VIAFLO GLUCOSA 5% & SODIUM CHLORIDE 0.9% SOLUTION FOR INFUSION

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Viaflo Glucose 5% and Sodium Chloride 0.9% Solution for Infusion

Active substance: glucose, sodium 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.

This medicine is called “Viaflo Glucose 5% and Sodium Chloride 0.9% Solution for Infusion”, but will be referred to as “Viaflo Glucose 5% and Sodium Chloride 0.9%” throughout this leaflet.

Contents of the pack

1. What Viaflo Glucose 5% and Sodium Chloride 0.9% is and what it is used for
2. What you need to know before you are given Viaflo Glucose 5% and Sodium Chloride 0.9%
3. How Viaflo Glucose 5% and Sodium Chloride 0.9% will be given
4. Possible side effects
5. Storage of Viaflo Glucose 5% and Sodium Chloride 0.9%
6. Contents of the pack and other information

1. What Viaflo Glucose 5% and Sodium Chloride 0.9% is and what it is used for

Viaflo Glucose 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 sources of energy. This solution provides 200 kilocalories per liter. Sodium and chloride are chemical substances found in the blood.

Viaflo Glucose 5% and Sodium Chloride 0.9% is used:

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

2. What you need to know before you are given Viaflo Glucose 5% and Sodium Chloride 0.9%

Viaflo Glucose 5% and Sodium Chloride 0.9% will not be given to you in the following cases:

• if you are allergic to the medicine
• when there is too much fluid in the spaces surrounding the body's cells (extracellular hyperhydration)
• when there is a higher volume of blood in the blood vessels than there should be (hypervolemia)
• more fluid and sodium in the body than normal (fluid and sodium retention)
• severe kidney problems that involve producing less urine than normal or none at all (oliguria or anuria)
• uncontrolled heart failure. This is heart failure that is not receiving appropriate treatment and is causing symptoms such as:
• • difficulty breathing
  • swelling of the ankles.
• high levels of sodium in the blood (hypernatremia)
• high levels of chloride in the blood (hyperchloremia)
• fluid accumulation under the skin, affecting the whole body (generalized edema)
• liver disease that causes fluid accumulation in the abdomen (ascitic cirrhosis)
• uncontrolled diabetes, so that the blood sugar concentration is higher than normal (uncontrolled diabetes)
• other states of glucose intolerance, for example:
• • metabolic aggression (when the body's metabolism is not working properly, for example due to a severe illness)
  • hyperosmolar coma (loss of consciousness). This is a type of coma that can occur if you have diabetes and are not receiving appropriate medication.
  • a very high amount of sugar in the blood (significant hyperglycemia)
  • high levels of lactate in the blood (hyperlactatemia)

Warnings and precautions

Tell 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 (thyrotoxic periodic paralysis),
• rapid loss of water from the body, e.g. due to vomiting or diarrhea,
• following a low-potassium diet for a long time,
• taking certain medications. See below “Other medicines and Viaflo Glucose 5% and Sodium Chloride 0.9%”,
• a disorder in which the blood becomes too acidic (metabolic acidosis).

• if you have a condition that could cause high levels of vasopressin, a hormone that regulates the body's 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 undergone surgery,
• 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 medicines and Viaflo Glucose 5% and Sodium Chloride 0.9%)

This may increase the risk of low sodium levels in the blood and can 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 injury.

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

• Aldosteronism (a disease that causes high levels of a hormone called aldosterone) associated with:
• poor liver function or liver disease that causes fluid accumulation in the abdomen (ascitic cirrhosis),
• high blood pressure (hypertension),
• heart failure,
• kidney failure.
• High blood pressure during pregnancy (preeclampsia),
• any other condition associated with sodium retention (when the body retains too much sodium), such as treatment with steroids (see below “Other medicines and Viaflo Glucose 5% and Sodium Chloride 0.9%”),
• allergy, in particular to corn (Viaflo Glucose 5% and Sodium Chloride 0.9% contains corn-derived sugar).

Infusion may cause:

• changes in the concentrations of chemical substances in the blood (electrolyte disturbances),
• fluid accumulation under the skin, affecting the whole body (generalized edema), around the ankles (peripheral edema), or in the lungs (pulmonary edema),
• a high amount of sugar in the blood (hyperglycemia).

When you receive this infusion, your doctor may take blood and urine samples to monitor:

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

Since Viaflo Glucose 5% and Sodium Chloride 0.9% contains sugar (glucose), it may increase blood sugar levels (hyperglycemia). If this occurs, your doctor may:

• 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 have recently had brain damage (acute stroke), as high blood sugar levels can worsen the effects of brain damage and affect recovery,
• if you suffered a head injury in the last 24 hours.

Your doctor should consider whether you are receiving parenteral nutrition (nutrition administered by infusion into a vein). During prolonged treatment with Viaflo Glucose 5% and Sodium Chloride 0.9%, you may need to receive additional nutrition. Your doctor should also monitor your blood potassium levels to avoid abnormally low levels (hypokalemia).

Children

Special care should be taken when administering this solution to children, infants, 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 those born prematurely and with low birth weight - are at higher risk of developing low or high blood glucose levels (hypo or hyperglycemia) and therefore need careful monitoring during treatment with intravenous glucose solutions to ensure appropriate blood sugar control and avoid potential long-term adverse effects. Low blood sugar levels in newborns can cause prolonged seizures, coma, and brain damage. High blood sugar levels can cause brain hemorrhages, bacterial or fungal infections, eye damage (retinopathy of prematurity), intestinal infections (necrotizing enterocolitis), lung problems (bronchopulmonary dysplasia), prolonged hospital stay, and death.

Children are at higher risk of having 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 all this and will carefully monitor the amount of chemical substances, such as sodium and chloride, in your child's blood (plasma electrolytes)

Other medicines and Viaflo Glucose 5% and Sodium Chloride 0.9%

Tell your doctor if you are taking, have recently taken, or might take any other medicines.

It is particularly important that you tell your doctor if you are taking:

• corticosteroids (anti-inflammatory medicines)

These medicines can cause the body to retain sodium and water, leading to:

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

Some medicines affect 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.

Other medicines that may affect or be affected by Viaflo Glucose 5% and Sodium Chloride 0.9%:

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

Viaflo Glucose 5% and Sodium Chloride 0.9% should not be administered through the same needle used for a blood transfusion, as it may damage red blood cells or cause them to clump.

Using Viaflo Glucose 5% and Sodium Chloride 0.9% with food and drinks

Ask your doctor what you can eat or drink.

Pregnancy and breastfeeding

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.

Viaflo Glucose 5% and Sodium Chloride 0.9% can be administered during breastfeeding.

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 Sodium Chloride 0.9% does not affect your ability to drive or use machines.

3. How Viaflo Glucose 5% and Sodium Chloride 0.9% will be given

Viaflo Glucose 5% and Sodium Chloride 0.9% will be administered to you by a doctor or nurse. Your doctor will decide how much you need and when it should be administered. 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 Viaflo Glucose 5% and Sodium Chloride 0.9% if there are particles floating in the solution or if the container is damaged in any way.

Generally, Viaflo Glucose 5% and Sodium Chloride 0.9% will be administered to you through a plastic tube attached to a needle inserted into a vein. However, your doctor may administer the medicine in another way.

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

Before and during 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 vasopressin hormone, or those taking other medicines that increase the effect of vasopressin).

If you are given too much Viaflo Glucose 5% and Sodium Chloride 0.9%

If you receive too much Viaflo 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's 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, lethargy, coma, brain inflammation (cerebral edema), and death.
• High sodium levels in the blood (hypernatremia). If this occurs, the most severe effect is a reduction in the brain's water content (brain dehydration). This causes lethargy and confusion and can lead to seizures (convulsions), loss of consciousness (coma), interruption of breathing (respiratory failure), and even death. Other symptoms include:
• thirst,
• dry mouth and eyes,
• fever,
• rapid heartbeat (tachycardia),
• high blood pressure (hypertension),
• headache,
• dizziness,
• restlessness,
• irritability,
• weakness.
• Fluid accumulation in the body that causes 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 medicine has been added to Viaflo Glucose 5% and Sodium Chloride 0.9% before excessive administration, that medicine may also cause symptoms. You should read the list of possible symptoms in the package leaflet of the added medicine.

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

Stopping the infusion of Viaflo Glucose 5% and Sodium Chloride 0.9%

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

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

4. Possible side effects

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

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

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

Side effects may be due to the administration technique. This includes:

• fever (febrile response),
• chills,
• itching (pruritus) or rash
• pain or local reaction (pain or blisters at the infusion site)
• irritation and inflammation of the vein into which the solution is infused (phlebitis). This can cause redness, pain, or burning and swelling along the vein into which the solution is infused.

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 of 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 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 Glucose 5% and Sodium Chloride 0.9%

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

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

Viaflo Glucose 5% and Sodium Chloride 0.9% should NOT be administered after the expiry date stated on the bag after EXP. The expiry date is the last day of the month indicated.

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

6. Container Contents and Additional Information

Composition of Viaflo Glucose 5% and Sodium Chloride 0.9%

The active ingredients are

• sugar (glucose): 50 g per liter
• sodium chloride: 9 g per liter

The other component is water for injectable preparations.

Appearance of the Product and Container Contents

Viaflo Glucose 5% and Sodium Chloride 0.9% is a clear, particle-free solution. It is presented in polyolefin/polyamide (Viaflo) plastic bags. Each bag is packaged in a sealed protective plastic 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 1000 ml
• 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 de Biescas, Senegüé

22666 Sabiñanigo (Huesca)

Spain

Baxter SA

Boulevard René Branquart, 80

7860 Lessines

Belgium

Date of Last Revision of thisProspectus: October 2023

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 connection can produce gas embolisms due to residual air drawn from the primary container before the administration of the liquid contained in the secondary container is complete.

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.

Medications can be introduced before or during infusion through the resealable medication port.

When adding medications, verify isotonicity before parenteral administration. A complete and careful aseptic mixture of any added medication is necessary. Solutions containing added medications should be used immediately and not stored.

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 must 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 monitored 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 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 hanger

b- Remove the plastic protector from the outlet port at the bottom of the container. - Hold the small wing of the outlet port 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 medication port

b- Using a syringe with a 19 G (1.10 mm) to 22 G (0.70 mm) needle, puncture the resealable medication port and inject.

c- Carefully mix the medication and solution. 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

a- Close the clamp on the administration set

b- Disinfect the medication port

c- Using a syringe with a 19 G (1.10 mm) to 22 G (0.70 mm) needle, puncture the resealable medication port 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- Carefully mix the solution and medication

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

1. Expiry Date for Use (Added Medications)

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

From a microbiological point of view, the diluted product must be used immediately. If not used immediately, the storage conditions and period before use are the responsibility of the user and will normally not exceed 24 hours at 2-8°C, unless reconstitution has been carried out under controlled and validated aseptic conditions.

5- Incompatibilities of Added Medications

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

It is the physician's responsibility to assess the incompatibility of the added medication with Viaflo Glucose 5% and Sodium Chloride 0.9% by examining any change in color and/or precipitate, insoluble complexes, or appearance of crystals. The prospectus of the medication to be added should be consulted.

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

As a guide, the following medications 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 hemolysis and agglutination may occur.

Medications known to be incompatible should not be used.