Iniectio Glucosi 5% Baxter

Leaflet accompanying the packaging: Information for the user

Injectio Glucosi 5% Baxter, solution for infusion

Active substance: glucose

Please read the contents of the leaflet carefully before using the medicine, as it contains important information for the patient.

• Please keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, please consult a doctor or nurse.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or nurse. See section 4.

Table of contents of the leaflet:

• 1. What is Injectio Glucosi 5% Baxter and what is it used for
• 2. Important information before administering Injectio Glucosi 5% Baxter
• 3. How Injectio Glucosi 5% Baxter will be administered
• 4. Possible side effects
• 5. How to store Injectio Glucosi 5% Baxter
• 6. Contents of the packaging and other information

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

The Injectio Glucosi 5% Baxter infusion solution 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.
Injectio Glucosi 5% Baxter infusion solution is used:

• as a source of fluid and sugar (carbohydrate);
• to dilute or administer other medicines that can be used in infusion.

2. Important information before administering Injectio Glucosi 5% Baxter

DO NOT administer Injectio Glucosi 5% Baxter if the patient has any of the following conditions:

• untreated diabetes, where blood sugar levels exceed normal levels (uncontrolled diabetes);
• glucose intolerance, e.g. when metabolism is not normal, e.g. due to severe illness (metabolic stress);
• hyperosmolar coma (loss of consciousness). This type of coma can occur in diabetic patients who do not receive sufficient doses of medication;
• higher than normal blood sugar levels (hyperglycemia);
• higher than normal blood lactate levels (hyperlactatemia);
• intolerance (hypersensitivity) to glucose. May occur in patients with corn allergy.

If another medicine is added to the infusion solution, you should always read the leaflet accompanying the packaging of that medicine. This will allow the patient to check if they can safely use the medicine.

Warnings and precautions

The patient should inform their doctor if they have or have ever had any of the following conditions:

• excess water in the body (water poisoning);
• diabetes or high blood sugar levels (hyperglycemia);
• kidneys not working properly;
• sepsis, injury, or shock;
• low levels of electrolytes (sodium, potassium, phosphorus, magnesium) in the blood;
• recently suffered a stroke (acute ischemic stroke). Increased blood sugar levels can exacerbate stroke symptoms and affect recovery;
• metabolic disorders due to starvation or a diet that does not provide the necessary nutrients (malnutrition);
• if the patient has a low thiamine (vitamin B) content. This can occur in patients with chronic alcoholism;
• allergy to corn (Injectio Glucosi 5% Baxter contains sugar derived from corn);
• a condition that can cause high levels of vasopressin, a hormone that regulates the amount of fluid in the body. Excessive vasopressin levels in the body can be caused by, for example:
• -sudden and severe illness;
• -pain;
• -surgery;
• -infections, burns, brain disease;
• -heart, liver, kidney, or central nervous system diseases;
• -taking certain medications (see also section "Injectio Glucosi 5% Baxter and other medicines"). This can increase the risk of low sodium levels in the blood and cause headache, nausea, seizures, drowsiness, coma, brain swelling, and death. Brain swelling increases the risk of death and brain damage. Patients at higher risk of brain swelling are:
• -children;
• -women (especially of childbearing age);
• -patients with problems with cerebrospinal fluid levels, for example, due to meningitis, intracranial hemorrhage, or brain damage.

During infusion of this solution, the doctor will take blood and urine samples to examine:

• the amount of electrolytes such as potassium in the blood (electrolyte levels in serum);
• the amount of sugar (glucose);
• the amount of fluid in the body (fluid balance);
• blood and urine acidity (acid-base balance changes).

Since Injectio Glucosi 5% Baxter contains sugar (glucose), it may cause an increase in blood sugar levels (hyperglycemia). In such a situation, the doctor may:

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

Injectio Glucosi 5% Baxter should not be administered through the same needle as blood transfusions. This can cause damage to red blood cells or their clumping.
The doctor will consider whether the patient is receiving parenteral nutrition (nutrition administered through intravenous infusion).
During long-term therapy with Injectio Glucosi 5% Baxter, additional nutrition may be necessary.

Children

Injectio Glucosi 5% Baxter should be administered with caution in children.
Children should be administered Injectio Glucosi 5% Baxter by a doctor or nurse. The dose to be administered will be decided by a doctor experienced in treating children and will depend on the child's age, weight, and condition. If Injectio Glucosi 5% Baxter is used to provide or dilute another medicine, or if other medicines are administered at the same time, this may also affect the dose.
In the case of infusion in children, the attending doctor will take blood and urine samples to control the amount of electrolytes in the blood, such as potassium (electrolytes in serum).
Newborns, especially premature and low-birth-weight infants, are more prone to developing too low or too high blood sugar levels (hypo- or hyperglycemia) and should therefore be closely monitored during treatment with intravenous glucose solutions to ensure proper blood sugar control and avoid possible long-term side effects.
Low blood sugar levels in newborns can cause prolonged seizures, coma, and brain damage. High blood sugar levels are associated with intraventricular hemorrhages, bacterial and fungal infections, vision damage (retinopathy of prematurity), gastrointestinal infections (necrotizing enterocolitis), respiratory problems (bronchopulmonary dysplasia), prolonged hospital stay, and death.
In the case of administration to newborns, the bag with the solution can be connected to an infusion pump, which will allow the administration of the required amount of solution at specified time intervals. The doctor or nurse will monitor the device to ensure safe administration.
In children (including newborns and older children) receiving Injectio Glucosi 5% Baxter, there is a higher risk of developing low sodium levels in the blood (hyponatremic hypoosmolarity) and brain disorders due to low sodium levels in the serum (hyponatremic encephalopathy).

Injectio Glucosi 5% Baxter and other medicines

Please tell your doctor or nurse about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
Injectio Glucosi 5% Baxter and other medicines taken at the same time may interact with each other.
Do not take Injectio Glucosi 5% Baxter with certain hormones (catecholamines), including adrenaline or steroids, which can increase blood sugar levels.
Some medicines may affect vasopressin hormone levels. These include:

• -antidiabetic medicines (chlorpropamide)
• -cholesterol-lowering medicines (clofibrate)
• -some anticancer medicines (vincristine, ifosfamide, cyclophosphamide)
• -selective serotonin reuptake inhibitors (used to treat depression)
• -antipsychotic or opioid medicines used to relieve severe pain
• -pain-relieving and/or anti-inflammatory medicines (also known as NSAIDs)
• -medicines that mimic or enhance the action 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 medicines (carbamazepine and oxcarbazepine)
• -diuretics (diuretics).

Injectio Glucosi 5% Baxter with food and drink

Please ask your doctor what you can eat and drink during treatment.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, please consult your doctor or nurse before using this medicine.

Pregnancy

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

Fertility

There is no relevant data on the effect of Injectio Glucosi 5% Baxter on fertility.
However, it is not expected to affect fertility.

Breastfeeding

There is no relevant data on the effect of Injectio Glucosi 5% Baxter on breastfeeding women. However, it is not expected to affect breastfeeding women.
Injectio Glucosi 5% Baxter can be used during breastfeeding.
If any other medicine is added to the Injectio Glucosi 5% Baxter solution used during pregnancy or breastfeeding, you should:

• consult a doctor;
• read the leaflet accompanying the packaging of the added medicine.

Driving and using machines

Please consult your doctor or nurse before driving or operating machinery.

3. How Injectio Glucosi 5% Baxter will be administered

Injectio Glucosi 5% Baxter is administered by a doctor or nurse. The dose of the medicine and the time of its administration will be decided by a doctor. This will depend on the patient's age, weight, condition, reason for treatment, and whether the infusion is used to provide or dilute another medicine.
The dose may also be affected by other therapies used at the same time.

DO NOT administer Injectio Glucosi 5% Baxter if it contains visible particles or if the packaging is damaged in any way.

The Injectio Glucosi 5% Baxter infusion solution is usually administered through a plastic tube connected to a needle inserted into a vein. Typically, this solution is administered through a vein in the arm. However, the doctor may use a different method to administer this medicine.
The Injectio Glucosi 5% Baxter infusion solution should be administered slowly to prevent the production of too much urine (osmotic diuresis).
Before and during infusion, the doctor will monitor:

• the amount of fluid in the body;
• blood and urine acidity;
• electrolyte levels in the body (especially sodium, in patients with high vasopressin hormone levels or taking other medicines that increase the effect of vasopressin).

Any unused remains of the solution should be discarded. DO NOT administer Injectio Glucosi 5% Baxter from a partially used bag.

Administration of a higher dose of Injectio Glucosi 5% Baxter than recommended

Administration of too much Injectio Glucosi 5% Baxter solution (overdose) or administration too quickly may cause the following symptoms:

• fluid accumulation in tissues causing swelling (edema) or water poisoning, with lower than normal sodium levels in the blood (hyponatremia);
• increased urine production (osmotic diuresis);
• excessive blood density (hyperosmolality);
• fluid loss from the body (dehydration);
• high blood sugar levels (hyperglycemia);
• sugar in the urine (glycosuria).

If any of the above symptoms worsen, please inform your doctor immediately.
In such a situation, the doctor will stop or reduce the infusion. Insulin should be administered and appropriate treatment should be used depending on the symptoms.
If another medicine has been added to the Injectio Glucosi 5% Baxter solution, it may also cause symptoms before the symptoms of infusion overdose occur. Please read the leaflet accompanying the packaging of the added medicine to learn about possible symptoms.

Discontinuation of Injectio Glucosi 5% Baxter

The decision to discontinue Injectio Glucosi 5% Baxter will be made by a doctor.
If you have any doubts about the use of the medicine, please consult a doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects may include:

• allergic reactions, including severe allergic reactions known as anaphylaxis (may occur in patients with corn allergy);
• changes in electrolyte levels in the blood (electrolyte disturbances);
• higher than normal blood sugar levels (hyperglycemia);
• fluid loss from the body (dehydration);
• excess fluid in the blood vessels (hypervolemia);
• excessive urine production (polyuria);
• low sodium levels in the blood (hyponatremia), which may be associated with hospital treatment (hospital hyponatremia) and related neurological disorders (acute hyponatremic encephalopathy). Hyponatremia can lead to irreversible brain damage and death due to brain swelling (see also section 2 "Warnings and precautions");
• reactions related to the technique of administering the medicine:
• reactions at the injection site:
• irritation of the vein into which the solution is administered. This can cause redness, pain, or burning and swelling along the vein into which the solution is administered;
• fever, febrile reactions;
• infection at the injection site;
• leakage of the infusion solution into the perivascular space (extravasation). This can damage tissues and lead to scarring;
• formation of blood clots in the veins (phlebitis) at the injection site, causing pain, swelling, or redness in the area of the clot.

If any of the above symptoms occur, please inform your doctor or nurse.
Reporting of side effects: If you experience any side effects, including any side effects not listed in this leaflet, please inform your doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Injectio Glucosi 5% Baxter

Store the medicine out of sight and reach of children.
Bags of 50 ml and 100 ml: do not store above 30°C.
Bags of 250 ml, 500 ml, and 1000 ml: no special storage precautions.
DO NOT use Injectio Glucosi 5% Baxter after the expiry date stated on the label, after the "Expiry Date" section. The expiry date refers to the last day of the given month.
DO NOT use Injectio Glucosi 5% Baxter if it contains visible particles or if the packaging is damaged.

6. Contents of the packaging and other information

What Injectio Glucosi 5% Baxter contains

Active substance: sugar (glucose): 50 g per liter.
The only other ingredient is water for injection.

What Injectio Glucosi 5% Baxter looks like and what the packaging contains

Injectio Glucosi 5% Baxter is a clear solution free from visible particles.
It is available in polyolefin/polyamide plastic bags (Viaflo). Each bag is placed in a closed, protective, outer plastic packaging.
Sizes of bags:

• -50 ml
• -100 ml
• -250 ml
• -500 ml
• -1000 ml

Sizes of packaging:

• 50 bags of 50 ml in a cardboard box
• 75 bags of 50 ml in a cardboard box
• 1 bag of 50 ml
• 50 bags of 100 ml in a cardboard box
• 60 bags of 100 ml in a cardboard box
• 1 bag of 100 ml
• 30 bags of 250 ml in a cardboard box
• 1 bag of 250 ml
• 20 bags of 500 ml in a cardboard box
• 1 bag of 500 ml
• 10 bags of 1000 ml in a cardboard box
• 12 bags of 1000 ml in a cardboard box
• 1 bag of 1000 ml

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:
Baxter Polska Sp. z o.o.
ul. Kruczkowskiego 8
00-380 Warsaw
Manufacturer:
Baxter S.A.
Boulevard René Branquart, 80
7860 Lessines
Belgium
Bieffe Medital S.A.
Ctra de Biescas, Senegüé
22666 Sabiñanigo (Huesca)
Spain
Vantive Manufacturing Limited
Moneen Road
Castlebar
County Mayo
Ireland
Bieffe Medital S.P.A.
Via Nuova Provinciale
23034 Grosotto (SO)
Italy
Date of last update of the leaflet:April 2025
Baxter and Viaflo are trademarks of Baxter International Inc.
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Information intended for healthcare professionals only:

Method of handling and preparation

Parenteral products should be inspected for visible particles and changes in color before administration, if the solution and packaging allow it.
Use only if the solution is clear and free from visible particles and the container is undamaged. Administer immediately after connecting the infusion set.
Do not remove from the protective packaging until use.
The inner bag ensures the sterility of the product.
Plastic containers should not be connected in series. Such use could cause an air embolism due to residual air drawn into the first container before the administration of the fluid from the second container is completed.
Applying additional pressure on intravenous solutions in flexible plastic containers to increase the flow rate may cause an air embolism if the residual air is not completely removed from the container before administration.
The use of intravenous administration sets with air vents, with the air vent valve in the open position, may cause an air embolism. Do not use intravenous administration sets with air vents, with the air vent valve in the open position, with flexible plastic containers.
The solution should be administered using sterile equipment and aseptic techniques. The infusion equipment should be pre-filled with the solution to prevent air from entering the system.
Electrolyte supplementation may be indicated, depending on the patient's clinical needs.
Additional medicines can be introduced into the solution before infusion or during infusion, through the self-sealing port for adding medicines.
When using another medicine, it is necessary to confirm the final osmolality before parenteral administration.
It is necessary to mix the solution thoroughly with the added medicine under aseptic conditions. Solutions containing added medicines should be used immediately, without storage.
Adding other medicines or improper administration technique may cause febrile reactions due to the possibility of introducing pyrogens. If a side effect occurs, the infusion should be stopped immediately.
Particular attention should be paid to the method of administration to avoid excessive fluid administration in newborns, which can be fatal. When using a syringe pump to administer fluids or medicines to newborns, do not leave the bag of fluid connected to the syringe.
When using an infusion pump, all clamps on the intravenous administration set must be closed before disconnecting the administration set from the pump or before turning off the pump. This is required regardless of whether the administration set has a free-flow protection device.
Intravenous administration equipment and infusion devices must be frequently checked.

Discard after single use.

Discard unused remains of the solution.

Do not reconnect partially used bags.

Do not store solutions to which additional medicinal products have been added.

When adding additional medicinal products to Injectio Glucosi 5% Baxter, follow aseptic techniques.

Mix thoroughly with the added medicinal product.

1. Opening

• a. Remove the Viaflo bag from the protective packaging immediately before use
• b. By squeezing the inner bag firmly, check for leakage. If leakage is detected, the bag should be discarded, as the contents may not be sterile.
• c. Check if the solution is clear and free from visible particles. If the solution is not clear or contains visible particles, it should be discarded.

2. Preparation for administration

During preparation and administration, sterile materials should be used.

• a. Hang the bag on a stand.
• b. Remove the plastic cover from the transfusion port at the bottom of the bag:
• grasp the smaller wing on the neck of the port with one hand,
• grasp the larger wing on the plug with the other hand and twist,
• the plug will come off.
• c. When connecting the infusion, follow aseptic techniques.
• d. Connect the infusion set according to the instructions provided with the set, regarding connection, filling the set, and administering the solution.

3. Methods of adding additional medicines

Warning: Added medicines may be incompatible (see below, section 5 "Incompatibility of added medicines").
Adding medicines before administration

• a. Disinfect the medicine addition port.
• b. Using a syringe with a suitable needle, insert the needle into the self-sealing medicine addition port and inject the medicine.
• c. Mix the solution thoroughly with the added medicine. For preparations with high density, such as potassium chloride, gently tap the ports with the bag in the upright position and mix.

Warning: Do not store bags containing added medicines.
Adding medicines during administration

• a. Close the clamp on the infusion set.
• b. Disinfect the medicine addition port.
• c. Using a syringe with a suitable needle, insert the needle into the self-sealing medicine addition port and inject the medicine.
• d. Remove the bag from the stand and/or turn it upside down.
• e. Empty both ports by gently tapping in the upright position.
• f. Mix the solution thoroughly with the medicine.
• g. Hang the bag in its previous position, reopen the clamp, and continue administration.

4. Shelf life during use (additional medicines)

Before use, the chemical and physical stability of each added medicine should be established in the pH of Injectio Glucosi 5% Baxter in the Viaflo container.
From a microbiological point of view, the diluted product should be used immediately, unless the dilution has been carried out under controlled and validated aseptic conditions. If the solution is not used immediately, the user is responsible for the storage time and conditions of the product.

5. Incompatibility of added medicines

As with any parenteral solution, the compatibility of added medicines with the solution in the Viaflo container should be checked before addition.
The doctor is responsible for assessing the incompatibility of the added medicine with Injectio Glucosi 5% Baxter after checking for any changes in color and/or the appearance of precipitates, insoluble complexes, or crystals. Please read the instructions for use of the medicinal product to be added to the solution.
Before adding a medicine, check if it is soluble and stable in water at the pH of the Injectio Glucosi 5% Baxter solution.
After adding a medicine with proven compatibility with Injectio Glucosi 5% Baxter, the solution should be administered immediately.
Substances known to be incompatible should not be used.
Baxter and Viaflo are trademarks of Baxter International Inc.