Glucose Baxter 10% solution for infusion

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Glucose Baxter 10% solution for infusion

Active substance: Glucose

Read the entire leaflet carefully before starting to use this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• If you experience any adverse reactions, consult your doctor, pharmacist, or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

This medicine is called "Glucose Baxter 10% solution for infusion", but will be referred to as "Glucose Baxter 10%" throughout the remainder of this leaflet.

Contents of the leaflet:

1. What Glucose Baxter 10% is and what it is used for
2. What you need to know before Glucose Baxter 10% is administered to you
3. How Glucose Baxter 10% will be administered to you
4. Possible side effects
5. How to store Glucose Baxter 10%
6. Contents of the pack and other information

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

Glucosa Baxter 10% is a sugar (glucose) solution in water. Glucose is one of the body's main sources of energy. This infusion solution provides 400 kilocalories per litre.

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 as a slow injection (infusion) into a vein.

• preventing or treating low blood sugar levels (hypoglycaemia, which causes symptoms but is not life-threatening).

• providing additional fluid to the patient when the body does not have enough water (dehydration) and extra sugar (carbohydrates) is needed.

• diluting with water other medicines that are to be administered intravenously.

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

Glucosa Baxter 10% will NOT be administered if you have any of the following conditions:

• diabetes that is not properly controlled, resulting in blood glucose levels higher than normal (decompensated diabetes),

• loss of consciousness (hyperosmolar coma). This is a type of coma that may occur if you have diabetes and are not receiving adequate treatment,

• dilution of the blood due to excessive fluid administration (hemodilution),

• excess fluid in the body's extracellular spaces (extracellular hyperhydration),

• increased blood volume in blood vessels beyond normal levels (hypervolemia),

• elevated blood glucose levels (hyperglycemia),

• elevated blood lactate levels (hyperlactatemia),

• severe renal failure (when kidneys do not function properly and dialysis is required),

• uncompensated heart failure. If heart failure has not been adequately treated and causes symptoms such as:

• difficulty breathing,

• swollen ankles,

• fluid accumulation under the skin affecting the entire body, including the brain and lungs (generalized edema),

• liver disease causing fluid accumulation in the abdomen (ascitic cirrhosis),

• any other condition affecting your body’s ability to regulate blood sugar levels,

• intolerance (hypersensitivity) to glucose. This may occur in patients with corn allergy.

If another medicine is added to your infusion solution, read its package leaflet to ensure that you can safely receive that medicine.

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.

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

• diabetes,

• renal failure,

• an acute, potentially life-threatening illness (acute critical illness),

• tell your doctor if you have had a head injury within the last 24 hours,

• increased pressure inside the skull (intracranial hypertension),

• stroke due to a blood clot in a blood vessel (cerebral infarction),

• heart disease (heart failure),

• lung disease (respiratory failure),

• reduced urine production (oliguria or anuria),

• excess water in the body (water intoxication),

• low sodium levels in the blood (hyponatremia),

• corn allergy (Glucosa Baxter 10% contains glucose derived from corn).

• If you have a condition that could lead to elevated levels of vasopressin, a hormone that regulates your body's fluid balance. You may have excessive vasopressin due to, for example:

• a sudden and severe illness,

• pain,

• recent surgery,

• infections, burns, or brain injury,

• diseases affecting the heart, liver, kidneys, or central nervous system,

• taking certain medications (see Other medicines and Glucosa Baxter 10%).

This may increase the risk of low sodium levels in the blood and may cause headache, nausea, seizures, lethargy, coma, brain swelling, and death. Brain swelling increases the risk of death and brain damage. Individuals at higher risk of brain swelling include:

• children,
• women (particularly those of childbearing age),
• individuals with conditions affecting cerebral fluid levels, such as meningitis, intracranial bleeding, or brain injury.

While receiving this infusion, your doctor will monitor:

• levels of electrolytes such as sodium and potassium in the blood (plasma electrolytes),
• blood glucose levels,
• fluid balance in your body (hydration status),
• acidity of your blood and urine (acid-base balance changes).

Your doctor will adjust the infusion rate based on laboratory test results. These tests will indicate whether additional potassium, a blood chemical, is needed. If required, potassium may be administered intravenously.

Because Glucosa Baxter 10% contains glucose (sugar), it may cause high blood sugar levels (hyperglycemia). If this occurs, your doctor may:

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

This is particularly important:

• if you have diabetes,
• if your kidneys are not functioning normally,
• if you have recently had a stroke (acute ischemic stroke). High blood sugar levels may worsen stroke effects and impair recovery,
• if you have metabolic disorders due to starvation or a diet lacking proper nutrient balance (malnutrition),
• if you have low thiamine levels (vitamin B1). This may occur in patients with chronic alcoholism.

This solution must not be administered through the same intravenous line used for blood transfusion, as it may damage red blood cells or cause them to clump together.

Children

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

Children should receive Glucosa Baxter 10% under the supervision of a doctor or nurse. The dose must be determined by a physician experienced in pediatric care and will depend on the child’s age, weight, and clinical condition. The dose may also be affected if the solution is used to administer or dilute another medicine or if other medicines are administered simultaneously.

When administering the infusion to children, your doctor will take blood and urine samples to monitor electrolyte levels such as potassium (plasma electrolytes).

Newborns—especially premature infants and those with low birth weight—are at increased risk of developing low or high blood glucose levels (hypo- or hyperglycemia). Therefore, they require close monitoring during intravenous glucose therapy to ensure appropriate blood glucose control and prevent potential long-term adverse effects. Low blood glucose in newborns may cause prolonged seizures, coma, and brain damage. High blood glucose may lead to brain hemorrhage, bacterial or fungal infections, eye damage (retinopathy of prematurity), intestinal tract infections (necrotizing enterocolitis), lung problems (bronchopulmonary dysplasia), prolonged hospitalization, and death.

When administered to a newborn, the solution container may be connected to an infusion pump device, which ensures precise delivery of the required amount over a defined time interval. Your doctor or nurse will monitor the device to ensure safe administration.

Children (including neonates and older children) receiving Glucosa Baxter 10% are at increased risk of developing low blood sodium levels (hypotonic hyponatremia) and a brain disorder caused by low plasma sodium levels (hyponatremic encephalopathy).

Other medicines and Glucosa Baxter 10%

Inform your doctor or nurse if you are taking, have recently taken, or might need to take any other medicines.

Glucosa Baxter 10% and any other medicines taken concurrently may interact with each other.

Do not use Glucosa Baxter 10% with certain hormones (catecholamines), including adrenaline or steroids, as they increase blood glucose levels.

Some medicines affect the hormone vasopressin. These may include:

• antidiabetic medications (chlorpropamide),
• cholesterol-lowering drugs (clofibrate),
• certain cancer treatments (vincristine, ifosfamide, cyclophosphamide),
• selective serotonin reuptake inhibitors (used to treat depression),
• antipsychotics,
• opioids for severe pain relief,
• pain and/or anti-inflammatory medicines (also known as NSAIDs),
• medicines that mimic or enhance the effects of vasopressin, such as desmopressin (used to treat excessive thirst and urination), terlipressin (used to treat esophageal bleeding), and oxytocin (used to induce labor),
• antiepileptic drugs (carbamazepine and oxcarbazepine),
• diuretics.

Use of Glucosa Baxter 10% with food and drink

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

Pregnancy, breastfeeding, and fertility

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

Pregnancy

Glucosa Baxter 10% may be used during pregnancy. However, caution is required when administering glucose solutions during labor.

Fertility

There are insufficient data on the effect of glucose on fertility; however, no effect on fertility is expected.

Breastfeeding

There are insufficient data on the use of glucose solutions during breastfeeding; however, no adverse effects are expected. Glucosa Baxter 10% may be used during breastfeeding.

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

• Consult your doctor.
• Read the package leaflet of the medicine being added.

Driving and using machines

Consult your doctor or nurse before driving or operating machinery.

3. How Glucosa Baxter 10% will be administered to you

Glucosa Baxter 10% will be administered to you by a doctor or a 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 must not 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 typically used for the infusion. However, your doctor may administer 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 level of electrolytes in your body (particularly sodium, in patients with high levels of vasopressin hormone, or those taking other medicines that enhance the effect of vasopressin).

Any unused portion of the solution must be discarded. DO NOT receive Glucosa Baxter 10% from a partially used bottle.

If you receive more Glucosa Baxter 10% than you should

If you receive too much 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 blood sodium levels lower than normal (hyponatremia),
• higher than normal blood sugar levels (hyperglycemia),
• excessive concentration of the blood (hyperosmolarity),
• presence of glucose in the urine (hyperglycosuria),
• increased urine production (osmotic diuresis),
• loss of water from the body (dehydration).

If you develop any of these symptoms, inform your doctor immediately. Your infusion will be stopped or slowed down. Insulin may be administered, and you will receive treatment according to your symptoms.

If any medicine has been added to Glucosa Baxter 10% before the overdose occurred, that medicine may also cause symptoms. You should read the list of possible side effects in the leaflet of the added medicine.

If you stop the infusion with Glucosa Baxter 10%

Your doctor will decide when the infusion should be stopped.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Adverse effects may include:

• Hypersensitivity reactions, including a severe allergic reaction called anaphylaxis (potential manifestation in patients with corn allergy),

• difficulty breathing,

• skin swelling of the face and lips or throat swelling,

• fever,

• hives (urticaria),

• skin rash,

• redness of the skin (cutaneous erythema),

• chills,

• changes in blood electrolyte levels (electrolyte disturbances), including

• low levels of sodium in the blood that may occur during hospitalization (nosocomial hyponatremia) and associated neurological disorder (acute hyponatremic encephalopathy). Hyponatremia may cause irreversible brain damage and death due to cerebral edema/swelling (see also section “Warnings and precautions”).

• low blood potassium levels (hypokalemia),

• low blood magnesium levels (hypomagnesemia),

• low blood phosphate levels (hypophosphatemia),

• high blood sugar levels (hyperglycemia),

• excess fluid in the blood vessels (hemodilution and hypervolemia),

• sugar in the urine (glucosuria),

• administration route-related reactions:

• fever, febrile reaction (pyrexia),

• infection at the injection site,

• leakage of the infusion solution into the surrounding tissues (extravasation). This may damage tissues and lead to scarring,

• blood clot formation (venous thrombosis) at the infusion site, causing pain, swelling, or redness at the clot site,

• irritation and inflammation of the vein used for infusion (phlebitis). This may cause redness, pain, burning, or swelling at the infusion vein,

• local reaction or pain (redness or swelling at the infusion site),

• sweating.

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

If any adverse effect occurs, the infusion should be stopped immediately.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Glucose Baxter 10%

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

Do not store above 25°C.

Glucose Baxter 10% must not be administered after the expiry date stated on the vial and carton after "exp". The expiry date refers to the last day of the month indicated.

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

6. Contents of the pack and other information

Composition of Glucosa Baxter 10%

The active substance is glucose (as monohydrate): 100 g per litre.

The only other component is water for injections.

Formula per 250 ml

Glucose (as monohydrate): 25 g

Formula per 500 ml

Glucose (as monohydrate): 50 g

Formula per 1000 ml

Glucose (as monohydrate): 100 g

Appearance of Glucosa Baxter 10% and contents of the pack

Glucosa Baxter 10% is a clear solution free from visible particles. It is supplied in type II glass bottles. Each bottle is sealed with a type I chlorobutyl stopper, which is covered with an aluminium cap.

Bottle sizes are: 250 ml, 500 ml or 1000 ml.

The bottles are supplied in cartons, 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 certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Baxter, S.L.

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

Spain

Manufacturer:

Bieffe Medital S.p.A.

Via Nuova Provinciale

23034 Grosotto (SO)

Italy

Date of the most recent revision of this summary: June 2019

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

This information is intended for healthcare professionals only:

Handling and preparation

The infusion solution should be inspected visually before use.

Parenteral solutions should be visually inspected for particulate matter and discoloration prior to administration, whenever solution and container permit. Use the bottle only if the solution is clear, free from visible particles, and the container is undamaged. It should be administered immediately after insertion of the infusion set.

The solution must be administered using a sterile set and aseptic technique. The set should be primed with the solution to prevent air from entering the system.

Addition of electrolytes may be indicated depending on the patient's clinical needs.

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

To avoid potentially fatal overdosing during intravenous infusion in neonates, special attention must be paid to the method of administration. When using a syringe pump to administer fluids or medications intravenously to neonates, a fluid bottle must not be left connected to the syringe.

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

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

Discard after single use.

Dispose of any unused portions.

Do not reconnect partially used bottles.

Do not store solutions containing other medications.

Aseptic technique must be used when adding medications to Glucosa Baxter 10%.

Mix the solution thoroughly after adding medications.

1. To open

• Remove the aluminium cap protecting the closure.

• Check the solution for clarity and absence of foreign particles. Discard the solution if it is not clear or contains foreign particles.

1. Preparation for administration

Use sterile materials for preparation and administration.

• Hang the container on the hanger provided in the shipping carton.

• Use an antiseptic method to prepare the infusion.

• Connect the administration set. Refer to the instructions accompanying the administration set for connection, priming, and solution administration.

1. Techniques for adding medications by injection

Warning: Added medications may be incompatible.

To add medication before administration

• Disinfect the injection site.

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

• Mix the medication and solution carefully. For high-density medications such as potassium chloride, gently invert the container while in vertical position and mix.

Precaution: do not store bottles with added medication.

To add medication during administration

• Close the clamp on the administration set.

• Disinfect the injection site.

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

• Remove the container from the intravenous stand and/or turn it to vertical position.

• Mix the solution and medication carefully.

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

1. In-use expiry (after addition of medications)

The chemical and physical stability of added medications in the pH range of Glucosa Baxter 10% (pH 3.5 to 6.5) in the glass bottle must be determined before use.

From a microbiological standpoint, the diluted product should be used immediately unless reconstitution has been carried out under controlled and validated aseptic conditions. If not used immediately, the storage conditions and duration are the responsibility of the user.

1. Incompatibilities of added medications

Glucose solution must not be administered simultaneously with, before, or after blood transfusion through the same infusion set, as this may cause haemolysis and clot formation.

Incompatibility of medications intended for addition with Glucosa Baxter 10% must be evaluated before addition.

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

The package leaflet of the medication to be added should be consulted.

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

When compatible medication is added to Glucosa Baxter 10%, the solution must be administered immediately.

Medications that are incompatible must not be used.