Label: information for the user

Glucose 5% and sodium chloride 0.33% Baxter solution for infusion

Active ingredients: sodium chloride, glucose

Read this 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 any adverse effects, consult your doctor or nurse, even if they are not listed in this label. See section 4.

This medication is called Glucose 5% and Sodium Chloride 0.33% Baxter solution for infusion, but it will be referred to as “Glucose 5% and Sodium Chloride 0.33% Baxter” in the rest of this label

1.What is Glucose 5% and Sodium Chloride 0.33% Baxter and how it is used

2.What you need to know before you are given Glucose 5% and Sodium Chloride 0.33% Baxter

3.How you will be given Glucose 5% and Sodium Chloride 0.33% Baxter

4.Possible adverse effects

5.Storage of Glucose 5% and Sodium Chloride 0.33% Baxter

6.Contents of the package and additional information

Glucosa 5% and sodium chloride 0.33% Baxter 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 200 kilocalories per liter. Sodium and chloride are chemical substances found in the blood.

Glucosa 5% and sodium chloride 0.33% Baxter 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.

for treatment, if the volume of blood in the blood vessels is low (hypovolemia).

You should not be administered Glucosa 5% and 0.33% Sodium Chloride Baxter if you have any of the following clinical situations:

• If you are allergic to any of the components of this medication.
• When there is a lot of 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 an excessive amount of fluid and sodium in the body (fluid and sodium retention).
• When you have 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 is not receiving adequate treatment and causes symptoms such as:
• Difficulty breathing.
• Swelling of the ankles.
• If you have sodium levels in the blood below normal (hypontremia).
• If you have chloride levels in the blood below normal (hypochloremia).
• If you have generalized edema, which affects the entire body.

• If you have liver disease that causes fluid accumulation in the abdomen (cirrhosis ascitis).

• If you have diabetes that is not receiving adequate treatment, so that the blood sugar 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 are not receiving adequate medication.
• High blood sugar 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 (cirrhosis ascitis).
• Kidney failure.
• High blood pressure during pregnancy (pre-eclampsia).

• Taking some medications (see also "Other medications and Glucosa 5% and 0.33% Sodium Chloride Baxter").

• A disorder in which the blood becomes too alkaline (metabolic alkalosis).
• 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 (Glucosa 5% and 0.33% Sodium Chloride Baxter contains corn-derived glucose).

• 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 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 and Glucosa 5% and 0.33% Sodium Chloride Baxter).

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 who have 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).
• A fluid accumulation under the skin, affecting all parts of the body (generalized edema), around the ankles (peripheral edema), or in the lungs (pulmonary edema).

When you are receiving 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 Glucosa 5% and 0.33% Sodium Chloride Baxter 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 Glucosa 5% and 0.33% Sodium Chloride Baxter, you may need to receive additional nutrition. Your doctor should monitor your blood potassium levels to avoid them decreasing too much (hypokalemia).

Children

Special care should be taken when administering this solution to children, infants, and newborns (especially premature babies and those with low birth weight). Children, infants, 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 sugar 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 (hypontremia hipo-osmolar). Hypontremia can cause headache, nausea, convulsions, lethargy, coma, brain inflammation (cerebral edema), and death. Acute hypontremia encephalopathy is a severe 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 Glucosa 5% and 0.33% Sodium Chloride Baxter

Inform your doctor or nurse if you are using, or have recently used, any other 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).
• Cancer medications (vincristine, ifosfamide, cyclophosphamide).
• Selective serotonin reuptake inhibitors (used to treat depression).
• Antipsychotics or opioids for severe pain relief.
• Pain and/or anti-inflammatory medications (also known as NSAIDs).
• Medications 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 medications (carbamazepine and oxcarbazepine).
• Diuretics.

Other medications that may affect or be affected by Glucosa 5% and 0.33% Sodium Chloride Baxter are:

• Lithium (used to treat psychiatric diseases).
• Insulin (used to treat diabetes).
• Beta-blockers (heart medications).

Use of Glucosa 5% and 0.33% Sodium Chloride Baxter 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.

Glucosa 5% and 0.33% Sodium Chloride Baxter 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 prospectus of the medication to be added.

Driving and using machines

Glucosa 5% and 0.33% Sodium Chloride Baxter does not affect your ability to drive or use machines.

Gluconate 5% and Sodium Chloride 0.33% Baxterwill be administered by a doctor or a nurse. Your doctor will decide how much you need and when you should receive it. This will depend on your age, weight, physical condition, and the reason for the treatment. The amount you receive may also be influenced by other treatments you are receiving.

You should not receiveGluconate 5% and Sodium Chloride 0.33% Baxterif there are particles floating in the solution or if the container is damaged in any way.

Before and during the infusion, your doctor will monitor:

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

Any unused remainder of the solution should be discarded. You should not receive Gluconate 5% and Sodium Chloride 0.33% Baxter from a bag that has already been started.

If you receive moreGluconate 5% and Sodium Chloride 0.33% Baxterthan you should

If you receive too much of the Gluconate 5% and Sodium Chloride 0.33% Baxter solution or if you receive it 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 tissues (dehydration)

-thirst

-increased urine production (osmotic diuresis)

-blurred vision

-fatigue.

• Low sodium levels in the blood (hyponatremia). Hyponatremia can cause headaches, nausea, seizures, drowsiness, coma, brain swelling (cerebral edema), and death.
• A buildup of fluid in the body that causes swelling (edema).

If you experience 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 Gluconate 5% and Sodium Chloride 0.33% Baxter before the excessive administration, the medication may also cause symptoms. You should read the list of possible symptoms in the medication's package insert.

If you interrupt the perfusion ofGluconate 5% and Sodium Chloride 0.33% Baxter

Your doctor will decide when to stop receiving this infusion.

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

Like all medications,Glucosa 5% and Sodium Chloride 0.33% Baxtercan produce adverse effects, although not all people will experience them.

Adverse effects may be related toGlucosa 5% and Sodium Chloride 0.33% Baxter. 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 bedue 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 the infusion of the solution (phlebitis), which may cause redness, pain, or burning and swelling along the vein in which the solution has been infused.

If a medication has been added to the infusion solution, it 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.If any of them occur, the infusion should be stopped.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.

Do not store at a temperature above 25°C.

Glucose 5% and Sodium Chloride 0.33% BaxterDO NOT administer after the expiration date that appears on the bag after CAD. The expiration date is the last day of the month indicated.

Do not administer Glucose 5% and Sodium Chloride 0.33% Baxter if there are particles floating in the solution or if the container is damaged in any way.

The active principles are:

-glucose: 50 g per liter

-sodium chloride: 3.3 g per liter

The other component is water for injectable preparations.

Appearance of the product and contents of the container

Glucose 5% and sodium chloride 0.33% Baxteris a transparent solution, free of visible particles. It is presented in plastic bags of polyolefin/polyamide (Viaflo). Each bag is packaged in a protective plastic overbag.

The bag sizes are:

• 250 ml
• 500 ml
• 1000 ml

The bags are packaged in cardboard boxes. Each cardboard box contains one of 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 commercially available

Holder of the marketing authorization and responsible for manufacturing

Holder

Baxter S.L.

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

Date of the last review 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 protective 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 cause gas embolism due to residual air carried from the primary container before the administration of the liquid in the secondary container is complete.

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

The use of an intravenous administration set with a ventilation filter in the open position may 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 a sterile device using an aseptic technique. The device must be primed with the solution to prevent air from entering the system.

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

From a physical-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 solution 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 carried out in controlled and validated aseptic conditions.

Discard after single use.

Discard partially used containers.

Do not reconnect partially used bags.

1-To open

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

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

c.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.

a.Hang the container by the loop

b.-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 it.

-The cap will come off.

c.Use an aseptic technique to prepare the infusion

d.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")

For adding medication before administration

a.Disinfect the injection port

b.Using a syringe with a 19gauge (1.10 mm)to 22gauge (0.70 mm)needle, prick the injection port and inject.

c.Mix the medication and solution completely. For high-density medicines, such as potassium chloride, gently tap the tubes while in the vertical position and mix.

Caution: Do not store bags with added medication.

For adding medication during administration

a.Close the clamp of the equipment

b.Disinfect the injection port

c.Using a syringe with a 19gauge (1.10 mm)to 22gauge (0.70 mm)needle, prick the injection port and inject.

d.Remove the container from the foot of the drip chamber and/or turn it to put it in the vertical position.

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

f.Mix the solution and medication completely.

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

4.Expiry in use (added medicines)

Before use, the physical and chemical stability of any additional medication to the pH of the solutionGlucose 5% and sodium chloride 0.33% Baxterin the Viaflo container must be established.

From a physical-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 solution 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 carried out in controlled and validated aseptic conditions.

5-Incompatibilities of added medicines

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

It is the responsibility of the doctor to judge the incompatibility of the added medication withGlucose 5% and sodium chloride 0.33% Baxterby examining any eventual change in color and/or precipitation, insoluble complexes, or appearance of crystals. The package insert of the medicine to be added should be consulted.

Before adding a medicine, verify thatit is soluble and stable in water at the pH of Glucose 5% and sodium chloride 0.33% Baxter (pH 3.5 - 6.5).

When adding compatible medication to Glucose 5% and sodium chloride 0.33% Baxter, 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 withGlucose 5% and sodium chloride 0.33% Baxter(this is not an exhaustive list):

-Sodium ampicillin

-Mitomycin

-Erythromycin lactobionate

-Human insulin

As it contains glucose,Glucose 5% and sodium chloride 0.33% Baxtershould 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.