Iniectio Glucosi 10% Baxter

LEAFLET INCLUDED IN THE PACKAGE: INFORMATION FOR THE USER

Injectio Glucosi 10% Baxter, solution for infusion

Active substance: glucose

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor, pharmacist, 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 10% Baxter and what is it used for
• 2. Important information before using Injectio Glucosi 10% Baxter
• 3. How to use Injectio Glucosi 10% Baxter
• 4. Possible side effects
• 5. How to store Injectio Glucosi 10% Baxter
• 6. Contents of the package and other information

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

Injectio Glucosi 10% Baxter is a sugar (glucose) solution in water. Glucose is one of the body's energy sources. This infusion solution provides 400 kilocalories per liter. Injectio Glucosi 10% Baxter is used:

• to provide sugar (carbohydrates) or in parenteral nutrition, if required. Parenteral nutrition is used in patients who are unable to eat. It is administered as an infusion (slow injection) into a vein;
• to prevent or treat decreased blood sugar levels (hypoglycemia, which causes symptoms but is not life-threatening);
• to provide fluids when there is not enough water in the body (in case of dehydration) and additional sugar (carbohydrates) is needed;
• to dissolve/dilute other medicines that are to be administered into a vein.

2. Important information before using Injectio Glucosi 10% Baxter

DO NOT use Injectio Glucosi 10% Baxter if the patient has any of the following conditions:

• untreated diabetes with high blood sugar levels (uncontrolled diabetes);
• loss of consciousness (hyperosmolar coma). This type of coma can occur in patients with diabetes who do not receive sufficient doses of medication;
• blood dilution caused by the administration of too much fluid (hemodilution);
• excess fluid in the spaces around the body's cells (extracellular overhydration);
• excess blood in the blood vessels (hypervolemia);
• higher than normal blood sugar levels (hyperglycemia);
• higher than normal levels of lactic acid, a chemical compound found in the blood (hyperlactatemia);
• severe kidney failure (a condition where the kidneys do not work properly and the patient requires dialysis);
• uncontrolled heart failure. This is heart failure that is not being treated properly and causes symptoms such as:
• shortness of breath;
• swelling of the ankles;
• fluid accumulation under the skin in all parts of the body, including the brain and lungs (generalized edema);
• liver disease causing fluid accumulation in the abdomen (liver cirrhosis with ascites);
• any condition that affects blood sugar regulation;
• glucose intolerance (hypersensitivity). This may occur in patients with a corn allergy.

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

Warnings and precautions

Injectio Glucosi 10% Baxter is a hypertonic solution (concentrated). The doctor will take this into account when calculating the amount of solution to be administered to the patient. The patient should inform the doctor if they have or have had any of the following medical conditions:

• diabetes;
• kidney disease;
• a disease that started recently and may be life-threatening (acute, severe disease);
• increased intracranial pressure (intracranial hypertension);
• head injury within the last 24 hours;
• stroke caused by a blood clot in a blood vessel in the brain (ischemic stroke);
• heart disease (heart failure);
• lung disease (respiratory failure);
• decreased urine production (oliguria or anuria);
• excess water in the body (water intoxication);
• low sodium levels in the blood (hyponatremia);
• allergy to corn (Injectio Glucosi 10% Baxter contains sugar derived from corn)
• a condition that may cause high levels of vasopressin, a hormone that regulates the amount of fluid in the body. Excessive vasopressin levels in the body may be caused by, for example:
• -sudden and severe illness;
• -pain;
• -surgery;
• -infections, burns, brain disease;
• -heart, liver, kidney, or central nervous system disorders;
• -taking certain medications (see also the section "Injectio Glucosi 10% Baxter and other medicines"). This may 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 include:
• -children;
• -women (especially of childbearing age);
• -patients with problems with cerebrospinal fluid levels, such as due to meningitis, intracranial hemorrhage, or brain damage.

During the administration of this solution to the patient, the doctor will check:

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

The doctor will decide how much of the infusion solution to administer to the patient based on the results of these tests. The tests will also provide the doctor with information on the need to administer potassium to the patient. If necessary, it can be administered intravenously. Since Injectio Glucosi 10% 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.

This is especially important:

• if the patient has diabetes;
• if the patient has abnormal kidney function;
• if the patient has recently had a stroke (acute ischemic stroke). High blood sugar levels may worsen stroke symptoms and affect recovery.
• if the patient has metabolic disorders due to starvation or a diet that does not provide the necessary nutrients (malnutrition);
• if the patient has low thiamine (vitamin B1) levels in the body. This may occur in patients with chronic alcoholism.

Do not administer this solution through the same needle as a blood transfusion. This may cause red blood cell breakdown or clumping.

Children

Injectio Glucosi 10% Baxter should be administered with caution in children. Children should only be administered Injectio Glucosi 10% 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 10% 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. During infusion in children, the doctor will take blood and urine samples to monitor the levels of electrolytes in the blood, such as potassium (electrolytes in serum). Newborns, especially premature and low-birth-weight infants, are more susceptible to hypoglycemia or hyperglycemia and should be closely monitored during treatment with intravenous glucose solutions to ensure proper blood sugar control and avoid potential long-term side effects. Low blood sugar in newborns can cause prolonged seizures, coma, and brain damage. High blood sugar levels are associated with brain hemorrhage, bacterial or fungal infection, vision damage (retinopathy of prematurity), gastrointestinal infections (necrotizing enterocolitis), lung disorders (bronchopulmonary dysplasia), prolonged hospital stay, and death. When administering to newborns, the solution bag can be connected to an infusion pump, which will allow for the administration of the required amount of solution at set time intervals. The doctor or nurse will monitor the device to ensure safe administration. In children (including newborns and older children) receiving Injectio Glucosi 10% Baxter, there is a higher risk of developing low sodium levels in the blood (hypotonic hyponatremia) and brain disorders due to low sodium levels in the serum (hyponatremic encephalopathy).

Injectio Glucosi 10% Baxter and other medicines

Tell the doctor or nurse about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take. Injectio Glucosi 10% Baxter and other medicines taken at the same time may interact with each other. Do not take Injectio Glucosi 10% Baxter with certain hormones (catecholamines), including adrenaline or steroids, as they may cause an increase in blood sugar levels. Some medicines may affect vasopressin hormone levels. These include:

• -antidiabetic medicines (chlorpropamide)
• -cholesterol-lowering medicines (clofibrate)
• -certain anticancer medicines (vincristine, ifosfamide, cyclophosphamide)
• -selective serotonin reuptake inhibitors (used to treat depression)
• -antipsychotic or narcotic medicines
• -pain relievers and/or anti-inflammatory medicines (also known as NSAIDs)
• -medicines that mimic or enhance the action of vasopressin, such as desmopressin (used to treat excessive thirst and urination), terlipressin (used to treat bleeding from the esophagus), and oxytocin (used to induce labor)
• -antiepileptic medicines (carbamazepine and oxcarbazepine)
• -diuretics (urinary tract medicines).

Injectio Glucosi 10% Baxter with food and drink

Ask the doctor what can be eaten or drunk.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, or thinks they may be pregnant or plans to have a child, they should consult a doctor or nurse before using this medicine.

Pregnancy

Glucose solution may be used during pregnancy. However, caution should be exercised when administering glucose to a patient during labor.

Fertility

There is no relevant data on the effect of glucose on fertility. However, it is not expected to affect fertility.

Breastfeeding

There is no relevant data on the use of glucose solution in breastfeeding women. However, it is not expected to affect breastfeeding women. Glucose solution may be used during breastfeeding. Before adding any medicine to the Injectio Glucosi 10% Baxter solution used during pregnancy or breastfeeding, the patient should:

• consult a doctor,
• read the leaflet included with the packaging of the medicine to be added.

Driving and using machines

Consult a doctor or nurse before driving or operating machines.

3. How to use Injectio Glucosi 10% Baxter

Injectio Glucosi 10% Baxter is administered by a doctor or nurse. The dose and duration of administration will be decided by the doctor. This will depend on the patient's age, weight, health status, and reason for treatment. The dose may also be affected by other medicines being taken at the same time.

DO NOT administer Injectio Glucosi 10% Baxter if it contains visible particles or if the packaging is damaged in any way.

Injectio Glucosi 10% Baxter is usually administered through a plastic tube connected to a needle inserted into a vein. Typically, an arm vein is used for infusion. However, the doctor may use a different method to administer this medicine. Before and during infusion, the doctor will monitor:

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

Any unused solution should be discarded. DO NOT administer Injectio Glucosi 10% Baxter from a partially used bag.

Administration of a higher dose of Injectio Glucosi 10% Baxter than recommended

Administration of too much Injectio Glucosi 10% Baxter (overdose) or administration too quickly or too frequently may cause the following symptoms:

• 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 density (hyperosmolality);
• sugar in the urine (glycosuria);
• increased urine production (osmotic diuresis);
• water loss from the body (dehydration).

If any of these symptoms occur, the doctor should be informed immediately. The doctor will stop or reduce the infusion. Insulin and appropriate treatment will be administered depending on the symptoms. If another medicine was added to the Injectio Glucosi 10% Baxter infusion before the overdose symptoms occurred, it may also be the cause of the symptoms. The patient should read the leaflet included with the packaging of the added medicine to learn about possible symptoms.

Discontinuation of Injectio Glucosi 10% Baxter

The decision to discontinue Injectio Glucosi 10% Baxter is made by the doctor. In case of doubts about the use of the medicine, the patient should consult a doctor or nurse.

4. Possible side effects

Like all medicines, Injectio Glucosi 10% Baxter can cause side effects, although not everybody gets them. Side effects may include:

• -allergic reactions, including a severe allergic reaction called anaphylaxis (potentially occurring in patients with a corn allergy):
• breathing difficulties;
• swelling of the face, lips, and throat;
• fever;
• hives;
• skin rash;
• redness of the skin (flushing);
• chills.
• changes in electrolyte levels in the blood (electrolyte disturbances), including:
• low sodium levels in the blood, which may be associated with hospital treatment (hospital hyponatremia). Hyponatremia can lead to irreversible brain damage and death due to brain swelling (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 (glycosuria);
• reactions related to the administration route:
• fever, febrile reaction;
• infection at the administration site;
• leakage of the infusion solution into the tissue surrounding the blood vessel (extravasation). This can damage tissues and lead to scarring;
• formation of blood clots in the veins (thrombophlebitis) at the infusion site, causing pain, swelling, or redness in the area of the clot;
• irritation or inflammation of the vein into which the solution is administered (phlebitis). This can cause redness, pain, or burning and swelling along the vein into which the solution is administered.
• local pain or reaction (redness or swelling at the administration site);
• sweating.

If another medicine is added to the infusion solution, it may also cause side effects. These side effects will depend on the added medicine. The patient should read the leaflet included with the packaging of the added medicine to learn about possible symptoms. If any side effects occur, the infusion should be stopped. If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or nurse.

Reporting side effects

If side effects occur, including any side effects not listed in this leaflet, the doctor or nurse should be informed. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, PL 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, e-mail: [email protected]. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Injectio Glucosi 10% Baxter

The medicine should be stored out of sight and reach of children. There are no special precautions for the storage of this medicinal product. DO NOT use Injectio Glucosi 10% Baxter after the expiration date stated on the bag and carton, after the "Expiration Date" section. The expiration date refers to the last day of the specified month. DO NOT administer Injectio Glucosi 10% Baxter if it contains visible particles or if the packaging is damaged in any way.

6. Contents of the package and other information

What Injectio Glucosi 10% Baxter contains

The active substance is glucose (in the form of glucose monohydrate): 100 g per liter. The only other ingredient is water for injections. Composition per 250 ml: Glucose (in the form of glucose monohydrate): 25 g. Composition per 500 ml: Glucose (in the form of glucose monohydrate): 50 g. Composition per 1000 ml: Glucose (in the form of glucose monohydrate): 100 g.

What Injectio Glucosi 10% Baxter looks like and contents of the package

Injectio Glucosi 10% 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. Bag sizes:

• 250 ml
• 500 ml
• 1000 ml

Package sizes:

• 30 or 36 bags of 250 ml in a carton
• 1 bag of 250 ml
• 20 or 24 bags of 500 ml in a carton
• 1 bag of 500 ml
• 10 or 12 bags of 1000 ml in a carton
• 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: Bieffe Medital S.A., Ctra de Biescas, Senegüé, 22666 Sabiñanigo (Huesca), Spain. Date of last revision of the leaflet:20.03.2019. Baxter and Viaflo are trademarks of Baxter International Inc.

Information intended for healthcare professionals only:

Procedure and preparation

Before administration, the infusion solution should be visually inspected. Products for parenteral administration should be inspected for visible particles or discoloration, if the solution and packaging allow. Use only if the solution is clear, free from visible particles, and the packaging is undamaged. Administer immediately after connecting the infusion set.

Do not remove the bag 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, caused by residual air drawn into the first container before the fluid is completely administered from the second container. Applying additional pressure on intravenous solutions contained in flexible plastic containers to increase the flow rate may cause an air embolism if the container is not completely emptied of air before administration. The use of infusion sets with air vents, with the air vent valve in the open position, may cause an air embolism. Do not use infusion 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 technique. The infusion equipment should be primed with the solution before administration to prevent air from entering the system. Electrolyte supplementation may be indicated based on the patient's clinical needs. Additional medicines can be added to the solution before or during infusion through the self-sealing port for adding medicines. When using another medicine, the final osmolality of the solution should be confirmed before parenteral administration. It is essential to carefully and cautiously mix the solution with any additional medicine under aseptic conditions. Solutions containing added medicines should be used immediately, without storage.

Discard after single use.

Discard any unused solution.

Do not reconnect partially used bags.

Do not store solutions with added medicines.

When adding medicines to Injectio Glucosi 10% Baxter, aseptic technique must be used.

Mix the solution with the added medicine thoroughly.

1. Opening

• a. Remove the Viaflo bag from the protective packaging immediately before use.
• b. By squeezing the inner bag firmly, check for leaks. If a leak is found, 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

Use sterile materials for preparation and administration.

• a. Hang the bag on the hanger.
• b. Remove the plastic cover from the transfer port at the bottom of the bag:
• hold the smaller wing on the neck of the port with one hand;
• hold the larger wing on the plug with the other hand and twist;
• the plug will come off.
• c. When connecting the infusion set, follow aseptic procedures.
• d. Connect the infusion set. Read all the instructions provided with the infusion set regarding connection, priming, and administration of the solution.

3. Methods of adding medicines

Warning: Added medicines may be incompatible.
Adding medicines before administration

• a. Disinfect the port for adding medicines.
• b. Using a needle with a diameter of 19G (1.10 mm) to 22G (0.70 mm), insert the needle into the self-sealing port for adding medicines and inject the medicine.
• c. Mix the solution with the medicine thoroughly. For dense preparations, such as potassium chloride, gently tap the ports with the bag in an upright position and mix.
• d. Note: Do not store bags containing added medicines.

Adding medicines during administration

• a. Close the clamp on the infusion set.
• b. Disinfect the port for adding medicines.
• c. Using a needle with a diameter of 19G (1.10 mm) to 22G (0.70 mm), insert the needle into the self-sealing port for adding medicines and inject the medicine.
• d. Remove the bag from the hanger and/or turn it upside down.
• e. Empty both ports by gently tapping the bag with the ports facing upwards.
• f. Mix the solution with the medicine thoroughly.
• g. Return the bag to its original position, reopen the clamp, and continue administration.

4. Stability: added medicines

Before use, the chemical and physical stability of each added medicine should be established in the pH of Injectio Glucosi 10% Baxter in the Viaflo container. From a microbiological point of view, the diluted product should be used immediately, unless dilution is performed under controlled and validated aseptic conditions. If the solution is not used immediately, the user is responsible for the storage time and conditions during use.

5. Incompatibility of added medicines

Glucose solution should not be administered through the same infusion set as blood, before or after blood transfusion, as this may cause hemolysis and agglutination. Before adding a medicine, its compatibility with the solution in the Viaflo container should be evaluated. In the absence of compatibility studies, this solution should not be mixed with other medicines. Read the instructions for use of the medicine to be added. Before adding a medicine, check if it is soluble and stable in water at the pH of Injectio Glucosi 10% Baxter (pH 3.5 to 6.5). After adding a compatible medicine to Injectio Glucosi 10% Baxter, the solution should be administered immediately. Do not use medicines known to be incompatible. Baxter and Viaflo are trademarks of Baxter International Inc.