GLUCOSE 5% & SODIUM CHLORIDE 0.33% BAXTER SOLUTION FOR INFUSION

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

Glucose 5% and Sodium Chloride 0.33% Baxter should not be given to you if you have any of the following conditions:

• If you are allergic to any of the components of 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 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 the proper treatment and is causing symptoms such as:
• breathing difficulties.
• swelling of the ankles.
• if you have low levels of sodium in the blood (hyponatremia).
• if you have low levels of chloride in the blood (hypochloremia).
• if you have fluid accumulation under the skin, affecting the whole body (generalized edema).

• other situations of glucose intolerance, such as:
• metabolic aggression (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 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 Glucose 5% and Sodium Chloride 0.33% Baxter”)

• 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 water from the body, e.g. due to vomiting or diarrhea
• being on a low-potassium diet for a long time
• allergy, particularly to corn (Glucose 5% and Sodium Chloride 0.33% 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 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 Glucose 5% and Sodium Chloride 0.33% Baxter).

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 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 monitor:

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

Since Glucose 5% and Sodium Chloride 0.33% Baxter contains sugar (glucose), it can increase blood sugar levels (hyperglycemia). If this happens, your doctor may:

• adjust the infusion rate
• give you insulin to reduce blood glucose levels

This is particularly important:

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 Glucose 5% and Sodium Chloride 0.33% Baxter

Tell your doctor or nurse if you are using, or have recently used, 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 swelling of tissues 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 Glucose 5% and Sodium Chloride 0.33% Baxter are:

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

Using Glucose 5% and Sodium Chloride 0.33% Baxter 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 plan to become pregnant, consult your doctor or nurse before using this medicine.

Glucose 5% and Sodium Chloride 0.33% Baxter 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

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

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

Glucose 5% and Sodium Chloride 0.33% Baxter 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.

You should not receive 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.

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 (especially 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. You should not receive Glucose 5% and Sodium Chloride 0.33% Baxter from a started bag.

If you receive more Glucose 5% and Sodium Chloride 0.33% Baxter than you should

If you receive too much Glucose 5% and Sodium Chloride 0.33% Baxter 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 notice these symptoms, tell your doctor immediately. The infusion will be stopped and you will receive treatment based on the symptoms.

If a medicine has been added to Glucose 5% and Sodium Chloride 0.33% Baxter before the excessive administration, this medicine may also cause symptoms. You should read the list of possible symptoms in the package leaflet of the added medicine.

If the infusion of Glucose 5% and Sodium Chloride 0.33% Baxter is interrupted

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 side effects

Like all medicines, Glucose 5% and Sodium Chloride 0.33% Baxter can cause side effects, although not everybody gets them.

Side effects may be related to Glucose 5% and Sodium Chloride 0.33% Baxter. 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), which can cause redness, pain, or burning and swelling along the vein in which the solution was infused.

If a medicine has been added to the infusion solution, it 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 they are not listed in this leaflet. If any of these occur, the infusion should be stopped. You can also report side effects directly through the Spanish Medicines and Healthcare Products 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 Glucose 5% and Sodium Chloride 0.33% Baxter

Keep out of sight and reach of children.

Do not store above 25°C.

Glucose 5% and Sodium Chloride 0.33% Baxter should not be administered after the expiry date stated on the bag after EXP. The expiry date is the last day of the month indicated.

You should not receive 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.

6. Contents of the pack and other information

The active ingredients are:

• sugar (glucose): 50 g per liter
• sodium chloride: 3.3 g per liter

The other ingredient is water for injections.

Appearance and pack contents

Glucose 5% and Sodium Chloride 0.33% Baxter is a clear solution, free from visible particles. It is presented in polyolefin/polyamide (Viaflo) plastic bags. Each bag is packaged in a protective overwrap.

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

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Baxter S.L.

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

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 for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es/

This information is intended only for healthcare professionals

Handling and Preparation

Use only if the solution is transparent, without visible particles, and if 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 can produce gas embolisms due to residual air dragged from the primary container before the administration of the liquid contained in the secondary container is completed.

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

The use of an intravenous administration device with a ventilation filter in the open position could cause a gas embolism. This type of intravenous administration device 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 in order to prevent air from entering the system.

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

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

From a microbiological point of view, solutions with added medication should be used immediately. If not used immediately, the conditions and storage period before use are the responsibility of the user and normally should not 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

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

• 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.

• 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.

• Hang the container by the tab

• - 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 twist.
  • The cap will come off.

• Use an aseptic technique to prepare the infusion

• 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

• Disinfect the injection point

• Using a syringe with a 19-gauge (1.10 mm) to 22-gauge (0.70 mm) needle, puncture the resealable injection point and inject.

• 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.

To Add Medication During Administration

• Close the equipment clamp

• Disinfect the injection point

• Using a syringe with a 19-gauge (1.10 mm) to 22-gauge (0.70 mm) needle, puncture the resealable injection point and inject.

• Remove the container from the drip stand and/or turn it to put it in a vertical position.

• Empty both tubes by gently tapping them while the container is in a vertical position

• Mix the solution and medication completely

• Return the container to the operating position, reopen the clamp, and continue administration.

4.Expiry in Use (Added Medications)

Before use, the physical and chemical stability of any added medication at the pH of the Glucose 5% and Sodium Chloride 0.33% Baxter 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 chemical and physical stability has been established for use.

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 normally should not 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 with Glucose 5% and Sodium Chloride 0.33% Baxter by examining any change in color and/or precipitation, insoluble complexes, or the appearance of crystals. The medication's package insert should be consulted.

Before adding a medication, verify that it 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 chemical and physical stability has been established for use. As a guide, the following medications are incompatible with Glucose 5% and Sodium Chloride 0.33% Baxter (this is not an exhaustive list):

• Sodium ampicillin
• Mitomycin
• Erythromycin lactobionate
• Human insulin

Since Glucose 5% and Sodium Chloride 0.33% Baxter 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.