VIAFLO GLUCOSA 3.3% & SODIUM CHLORIDE 0.3% SOLUTION FOR INFUSION

Introduction

Package Leaflet: Information for the User

Viaflo Glucose 3.3% and Sodium Chloride 0.3%, Solution for Infusion

Active substance: sodium chloride, 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 and other information:

1. What Viaflo Glucose 3.3% and Sodium Chloride 0.3% is and what it is used for
2. What you need to know before you are given Viaflo Glucose 3.3% and Sodium Chloride 0.3%
3. How Viaflo Glucose 3.3% and Sodium Chloride 0.3% will be given to you
4. Possible side effects
5. Storage of Viaflo Glucose 3.3% and Sodium Chloride 0.3%
6. Contents of the pack and other information

1. What Viaflo Glucose 3.3% and Sodium Chloride 0.3% is and what it is used for

Viaflo Glucose 3.3% and Sodium Chloride 0.3% is a solution of the following substances in water:

• Sugar (glucose)
• Sodium chloride

Glucose is one of the body's sources of energy. This solution provides 132 kilocalories per liter. Sodium and chloride are chemical substances found in the blood.

Viaflo Glucose 3.3% and Sodium Chloride 0.3% is used:

• as a source of carbohydrates (sugar),
• to treat loss of water (dehydration) and chemicals (e.g. excessive sweating, kidney disorders) from the body,
• to treat low blood volume in the blood vessels (hypovolemia).

2. What you need to know before you are given Viaflo Glucose 3.3% and Sodium Chloride 0.3%

Viaflo Glucose 3.3% and Sodium Chloride 0.3% should not be given to you if you have any of the following conditions

• if you know you are allergic to this medicine.
• when there is too much fluid in the spaces surrounding the body's cells (extracellular hyperhydration)
• when there is more blood volume in the blood vessels than there should be (hypervolemia)
• more fluid and sodium in the body than normal (fluid and sodium retention)
• severe kidney problems, meaning less urine is produced than normal or none at all (oliguria or anuria)
• if you have uncompensated heart failure. This is heart failure that is not receiving proper treatment and is causing symptoms such as:
• difficulty breathing
• swelling of the ankles.
• low sodium levels in the blood (hyponatremia).
• low chloride levels in the blood (hypochloremia).
• if there is fluid accumulation under the skin, affecting the whole body (generalized edema).
• if you have a liver disease that causes fluid accumulation in the abdomen (ascitic cirrhosis).
• if you have uncontrolled diabetes, so that your blood sugar levels are higher than normal (uncontrolled diabetes).
• other situations of glucose intolerance, such as:
• metabolic stress (when the body's metabolism is not working properly, e.g. due to severe illness).
• hyperosmolar coma (loss of consciousness). This is a type of coma that can occur if you have diabetes and are not receiving proper medication.
• high blood sugar levels (hyperglycemia)
• high blood lactate levels (hyperlactatemia).

Warnings and precautions

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

• conditions associated with sodium retention, fluid overload, and edema, such as:

• aldosteronism (a disease that causes high levels of a hormone called aldosterone) associated with:
• high blood pressure (hypertension)
• heart failure
• poor liver function or a liver disease that causes fluid accumulation in the abdomen (ascitic cirrhosis)
• kidney failure
• high blood pressure during pregnancy (pre-eclampsia)

• taking certain medications (see also "Other medicines and Viaflo Glucose 3.3% and Sodium Chloride 0.3%")

• a disorder in which the blood becomes too alkaline (metabolic alkalosis)
• muscle weakness and periodic paralysis due to low thyroid activity (thyrotoxic periodic paralysis)
• rapid loss of body water, e.g. due to vomiting or diarrhea
• being on a low-potassium diet for a long time
• allergy, particularly to corn (Viaflo Glucose 3.3% and Sodium Chloride 0.3% 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 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 medications (see Other medicines and Viaflo Glucose 3.3% and Sodium Chloride 0.3%).

This may 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 (particularly if they are of childbearing age)
• people who have problems with their brain fluid levels, e.g. due to meningitis, bleeding in the skull, or a head injury.
• changes in blood chemical levels (electrolyte disturbances)
• fluid accumulation under the skin, affecting the whole body (generalized edema), around the ankles (peripheral edema), or in the lungs (pulmonary edema).

When you are being given this solution, your doctor will take blood and urine samples to check:

• the amount of chemicals such as sodium and chloride in your blood (your plasma electrolytes)
• the amount of sugar (glucose)

Since Viaflo Glucose 3.3% and Sodium Chloride 0.3% contains sugar (glucose), it may increase your blood sugar levels (hyperglycemia). If this happens, your doctor may:

• adjust the infusion rate
• give you insulin to reduce your blood sugar levels.

This is particularly important:

• If you are diabetic.
• If you have not been eating well or have been drinking too much alcohol for a long time.
• If you have recently had a brain injury (acute stroke). High blood sugar levels can worsen the effects of the brain injury and affect your recovery.
• If you have had a head injury in the last 24 hours.

Your doctor should consider whether you are receiving parenteral nutrition (nutrition given through a vein). During prolonged treatment with Viaflo Glucose 3.3% and Sodium Chloride 0.3%, you may need to receive additional nutrition. Your doctor should check your blood potassium levels to prevent them from dropping too low (hypokalemia).

Children

Special care should be taken when giving this solution to children, babies, and newborns (especially premature babies and those with low birth weight). Children, babies, and newborns may not have a good ability to handle the chemicals in the solution.

Younger children are at higher risk of developing low or high blood sugar levels and therefore need careful monitoring during treatment to ensure proper control of blood sugar levels. Low blood sugar levels in newborns can cause prolonged seizures, coma, and brain damage. High blood sugar levels have been associated with brain hemorrhages, bacterial or fungal infections, eye damage (retinopathy of prematurity), intestinal infections, lung problems, prolonged hospital stay, and death.

Children are at higher risk of developing low sodium levels in the blood (hyponatremia). Hyponatremia can cause headache, nausea, seizures, lethargy, coma, brain inflammation (cerebral edema), and death. Acute hyponatremic encephalopathy is a serious complication, especially in children.

Your doctor is aware of all of the above and will carefully monitor the levels of chemicals such as glucose (sugar), sodium, and chloride in your child's blood (plasma electrolytes).

Other medicines and Viaflo Glucose 3.3% and Sodium Chloride 0.3%

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

It is particularly important that you tell your doctor if you are taking:

• corticosteroids (anti-inflammatory medicines)

These medicines can cause the body to retain sodium and water, leading to tissue swelling due to fluid accumulation under the skin (edema) or high blood pressure (hypertension).

Some medicines affect the hormone vasopressin. These may include:

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

Other medicines that may be affected by or affect Viaflo Glucose 3.3% and Sodium Chloride 0.3% are:

• lithium (used to treat psychiatric illnesses)
• insulin (used to treat diabetes)
• beta-blockers (heart pills)

Using Viaflo Glucose 3.3% and Sodium Chloride 0.3% with food and drink

Ask your doctor about what you can eat or drink.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or nurse for advice before using this medicine.

Viaflo Glucose 3.3% and Sodium Chloride 0.3% can be used safely during pregnancy and breastfeeding.

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

• ask your doctor
• read the package leaflet of the medicine to be added

Driving and using machines

Viaflo Glucose 3.3% and Sodium Chloride 0.3% does not affect your ability to drive or use machines.

3. How Viaflo Glucose 3.3% and Sodium Chloride 0.3% will be given to you

Viaflo Glucose 3.3% and Sodium Chloride 0.3% 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 treatment. The amount you receive may also be influenced by other treatments you are receiving.

DO NOT receive Viaflo Glucose 3.3% and Sodium Chloride 0.3% if there are particles floating in the solution or if the packaging is damaged in any way.

Viaflo Glucose 3.3% and Sodium Chloride 0.3% is usually given through a plastic tube attached to a needle inserted into a vein. A vein in the arm is usually used to give the infusion. However, your doctor may give you the medicine in another way.

Before and during the infusion, your doctor will check:

• 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 medicines that increase the effect of vasopressin).

Any unused solution should be discarded. DO NOT receive Viaflo Glucose 3.3% and Sodium Chloride 0.3% from a started bag.

If you receive more Viaflo Glucose 3.3% and Sodium Chloride 0.3% than you should

If you receive too much Viaflo Glucose 3.3% and Sodium Chloride 0.3% solution or if it is given too quickly, you may experience the following symptoms:

• High blood sugar levels (hyperglycemia). Symptoms include:

• dry mouth due to lack of water in the body's tissues (dehydration)
• thirst
• increased urine production (osmotic diuresis)
• blurred vision
• fatigue.

• Low sodium levels in the blood (hyponatremia). Hyponatremia can cause headache, nausea, seizures, lethargy, coma, brain inflammation (cerebral edema), and death.
• Fluid accumulation in the body, causing swelling (edema).

If you develop these symptoms, tell your doctor immediately. The infusion will be stopped and you will receive treatment based on your symptoms.

If a medicine has been added to the Viaflo Glucose 3.3% and Sodium Chloride 0.3% solution before administration, this medicine may also cause symptoms. You should read the list of possible symptoms in the package leaflet of the added medicine.

If you stop receiving Viaflo Glucose 3.3% and Sodium Chloride 0.3% infusion

Your doctor will decide when you should stop receiving this infusion.

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

4. Possible side effects

Like all medicines, Viaflo Glucose 3.3% and Sodium Chloride 0.3% can cause side effects, although not everybody gets them.

Side effects may be related to Viaflo Glucose 3.3% and Sodium Chloride 0.3%. These include:

• Hypersensitivity reactions, including a severe allergic reaction called anaphylaxis (potential manifestation in patients with corn allergy)
• High blood sugar levels (hyperglycemia)
• 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 inflammation (see also section 2 "Warnings and precautions").

Side effects may be due to the administration technique. These include:

• fever (febrile response)
• chills
• itching or pruritus

• local pain or reaction (redness or swelling at the infusion site)
• irritation and inflammation of the vein used for the infusion (phlebitis). This can cause redness, pain, or burning and swelling along the vein where the solution was infused.

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

Reporting of 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 side effects directly through the Spanish Medicines Agency's website: 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 3.3% and Sodium Chloride 0.3%

Keep out of the sight and reach of children.

Viaflo Glucose 3.3% and Sodium Chloride 0.3% does not require special storage conditions.

Viaflo Glucose 3.3% and Sodium Chloride 0.3% should not be used after the expiry date stated on the bag after EXP. The expiry date is the last day of the month shown.

Do not receive Viaflo Glucose 3.3% and Sodium Chloride 0.3% if there are particles floating in the solution or if the packaging is damaged in any way.

6. Container Content and Additional Information

Composition of Viaflo glucose 3.3% and sodium chloride 0.3%

The active ingredients are:

• sugar (glucose): 33 g per liter
• sodium chloride: 3 g per liter

The other component is water for injectable preparations.

Appearance of the Product and Container Content

Viaflo glucose 3.3% and sodium chloride 0.3% is a clear and particle-free solution. It is presented in polyolefin/polyamide (Viaflo) plastic bags. Each bag is packaged in a sealed protective plastic overbag.

The bag sizes are

• 250 ml
• 500 ml
• 1000 ml

The bags are supplied in boxes, containing the following quantities:

• 30 bags of 250 ml
• 20 bags of 500 ml
• 10 bags of 1000 ml
• 12 bags of 1000 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)

Spain

Baxter Manufacturing Sp. z o.o.

42 B Wojciechowska Str., 20-0704 Lublin

Poland

Bieffe Medital S.A.

Ctra. Biescas-Senegüé s/n, 22666 Sabiñánigo

(Huesca), Spain

Date of the 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

Use only if the solution is clear, free of visible particles, and 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 liquid contained in the secondary container is completely administered.

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

Added medications can be introduced before or during infusion through the injection point. When adding medications, the tonicity should be checked before parenteral administration.

From a physico-chemical point of view, the solution containing added medications should be used immediately unless the chemical and physical stability in use has been established.

From a microbiological point of view, solutions containing added medications should be used immediately and should not be stored. If not used immediately, the storage conditions and period before use are the responsibility of the user and should not normally exceed 24 hours at 2-8°C, unless the reconstitution has been carried out in controlled and validated aseptic conditions.

Discard after a single use.

Discard partially used containers.

Do not reconnect partially used bags.

1- To Open

1. Remove the Viaflo bag from the overbag just before use.
2. 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.
3. 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.

1. Hang the container by the hanger
2. 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.

1. Use an aseptic technique to prepare the infusion
2. Connect the administration equipment. Consult the equipment instructions 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" below)

To Add Medication Before Administration

1. Disinfect the injection point
2. Using a syringe with a 19G to 22G needle, puncture the resealable injection point and inject.
3. Mix the medication and solution completely. For high-density medications, such as potassium chloride, gently tap the tubes while they are in a vertical position and mix.

Precaution: Do not store bags with added medication. See section 4 "Expiry Date for Use".

To Add Medication During Administration

1. Close the equipment clamp
2. Disinfect the injection point
3. Using a syringe with a 19G to 22G needle, puncture the resealable injection point and inject.
4. Remove the container from the drip stand and/or turn it to put it in a vertical position.
5. Empty both tubes by gently tapping them while the container is in a vertical position
6. Mix the solution and medication completely
7. Put the container back in the operating position, reopen the clamp, and continue administration.

1. Expiry Date for Use (Added Medications)

Before use, the physical and chemical stability of any added medication at the pH of the Viaflo glucose 3.3% and sodium chloride 0.3% solution in the Viaflo container must be established.

From a physico-chemical point of view, the solution containing added medications should be used immediately unless the chemical and physical stability in use has been established.

From a microbiological point of view, the diluted product should be used immediately. If not used immediately, the storage time and conditions before use are the responsibility of the user and should not normally exceed 24 hours at 2-8°C, unless the addition of medications has been carried out in controlled and validated aseptic conditions.

5- Incompatibilities of Added Medications

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

It is the responsibility of the physician to judge the incompatibility of the added medication to Viaflo glucose 3.3% and sodium chloride 0.3% 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 Viaflo glucose 3.3% and sodium chloride 0.3% (pH 3.5-6.5).

When adding compatible medication to Viaflo glucose 3.3% and sodium chloride 0.3%, the solution should be administered immediately, unless the chemical and physical stability in use has been established.

As a guide, the following medications are incompatible with Viaflo glucose 3.3% and sodium chloride 0.3% (this is not an exhaustive list):

• Sodium ampicillin
• Mitomycin
• Erythromycin lactobionate
• Human insulin

Since Viaflo glucose 3.3% and sodium chloride 0.3% contains glucose, it should not be administered with whole blood through the same infusion equipment, due to the possibility of hemolysis and agglutination.

Medications whose incompatibility is known should not be used.