GLUCOSE 3.33% & SODIUM CHLORIDE 0.3% BAXTER SOLUTION FOR INFUSION

2. What you need to know before you are given Glucose 3.33% and Sodium Chloride 0.3% Baxter

You should not be given Glucose 3.33% and Sodium Chloride 0.3% Baxter if you have any of the following conditions:

• if you know 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 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 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 the proper treatment and is causing symptoms such as:
  • difficulty breathing
  • swelling of the ankles.
  • if you have low sodium levels in the blood (hyponatremia).
  • if you have low chloride levels in the blood (hypochloremia).
  • if there is fluid accumulation under the skin, affecting the whole body (generalized edema).

• if you have a liver disease that causes fluid accumulation in the abdomen (ascitic cirrhosis).

• if you have uncontrolled diabetes, so that your blood sugar levels are higher than normal (uncontrolled diabetes).
• other situations of glucose intolerance, such as:
• metabolic stress (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 3.33% and Sodium Chloride 0.3% 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 3.33% and Sodium Chloride 0.3% Baxter contains glucose derived from corn)

• 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 3.33% and Sodium Chloride 0.3% 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 (especially 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 a head injury.

• changes in the concentrations of chemicals in the blood (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 3.33% and Sodium Chloride 0.3% Baxter contains sugar (glucose), it may 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 especially 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 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 consider whether you are receiving parenteral nutrition (nutrition given by infusion into a vein). During prolonged treatment with Glucose 3.33% and Sodium Chloride 0.3% Baxter, you may need to receive extra nutrition. Your doctor should monitor your blood potassium levels to prevent them from falling too low (hypokalemia).

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 intravenous infusion 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 3.33% and Sodium Chloride 0.3% Baxter

Tell your doctor or nurse if you are using or have recently used any other medicines.

It is especially 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 tissue swelling 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 3.33% and Sodium Chloride 0.3% Baxter are:

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

Using Glucose 3.33% and Sodium Chloride 0.3% 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 3.33% and Sodium Chloride 0.3% 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 3.33% and Sodium Chloride 0.3% Baxter does not affect your ability to drive or use machines.

3. How Glucose 3.33% and Sodium Chloride 0.3% Baxter will be given to you

Glucose 3.33% and Sodium Chloride 0.3% 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, medical 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 3.33% and Sodium Chloride 0.3% Baxter if there are particles floating in the solution or if the container is damaged in any way.

Glucose 3.33% and Sodium Chloride 0.3% Baxter is usually given through a plastic tube attached to a needle inserted into a vein. A vein in the arm is usually used to give the infusion. However, your doctor may give you the medicine in another 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 3.33% and Sodium Chloride 0.3% Baxter from a bottle that has already been used.

If you receive more Glucose 3.33% and Sodium Chloride 0.3% Baxter than you should

If you receive too much Glucose 3.33% and Sodium Chloride 0.3% 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 that causes swelling (edema).

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

If a medicine has been added to Glucose 3.33% and Sodium Chloride 0.3% Baxter before an overdose occurs, you should be aware that the added medicine may also cause symptoms. You should read the list of possible symptoms in the package leaflet of the added medicine.

If you stop receiving Glucose 3.33% and Sodium Chloride 0.3% Baxter

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 side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

• Side effects may be related to Glucose 3.33% and Sodium Chloride 0.3% Baxter. These include:
• allergic reactions, including severe allergic reactions 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 infusion 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). This 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 side effects:

If you experience any side effects, talk to your doctor or nurse, even if it is possible side effects 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 Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Glucose 3.33% and Sodium Chloride 0.3% Baxter

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

Do not store above 25°C.

Glucose 3.33% and Sodium Chloride 0.3% Baxter should not be administered after the expiry date stated on the bottle after EXP. The expiry date is the last day of the month shown.

You should not receive Glucose 3.33% and Sodium Chloride 0.3% Baxter if there are particles floating in the solution or if the container is damaged in any way.

6. Contents of the pack and further information

Composition of Glucose 3.33% and Sodium Chloride 0.3% Baxter

The active ingredients are:

• sugar (glucose): 33.3 g per liter
• sodium chloride: 3 g per liter

The other component is water for injectable preparations.

Appearance of the product and packaging content

Glucose 3.33% and Sodium Chloride 0.3% Baxter is a clear, particle-free solution. It is presented in Type II glass vials.

The vial sizes are 50 ml, 100 ml, 250, 500, or 1,000 ml.

The vials are packaged in cardboard boxes. Each cardboard box contains one of the following quantities:

25 vials of 50 ml

25 vials of 100 ml

30 vials of 250 ml

10 vials of 500 ml

10 vials of 1000 ml

Only some packaging sizes may be marketed.

Marketing authorization holder and manufacturer

Holder

Baxter S.L.

Polígono Industrial Sector 14. Pouet de Camilo 2,

46394 Ribarroja del Turia (Valencia)

Spain

Manufacturer:

Date of the last revision of this prospectus:June 2019

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

This information is intended only for healthcare professionals

Handling and preparation

Use only if the solution is clear, free of visible particles, and the container is not damaged. Administer immediately after connecting the infusion equipment.

The solution should be administered with sterile equipment using an aseptic technique. The equipment should be primed with the solution to prevent air from entering the system.

Medications can be introduced before or during infusion through the injection point. When adding medications, check the isotonicity before parenteral administration.

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

From a microbiological point of view, solutions containing added medications should be used immediately. If not used immediately, the storage times and conditions prior to use are the responsibility of the user and should not normally exceed 24 hours between 2 and 8°C, unless the addition has taken place in controlled and validated aseptic conditions.

Discard after a single use.

Discard partially used vials.

Do not reconnect partially used vials.

1- To open

• Remove the aluminum cap that protects the closure.

• Check the clarity of the solution and the absence of foreign particles. If the solution is not clear or contains foreign particles, discard the solution.

2- Preparation for administration

Use sterile material for preparation and administration.

• Hang the container by the hanger that accompanies the shipping box.

• Use an aseptic method 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").

To add medications before administration:

• Disinfect the medication injection site.

• Using a syringe with a 19 G to 22 G needle, puncture the resealable injection point and inject.

• Mix the solution and medication completely. For high-density medications, such as potassium chloride, gently move while in a vertical position and mix.

Precaution: Do not store vials with added medication; see paragraph 4 "Expiry in use (added medications)".

To add medications during administration:

• Close the equipment clamp.

• Disinfect the medication injection site.

• Using a syringe with a 19 G to 22 G needle, puncture the resealable injection point and inject.

• Remove the container from the drip stand and/or change to 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.

1. Expiry in use (added medications)

Before use, the physical and chemical stability of any added medication at the pH of the Glucose 3.33% and Sodium Chloride 0.3% Baxter solution must be established.

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

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

5- Incompatibilities of added medications

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

It is the responsibility of the physician to judge the incompatibility of the added medication with Glucose 3.33% and Sodium Chloride 0.3% Baxter by examining any change in color and/or precipitation, insoluble complexes, or crystal formation. The medication's prospectus should be consulted.

Before adding a medication, verify that it is soluble and stable in water at the pH of Glucose 3.33% and Sodium Chloride 0.3% Baxter (pH 3.5 – 6.5).

When adding compatible medication to Glucose 3.33% and Sodium Chloride 0.3% Baxter, the solution should be administered immediately unless the chemical and physical stability in use has been established.

As a guide, the following medications are incompatible with Glucose 3.33% and Sodium Chloride 0.3% Baxter (this is not an exhaustive list):

• Sodium ampicillin
• Mitomycin
• Erythromycin lactobionate
• Human insulin

Since Glucose 3.33% and Sodium Chloride 0.3% 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 that are known to be incompatible should not be used.