PATIENT INFORMATION LEAFLET

Viaflo Glucose 5% and Sodium Chloride 0.9% Infusion Solution

Active ingredient: glucose, sodium chloride

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or nurse.
• If you experience any side effects, consult your doctor or nurse, even if they are not listed in this leaflet. See section 4.

This medicine is called “Viaflo Glucose 5% and Sodium Chloride 0.9% Infusion Solution”, but it will be referred to as “Viaflo Glucose 5% and Sodium Chloride 0.9%” in the rest of this leaflet.

Viaflo Glucosa 5% and Sodium Chloride 0.9% is a solution of the following substances in water:

• Sugar (glucose)
• Sodium chloride (salt)

Glucose is one of the body's energy sources. This solution provides 200 kilocalories per liter. Sodium and chloride are chemical substances found in the blood.

Viaflo Glucosa 5% and sodium chloride 0.9% is used:

• as a source ofcarbohydrates(sugar).
• to treat a loss of sodium from the blood and the body (sodium depletion)
• to treat a loss of water from the body, for example after being ill or having diarrhea (extracellular dehydration)
• to treat, if the volume of blood in your blood vessels is low (hypovolemia).

You should not receive Viaflo Glucosa 5% and Cloruro sódico 0.9% in the following cases:

• if you are allergic to the medication
• if there is too much fluid in the spaces around the body's cells (hyperhydration extracellular)
• if there is an excessive volume of blood in the blood vessels (hypervolemia)
• if there is too much fluid and sodium in the body (fluid and sodium retention)
• if you have severe kidney problems that involve producing less urine than normal or none at all (oliguria or anuria)
• if you have decompensated heart failure. This is a heart failure that does not receive adequate treatment and causes symptoms such as:
• • difficulty breathing
  • swelling of the ankles.
• if you have high sodium levels in the blood (hypernatremia)
• if you have high chloride levels in the blood (hyperchloremia)
• if you have fluid accumulation under the skin that affects the entire body (generalized edema)
• if you have liver disease that causes fluid accumulation in the abdomen (cirrhosis ascítica)
• if you have diabetes that does not receive adequate treatment, so the blood sugar concentration is higher than normal (uncompensated diabetes)
• if you have other states of glucose intolerance, for example:
• • metabolic aggression (when the body's metabolism does not function correctly, for example, due to a severe disease)
  • hyperosmolar coma (loss of consciousness). This is a type of coma that can occur if you have diabetes and do not receive adequate medication.
  • high blood sugar (significant hyperglycemia)
  • high lactate levels in the blood (hyperlactatemia)

Warnings and precautions

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

• a disorder in which the blood becomes too alkaline (metabolic alkalosis),
• muscle weakness and periodic paralysis due to low thyroid activity (periodic thyroid paralysis),
• rapid loss of body water, for example, due to vomiting or diarrhea,
• following a low-potassium diet for a long time,
• taking certain medications. See below “Other medications and Viaflo Glucosa 5% and Cloruro sódico 0.9%”,
• a disorder in which the blood becomes too acidic (metabolic acidosis).

• 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 severe illness,
• you have pain,
• you have been operated on,
• you have infections, burns, or brain injury
• you have diseases related to your heart, liver, kidneys, or central nervous system,
• you are taking certain medications (see Other medications and Viaflo Glucosa 5% and Cloruro sódico 0.9%)

This may increase the risk of having low sodium levels in the blood and may cause headache, nausea, convulsions, lethargy, coma, brain inflammation, and death. Brain inflammation increases the risk of death and brain damage. People at higher risk of brain inflammation are:

• children
• women (particularly if you are of childbearing age)
• people who have problems with their cerebrospinal fluid levels, for example, due to meningitis, intracranial bleeding, or brain injury.

Conditions associated with sodium retention, fluid overload, and edema, such as:

• Aldosteronism (a disease that causes high levels of the aldosterone hormone) associated with:
• poor liver functionor liver disease that causes fluid accumulation in the abdomen (cirrhosis ascítica),
• high blood pressure (hypertension),
• heart failure,
• renal insufficiency.
• High blood pressure during pregnancy (preeclampsia),
• any other condition associated with sodium retention (when the body retains too much sodium), such as steroid treatment (see below “Other medications and Viaflo Glucosa 5% and Cloruro sódico 0.9%”),
• allergy, particularly to corn (Viaflo Glucosa 5% and Cloruro sódico 0.9% contains corn-derived sugar).

The infusion may cause:

• changes in the concentrations of chemical substances in the blood (electrolyte imbalances),
• fluid accumulation under the skin that affects all parts of the body (generalized edema), around the ankles (peripheral edema) or in the lungs (pulmonary edema),
• high blood sugar (hyperglycemia).

When you receive this infusion, your doctor will be able to take blood and urine samples to control:

• the amount of chemical substances such as sodium and chloride in your blood (your plasma electrolytes),
• the amount of sugar (glucose)

As Viaflo Glucosa 5% and Cloruro sódico 0.9% contains sugar (glucose), it may increase blood sugar (hyperglycemia). If this occurs, your doctor will be able to:

• adjust the infusion rate,
• administer insulin to reduce blood sugar levels.

This is particularly important:

• if you are diabetic,
• if you have not been eating well or have been drinking too much alcohol for a long time,
• if you recently had a brain injury (acute cerebral stroke), as high blood sugar levels can worsen the effects of the brain injury and affect your recovery,
• if you suffered a head injury in the last 24 hours.

Your doctor should take into account if you are receiving parenteral nutrition (nutrition administered through an intravenous infusion in a vein). During prolonged treatments with Viaflo Glucosa 5% and Cloruro sódico 0.9%, you may need to receive additional nutrition. Your doctor should also monitor your potassium levels in the blood to avoid them decreasing too much (hypokalemia).

Children

Special care should be taken when administering this solution to children, babies, and newborns (especially premature babies and those with low birth weight) as they may not have a good ability to handle the chemical substances in the solution.

Newborns - especially premature babies and those with low birth weight - are at higher risk of developing low or high blood sugar levels (hypoglycemia or hyperglycemia) and therefore require careful monitoring during treatment with intravenous solutions containing glucose to ensure proper control of blood sugar levels to avoid potential long-term adverse effects. Low blood sugar levels in newborns can cause prolonged convulsions, coma, and brain damage. High blood sugar levels can cause cerebral hemorrhage, bacterial or fungal infections, eye damage (retinopathy of prematurity), intestinal infections (necrotizing enterocolitis), respiratory 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, convulsions, lethargy, coma, brain inflammation (cerebral edema), and death. Acute hyponatremic encephalopathy is a serious complication, especially in children. Your doctor knows all this and will carefully monitor the amount of chemical substances, such as sodium and chloride, in your child's blood (plasma electrolytes)

Other medications and Viaflo Glucosa 5% and Cloruro sódico 0.9%

Inform your doctor if you are taking, have taken recently, or may need to take any other medication.

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

• corticosteroids (anti-inflammatory medications)

These medications can cause the body to accumulate sodium and water, leading to:

• swelling of the tissue due to fluid accumulation under the skin (edema),
• high blood pressure (hypertension).

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

• diabetes medications (chlorpropamide)
• cholesterol-lowering medications (clofibrate)
• some cancer medications (vincristine, ifosfamide, cyclophosphamide)
• selective serotonin reuptake inhibitors (used to treat depression)
• antipsychotics
• opioids for severe pain relief
• medications for pain and/or inflammation (also known as NSAIDs)
• medications that mimic or strengthen the effects of vasopressin, such as desmopressin (used to treat excessive thirst and urination), terlipressin (used to treat esophageal bleeding), and oxytocin (used to induce labor)
• antiepileptic medications (carbamazepine and oxcarbazepine)
• diuretics.

Other medications that may affect or be affected by Viaflo Glucosa 5% and Cloruro sódico 0.9%:

• Lithium (used to treat psychiatric diseases),
• insulin (used to treat diabetes),
• diuretics,
• beta-blockers (heart medications)

Viaflo Glucosa 5% and Cloruro sódico 0.9% should not be administered through the same needle as used in a blood transfusion, as it may damage red blood cells or cause them to clump.

Use of Viaflo Glucosa 5% and Cloruro sódico 0.9% with food and drinksandbeverages

Ask your doctor about what you can eat or drink.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, consult your doctor or nurse before using a medication.

Viaflo Glucosa 5% and Cloruro sódico 0.9% can be administered during breastfeeding.

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

• consult your doctor.
• read the medication's prospectus.

Driving and using machines

Viaflo Glucosa 5% and Cloruro sódico 0.9% does not affect your ability to drive or use machines.

Infusion of Glucose 5% and Sodium Chloride 0.9% will be administered by a doctor or nurse. Your doctor will decide how much you need and when to administer it. This will depend on your age, weight, physical condition, and the reason for treatment. The amount you receive may also be influenced by other treatments you are receiving.

DO NOT receive Glucose 5% and Sodium Chloride 0.9% if there are particles floating in the solution or if the container is damaged in any way.

Glucose 5% and Sodium Chloride 0.9% will usually be administered through a plastic tube connected to a needle inserted into a vein. However, your doctor may administer the medication in another way.

Any unused solution should be discarded. DO NOT receive Glucose 5% and Sodium Chloride 0.9% from a bag that has been partially used.

Before and during the infusion, your doctor will monitor:

• 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 the hormone vasopressin, or those taking other medications that increase the effect of vasopressin).

If you are administered more Glucose 5% and Sodium Chloride 0.9% than you should

If you receive too much of the Glucose 5% and Sodium Chloride 0.9% solution or if the administration is too rapid, you may experience the following symptoms:

• High blood sugar levels (hyperglycemia). Symptoms include:
• dry mouth due to lack of water in the body tissues (dehydration),
• thirst,
• fatigue,
• frequent urination due to increased urine production (osmotic diuresis),
• blurred vision.
• Low sodium levels in the blood (hyponatremia). Hyponatremia can cause headache, nausea, seizures, drowsiness, coma, brain swelling (cerebral edema), and death.
• High sodium levels in the blood (hypernatremia). If this occurs, the most severe effect is a reduction in brain water content (cerebral dehydration). This causes drowsiness and confusion and may cause seizures, loss of consciousness (coma), respiratory failure, and even death. Other symptoms include:
• thirst,
• dry mouth and eyes,
• fever,
• rapid heart rate (tachycardia),
• high blood pressure (hypertension),
• headache,
• dizziness,
• restlessness,
• irritability,
• weakness.
• A buildup of fluid in the body causing swelling (edema).

If you develop any of these symptoms,inform your doctor immediately.The infusion will be stopped and you will receive treatment based on the symptoms.

If a medication has been added to Glucose 5% and Sodium Chloride 0.9% before the excessive administration, the medication may also cause symptoms. Please read the list of possible symptoms in the medication's package insert.

In case of overdose or accidental ingestion, consult the Toxicology Information Service. Phone: 91 562 04 20.

Stopping the infusion ofGlucose 5% and Sodium Chloride 0.9%

Your doctor will decide when to stop receiving this infusion.

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

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Adverse effects may be related to Viaflo Glucose 5% and Sodium Chloride 0.9%. These include:

• allergic reactions, including a severe allergic reaction called anaphylaxis (potential manifestation in patients with corn allergy).
• high levels of sodium in the blood (hypernatremia)
• high levels of sugar in the blood (hyperglycemia).
• low levels of sodium 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”).

Adverse effects maymay be due tothe administration technique. This includes:

• fever (febrile response),
• chills,
• itching (pruritus) or hives
• pain or local reaction (pain or vesicles at the infusion site)
• irritation and inflammation of the vein in which the solution is infused (phlebitis). This may cause redness, pain, or burning and swelling along the vein in which the solution has been infused.

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

Reporting Adverse Effects:

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

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

Viaflo Glucose 5% and Sodium Chloride 0.9% does not require special conditions for conservation.

Viaflo Glucose 5% and Sodium Chloride 0.9% should not be administered after the expiration date that appears on the bag after CAD. The expiration date is the last day of the month indicated.

Viaflo Glucose 5% and Sodium Chloride 0.9% should not be received if there are particles floating in the solution or if the container is damaged in any way.

Composition of Viaflo Glucose 5% and Sodium Chloride 0.9%

The active principles are

• glucose: 50 g per liter
• sodium chloride: 9 g per liter

The other component is water for injection preparations.

Appearance of the product and contents of the container

Viaflo Glucose 5% and Sodium Chloride 0.9% 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:

• 250 ml
• 500 ml
• 1000 ml

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

• 30 bags of 250 ml
• 20 bags of 500 ml
• 10 bags of 1,000 ml
• 12 bags of 1,000 ml

Only some sizes of containers may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder

Baxter S.L.

Camilo Pouet Street, 2

46394, Ribarroja del Turia (Valencia)

Responsible for manufacturing:

Bieffe Medital S.A.

Biescas Road, Senegüé

22666 Sabiñanigo (Huesca)

Spain

Baxter SA

René Branquart Boulevard, 80

7860 Lessines

Belgium

Last review date of this prospectus: October 2023

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

This information is intended solely for healthcare professionals

Handling and preparation

Use only if the solution is transparent, free of visible particles, and the container is not damaged. Administer immediately after connecting the infusion equipment.

Do not remove the bag from its protective overbag until it is ready for use.

The inner bag maintains the sterility of the product.

Do not connect in series plastic containers. This type of connection may cause gas embolism due to residual air carried from the primary container before the secondary container is fully administered.

The pressurization of intravenous solutions in flexible plastic containers to increase flow rates may lead to gas embolism if the residual air in the container is not fully evacuated before administration.

The use of an intravenous administration equipment with a ventilation filter in open position may cause gas embolism. This type of intravenous administration equipment with the ventilation filter in 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 introduced before or during infusion through the resuable medication port.

When adding medicines, verify isotonicity before parenteral administration. A complete and careful aseptic mixing of any added medicine is required. Solutions containing added medicines must be used immediately and should not be stored.

Pediatric population

To avoid a potentially fatal overdose during intravenous infusion of solutions in newborns, special attention should 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 of 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 equipment and administration equipment must be controlled frequently.

Discard after single use

Discard any remaining portion.

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 port at the bottom of the container.
-hold one hand on the small handle of the neck of the outlet port.
-hold the other hand on the large handle of the closure 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 its 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 medication port

bUsing a syringe with a 19 G (1.10 mm) to 22 G (0.70 mm) needle, puncture the resuable medication port and inject.

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

Caution: Do not store bags with added medication.

To add medication during administration

aClose the clamp of the equipment

bDisinfect the medication port

cUsing a syringe with a 19 G (1.10 mm) to 22 G (0.70 mm) needle, puncture the resuable medication port and inject.

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

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

fMix the solution and medication carefully

gReturn the container to its original position, reopen the clamp, and continue administration

4.Expiry in use (added medicines)

Before use, the physical and chemical stability of any additional medication to the pH of the Viaflo Glucose 5% and Sodium Chloride 0.9% solution in the Viaflo container must be established.

From a microbiological point of view, the diluted product must be used immediately. If not used immediately, the conditions and storage period before use are the responsibility of the user and are normally not greater than 24 hours at 2-8°C, unlessthe reconstitution was performed in controlled and validated aseptic conditions.

5-Incompatibilities of added medicines

As with all parenteral solutions, the compatibility of added medicines to the solution in the Viaflo bag must be verified before addition.

It is the responsibility of the doctor to judge the incompatibility of the added medicine to Viaflo Glucose 5% and Sodium Chloride 0.9% by examining any eventual change in color and/or precipitation, insoluble complexes, or appearance of crystals. The prospectus of the medicine to be added should be consulted.

Before adding a medicine, verify that it is soluble and stable in water at the pH of the Viaflo Glucose 5% and Sodium Chloride 0.9% solution (pH 3.5 to 6.5).

When adding a compatible medicine to Viaflo Glucose 5% and Sodium Chloride 0.9%, the solution must be used immediately.

As a guideline, the following medicines are incompatible with Viaflo Glucose 5% and Sodium Chloride 0.9% (non-exhaustive list):

- Sodium ampicillin

- Mitomycin

- Amphotericin B

- Erythromycin lactobionate.

Due to the presence of glucose, Viaflo Glucose 5% and Sodium Chloride 0.9% should not be administered through the same infusion equipment as whole blood, as it may cause hemolysis and agglutination.

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