ViaFLEX Glucosa Baxter 70% solution for infusion

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Viaflex Glucosa Baxter 70% solution for infusion

Active substance: Glucose

Read the entire leaflet carefully before this medicine is administered to you, 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, pharmacist, or nurse.
• If you experience any adverse reactions, consult your doctor, pharmacist, or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents:

1. What Viaflex Glucosa 70% is and what it is used for
2. What you need to know before being administered Viaflex Glucosa 70%
3. How to use Viaflex Glucosa 70%
4. Possible adverse effects
5. How to store Viaflex Glucosa 70%
6. Contents of the pack and other information

1. What Viaflex Glucose 70% is and what it is used for

Viaflex Glucose 70% is a sugar (glucose) solution in water. Glucose is one of the main sources of body energy. This infusion solution provides 2800 kilocalories per litre.

Viaflex Glucose 70% is used for:

• providing 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 by infusion (slow injection) through a vein.
• preventing or treating low blood sugar levels (hypoglycaemia)
• providing additional fluid to the patient when the body does not have enough water (dehydration) and requires extra carbohydrates (sugar).
• as a diluent solution for the administration of compatible medicinal products.

2. What you need to know before you are given Viaflex Glucose 70%

Do not be given Viaflex Glucose 70% if you have any of the following conditions:

• if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6),

• if you have diabetes that is not properly treated, resulting in blood glucose levels higher than normal (decompensated diabetes),

• loss of consciousness (hyperosmolar coma). This is a type of coma that may occur if you have diabetes and are not receiving adequate treatment,

• thinning of the blood due to excessive fluid intake (hemodilution),

• excess fluid in the body's extracellular spaces (extracellular hyperhydration),

• abnormally high blood volume in blood vessels (hypervolemia),

• elevated blood glucose levels (hyperglycemia),

• elevated blood lactate levels (hyperlactatemia),

• severe renal failure (when kidneys do not function properly and dialysis is required),

• uncompensated heart failure. If heart failure has not been adequately treated and causes symptoms such as:

• difficulty breathing,

• swollen ankles,

• fluid accumulation under the skin affecting the entire body including the brain and lungs (generalized edema),

• liver disease causing fluid buildup in the abdomen (ascitic cirrhosis),

• any other condition affecting how your body regulates blood sugar levels,

• intolerance (hypersensitivity) to glucose, which may occur in patients allergic to corn.

Do not be given glucose-containing infusion solutions, including Viaflex Glucose 70%, within the first 24 hours after sustaining a head injury.

If another medicine is added to your infusion solution, read its package leaflet to ensure it can be safely used together.

Warnings and precautions

Viaflex Glucose 70% is a hypertonic (concentrated) solution. Your doctor will take this into account when calculating the amount of solution to administer.

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

• Diabetes,

• renal failure,

• an acute, potentially life-threatening illness (acute critical illness),

• tell your doctor if you have had a head injury within the past 24 hours,

• increased pressure inside the skull (intracranial hypertension),

• stroke caused by a blood clot in a blood vessel (cerebral infarction),

• heart disease (cardiac failure),

• lung disease (respiratory failure),

• reduced urine production (oliguria or anuria),

• excess water in the body (water intoxication),

• low sodium levels in the blood (hyponatremia),

• allergy to corn (Viaflex Glucose 70% contains glucose derived from corn).

• If you have a condition that could lead to elevated levels of vasopressin, a hormone that regulates your body's fluid balance. You may have excess vasopressin due to, for example:

• a sudden and severe illness,

• pain,

• recent surgery,

• infections, burns, or brain injury,

• heart, liver, kidney, or central nervous system disorders,

• taking certain medications (see Other medicines and Viaflex Glucose 70%).

This may increase the risk of low sodium levels in the blood and may cause headache, nausea, seizures, lethargy, coma, brain swelling, and death. Brain swelling increases the risk of death and brain damage. Individuals at higher risk of brain swelling include:

• children,
• women (particularly those of childbearing age),
• individuals with conditions affecting cerebral fluid levels, such as meningitis, intracranial bleeding, or brain injury.

While receiving this infusion, your doctor will monitor:

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

Your doctor will adjust the infusion rate based on laboratory test results. These tests will indicate whether additional potassium, a blood chemical, is needed. If required, potassium may be administered intravenously.

Because Viaflex Glucose 70% contains glucose, it may cause high blood sugar levels (hyperglycemia). If this occurs, your doctor may:

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

This is particularly important:

• if you have diabetes,
• if your kidneys are not functioning normally,
• if you recently had a stroke (acute ischemic stroke). High blood sugar levels may worsen stroke effects and impair recovery,
• if you have metabolic disorders due to starvation or an unbalanced diet lacking proper nutrients (malnutrition),
• if you have low thiamine levels (vitamin B1). This may occur in individuals with chronic alcoholism.

This solution must not be administered through the same needle used for blood transfusion, as it may damage red blood cells or cause them to clump.

Your doctor will consider whether you are receiving parenteral nutrition (nutrition delivered via intravenous infusion). During long-term treatment with Viaflex Glucose 70%, additional nutritional support may be required.

To reduce the risk of low blood sugar, your doctor may adjust the rate of parenteral nutrition.

Depending on your specific condition, nutrients such as vitamins, minerals, proteins, and fats may be added to parenteral nutrition to prevent complications and meet daily requirements.

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

The liver in some patients may become overworked during parenteral nutrition. Your doctor may order laboratory tests to monitor liver function and may modify your parenteral nutrition accordingly.

While receiving parenteral nutrition, you may be at risk of infection. Keeping the nutrition bag and tubing clean may help reduce infection risk.

Since sugar-like crystals may form in nutrition bags, it is good practice to carefully inspect the liquid in the bag and tubing to ensure no sugar-like crystals are present. Do not use the nutrition bag if crystals are visible.

If you experience breathing difficulties, seek immediate medical help.

Children

Viaflex Glucose 70% must be administered with special care in children.

Children should receive Viaflex Glucose 70% only under the supervision of a doctor or nurse. The dose must be determined by a physician experienced in pediatric care and will depend on the child’s age, weight, and clinical condition. The dose may also be affected if the solution is used to administer or dilute another medicine or if other medicines are given simultaneously.

When administering the infusion to children, your doctor will take blood and urine samples to monitor electrolyte levels such as potassium (plasma electrolytes).

Newborns—especially those born prematurely and with low birth weight—are at increased risk of developing low or high blood glucose levels (hypo- or hyperglycemia). Therefore, they require close monitoring during intravenous glucose therapy to ensure appropriate blood glucose control and prevent potential long-term adverse effects. Low blood sugar in newborns may cause prolonged seizures, coma, and brain damage. High blood sugar may lead to brain hemorrhage, bacterial or fungal infections, eye damage (retinopathy of prematurity), intestinal infection (necrotizing enterocolitis), lung problems (bronchopulmonary dysplasia), prolonged hospitalization, and death.

When administered to a newborn, the solution bag may be connected to an infusion pump device, which ensures precise delivery of the required amount over a defined time interval. Your doctor or nurse will monitor the device to ensure safe administration.

Children (including neonates and older children) receiving Viaflex Glucose 70% are at increased risk of developing low blood sodium levels (hypotonic hyponatremia) and a brain disorder caused by low plasma sodium levels (hyponatremic encephalopathy).

Other medicines and Viaflex Glucose 70%

Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.

Viaflex Glucose 70% and any other medicines taken at the same time may affect each other.

Do not use Viaflex Glucose 70% with certain hormones (catecholamines), including adrenaline, or steroids, as they increase blood sugar levels.

Consult your doctor if you are taking corticosteroids (medicines that reduce inflammation), corticotrophins, or diabetes medications.

Some medicines affect the hormone vasopressin. These may include:

• antidiabetic drugs (chlorpropamide),
• cholesterol-lowering drugs (clofibrate),
• certain cancer treatments (vincristine, ifosfamide, cyclophosphamide),
• selective serotonin reuptake inhibitors (used to treat depression),
• antipsychotics or opioids for severe pain relief,
• pain and/or anti-inflammatory medicines (also known as NSAIDs),
• medicines that mimic or enhance 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 drugs (carbamazepine and oxcarbazepine),
• diuretics.

Use of Viaflex Glucose 70% with food and drink

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

Pregnancy, breastfeeding, and fertility

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

Pregnancy

Viaflex Glucose 70% may be used during pregnancy. However, caution is advised when using glucose solutions during labor.

Fertility

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

Breastfeeding

There are insufficient data on the use of glucose solutions during breastfeeding, although no adverse effects are expected. Viaflex Glucose 70% may be used during breastfeeding.

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

• Consult your doctor.
• Read the package leaflet of the added medicine.

Driving and using machines

Viaflex Glucose 70% does not affect your ability to drive or operate machinery.

3. How Viaflex Glucose 70% will be administered to you

Viaflex Glucose 70% will be administered to you by a doctor or nurse. Your doctor will decide how much you need and when it should be given. This will depend on your age, weight, physical condition, and the reason for treatment. The amount you receive may also be influenced by any other treatments you are receiving.

Do not receive Viaflex Glucose 70% if there are particles floating in the solution or if the container is damaged in any way.

Usually, Viaflex Glucose 70% is administered through a plastic tube inserted into a large vein in your chest. However, your doctor may choose to administer the medicine in another way.

Viaflex Glucose 70% must 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 levels of electrolytes in your body (particularly sodium, in patients with high levels of vasopressin hormone, or those taking other medicines that increase the effect of vasopressin).

Any unused portion of the solution must be discarded. DO NOT receive Viaflex Glucose 70% from a partially used bag.

If you receive more Viaflex Glucose 70% than you should

If you receive too much Viaflex Glucose 70% (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 abnormally low levels of sodium in the blood (hyponatremia),
• higher than normal blood sugar levels (hyperglycemia),
• excessive concentration of the blood (hyperosmolarity),
• presence of glucose in the urine (glucosuria),
• increased urine output (osmotic diuresis),
• loss of water from the body (dehydration).

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

If any medicine has been added to Viaflex Glucose 70% before the overdose, that medicine may also cause symptoms. You should read the list of possible symptoms in the leaflet of the added medicine.

In case of overdose or accidental ingestion, contact the Toxicology Information Service. Telephone: 915.620.420

Stopping the infusion of Viaflex Glucose 70%

Your doctor will decide when this infusion should be stopped.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effect not listed in this leaflet, inform your doctor or pharmacist. These may be signs of a very serious or even life-threatening allergic reaction (hypersensitivity):

Adverse effects may include:

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

• difficulty breathing,

• skin swelling of the face and lips or swelling of the throat,

• fever,

• hives (urticaria),

• skin rash,

• redness of the skin (cutaneous erythema),

• chills,

• changes in blood electrolyte levels (electrolyte disturbances), including

• low levels of sodium in the blood that may occur during hospitalization (nosocomial hyponatremia) and associated neurological disorder (acute hyponatremic encephalopathy). Hyponatremia can lead to irreversible brain damage and death due to cerebral edema/inflammation (see also section "Warnings and precautions").

• low blood potassium levels (hypokalemia),

• low blood magnesium levels (hypomagnesemia),

• low blood phosphate levels (hypophosphatemia),

• high blood sugar levels (hyperglycemia),

• excess fluid in the blood vessels (hemodilution and hypervolemia),

• sugar in the urine (glucosuria),

• administration route-related reactions:

• fever, febrile reaction (pyrexia),

• sweating,

• infection at the injection site,

• leakage of the infusion solution into the surrounding tissues (extravasation). This may damage tissues and lead to scarring,

• formation of a blood clot (venous thrombosis) at the infusion site, causing pain, swelling, or redness in the area of the clot,

• irritation and inflammation of the vein used for infusion (phlebitis). This may cause redness, pain, burning, or swelling along the infused vein,

• local reaction or pain (redness or swelling at the infusion site),

If any adverse effect occurs, the infusion should be stopped immediately.

You will be prescribed treatment according to your symptoms.

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or nurse, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Viaflex Glucose 70%

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

Do not store above 25°C.

Do not use this medicine after the expiry date stated on the bag and the carton after exp. The expiry date refers to the last day of the month indicated.

Viaflex Glucose 70% must not be administered if there are any floating particles in the solution or if the unit is in any way damaged.

6. Contents of the container and additional information

Composition of Viaflex Glucose 70%

The active substance is sugar (glucose): 70 g per litre.

The other component is water for injections.

Appearance of the product and contents of the container

Viaflex Glucose 70% is a clear solution, free from visible particles. It is supplied in plastic PVC bags (Viaflex). Each bag is enclosed in a sealed protective overpouch made of plastic.

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 certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer Responsible

Marketing Authorization Holder:

Baxter, S.L.
Pouet de Camilo 2, 46394 Ribarroja del Turia

Manufacturer Responsible:

Baxter S.A.
Boulevard René Branquart, 80 7860 Lessines
Belgium

Date of the most recent review of this summary: February 2020.

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

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This information is intended for healthcare professionals only:

Special precautions for disposal and other handling:

The solution must be administered using a sterile administration set including a filter, employing an aseptic technique. The administration set should be primed with the solution to prevent air from entering the system.

Use only if the solution is clear, free from visible particles, and the container is undamaged. Administer immediately after connecting the infusion set.

Do not remove the unit from the overpouch until ready for use. The inner bag maintains the sterility of the product.

Do not connect plastic containers in series. This type of use may lead to gas embolism due to residual air being drawn from the primary container before the liquid in the secondary container is fully administered.

Disposal of unused medication and of all materials that have come into contact with it must comply with local regulations.

Discard after single use.

Discard any remaining portion.

Do not reconnect partially used bags.

1- To open

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

b- Check for small leaks by firmly squeezing the inner bag. If leaks are detected, discard the solution, as it may no longer be sterile.

c- Check the clarity of the solution and absence of foreign particles. Discard the solution if it is not clear or contains foreign particles.

2- Preparation for administration

Use sterile materials for preparation and administration.

a- Hang the container by the hanger hole.

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

• Hold the small fin on the neck of the outlet tube with one hand.
• Hold the large fin on the closure cap with the other hand and twist.
• The cap will detach.

c- Use an aseptic technique for preparing the infusion.

d- Connect the administration set. Refer to the instructions accompanying the administration set for 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:

a- Disinfect the injection site.

b- Using a syringe with a 19G to 22G needle, puncture the resealable injection site and inject the medication.

c- Carefully mix the medication and solution. For high-density medications such as potassium chloride, gently invert the bag while in vertical position and mix.

Caution: Do not store bags with added medication.

To add medication during administration:

a- Close the clamp on the administration set.

b- Disinfect the injection site.

c- Using a syringe with a 19G to 22G needle, puncture the resealable injection site and inject the medication.

d- Remove the container from the IV stand and/or turn it to place it in vertical position.

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

f- Carefully mix the solution and medication.

g- Return the container to its upright position, reopen the clamp, and resume administration.

1. In-use shelf life (with additives)

The chemical and physical stability of medications added to Viaflex Glucose 70% at its pH must be determined prior to use.

From a microbiological standpoint, the diluted product should be used immediately unless reconstitution has been performed under controlled, validated aseptic conditions. If not used immediately, the storage conditions and duration are the responsibility of the user.

1. Incompatibilities of added medications

Glucose solution must not be administered simultaneously with, before, or after blood transfusion through the same infusion set, as this may cause hemolysis and clot formation.

Incompatibility of medications intended for addition to Viaflex Glucose 70% must be evaluated before adding them.

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

The summary of product characteristics of the medication to be added should be consulted.

Before adding a medication, verify that it is soluble and stable in water within the pH range of Viaflex Glucose 70% (pH 3.2 to 6.5).

When compatible medication is added to Viaflex Glucose 70%, the solution must be administered immediately.

Additional medications that are not compatible must not be used.