Glucose Baxter

PACKAGE LEAFLET: INFORMATION FOR THE USER

Glucosio Baxter

10% Solution for infusion
Active substance: glucose
Read this leaflet carefully before this medicine is administered to you
because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or nurse. See section 4.

The medicine is called “Glucosio Baxter, 10% Solution for infusion”, but we will refer to it as “Glucosio Baxter 10% Infusion” throughout this package leaflet.
Contents of this leaflet:

1. What Glucosio Baxter 10% Infusion is and what it is used for
2. What you need to know before Glucosio Baxter 10% Infusion is administered to you
3. How Glucosio Baxter 10% Infusion will be administered to you
4. Possible side effects
5. How to store Glucosio Baxter 10% Infusion
6. Contents of the pack and other information

1. WHAT GLUCOSE BAXTER 10% INFUSION IS AND WHAT IT IS USED FOR

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

• Providing a source of sugar (carbohydrates), alone or, as required, for parenteral nutrition, which is used to feed patients who are unable to eat. It is administered as an intravenous infusion (slow injection).
• Preventing or treating low blood sugar levels (hypoglycaemia, which causes symptoms but is not life-threatening).
• Providing additional fluids in case of dehydration (when the body does not have enough water) and when you have an increased need for sugar (carbohydrates).
• Diluting other medicines to be administered intravenously.

2. WHAT YOU SHOULD KNOW BEFORE BEING GIVEN

GLUCOSE BAXTER 10% INFUSION
DO NOT take Glucose Baxter 10% Infusion if you have any of the following conditions:

• Untreated or inadequately treated diabetes, causing your blood sugar levels to rise above normal (uncompensated diabetes).
• Unconsciousness (hyperosmolar coma); this is a type of coma that may occur if you have diabetes and do not receive sufficient medication.
• Dilution of the blood due to the addition of excessive fluids (hemodilution).
• Excess fluid in the extracellular spaces (extracellular hyperhydration).
• Blood volume in the blood vessels higher than normal (hypervolemia).
• Elevated blood sugar levels (hyperglycemia).
• Elevated levels of lactate, a chemical substance in the blood (hyperlactatemia).
• Severe renal failure (when your kidneys do not function properly and dialysis is required).
• Uncompensated heart failure. This is heart failure that has not been adequately treated and causes symptoms such as:
  • shortness of breath,
  • swelling of the ankles.
• Subcutaneous accumulation of fluid affecting all parts of the body, including the brain and lungs (generalized edema).
• Liver disease causing fluid accumulation in the abdomen (ascitic cirrhosis).
• Any condition affecting how your body regulates blood sugar levels.
• Intolerance (hypersensitivity) to glucose. This may occur in patients with a corn allergy.

If another medicine is added to your infusion solution, always read the package leaflet of that drug to determine whether its use is safe for you.
Warnings and Precautions
Glucose Baxter 10% Infusion is a hypertonic (concentrated) solution. Your doctor will take this into account when calculating the amount of solution to administer to you.
Please inform your doctor if you have or have had any of the following medical conditions:

• Diabetes
• Kidney disease
• A recently developed, life-threatening illness (acute critical illness)
• Increased pressure within the skull (intracranial hypertension)
• Inform your doctor if you have had a head injury within the last 24 hours
• Stroke due to a blood clot in a brain vessel (ischemic stroke)
• Heart disease (heart failure)
• Lung disease (respiratory failure)
• Reduced urine production (oliguria or anuria)
• Excess water in the body (water intoxication)
• Low sodium levels in the blood (hyponatremia)
• Corn allergy (Glucose Baxter 10% Infusion contains sugar derived from corn)
• If you are in a condition that may cause high levels of vasopressin, a hormone that regulates fluids in your body. You may have excess vasopressin in your body, for example, if you:
  • have a sudden, severe illness
  • are in pain
  • have recently undergone surgery
  • have infections, burns, or brain diseases
  • have diseases affecting the heart, liver, kidneys, or central nervous system
  • are taking certain medications (see also the section “Other medicines and Glucose Baxter 10% Infusion” below)
    This may increase the risk of low sodium levels in your blood and may lead to headache, nausea, seizures, lethargy, coma, cerebral edema, and death. Cerebral edema increases the risk of death and brain damage. People at higher risk of cerebral edema include:
  • children
  • women (especially those of childbearing age)
  • individuals who have problems with their cerebral fluid levels, for example, due to meningitis, intracranial hemorrhage, or brain injury

During administration of this infusion, your doctor will monitor:

• levels of electrolytes such as sodium and potassium in your blood (your plasma electrolytes)
• blood sugar (glucose) levels
• fluid levels in your body (your fluid balance)
• acidity of blood and urine (changes in acid-base balance)

Based on the results of these tests, your doctor will adjust the amount of infusion solution to be administered. These tests also help determine whether you need potassium supplementation, a chemical substance in the blood, which may be given intravenously if necessary.
Glucose Baxter 10% Infusion contains sugar (glucose) and may therefore cause an increase in blood sugar levels (hyperglycemia). In such cases, your doctor may:

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

This is particularly important:

• if you have diabetes
• if your kidneys do not function normally
• if you have recently had a stroke (acute ischemic stroke). High blood sugar levels may worsen stroke effects and impair recovery
• if you have metabolic disorders due to starvation or a diet lacking proper nutrient proportions (malnutrition)
• if you have low levels of thiamine (vitamin B1). This may occur in chronic alcoholism.

This solution must not be administered through the same needle used for blood transfusion, as it may damage red blood cells or cause their agglutination.
Children
Glucose Baxter 10% Infusion must be administered with special care in children.
Glucose 10% must be administered to children by a doctor or nurse. The dose administered must be determined by a physician specialized in pediatric care and will depend on the child's age, weight, and medical condition. If Glucose 10% is used to administer or dilute another drug, or if other drugs are administered simultaneously, this may also influence the dosage.
When this infusion is administered to children, the child’s doctor will take blood and urine samples to monitor levels of electrolytes such as potassium in the blood (plasma electrolytes).
Newborns, especially those born prematurely and with low birth weight, are at increased risk of developing blood sugar levels that are too low or too high (hypo- or hyperglycemia) and therefore require careful monitoring during treatment with intravenous glucose solutions to ensure adequate blood sugar control and prevent potential long-term adverse effects. Low blood sugar in newborns may cause prolonged seizures, coma, and brain damage. High blood sugar levels have been associated with brain hemorrhage, bacterial and fungal infections, eye damage (retinopathy of prematurity), intestinal tract infections (necrotizing enterocolitis), lung problems (bronchopulmonary dysplasia), prolonged hospital stay, and death.
If administered to a newborn, the solution bag must be connected to an infusion pump, which ensures accurate delivery of the required amount of solution over the defined time interval. Your doctor or nurse will monitor the device to ensure safe administration.
Children (including newborns and other children) receiving Glucose Baxter 10% Infusion are at increased risk of developing low sodium levels in the blood (hypotonic hyponatremia) and a brain disorder resulting from low blood sodium levels (hyponatremic encephalopathy).
Other medicines and Glucose Baxter 10% Infusion
Tell your doctor or nurse if you are taking, have recently taken, or might take any other medicines.
Glucose Baxter 10% Infusion and other medicines taken concurrently may affect each other.
Do not take Glucose Baxter 10% Infusion with certain hormones (catecholamines), including adrenaline, or steroids, as these may increase your blood sugar levels.
Some medicines affect the hormone vasopressin. These may include:

• antidiabetic drugs (chlorpropamide)
• cholesterol-lowering drugs (clofibrate)
• certain anticancer drugs (vincristine, ifosfamide, cyclophosphamide)
• selective serotonin reuptake inhibitors (used to treat depression)
• antipsychotics or opioids for severe pain relief
• painkillers and/or anti-inflammatory drugs (also known as NSAIDs)
• drugs that mimic or enhance the effect of vasopressin, such as desmopressin (used to treat excessive thirst and urination), terlipressin (used to treat esophageal bleeding), and oxytocin (used to induce labor)
• antiepileptic drugs (carbamazepine and oxcarbazepine)
• diuretics (medicines to increase urine production)

Glucose Baxter 10% Infusion with food and drink
Ask your doctor what you may eat or drink.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or nurse before taking this medicine.
Pregnancy
Glucose solution may be used during pregnancy. However, caution is required when the solution is used during childbirth.
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 effect of glucose on breastfeeding. However, no effect on breastfeeding is expected. Glucose solution may be used during breastfeeding.
If another drug is added to your infusion solution during pregnancy or breastfeeding, you must:

• consult your doctor;
• read the package leaflet of the drug to be added.

Driving and using machines
Ask your doctor or nurse for advice before driving or operating machinery.

3. HOW GLUCOSE BAXTER 10% INFUSION WILL BE ADMINISTERED TO YOU

Glucose Baxter 10% Infusion will be administered to you by a doctor or nurse. Your doctor will decide the dose you require and when it should be given. This will depend on your age, body weight, clinical condition, and the reason for treatment. The amount administered may also depend on any other treatments you are currently receiving.
If there are particles floating in the solution or if the packaging is in any way damaged, Glucose Baxter 10% Infusion must NOT be administered to you.
Glucose Baxter 10% Infusion is generally administered through a plastic tube connected to a needle inserted into a vein. Usually, a vein in the arm is used; however, your doctor may choose another method to administer the medicine.
Before and during the infusion, your doctor will monitor:

• the amount of fluid in your body
• the acidity of your blood and urine
• the levels of electrolytes in your body (particularly sodium, in patients with high levels of vasopressin or who are taking other medicines that enhance the effect of vasopressin).

Any unused solution must be discarded. DO NOT receive an infusion of Glucose Baxter 10% Infusion from a partially used bag.
If you receive more Glucose Baxter 10% Infusion than you should
If you are given more Glucose Baxter 10% Infusion than required (over-infusion), or if it is administered too quickly or too frequently, the following symptoms may occur:

• 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 concentration of the blood (hyperosmolarity)
• glucose in the urine (glucosuria)
• increased urine production (osmotic diuresis)
• loss of water from the body (dehydration)

If any of these symptoms occur, inform your doctor immediately. The infusion will be stopped or reduced. Insulin will be administered and specific treatment provided depending on your symptoms.
If a medicine has been added to your Glucose Baxter 10% Infusion prior to over-infusion, the added drug may be the cause of the symptoms. Please read the package leaflet of the added medicine for a list of possible side effects.
Stopping the Glucose Baxter 10% Infusion
Your doctor will decide when to stop this infusion.
If you have any doubts about the use of this product, consult your doctor or nurse.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicinal product can cause adverse reactions, although not everyone experiences them.
Adverse reactions may include:

• hypersensitivity reactions, including severe allergic reaction known as anaphylaxis (potential manifestation in patients with maize allergy)
• breathing difficulties
• swelling of the skin of the face, lips, and throat swelling
• fever (pyrexia)
• urticaria
• skin rash
• skin redness (erythema)
• chills
• changes in blood electrolyte levels (electrolyte disturbance), including:
• low sodium levels in the blood, which may occur during hospitalization (nosocomial hyponatremia) and may be associated with neurological disorders (acute hyponatremic encephalopathy). Hyponatremia may cause irreversible brain damage and death due to the development of cerebral edema/swelling (see also 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 (glucosuria)
• administration route-related reactions: fever, febrile reaction (pyrexia); injection site infection
• leakage of the infusion solution into surrounding tissues near the vein (extravasation), which may damage tissues and lead to scarring
• formation of a blood clot (venous thrombosis) at the infusion site, causing pain, swelling, or redness in the area of the clot
• irritation and inflammation of the vein into which the solution is infused (phlebitis), which may cause redness, pain or burning, and swelling along the vein
• pain or local reaction (redness or swelling at the infusion site)
• sweating

If a medicinal product has been added to the infusion solution, the added medicine may also cause
adverse reactions. These adverse reactions will depend on the medicine added. Please read the package leaflet
of the added medicine for a list of possible symptoms.
If any adverse reaction occurs, the infusion must be stopped.
Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, contact your
doctor, pharmacist, or nurse. You may also report adverse reactions directly
through the national reporting system at the following address: http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting adverse reactions, you can help provide more information on the safety
of this medicine.

5. HOW TO STORE GLUCOSE BAXTER 10% INFUSION

Keep this medicine out of the sight and reach of children.
This medicine has no special storage conditions.
DO NOT use Glucose Baxter 10% Infusion after the expiry date stated on the bag and the cardboard boxes, following EXP. The expiry date refers to the last day of the month.
If there are particles floating in the solution or if the unit is in any way damaged, Glucose Baxter 10% Infusion must not be administered.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What Glucosio Baxter 10% Infusion contains
The active substance is glucose (as monohydrate): 100 g per litre.
The only excipient is water for injections.
Formula per 250 ml
Glucose (as monohydrate): 25 g
Formula per 500 ml
Glucose (as monohydrate): 50 g
Formula per 1000 ml
Glucose (as monohydrate): 100 g

Description of the appearance of Glucosio Baxter 10% for infusion and contents of the
package
Glucosio Baxter 10% for infusion is a clear solution free from visible particles. It is supplied in plastic bags made of polyolefin/polyamide (Viaflo). Each bag is enclosed in an outer sealed plastic protective wrapper.
The following bag sizes are available:

• 250 ml
• 500 ml
• 1000 ml

Packaging:

• 30 or 36 bags of 250 ml per carton
• 1 bag of 250 ml
• 20 or 24 bags of 500 ml per carton
• 1 bag of 500 ml
• 10 or 12 bags of 1000 ml per carton
• 1 bag of 1000 ml

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Baxter S.p.A.
Piazzale dell’Industria 20
00144 Rome - Italy

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

The following information is intended for healthcare professionals only:
Handling and preparation
The infusion solution should be inspected visually before use.
Parenteral medications should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Use only if the solution is clear and free from visible precipitates and if the container is undamaged.
Administer immediately after inserting the infusion set.
Do not remove the unit from the outer wrapper until ready for use.
The inner bag maintains the sterility of the medicinal product.
Do not use plastic containers connected in series. This may lead to gas embolism due to residual air being drawn from the primary container before completion of fluid administration from the secondary container.
Pressurizing intravenous solutions contained in flexible plastic containers to increase flow rates may cause gas embolism if residual air in the container is not completely expelled before administration.
Using an intravenous administration set with the vent in the open position may cause gas embolism. Intravenous administration sets with the vent in the open position must not be used with flexible plastic containers.
The solution must be administered using sterile devices and aseptic technique. Prime administration devices with the solution to prevent air from entering the system.
Electrolyte supplementation may be indicated depending on the patient's clinical requirements. Additives may be introduced before or during infusion through the resealable entry site. When using additives, verify their isotonicity before parenteral administration. Mix thoroughly using aseptic technique. After additives have been added, use the solution immediately and do not store.
To avoid potentially fatal over-infusion of intravenous fluids in neonates, special care must be taken with the method of administration. When using a syringe pump to administer intravenous fluids or medications to neonates, a fluid bag must not be left connected to the syringe.
When using an infusion pump, all clamps on the intravenous administration set must be closed before removing the set from the pump or switching off the pump. This is required regardless of whether the administration set has a free-flow protection device.
The intravenous infusion device and administration equipment must be monitored frequently.
Discard after single use.
Discard any unused residue.
Do not reconnect partially used bags.
Do not store solutions containing additives.
When additives are added to the Glucose solution, aseptic technique must be used.
Mix the solution thoroughly after additives have been introduced.

1. Opening

a. Remove the Viaflo container from the outer wrapper immediately before use.
b. Check for any small leaks by firmly compressing the inner bag. If leaks are detected, discard the solution, as sterility may be compromised.
c. Check that the solution is clear and free from foreign particles. If the solution is not clear or contains foreign particles, discard the solution.

2. Preparation for Administration

Use sterile equipment for preparation and administration.
a. Suspend the container by the support hole.
b. Remove the plastic cover from the outlet port at the bottom of the container:

• with one hand, hold the small tab on the neck of the port;
• with the other hand, grasp the large tab on the cap and twist;
• the cap will open.
  c. Using an aseptic technique, prepare the infusion.
  d. Connect the administration set. Refer to the complete instructions provided with the administration set for connection, priming the set, and administering the solution.

3. Techniques for Injection of Additional Drugs

Warning: additives may be incompatible.
To add a drug prior to administration
a. Disinfect the medication entry site.
b. Using a syringe with a 19 (1.10 mm) - 22 (0.70 mm) gauge needle, puncture the resealable medication site and inject the drug.
c. Mix the solution and drug thoroughly. For high-density drugs, such as potassium chloride, gently tap the access sites while holding the container upright to ensure proper mixing.
d. Caution: do not store bags containing added medicinal substances.

To add a drug during administration
a. Close the clamp on the administration set.
b. Disinfect the medication entry site.
c. Using a syringe with a 19 (1.10 mm) - 22 (0.70 mm) gauge needle, puncture the resealable medication site and inject the drug.
d. Remove the container from the infusion stand and/or invert it.
e. Gently tap both access sites to release any air bubbles while the container is in the upright position.
f. Mix the solution and drug thoroughly.
g. Return the container to its normal administration position, reopen the clamp, and continue administration.

4. In-use shelf life: additions

Prior to use, the chemical and physical stability of any additive at the pH of Glucose 10% for infusion in the Viaflo container must be determined.
From a microbiological standpoint, the diluted product should be used immediately unless the dilution has been carried out under controlled and validated aseptic conditions. If not used immediately, the duration and conditions of storage during use are the responsibility of the user.

5. Incompatibilities of medicinal product additions

Do not administer the glucose solution before, simultaneously with, or after a blood transfusion
through the same line, due to the risk of haemolysis and agglutination.
Before adding any medicinal products to the solution in the Viaflo container, incompatibilities must be checked.
In the absence of incompatibility studies, this solution must not be mixed with other products.
Refer to the instructions for use of the medicinal product to be added.
Before adding a drug, verify whether it is soluble and stable in water within the pH range of Glucosio Baxter, 10% for infusion (pH 3.5 – 6.5).
When adding a compatible drug to the Glucosio Baxter 10% infusion, the solution must be administered immediately.
Do not use additives known to be incompatible.