Injectio glucosi 5% baxter

Package leaflet: Information for the user

Injectio Glucosi 5% Baxter, infusion solution
Active substance: glucose
Please read this leaflet carefully before using this medicine, because it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, please consult your doctor or nurse.
• If the patient experiences any side effects, including any not listed in this leaflet, please inform your doctor or nurse. See section 4.

Contents of the leaflet:

1. What Injectio Glucosi 5% Baxter is and what it is used for
2. Important information before administration of 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 pack and other information

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

Injectio Glucosi 5% Baxter infusion solution is a solution of sugar (glucose) in water.
Glucose is one of the body's sources of energy. This infusion solution provides 200 kilocalories per litre.
Injectio Glucosi 5% Baxter infusion solution is used:

• as a source of fluid and sugar (carbohydrate);
• for diluting or administering other medicinal products that may be given by infusion.

2. Important information before administering Injectio Glucosi 5% Baxter

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

• Untreated or inadequately treated diabetes in which blood sugar levels exceed normal (uncontrolled diabetes);
• Glucose intolerance, for example: when metabolism is impaired, e.g., due to severe illness (metabolic stress);
• Hyperosmolar coma (loss of consciousness). This type of coma may occur in patients with diabetes who are not receiving adequate medication;
• Higher than normal blood sugar levels (hyperglycemia);
• Higher than normal blood lactate levels (hyperlactatemia);
• Hypersensitivity (allergy) to glucose. 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 way, the patient can check whether it is safe to use the medicine.

Warnings and precautions

The patient should inform the doctor if any of the following conditions are present or have ever occurred:

• Excess body water (water intoxication);
• Diabetes or high blood sugar levels (hyperglycemia);
• Impaired kidney function;
• Sepsis, trauma, or shock;
• Low levels of electrolytes (sodium, potassium, phosphorus, magnesium) in the blood;
• Recent stroke (acute ischemic stroke). Elevated blood sugar levels may worsen stroke symptoms and affect recovery;
• Metabolic disturbances due to starvation or diets lacking proper proportions of essential nutrients (malnutrition);
• Low thiamine (vitamin B_) levels in the patient's body. This may occur in patients with chronic alcoholism;
• Allergy to corn (the product Injectio Glucosi 5% 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 be caused, for example, by:
  • 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 5% Baxter and other medicines").

This may increase the risk of low blood sodium levels 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 those of childbearing age);
• Patients with conditions affecting cerebrospinal fluid levels, such as meningitis, intracranial hemorrhage, or brain injury.

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

• Levels of electrolytes such as potassium in the blood (serum electrolyte concentrations);
• Blood sugar (glucose) levels;
• Fluid balance in the body (fluid status);
• Blood and urine acidity (acid-base balance).

Because Injectio Glucosi 5% Baxter contains sugar (glucose), it may cause increased blood sugar levels (hyperglycemia). In such cases, the doctor may:

• Adjust the infusion rate;
• Administer insulin to reduce blood sugar levels;
• If necessary, supplement potassium.

Injectio Glucosi 5% Baxter must not be administered through the same needle used for blood transfusion. This may cause damage to red blood cells or their aggregation.

The doctor will consider whether the patient is receiving parenteral nutrition (intravenous feeding).

During prolonged therapy with Injectio Glucosi 5% Baxter, additional nutritional support may be required.

Children

Injectio Glucosi 5% Baxter should be administered with particular caution in children.

Injectio Glucosi 5% Baxter must be administered to children by a doctor 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 5% Baxter is used to deliver or dilute another medicine or if other medicines are administered simultaneously, this may also affect dosing.

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

Newborns, especially those born prematurely and with low birth weight, are more susceptible to abnormally low or high blood sugar 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 blood sugar in newborns may lead to prolonged seizures, coma, and brain damage. High blood sugar is associated with intraventricular 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 delivery of the required amount of solution at precise 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 an increased risk of low blood sodium levels (hypotonic hyponatremia) and brain-related disorders due to low serum sodium concentration (hyponatremic encephalopathy).

Injectio Glucosi 5% Baxter and other medicines

Inform the doctor or nurse about all medicines currently or recently taken, as well as any medicines the patient plans to take.

Injectio Glucosi 5% Baxter and other concurrently administered medicines may interact with each other.

Do not administer Injectio Glucosi 5% Baxter with certain hormones (catecholamines), including adrenaline, or steroids, which may increase blood sugar 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 opioids used to relieve severe pain;
• Analgesic 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 5% Baxter with food and drink

Ask the doctor what can be eaten and drunk during treatment.

Pregnancy, breastfeeding, and effects on fertility

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

Pregnancy

Injectio Glucosi 5% Baxter may be used during pregnancy. However, caution is advised when administering glucose solution during labor.

Effect on fertility

There are no adequate data on the effect of Injectio Glucosi 5% Baxter on fertility. However, an effect on fertility is not expected.

Breastfeeding

There are no adequate data on the effect of Injectio Glucosi 5% Baxter in breastfeeding women. However, an effect in breastfeeding women is not expected.

Injectio Glucosi 5% Baxter may be used during breastfeeding.

If any medicine is added to the Injectio Glucosi 5% Baxter solution used during pregnancy or breastfeeding:

• Consult the doctor;
• Read the package leaflet of the added medicine.

Driving and operating machinery

Consult a doctor or nurse before driving or operating machinery.

3. How will Injectio Glucosi 5% Baxter be administered

Injectio Glucosi 5% Baxter is administered by a doctor or nurse. The dose and duration of administration are determined by the physician, depending on the patient's age, body weight, clinical condition, reason for treatment, and whether the infusion is used to deliver or dilute another medicine. The administered dose may also be influenced by other concurrent therapies.
DO NOT use Injectio Glucosi 5% Baxter if it contains visible particles or if the packaging is in any way damaged.
The infusion solution Injectio Glucosi 5% Baxter is usually administered through a plastic tube connected to a needle placed into a vein. Typically, this solution is infused into a vein in the arm. However, the doctor may choose another method of administration.
The infusion solution Injectio Glucosi 5% Baxter should be administered slowly to prevent excessive urine production (osmotic diuresis).
Before and during the infusion, the doctor will monitor:

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

Any unused portions of the solution must be discarded. DO NOT administer Injectio Glucosi 5% Baxter from a partially used bag.
Administration of a higher than recommended dose of Injectio Glucosi 5% Baxter
Administering too much Injectio Glucosi 5% Baxter solution (overdose) or administering it too rapidly may cause the following symptoms:

• fluid accumulation in tissues leading to swelling (edema) or water intoxication, with lower than normal blood sodium levels (hyponatremia);
• increased urine production (osmotic diuresis);
• increased blood concentration (hyperosmolality);
• loss of body water (dehydration);
• high blood sugar levels (hyperglycemia);
• glucose in the urine (hyperglycosuria).

If any of the above symptoms worsen, the doctor must be notified immediately. In such a case, the doctor will stop or reduce the infusion. Insulin should be administered and appropriate symptomatic treatment initiated.
If another medicine has been added to the Injectio Glucosi 5% Baxter infusion solution, it may also cause symptoms before signs of infusion overdose appear. Please read the package leaflet of the added medicine to become familiar with possible adverse effects.
Discontinuation of Injectio Glucosi 5% Baxter
The decision to discontinue Injectio Glucosi 5% Baxter will be made by the doctor.
If you have any doubts regarding the use of this medicine, consult your doctor or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody gets them.
Adverse reactions may include:

• hypersensitivity reactions, including severe allergic reactions known as anaphylaxis (possible occurrence in patients with allergy to maize/corn);
• changes in blood electrolyte levels (electrolyte disturbances);
• higher than normal blood glucose concentration (hyperglycaemia);
• loss of body water (dehydration);
• excess fluid in the blood vessels (hypervolaemia);
• excessive urination (polyuria);
• low sodium concentration in blood (hyponatraemia), which may be associated with hospital treatment (hospital-acquired hyponatraemia) and related neurological complications (acute hyponatraemic encephalopathy). Hyponatraemia may lead to irreversible brain damage and death due to cerebral oedema (see also section 2 "Warnings and precautions");
• reactions related to the method of administration:
• reactions at the site of administration:
  • irritation of the vein into which the solution is infused. This may cause redness, pain or burning sensation, and swelling along the vein;
  • fever, febrile reactions;
  • infection at the site of administration;
  • leakage of the infusion solution into the surrounding tissue (extravasation). This may damage tissues and lead to scarring;
  • formation of blood clots in veins (venous thrombosis) at the infusion site, causing pain, swelling or redness in the area of the clot.

If another medicine is added to the intravenous solution, it may also cause
adverse reactions. These will depend on the type of medicine added. Please read the
Package Leaflet included with the added medicine to learn about possible adverse
reactions it may cause.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in
this leaflet, inform your doctor, pharmacist, or nurse.
Adverse reactions can be reported directly to the Department for Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions contributes to enhancing the safety information of the medicinal product.

5. How to store Injectio Glucosi 5% Baxter

Keep this medicine out of the 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 for the medicine.
DO NOT use Injectio Glucosi 5% Baxter after the expiry date stated on the label after the words "Expiry date". The expiry date refers to the last day of the specified month.
Do not use Injectio Glucosi 5% Baxter if visible particles are present or if the unit packaging shows any damage.

6. Contents of the package and other information

What Injectio Glucosi 5% Baxter contains
The active substance is sugar (glucose): 50 g per litre.
The only other ingredient is water for injections.
What Injectio Glucosi 5% Baxter looks like and contents of the pack
Injectio Glucosi 5% Baxter is a clear solution free from visible particles.
It is available in polyolefin/polyamide plastic bags (Viaflo). Each bag is
contained within a sealed protective outer plastic packaging.
Bag sizes:

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

Pack sizes:

• 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 types may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Baxter Polska Sp. z o.o.
ul. Kruczkowskiego 8
00-380 Warszawa
Manufacturers:
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
Baxter and Viaflo are trademarks of Baxter International Inc.

Information intended exclusively for healthcare professionals:

Administration and preparation
Parenteral products 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.
Do not remove from protective overwrap until ready for use.
The inner bag ensures product sterility.
Plastic containers must not be used in series (cascaded). Cascading could result in air embolism due to residual air being drawn from the first container before the second container is completely emptied.
Applying additional pressure to intravenous solutions contained in flexible plastic containers to increase the flow rate may cause air embolism if residual air has not been completely removed from the container prior to administration.
The use of vented administration sets with the vent in the open position may lead to air embolism. Vented administration sets with the vent in the open position must not be used with flexible plastic containers.
The solution should be administered using sterile equipment and aseptic techniques. 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 self-sealing properties.
When adding another medication, final osmolarity must be confirmed prior to parenteral administration.
Careful and thorough mixing under aseptic conditions is required with each added medication. Solutions containing added medications should be used immediately and must not be stored.
The addition of other drugs or improper administration techniques may lead to febrile reactions due to the potential introduction of pyrogens. In case of adverse reactions, infusion must be stopped immediately.
Special caution must be exercised when administering to neonates to avoid excessive intravenous fluid infusion, 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 administration set from the pump or before turning off the pump, regardless of whether the administration set has an anti-siphon protection 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 medicinal products have been added.
When adding additional medicinal products to Injectio Glucosi 5% Baxter, follow aseptic procedures.
Mix thoroughly with the added medicinal product.

1. Opening

a. Remove the Viaflo bag from its protective overwrap immediately before use.
b. Firmly squeeze the inner bag to check for leakage. If leakage is detected, 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

Sterile materials must be used during preparation and administration.
a. Hang the bag on an infusion stand.
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,
• Hold the larger wing on the cap with the other hand and twist,
• The cap will pop off.
  c. Maintain aseptic technique when connecting the infusion.
  d. Connect the administration set, following the manufacturer's instructions for connection, priming, and administration of the solution.

3. Methods of adding additional medications

Note: Added medications may be incompatible (see section 5 "Incompatibilities of added medications" below).
Adding medications prior to administration
a. Disinfect the medication addition port.
b. Using a syringe with an appropriate needle, insert the needle into the self-sealing medication addition port and inject the medication.
c. Mix the solution thoroughly with the added medication. For viscous preparations such as potassium chloride, gently tap the ports while holding the bag with ports facing upward and mix thoroughly.
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 an appropriate needle, insert the needle into 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 while holding the bag with ports facing upward.
f. Mix the solution thoroughly with the medication.
g. Hang the bag back in its original position, reopen the clamp, and continue administration.

4. Stability during use (added medications)

Prior to use, the chemical and physical stability of each added medication in the pH environment of Injectio Glucosi 5% Baxter in the Viaflo container must be established.
From a microbiological standpoint, the diluted product should be used immediately unless dilution occurred under controlled and validated aseptic conditions. If the solution is not used immediately, the user is responsible for the storage duration and conditions.

5. Incompatibilities of added medications

As with any parenteral solution, compatibility of added medications with the solution in the Viaflo container must be verified before addition.
The physician is responsible for assessing incompatibility of the added medication with Injectio Glucosi 5% Baxter, after checking for any change in color and (or) the presence of precipitate, insoluble complexes, or crystals. Refer to the package insert of the medicinal product to be added to the solution.
Before adding a medication, verify that it is soluble and stable in water at the pH of the Injectio Glucosi 5% Baxter solution.
After adding a medication confirmed to be compatible with Injectio Glucosi 5% Baxter, the solution must be administered immediately.
Substances known to be incompatible must not be used.
Baxter and Viaflo are trademarks of Baxter International Inc.