GLUCOSIO 10% Roztwór do infuzji

Treść ulotki

1. Glucosio Baxter
   1. WHAT IS GLUCOSIO BAXTER 10% INFUSION AND WHAT IS IT USED FOR
   2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN
   3. HOW GLUCOSIO BAXTER 10% INFUSION WILL BE GIVEN TO YOU
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE GLUCOSIO BAXTER 10% INFUSION
   6. CONTENT OF THE PACK AND OTHER INFORMATION
   7. Opening
   8. Preparation for administration
   9. Techniques for the injection of additional drugs
   10. Period of validity during use: additions
   11. Incompatibilities with medicinal additions

Glucosio Baxter

10% Infusion Solution
Active ingredient: glucose

Read this leaflet carefully before you are given this medicine
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 any side effects occur, including any not listed in this leaflet, tell your doctor or nurse. See section 4.

The medicine is called “Glucosio Baxter, 10% Infusion Solution”, but we will refer to it

Contents of this leaflet:

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

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

Glucosio 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.
Glucosio Baxter 10% Infusion is used for:

• Providing a source of sugars (carbohydrates) alone or, as required, for parenteral nutrition, which is used to feed patients who are unable to eat. It is administered as an infusion into a vein (slow injection).
• Preventing or treating a low level of sugar in the blood (hypoglycemia, which causes symptoms but does not put the patient's life at risk).
• Providing extra fluids, in case of dehydration (the body does not have enough water) and you have an extra need for sugars (carbohydrates).
• Diluting other medicines to be administered intravenously.

2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN

GLUCOSE BAXTER 10% INFUSION
Do not use Glucose Baxter 10% Infusion if you suffer from any of the following
conditions:

• Untreated diabetes, which causes your blood sugar levels to rise above normal (uncontrolled diabetes).
• Unconsciousness (hyperosmolar coma); this is a type of coma that can occur if you have diabetes and do not receive enough medication.
• Blood dilution due to the addition of too many fluids (hemodilution).
• Presence of too much fluid in the spaces between cells (extracellular hyperhydration).
• Presence of a blood volume in the blood vessels higher than due (hypervolemia).
• Blood sugar level higher than normal (hyperglycemia).
• Lactate level, a chemical substance present in the blood, higher than due (hyperlactatemia).
• Severe kidney failure (when your kidneys do not work well and dialysis is necessary).
• Uncompensated heart failure. This is heart failure that is not adequately treated and causes symptoms such as:
• shortness of breath,
• swelling of the ankles.
• Subcutaneous accumulation of fluids, which affects all parts of the body including your brain and lungs (general edema).
• Liver disease that causes fluid accumulation in the abdomen (ascitic cirrhosis).
• Any condition that affects the way your body controls your sugar level.
• Intolerance (hypersensitivity) to glucose. This can occur in patients with an allergy to corn.

If another medication is added to your infusion solution, always read the package insert
of that medication to know if taking it is safe for you.

Warnings and Precautions
Glucose Baxter 10% Infusion is a hypertonic (concentrated) solution. Your doctor will consider
this aspect 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 illness that could be life-threatening (acute critical illness)
• High pressure in the skull (intracranial hypertension)
• Inform your doctor if you have had a head injury in the last 24 hours
• Stroke due to a blood clot in a blood vessel in the brain (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)
• Allergy to corn (Glucose Baxter 10% Infusion contains sugar derived from corn)
• if you are in a condition that can cause high levels of vasopressin, a hormone that regulates fluids in your body. You may have too much vasopressin in your body because for example:
• you have a sudden and severe illness
• you are in pain
• you have undergone surgery
• you have infections, burns or brain diseases
• you have diseases related to your heart, liver, kidneys or central nervous system
• because you are taking certain medications (see also the section below “Other medicines and Glucose Baxter 10% Infusion”) This can increase the risk of low sodium levels in your blood and can lead to migraine, nausea, seizures, lethargy, coma, cerebral edema and death. Cerebral edema increases the risk of death and brain damage. People who are at higher risk of cerebral edema are:
• children
• women (especially of childbearing age) - people who have problems with their brain fluid levels, for example, due to meningitis, intracranial bleeding or brain damage

During the administration of this infusion, the doctor will monitor:

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

Based on the results of these tests, your doctor will adjust the amount of solution to administer to you
for infusion. In addition, these tests can help determine if you need potassium supplementation, a
chemical substance present in the blood, which can be administered intravenously if necessary.
Glucose Baxter 10% Infusion contains sugar (glucose), therefore it can cause a rise in
blood sugar levels (hyperglycemia). In this case, your doctor may:

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

This is particularly important:

• if you suffer from diabetes
• if your kidneys do not work normally
• if you have recently had a stroke (acute ischemic stroke). High blood sugar levels can worsen the effects of stroke and affect recovery
• if you have metabolic disorders due to hunger or a diet that does not provide the right proportion of nutrients (malnutrition)
• if you have a low level of thiamine (vitamin B1). This can happen if you suffer from chronic alcoholism.

This solution should not be administered through the same needle with a blood transfusion,
because it could damage red blood cells or cause their agglutination.

Children
The infusion of Glucose Baxter 10% Infusion must be administered with special care in
children.
Glucose 10% should be administered to children by a doctor or nurse. The amount
administered must be decided by a doctor specializing in the care of children and will depend
on the age, weight and condition of the child. If Glucose 10% is used to administer or dilute another
drug, or if other drugs are administered simultaneously, this can also affect
the dosage.
When this infusion is administered to children, the child's doctor will take blood and urine samples to monitor the amount of electrolytes such as potassium in the blood (plasma electrolytes).
Newborns, especially those born prematurely and with a low birth weight, are at
increased risk of developing too low or too high blood sugar levels (hypoglycemia or
hyperglycemia) and, therefore, require careful monitoring during treatment with intravenous glucose solutions to ensure adequate control of sugar levels to avoid potential
long-term adverse effects. Low blood sugar levels in newborns can 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 bag with the solution must be connected to an infusion pump, which allows accurate administration of the required amount of solution through
the defined time interval. Your doctor or nurse will monitor the device to ensure safe
administration.
Children (including newborns and other children) who are given Glucose Baxter 10% Infusion
are at greater risk of developing low sodium levels in the blood (hyponatremic hypotonicity) and
a disorder that affects the brain following low sodium levels in the blood (hyponatremic encephalopathy).

Other medicines and Glucose Baxter 10% Infusion
Tell your doctor or nurse if you are taking, have recently taken or may take any
other medicine.
Glucose Baxter 10% Infusion and other medicines taken at the same time can influence
each other.
Do not take Glucose Baxter 10% Infusion with certain hormones (catecholamines) including adrenaline or
steroids given that these can increase your blood sugar level.
Some medications affect the vasopressin hormone. These may include:

• antidiabetic drugs (chlorpropamide)
• cholesterol drugs (clofibrate)
• some cancer drugs (vincristine, ifosfamide, cyclophosphamide)
• selective serotonin reuptake inhibitors (used to treat depression)
• antipsychotics or opioids for relief from severe pain
• pain relievers and/or anti-inflammatory drugs (also known as NSAIDs)
• drugs that reproduce or enhance the effect of vasopressin such as desmopressin (used to treat thirst and increased urination), terlipressin (used to treat esophageal bleeding) and oxytocin (used to induce labor)
• antiepileptic drugs (carbamazepine and oxcarbazepine)
• diuretics (drugs to increase diuresis)

Glucose Baxter 10% Infusionwith foods and drinks
Ask your doctor what you can eat or drink.

Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant or are planning
to become pregnant, ask your doctor or nurse for advice before taking this medicine.

Pregnancy
Glucose solution can be used during pregnancy. However, caution must be exercised
when the solution is used during childbirth

Fertility
There is no adequate data on the effect of Glucose on fertility. However, no effect on
fertility is expected

Breastfeeding
There is no adequate data on the effect of Glucose on breastfeeding. However, no effect
on breastfeeding is expected. Glucose solution can be used during breastfeeding
If another drug is added to your infusion solution during pregnancy or breastfeeding, you must:

• consult your doctor;

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

3. HOW GLUCOSIO BAXTER 10% INFUSION WILL BE GIVEN TO YOU

Glucosio Baxter 10% Infusion must be administered by a doctor or nurse. The
doctor will decide what dose you need and when to administer it. This will depend
on your age, weight, clinical condition and the reasons for treatment. The amount that will be
administered to you may also depend on other treatments you are receiving.

If there are particles floating in the solution or if the packaging is damaged in
any way, do NOT be administered Glucosio Baxter 10% Infusion.
The infusion of Glucosio Baxter 10% Infusion is generally administered through a plastic tube attached to a needle inserted into a vein. Generally a vein in the arm is used;
however, the doctor may also use another method to administer the medication.
Before and during the infusion your doctor will monitor:

• the amount of fluids in your body
• the acidity of blood and urine the amount of electrolytes in your body (in particular sodium, in patients with high levels of vasopressin, or who are taking other drugs that increase the effect of vasopressin).

Any unused solution must be discarded. You should NOT be administered
an infusion of Glucosio Baxter 10% Infusion from a partially used bag.

If You Receive More Glucosio Baxter 10% InfusionThan You Should
If you are administered a greater amount of Glucosio Baxter 10% Infusion than due
(overinfusion) or if it is administered too quickly or too often, the following symptoms may occur:

• development of fluid in the tissues causing swelling (edema) or water intoxication with lower than normal levels of sodium in the blood (hyponatremia)
• a higher than normal blood sugar level (hyperglycemia);
• excessive concentration of the blood (hyperosmolarity);
• sugar in the urine (hyperglycosuria);
• 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. You will be administered insulin and provided with specific treatment based on your symptoms.
If a medication has been added to your Glucosio Baxter 10% Infusion before the overinfusion,
added for a list of possible symptoms.

Discontinuation of Glucosio Baxter 10% Infusion
Your doctor will decide when to stop this infusion.
If you have any doubts about the use of this product, ask your doctor or nurse.

4. POSSIBLE SIDE EFFECTS

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

• hypersensitivity reactions, including a severe allergic reaction called anaphylaxis (potential manifestation in patients with corn allergy)
• difficulty breathing
• swelling of the skin of the face, lips and swelling of the throat
• fever (pyrexia)
• urticaria
• skin rash
• redness of the skin (erythema)
• chills
• changes in blood electrolyte levels (electrolyte imbalance), which includes:
• low levels of sodium in the blood that can be acquired during hospitalization (nosocomial hyponatremia) and related to neurological disorders (acute hyponatremic encephalopathy). Hyponatremia can cause irreversible brain damage and death, due to the development of cerebral edema/swelling (see also the “Warnings and Precautions” section)
• a low level of potassium in the blood (hypokalaemia),
• a low level of magnesium in the blood (hypomagnesaemia),
• a low level of phosphate in the blood (hypophosphataemia),
• an elevated level of sugars in the blood (hyperglycaemia);
• an excess of fluids in the blood vessels (hemodilution and hypervolemia);
• sugars in the urine (glycosuria);
• reactions related to the route of administration: fever, febrile reaction (pyrexia); infection at the injection site;
• leakage of the infusion solution into the tissues surrounding the vein (extravasation), which can damage the tissues and cause scarring;
• the formation of a blood clot (venous thrombosis) at the infusion site, which causes pain, swelling or redness in the area of the clot;
• irritation and inflammation of the vein into which the solution is infused (phlebitis), which can cause redness, pain or burning and swelling along the vein into which the solution is infused
• pain or local reaction (redness or swelling at the infusion site)
• sweating

If a medicine has been added to the infusion solution, the added medicine can also cause
of the added medicine for a list of possible symptoms.
If any side effect occurs, the infusion must be stopped.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor, pharmacist or nurse. You can also report side effects directly
through the national reporting system at the address: http://www.aifa.gov.it/content/segnalazioni-
reazioni-avverse .
By reporting side effects you can help provide more information on the safety of
this medicine

5. HOW TO STORE GLUCOSIO BAXTER 10% INFUSION

Keep this medicine out of the sight and reach of children.
This medicine does not have any special storage conditions.
DO NOT use Glucosio Baxter 10% Infusion after the expiry date, which appears on the bag and on the
cardboard boxes after 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 damaged in any way, Glucosio Baxter 10% Infusion should not be administered.

6. CONTENT OF THE PACK AND OTHER INFORMATION

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

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

• 250 ml
• 500 ml
• 1000 ml

Pack sizes:

• 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
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The following information is intended exclusively for healthcare professionals:
Handling and preparation
The infusion solution must be visually inspected before use.
Parenteral drugs should be visually inspected for particulate matter and
discoloration before administration, when the solution and container permit.
Use only if the solution is clear and without visible precipitates and if the container is undamaged.
Administer immediately after insertion of the infusion set.

Do not remove the unit from the outer wrapper until it is ready for use.
The inner bag maintains the sterility of the medicinal product.
Do not use containers in series connection. Such use could result in gaseous embolism due to residual air
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 can cause gaseous embolism if the residual air in the container is not completely
eliminated before administration.
The use of an intravenous administration set with the vent in the open position can cause
gaseous embolism. Intravenous administration sets with the vent in the open position must not
be used with flexible plastic containers.
The solution must be administered with sterile devices using aseptic technique. Priming of the devices with
the solution is necessary to prevent air from entering the system.
An electrolyte supplement may be indicated depending on the patient's clinical needs. Additives
may be introduced before or during the infusion through the resealable access point. When
using an additive, check its isotonicity before parenteral administration. Thoroughly mix any additive
using aseptic technique. After adding additives, use the solution immediately and do not store it.
To avoid excessive, potentially fatal, intravenous fluid infusions in neonates, special attention must be
paid to the method of administration. When using a syringe pump to administer intravenous fluids or
drugs 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 administration set from the pump, or turning 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
frequently monitored.

Discard after single use.
Discard any unused residue.
Do not reconnect partially used bags.
Do not store solutions containing supplements.
When adding supplements to the Glucose solution, an aseptic technique must be used.
Thoroughly mix the solution when supplements have been introduced.

1. Opening

• a. Remove the Viaflo container from the outer packaging immediately before use.
• b. Check for any small leaks by firmly compressing the inner bag. If any leaks are detected, discard the solution, as sterility may be compromised.
• c. Verify that the solution is clear and that there are no foreign particles. If the solution is not clear or contains foreign particles, discard the solution.

2. Preparation for administration

Use sterile material for preparation and administration.

• a. Suspend the container by the support hole.
• b. Remove the plastic protection from the outlet point at the bottom of the container:
• grasp the small flap on the neck of the point with one hand;
• grasp the large flap on the cap with the other hand and rotate;
• the cap will open.
• c. Prepare the infusion using an aseptic method.
• d. Connect the administration set. Refer to the complete instructions provided with the set for connection, set priming, and solution administration.

3. Techniques for the injection of additional drugs

Warning: additives may be incompatible.

To add a drug before administration

• a. Disinfect the entry point for the dressing.
• b. Using a syringe with a 19 (1.10 mm) - 22 (0.70 mm) gauge needle, puncture the resealable dressing point and inject.
• c. Mix the solution and the drug well. For high-density drugs, such as potassium chloride, gently tap the access points while keeping them in a vertical position and mix.
• d. Caution: do not store bags containing medicinal additions.

To add a drug during administration

• a. Close the clamp on the set.
• b. Disinfect the entry point for the dressing.
• c. Using a syringe with a 19 (1.10 mm) - 22 (0.70 mm) gauge needle, puncture the resealable dressing point and inject.
• d. Remove the container from the IV pole and/or invert it.
• e. Release both access points by gently tapping, while the container is in a vertical position.
• f. Mix the solution and the drug well.
• g. Return the container to the use position, reopen the clamp and continue administration.

4. Period of validity during use: additions

Before 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 point of view, the diluted product must be used immediately unless
the dilution has been carried out under controlled and validated aseptic conditions. If not used
immediately, the time and conditions of storage during use are the responsibility
of the user.

5. Incompatibilities with medicinal additions

Do not administer glucose solution before, concurrently with, or after a blood transfusion through the same line, due to the risk of hemolysis and agglutination.
Before adding 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.
Consult the instructions for use of the medicinal product to be added.
Before adding a drug, verify that 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 additions of which incompatibility is known.