VIAFLEX GLUCOSA BAXTER 70 % PERFUSION SOLUTION

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Viaflex Glucose Baxter 70%solution for infusion

Active ingredient: Glucose

Read all of this leaflet carefully before you are given 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, pharmacist or nurse.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

1. What Viaflex Glucose 70% is and what it is used for
2. What you need to know before you are given Viaflex Glucose 70%
3. How Viaflex Glucose 70% is given
4. Possible side effects
5. Storage of Viaflex Glucose 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 solution of sugar (glucose) in water. Glucose is one of the main sources of energy for the body. This solution for infusion provides 2800 kilocalories per liter.

Viaflex Glucose 70% is used 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 given by infusion (slow injection) through a vein.
• prevent or treat low blood sugar levels (hypoglycaemia)
• provide the patient with extra fluid when the body does not have enough water (dehydration) and needs extra carbohydrates (sugar).
• as a support solution for giving other compatible medicines.

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

Viaflex Glucose 70% must not be given to you if you:

• are allergic to the active ingredient or any of the other ingredients of this medicine (listed in section 6).
• have untreated diabetes, so that the blood glucose concentration is higher than normal (uncontrolled diabetes),
• have a loss of consciousness (hyperosmolar coma). This is a type of coma that can occur if you have diabetes and do not receive adequate medication,
• have a condition where there is too much fluid in the blood (haemodilution),
• have too much fluid in the body tissues (extracellular hyperhydration),
• have too much blood in the blood vessels (hypervolaemia),
• have high blood glucose levels (hyperglycaemia),
• have high blood lactate levels (hyperlactataemia),
• have severe kidney failure (when the kidneys do not work well and dialysis is needed)
• have untreated heart failure. If heart failure is not treated adequately and causes symptoms such as:

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

Viaflex Glucose 70% must not be given to you in the first 24 hours after a head injury.

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

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 give you.

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

• Diabetes,
• kidney failure,
• a life-threatening condition (critical illness),
• tell your doctor if you have had a head injury in the last 24 hours,
• increased pressure inside the skull (intracranial hypertension),
• stroke due to a blood clot in a blood vessel (cerebral stroke),
• heart disease (heart failure),
• lung disease (respiratory failure),
• reduced urine production (oliguria or anuria),
• excess water in the body (water intoxication),
• low sodium levels in the blood (hyponatraemia),
• allergy to corn (Viaflex Glucose 70% contains corn-derived sugar).
• 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:

• you have had a sudden and severe illness,
• you are in 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 medicines (see Other medicines and Viaflex Glucose 70%).

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

• children
• women (especially 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 head injury.

When you receive this infusion, your doctor will monitor:

• the amount of electrolytes such as sodium and potassium in your 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 give you based on the results of these tests. These tests will tell your doctor if you need extra potassium, a chemical in the blood. If necessary, this can be given through a vein.

Since Viaflex Glucose 70% contains sugar (glucose), it can cause high blood sugar levels (hyperglycaemia). If this happens, your doctor may:

• adjust the infusion rate,
• give you insulin to lower your blood sugar levels,
• if necessary, give you extra potassium.

This is especially important:

• if you have diabetes,
• if your kidneys do not work 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 starvation or a diet that does not provide the right balance of nutrients (malnutrition),
• if you have low levels of thiamine (vitamin B1). This can happen if you have chronic alcoholism.

This solution must not be given using the same needle as a blood transfusion, as it could damage the red blood cells or cause them to clump together.

Your doctor will take into account if you are receiving parenteral nutrition (nutrition given through a vein). During long-term treatment with Viaflex Glucose 70%, you may need to receive extra nutrition.

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

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

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

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 may change your parenteral nutrition based on how you respond.

While receiving parenteral nutrition, you may be at risk of infection. Keeping the nutrition bag and tubes that go into your body clean can help reduce the risk of infection.

As sugar-like crystals can form in the nutrition bags, it is a good idea to closely inspect the liquid in the bag and the tube to make sure there are no sugar-like crystals. Do not use the nutrition bag if you see sugar-like crystals.

If you have difficulty breathing, seek help immediately.

Children

Viaflex Glucose 70% should be given to children with special care.

Children should receive Viaflex Glucose 70% from a doctor or nurse. The amount given will be determined by a doctor specializing in the treatment of children and will depend on the child's age, weight and condition. If it is used to give or dilute another medicine, or if other medicines are given at the same time, the dose may also be affected.

When the infusion is given 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 sugar levels (hypo- or hyperglycaemia). They need close monitoring during treatment with glucose solutions given through a vein to ensure adequate control of blood sugar levels and prevent possible long-term side effects. Low blood sugar levels in newborns can cause prolonged seizures, coma and brain damage. High blood sugar levels can cause brain bleeding, bacterial or fungal infections, eye damage (retinopathy of prematurity), intestinal infections (necrotizing enterocolitis), lung problems (bronchopulmonary dysplasia), prolonged hospital stay and death.

When given to a newborn, the solution bag may be connected to an infusion pump device, which allows for the exact administration of the required amount over a defined period of time. Your doctor or nurse will monitor the device to ensure safe administration.

Children (including newborns and older children) who receive Viaflex Glucose 70% are at higher risk of having low sodium levels in the blood (hypotonic hyponatraemia) and a condition that affects the brain due to low sodium levels in the blood (hyponatraemic encephalopathy).

Other medicines and Viaflex Glucose 70%

Tell your doctor or pharmacist if you are using, have recently used or might 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.

Ask your doctor if you are taking corticosteroids (medicines that reduce inflammation), corticotropin or diabetes medicines.

Some medicines affect the hormone vasopressin. These may include:

• anti-diabetic medication (chlorpropamide)
• cholesterol medication (clofibrate)
• certain cancer medicines (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 enhance the effects of vasopressin, such as desmopressin (used to treat increased thirst and urination), terlipressin (used to treat bleeding from the oesophagus) and oxytocin (used to induce labour)
• antiepileptic medicines (carbamazepine and oxcarbazepine)
• diuretics

Using Viaflex Glucose 70% with food and drink

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

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Pregnancy

Viaflex Glucose 70% can be used during pregnancy. However, caution should be exercised when using a glucose solution during labour.

Fertility

There is not enough data on the effect of glucose on fertility, although no effect is expected.

Breast-feeding

There is not enough data on the use of a glucose solution during breast-feeding, although no effect is expected. Viaflex Glucose 70% can be used during breast-feeding.

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

• Ask your doctor.
• Read the package leaflet for the medicine to be added.

Driving and using machines

Viaflex Glucose 70% does not affect your ability to drive or use machines.

3. How you will be given Viaflex Glucose 70%

Viaflex Glucose 70% will be given 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 the treatment. The amount you receive may also be affected by other treatments you are receiving.

You must not be given Viaflex Glucose 70% if:

there are particles floating in the solution or if the container is damaged in any way.

Viaflex Glucose 70% is usually given through a plastic tube connected to a large vein in your chest. However, your doctor may give you the medicine in a different way.

Viaflex Glucose 70% must be given 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 who are taking other medicines that increase the effect of vasopressin).

Any unused solution should be discarded. You must not receive Viaflex Glucose 70% from a started bag.

If you receive more Viaflex Glucose 70% than you should

If you receive too much Viaflex Glucose 70% (overdose) or if it is given too quickly or too frequently, the following symptoms may occur:

• fluid accumulation in the tissues causing swelling (edema) or water intoxication, with low sodium levels in the blood (hyponatraemia),
• high blood sugar levels (hyperglycaemia),
• excessive blood concentration (hyperosmolarity),
• glucose in the urine (hyperglycosuria),
• increased urine production (osmotic diuresis),
• water loss from the body (dehydration),

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

If another 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 package leaflet for 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 you should stop this infusion.

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

4. Possible Adverse Effects

Like all medicines, this medicine may cause adverse effects, although not all people suffer from them.

If you consider that any of the adverse effects you suffer from is serious or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist. They may be signs of a very serious or even life-threatening allergic reaction (hypersensitivity):

Adverse effects may include:

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

• difficulty breathing,
• inflammation of the skin of the face and lips or inflammation of the throat,
• fever,
• hives (urticaria),
• skin rash,
• redness of the skin (cutaneous erythema),
• chills,

• changes in blood electrolyte levels (electrolyte disturbances), including
• 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 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 infusion solution to the surrounding tissues (extravasation). This can damage tissues and cause scarring,
• formation of a clot (thrombosis) at the infusion site, which causes pain, inflammation, or redness in the area of the clot,
• irritation and inflammation of the vein through which the infusion is performed (phlebitis). It can cause redness, pain, or itching or swelling in the infusion vein,
• local reaction or pain (redness or swelling at the infusion site),

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

You will be prescribed a treatment according to the symptoms.

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

Adverse Effect Notification

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 it directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Viaflex Glucose 70%

Keep this medicine out of sight and reach of children.

Do not store at a temperature above 25°C.

Do not use this medicine after the expiration date that appears on the bag and on the box after the expiration date. The expiration date is the last day of the month indicated.

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

6. Package Contents and Additional Information

Viaflex Glucose 70% Composition

The active ingredient is sugar (glucose): 70 g per liter.

The other component is water for injectable preparations.

Appearance of the Product and Package Contents

Viaflex Glucose 70% is a clear solution, without visible particles. It is supplied in PVC plastic bags (Viaflex). Each bag is wrapped with a protective overbag sealed with plastic.

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 package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Baxter, S.L.

Pouet de Camilo 2, 46394 Ribarroja del Turia

Manufacturer:

Baxter S.A.

Boulevard René Branquart, 80 7860 Lessines

Belgium

Date of the Last Revision of this Prospectus in February 2020.

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

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This information is intended only for healthcare professionals:

Special Precautions for Disposal and Other Handling:

The solution should be administered with sterile equipment that includes a filter using an aseptic technique. The equipment should be primed with the solution to prevent air from entering the system.

Use only if the solution is clear, without visible particles, and if the packaging is not damaged. Administer immediately after inserting the infusion equipment.

Do not remove the unit from the 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 use can produce gas embolisms due to residual air dragged from the primary container before the liquid contained in the secondary container is completely administered.

Disposal of unused medicine and all materials that have come into contact with it will be carried out in accordance with local regulations

Discard after a single use

Discard 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 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 handle

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

• hold the small wing of the outlet tube 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 equipment. Consult the instructions accompanying the equipment for connection, priming, and administration of the solution.

3- Techniques for Injecting Added Medication

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

a- Disinfect the injection point

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

c- Mix the medication and solution carefully. 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 equipment clamp

b- Disinfect the injection point

c- Using a syringe with a 19G to 22G needle, puncture the resealable injection point 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- Mix the solution and medication carefully

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

1. In-use expiration date (additives)

The chemical and physical stability of medications added to the pH of Viaflex Glucose 70% in the Viaflex container must be determined before use.

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

1. Incompatibilities of added medications

The glucose solution should not be administered simultaneously with, before, or after a blood transfusion through the same infusion equipment, as it could cause hemolysis and clot formation.

The incompatibility of the medications to be added with Viaflex Glucose 70% should be evaluated before adding them.

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

The prospectus 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 should be administered immediately.

Medications that are not compatible should not be used.