Label: information for theuser

Glucosa Baxter 10%solution for infusion

Active ingredient: Glucosa

Read this label carefully before starting to use this 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, pharmacist, or nurse.
• Ifyou experienceadverse effects, consult your doctor, pharmacist, or nurse,even if they are not listed in this label. See section 4.

This medication is called “Glucosa Baxter 10%solution for infusion”, but it will be referred to as “Glucosa Baxter 10%” in the rest of this label.

1.What is Glucosa Baxter 10% and what it is used for

2.What you need to know before Glucosa Baxter 10% is administered

3.How Glucosa Baxter 10% will be administered

4.Possible adverse effects

5.Storage of Glucosa Baxter 10%

6.Contents of the package and additional information

Glucosa Baxter 10% is a sugar (glucose) solution in water. Glucose is one of the main sources of bodily energy. This perfusion solution provides 400 kilocalories per liter.

Glucosa Baxter 10% is used for:

• providing a source of sugar (carbohydrates) alone or, if required, for parenteral nutrition. Parenteral nutrition is used to feed patients who cannot eat. It is administered through a slow injection (perfusion) through a vein.
• preventing or treating low blood sugar (hypoglycemia, which causes symptoms but is not fatal).
• providing additional liquid to the patient when the body does not have enough water (dehydration) and you need extra sugar (carbohydrates).

-diluting with water other medications that are desired to be administered intravenously.

Do not administer Glucosa Baxter 10% if you suffer from any of the following conditions:

• if you suffer from diabetes that is not receiving adequate treatment, resulting in a blood glucose concentration above normal (uncontrolled diabetes),
• loss of consciousness (hyperosmolar coma). This is a type of coma that can occur if you have diabetes and are not receiving adequate medication,
• blood dilution due to the addition of too much fluid (hemodilution),
• when there is excessive fluid in the extracellular spaces of the body (extracellular hyperhydration),
• when there is an increased volume of blood in the blood vessels than there should be (hypervolemia),
• when the blood glucose concentration is above normal (hyperglycemia),
• when the blood lactate concentration is above normal (hyperlactatemia),
• severe renal insufficiency (when the kidneys do not function properly and dialysis is required)
• uncompensated heart failure. If heart failure is not adequately treated and causes symptoms such as:

• difficulty breathing,
• swelling of the ankles,
• if there is accumulation of fluid under the skin, affecting the entire body, including the brain and lungs (generalized edema),
• liver disease that causes fluid accumulation in the abdomen (ascitic cirrhosis),
• any other condition that affects the way your body controls blood sugar levels,
• intolerance (hypersensitivity) to glucose. This can occur in patients with corn allergy.

If another medication is added to your infusion solution, read the package insert. This will ensure that you can take that medication.

Warnings and precautions

Glucosa Baxter 10% is a hypertonic (concentrated) solution. Your doctor will take this into account when calculating the amount of solution to administer.

If you develop or have developed any of the following conditions, inform your doctor.

• Diabetes,
• renal insufficiency,
• an acute and potentially life-threatening disease (acute critical illness),
• inform your doctor if you have had a head injury in the last 24 hours,
• increased pressure inside the skull (intracranial hypertension),
• stroke due to a blood clot in a blood vessel (cerebral hemorrhage),
• heart disease (heart failure),
• lung disease (respiratory insufficiency),
• reduced urine production (oliguria or anuria),
• excess water in the body (water intoxication),
• low sodium levels in the blood (hyponatremia),
• allergy to corn (Glucosa Baxter 10% contains corn-derived sugar).

• If you have a condition that could cause high levels of vasopressin, a hormone that regulates fluid in your body. 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 head injury
• you have diseases related to your heart, liver, kidneys, or central nervous system,
• you are taking certain medications (see Other medications and Glucosa Baxter 10%).

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 head injury.

When you receive this infusion,your doctor will monitor:

• the amount of electrolytes such as sodium and potassium in the blood (your 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).

Your doctor will adjust the amount of infusion solution to administer based on the results of the tests. These tests will indicate to your doctor if you need additional potassium, a blood chemical. If necessary, it can be administered intravenously.

Since Glucosa Baxter 10% contains sugar (glucose), and it can cause high blood sugar levels (hyperglycemia).if this occurs, your doctor may:

• adjust the infusion rate,
• administer insulin to reduce blood sugar levels,
• if necessary, administer additional potassium.

This is very important:

• if you have diabetes,
• if your kidneys do not function as well as normal,
• 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 appropriate ratio of necessary nutrients (malnutrition),
• if you have low levels of thiamine (vitamin B1). This can occur if you have chronic alcoholism.

This solution will not be administered using the same needle as a blood transfusion, as it may damage red blood cells or cause them to clump.

Children

Glucosa Baxter 10%must be administered with special care in children.

Children should receive Glucosa Baxter 10% 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 administering the infusion 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 sugar levels (hypoglycemia or hyperglycemia). Therefore, they require close monitoring during treatment with glucose solutions by intravenous infusion, which ensures adequate control of blood sugar levels to prevent potential long-term adverse effects. Low blood sugar levels in newborns can cause prolonged convulsions, coma, and brain damage. High blood sugar levels can cause cerebral hemorrhage, bacterial or fungal infections, eye damage (retinopathy of prematurity), intestinal infections (necrotizing enterocolitis), respiratory problems (bronchopulmonary dysplasia), prolonged hospital stay, and death.

When administered to a newborn,,the solution container may be connected to a pump infusion device, whichallows for the exact administration of the required amount over the defined time interval. Your doctor or nurse will be controlling the device to ensure safe administration.

Children (including newborns and older children) receivingGlucosa Baxter 10%are at higher risk of having low sodium levels in the blood (hypotonic hyponatremia) and a condition affecting the brain due to low plasma sodium levels (hypotonic encephalopathy).

Other medications andGlucosa Baxter 10%

Inform your doctor or nurse if you are using, have used recentlyor may need to useany other medication.

Glucosa Baxter 10% and any other medication taken at the same time may affect each other.

Do not use Glucosa Baxter 10% with certain hormones (catecholamines) including adrenaline or steroids, as they 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
• opioids for severe pain relief
• medications for pain and/or inflammation (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

Use of Glucosa Baxter 10% with food and drinks

You should ask your doctor what you can eat or drink.

Pregnancy, breastfeedingand fertility

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

Pregnancy

Glucosa Baxter 10% 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 glucose on fertility, although no effect is expected.

Breastfeeding

There is insufficient data on the use of a glucose solution during breastfeeding, although no effect is expected. Glucosa Baxter 10% 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 of the medication to be added.

Driving and operating machinery

Consult your doctor or nurse before driving or operating machinery.

Glucosa Baxter 10% will be administered by a doctor or nurse. Your doctor will decide how much you need and when to administer it. 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.

Noshould receive Glucosa Baxter 10% if there are particles floating in the solution or if the container is damaged in any way.

Glucosa Baxter 10% is usually administered through a plastic tube attached 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.

Your doctor will monitor the following before and during the infusion:

• 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 solution should be discarded. Do not receiveGlucosa Baxter 10%from a startedcontainer.

If you receive more Glucosa Baxter 10% than you should

If you receive an excessive amount of Glucosa Baxter 10% (overdose) or if it is administered too quickly or too frequently, the following symptoms may occur:

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

If you develop any of these symptoms, inform your doctor immediately. Your infusion will be stopped or reduced. Insulin will be administered, and you will receive treatment based on your symptoms.

If a medication has been added to Glucosa Baxter 10% before the 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 infusion withGlucosa Baxter 10%

Your doctor will decide when to stop this infusion.

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

Like all medicines, this medicine can 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),

• difficulty breathing,
• inflammation of the face and lips skin or inflammation of the throat,
• fever,
• hives (urticaria),
• skin rash,
• skin redness (cutaneous erythema),
• chills,

• changes in the levels of blood electrolytes (electrolyte disturbances), including
• 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 cerebral edema/inflammation (see also the section “Warnings and precautions”).
• low potassium levels in the blood (hypokalemia),
• low magnesium levels in the blood (hypomagnesemia),
• low phosphate levels in the blood (hypophosphatemia),
• high blood sugar levels (hyperglycemia),

• excess fluid in the blood vessels (hemodilution and hypervolemia),
• sugar in the urine (glucosuria),
• reactions related to the administration route:
• fever, febrile reaction (pyrexia),
• infection at the injection site,
• escape of the perfusion solution to the surrounding tissues (extravasation). This can damage tissues and cause scarring,
• formation of a blood clot(venous thrombosis) at the perfusion site, which causes pain, inflammation, or redness inthe clot area,
• irritation and inflammation of the vein through which the perfusion is performed (phlebitis). It can cause redness, pain, or itching or swelling in the perfusion vein,
• local reaction or pain (redness or swelling at the perfusion site),
• sweating.

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

If any side effect occurs, the perfusion should be stopped.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is about possible side effects that do 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.

Baxter Glucose 10% should not be administered after the expiration date appearing on the bottleand on the box aftercad. The expiration date is the last day of the month indicated.

Do not administer Baxter Glucose 10% if there are floating particles in the solution or if the unit is damaged in any way.

Composition ofGlucosa Baxter 10%

The active ingredient is glucose (as monohydrate): 100 g per liter.

The only other component is water for injection.

Formula for 250 ml

Glucose (as monohydrate): 25 g

Formula for 500 ml

Glucose (as monohydrate): 50 g

Formula for 1000 ml

Glucose (as monohydrate): 100 g

Appearance of Glucosa Baxter 10% and packaging contents

Glucosa Baxter 10% is a transparent solution, without visible particles. It is presented in type II glass bottles. Each bottle is closed by a type I chlorobutyl stopper, which is in turn covered with an aluminum cap.

The bottle sizes are: 250 ml, 500 ml, or 1000 ml.

The bottles are supplied in boxes, each containing the following quantities:

• 1 bottle of 250 ml
• 10 bottles of 500 ml
• 1 bottle of 500 ml
• 1 bottle of 1000 ml

Only some packaging sizes 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)

Spain

Responsible manufacturer:

Bieffe Medital S.p.A.

Via Nuova Provinciale

23034 Grosotto (SO)

Italy

Last review date of this leaflet: June 2019

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:

Manipulation and preparation

The infusion solution must be visually checked before use.

Parenteral solutions must be visually inspected before administration to detect particles and discoloration, whenever the solution and packaging permit.Use the bottle only if the solution is transparent, contains no visible particles, and the packaging is not damaged. It must be administered immediately after the infusion equipment is inserted.

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.

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

Medicaments may be added before or during infusion through the injection port. When used, the final osmolarity must be checked before parenteral administration. The mixture must be aseptic and must be prepared carefully and meticulously. Solutions containing additional medicaments must not be stored and must be used immediately.

To avoid a potentially fatal overdose during intravenous infusion in newborns, special attention must be paid to the administration method. When using a syringe pump to administer liquids or medicaments intravenously to newborns, a bottle of liquid must not be left connected to the syringe.

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

The entire device and its administration via intravenous infusion must be frequently monitored.

Dispose of after single use.

Dispose of unused residue.

Do not reconnect partially used bottles.

Do not store solutions containing other medicaments.

Use an aseptic technique when adding medicaments to Glucosa Baxter 10%.

Mix the solution well when adding medicaments.

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. Dispose of 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 from the hanger provided with the shipping box.

b.Use an antisepsis method to prepare the infusion.

c.Connect the administration equipment. Consult the instructions provided with the equipment for its connection, priming, and administration of the solution.

3.Techniques for injecting added medicaments

Warning: Added medicaments may be incompatible.

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, prick the resellable injection port and inject.

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

Caution: Do not store bottles with added medication.

To add medication during administration

a.Close the clamp on the equipment.

b.Disinfect the injection port.

c.Using a syringe with a 19 (1.10 mm) to 22 (0.70 mm) gauge needle, prick 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 with administration.

4.Expiry in use (added medicaments)

The chemical and physical stability of added medicaments in the pH of Glucosa Baxter 10% in the glass bottle must be determined before use.

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

5.Medicament incompatibilities

The glucose solution must not be administered simultaneously with, before, or after blood administration through the same infusion equipment, as it may cause hemolysis and clot formation.

The incompatibility of medicaments to be added with Glucosa Baxter 10% must be evaluated before adding them.

In the absence of incompatibility studies, this product must not be mixed with others.

The prospectus of the medicament to be added must be consulted.

Before adding a medicament, verify that it is soluble and stable in water within the pH range of Glucosa Baxter 10% (pH of 3.5 to 6.5).

When adding compatible medicaments to Glucosa Baxter 10%, the solution must be administered immediately.

Medicaments that are incompatible must not be used.