Glucose Baxter 5% solution for infusion

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Glucosa Baxter 5% solution for infusion

Active substance: glucose

Read the entire leaflet carefully before you start using 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 or nurse.
• If you experience any adverse reactions, consult your doctor or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents:

1. What Glucosa Baxter 5% is and what it is used for
2. What you need to know before Glucosa Baxter 5% is administered to you
3. How Glucosa Baxter 5% will be administered to you
4. Possible adverse effects
5. How to store Glucosa Baxter 5%

Contents of the pack and other information

1. What Glucosa Baxter 5% is and what it is used for

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

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

Glucosa Baxter 5% is used:

• to provide fluids and carbohydrates (sugar).
• to dilute or administer other medicines that can be given by infusion.

2. What you need to know before Glucosa Baxter 5% is administered to you

DO NOT be given Glucosa Baxter 5% if you have any of the following clinical conditions

• if you have diabetes that is not properly treated, resulting in blood glucose levels higher than normal (uncontrolled diabetes).
• if you have glucose intolerance, for example: when the body's metabolism is not functioning properly, such as in severe illnesses (metabolic stress).
• hyperosmolar coma (loss of consciousness). This is a type of coma that may occur if you have diabetes and are not receiving adequate medication.
• higher-than-normal blood glucose concentration (hyperglycemia)
• higher-than-normal blood lactate concentration (hyperlactatemia).
• Intolerance (hypersensitivity) to glucose. This may occur in patients with corn allergy.

If another medicine is added to your infusion solution, you should always read the leaflet of that medicine. This will inform you whether that medicine is safe for you.

Warnings and precautions

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

• Excess water in the body (water intoxication)

• If you are diabetic or have high blood sugar levels (hyperglycemia).

• If your kidneys are not functioning as well as they normally should.

• If you have sepsis, trauma, or shock.

• Low levels of electrolytes (sodium, potassium, phosphorus, magnesium) in the blood.

• Head injury within the last 24 hours.

• If you have recently had a stroke (acute ischemic stroke). High blood sugar levels can worsen the effects of stroke and affect recovery.

• If you have metabolic disturbances due to starvation or a diet lacking the proper proportion of essential nutrients (malnutrition).

• If you have low levels of thiamine (vitamin B1) in your body. This may occur if you suffer from chronic alcoholism.

• Corn allergy (Glucosa Baxter 5% contains glucose derived from corn).

• If you have a condition that could cause elevated levels of vasopressin, a hormone that regulates fluid in your body. You may have too much vasopressin in your body, for example, because:

• you have had a sudden and serious illness,

• you are in pain,

• you have undergone surgery,

• you have infections, burns, or brain injury,

• you have conditions affecting your heart, liver, kidneys, or central nervous system,

• you are taking certain medications (see Other medicines and Glucosa Baxter 5%)

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 if of childbearing age)
• individuals with problems related to cerebral fluid levels, for example, due to meningitis, intracranial bleeding, or brain injury.

While receiving this infusion, your doctor will take blood and urine samples to monitor:

• the amount of electrolytes such as 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).

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

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

Glucosa Baxter 5% must not be administered through the same needle used for blood transfusion. This could damage red blood cells or cause them to clump.

Your doctor will consider whether you are receiving parenteral nutrition (nutrition delivered by intravenous infusion).

You may require supplementary nutrition during long-term treatment with Glucosa Baxter 5%.

Children

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

Children should receive Glucosa Baxter 5% from a doctor or nurse. The amount administered must be determined by a doctor specialized in pediatric treatment and will depend on the child's age, weight, and condition. If used to administer or dilute another medicine, or if other medicines are given simultaneously, 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 those born prematurely and with low birth weight – are at increased risk of developing low or high blood glucose levels (hypo- or hyperglycemia) and therefore require careful monitoring during treatment with intravenous glucose solutions to ensure adequate control of blood sugar levels, in order to avoid possible long-term adverse effects. Low blood sugar levels in newborns may cause seizures, prolonged coma, and brain damage. High blood sugar levels may cause brain hemorrhages, bacterial or fungal infections, eye damage (retinopathy of prematurity), intestinal tract infections (necrotizing enterocolitis), lung problems (bronchopulmonary dysplasia), prolonged hospital stay, and death.

When administered to newborns, the solution container may be connected to an infusion pump device that allows precise delivery of the required amount of solution over a defined time interval. Your doctor or nurse must supervise the device to ensure safe administration.

Children (including newborns and older children) receiving Glucosa Baxter 5% 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 5%

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

Glucosa Baxter 5% and another medicine 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 medicines affect the hormone vasopressin. These may include:

• antidiabetic medicines (chlorpropamide)
• cholesterol-lowering medicines (clofibrate)
• some cancer medicines (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 excessive thirst and urination), terlipressin (used to treat esophageal bleeding), and oxytocin (used to induce labor)
• antiepileptic medicines (carbamazepine and oxcarbazepine)
• diuretics

Glucosa Baxter 5% with food and drink

You should ask your doctor which foods and drinks you may consume.

Pregnancy, breastfeeding, and fertility

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

Pregnancy

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

Fertility

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

Breastfeeding

There are insufficient data on the use of Glucosa Baxter 5% during breastfeeding, although no effect on breastfeeding is expected. Glucosa Baxter 5% 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 leaflet of the medicine to be added.

Driving and use of machines

Consult your doctor or nurse before driving or operating machinery.

3. How Glucosa Baxter 5% will be administered to you

Glucosa Baxter 5% will be administered 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, physical condition, the reason for treatment, and whether the infusion is to be used to deliver or dilute another medicine. The amount you receive may also be influenced by other treatments you are receiving.

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

Glucosa Baxter 5% is usually administered through a plastic tube connected 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.

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

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 increase the effect of vasopressin).

Any unused portion of the solution must be discarded. DO NOT receive Glucosa Baxter 5% from a partially used container.

If you receive more Glucosa Baxter 5% than you should

If you receive too much Glucosa Baxter 5% or if it is administered too quickly, you may experience the following symptoms:

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

If you notice these symptoms, inform your doctor immediately. The infusion will be stopped or reduced. Insulin may be administered, and treatment will be provided according to your symptoms.

If another medicine has been added to Glucosa Baxter 5% before the overdose occurred, that medicine may also cause symptoms. Please read the list of possible side effects in the package leaflet of the added medicine.

If the infusion of Glucosa Baxter 5% is interrupted

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

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

4. Possible adverse effects

Like all medicines, Glucosa Baxter 5% may produce 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),
• Changes in blood levels of chemicals (electrolyte disturbances),
• Blood glucose concentration higher than normal (hyperglycemia),
• Loss of water from the body (dehydration),
• Excess fluid in the blood vessels (hypervolemia),
• Excessive urine volume (polyuria),
• Low levels of sodium in the blood that may occur during hospitalization (nosocomial hyponatremia) and associated 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 the administration technique:
  • Reactions at the injection site:
    • irritation and inflammation of the vein where the solution is administered. This may cause redness, pain or burning, and swelling along the vein,
    • pain or local reaction (redness or swelling at the infusion site),
    • fever, febrile response (pyrexia),
    • infection at the infusion site,
    • leakage of the infusion solution into the surrounding tissues (extravasation), which may damage tissues and lead to scarring,
    • formation of a blood clot (venous thrombosis) at the infusion site, causing pain, swelling, or redness in the area of the clot.

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

Reporting of adverse effects:

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

5. Storage of Glucosa Baxter 5%

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

Do not store above 25°C. Do not freeze.

Glucosa Baxter 5% must not be administered after the expiry date stated on the vial after EXP. The expiry date refers to the last day of the month indicated.

Do not use Glucosa Baxter 5% if you see particles floating in the solution or if the container is damaged in any way.

6. Contents of the pack and other information

Composition of Glucosa Baxter 5%

The active substance is sugar (glucose): 50 g per litre.

The other component is water for injections.

Appearance of the product and pack contents

Glucosa Baxter 5% from Baxter is a clear, particle-free solution. It is supplied in type II glass bottles. Each bottle is sealed with a type I chlorobutyl rubber stopper, which is in turn covered with an aluminium cap.

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

The bottles are supplied in cartons, 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 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 package leaflet: April 2018

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

This information is intended for healthcare professionals only

Handling and preparation

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

The solution must be administered using sterile equipment and aseptic technique. The administration 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 prior to or during infusion through the resealable injection site.

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

The addition of other medications or incorrect administration techniques may lead to febrile reactions due to potential introduction of pyrogens. In case of an adverse reaction, infusion must be stopped 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 bottle of solution 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 disconnecting the pump. This is required regardless of whether the administration set includes an anti-free-flow device.

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

Discard after single use.

Discard partially used containers.

Do not reconnect partially used bottles.

Do not store solutions containing added medications.

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

Mix the solution thoroughly after adding medications.

1- Opening

• 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.

2- Preparation for administration

Use sterile materials for preparation and administration.

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

• Use aseptic technique to prepare the infusion.

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

3- Techniques for adding medication

Warning: Added medications may be incompatible (see section 5 “Incompatibilities of added medications”).

To add medication prior to administration

• Disinfect the injection site.

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

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

Caution: 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 19-gauge (1.10 mm) to 22-gauge (0.70 mm) needle, puncture the resealable injection site and inject the medication.

• Remove the container from the IV stand and/or turn it to an upright position.

• Mix the solution and medication carefully.

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

1. In-use shelf life (with added medications)

Prior to use, the physical and chemical stability of any added medication at the pH of Glucosa Baxter 5% solution in the glass bottle must be established.

From a microbiological standpoint, the diluted product should be used immediately unless the addition of medication was performed under controlled and validated aseptic conditions. If not used immediately, the conditions and duration of storage prior to use are the responsibility of the user.

5- Incompatibilities of added medications

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

It is the physician’s responsibility to assess incompatibility of the added medication by examining for any change in color and/or precipitation, formation of insoluble complexes, or appearance of crystals. 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 at the pH of Glucosa Baxter 5% solution.

When a compatible medication is added to Glucosa Baxter 5%, the solution must be used immediately.

Medications known to be incompatible must not be used.