Label: information for the user

Glucosa Baxter 5% solution for infusion

Active ingredient: 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 refer to 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.

Contents of the package and additional information

Glucosa Baxter 5% is a sugar (glucose) solution in water.

Glucose is one of the body's energy sources. This perfusion solution provides 200 kilocalories per liter.

Glucosa Baxter 5% is used:

• as a source of liquids and carbohydrates (sugar).
• to dilute or apply other medications that can be administered via perfusion.

You should not be administered Glucosa Baxter 5% if you have any of the following clinical situations

• if you have diabetes that is not receiving adequate treatment, resulting in a blood glucose concentration higher than normal (uncontrolled diabetes).
• if there are situations of glucose intolerance, for example: when the body's metabolism does not function correctly, for example, due to severe diseases (metabolic stress).
• coma hyperosmolar (loss of consciousness). This is a type of coma that can occur if you have diabetes and do not receive adequate medication.
• blood glucose concentration higher than normal (hyperglycemia)
• blood lactate concentration higher than normal (hyperlactatemia).
• Intolerance (hypersensitivity) to glucose. This can occur in patients with an allergy to corn.

If another medication is added to your infusion solution, you should always read the package insert for that medication. In this way, you will know if that medication is safe for you.

Warnings and precautions

Inform your doctor if you have or have had any of the following medical conditions.

• Excess water in the body (water intoxication)
• If you are diabetic or have high blood sugar levels (hyperglycemia).
• If your kidneys do not function as well as they normally do.
• If you have sepsis, trauma, or shock.
• Low levels of electrolytes (sodium, potassium, phosphorus, magnesium) in the blood.
• Head injury in the last 24 hours.
• If you have recently had a stroke (acute ischemic stroke). High blood sugar levels can worsen the effects of the stroke and affect recovery.
• If you have metabolic disorders due to malnutrition or a diet that does not provide the necessary nutrients in the right proportion (malnutrition).
• If you have low levels of thiamine (vitamin B1) in your body. This can occur if you have chronic alcoholism.
• Allegy to corn (Glucosa Baxter 5% contains glucose derived from corn).
• If you have a condition that could cause high levels of vasopresin, a hormone that regulates the fluid in your body. 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 been operated on,
• you have infections, burns, or brain injury
• you have heart, liver, kidney, or central nervous system diseases,
• you are taking certain medications (see Other medications and Glucosa Baxter 5%)

This can increase the risk of having low sodium levels in the blood and can cause headaches, 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.

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

• the amount of electrolytes such as potassium present in the blood (plasma electrolytes),
• the amount of sugar (glucose),
• the amount of fluid in your body (your fluid balance),
• the acidity of your blood and urine (changes in acid-base balance).

Since Glucosa Baxter 5% contains sugar (glucose), it can increase blood glucose concentration (hyperglycemia). If this occurs, your doctor can:

• adjust the infusion rate
• administer insulin to reduce blood glucose concentration
• if necessary, administer more potassium

Glucosa Baxter 5% should not be administered with the same needle used for a blood transfusion. The red blood cells may be damaged or clumped.

Your doctor will take into account if you are receiving parenteral nutrition (nutrition given by infusion through a vein).

You may need complementary nutrition during long-term treatment with Glucosa Baxter 5%.

Children

Glucosa Baxter 5% should be administered with special care in children.

Children should receive Glucosa Baxter 5% from a doctor or nurse. The amount administered should be determined by a pediatric specialist and will depend on the child's age, weight, and condition. If it is used to administer or dilute another medication, or if other medications are administered at the same time, the dose may also be affected.

When the infusion is administered to children, your doctor will take blood and urine samples to monitor the amount of electrolytes such as potassium in the blood (plasma electrolytes).

Newborns - especially premature and low-birth-weight babies - are at higher risk of developing low or high blood glucose levels (hypoglycemia or hyperglycemia) and therefore require careful monitoring during treatment with glucose solutions by intravenous infusion to ensure proper control of blood sugar levels to prevent possible long-term adverse effects. Low blood sugar levels in newborns can cause convulsions, prolonged coma, and brain damage. High blood sugar levels can cause bleeding in the brain, bacterial or fungal infections, eye damage (retinopathy of prematurity), intestinal infections (necrotizing enterocolitis), lung problems (bronchopulmonary dysplasia), prolonged hospital stay, and death.

When administered to newborns, the bottle with the solution can be connected to a pump device that allows the exact amount of solution to be administered during the defined time interval. Your doctor or nurse should supervise the device to ensure the safety of administration.

Children (including newborns and older children) receiving Glucosa Baxter 5% are at higher risk of developing low sodium levels in the blood (hyponatremia) and a condition that affects the brain due to low plasma sodium levels (hypontatremic encephalopathy).

Other medications and Glucosa Baxter 5%

Inform your doctor or nurse if you are taking or have taken recently or may need to take any other medication.

Glucosa Baxter 5% and another medication taken at the same time may affect each other.

Do not take Glucosa Baxter 5% with certain hormones (catecholamines) including adrenaline or steroids, as they may increase blood sugar levels.

Some medications act on the vasopressin 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 enhance the effects of vasopresin, such as desmopressin (used to treat excessive thirst and urination), terlipressin (used to treat bleeding from the esophagus), and oxytocin (used to induce labor)
• antiepileptic medications (carbamazepine and oxcarbazepine)
• diuretics

Glucosa Baxter 5% with food and drinks

You should ask your doctor what foods and drinks you can take.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant or plan to become pregnant, consult your doctor before using this medication.

Pregnancy

Glucosa Baxter 5% can be used during pregnancy. However, caution should be exercised when using a glucose solution during labor.

Fertility

There is insufficient data on the effect of Glucosa Baxter 5% on fertility, although no effect is expected.

Breastfeeding

There is insufficient data on the use of Glucosa Baxter 5% during breastfeeding, although no effect is expected. Glucosa Baxter 5% can be used during breastfeeding.

However, if another medication is added to the infusion solution during pregnancy or breastfeeding, you should:

• consult your doctor.
• read the package insert for the medication to be added.

Driving and operating machines

Consult your doctor or nurse before driving or operating machines.

Glucose Baxter 5% will be administered by a doctor or nurse. Your doctor will decide how much you need and when it should be administered. This will depend on your age, weight, physical condition, the reason for treatment, and if the infusion is to be used to administer or dilute another medication. The amount you receive may also be influenced by other treatments you are receiving.

DO NOT receive Glucose Baxter 5% if there are particles floating in the solution or if the container is damaged in any way.

Glucose Baxter 5% will usually be administered through a plastic tube connected to a needle inserted into a vein. A vein in the arm is often used to administer the infusion. However, your doctor may administer the medication in another way.

Glucose Baxter 5% should be administered slowly to avoid excessive urine production (osmotic diuresis).

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 remaining solution not used should be discarded. DO NOT receive Glucose Baxter 5% from a started container.

If you receive more Glucose Baxter 5% than you should

If you receive an excessive amount of Glucose Baxter 5% or administer it too quickly, you may experience the following symptoms:

• fluid accumulation in tissues causing swelling (edema) or water intoxication, with a lower than normal sodium level in the blood (hyponatremia)
• increased urine production (osmotic diuresis)
• excessive blood concentration (hyperosmolarity)
• water loss from the body (dehydration)
• high blood glucose concentration (hyperglycemia)
• glucose presence in the urine (hyperglycosuria)

If you observe these symptoms, inform your doctor immediately. The infusion will be suspended or reduced. Insulin will be administered, and you will receive treatment based on your symptoms.

If a medication has been added to Glucose Baxter 5% before excessive administration, that medication may also cause symptoms. Please read the list of possible symptoms in the prospectus of the added medication.

If you interrupt the Glucose Baxter 5% infusion

Your doctor will decide when you should stop receiving this infusion.

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

Like all medicines, Glucosa Baxter 5% may cause side effects, although not everyone will experience them.

The side effects may include:

• Allergic reactions, including a severe allergic reaction called anaphylaxis (potential manifestation in patients with corn allergy),
• Changes in blood chemistry substance concentrations (electrolyte disorders).
• High blood glucose concentration (hyperglycemia).
• Loss of body water (dehydration).
• Excess fluid in the blood vessels (hypervolemia),
• Excessive urine volume (polyuria)
• 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”).
• Reactions due to administration technique:
• • Reaction at the injection site:
  • • Irritation and inflammation of the vein in which the solution is administered. This may produce redness, pain, or itching and swelling along the vein in which the solution is administered,
    • Pain or local reaction (redness or swelling at the perfusion site),
    • Fever, febrile response (pyrexia),
    • Infection at the perfusion site,
    • Leakage of the perfusion solution to the surrounding tissues (extravasation), which may damage the tissues and cause scarring,
    • Formation of a blood clot (venous thrombosis), at the perfusion site, which causes pain, swelling, or redness in the area of the clot.

If a medication has been added to the perfusion solution, it may also cause side effects. These side effects will depend on the added medication. You should read the list of possible symptoms in the prospectus of the added medication.

Reporting of side effects:

If you experience any type of side effect, consult your doctor or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children

Do not store at a temperature above 25°C. Do not freeze

Baxter 5% Glucose should not be administered after the expiration date that appears on the container after CAD. The expiration date is the last day of the month indicated.

Do not receive Baxter 5% Glucose if there are particles floating in the solution or if the container is damaged in any way.

Glucose Baxter 5% Composition

The active ingredient is sugar (glucose): 50 g per liter.

The other component is water for injectable preparations.

Appearance of the product and contents of the container

Glucose Baxter 5% from Baxter is a transparent, particle-free solution. It is presented in type II glass bottles. Each bottle is closed by a type I chlorobutyl stopper, which is covered with an aluminum cap.

Bottle sizes: 50, 100, 250, 500 or 1000 ml

The bottles are supplied in boxes, each containing 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 1000 ml

Only some sizes of containers may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Baxter S.L.

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

Responsible manufacturer:

Bieffe Medital S.p.A.

Via Nuova Provinciale

23034 Grosotto (SO)

Italy

Last review date of this leaflet: April 2018

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

Parenteral solutions must be visually inspected before administration to detect particles and discoloration, whenever the solution and container permit. 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 entry into the system.

The addition of electrolytes may be indicated based on the patient's clinical needs.

Medications may be introduced before or during infusion through the injection port.

When adding medications, verify the final osmolarity before parenteral administration. A complete and careful aseptic mixing of any medication is required. Solutions containing medications must be used immediately and not stored.

The addition of other medications or the use of an incorrect administration technique may cause the appearance of fever reactions due to the possible introduction of pyrogens. In case of an adverse reaction, infusion must be stopped immediately.

To avoid a potentially fatal overdose during intravenous infusion of solutions in newborns, special attention must be paid to the administration method. When using a syringe pump to administer liquids or medications intravenously to newborns, do not leave a solution container connected to the syringe.

When using an infusion pump, all clamps of the intravenous administration equipment must be closed before removing the administration equipment from the pump or disconnecting the pump. This is required regardless of whether the administration equipment has a free-flow device.

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

Dispose of after single use.

Dispose of partially used containers.

Do not reconnect partially used containers.

Do not store solutions containing other medications.

Aseptic technique must be used when adding medications to Glucose Baxter 5%.

Mix the solution well when adding medications.

1-To open

a. Remove the aluminum cap that protects the closure

b. 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 on the hanger provided with the shipping box.

b. Use an aseptic technique to prepare the infusion.

c. Connect the administration equipment. Consult the instructions accompanying the equipment for its 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 medication before administration.

a. Disinfect the injection port.

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

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

Caution: Do not store containers with added medication.

To add medication during administration

a. Close the clamp of the equipment.

b. Disinfect the injection port.

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

d. Remove the container from the intravenous support and/or turn it to place it in the vertical position.

e. Mix the solution and medication carefully.

f. Place the container back in the use position, reopen the clamp, and continue administration.

4.Expiry in use (added medications)

Before use, the physical and chemical stability of any additional medication to the pH of the Glucose Baxter 5% solution in the glass bottle must be established.

From a microbiological point of view, the diluted product must be used immediately unless the addition of medications has been carried out in controlled and validated aseptic conditions. If not used immediately, the conditions and storage times used before use are the responsibility of the user.

5-Incompatibilities of added medications

As with all parenteral solutions, the incompatibility of added medications with the solution in the glass bottle must be verified before addition.

It is the responsibility of the doctor to judge the incompatibility of the added medication with Glucose Baxter 5% by examining any eventual change in color and/or precipitation, insoluble complexes, or appearance of crystals. The medication's prospectus should be consulted.

Before adding a medication, verify that it is soluble and stable in water at the pH of the Glucose Baxter 5% solution.

When adding a medication compatible with Glucose Baxter 5%, the solution must be used immediately.

Medications that are known to be incompatible should not be used.