Label: information for the user

Glucose 3.33% and Sodium Chloride 0.3% Baxter solution for infusion

Active ingredient: sodium chloride, glucose

Read this label carefully before starting to use this medication, as 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 3.33% and Sodium Chloride 0.3% Baxter solution for infusion, but it will be referred to as “Glucose 3.33% and Sodium Chloride 0.3% Baxter” in the rest of this label

Contents of the package and additional information

Glucosa 3,33% and Cloruro sódico 0,3% Baxteris a solution of the following substances in water:

• Sugar (glucose)
• Sodium chloride

Glucose is one of the body's energy sources. This solution provides 132 kilocalories per liter. Sodium and chloride are chemical substances found in the blood

Glucosa 3,33% and Cloruro sódico 0,3% Baxteris 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.
• to treat, if the volume of blood in the blood vessels is low (hypovolemia).

You should not be administered Glucosa 3.33% and Cloruro sódico 0.3% Baxter if you have any of the following clinical situations:

-if you know you are allergic to this medication

• when there is a lot of fluid in the spaces around the body's cells (extracellular hyperhydration)
• when there is an excessive amount 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 the appropriate treatment and causes symptoms such as:
• difficulty breathing
• swelling of the ankles
• if your blood sodium levels are lower than normal (hypnatremia)
• if your blood chloride levels are lower than normal (hypochloremia)
• if there is a buildup of fluid under the skin that affects the entire body (generalized edema)

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

• if you have diabetes that is not receiving the appropriate treatment, so that your 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 the appropriate 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 (ascitic cirrhosis)
• kidney failure
• high blood pressure during pregnancy (pre-eclampsia)

• taking some medications (see also “Other medications andGlucosa 3.33% and Cloruro sódico 0.3% Baxter”)

• metabolic alkalosis (a condition in which the blood becomes too alkaline)
• 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 3.33% and Cloruro sódico 0.3% Baxtercontains glucose derived from corn)

• if you have a condition that could cause high levels of vasopresin, a hormone that regulates the body's fluid. You may have too much vasopresin 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 andGlucosa 3.33% and Cloruro sódico 0.3% Baxter).

This may increase the risk of having 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, brain bleeding, or brain injury

• changes in the concentrations ofchemical substances in the blood (electrolyte alterations)
• a buildup of fluid under the skin that affects 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 will be able to 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)

AsGlucosa 3.33% and Cloruro sódico 0.3% Baxtercontains sugar (glucose), it may increase blood sugar levels (hyperglycemia). If this occurs, your doctor will be able to:

• 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 the 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 3.33% and Cloruro sódico 0.3% Baxter, you may need to receive extra nutrition. Your doctor should control your blood potassium levels to avoid them decreasing too much (hypokalemia).

Children

Special care should be taken when administering 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 chemical substances in the solution.

Younger children are at higher risk of developinglow or high blood sugar levelsandtherefore requireclose monitoringduring intravenous infusion treatment to ensure proper control of blood sugar levels. Low blood sugar in newborns can cause prolonged convulsions, coma, and brain damage. High blood sugar has been associated withbrain hemorrhage,infections (bacterial or fungal), 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 (hypotonic hyponatremia). Hyponatremia can cause headache, nausea, convulsions, lethargy, coma, brain inflammation (cerebral edema), and death. Acute hyponatremic encephalopathy is a severe complication, especially in children.

Your doctor knows all this and will closely monitor the amount of chemical substances such as glucose (sugar), sodium, and chloride in your child's blood (plasma electrolytes).

Other medications and Glucosa 3.33% and Cloruro sódico 0.3% Baxter

Inform your doctor or nurse if you are using or have recently usedany othermedication.

It is particularly important that you 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) orhigh blood pressure (hypertension).

Some medications act on the vasopresin hormone. These may include:

• diabetes medication (chlorpropamide)
• cholesterol-lowering medication (clofibrate)
• some cancer medications (vincristine, ifosfamide, cyclophosphamide)
• selective serotonin reuptake inhibitors (used to treat depression)
• antipsychotics or opioids for severe pain relief
• medications for pain and/or inflammation (also known as NSAIDs)
• medications that mimic or strengthen the effects of vasopresin, such as desmopressin (used to treat increased thirst and urination), terlipressin (used to treat esophageal bleeding), and oxytocin (used to induce labor)
• antiepileptic medications (carbamazepine and oxcarbazepine)
• diuretics

Other medications that may affect or be affected by Glucosa 3.33% and Cloruro sódico 0.3% Baxter are:

• lithium (used to treat psychiatric diseases)
• insulin (used to treat diabetes)
• beta-blockers (heart medications)

Use ofGlucosa 3.33% and Cloruro sódico 0.3% Baxterwith 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, consultyour doctor ornursebefore usingthismedication.

Glucosa 3.33% and Cloruro sódico 0.3% 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 medication's prospectus

Driving and using machines

Glucosa 3.33% and Cloruro sódico 0.3% Baxterdoes not affect your ability to drive or usemachines.

Glucose 3.33% and Sodium Chloride 0.3% Baxterwill be administered by a doctor or a nurse. Your doctor will decide how much you need and when to administer it. This will depend on your age, weight, clinical condition, and the reason for treatment. The amount you receive may also be influenced by other treatments you are receiving.

Noshould receive Glucose 3.33% and Sodium Chloride 0.3% Baxterif there are particles floating in the solution or if the container is damaged in any way.

GenerallyGlucose 3.33% and Sodium Chloride 0.3% Baxterwill be administered through a plastic tube attached to a needle inserted into a vein. A vein in the arm is usually used to administer the infusion. However, your doctor may administer the medication 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 (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. Do not receiveGlucose 3.33% and Sodium Chloride 0.3% Baxterfrom a bottlethat has already been used.

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

If you receive too much of the solution ofGlucose 3.33% and Sodium Chloride 0.3% Baxteror if you receive it too quickly, you may experience the following symptoms:

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

If you develop 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 Glucose 3.33% and Sodium Chloride 0.3% Baxterbefore an overdose occurs, be aware that the added medication may also cause symptoms. Read the list of possible symptoms in the medication's package insert.

If you interruptthe infusion ofGlucose 3.33% and Sodium Chloride 0.3% Baxter

Your doctor will decide when to stop receiving this infusion.

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

Like all medications,this medicationcan produce adverse effects, although not all people will experience them.

• Adverse effects may be related toGlucose 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 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). This 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, this medication 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

Keepthis medicationout of sightand out of reachof children.

Do not store at a temperature above 25°C.

Glucose 3.33% and Sodium Chloride 0.3% BaxterDO NOT administer after the expiration date that appears on the bottle after CAD. The expiration date is the last day of the month indicated.

Do not receiveGlucose 3.33% and Sodium Chloride 0.3% Baxterif 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 Composition

The active principles are:

- Glucose (sugar): 33.3 g per liter

- Sodium Chloride: 3 g per liter

The other component is Water for Injection.

Appearance of the product and contents of the container

Glucose 3.33% and Sodium Chloride 0.3% Baxter is a transparent solution, free of visible particles. It is presented in Type II glass bottles.

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

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

25 bottles of 50 ml

25 bottles of 100 ml

30 bottles of 250 ml

10 bottles of 500 ml

10 bottles of 1,000 ml

Only some sizes of containers may be commercially available.

Marketing Authorization Holder and Responsible Person for Manufacturing

Marketing Authorization Holder

Baxter S.L.

Polígono Industrial Sector 14. Pouet de Camilo 2,

46394 Ribarroja del Turia (Valencia)

Spain

Responsible Person for Manufacturing:

Last review date of this prospectus: June 2019

The detailed and updated information on this medication 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.

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

Medications may 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 has been established in use.

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 at 2-8°C, unless the addition has taken place in controlled and validated aseptic conditions.

Discard after single use.

Discard partially used bottles.

Do not reconnect partially used bottles.

1- To open

a. Remove the aluminum cap that protects the closure.

b. Verify the clarity of the solution and the absence of foreign particles. If the solution is not transparent or contains foreign particles, discard the solution.

2- Preparation for administration

Use sterile material for preparation and administration.

a. Hang the container by the hanger provided with the shipping box.

b. Use an aseptic method to prepare the infusion.

c. 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:

a. Disinfect the injection site of the medication.

b. Using a syringe with a 19 G to 22 G needle, pierce the resellable injection point and inject.

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

Caution: Do not store bottles with added medication. See paragraph 4 "Expiration in use (added medications)".

To add medications during administration:

a. Close the equipment clamp.

b. Disinfect the injection site of the medication.

c. Using a syringe with a 19 G to 22 G needle, pierce the resellable injection point and inject.

d. Remove the container from the drip chamber and/or change to a vertical position.

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

f. Mix the solution and medication thoroughly.

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

4. Expiration in use (added medications)

Before use, the physical and chemical stability of any additional medication to 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 has been established in use.

From a microbiological point of view, the diluted product 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 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 the added medications with the solution must be verified before addition.

It is the responsibility of the doctor to judge the incompatibility of the added medication with Glucose 3.33% and Sodium Chloride 0.3% Baxter by examining any eventual change in color and/or precipitation, insoluble complexes, or appearance of crystals. The medication 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 with Glucose 3.33% and Sodium Chloride 0.3% Baxter the solution should be administered immediately unless the chemical and physical stability has been established in use.

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

- Ampicillin sodium

- Mitomycin

- Erythromycin lactobionate

- Human insulin

Due to containing glucose, Glucose 3.33% and Sodium Chloride 0.3% Baxter , 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.