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

Package leaflet: Information for the user

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

Contents of this leaflet:

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 administered to you
4. Possible side effects
5. How to store 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 containing 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 present 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 loss of chemical substances (e.g., excessive sweating, kidney disorders) from the body,
• for treatment when blood volume in the blood vessels is low (hypovolemia).

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

Do NOT receive Viaflo glucose 3.3% and sodium chloride 0.3% if you have any of the following clinical conditions

• if 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 a higher than normal volume of blood in the blood vessels (hypervolemia)
• excess fluid and sodium in the body (fluid and sodium retention)
• severe kidney problems meaning that less than normal or no urine is produced (oliguria or anuria)
• uncompensated heart failure. This is heart failure that is not receiving adequate treatment and causes symptoms such as:
• difficulty breathing
• swelling of the ankles.
• lower than normal levels of sodium in the blood (hyponatremia).
• lower than normal levels of chloride in the blood (hypochloremia).
• accumulation of fluid under the skin affecting the entire body (generalized edema).
• if you have a liver disease causing fluid accumulation in the abdomen (ascitic cirrhosis).
• if you have untreated diabetes, resulting in higher than normal blood sugar concentration (uncompensated diabetes).
• other conditions involving glucose intolerance, for example:
• metabolic stress (when the body's metabolism is not functioning properly, e.g., due to severe illness).
• hyperosmolar coma (loss of consciousness). This is a type of coma that may occur if you have diabetes and are not receiving adequate medication.
• higher than normal blood glucose concentration (hyperglycemia)
• higher than normal blood lactate concentration (hyperlactatemia).

Warnings and precautions

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

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

• aldosteronism (a disorder causing high levels of a hormone called aldosterone) associated with:

• high blood pressure (hypertension)

• heart failure

• poor liver function or liver disease causing fluid accumulation in the abdomen (ascitic cirrhosis)

• kidney failure

• high blood pressure during pregnancy (pre-eclampsia)

• taking certain medicines (see also “Other medicines and Viaflo glucose 3.3% and sodium chloride 0.3%”)

• a disorder causing the blood to become 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 prolonged period

• 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 elevated levels of vasopressin, a hormone that regulates your body's fluid. You may have too much vasopressin in your body, for example, if:

• you have had an acute and severe illness,

• you are in 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 3.3% and sodium chloride 0.3%).

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 include:

• 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.
• changes in blood chemical concentrations (electrolyte imbalances)
• accumulation of fluid under the skin affecting all body parts (generalized edema), around the ankles (peripheral edema), or in the lungs (pulmonary edema).

While you are receiving this solution, your doctor may take blood and urine samples to monitor:

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

Since 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 properly or have been drinking excessive alcohol for a prolonged period.
• If you have recently suffered brain damage (acute stroke). High blood sugar levels may worsen the effects of brain damage and affect your recovery.
• If you have had a head injury within the last 24 hours.

Your doctor should consider whether you are receiving parenteral nutrition (nutrition delivered by intravenous infusion). During prolonged treatment with Viaflo glucose 3.3% and sodium chloride 0.3%, you may require additional nutrition. Your doctor should monitor your blood potassium levels to prevent abnormally low levels (hypokalemia).

Children

Special care should be taken when administering this solution to children, infants, and newborns (especially premature infants and those with low birth weight). Children, infants, and newborns may have limited ability to handle the chemicals in the solution.

Younger children are at higher risk of developing low or high blood glucose levels and therefore require careful monitoring during treatment to ensure adequate blood sugar control. Low blood sugar in newborns may 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 tract infections, lung problems, prolonged hospital stay, and death.

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

Your doctor is aware of all 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%

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

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

• corticosteroids (anti-inflammatory medicines)

These medicines may 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:

• antidiabetic medications (chlorpropamide)
• cholesterol-lowering medicines (clofibrate)
• certain cancer treatments (vincristine, ifosfamide, cyclophosphamide)
• selective serotonin reuptake inhibitors (used to treat depression)
• antipsychotics or opioids for severe pain relief
• 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

Other medicines that may interact with or be affected by Viaflo glucose 3.3% and sodium chloride 0.3% include:

• 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 drink

Ask your doctor about what you may 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 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 being added

Driving and using machines

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

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

Viaflo glucose 3.3% and sodium chloride 0.3% will be administered 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.

You MUST NOT receive Viaflo glucose 3.3% and sodium chloride 0.3% if there are particles floating in the solution or if the container is damaged in any way.

Viaflo glucose 3.3% and sodium chloride 0.3% is usually administered through a plastic tube connected 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.

Before and during the infusion, your doctor will monitor:

• your body fluid levels
• the acidity of your blood and urine
• the levels of electrolytes in your body (particularly sodium, in patients with high levels of vasopressin hormone, or who are taking other medicines that increase the effect of vasopressin).

Any unused portion of the solution must be discarded. DO NOT receive Viaflo glucose 3.3% and sodium chloride 0,3% from a partially used 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 (hyperglycaemia). Symptoms include:

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

• Low sodium levels in the blood (hyponatraemia). Hyponatraemia can cause headache, nausea, seizures, drowsiness, coma, brain swelling (cerebral oedema), and death.

• Fluid accumulation in the body causing swelling (oedema).

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

If any medicine has been added to Viaflo glucose 3.3% and sodium chloride 0.3% before the overdose occurred, that medicine may also cause symptoms. You should read the list of possible symptoms in the leaflet of the added medicine.

If the infusion of Viaflo glucose 3.3% and sodium chloride 0.3% is stopped

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 adverse effects

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

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

• Hypersensitivity reactions, including a severe allergic reaction called anaphylaxis (potential manifestation in patients with corn allergy)
• High blood sugar levels (hyperglycaemia)
• Low sodium levels in the blood that may be acquired during hospitalization (hospital-acquired hyponatraemia) and associated neurological disorder (acute hyponatraemic encephalopathy). Hyponatraemia may lead to irreversible brain damage and death due to cerebral oedema/inflammation (see also section 2 “Warnings and precautions”).

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

• Fever (febrile reaction)
• Chills
• Pruritus or itching
• Local pain or reaction (redness or swelling at the site of administration)
• Irritation and inflammation of the vein used for infusion of the solution (phlebitis). This may cause redness, pain or burning sensation, and swelling along the vein where the solution has been infused.

If a medicine has been added to the infusion solution, it may also cause adverse effects. These adverse 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 adverse effects:

If you experience any type of adverse effect, consult your doctor or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: 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 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% 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 3.3% and sodium chloride 0.3% 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 3.3% and sodium chloride 0.3%

The active substances are:

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

The other component is water for injections.

Appearance of the product and contents of the container

Viaflo glucose 3.3% and sodium chloride 0.3% is a clear solution free from visible particles. It is supplied in plastic bags made of polyolefin/polyamide (Viaflo). Each bag is contained within a sealed protective plastic overpouch.

The bag sizes are:

• 250 ml
• 500 ml
• 1000 ml

The bags are supplied in cartons containing the following quantities:

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

Some pack sizes may not be marketed.

Marketing Authorization Holder and Manufacturer

Holder:

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

Manufacturer: Baxter S.A. Av. René Branquart 80, Lessines Belgium

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 last revision of this leaflet: October 2023

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/

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This information is intended for healthcare professionals only

Handling and preparation

Use only if the solution is clear, free of visible particles, and if 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 cause gas embolism due to residual air being drawn from the primary container before completion of administration of the solution in the secondary container.

Pressurization of intravenous solutions in flexible plastic containers to increase flow rates may result in gas embolism if residual air in the container is not completely evacuated prior to administration.

The use of 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 aseptic technique. The administration set should be primed with the solution to prevent air from entering the system.

Medications may be added before or during infusion through the injection site. When adding medications, tonicity must be checked before parenteral administration.

From a physico-chemical standpoint, the solution containing added medications should be used immediately unless chemical and physical stability under use conditions has been established.

From a microbiological standpoint, solutions containing added medications should be used immediately and must not be stored. If not used immediately, the conditions and duration of storage prior to use are the responsibility of the user and normally should not exceed 24 hours at 2–8°C, unless reconstitution was performed under 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 overpouch immediately before use.
2. Check for leaks by firmly squeezing the inner bag. If leaks are detected, discard the solution, as it may not be sterile.
3. 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.

1. Hang the container by the hanger loop.
2. • 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.

1. Use aseptic technique to prepare the infusion.
2. Connect the administration set. Refer to the administration set instructions 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” below)

To add medication before administration

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

Caution: Do not store bags with added medication. See section 4 “In-use shelf life”.

To add medication during administration

1. Close the clamp on the administration set.
2. Disinfect the injection site.
3. Using a syringe with a 19G to 22G needle, puncture the resealable injection site and inject the medication.
4. Remove the container from the infusion stand and/or turn it to vertical position.
5. Empty both tubes by gently tapping them while the container is in vertical position.
6. Mix the solution and medication thoroughly.
7. Return the container to its administration position, reopen the clamp, and continue administration.

4- In-use shelf life (added medications)

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

From a physico-chemical standpoint, the solution containing added medications should be used immediately unless chemical and physical stability under use conditions has been established.

From a microbiological standpoint, the diluted product should be used immediately. If not used immediately, the storage duration and conditions prior to use are the responsibility of the user and normally should not exceed 24 hours at 2–8°C, unless the addition of medication was carried out under controlled and validated aseptic conditions.

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 added medication to Viaflo 3.3% glucose and 0.3% sodium chloride by examining 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 3.3% glucose and 0.3% sodium chloride (pH 3.5–6.5).

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

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

• Sodium ampicillin
• Mitomycin
• Erythromycin lactobionate
• Human insulin

Because it contains glucose, Viaflo 3.3% glucose and 0.3% sodium chloride must not be administered simultaneously with whole blood through the same infusion set due to the risk of haemolysis and agglutination.

Medications with known incompatibility must not be used.