VIAFLO GLUCOSA 5% SOLUTION FOR INTRAVENOUS INFUSION

Introduction

Package Leaflet: Information for the User

Viaflo Glucose 5% Solution for Infusion

Active ingredient: 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 further questions, ask your doctor or nurse.
• If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

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 given to you
4. Possible side effects
5. Storage of 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 solution of sugar (glucose) in water.

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

Viaflo Glucose 5% is used:

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

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

2. What you need to know before you are given Viaflo Glucose 5%

Viaflo Glucose 5% should not be given to you if you have any of the following conditions:

• if you have diabetes that is not being treated, so that the blood glucose concentration is higher than normal (uncontrolled diabetes).
• if there are situations of glucose intolerance, for example: when the body's metabolism is not working properly, for example, due to serious illnesses (metabolic stress).

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

If another medicine is added to your infusion solution, you should always read the leaflet for that medicine. This will allow you to know if the medicine is safe for you.

Warnings and precautions

Tell 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 working 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 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 disorders due to starvation or a diet that does not provide the proper proportion of necessary nutrients (malnutrition).
• If you have low levels of thiamine (vitamin B1) in your body. This can happen if you have chronic alcoholism.
• Allergy to corn (Viaflo Glucose 5% contains glucose derived from corn).
• If you have a condition that could cause high levels of vasopressin, a hormone that regulates the body's fluid. 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 been operated on,
• 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 medicines and Viaflo Glucose 5%)

This can increase the risk of low sodium levels in the blood and can cause headache, nausea, seizures, 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 (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 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 (fluid balance),
• the acidity of your blood and urine (changes in acid-base balance).

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

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

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

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

It is possible that during long-term treatment with Viaflo Glucose 5%, you may need additional nutrition.

Children

Viaflo Glucose 5%should be administered withspecial carein children.

Children should receive Viaflo Glucose 5% from a doctor or nurse. The amount administered will be determined by a doctor specializing in pediatric treatment 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, the 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 (hypo or hyperglycemia) and therefore require careful monitoring during treatment with glucose solutions by intravenous infusion to ensure adequate control of blood sugar levels and prevent possible long-term side effects. Low blood sugar levels in newborns can cause seizures, prolonged coma, and brain damage. High blood sugar levels can cause brain hemorrhages, 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 an infusion pump device that allows the exact amount of solution required to be administered during the defined time interval. Your doctor or nurse should supervise the device to ensure safe administration.

Children (including newborns and older children) who receive Viaflo Glucose 5% are at higher risk of suffering from low sodium levels in the blood (hyponatremia) and a neurological disorder related to low sodium levels (hyponatremic encephalopathy).

Other medicines and Viaflo Glucose 5%

Tell your doctor or nurse if you are taking or have recently taken or might take any other medicines.

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

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

Some medicines act on the vasopressin hormone. These can include:

• antidiabetic medication (chlorpropamide)
• cholesterol medication (clofibrate)
• certain anticancer medications (vincristine, ifosfamide, cyclophosphamide)
• selective serotonin reuptake inhibitors (used to treat depression)
• antipsychotics
• 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 esophageal bleeding), and oxytocin (used to induce labor)
• antiepileptic medications (carbamazepine and oxcarbazepine)
• diuretics

Viaflo Glucose 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, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

Pregnancy

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

Fertility

There are not enough data on the effect of Viaflo glucose 5% on fertility, although no effect is expected.

Breastfeeding

There are not enough data on the use of Viaflo Glucose 5% during breastfeeding, although no effect is expected. Viaflo glucose 5% 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 for the medicine to be added.

Driving and using machines

Consult your doctor or nurse before driving or using machines.

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

Viaflo Glucose 5% 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, 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 there are particles floating in the solution or if the container is damaged in any way.

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

Viaflo Glucose 5% 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 (especially sodium, in patients with high levels of the hormone vasopressin, or those taking other medicines that increase the effect of vasopressin).

Any unused solution should be discarded. DO NOT receive Viaflo Glucose 5% from a started 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 the tissues causing swelling (edema) or water intoxication, with low sodium levels in the blood (hyponatremia)
• increased urine production (osmotic diuresis)
• excessive blood concentration (hyperosmolarity)
• loss of water from the body (dehydration)
• high blood glucose concentration (hyperglycemia)
• presence of glucose in the urine (hyperglycosuria)

If you notice these symptoms, tell your doctor immediately. The infusion will be stopped or reduced. Insulin will be administered and you will receive treatment based on the symptoms.

If another medicine has been added to Viaflo Glucose 5% before excessive administration, that medicine may also cause symptoms. You should read the list of possible symptoms in the leaflet for the added medicine.

If you stop the Viaflo Glucose 5% infusion

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 side effects

Like all medicines, Viaflo Glucose 5% can cause side effects, although not everybody gets them.

Side effects can include:

• Hypersensitivity reactions, including a severe allergic reaction called anaphylaxis (potential manifestation in patients with corn allergy),
• Changes in blood chemical levels (electrolyte disorders).
• High blood glucose concentration (hyperglycemia).
• Loss of water from the body (dehydration).
• Excess fluid in the blood vessels (hypervolemia),
• Excessive urine production (polyuria)
• 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 brain 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 can cause redness, pain, or itching and swelling along the vein where the solution is administered,
• 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 tissues surrounding the vein (extravasation), which can damage tissues and cause 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 medicine has been added to the infusion solution, it can also cause side effects. These side effects will depend on the added medicine. You should read the list of possible symptoms in the leaflet for the added medicine.

Reporting side effects:

If you experience any side effects, talk to your doctor or nurse, even if it is possible side effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side 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

Bags of 50 and 100 ml: Do not store 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 stated on the bag after EXP. The expiration date is the last day of the month indicated.

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

6. Container Contents and Additional Information

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 Container Contents

Viaflo Glucose 5% is a clear solution, free from visible particles. It is presented in polyolefin/polyamide (Viaflo) plastic bags. Each bag is packaged in a sealed protective plastic 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 1,000 ml

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Holder

Baxter S.L.

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

Manufacturer:

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 Last Revision of this Prospectus: October 2023

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

This information is intended only for healthcare professionals

Handling and Preparation

Parenteral solutions should be visually inspected before administration to detect particles and discoloration, whenever the solution and container permit.

Use only if the solution is clear, free from visible particles, and if 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 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 administration of the liquid contained in the secondary container is completed.

The pressurization of intravenous solutions in flexible plastic containers to increase flow rates can lead to a gas embolism if the residual air in the container is not fully evacuated before administration.

The use of an intravenous administration set with a ventilation filter in the open position could cause a gas embolism.

This type of intravenous administration set with the ventilation filter in the open position should not be used with flexible plastic containers.

The solution should be administered with sterile equipment using an aseptic technique. The equipment should 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.

Medications can be introduced before or during infusion through the injection point.

When adding medications, verify the final osmolarity before parenteral administration. A complete and careful aseptic mixture 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 can cause the appearance of febrile reactions due to the possible introduction of pyrogens. In the event of an adverse reaction, the infusion should be interrupted immediately.

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

When using an infusion pump, all clamps on the intravenous administration set should be closed before removing the administration set from the pump or disconnecting the pump. This is required regardless of whether the administration set has an anti-free flow device.

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

Discard after a single use.

Discard partially unused containers.

Do not reconnect partially used bags.

Do not store solutions containing other medications.

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

Mix the solution well when adding medications.

1- To open

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

• 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.

• 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.

• Hang the container by the hanger

• 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.

• Use an aseptic technique to prepare the infusion.

• Connect the administration set. Consult the instructions accompanying the set for 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.

• Disinfect the injection point.

• Using a syringe with a suitable caliber needle, puncture the resealable injection point and inject.

• 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

• Close the clamp on the administration set.

• Disinfect the injection point.

• Using a syringe with a suitable caliber needle, puncture the resealable injection point and inject.

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

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

• Mix the solution and medication carefully.

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

1. Expiry date for use (added medications)

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

From a microbiological point of view, the diluted product should be used immediately unless the addition of medications has been carried out under controlled and validated aseptic conditions. If it is not used immediately, the conditions and storage times used before its 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 should be verified before addition.

It is the responsibility of the physician to judge the incompatibility of the added medication to Viaflo Glucose 5% by examining any change in color and/or precipitation, insoluble complexes, or the appearance of crystals. The prospectus 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 to Viaflo Glucose 5%, the solution should be used immediately.

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