viaflo Glucosalino Potásico)

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 brain damage.

• any disorder that causes high levels of potassium in the blood (hyperkalemia), such as:

• kidney failure,
• adrenocortical insufficiency. This is a disorder that affects the hormones that control the concentration of chemical substances in the body,
• acute dehydration (rapid loss of water, for example, due to vomiting or diarrhea),
• extensive tissue damage (such as can occur in severe burns),
  • high blood pressure (hypertension),
  • fluid accumulation under the skin (peripheral edema), especially around the ankles,
  • fluid accumulation in the lungs (pulmonary edema),
  • high blood pressure during pregnancy (preeclampsia),
  • any disorder associated with sodium retention (when there is a high presence of sodium in the body), such as treatments with steroids (medicines that reduce inflammation) (see also "Other Medicines and Viaflo Glucosalino Potásico"),
  • diabetes, as it may be necessary to change insulin treatment due to the presence of glucose (a type of sugar) in the solution,
  • allergy to corn (Viaflo Glucosalino Potásico contains corn-derived sugar)

If you develop any of these disorders, additional tests will be necessary to monitor your condition. Your doctor will take blood and urine samples to check the levels of chemical substances in the blood (plasma electrolytes). You will also have an electrocardiogram (ECG) performed.

It may be necessary to change your other medications.

Children

Viaflo Glucosalino Potásico should be administered with caution in children.

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

Children are at higher risk of having or developing low sodium levels in the blood (hyponatremia). Hyponatremia can cause headache, nausea, seizures, lethargy, coma, brain inflammation (cerebral edema), and death. Acute hyponatremic encephalopathy is a serious complication, especially in children.

Your doctor is aware of this and will closely monitor the amount of chemical substances such as sodium and chloride in your child's blood (plasma electrolytes).

Other Medicines and Viaflo Glucosalino Potásico

Tell your doctor or pharmacist if you are using or have recently used other medicines.

Other medicines that may affect or be affected by potassium chloride, sodium chloride, and glucose infusion include:

• lithium (used to treat psychiatric diseases)
• potassium-sparing diuretics (some pills such as amiloride, spironolactone, triamterene)
• medicines that contain potassium (e.g., potassium supplements, potassium-containing salt substitutes, and some types of penicillin)
• medicines that increase the risk of hyponatremia or sodium and fluid retention
• angiotensin-converting enzyme inhibitors (ACE inhibitors) (used to treat high blood pressure)
• cyclosporine (used to prevent transplant rejection)
• corticosteroids (anti-inflammatory medicines)

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

• antidiabetic medication (chlorpropamide)
• cholesterol medication (clofibrate)
• some anticancer medicines (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 esophageal bleeding), and oxytocin (used to induce labor)
• antiepileptic medicines (carbamazepine and oxcarbazepine)
• diuretics

If you need a blood transfusion at the same time as the infusion, you will receive the blood in another vein.

Using Viaflo Glucosalino Potásico with Food and Drinks

You should ask your doctor what you can eat or drink.

Pregnancy, Breast-feeding, and Fertility

Consult your doctor or nurse before using this medicine.

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, consult your doctor or nurse before using this medicine.

If you are given Viaflo Glucosalino Potásico during labor, there is a small possibility that the glucose may affect the fetus, causing:

• hyperglycemia (high blood sugar levels, which causes acute thirst, dry mouth, and frequent urination)
• hyperinsulinemia (high levels of insulin, the hormone that regulates blood sugar. Blood sugar levels may drop dramatically)
• acidosis (imbalance of blood chemical parameters), which can lead to low blood sugar levels and jaundice (yellowing of the skin or the white of the eye)

However, no relationship has been demonstrated between glucose infusion and the mentioned effects.

If another medicine is added to this infusion solution during pregnancy or breast-feeding, you should:

• consult your doctor
• read the package leaflet of the medicine to be added

Driving and Using Machines

The infusion does not affect your ability to drive or use machines.

3. How Viaflo Glucosalino Potásico will be given to you

A doctor or nurse will give you the infusion. Your doctor will decide how much you need and when it will be given to you, depending on your age, weight, clinical and biological status (your state of health). This may also be influenced by other treatments you are receiving.

If you require a high volume or rapid infusion of Viaflo Glucosalino Potásico, your doctor will monitor your ECG (electrocardiogram).

It will usually be given to you through a plastic tube connected to a needle in a vein, almost always in your arm. However, your doctor may use another method to administer the medicine to you.

Before and during the infusion, your doctor will monitor:

• the amount of potassium in your body
• 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 who are taking other medicines that increase the effect of vasopressin)

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

If you are given too much Viaflo Glucosalino Potásico

If you are given too much Viaflo Glucosalino Potásico (overdose), the following symptoms may occur:

• high blood sugar levels (hyperglycemia), which causes intense thirst, dry mouth, and frequent urination
• low sodium levels in the blood (hyponatremia). Hyponatremia can cause headache, nausea, seizures, lethargy, coma, brain inflammation (cerebral edema), and death.
• fluid accumulation under the skin (peripheral edema), especially around the ankles
• high levels of potassium (hyperkalemia), symptoms include:
• tingling sensation (paresthesia) in arms and legs
• respiratory paralysis (inability to breathe)
• gastrointestinal symptoms (painful intestinal obstruction, nausea, vomiting, abdominal pain)
• low blood pressure (hypotension)
• muscle weakness
• inability to move muscles (paralysis)
• abnormal heart rhythm (cardiac arrhythmia)
• heart block (very slow heart rate)
• cardiac arrest (the heart stops beating, which can cause death)

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 Glucosalino Potásico before the overdose, this medicine may also cause side effects. You should read the list of possible symptoms in the package leaflet of the added medicine.

If you stop the Viaflo Glucosalino Potásico infusion

Your doctor will decide when you should stop receiving this infusion

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

4. Possible Side Effects

Like all medicines, Viaflo Glucosalino Potásico can cause side effects, although not everybody gets them.

Some of the possible side effects related to the method of administration are:

• hypersensitivity reactions, including a severe allergic reaction called anaphylaxis (potential manifestation in patients with corn allergy).
• low sodium levels 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/edema (see also section 2 "Warnings and Precautions")
• hyperglycemia (high blood sugar levels)
• irritation and inflammation of the vein through which the infusion is performed (phlebitis). This can cause redness, pain, or itching and swelling in the vein
• rash
• pruritus (itching of the skin)
• fever (pyrexia).
• infection at the injection site.
• local pain or reaction (redness or swelling) at the injection site.
• blisters at the injection site.
• chills.
• high levels of potassium in the blood (hyperkalemia).
• cardiac arrest.
• formation of a blood clot (thrombosis) at the infusion site, which causes pain, inflammation, or redness.
• leakage of the infusion solution into the tissues surrounding the vein (extravasation), which can damage tissues and cause scarring.
• excess fluid in the blood vessels (hypervolemia).

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.

Reporting Side Effects

If you experience side effects, talk to your doctor or nurse, even if it is a side effect 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 Glucosalino Potásico

Viaflo Glucosalino Potásico does not require special storage conditions

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

Do not use Viaflo Glucosalino Potásico after the expiration date stated on the bag after CAD. The expiration date is the last day of the month indicated.

Viaflo Glucosalino Potásico should not be administered if:

• there are particles in the solution
• the solution changes color, or

the container is damaged.

6. Container Content and Additional Information

This leaflet does not contain all the information about this medicine. If you have any doubts, ask your doctor, pharmacist, or nurse.

Composition of Viaflo Glucosalino Potásico

The active ingredients are potassium chloride (1.5 g per liter), sodium chloride (1.8 g per liter), and glucose (40 g per liter, equivalent to glucose monohydrate 44 g).

The only excipient is water for injectable preparations.

Appearance of the Productand Container Content

Viaflo Glucosalino Potásico is a clear solution, free from visible particles. It is presented in polyolefin/polyamide plastic bags (Viaflo). 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

Baxter S.L.

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

Manufacturer

Bieffe Medital SA

Ctra de Biescas-Senegüé, 22666 Sabiñánigo (Huesca), Spain

Date of Last Revision of this Leaflet: April 2018

Detailed and updated information on this medicine 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, without visible particles, and if the container is not damaged. Administer immediately after connecting the infusion equipment.

Do not remove the unit from the 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 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.

Added medications can be introduced before or during infusion through the injection point.

Medications known or determined to be incompatible should not be used.

Before adding a medication, verify that it is soluble and/or stable in Viaflo Glucosalino Potásico 4%, 0.18%, 0.15% and that the pH range of the solution is adequate.

Consult the leaflet of the medication to be added and any other relevant literature.

After addition, if there is a change in color and/or precipitates, insoluble complexes, or crystals appear, do not use the solution.

Mix the solution well when medications have been added.

Do not store solutions containing added medications.

For single use.

When medications are added, the tonicity should be checked before parenteral administration. A complete and careful aseptic mixture of any added medication is necessary. Solutions containing added medications should be used immediately after preparation, unless this has been carried out under controlled and validated aseptic 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 case 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 administration method. When using a syringe pump to administer liquids 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 set should be closed before removing the administration set from the pump or disconnecting the pump. This is required regardless of whether the administration set has an anti-free flow device.

The intravenous infusion device and administration set should be frequently monitored.

Discard after a single use.

Discard unused solution remains.

Do not reconnect partially used bags.

1. To Open

a- Remove the Viaflo bag from the protective overbag immediately before use.

b- 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.

c- 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.

a- Hang the container by the handle

b- 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.

c- Use an aseptic technique to prepare the infusion

d- Connect the administration set. Consult the instructions accompanying the set for connection, priming, and administration of the solution.

3- Techniques for Injecting Added Medication

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

To Add Medication Before Administration

a Disinfect the injection point

b Using a syringe with a 19G to 22G needle, puncture the resealable injection point and inject.

c Mix the medication and solution completely. For high-density medications, such as potassium chloride, gently tap the tubes while they are in a vertical position and mix.

Precaution: do not store bags with added medication.

To Add Medication During Administration

a Close the clamp on the administration set.

b Disinfect the injection point.

c Using a syringe with a 19G to 22G needle, puncture the resealable injection point and inject.

d Remove the container from the IV stand and/or turn it to put it in a vertical position.

e Empty both tubes by gently tapping them while the container is in a vertical position.

f Mix the solution and medication completely.

g Put the container back in the use position, reopen the clamp, and continue administration.

1. Validity Period in Use (Added Medications)

Before use, the physical and chemical stability of any medication added to the pH and Viaflo Glucosalino Potásico bag must be established. From a microbiological point of view, the diluted product should be used immediately unless the dilution has been carried out under controlled and validated aseptic 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 Medications

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

It is the responsibility of the physician to judge the incompatibility of the added medication to Viaflo Glucosalino Potásico by examining any change in color and/or precipitate, appearance of insoluble complexes, or crystals.

Consult the leaflet of the medication to be added.

Before adding a medication, verify that it is soluble and stable in water at the pH of Viaflo Glucosalino Potásico.

When compatible medication is added to this formulation, the solution should be administered immediately, unless the dilution has been carried out under controlled and validated aseptic conditions.

As a guide, the following medications are incompatible with Viaflo Glucosalino Potásico, although this list is not exhaustive:

• amphotericin B
• dobutamine

Do not administer glucose simultaneously with whole blood through the same infusion equipment, as hemolysis and agglutination may occur.

Medications known to be incompatible should not be used.