PATIENT INFORMATION LEAFLET

Viaflex Glucosa Baxter 20%Infusion Solution

Active Ingredient: Glucosa

Read this leaflet carefully before you receive this medicine, as 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, pharmacist or nurse.
• If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

1.What is Viaflex Glucosa 20% and what it is used for

2.What you need to know before you receive Viaflex Glucosa 20%

3.How to use Viaflex Glucosa 20%

4.Possible side effects

5.Storage of Viaflex Glucosa 20%

6.Contents of the pack and additional information

Viaflex Glucosa 20%is a sugar (glucose) solution in water. Glucose is one of the main sources of bodily energy. This perfusion solution provides 800 kilocalories per liter

Viaflex Glucosa 20% is used for:

• to provide a source of carbohydrates (sugar) alone or, if required, for parenteral nutrition. Parenteral nutrition is used to feed patients who cannot eat. It is administered through a slow infusion (injection) through a vein.
• to prevent or treat low blood sugar (hypoglycemia)
• to provide additional liquid to the patient when the body does not have enough water (dehydration) and needs extra carbohydrates (sugar).

as a supportive solution to administer other compatible medications.

You should not be given Viaflex Glucosa 20% if you have any of the following conditions:

• if you are allergic to the active ingredient or any of the other components of this medicine (listed in section 6).
• if you have diabetes that is not being properly treated, resulting in a blood glucose concentration higher than normal (uncontrolled diabetes),
• hypersomolar coma. This is a type of coma that can occur if you have diabetes and are not receiving adequate medication,
• fluid overload due to the addition of too much liquid (hemodilution),
• when there is too much fluid in the extracellular spaces of the body (extracellular hyperhydration),
• when there is an increased volume of blood in the blood vessels than there should be (hypervolemia),
• when the blood glucose concentration is higher than normal (hyperglycemia),
• when the blood lactate concentration is higher than normal (hyperlactatemia),
• severe renal insufficiency (when the kidneys do not function properly and dialysis is required)
• uncompensated heart failure. If heart failure has not been adequately treated and is causing symptoms such as:

• difficulty breathing,
• swelling of the ankles,
• if there is accumulation of fluid under the skin, affecting the entire body including the brain and lungs (generalized edema),
• liver disease resulting in fluid accumulation in the abdomen (ascitic cirrhosis),
• any other condition that affects the way your body controls blood sugar levels,
• intolerance (hypersensitivity) to glucose, which can occur in patients with maize allergy.

You should not be given solutions for infusion that contain glucose, including Viaflex Glucosa 20%, in the first 24 hours after a head injury.

If another medicine is added to your infusion solution, read the leaflet. This will ensure that you can take that medicine.

Warnings and precautions

Viaflex Glucosa 20% is a hypertonic (concentrated) solution. Your doctor will take this into account when calculating the amount of solution to be administered.

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

• Diabetes,
• renal insufficiency,
• an acute and potentially life-threatening disease (acute critical illness),
• inform your doctor if you have had a head injury in the last 24 hours,
• increased pressure inside the skull (intracranial hypertension),
• cerebral hemorrhage due to a blood clot in a blood vessel (cerebral stroke),
• heart disease (heart failure),
• lung disease (respiratory insufficiency),
• reduced urine production (oliguria or anuria),
• excess water in the body (water intoxication),
• low sodium levels in the blood (hyponatremia),
• maize allergy (Viaflex Glucosa 20% contains sugar derived from maize).
• If you have a condition that could cause high levels of vasopressin, a hormone that regulates fluid in your body. You may have too much vasopressin in your body because, for example:

• have had a sudden and severe illness,
• have pain,
• have had surgery,
• have infections, burns or cerebral injury
• have diseases related to your heart, liver, kidneys or central nervous system,
• are taking certain medicines (see Other medicines and Viaflex Glucosa 20%).

This may increase the risk of low sodium levels in the blood and can cause headache, nausea, convulsions, lethargy, coma, inflammation of the brain 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 cerebral injury.

When you receive this infusion,your doctor will monitor:

• the amount of electrolytes such as sodium and potassium in the blood (your 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).

Your doctor will adjust the amount of infusion solution to be administered according to the results of the tests. These tests will indicate to your doctor if you need additional potassium, a blood chemical. If necessary, it can be administered intravenously.

As Viaflex Glucosa 20% contains sugar (glucose), and can cause high blood sugar levels (hyperglycemia).If this occurs, your doctor may:

• adjust the infusion rate,
• administer insulin to reduce blood sugar levels,
• if necessary, administer additional potassium.

This is very important:

• if you have diabetes,
• if your kidneys do not function as well as normal,
• 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 disorders due to malnutrition or a diet that does not provide the appropriate proportion of necessary nutrients (malnutrition),
• if you have low levels of thiamine (vitamin B1). This can occur if you have chronic alcoholism.

This solution will not be administered using the same needle as a blood transfusion, as it may damage red blood cells or cause them to clump.

Your doctor will take into account if you are receiving parenteral nutrition (nutrition administered by infusion into a vein). During long-term treatment withViaflex Glucosa 20%, you may need additional nutrition.

To reduce the risk of low blood sugar levels, your doctor may adjust the rate at which you receive parenteral nutrition.

According to your specific situation, additional nutrients such as vitamins, minerals, proteins and fats may be added to parenteral nutrition to prevent problems and meet your daily needs.

To reduce the risk of high blood sugar levels, your doctor may need to adjust the components of parenteral nutrition as necessary.

Some patients' livers may work too hard while receiving parenteral nutrition. Your doctor may request laboratory tests to see how your liver is responding and/or change your parenteral nutrition accordingly.

While receiving parenteral nutrition, you may develop an infection. Keeping the nutrition bag and tubes clean can help reduce the risk of infection.

Since crystals similar to sugar may form in the nutrition bags, closely observing the liquid in the bag and tube to ensure that no sugar-like crystals are present is a good practice. Do not use the nutrition bag if you see sugar-like crystals.

If you have difficulty breathing, seek help immediately.

Children

Viaflex Glucosa 20%should be administered with special care in children.

Children should receive Viaflex Glucosa 20% 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 medicine, or if other medicines 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 control 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 sugar levels (hypoglycemia or hyperglycemia). Therefore, they require close monitoring during treatment with glucose solutions by intravenous infusion, ensuring adequate control of blood sugar levels to prevent 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), lung problems (bronchopulmonary dysplasia), prolonged hospital stay and death.

When administered to a newborn,,the solution bag may be connected to a pump infusion device, whichallows for the exact administration of the required amount over the defined time interval. Your doctor or nurse will be controlling the device to ensure safe administration.

Children (including newborns and older children) receivingViaflex Glucosa 20%are at higher risk of having low sodium levels in the blood (hypotonic hyponatremia) and a disorder affecting the brain due to low plasma sodium levels (hypotonic encephalopathy).

Other medicines and Viaflex Glucosa 20%

Inform your doctor or pharmacist if you are using, have used recentlyor may need to use any other medicine.

Viaflex Glucosa 20% and any other medicine taken at the same time may affect each other.

Do not use Viaflex Glucosa 20% with certain hormones (catecholamines) including adrenaline or steroids as they increase blood sugar levels.

Consult your doctor if you are takingcorticosteroids(inflammation-reducing medicines),corticotropins or diabetes medicines.

Some medicines 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 or opioids for severe pain relief
• medicines for pain and/or inflammation (also known as NSAIDs)
• medicines 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

Use of Viaflex Glucosa 20% with food and drinks

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

Pregnancy, breastfeedingand fertility

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor before using this medicine.

Pregnancy

Viaflex Glucosa 20%can be used during pregnancy. However, caution should be exercised when using a glucose solution during delivery.

Fertility

There are no sufficient data on the effect of glucose on fertility, although no effect is expected.

Breastfeeding

There are no sufficient data on the use of a glucose solution during breastfeeding, although no effect is expected.Viaflex Glucosa 20%can be used during breastfeeding.

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

• Consult your doctor.
• Read the leaflet of the medicine to be added.

Driving and using machines

Viaflex Glucosa 20% does not affect your ability to drive or use machines.

Viaflex Glucosa 20% 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.

Noshould receive Viaflex Glucosa 20%if there are particles floating in the solution or if the container is damaged in any way.

Generally, Viaflex Glucosa 20% is administered through a plastic tube connected to a large vein in your chest. However, your doctor may administer the medication in another way.

Viaflex Glucosa 20% should be administered slowly to prevent 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 the hormone vasopressin, or those taking other medications that increase the effect of vasopressin).

Any unused solution should be discarded. Do not receiveViaflex Glucosa 20%from a bagthat has been started.

If you receive more Viaflex Glucosa 20% than you should

If you receive an excessive amount of Viaflex Glucosa 20% (overdose) or if it is administered too quickly or too frequently, the following symptoms may occur:

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

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

If a medication has been added to Viaflex Glucosa 20%before the excessive administration, that medication may also cause symptoms. Please read the list of possible symptoms in the prospectus of the added medication.

In case of overdose or accidental ingestion, consult the Toxicological Information Service. Phone 915.620.420

Stopping the infusion ofViaflex Glucosa 20%

Your doctor will decide when to stop this infusion.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

If you consider that any of the side effects you are experiencing are severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.They may be signs of a severe or even fatal allergic reaction (hypersensitivity):

The side effects may include:

• Allergic reactions, including a severe allergic reaction called anaphylaxis (potential manifestation in patients with corn allergy),

• Difficulty breathing,
• Swelling of the face and lips or inflammation of the throat,
• Fever,
• Hives (urticaria),
• Skin rash,
• Redness of the skin (cutaneous erythema),
• Chills,

• Changes in the levels of electrolytes in the blood (electrolyte imbalances), including
• Low sodium levels in the blood that may occur 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 the "Warnings and precautions" section).
• Low potassium levels in the blood (hypokalemia),
• Low magnesium levels in the blood (hypomagnesemia),
• Low phosphate levels in the blood (hypophosphatemia),
• High blood sugar levels (hyperglycemia),

• Excess fluid in the blood vessels (hemodilution and hypervolemia),
• Sugar in the urine (glucosuria),
• Reactions related to the administration route:
• Fever, febrile reaction (pyrexia),
• Sweating,
• Infection at the injection site,
• Leakage of the perfusion solution to the surrounding tissues (extravasation). This can damage tissues and cause scarring,
• Formation of a blood clot (thrombosis) at the perfusion site, which causes pain, inflammation, or redness in the clot area,
• Irritation and inflammation of the vein through which the perfusion is performed (phlebitis). It can cause redness, pain, or itching or swelling in the perfusion vein,
• Local reaction or pain (redness or swelling at the perfusion site),

If any side effect occurs, the perfusion should be stopped.

You will be prescribed treatment according to your symptoms.

If a medicine has been added to the perfusion solution, it may also cause side effects. These will depend on the added medicine.You should read the leaflet for that medicine to get a list of possible symptoms.

Reporting of side effects

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

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

Do not store at a temperature above 25°C.

Do not usethis medication after the expiration date that appears on the bagand on the box aftercad. The expiration date is the last day of the month indicated.

Do not administer Viaflex Glucose 20% if there are floating particles in the solution or if the unit is damaged in any way.

Composition of Viaflex Glucose 20%

The active ingredient is sugar (glucose): 20 g per liter.

The other component is water for injectable preparations.

Appearance of the product and contents of the package

Viaflex Glucose 20% is a transparent solution, without visible particles. It is supplied in PVC plastic bags (Viaflex). Each bag is wrapped in a protective plastic overbag.

The bag sizes are:

• 250 ml
• 500 ml
• 1000 ml

The bags are supplied in cardboard boxes. Each cardboard box contains one of the following quantities:

• 20 bags of 250 ml
• 20 bags of 500 ml
• 10 bags of 1000 ml

Only some sizes of packaging may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Baxter, S.L.

Pouet de Camilo 2, 46394 Ribarroja del Turia

Responsible for manufacturing:

Baxter S.A.

Boulevard René Branquart, 80 7860 Lessines

Belgium

Date of the last review of this leaflet in February 2020.

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/

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This information is intended solely for healthcare professionals:

Special precautions for disposal and other manipulations:

The solution must be administered with a sterile equipmentthat includes a filterusing an aseptic technique. The equipment must be primed with the solution in order to prevent air from entering the system.

Use only if the solution is transparent, without visible particles, and if the container is not damaged. Administer immediately after the insertion of the infusion equipment.

Do not remove the unit from the 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 use may produce gas embolism due to residual air carried from the primary container before the administration of the liquid contained in the secondary container is completed.

The disposal of unused medication and all materials that have been in contact with it will be carried out in accordance with local regulations

Dispose of after a single use

Dispose of any remaining portion.

Do not reconnect partially used bags.

1-To open

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

b-Check for small leaks by compressing the inner bag tightly. 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 in the lower part of the container.

-hold with one hand the small latch on the neck of the outlet tube.

-hold with the other hand the large latch on 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 injection of added medication

Warning: Added medications may be incompatible.To add medication before administration

aDisinfect the injection site

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

cMix 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

aClose the clamp of the equipment

bDisinfect the injection site

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

dRemove the container from the IV support and/or turn it to place it in the vertical position.

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

fMix the solution and medication carefully

gPlace the container back in the use position, reopen the clamp, and continue administration

4.Expiry in use (additives)

The chemical and physical stability of the added medications to the pH of Viaflex Glucose 20% in the Viaflex container must be determined before use.

From a microbiological point of view, the diluted product must be used immediately unless reconstitution has been carried out in controlled and validated aseptic conditions. If not used immediately, the conditions and storage times used are the responsibility of the user.

5.Incompatibilities of added medications

The glucose solution should not be administered simultaneously with, before or after blood administration through the same infusion equipment, as it may produce hemolysis and clot formation.

The incompatibility of the medications to be added with Viaflex Glucose 20% must be evaluated before adding them.

In the absence of incompatibility studies, this product should not be mixed with others.

Consult the prospectus of the medication to be added.

Before adding a medication, verify that it is soluble and stable in water within the pH range of Viaflex Glucose 20% (pH of 3.2 to 6.5).

When adding compatible medication to Viaflex Glucose 20%, the solution must be administered immediately.

Do not use additional medications that are not compatible.