Viaflo glucose 5% and sodium chloride 0.9% solution for infusion

Patient Information Leaflet

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Viaflo Glucose 5% and Sodium Chloride 0.9% solution for infusion

Active substances: glucose, sodium chloride

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor or nurse.
• If you get any side effects, talk to your doctor or nurse, even if they are not listed in this leaflet. See section 4.

This medicine is called "Viaflo Glucose 5% and Sodium Chloride 0.9% solution for infusion", but will be referred to as "Viaflo Glucose 5% and Sodium Chloride 0.9%" throughout the rest of this leaflet.

Leaflet contents

1. What Viaflo Glucose 5% and Sodium Chloride 0.9% is and what it is used for
2. What you need to know before being administered Viaflo Glucose 5% and Sodium Chloride 0.9%
3. How Viaflo Glucose 5% and Sodium Chloride 0.9% is administered
4. Possible side effects
5. How to store Viaflo Glucose 5% and Sodium Chloride 0.9%
6. Contents of the pack and other information

1. What Viaflo Glucose 5% and Sodium Chloride 0.9% is and what it is used for

Viaflo Glucose 5% and Sodium Chloride 0.9% is a solution for infusion. It contains two active substances: Glucose (also known as dextrose) at a concentration of 5% and Sodium Chloride at a concentration of 0.9% (commonly referred to as physiological saline).

This solution is used to:

• Replace lost body fluids and electrolytes (such as sodium and chloride) when the body cannot take them orally.
• Provide carbohydrate in the form of glucose to supply energy, especially in patients unable to eat or drink.
• Serve as a vehicle for the intravenous administration of other medicinal products compatible with this solution.

It is typically used in clinical settings for patients requiring fluid and energy supplementation, such as those undergoing surgery, suffering from dehydration, or unable to maintain adequate oral intake.

Viaflo Glucose 5% and Sodium Chloride 0.9% is a solution containing the following substances in water:

• Sugar (glucose)
• Sodium chloride (salt)

Glucose is one of the body's sources of energy. This solution provides 200 kilocalories per liter. Sodium and chloride are chemical substances found in the blood.

Viaflo Glucose 5% and Sodium Chloride 0.9% is used:

• as a source of carbohydrates (sugar).
• to treat loss of sodium from the blood and body (sodium depletion).
• to treat loss of body water, for example after illness or diarrhea (extracellular dehydration).
• for treatment when blood volume in the blood vessels is low (hypovolemia).

2. What you need to know before Viaflo Glucose 5% and Sodium Chloride 0.9% is administered to you

Viaflo Glucose 5% and Sodium Chloride 0.9% will not be administered to you in the following cases:

• if you are allergic to the medicine
• when there is too much fluid in the spaces surrounding the body's cells (extracellular hyperhydration)
• when there is a higher-than-normal blood volume in the blood vessels (hypervolemia)
• excess fluid and sodium in the body (fluid and sodium retention)
• severe kidney problems resulting in reduced or no urine production (oliguria or anuria)
• decompensated heart failure. This is heart failure that is not adequately treated and causes symptoms such as:
  • difficulty breathing
  • swelling of the ankles.
• abnormally high levels of sodium in the blood (hypernatremia)
• abnormally high levels of chloride in the blood (hyperchloremia)
• accumulation of fluid under the skin affecting the entire body (generalized edema)
• liver disease causing fluid accumulation in the abdomen (ascitic cirrhosis)
• inadequately treated diabetes, resulting in abnormally high 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 a serious illness)
  • hyperosmolar coma (loss of consciousness). This is a type of coma that may occur if you have diabetes and are not receiving adequate treatment.
  • very high blood sugar levels (significant hyperglycemia)
  • abnormally high levels of lactate in the blood (hyperlactatemia)

Warnings and precautions

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

• a disorder causing the blood to become too alkaline (metabolic alkalosis),

• muscle weakness and periodic paralysis due to overactive thyroid (thyrotoxic periodic paralysis),

• rapid loss of body water, e.g., due to vomiting or diarrhea,

• prolonged adherence to a low-potassium diet,

• taking certain medications. See below “Other medicines and Viaflo Glucose 5% and Sodium Chloride 0.9%”,

• a disorder in which the blood becomes too acidic (metabolic acidosis).

• if you have a condition that could lead to elevated levels of vasopressin, a hormone that regulates your body's fluid balance. You may have excess vasopressin in your body because, for example:

• 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 5% and Sodium Chloride 0.9%)

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. Individuals at higher risk of brain swelling include:

• children
• women (particularly those of childbearing age)
• individuals with conditions affecting cerebral fluid levels, such as meningitis, intracranial bleeding, or brain injury.

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

• Aldosteronism (a disorder causing high levels of a hormone called aldosterone) associated with:
• impaired liver function or liver disease causing fluid accumulation in the abdomen (ascitic cirrhosis),
• high blood pressure (hypertension),
• heart failure,
• kidney failure.
• high blood pressure during pregnancy (preeclampsia),
• any other condition associated with sodium retention (when the body retains too much sodium), such as treatment with steroids (see below “Other medicines and Viaflo Glucose 5% and Sodium Chloride 0.9%”),
• allergy, particularly to corn (Viaflo Glucose 5% and Sodium Chloride 0.9% contains corn-derived sugar).

Infusion may cause:

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

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

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

Since Viaflo Glucose 5% and Sodium Chloride 0.9% 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 sugar levels.

This is particularly important:

• if you are diabetic,
• if you have not been eating properly or have been consuming excessive alcohol for a prolonged period,
• if you have recently suffered a brain injury (acute stroke), as high blood sugar levels may worsen the effects of brain damage and affect recovery,
• if you sustained a head injury within the last 24 hours.

Your doctor should consider whether you are receiving parenteral nutrition (nutrition delivered via intravenous infusion). During prolonged treatment with Viaflo Glucose 5% and Sodium Chloride 0.9%, you may require additional nutrition. Your doctor should also monitor your blood potassium levels to prevent abnormally low levels (hypokalemia).

Children

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

Newborns—particularly 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 intravenous glucose solution therapy to ensure appropriate blood sugar control and prevent potential long-term adverse effects. Low blood sugar in newborns may cause prolonged seizures, coma, and brain damage. High blood sugar may lead to brain hemorrhages, bacterial or fungal infections, eye damage (retinopathy of prematurity), intestinal tract infections (necrotizing enterocolitis), lung problems (bronchopulmonary dysplasia), prolonged hospitalization, and death.

Children are at increased risk of developing or worsening low sodium levels in the blood (hyponatremia). Hyponatremia may cause headache, nausea, seizures, drowsiness, coma, brain swelling (cerebral edema), and death. Acute hyponatremic encephalopathy is a serious complication, especially in children. Your doctor is aware of these risks and will carefully monitor the levels of chemicals such as sodium and chloride in your child's blood (plasma electrolytes).

Other medicines and Viaflo Glucose 5% and Sodium Chloride 0.9%

Inform your doctor if you are taking, have recently taken, or might need to take 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),
• high blood pressure (hypertension).

Some medicines affect the hormone vasopressin. These may include:

• antidiabetic medicines (chlorpropamide)
• cholesterol-lowering medicines (clofibrate)
• certain cancer treatments (vincristine, ifosfamide, cyclophosphamide)
• selective serotonin reuptake inhibitors (used to treat depression)
• antipsychotics
• 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 5% and Sodium Chloride 0.9%:

• Lithium (used to treat psychiatric disorders),
• insulin (used to treat diabetes),
• diuretics,
• beta-blockers (heart medications)

Viaflo Glucose 5% and Sodium Chloride 0.9% must not be administered through the same cannula used for blood transfusion, as it may damage red blood cells or cause them to clump together.

Use of Viaflo Glucose 5% and Sodium Chloride 0.9% with food and drinks

Ask your doctor what you may eat or drink.

Pregnancy and breastfeeding

If you are pregnant, breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or nurse before using any medicine.

Viaflo Glucose 5% and Sodium Chloride 0.9% may be administered during breastfeeding.

If another medicine is added to the infusion solution during pregnancy or breastfeeding, you must:

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

Driving and using machines

Viaflo Glucose 5% and Sodium Chloride 0.9% does not affect your ability to drive or operate machinery.

3. How Viaflo glucose 5% and sodium chloride 0.9% is administered

Viaflo Glucose 5% and Sodium Chloride 0.9% 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.

DO NOT receive Viaflo Glucose 5% and Sodium Chloride 0.9% if there are particles floating in the solution or if the container is damaged in any way.

Generally, Viaflo Glucose 5% and Sodium Chloride 0.9% will be administered through a plastic tube connected to a needle inserted into a vein. However, your doctor may administer the medicine in another way.

Any unused portion of the solution must be discarded. DO NOT receive Viaflo Glucose 5% and Sodium Chloride 0.9% from a bag that has been partially used.

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 medications that increase the effect of vasopressin).

If you are given more Viaflo Glucose 5% and Sodium Chloride 0.9% than you should

If you receive too much 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 lack of water in body tissues (dehydration),
• thirst,
• fatigue,
• frequent urination due to increased urine production (osmotic diuresis),
• blurred vision.
• Low sodium levels in the blood (hyponatremia). Hyponatremia may cause headache, nausea, seizures, drowsiness, coma, brain swelling (cerebral edema), and death.
• High sodium levels in the blood (hypernatremia). If this occurs, the most serious effect is a reduction in brain water content (brain dehydration). This causes drowsiness and confusion and may lead to seizures, loss of consciousness (coma), breathing interruption (respiratory failure), and even death. Other symptoms include:
• thirst,
• dryness of mouth and eyes,
• fever,
• rapid heartbeat (tachycardia),
• high blood pressure (hypertension),
• headache,
• dizziness,
• restlessness,
• irritability,
• weakness.
• Fluid accumulation in the body causing swelling (edema).

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 medication has been added to Viaflo Glucose 5% and Sodium Chloride 0.9% before the overdose occurred, that medication may also cause symptoms. You should read the list of possible side effects in the leaflet of the added medicine.

In case of overdose or accidental ingestion, contact the Toxicology Information Service. Telephone: 91 562 04 20.

Stopping the infusion of Viaflo Glucose 5% and Sodium Chloride 0.9%

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, this medicine may cause adverse effects, although not everyone will experience them.

The adverse effects may be related to Viaflo Glucose 5% and Sodium Chloride 0.9%. These include:

• hypersensitivity reactions, including a severe allergic reaction called anaphylaxis (potential manifestation in patients with corn allergy).
• sodium levels in the blood higher than normal (hypernatremia)
• blood sugar levels higher than normal (hyperglycemia).
• low levels of sodium in the blood that may be acquired during hospitalization (hospital-acquired hyponatremia) and associated neurological disorder (acute hyponatremic encephalopathy). Hyponatremia may cause irreversible brain damage and death due to cerebral edema/inflammation (see also section 2 “Warnings and precautions”).

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

• fever (febrile reaction),
• chills,
• itching (pruritus) or rash,
• pain or local reaction (pain or blisters at the infusion site),
• irritation and inflammation of the vein into which the solution is infused (phlebitis). This may cause redness, pain, burning, 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 that medicine.

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 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 5% and sodium chloride 0.9%

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

Viaflo glucose 5% and sodium chloride 0.9% does not require special storage conditions.

Viaflo glucose 5% and sodium chloride 0.9% MUST NOT be administered after the expiry date stated on the bag after EXP. The expiry date is the last day of the month indicated.

Do not use Viaflo glucose 5% and sodium chloride 0.9% if there are 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% and Sodium Chloride 0.9%

The active substances are:

• sugar (glucose): 50 g per litre
• sodium chloride: 9 g per litre

The other component is water for injections.

Appearance of the product and contents of the container

Viaflo Glucose 5% and Sodium Chloride 0.9% 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 overpouch made of plastic.

The bag sizes are:

• 250 ml
• 500 ml
• 1000 ml

The bags are supplied in cartons, each containing the following quantities:

• 30 bags of 250 ml
• 20 bags of 500 ml
• 10 bags of 1,000 ml
• 12 bags of 1,000 ml

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Holder:

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

Manufacturer:

Bieffe Medital S.A.
Ctra de Biescas, Senegüé
22666 Sabiñanigo (Huesca)
Spain

Baxter SA
Boulevard René Branquart, 80
7860 Lessines
Belgium

Date of latest revision of the package leaflet: October 2023

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

This information is intended for healthcare professionals only

Handling and preparation

Use only if the solution is clear, free from 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 connection may result in gas embolism due to residual air being carried over from the primary container before completion of administration of the fluid in the secondary container.

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 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 the vent filter in the open position must not be used with flexible plastic containers.

The solution must be administered using a sterile set 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 resealable medication port.

When medications are added, isotonicity must be verified before parenteral administration. Complete and careful aseptic mixing of any added medication is required. Solutions containing added medications should be used immediately and must not be stored.

Paediatric population

To avoid potentially fatal overdosing during intravenous infusion of solutions 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 is required regardless of whether the administration set has a free-flow protection device.

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

Discard after single use.

Discard any remaining portion.

Do not reconnect partially used bags.

1- To open

a- Remove the Viaflo bag from the protective overpouch immediately before use.

b- Check for leaks by firmly squeezing the inner bag. If leaks are detected, discard the solution as it may not be sterile.

c- Check the clarity of the solution 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.

a- Hang the container by the hanger loop.

b- Remove the plastic protector from the outlet port at the bottom of the container.

• Hold the small fin on the neck of the outlet port with one hand.
• Hold the large fin on the closure cap with the other hand and twist.
• The cap will detach.

c- Use an aseptic technique to prepare the infusion.

d- Connect the administration set. Refer to the instructions accompanying the administration set for connection, priming, and administration of the solution.

3- Techniques for injection of added medication

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

To add medication before administration:

a- Disinfect the medication port.

b- Using a syringe with a 19 G (1.10 mm) to 22 G (0.70 mm) needle, puncture the resealable medication port and inject.

c- Carefully mix the medication and solution. For high-density medications, such as potassium chloride, gently move the bag while in vertical position to mix.

Caution: Do not store bags with added medication.

To add medication during administration:

a- Close the clamp on the administration set.

b- Disinfect the medication port.

c- Using a syringe with a 19 G (1.10 mm) to 22 G (0.70 mm) needle, puncture the resealable medication port and inject.

d- Remove the container from the IV support and/or rotate it to place it in vertical position.

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

f- Carefully mix the solution and medication.

g- Return the container to its administration position, reopen the clamp, and continue administration.

1. In-use expiry (with added medications)

Prior to use, the physical and chemical stability of any additional medication at the pH of the Viaflo Glucose 5% and Sodium Chloride 0.9% solution in the Viaflo container must be established.

From a microbiological standpoint, the diluted product should be used immediately. 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 has been carried out under controlled and validated aseptic conditions.

5- Incompatibilities of added medications

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

It is the physician's responsibility to assess incompatibility of added medications with Viaflo Glucose 5% and Sodium Chloride 0.9% by checking for any change in colour 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, ensure that it is soluble and stable in water at the pH of the Viaflo Glucose 5% and Sodium Chloride 0.9% solution (pH 3.5 to 6.5).

When compatible medication is added to Viaflo Glucose 5% and Sodium Chloride 0.9%, the solution must be used immediately.

As a guide, the following medications are incompatible with Viaflo Glucose 5% and Sodium Chloride 0.9% (non-exhaustive list):

• Sodium ampicillin
• Mitomycin
• Amphotericin B
• Erythromycin lactobionate

Due to the presence of glucose, Viaflo Glucose 5% and Sodium Chloride 0.9% must not be administered through the same infusion set as whole blood, as haemolysis and agglutination may occur.

Medications known to be incompatible must not be used.