Injectio glucosi 10% baxter

PACKAGE LEAFLET: INFORMATION FOR THE USER

Injectio Glucosi 10% Baxter, infusion solution
Active substance: glucose
Please read carefully the entire leaflet before using the medicine, as it contains
important information for the patient.

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

Leaflet contents:

1. What Injectio Glucosi 10% Baxter is and what it is 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 pack and other information

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

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

• to supply sugar (carbohydrates) alone or as part of parenteral nutrition, when 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 low blood sugar levels (hypoglycaemia, which causes symptoms but is not life-threatening);
• to supply fluids when there is insufficient water in the body (in cases of dehydration) and additional sugar (carbohydrates) is needed;
• to dissolve/dilute other medicines that are to be administered intravenously.

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:

• inadequately treated diabetes, with blood glucose levels above normal (uncontrolled diabetes);
• loss of consciousness (hyperosmolar coma). This type of coma may occur in patients with diabetes who are not receiving adequate doses of medication;
• dilution of the blood caused by administration of excessive fluid (hemodilution);
• excess fluid in the spaces surrounding the body's cells (extracellular fluid overload);
• abnormally high blood volume in the blood vessels (hypervolemia);
• abnormally high blood glucose levels (hyperglycemia);
• abnormally high levels of lactate, chemical compounds present in the blood (hyperlactatemia);
• severe kidney failure (a condition in which the kidneys do not function properly and the patient requires dialysis);
• uncontrolled heart failure. This is heart failure that is not adequately treated and causes symptoms such as:
  • shortness of breath;
  • swelling around the ankles;
  • accumulation of fluid under the skin throughout the body, including the brain and lungs (generalized edema);
• liver disease causing fluid accumulation in the abdomen (cirrhosis with ascites);
• any condition affecting the regulation of glucose in the body;
• glucose intolerance (hypersensitivity). This may occur in patients allergic to corn.

If another medicine is added to the infusion solution, always read the package leaflet included with that medicine. This will allow the patient to verify whether it is safe to use the medicine.

Warnings and precautions

Injectio Glucosi 10% Baxter is a hypertonic (concentrated) solution. The physician will take this into account when calculating the volume of solution to be administered to the patient.

Inform the physician if the patient has or has had any of the following medical conditions:

• diabetes;
• kidney disease;
• acute, severe illness (a recently developed condition that may be life-threatening);
• increased intracranial pressure (intracranial hypertension);
• head injury within the last 24 hours;
• stroke caused by a blood clot in a cerebral blood vessel (ischemic stroke);
• heart disease (heart failure);
• lung disease (respiratory failure);
• reduced urine output (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);
• conditions that may cause elevated levels of vasopressin, a hormone regulating fluid balance in the body. Excessively high vasopressin levels may result from, for example:
  • acute and serious illness;
  • pain;
  • surgery;
  • infections, burns, or brain disorders;
  • diseases affecting the heart, liver, kidneys, or central nervous system;
  • use of certain medications (see also section “Injectio Glucosi 10% Baxter and other medicines”). This may increase the risk of low blood sodium levels and may cause headache, nausea, seizures, drowsiness, coma, brain edema, and death. Brain edema increases the risk of death and brain damage. Patients at higher risk of brain edema include:
  • children;
  • women (especially those of childbearing age);
  • patients with problems related to cerebrospinal fluid levels, for example due to meningitis, intracranial hemorrhage, or brain injury.

During administration of this solution, the physician will monitor:

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

The physician will determine the appropriate infusion volume based on these test results. These tests will also provide information on whether potassium supplementation is needed. Potassium, a chemical component present in the blood, may be administered intravenously if required.

Because Injectio Glucosi 10% Baxter contains sugar (glucose), it may cause increased blood glucose levels (hyperglycemia). In such cases, the physician may:

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

This is particularly important:

• if the patient has diabetes;
• if the patient has impaired kidney function;
• if the patient has recently experienced a stroke (acute ischemic stroke). Elevated blood glucose levels may worsen stroke symptoms and affect recovery;
• if the patient has metabolic disturbances due to starvation or diets lacking adequate proportions of essential nutrients (malnutrition);
• if the patient has low thiamine (vitamin B1) levels. This may occur in patients with chronic alcoholism.

Do not administer this solution through the same needle used for blood transfusion. This may cause red blood cell lysis or clumping.

Children

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

Injectio Glucosi 10% Baxter must be administered to children by a physician or nurse. The dose must be determined by a physician experienced in pediatric care and will depend on the child's age, body weight, and clinical condition. If Injectio Glucosi 10% Baxter is used to deliver or dilute another medicine, or if other medicines are administered simultaneously, this may also affect the dosage.

During infusion in children, the treating physician will collect blood and urine samples to monitor electrolyte levels in the blood, such as potassium (serum electrolytes).

Newborns, especially those born prematurely and with low birth weight, are at higher risk of developing abnormally low or high blood glucose levels (hypo- or hyperglycemia). Therefore, they require close monitoring during intravenous glucose therapy to ensure appropriate glucose control and to avoid potential long-term adverse effects. Low glucose levels in newborns may lead to prolonged seizures, coma, and brain damage. High blood glucose levels are associated with intracranial hemorrhage, bacterial and fungal infections, visual impairment (retinopathy of prematurity), gastrointestinal infections (necrotizing enterocolitis), lung disorders (bronchopulmonary dysplasia), prolonged hospitalization, and death.

When administering to newborns, the solution bag may be connected to an infusion pump, which allows precise delivery of the required volume at specified time intervals. The physician or nurse will monitor the device to ensure safe administration.

In children (including newborns and older children) receiving Injectio Glucosi 10% Baxter, there is an increased risk of developing low blood sodium levels (hypotonic hyponatremia) and brain-related disorders due to low serum sodium concentration (hyponatremic encephalopathy).

Injectio Glucosi 10% Baxter and other medicines

Inform the physician or nurse about all medicines currently used, recently used, or planned for use by the patient.

Injectio Glucosi 10% Baxter and other concurrently administered medicines may interact with each other.

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

Some medicines may affect vasopressin hormone levels. These include:

• antidiabetic drugs (chlorpropamide);
• cholesterol-lowering drugs (clofibrate);
• certain anticancer drugs (vincristine, ifosfamide, cyclophosphamide);
• selective serotonin reuptake inhibitors (used in depression treatment);
• antipsychotics or narcotics;
• pain-relieving and/or anti-inflammatory drugs (also known as NSAIDs);
• drugs mimicking or enhancing vasopressin action, such as desmopressin (used to treat excessive thirst and urine output), terlipressin (used to treat esophageal bleeding), and oxytocin (used to induce labor);
• antiepileptic drugs (carbamazepine and oxcarbazepine);
• diuretics (water pills).

Injectio Glucosi 10% Baxter with food and drink

Ask the physician what the patient may eat or drink.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant, breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult a physician or nurse before using this medicine.

Pregnancy

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

Effect on fertility

There are no adequate data on the effect of glucose on fertility. However, no effect on fertility is expected.

Breastfeeding

There are no adequate data on the use of glucose solution in breastfeeding women. However, no adverse effects in breastfeeding women are expected. Glucose solution may be used during breastfeeding.

Before adding any medicine to the Injectio Glucosi 10% Baxter solution during pregnancy or breastfeeding:

• consult the physician;
• read the package leaflet of the medicine to be added.

Driving and using machines

Consult the physician or nurse before driving or operating machinery.

3. How to use Injectio Glucosi 10% Baxter

Injectio Glucosi 10% Baxter is administered by a physician or nurse. The physician determines the dose and duration of administration, based on the patient's age, body weight, health status, and reason for treatment. Concurrently administered medicines may also influence the dosage.

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 placed in a vein. Typically, a vein in the arm is used. However, the physician may use another method of administration.

Before and during infusion, the physician will monitor:

• fluid balance in the body;
• blood and urine acidity;
• electrolyte concentrations in the body (especially sodium, in patients with high vasopressin levels or those taking other medicines that enhance vasopressin effects).

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

Overdose of Injectio Glucosi 10% Baxter

Administering too large a volume of Injectio Glucosi 10% Baxter (overdose), or administering it too rapidly 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);
• abnormally high blood glucose levels (hyperglycemia);
• abnormally high blood osmolarity (hyperosmolality);
• glucose in the urine (hyperglycosuria);
• increased urine output (osmotic diuresis);
• loss of water from the body (dehydration).

If any of these symptoms occur, inform the physician immediately. The physician will stop or reduce the infusion. Insulin should be administered, and appropriate symptomatic treatment initiated.

If another medicine was added to the Injectio Glucosi 10% Baxter infusion before overdose symptoms appeared, that medicine may also be responsible for the symptoms. Refer to the package leaflet of the added medicine to review possible adverse effects.

Discontinuing treatment with Injectio Glucosi 10% Baxter

The decision to discontinue treatment with Injectio Glucosi 10% Baxter is made by the physician.

If in doubt about using this medicine, consult the physician or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Adverse reactions may include:

• hypersensitivity reactions, including a severe allergic reaction called anaphylaxis (potentially occurring in patients allergic to corn):
• difficulty breathing;
• swelling of the facial skin, lips and throat;
• fever;
• rash (urticaria);
• skin rash;
• skin redness (flushing);
• chills.
• changes in blood electrolyte concentrations (electrolyte disturbances), including:
• low blood sodium concentration, which may be associated with hospital treatment (hospital-acquired hyponatremia). Hyponatremia may lead to irreversible brain damage and death due to cerebral edema (see also section “Warnings and precautions”).
• decreased blood potassium concentration (hypokalemia);
• decreased blood magnesium concentration (hypomagnesemia);
• decreased blood phosphate concentration (hypophosphatemia).
• increased blood glucose concentration (hyperglycemia);
• excess fluid in the blood vessels (hemodilution and hypervolemia);
• glucose in urine (glucosuria);
• reactions related to the route of administration:
• fever, febrile reaction;
• infection at the site of administration;
• leakage of infusion solution into the surrounding tissue (extravasation). This may damage tissues and lead to scarring;
• blood clot formation in veins (venous thrombosis) at the infusion site, causing pain, swelling or redness around the clot;
• irritation or inflammation of the vein into which the solution is administered (phlebitis). This may cause redness, pain or burning sensation, and swelling along the vein.
• local pain or reaction (redness or swelling at the site of administration);
• sweating.

If a medicine has been added to the infusion solution, it may also cause adverse reactions.
These adverse reactions will depend on the added medicine. Please read the package leaflet of the added medicine to become familiar with possible symptoms.
If any adverse symptoms occur, the infusion should be stopped.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or nurse.
Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
PL 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
e-mail: [email protected]
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store the medicinal product Injectio Glucosi 10% Baxter

Keep the medicinal product out of the sight and reach of children.
No special storage precautions are required for this medicinal product.
DO NOT use Injectio Glucosi 10% Baxter after the expiry date stated on the bag and
the cardboard carton after the words "Expiry date". The expiry date refers to the last day of the stated month.
Do not administer Injectio Glucosi 10% Baxter if it contains visible particles or if the container 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 monohydrate glucose): 100 g per litre.
The only other ingredient is water for injections.

Composition per 250 ml:
Glucose (in the form of monohydrate glucose): 25 g

Composition per 500 ml:
Glucose (in the form of monohydrate glucose): 50 g

Composition per 1000 ml:
Glucose (in the form of monohydrate glucose): 100 g

What Injectio Glucosi 10% Baxter looks like and contents of the pack
Injectio Glucosi 10% Baxter is a clear, transparent solution free from visible particles. It is available in polyolefin/poliamide plastic bags (Viaflo). Each bag is enclosed in a sealed, protective, outer plastic container.

Bag sizes:

• 250 ml
• 500 ml
• 1000 ml

Pack sizes:

• 30 or 36 bags of 250 ml in a cardboard box
• 1 bag of 250 ml
• 20 or 24 bags of 500 ml in a cardboard box
• 1 bag of 500 ml
• 10 or 12 bags of 1000 ml in a cardboard box
• 1 bag of 1000 ml

Not all pack types may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Baxter Polska Sp. z o.o.
Ul. Kruczkowskiego 8
00-380 Warszawa

Manufacturer:
Bieffe Medital S.A.
Ctra de Biescas, Senegüé
22666 Sabiñanigo (Huesca)
Spain

Baxter and Viaflo are trademarks of Baxter International Inc.

Information intended exclusively for medical professionals:

Handling and Preparation
Before use, visually inspect the infusion solution.
Parenteral products should be examined for visible particulate matter or discoloration prior to administration, provided that the solution and container permit such inspection.
Use only if the solution is clear and free of visible particles, and the container is undamaged. Administer immediately after connecting the infusion set.
Do not remove the bag from its protective overwrap until ready for use.
The inner bag ensures product sterility.
Plastic containers must not be used in series (i.e., "piggybacked"). Such use could result in an air embolism due to residual air being drawn from the first container before completion of fluid delivery from the second container.
Applying additional pressure to intravenous solutions contained in flexible plastic containers to increase the flow rate may cause an air embolism if all residual air has not been completely removed from the container prior to administration.
The use of vented intravenous administration sets with the air vent open may lead to air embolism. Vented intravenous administration sets with the air vent open must not be used with flexible plastic containers.
The solution must be administered using sterile equipment and aseptic technique. The infusion set 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 condition.
Additional medications may be added to the solution before or during infusion via the medication addition port with a self-sealing rubber stopper. When administering additional drugs parenterally, their final osmolarity must be confirmed prior to administration. Careful and gentle mixing with each added drug under aseptic conditions is required. Solutions containing added medications should be used immediately and must not be stored.
Extreme caution must be exercised in the administration method to avoid excessive intravenous fluid infusion in neonates, which may be fatal. When using a syringe pump to administer intravenous fluids or medications to neonates, do not leave the fluid bag connected to the syringe. When using an infusion pump, all clamps on the intravenous administration set must be closed before disconnecting the set from the pump or before turning off the pump. This is required regardless of whether the administration set has a backflow prevention feature.
Intravenous infusion equipment and administration devices must be frequently checked.
Discard after single use.
Discard any unused portion of the solution.
Do not reconnect partially used bags.
Do not store solutions to which additional medications have been added.
Aseptic technique must be used when adding medications to Injectio Glucosi 10% Baxter.
Thoroughly mix the solution after adding medication.

1. Opening

a. Remove the Viaflo bag from its protective overwrap immediately before use.
b. Squeeze the inner bag firmly to check for leakage. If leakage is found, discard the bag, as the contents may no longer be sterile.
c. Check whether the solution is clear and free of insoluble particles. If the solution is not clear or contains insoluble particles, discard it.

2. Preparation for Administration

Use sterile materials for preparation and administration.
a. Hang the bag by the hanger.
b. Remove the plastic cover from the administration port located at the bottom of the bag:

• Hold the smaller wing on the neck of the port with one hand;
• With the other hand, grasp the larger wing on the cap and twist;
• The cap will pop off.
  c. Maintain aseptic technique when connecting the infusion.
  d. Connect the administration set. Refer to all instructions provided with the set regarding connection, priming, and administration of the solution.

3. Methods of Adding Medications

Warning: Added medications may be incompatible.
Adding medications prior to administration
a. Disinfect the medication addition port.
b. Using a syringe with a 19G (1.10 mm) to 22G (0.70 mm) needle, insert the needle through the self-sealing medication addition port and inject the medication.
c. Mix the solution thoroughly with the medication. For viscous preparations such as potassium chloride, gently tap the ports while the bag is held with ports upward and mix well.
d. Note: Do not store bags containing added medications.
Adding medications during administration
a. Close the clamp on the administration set.
b. Disinfect the medication addition port.
c. Using a syringe with a 19G (1.10 mm) to 22G (0.70 mm) needle, insert the needle through the self-sealing medication addition port and inject the medication.
d. Remove the bag from the stand and/or invert it with ports facing upward.
e. Empty both ports by gently tapping them while the bag is held with ports upward.
f. Mix the solution thoroughly with the medication.
g. Return the bag to its original position, reopen the clamp, and continue administration.

4. Stability: Added Medications

Prior to use, the chemical and physical stability of each added medication in the pH of Injectio Glucosi 10% Baxter must be established.
From a microbiological standpoint, the diluted product should be used immediately unless dilution was performed under controlled and validated aseptic conditions. If the solution is not used immediately, the user is responsible for the storage duration and conditions during use.

5. Incompatibilities of Added Medications

Glucose solution must not be administered through the same infusion set simultaneously with, before, or after blood transfusion, as hemolysis and agglutination may occur.
Prior to adding any medication, assess its compatibility with the solution in the Viaflo container.
In the absence of compatibility studies, this solution must not be mixed with other medications.
Refer to the instructions for use of the medication to be added.
Before adding a medication, verify that 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 medication to Injectio Glucosi 10% Baxter, the solution must be administered immediately.
Do not use medications known to be incompatible.
Baxter and Viaflo are trademarks of Baxter International Inc.