Viaflo glucose 5% solution for intravenous infusion

Patient Information Leaflet

Introduction

Patient Information Leaflet

Viaflo Glucose 5% solution for infusion

Active substance: glucose

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 questions, ask your doctor or nurse.
• If you experience any side effects, talk to your doctor or nurse, even if it is a side effect not listed in this leaflet. See section 4.

Contents of this leaflet:

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

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

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

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

Viaflo Glucose 5% is used:

• to provide fluids and carbohydrates (sugar).

• to dilute or administer other medicines that can be given by infusion.

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

DO NOT be given Viaflo Glucose 5% if you have any of the following clinical conditions

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

• if you have glucose intolerance, for example: when the body's metabolism is not functioning properly, such as in severe illnesses (metabolic stress).

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

• blood glucose levels higher than normal (hyperglycemia)

• blood lactate levels higher than normal (hyperlactatemia).

• intolerance (hypersensitivity) to glucose. This may occur in patients with corn allergy.

If another medicine is added to your infusion solution, you must always read the leaflet of that medicine. This way, you will know whether that medicine 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 are not functioning as well as they should.

• If you have sepsis, trauma, or shock.

• Low levels of electrolytes (sodium, potassium, phosphorus, magnesium) in the blood.

• Head injury within the last 24 hours.

• If you have recently had a stroke (acute ischemic stroke). High blood sugar levels may worsen the effects of stroke and affect recovery.

• If you have metabolic disturbances due to starvation or a diet lacking the proper proportion of essential nutrients (malnutrition).

• If you have low levels of thiamine (vitamin B1) in your body. This may occur if you suffer from chronic alcoholism.

• Corn allergy (Viaflo Glucose 5% contains glucose derived from corn).

• If you have a condition that could cause elevated levels of vasopressin, a hormone that regulates fluid in your body. You may have too much vasopressin in your body, for example, because:

• you have had an acute and severe illness,

• you have pain,

• you have undergone surgery,

• you have infections, burns, or brain injury,

• you have diseases affecting your heart, liver, kidneys, or central nervous system,

• you are taking certain medications (see Other medicines and Viaflo Glucose 5%)

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. People at higher risk of brain swelling are:

• children
• women (particularly those of childbearing age)
• individuals who have problems with their cerebral fluid levels, for example, due to meningitis, bleeding in the skull, or brain injury.

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

• the amount of electrolytes such as 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).

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

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

Viaflo Glucose 5% must not be administered through the same needle used for blood transfusion. This could damage red blood cells or cause them to clump together.

Your doctor will consider whether you are receiving parenteral nutrition (nutrition delivered by intravenous infusion).

You may require supplemental nutrition during long-term treatment with Viaflo Glucose 5%.

Children

Viaflo Glucose 5% must be administered with special care in children.

Children should receive Viaflo Glucose 5% from a doctor or nurse. The amount administered must be determined by a physician specialized in pediatric care and will depend on the child's age, weight, and condition. If used to administer or dilute another medicine, or if other medicines are administered simultaneously, the dose may also be affected.

When administering the infusion to children, your doctor will take blood and urine samples to monitor the levels of electrolytes such as potassium in the blood (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) and therefore require careful monitoring during treatment with intravenous glucose solutions to ensure adequate control of blood sugar levels, in order to avoid possible long-term adverse effects. Low blood sugar levels in newborns may cause seizures, prolonged coma, and brain damage. High blood sugar levels may cause brain hemorrhages, bacterial or fungal infections, eye damage (retinopathy of prematurity), intestinal tract infections (necrotizing enterocolitis), lung problems (bronchopulmonary dysplasia), prolonged hospital stay, and death.

When administered to newborns, the solution bag may be connected to an infusion pump device that allows precise delivery of the required amount of solution over a defined time interval. Your doctor or nurse must supervise the device to ensure safe administration.

Children (including newborns and older children) receiving Viaflo Glucose 5% are at increased risk of developing low blood sodium levels (hypo-osmolar hyponatremia) and a brain disorder due to low plasma sodium levels (hyponatremic encephalopathy).

Other medicines and Viaflo Glucose 5%

Inform your doctor or nurse if you are taking, have recently taken, or might need to take any other medicines.

Viaflo Glucose 5% and another medicine taken at the same time may affect each other.

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

Some medicines affect the hormone vasopressin. These may include:

• antidiabetic medications (chlorpropamide)
• cholesterol-lowering drugs (clofibrate)
• some cancer medications (vincristine, ifosfamide, cyclophosphamide)
• selective serotonin reuptake inhibitors (used to treat depression)
• antipsychotics
• opioid pain relievers for severe pain
• 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 medicines (carbamazepine and oxcarbazepine)
• diuretics

Viaflo Glucose 5% with food and drink

You should ask your doctor which foods and drinks you may consume.

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

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

Fertility

There are insufficient data on the effect of Viaflo Glucose 5% on fertility; however, no effect on fertility is expected.

Breastfeeding

There are insufficient data on the use of Viaflo Glucose 5% during breastfeeding, although no effect on breastfeeding is expected. Viaflo Glucose 5% 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 leaflet of the medicine to be added.

Driving and use of machines

Consult your doctor or nurse before driving or operating machinery.

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

Viaflo Glucose 5% will be administered to you by a doctor or a nurse. Your doctor will decide how much you need and when it should be given. This will depend on your age, body weight, physical condition, the reason for treatment, and whether the infusion is to be used to administer or dilute another medicine. The amount you receive may also be influenced by other treatments you are receiving.

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

Usually, Viaflo Glucose 5% will be administered through a plastic tube attached to a needle inserted into a vein. A vein in the arm is typically used for the infusion. However, your doctor may administer the medicine in another way.

Viaflo Glucose 5% must 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 level 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 Viaflo Glucose 5% from a partially used bag.

If you receive more Viaflo Glucose 5% than you should

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

• fluid accumulation in tissues causing swelling (edema) or water intoxication, with abnormally low sodium levels in the blood (hyponatremia)
• increased urine output (osmotic diuresis)
• excessive concentration of the blood (hyperosmolarity)
• loss of body water (dehydration)
• elevated blood glucose concentration (hyperglycemia)
• presence of glucose in the urine (glucosuria)

If you notice these symptoms, inform your doctor immediately. The infusion will be stopped or reduced. Insulin may be administered, and you will receive treatment according to your symptoms.

If any medicine has been added to Viaflo Glucose 5% before the overdose occurred, that medicine may also cause symptoms. You should read the list of possible side effects in the package leaflet of the added medicine.

If the infusion of Viaflo Glucose 5% is interrupted

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 adverse effects

Like all medicines, Viaflo Glucose 5% can cause adverse effects, although not everyone will experience them.

Adverse effects may include:

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

• Changes in blood concentrations of chemicals (electrolyte disturbances),

• Blood glucose concentration higher than normal (hyperglycemia),

• Loss of water from the body (dehydration),

• Excess fluid in the blood vessels (hypervolemia),

• Excessive urine volume (polyuria),

• Low levels of sodium in the blood that may develop during hospitalization (nosocomial hyponatremia) and associated neurological disorder (acute hyponatremic encephalopathy). Hyponatremia may lead to irreversible brain damage and death due to cerebral edema/inflammation (see also section 2 "Warnings and precautions"),

• Reactions due to the administration technique:

• Reaction at the injection site:

• irritation and inflammation of the vein where the solution is administered. This may cause redness, pain or burning, and swelling along the vein,

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

• fever, febrile response (pyrexia),

• infection at the infusion site,

• leakage of the infusion solution into the surrounding tissues (extravasation), which 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.

If a medication has been added to the infusion 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 package leaflet of the added medication.

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 Viaflo Glucose 5%

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

50 and 100 ml bags: Do not store above 30°C.

250, 500 and 1000 ml bags: No special storage conditions required.

Viaflo Glucose 5% must not be administered after the expiry date stated on the bag after EXP. The expiry date refers to the last day of the month indicated.

Do not use Viaflo Glucose 5% if you see particles floating in the solution or if the container is damaged in any way.

6. Contents of the pack and other information

Composition of Viaflo Glucose 5%

The active substance is sugar (glucose): 50 g per litre.

The other component is water for injections.

Appearance of the product and contents of the container

Viaflo Glucose 5% is a clear, particle-free solution. It is supplied in plastic bags made of polyolefin/polyamide (Viaflo). Each bag is contained within a sealed protective overpouch made of plastic.

The available bag sizes are:

• 50 ml
• 100 ml
• 250 ml
• 500 ml
• 1000 ml

Pack 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 certain pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

Holder:

Baxter S.L.
Pouet de Camilo 2, 46394 Ribarroja del Turia (Valencia)
Spain

Manufacturers:

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

Date of latest revision of this leaflet: October 2023

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

This information is intended for healthcare professionals only

Handling and preparation

Parenteral solutions should be inspected visually for particulate matter and discoloration prior to administration, whenever the solution and container permit.

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 bag from its 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 result in gas embolism due to residual air being drawn from the primary container before the liquid in the secondary container is fully administered.

Pressurizing intravenous solutions in flexible plastic containers to increase flow rates may lead to gas embolism if residual air in the container is not completely evacuated before administration.

Using an intravenous administration set with a vent filter in the open position may cause gas embolism.

Such intravenous administration sets with vent filter in the open position must not be used with flexible plastic containers.

The solution must be administered using sterile equipment and an aseptic technique. The administration set should be primed with the solution to prevent air from entering the system.

Addition of electrolytes may be indicated depending on the patient's clinical needs.

Medications may be introduced before or during infusion via the injection site.

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

The addition of other medications or incorrect administration techniques may lead to febrile reactions due to possible introduction of pyrogens. In case of an adverse reaction, infusion must be stopped immediately.

To avoid potentially fatal overdosing during intravenous infusion in newborns, special attention must be paid to the method of administration. When using a syringe pump to administer fluids or medications intravenously to newborns, a solution bag must 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 requirement applies regardless of whether the administration set includes an anti-free-flow device.

The intravenous infusion device and administration set must be frequently monitored.

Discard after single use.

Discard partially used containers.

Do not reconnect partially used bags.

Do not store solutions containing added medications.

An aseptic technique must be used when adding medications to Viaflo Glucose 5%.

Mix the solution thoroughly after adding medications.

1- To open

• Remove the Viaflo bag from the protective overpouch immediately before use.

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

• Check the solution for clarity 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.

• Hang the container by the eyelet.

• 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.

• Use an aseptic technique to prepare the infusion.

• Connect the administration set. Refer to the instructions provided with the administration set for connection, priming, and administration of the solution.

3- Techniques for adding medication

Warning: Added medications may be incompatible (see section 5 “Incompatibilities of added medications”).

To add medication before administration

• Disinfect the injection site.

• Using a syringe with an appropriate gauge needle, pierce the resealable injection site and inject the medication.

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

Caution: do not store bags with added medication.

To add medication during administration

• Close the clamp on the administration set.

• Disinfect the injection site.

• Using a syringe with an appropriate gauge needle, pierce the resealable injection site and inject the medication.

• Remove the container from the intravenous stand and/or turn it to vertical position.

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

• Carefully mix the solution and medication.

• Return the container to its normal position, reopen the clamp, and continue administration.

1. In-use expiry (with added medications)

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

From a microbiological standpoint, the diluted product should be used immediately unless the addition of medication was performed under controlled, validated aseptic conditions. If not used immediately, the conditions and duration of storage prior to use are the responsibility of the user.

5- Incompatibilities of added medications

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

It is the physician's responsibility to assess incompatibility of the added medication with Viaflo Glucose 5% by checking for any change in color and/or precipitation, formation of insoluble complexes, or appearance of crystals. The package leaflet 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 Viaflo Glucose 5% solution.

When a compatible solution is added to Viaflo Glucose 5%, the solution should be used immediately.

Medications known to be incompatible must not be used.