Leaflet: information for the user

Viaflo Glucosalino Potásico 4%, 0.18%, 0.15%, solution for infusion

Active ingredients: glucose monohydrate, 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, consult your doctor or nurse.

-If you experience any side effects, consult your doctor or nurse, even if they are 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.

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

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

3.How you will be given Viaflo Glucosalino Potásico

4.Possible side effects

5.Storage of Viaflo Glucosalino Potásico

6.Contents of the pack and additional information

Viaflo Glucosalino Potásico is a solution of monohydrated glucose, 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 there is a loss of gastrointestinal (stomach) fluid. This may be caused by:

-vomiting

-diarrhea

-drainage from a wound after surgery (through the collection of bodily fluid in a bag)

-gastric suction to empty the stomach contents

-diversion of part of the digestive system that prevents the passage of food through the small intestine. This procedure is called intestinal bypass

-perforation of the small intestine (small intestine fistula)

• excessive intake of laxatives (medicines to empty the intestines)
• development of malabsorption syndrome (insufficient nutrient absorption)
• tumor in the small intestine that produces mucus (secretory villous adenoma)
• kidney problems that can cause excessive loss of salts
• excessive intake of diuretics (tablets that increase urine production)

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

Do not administer Viaflo Glucosalino Potásicoin the following cases:

• high levels of potassium in the blood (hyperkalemia)
• high levels of chloride in the blood (hyperchloremia)
• severe renal insufficiency (when the kidneys do not work well and dialysis is needed)
• uncompensated heart failure. This is a heart failure that is not properly 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 high blood sugar levels (hyperglycemia)

-High levels 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 monohydrateor to any of the other components of this medication (including in section 6).

Your doctor should take special care when administering Viaflo Glucosalino Potásico

Viaflo Glucosalino Potásico is a hypertonic solution (concentrated). When 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.

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 vasopresin, a hormone that regulates the fluid in your body. You may have too much vasopresin in your body because, for example:

• you have had a sudden and serious 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 Other medications and Viaflo Glucosalino potásico)

This may increase the risk of having low sodium levels in the blood and may cause headaches, nausea, convulsions, drowsiness, 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 cerebrospinal fluid levels, for example, due to meningitis, bleeding in the skull, or brain injury.

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

-renal insufficiency,

-adrenocortical insufficiency. It 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),
• peripheral edema, especially around the ankles,
• pulmonary edema,
• high blood pressure during pregnancy (preeclampsia),
• any disorder associated with sodium retention (when there is an elevated presence of sodium in the body), such as steroid treatments (anti-inflammatory medications) (see also "Other medications 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,
• corn allergy (Viaflo glucosalino potásico contains sugar derived from corn)

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 control the levels of chemical substances in the blood (electrolytes in plasma). You will also have an electrocardiogram (ECG).

You may need to change your other medications.

Children

Viaflo glucosalino potásicoshould be administered withcaution in children.

Newborns,especiallypremature andlow-birth-weight babies,have a higherrisk of developinghigh or lowblood sugar levels (hypoglycemiaor hyperglycemia) due to the perfusion of glucose solutions. Low blood sugar in newborns can cause prolonged convulsions, coma, and brain damage. High blood sugar levels have been associated with cerebral hemorrhage, late-onset bacterial and fungal infections, necrotizing enterocolitis, eye problems (retinopathy of prematurity), respiratory problems (bronchopulmonary dysplasia), prolonged hospital stay, and death

Children have a higher risk of having or developing a concentration of too low sodium in the blood (hyponatremia). Hyponatremia can cause headaches, nausea, convulsions, drowsiness, coma, brain inflammation, and death. Acute hyponatremic encephalopathy is a serious complication, especially in children.

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

Other medications and Viaflo glucosalino potásico

Inform your doctor or pharmacist if you are using or have recently used other medications.

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

-lithium (used to treat psychiatric disorders)

-potassium-sparing diuretics (some tablets such as amiloride, spironolactone, triamterene)

-medications that contain potassium (for example, potassium supplements, salt substitutes that contain potassium, and some types of penicillin)

-medications that increase the risk of hyponatremia or sodium and fluid retention

-angiotensin-converting enzyme inhibitors (ACE inhibitors) (used to treat high blood pressure)

-ciclosporin (used to prevent transplant rejection)

-corticosteroids (anti-inflammatory medications)

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

• diabetes medication (chlorpropamide)
• cholesterol-lowering medication (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

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

Use of Viaflo Glucosalino Potásico with food and drinks

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

Pregnancy, breastfeeding, and fertility

Consult your doctor or nurse before using this medication.

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

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

• hyperglycemia (high blood sugar levels, which cause intense thirst, dry mouth, and frequent urination)
• hyperinsulinemia (high insulin levels, the hormone that regulates blood sugar levels. Blood glucose levels may drop dramatically)
• acidosis (imbalance of chemical parameters in the blood), which may 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 perfusion and the effects mentioned.

If another medication is added to this perfusion solution during pregnancy or breastfeeding, you should:

• consult your doctor
• read the prospectus of the medication to be added

Driving and operating machines

The perfusion does not affect your ability to drive or operate machines.

A healthcare professional, such as a doctor or nurse, will administer the infusion.Your doctor will decide how much you need and when it will be administered, which will depend on your age, weight, clinical and biological status (your health status). It may also be influenced by other treatments you receive.

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

The infusion will generally be administered through a plastic tube connected to a vein in your arm using a needle. However, your doctor may use another method to administer the medication.

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

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

If you receive more Viaflo Glucosalino Potásico than you should

If you are administered an excessive amount of 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 headaches, nausea, seizures, drowsiness, coma, brain swelling (cerebral edema), and death.
• Fluid accumulation under the skin (peripheral edema), especially around the ankles.
• High potassium levels (hyperkalemia), symptoms include:
• Needle-like sensations (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).
• Cardiac block (very slow heart rhythm).
• Cardiac arrest (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 based on the symptoms.

If a medication has been added to Viaflo Glucosalino Potásico before the excessive administration,that medication may also cause adverse effects.You shouldread the list of possible symptoms in the prospectus of the added medication.

If you interrupt 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.

Like all medications, Viaflo Glucosalino Potásico may cause adverse effects, although not everyone will experience them.

Some possible adverse effects related to the administration method are as follows:

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

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

Reporting Adverse Effects

If you experience adverse effects, consult your doctor or nurse , even if they do not appear in this prospectus

You can also report them directly through the Spanish System of Pharmacovigilance for human use medications, https://www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication

.

Viaflo glucosaline potassium does not require special conservation conditions

Keepthis medicationout of the sight and reach of children.

Do not useViaflo Glucosaline Potassiumafterthe expiration date printed on the bagafter CAD. The expiration date is the last day of the month indicated.

Do not administer Viaflo Glucosaline Potassium if:

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

the container is damaged.

This leaflet does not contain all the information about this medicine. If you have any questions, 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 injection.

Appearance of the product and contents of the package

Viaflo Glucosalino Potásico is a transparent, particle-free solution. It is presented in polyolefin/polyamide (Viaflo) plastic bags. Each bag is packaged in a sealed plastic 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 sizes of packaging may be marketed.

Marketing Authorization Holder

Baxter S.L.

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

Responsible for manufacturing

Bieffe Medital SA

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

Last review date of this leaflet: April 2018

For detailed and updated information on this medicine, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/

This information is intended only for healthcare professionals

Handling and preparation

Use only if the solution is transparent, particle-free and the package is not damaged. Administer immediately after connecting the infusion equipment.

Do not remove the unit from the protective overbag until it is ready for use. The inner bag maintains the sterility of the product.

Do not connect plastic bags 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 pressurization of intravenous solutions in flexible plastic containers to increase flow rates may cause gas embolism if the residual air in the container is not completely evacuated before administration.

The use of an intravenous administration set with a ventilation filter in the open position may cause 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 a sterile equipment using an aseptic technique. The equipment must be primed with the solution to prevent air entry into the system.

Medicines may be added before or during infusion through the injection port.

Do not use medicines known or determined to be incompatible.

Before adding a medicine, 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 suitable.

Consult the medicine's leaflet and any other relevant literature.

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

Mix the solution well when medicines have been added.

Do not store solutions containing added medicines.

For single use only.

When adding medicines, the tonicity must be checked before parenteral administration. A complete and careful aseptic mixing of any added medicine is required. Solutions containing added medicines must be used immediately after preparation, unless this has been carried out in controlled and validated aseptic conditions.

The addition of other medicines or the use of an incorrect administration technique may cause the appearance of febrile reactions due to the possible introduction of pyrogens. In case of an adverse reaction, the infusion must be stopped immediately.

Pediatric population

To avoid a potentially fatal overdose during the infusion of intravenous solutions in newborns, special attention must be paid to the administration method. When using a syringe pump to administer liquids or medicines intravenously to newborns, do not leave a solution bag connected to the syringe.

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

The intravenous infusion device and administration equipment must be frequently monitored.

Dispose of after single use.

Dispose of unused solution residues.

Do not reconnect partially used bags.

1.To open

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

b-Check for small leaks by pressing 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 hanger.

b-Remove the plastic protector from the outlet on the bottom of the container.

-Hold one hand on the small handle of the outlet tube.

-Hold the other hand on the large handle of the cap and turn.

-The cap will come off.

c-Use an aseptic technique to prepare the infusion.

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

3-Techniques for injecting added medication

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

To add medication before administration

aDisinfect the injection port.

bUsing a syringe with a 19G to 22G needle, pierce the resellable injection port and inject.

cMix the medication and solution completely. For high-density medicines, such as potassium chloride, gently shake the tubes while in the vertical position and mix.

Caution: Do not store bags with added medication.

To add medication during administration

aClose the clamp on the equipment.

bDisinfect the injection port.

cUsing a syringe with a 19G to 22G needle, pierce the resellable injection port and inject.

dRemove the container from the IV stand and/or turn it to the vertical position.

eEmpty both tubes by gently shaking them while the container is in the vertical position.

fMix the solution and medication completely.

gReplace the container in the vertical position, reopen the clamp and continue the administration.

4.Valid period in use (added medicines)

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

If not used immediately, the conditions and storage times used before use are the responsibility of the user.

5-Incompatibilities of added medicines

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

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

Consult the leaflet of the medicine to be added.

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

When adding compatible medication to this formulation, the solution must be administered immediately, unless the dilution has been carried out in controlled and validated aseptic conditions.

As a guide, the following medicines 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 it may cause hemolysis and agglutination.

Medicines known to be incompatible should not be used.