Leaflet: information for the user

Viaflo Glucose 5% solution for perfusion

Active ingredient: glucose

Read this leaflet carefully before starting to usethismedicine,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 ornurse.

- Ifyouexperienceadverse effects, consult your doctor or nurse, evenifthe adverse effects do not appearin this leaflet. See section 4.

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

2.What you need to know before Viaflo Glucose 5% is administered to you

3.How Viaflo Glucose 5% will be administered to you

4.Possible adverse effects

5.Storage of Viaflo Glucose 5%

6.Contents of the package and additional information

Viaflo Glucosa 5% is a sugar (glucose) solution in water.

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

Viaflo Glucosa 5% is used:

• as a source of liquids and carbohydrates (sugar).

-to dilute or apply other medications that can be administered via perfusion.

You should not be administered Viaflo Glucosa 5% if you have any of the following clinical situations

• if you have diabetes that is not receiving adequate treatment, resulting in a blood glucose concentration above the normal range (uncontrolled diabetes).
• if there are situations of glucose intolerance, for example: when the body's metabolism does not function correctly, for example, due to severe diseases (metabolic stress).

• coma hyperosmolar (loss of consciousness). This is a type of coma that can occur if you have diabetes and are not receiving adequate medication.
• blood glucose concentration above the normal range (hyperglycemia)
• blood lactate concentration above the normal range (hyperlactatemia).
• intolerance (hypersensitivity) to glucose. This can occur in patients with an allergy to corn.

If another medication is added to your infusion solution, you should always read the package insert for that medication. In this way, you will know if that medication is safe for you.

Warnings and precautions

Inform your doctor if you have or have had any of the following medical conditions.

• Excess water in the body (water intoxication)
• If you are diabetic or have high blood sugar levels (hyperglycemia).
• If your kidneys do not function as well as they normally do.
• If you have sepsis, trauma, or shock.
• Low levels of electrolytes (sodium, potassium, phosphate, magnesium) in the blood.
• Head injury in the last 24 hours.
• If you have recently had a stroke (acute ischemic stroke). High blood sugar levels can worsen the effects of the stroke and affect recovery.
• If you have metabolic alterations due to malnutrition or a diet that does not provide the necessary nutrient balance (malnutrition).
• If you have low levels of thiamine (vitamin B1) in your body. This can occur if you have chronic alcoholism.
• Allegy to corn (Viaflo Glucosa 5% contains glucose derived from corn).
• 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 had surgery,
• you have infections, burns, or head injury
• you have diseases related to your heart, liver, kidneys, or central nervous system,
• you are taking certain medications (see Other medications and Viaflo Glucosa 5%)

This can increase the risk of having low sodium levels in the blood and can cause headaches, 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 they are of childbearing age)
• people who have problems with their cerebrospinal fluid levels, for example, due to meningitis, bleeding in the skull, or head injury.

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

• the amount of electrolytes such as potassium present in the blood (plasma electrolytes),
• the amount of sugar (glucose),
• the amount of fluid in your body (your fluid balance),
• the acidity of your blood and urine (changes in acid-base balance).

Since Viaflo Glucosa 5% contains sugar (glucose), it can increase blood glucose concentration (hyperglycemia). If this occurs, your doctor can:

• adjust the infusion rate
• administer insulin to reduce blood glucose concentration
• if necessary, administer more potassium

Viaflo Glucosa 5% should not be administered with the same needle used for a blood transfusion. The red blood cells may be damaged or clumped.

Your doctor will take into account if you are receiving parenteral nutrition (nutrition given by infusion through a vein).

You may need complementary nutrition during long-term treatment with Viaflo Glucosa 5%.

Children

Viaflo Glucosa 5%should be administered withspecial carein children.

Children should receive Viaflo Glucosa 5% from a doctor or nurse. The amount administered should be determined by a pediatric specialist and will depend on the child's age, weight, and condition. If it is used to administer or dilute another medication, or if other medications are administered at the same time, the dose may also be affected.

When the infusion is administered to children, your doctor will take blood and urine samples to monitor the amount of electrolytes such as potassium in the blood (plasma electrolytes).

Newborns - especially premature and low-birth-weight babies - are at higher risk of developing low or high blood glucose levels (hypoglycemia or hyperglycemia) and therefore require careful monitoring during treatment with glucose solutions by intravenous infusion to ensure adequate control of blood sugar levels to prevent possible long-term adverse effects. Low blood sugar levels in newborns can cause convulsions, prolonged coma, and brain damage. High blood sugar levels can cause bleeding in the brain, bacterial or fungal infections, eye damage (retinopathy of prematurity), intestinal infections (necrotizing enterocolitis), lung problems (bronchopulmonary dysplasia), prolonged hospital stay, and death.

When administered to newborns, the bag with the solution can be connected to a pump device that allows the exact amount of solution to be administered during the defined time interval. Your doctor or nurse should supervise the device to ensure the safety of administration.

Children (including newborns and older children) receiving Viaflo Glucosa 5% are at higher risk of developing low sodium levels in the blood (hyponatremia) and a condition that affects the brain due to low plasma sodium levels (hypontatremic encephalopathy).

Other medications and Viaflo Glucosa 5%

Inform your doctor ornurseif you aretakingor havetakenrecentlyor may need to takeany othermedication.

Viaflo Glucosa 5% and another medication taken at the same time may affect each other.

Do not take Viaflo Glucosa 5% with certain hormones (catecholamines) including adrenaline or steroids, as they may increase blood sugar levels.

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 enhance the effects of vasopresin, 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

Viaflo Glucosa 5% with food and drinks

You should ask your doctor what foods and drinks you can take.

Pregnancy, breastfeeding, and fertility

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

Pregnancy

Viaflo Glucosa 5% can be used during pregnancy. However, caution should be exercised when using a glucose solution during labor.

Fertility

There is insufficient data on the effect of Viaflo Glucosa 5% on fertility, although no effect is expected.

Breastfeeding

There is insufficient data on the use ofViaflo Glucosa 5% during breastfeeding, although no effect is expected. Viaflo Glucosa 5% can be used during breastfeeding.

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

• consult your doctor.
• read the package insert for the medication to be added.

Driving and operating machines

Consult your doctor or nurse before driving or operating machines.

Glucose 5% Viaflo 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, the reason for treatment, and whether the infusion is to be used to administer or dilute another medication. The amount you receive may also be influenced by other treatments you are receiving.

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

Glucose 5% Viaflo will usually be administered through a plastic tube connected to a needle inserted into a vein. A vein in the arm is often used to administer the infusion. However, your doctor may administer the medication in another way.

Glucose 5% Viaflo should be administered slowly to avoid excessive urine production (osmotic diuresis).

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

Any unused solution should be discarded. DO NOT receive Glucose 5% Viaflo from a started bag.

If you receive more Glucose 5% Viaflo than you should

If you receive an excessive amount of Glucose 5% Viaflo or if it is administered too quickly, you may experience the following symptoms:

• fluid accumulation in tissues causing swelling (edema) or water intoxication, with a lower than normal sodium level in the blood (hyponatremia)
• increased urine production (osmotic diuresis)
• excessive blood concentration (hyperosmolarity)
• water loss from the body (dehydration)
• high blood glucose concentration (hyperglycemia)
• glucose presence in urine (hyperglycosuria)

If you observe these symptoms, inform your doctor immediately. The infusion will be suspended or reduced. Insulin will be administered, and you will receive treatment based on your symptoms.

If a medication was added to Glucose 5% Viaflo before the excessive administration, that medication may also cause symptoms. Please read the list of possible symptoms in the prospectus of the added medication.

If you interrupt the infusion ofGlucose 5% Viaflo

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, Viaflo Glucosa 5% may cause adverse effects, although not everyone will experience them.

The adverse effects may include:

• Hypersensitivity reactions, including a severe allergic reaction called anaphylaxis (potential manifestation in patients with corn allergy),
• Changes in blood chemistry concentrations (electrolyte disorders).
• High blood glucose concentration (hyperglycemia).
• Loss of body water (dehydration).
• Excess fluid in the blood vessels (hypervolemia),
• Excessive urine production (polyuria)
• 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").
• Reactions due to administration technique:
• Reaction at the injection site:

• Irritation and inflammation of the vein in which the solution is administered. This may produce redness, pain, or itching and swelling along the vein in which the solution is administered,
• Pain or local reaction (redness or swelling at the perfusion site),
• Fever, febrile response (pyrexia),
• Infection at the perfusion site,
• Leakage of the perfusion solution to the tissues surrounding the vein (extravasation), which can damage tissues and cause scarring,
• Formation of a blood clot (venous thrombosis),at the perfusion site, which causes pain, swelling, or redness in the area of the clot.

If a medication has been added to the perfusion solution, it may also cause 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.

Keepthis medicationout of the sight and reach of children

Bags of 50 and 100 ml:Do not store at a temperature above 30°C

Bags of 250, 500, and 1000 ml:No special storage conditions are required.

Viaflo Glucose 5% should not be administered after the expiration date appearing on the bag after CAD. The expiration date is the last day of the month indicated.

Do not administer Viaflo Glucose 5% if there are particles floating in the solution or if the container is damaged in any way.

Composition of Viaflo Glucose 5%

The active ingredient is sugar (glucose): 50 g per liter.

The other component is water for injectable preparations.

Appearance of the product and contents of the package

Viaflo Glucose 5% is a transparent, particle-free solution. It is presented in polyolefin/polyamide plastic bags (Viaflo). Each bag is packaged in a sealed plastic protective overbag.

The bag sizes are:

-50 ml

-100 ml

-250 ml

-500 ml

-1000 ml

The presentations are:

• 50 bags of 50 ml per box
• 75 bags of 50 ml per box
• 1 bag of 50 ml
• 50 bags of 100 ml per box
• 60 bags of 100 ml per box
• 1 bag of 100 ml
• 30 bags of 250 ml per box
• 1 bag of 250 ml
• 20 bags of 500 ml per box
• 1 bag of 500 ml
• 10 bags of 1,000 ml per box
• 12 bags of 1,000 ml per box
• 1 bag of 1000 ml

Only some sizes of containers may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder

Baxter S.L.

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

Responsible for manufacturing:

Bieffe Medital S.A.

Ctra de Biescas, Senegüé

22666 Sabiñanigo (Huesca)

Spain

Baxter SA

Boulevard René Branquart, 80

7860 Lessines

Belgium

Vantive Manufacturing Limited

Moneen Road

Castlebar

County Mayo

Ireland

Bieffe Medital S.p.A.

Via Nuova Provinciale

23034 Grosotto (SO)

Italy

Last review date of this leaflet: October 2023

The detailed and updated information on this medicine 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

Injectable solutions must be visually inspected before administration to detect particles and discoloration, whenever the solution and container allow it.

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 overbag until it is ready for use.

The inner bag maintains the sterility of the product.

Do not connect plastic containers in series. This type of use may cause gas embolism due to residual air carried 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 may cause gas embolism if the residual air in the container is not completely evacuated before administration.

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

The addition of electrolytes may be indicated based on the patient's clinical needs.

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

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

The addition of other medications or the use of an incorrect administration technique may cause the appearance of fever reactions due to the possible introduction of pyrogens. In case of an adverse reaction, the infusion should be interrupted immediately.

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

When using a perfusion 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 an anti-free flow device.

The intravenous administration equipment and the administration equipment must be frequently supervised.

Dispose of after single use.

Dispose of partially used containers.

Do not reconnect partially used bags.

Do not store solutions containing other medications.

Use an aseptic technique when adding medications to Viaflo Glucose 5%.

Mix the solution well when adding medications.

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 you detect leaks, 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 closure cap and turn it.

-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 medications may be incompatible (see section 5 "incompatibilities of added medications").

To add medication before administration.

a.Disinfect the injection port.

b.Using a syringe with a suitable gauge needle, pierce the injection port and inject.

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

Caution: Do not store bags with added medication.

To add medication during administration

a.Close the clamp on the equipment.

b.Disinfect the injection port.

c.Using a syringe with a suitable gauge needle, pierce the injection port and inject.

d.Remove the container from the intravenous support and/or turn it to put it in the vertical position.

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

f.Mix the solution and medication carefully.

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

4.Expiry in use (added medications)

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

From a microbiological point of view, the diluted product should be used immediately unless the addition of medications 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 medications

As with all parenteral solutions, the incompatibility of added medications with 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 medication with Viaflo Glucose 5% by examining any eventual change in color and/or precipitation, insoluble complexes, or appearance of crystals. The package insert 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% solution.

When adding a compatible solution with Viaflo Glucose 5%, the solution should be used immediately.

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