Label: information for the user

Viaflo glucose 3.3% and sodium chloride 0.3%, solution for infusion

Active ingredient: sodium chloride, glucose

Read the entire label carefully before starting to use the medication because it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or nurse.
• If you experience adverse effects, consult your doctor or nurse, even if they are not listed in this label. See section 4.

1. What is Viaflo glucose 3.3% and sodium chloride 0.3% and for what it is used

2. What you need to know before Viaflo glucose 3.3% and sodium chloride 0.3% is administered to you

3. How Viaflo glucose 3.3% and sodium chloride 0.3% will be administered to you

4. Possible adverse effects

5. Storage of Viaflo glucose 3.3% and sodium chloride 0.3%

6. Contents of the package and additional information

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 energy sources. 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 a loss of water (dehydration) and chemical substances (for example excessive sweating, renal alterations) from the body,
• to treat, if the volume of blood in the blood vessels is low (hypovolemia).

You should not be administered Viaflo glucose 3.3% and sodium chloride 0.3% if you have any of the following clinical situations

• if you know you are allergic to this medication.
• when there is too much fluid in the spaces surrounding the body's cells (extracellular hyperhydration)
• when there is an excessive volume of blood in the blood vessels (hypervolemia)
• when there is excessive fluid and sodium in the body (fluid and sodium retention)
• severe kidney problems that mean you produce less urine than normal or none at all (oliguria or anuria)
• if you have uncompensated heart failure. This is heart failure that does not receive adequate treatment and causes symptoms such as:
• difficulty breathing
• swelling of the ankles.
• low sodium levels in the blood (hyponatremia).
• low chloride levels in the blood (hypochloremia).
• if you have generalized edema, which affects the entire body.
• if you have liver disease that causes fluid accumulation in the abdomen (ascitic cirrhosis).
• if you have uncontrolled diabetes, so that the blood glucose concentration is higher than normal (uncompensated diabetes).
• other situations of glucose intolerance, for example:
• metabolic aggression (when the body's metabolism does not function correctly, for example, due to severe diseases).
• hyperosmolar coma (loss of consciousness). This is a type of coma that can occur if you have diabetes and do not receive adequate medication.
• high blood glucose concentration (hyperglycemia)
• high blood lactate concentration (hyperlactatemia).

Warnings and precautions

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

• 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 liver disease that causes fluid accumulation in the abdomen (ascitic cirrhosis)
• kidney failure
• high blood pressure during pregnancy (pre-eclampsia)

• taking some medications (see also “Other medications andViaflo glucose 3.3% and sodium chloride 0.3%”)

• metabolic alkalosis (when the blood becomes too alkaline)
• muscle weakness and periodic paralysis due to low thyroid activity (periodic thyroid paralysis)
• rapid loss of body water, for example, due to vomiting or diarrhea
• long-term low-potassium diet
• 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 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 have pain,
• you have had surgery,
• you have infections, burns, or brain injury
• you have diseases related to your heart, liver, kidneys, or central nervous system,
• you are taking certain medications (see Other medications andViaflo 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, convulsions, 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 with problems with their cerebrospinal fluid levels, for example, due to meningitis, bleeding in the skull, or brain injury.
• changes in the concentrations of chemical substances in the blood (electrolyte alterations)
• generalized edema, which affects all parts of the body, around the ankles (peripheral edema) or in the lungs (pulmonary edema).

When you are being administered this solution, your doctor may take blood and urine samples to control:

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

As Viaflo glucose 3.3% and sodium chloride 0.3% contains sugar (glucose), it may increase blood sugar levels (hyperglycemia). If this occurs, your doctor may:

• adjust the infusion rate
• administer insulin to reduce blood glucose concentration.

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 cerebral stroke). High blood sugar levels can worsen the effects of brain injury and affect your recovery.
• If you have had a head injury in the last 24 hours.

Your doctor should take into account if you are receiving parenteral nutrition (nutrition administered through a vein). During prolonged treatments with Viaflo glucose 3.3% and sodium chloride 0.3%, you may need to receive additional nutrition. Your doctor should monitor your potassium levels in the blood to avoid them decreasing too much (hypokalemia).

Children

Special care should be taken when administering 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 chemical substances in the solution.

The smallest children are at higher risk of developing low or high blood glucose levels and therefore, require careful monitoring during treatment to ensure adequate control of blood sugar levels. Low blood sugar in newborns can cause prolonged convulsions, coma, and brain damage. High blood sugar has been associated with brain hemorrhage, bacterial or fungal infections, eye damage (retinopathy of prematurity), intestinal infections, respiratory 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, convulsions, lethargy, coma, brain inflammation (cerebral edema), and death. Acute hyponatremic encephalopathy is a serious complication, especially in children.

Your doctor knows all this and will carefully monitor the amount of chemical substances such as glucose (sugar), sodium, and chloride in your child's blood (plasma electrolytes).

Other medications and Viaflo glucose 3.3% and sodium chloride 0.3%

Inform your doctor or pharmacist if you are using, have used recentlyanyother medication.

It is particularly important to inform your doctor if you are taking:

• corticosteroids (anti-inflammatory medications)

These medications can cause the body to accumulate sodium and water, leading to swelling of tissues due to fluid accumulation under the skin (edema) or high blood pressure (hypertension).

Some medications act on the vasopressin hormone. These may include:

• diabetes medication (chlorpropamide)
• cholesterol-lowering medication (clofibrate)
• some cancer medications (vincristine, ifosfamide, cyclophosphamide)
• selective serotonin reuptake inhibitors (used to treat depression)
• antipsychotics or opioids for severe pain relief
• medications for pain and/or inflammation (also known as NSAIDs)
• medications that mimic or strengthen the effects of vasopressin, such as desmopressin (used to treat excessive thirst and urination), terlipressin (used to treat bleeding from the esophagus), and oxytocin (used to induce labor)
• antiepileptic medications (carbamazepine and oxcarbazepine)
• diuretics

Other medications that may affect or be affected by Viaflo glucose 3.3% and sodium chloride 0.3% are:

• lithium (used to treat psychiatric disorders)
• insulin (used to treat diabetes)
• beta-blockers (heart medications)

Use of Viaflo glucose 3.3% and sodium chloride 0.3% with food and drinks

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 plan to become pregnant, consult your doctor or nurse before using this medication.

Viaflo glucose 3.3% and sodium chloride 0.3% can be used safely during pregnancy and breastfeeding.

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

• ask your doctor
• read the medication's leaflet

Driving and operating machines

Viaflo glucose 3.3% and sodium chloride 0.3% does not affect your ability to drive or operate machines.

Glucose 3.3% and Sodium Chloride 0.3% solution will be administered by a doctor or nurse. Your doctor will decide how much you need and when to administer it. 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 Glucose 3.3% and Sodium Chloride 0.3% solution if there are particles floating in the solution or if the container is damaged in any way.

Glucose 3.3% and Sodium Chloride 0.3% solution is usually administered through a plastic tube connected to a needle inserted into a vein. A vein in the arm is often used to administer the infusion. However, your doctor may administer the medication in another way.

Your doctor will monitor the following before and during the infusion:

- 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 medications that increase the effect of vasopressin).

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

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

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

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

-dry mouth due to dehydration

-thirst

• increased urine production (osmotic diuresis)
• blurred vision
• fatigue

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

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

If a medication has been added to Glucose 3.3% and Sodium Chloride 0.3% solution before the excessive administration, that medication may also cause symptoms. You should read the list of possible symptoms in the medication's package insert.

If you interrupt the infusion of Glucose 3.3% and Sodium Chloride 0.3% solution

Your doctor will decide when to stop receiving this infusion.

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

Like all medications, Viaflo glucose 3.3% and sodium chloride 0.3% may produce adverse effects, although not everyone will experience them.

Adverse effects may be related to Viaflo glucose 3.3% and sodium chloride 0.3%. These include:

• allergic 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 may 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 section 2 “Warnings and Precautions”).

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

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

• local pain or reaction (redness or swelling at the administration site)
• irritation and inflammation of the vein used for perfusion of the solution (phlebitis). This may cause redness, pain, or burning and swelling along the vein in which the solution has been perfused.

If a medication has been added to the perfusion solution, this medication may also produce adverse effects. These adverse effects will depend on the added medication. You should read the list of possible symptoms in the prospectus of the added medication.

Reporting Adverse Effects:

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

Keep out of sight and reach of children.

Viaflo glucose 3.3% and sodium chloride 0.3% does not require special conservation conditions.

Viaflo glucose 3.3% and sodium chloride 0.3% MUST NOT be administered after the expiration date appearing on the bag after CAD. The expiration date is the last day of the month indicated.

Viaflo glucose 3.3% and sodium chloride 0.3% should not be received if there are particles floating in the solution or if the container is damaged in any way.

Composition of Viaflo glucose 3.3% and sodium chloride 0.3%

The active principles are:

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

The other component is water for injection.

Appearance of the product and contents of the package

Viaflo glucose 3.3% and sodium chloride 0.3% is a transparent and particle-free solution. It is presented in polyolefin/polyamide (Viaflo) plastic bags. Each bag is packaged in a sealed plastic protective 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 sizes of containers may be marketed.

Holder of the marketing authorization and responsible for manufacturing

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

Last review date of this leaflet: October 2023

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/

……………………………………………………………………………………………………

This information is intended solely for healthcare professionals

Handling and preparation

Use only if the solution is transparent, 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 sterility of the product.

Do not connect plastic containers in series. This type of use may produce gas embolism due to residual air carried from the primary container before the secondary container is completed.

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

The use of an intravenous administration equipment with a ventilation filter in open position may cause a gas embolism. This type of administration equipment with the ventilation filter in open position should not be used with flexible plastic containers.

The solution must be administered with a sterile equipment using an aseptic technique. The equipment must be primed with the solution to prevent air entry into the system.

Medicines added may be introduced before or during infusion through the injection port. When adding medicines, check the tonicity before parenteral administration.

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

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

Discard after 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 small leaks by pressing 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 spigot
2. -Remove the plastic protector from the outlet in the lower part of the container.

• Hold one hand on the small handle of the outlet tube.
• Hold the other hand on the large handle of the closure cap 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 medicines may be incompatible. (see below the section 5 “incompatibilities of added medicines”)

To add medication before administration

1. Disinfect the injection port
2. Using a syringe with a 19G to 22G needle, pierce the injection port and inject.
3. Mix the medication and solution completely. For high-density medicines, such as potassium chloride, gently shake the tubes while in the vertical position and mix.

Caution: Do not store bags with added medication. See section 4 “Expiry in use”.

To add medication during administration

1. Close the clamp on the equipment
2. Disinfect the injection port
3. Using a syringe with a 19G to 22G needle, pierce the injection port and inject.
4. Remove the container from the drip chamber and/or turn it to the vertical position.
5. Empty both tubes by gently shaking them while the container is in the vertical position.
6. Mix the solution and medication completely.
7. Replace the container in the original position, reopen the clamp, and continue administration.

4.Expiry in use (added medicines)

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

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

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

5-Incompatibilities of added medicines

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

It is the responsibility of the doctor to judge the incompatibility of the added medication with Viaflo glucose 3.3% and sodium chloride 0.3% by examining any eventual change in color and/or precipitation, insoluble complexes, or appearance of crystals. The prospectus of the medicine to be added should be consulted.

Before adding a medicine, 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 medicines to Viaflo glucose 3.3% and sodium chloride 0.3%, the solution should be administered immediately, unless the chemical and physical stability has been established in use.

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

• Sodium ampicillin
• Mitomycin
• Erythromycin lactobionate
• Human insulin

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

Medicines whose incompatibility is known should not be used.