GLUCOSA BAXTER 5% SOLUTION FOR INFUSION

2. What you need to know before you are given Baxter Glucose 5%

Baxter Glucose 5% should not be given to you if you have any of the following conditions

• hyperosmolar coma (loss of consciousness). This is a type of coma that can occur if you have diabetes and are not receiving adequate medication.
• high blood glucose levels (hyperglycemia)
• high blood lactate levels (hyperlactatemia).
• Intolerance (hypersensitivity) to glucose. This can occur in patients with corn allergy.

If another medicine is added to your infusion solution, you should always read the leaflet for that medicine. This will allow you to know if the medicine is safe for you.

Warnings and precautions

Tell 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 are not working as well as they should.
• 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 starvation or a diet that does not provide the proper proportion of necessary nutrients (malnutrition).
• If you have low levels of thiamine (vitamin B1) in your body. This can happen if you suffer from chronic alcoholism.
• Allergy to corn (Baxter Glucose 5% contains glucose derived from corn).
• If you have a condition that could cause high levels of vasopressin, a hormone that regulates the 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 are in pain,
• you have had surgery,
• you have infections, burns, or head injury
• you have heart, liver, kidney, or central nervous system disorders,
• you are taking certain medications (see Other medicines and Baxter Glucose 5%)

This can increase the risk of low sodium levels in the blood and can cause headache, nausea, seizures, 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 (especially if they are of childbearing age)
• people who have problems with their brain fluid levels, for example, due to meningitis, bleeding in the skull, or head 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 (fluid balance),
• the acidity of your blood and urine (changes in acid-base balance).

Since Baxter Glucose 5% contains sugar (glucose), it can increase blood glucose levels (hyperglycemia). If this happens, your doctor may:

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

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

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

It is possible that during long-term treatment with Baxter Glucose 5%, you may need additional nutrition.

Children

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

Children should receive Baxter Glucose 5% from a doctor or nurse. The amount administered will be determined by a doctor specializing in pediatric treatment and will depend on the child's age, weight, and condition. If it is used to administer or dilute another medicine, or if other medicines 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 (hypo or hyperglycemia) and therefore require careful monitoring during treatment with glucose solutions by intravenous infusion to ensure adequate control of blood sugar levels to avoid potential long-term side effects. Low blood sugar levels in newborns can cause seizures, prolonged coma, and brain damage. High blood sugar levels can cause brain hemorrhages, 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 vial with the solution can be connected to an infusion pump device that allows the exact amount of solution required to be administered during the defined time interval. Your doctor or nurse should supervise the device to ensure safe administration.

Children (including newborns and older children) who receive Baxter Glucose 5% are at higher risk of suffering from low sodium levels in the blood (hyponatremia) and a neurological disorder related to low plasma sodium levels (hyponatremic encephalopathy).

Other medicines and Baxter Glucose 5%

Tell your doctor or nurse if you are taking or have recently taken or might take any other medicines.

Baxter Glucose 5% and another medicine taken at the same time can affect each other.

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

Some medicines act on the vasopressin hormone. These can include:

• anti-diabetic medication (chlorpropamide)
• cholesterol medication (clofibrate)
• certain cancer medications (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 increased thirst and urination), terlipressin (used to treat esophageal bleeding), and oxytocin (used to induce labor)
• antiepileptic medications (carbamazepine and oxcarbazepine)
• diuretics

Baxter Glucose 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, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

Pregnancy

Baxter Glucose 5% can 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 Baxter Glucose 5% on fertility, although no effect is expected.

Breastfeeding

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

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

• consult your doctor.
• read the leaflet for the medicine to be added.

Driving and using machines

Consult your doctor or nurse before driving or using machines.

3. How Baxter Glucose 5% will be given to you

Baxter Glucose 5% will be given to you 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 administer or dilute another medicine. The amount you receive may also be influenced by other treatments you are receiving.

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

Usually, Baxter Glucose 5% will be given to you 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 medicine in another way.

Baxter Glucose 5% should 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 amount of electrolytes in your body (particularly sodium, in patients with high levels of the vasopressin hormone, or those taking other medicines that increase the effect of vasopressin).

Any unused solution should be discarded. DO NOT receive Baxter Glucose 5% from a started vial.

If you receive more Baxter Glucose 5% than you should

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

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

If you notice these symptoms, tell your doctor immediately. The infusion will be stopped or reduced. Insulin will be administered, and you will receive treatment based on the symptoms.

If another medicine has been added to Baxter Glucose 5% before excessive administration, that medicine may also cause symptoms. You should read the list of possible symptoms in the leaflet for the added medicine.

If you stop receiving Baxter Glucose 5% infusions

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 side effects

Like all medicines, Baxter Glucose 5% can cause side effects, although not everybody gets them.

Side effects can include:

• Hypersensitivity reactions, including a severe allergic reaction called anaphylaxis (potential manifestation in patients with corn allergy),
• Changes in blood chemical levels (electrolyte disorders).
• High blood glucose levels (hyperglycemia).
• Water loss from the body (dehydration).
• Excess fluid in the blood vessels (hypervolemia),
• Excessive urine production (polyuria)
• 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 brain edema/inflammation (see also section 2 "Warnings and precautions").
• Reactions due to the administration technique:
• • Reaction at the injection site:
  • • irritation and inflammation of the vein where the solution is administered. This can cause redness, pain, or itching and swelling along the vein where the solution is administered,
    • local pain or reaction (redness or swelling at the infusion site),
    • fever, febrile response (pyrexia),
    • infection at the infusion site,
    • leakage of the infusion solution into the tissues surrounding the vein (extravasation), which can damage the tissues and cause scarring,
    • formation of a blood clot (venous thrombosis) at the infusion site, causing pain, swelling, or redness in the area of the clot.

If another medicine has been added to the infusion solution, it can also cause side effects. These side effects will depend on the added medicine. You should read the list of possible symptoms in the leaflet for the added medicine.

Reporting of side effects:

If you experience any side effects, talk to your doctor or nurse, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Baxter Glucose 5%

Keep this medicine out of the sight and reach of children

Do not store above 25°C. Do not freeze

Baxter Glucose 5% should NOT be administered after the expiry date stated on the vial after EXP. The expiry date is the last day of the month indicated.

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

6. Container Content and Additional Information

Composition of Glucosa Baxter 5%

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

The other component is water for injectable preparations.

Appearance of the Product and Container Content

Glucosa Baxter 5% from Baxter is a transparent solution, free of visible particles. It is presented in type II glass vials. Each vial is closed by a type I chlorobutyl stopper, which is covered with an aluminum cap.

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

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

• 25 vials of 50 ml
• 25 vials of 100 ml
• 30 vials of 250 ml
• 10 vials of 500 ml
• 10 vials of 1000 ml

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Holder

Baxter S.L.

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

Manufacturer:

Bieffe Medital S.p.A.

Via Nuova Provinciale

23034 Grosotto (SO)

Italy

Date of the Last Revision of this Prospectus: April 2018

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

This information is intended only for healthcare professionals

Handling and Preparation

Parenteral solutions must be visually inspected before administration to detect particles and discoloration, whenever the solution and container allow it. Use only if the solution is transparent, without visible particles, and if 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.

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

Medications can be introduced before infusion or during infusion through the injection point.

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

The addition of other medications or the use of an incorrect administration technique can cause the appearance of febrile reactions due to the possible introduction of pyrogens. In case of an adverse reaction, the infusion should be interrupted immediately.

In order to avoid a potentially fatal overdose during the infusion of intravenous solutions to newborns, special attention should be paid to the administration method. When using a syringe pump to administer fluids or medications intravenously to newborns, a vial of solution should 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 equipment from the pump or disconnecting the pump. This is required regardless of whether the administration equipment has an anti-free flow device.

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

Discard after a single use.

Discard partially unused containers.

Do not reconnect partially used vials.

Do not store solutions containing other medications.

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

Mix the solution well when adding medications.

1- To open

• Remove the aluminum cap that protects the closure

• 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.

• Hang the container by the hanger that accompanies the shipping box.

• Use an aseptic technique to prepare the infusion.

• Connect the administration equipment. Consult the instructions that accompany the equipment 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 medication before administration.

• Disinfect the injection point.

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

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

Precaution: do not store vials with added medication.

To add medication during administration

• Close the clamp on the equipment.

• Disinfect the injection point.

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

• Remove the container from the intravenous support and/or turn it to put it in a vertical position.

• Mix the solution and medication carefully.

• Put the container back in the position of use, reopen the clamp, and continue administration.

1. Expiry date for use (added medications)

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

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

5- Incompatibilities of added medications

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

It is the responsibility of the physician to judge the incompatibility of the added medication to Glucosa Baxter 5% by examining any change in color and/or precipitation, insoluble complexes, or the appearance of crystals. The prospectus 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 the Glucosa Baxter 5% solution.

When adding a compatible medication to Glucosa Baxter 5%, the solution should be used immediately.

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