GLUCOSIO 50 ML Roztwór do infuzji

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1. Glucosio 5 % Baxter solution for infusion
   1. WHAT IS GLUCOSIO 5% BAXTER FOR INFUSION AND WHAT IS IT USED FOR
   2. WHAT YOU NEED TO KNOW BEFORE GLUCOSIO 5% IS GIVEN TO YOU
   3. HOW GLUCOSIO 5% BAXTER FOR INFUSION WILL BE GIVEN TO YOU
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE GLUCOSIO 5% BAXTER
   6. CONTENT OF THE PACK AND OTHER INFORMATION
   7. Opening
   8. Preparation for administration
   9. Techniques for Adding Medication Additives

Package Leaflet: Information for the patient

Glucosio 5 % Baxter solution for infusion

Active substance: glucosio

Read this leaflet carefully before you are given this medicine as it
contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or nurse.
• - If any side effect occurs, including any not listed in this leaflet, tell your doctor or nurse. Contents of this leaflet :
• 1. What Glucosio 5% Baxter is and what it is used for
• 2. What you need to know before you are given Glucosio 5% Baxter
• 3. How Glucosio 5% Baxter will be given to you
• 4. Possible side effects
• 5. How to store Glucosio 5% Baxter
• 6. Contents of the pack and other information

1. WHAT IS GLUCOSIO 5% BAXTER FOR INFUSION AND WHAT IS IT USED FOR

Glucosio 5% Baxter is a sugar (glucose) solution in water. Glucose is one of the sources of
energy for the body. This infusion solution provides 200 kilocalories per liter.
The infusion of Glucosio 5% is used:

• as a source of fluids and carbohydrates (sugar)
• to dilute or administer other medicinal products for infusion

2. WHAT YOU NEED TO KNOW BEFORE GLUCOSIO 5% IS GIVEN TO YOU

BAXTER FOR INFUSION
DO NOT take Glucosio 5% Baxter if you suffer from any of the following conditions:

• uncontrolled diabetes, causing your blood sugar levels to rise above normal (uncompensated diabetes)
• states of glucose intolerance, for example:
• metabolic stress (when the body's metabolism is not functioning correctly, e.g. following a serious illness)
• hyperosmolar coma (state of unconsciousness). This is a type of coma that can occur if you have diabetes and do not receive enough medication
• a blood sugar level higher than normal (hyperglycemia)
• a higher than normal lactate level in the blood (hyperlactatemia) If another medicinal product is added to your solution, always read the package leaflet carefully to understand if you can take the solution.

Warnings and precautions
Please tell your doctor if you have or have had any of the following medical conditions

• heart failure
• respiratory problems (lung disease)
• weak kidney function
• reduced urine production (oliguria or anuria)
• excess water in the body (water intoxication)
• head trauma within the last 24 hours
• high blood pressure in the skull (intracranial hypertension)
• stroke due to a blood clot in a blood vessel in the brain (ischemic stroke)
• allergy to wheat (Glucosio 5% Baxter contains sugars derived from wheat)

When you are given this infusion, your doctor will take blood and urine samples
to monitor:

• the amount of chemical compounds such as potassium in your blood (your plasma electrolytes)
• the amount of sugar (glucose)

Since Glucosio 5% for infusion contains sugar (glucose), it may cause a high level
of sugar in the blood (hyperglycemia). If this happens, your doctor may:

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

This is particularly important:

• if you are diabetic
• if your kidneys are not working normally
• if you have recently had a stroke (severe ischemic stroke). High blood sugar levels can worsen the effects of the stroke and affect recovery

Glucosio 5% for infusion must not be administered through the same needle as a
blood transfusion. This may damage red blood cells or cause them to agglutinate together.
Your doctor will consider whether you are receiving parenteral nutrition (nutrition administered
by intravenous infusion).
During long-term treatment with Glucosio 5% for infusion you may need to be given extra nutrition.

Children
The infusion of Glucosio 5% must be administered with special care in children.
Newborns - especially those born prematurely and with low birth weight - are at increased risk of
developing a blood sugar level that is too low or too high (hypo- 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, fungal and bacterial 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 can be connected to an infusion pump, which allows for the accurate administration of the required amount of solution over
the defined time interval. Your doctor or nurse will monitor the device to ensure
safe administration.

Glucosio 5% Baxter and other medicines
Consult your doctor or nurse if you are using, have recently used or may
use any other medicines.
Glucosio 5% and other medicines taken at the same time can influence each other.
Do not take Glucosio 5% with certain hormones (catecholamines) including adrenaline or steroids since
these can increase your blood sugar level.

Glucosio 5% Baxter with food and drink
You should ask your doctor what you can drink or eat.

Pregnancy and breastfeeding
Ask your doctor or pharmacist before taking any medicine.
Tell your doctor if you are pregnant or if you are breastfeeding.
Glucosio 5% can be used safely during pregnancy, labor or breastfeeding.
In any case, if you are pregnant or breastfeeding and any medicine needs to be added to your
infusion solution you should:

• consult your doctor
• read the package leaflet of the medicine being added carefully

Driving and operating machinery
Glucosio 5% for infusion has no effects on your ability to drive or operate machinery.

3. HOW GLUCOSIO 5% BAXTER FOR INFUSION WILL BE GIVEN TO YOU

Glucosio 5% for infusion will be administered to you by a doctor or nurse. Your
doctor will decide how much product you need and when it will be administered to you. This will depend on
your age, weight, condition, reason for treatment and whether the infusion is or is not used to
administer or dilute another medicine. The amount that is administered to you will also depend
on other treatments you are undergoing.

You must not be administered Glucosio 5% for infusion if there are
particles in suspension in the solution or if the packaging is damaged in any way.
Glucosio 5% for infusion is commonly administered intravenously through a plastic tube connected to a
needle. Usually, a vein in your arm is used for the
administration of the solution. However, your doctor may choose a different route of
administration.
Glucosio 5% for infusion must be administered slowly to prevent you from producing
too much urine (osmotic diuresis)
Any unused solution must be discarded. NEVER administer an infusion of
Glucosio 5% from a partially used bag.

If you are given more Glucosio 5% than you should
If you are given too much Glucosio 5% (overinfusion) or if it is administered too
quickly, this can lead to the following symptoms:

• accumulation of fluid in the tissues causing swelling (edema) or water intoxication with lower than normal blood sodium levels (hyponatremia)
• an increase in the amount of urine you produce (osmotic diuresis)
• the blood becomes too concentrated (hyperosmolarity)
• a loss of water from the body (dehydration)
• a high level of sugar in the blood (hyperglycemia)
• sugars in the urine (hyperglycosuria)

If you develop any of these symptoms you should immediately inform your doctor. Your
infusion should be stopped and you will be given treatment depending on the symptoms.
If a medicine has been added to your Glucosio 5% for infusion before the overinfusion, also
for the list of all possible symptoms.

Stopping the Glucosio 5% infusion
Your doctor will decide when to stop administering the infusion to you.
If you have any further questions about the use of this product you can ask your doctor or nurse.

4. POSSIBLE SIDE EFFECTS

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

• changes in the amounts of chemical compounds in the blood (electrolyte disorders)
• higher than normal blood sugar levels (hyperglycemia)
• loss of water from the body (dehydration)
• excessive urination (polyuria)
• hypersensitivity reactions, including a severe allergic reaction called anaphylaxis (potential manifestation in patients with wheat allergy)
• fever (pyrexia)
• chills
• reactions due to the administration technique:
• - Fever (febrile response)
• - Infection at the infusion site
• - Pain or reaction (redness and/or swelling) localized to the infusion site
• - Irritation and inflammation of the vein into which the infusion was performed (phlebitis). This may cause redness, pain, burning and swelling along the path of the vein into which the solution was infused
• - Formation of a blood clot (venous thrombosis) at the infusion site, which causes pain, swelling or redness in the area of the clot.
• - Leakage of the infused solution into the tissues around the vein (extravasation). This can damage the tissues and cause scarring

If a medicine has been added to the infusion solution, the added medicine may also cause
side effects. These side effects depend on the medicine that has been added. Must
If any of the side effects worsen, or if you notice the appearance of any effect

5. HOW TO STORE GLUCOSIO 5% BAXTER

Keep this medicine out of the sight and reach of children.
Bags of 50 and 100 ml: Do not store at a temperature above 30°C
Bags of 250, 500 and 1000 ml: This medicine does not require any special storage conditions
You must not be administered Glucosio 5% for infusion after the expiry date stated
on the packaging after “Scad”. The expiry date refers to the last day of the month indicated.
You must not be administered Glucosio 5% for infusion if particles are present in the solution
or if the packaging is damaged in any way.

6. CONTENT OF THE PACK AND OTHER INFORMATION

What Glucosio 5% contains
The active ingredient is sugar (glucose): 50 g per litre
The only excipient is water for injections.

Description of the appearance of Glucosio 5% Baxter and contents of the pack
Glucosio 5% for infusion is a clear solution, free from visible particles. It is dispensed in
polyolefin/polyamide bags (Viaflo).
Each bag is wrapped in a sealed protective covering made of plastic material.
The sizes of the bags are:

• 50 ml
• 100 ml
• 250 ml
• 500 ml
• 1000 ml The bags are placed inside cardboard boxes. Each carton contains one of the following quantities:
• 50 bags of 50 ml
• 1 bag of 50 ml
• 50 bags of 100 ml
• 1 bag of 100 ml
• 30 bags of 250 ml
• 1 bag of 250 ml
• 20 bags of 500 ml
• 1 bag of 500 ml
• 10 bags of 1000 ml
• 1 bag of 1000 ml

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturers
Marketing Authorisation Holder:
Baxter S.p.A., Piazzale dell’Industria 20, 00144 Rome
Manufacturers:
Baxter S.A.
Boulevard Rene Branquart, 80
B–7860 Lessines, Belgium
Baxter Healthcare Ltd.
Caxton Way,
Thetford Norfolk IP24 3SE
United Kingdom
Bieffe Medital S.A.
Ctra de Biescas, Senegüé
22666 Sabiñanigo(Huesca)
Spain
Baxter Healthcare S.A.
Moneen Road
Castlebar
County Mayo
Ireland
Bieffe Medital S.p.A.
Via Nuova Provinciale
23034 Grosotto (SO)
Italy
Baxter Manufacturing Sp. z o.o.
42 B Wojciechowska Str.
20-704 Lublin
Poland
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The following information is intended exclusively for doctors and healthcare professionals:
Handling and Preparation
Use only if the solution is clear, free from visible particles and if the container is undamaged.
Administer immediately after inserting the infusion set.
Do not remove the unit from the packaging before it is ready for use.
The inner bag maintains the sterility of the product.
Do not use containers connected in series. This may cause gas embolism due to residual air being drawn from the primary container before the administration of fluid from the secondary container is completed.
Pressurising intravenous solutions contained in flexible plastic containers to increase flow rates may cause gas 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 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 with sterile equipment and using aseptic technique. The device must be filled with the solution in such a way as to prevent air from entering the system.
Additives can be added before or during the infusion through the resealable access point.
When adding additives, check the tonicity before parenteral administration.
Complete and careful aseptic mixing of any additive is mandatory.
Solutions containing additives must be administered immediately and not stored.
The addition of medicines or incorrect administration technique may cause febrile reactions due to the possible introduction of pyrogens. In case of adverse reactions, the infusion must be immediately stopped.
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 bag of fluid 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 before switching off the pump. This is required even if the administration set has a non-return valve.
The intravenous infusion device and administration equipment must be frequently monitored.

Dispose of after each single use.
Discard any unused product residue.
Do not reconnect partially used bags.

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. Check that the solution is clear and that no foreign particles are visible. Discard the solution if foreign material and turbidity are visible

2. Preparation for administration

Use sterile material for both preparation and administration.

• a. Suspend the container by the support hole
• b. Remove the plastic cap from the outlet point located at the bottom of the container:
• firmly hold the flap located on the neck of the outlet point with one hand,
• with the other hand, grasp the flap located on the cap and rotate,
• the cap will open
• c. Use an aseptic method to prepare the infusion
• d. Connect the infusion set. Consult the instructions included with the set for connecting and filling the device and for administering the solution.

3. Techniques for Adding Medication Additives

Warning: additives may be incompatible (see the following paragraph 5

“Additive Incompatibilities”).

Adding medications before administration

• a. Disinfect the entry point for the dressing
• b. Using a syringe with a 19 (1.10 mm) to 22 gauge (0.70 mm) needle, puncture the resealable dressing port and inject.
• c. Thoroughly mix the solution and the medication. For high-density medications, such as potassium chloride, gently tap the access points while keeping them in a perpendicular position and mix. Caution: do not store bags that contain medication additives.

Adding medications during administration

• a. Close a clamp on the infusion set
• b. Disinfect the entry point of the dressing
• c. Use the syringe with a 19 (1.10 mm) to 22 gauge (0.70 mm) needle, puncture the dressing entry point and inject.
• d. Remove the container from the pole of the infusion device and invert it
• e. Eliminate any residual medication and solution from both access points by gently tapping while the container is in a vertical position
• f. Thoroughly mix the solution and added medication

• g. Return the container to the correct position for use, reopen the clamp and continue administration

4Validity during use: Additives
The chemical and physical stability of each medication added to the pH of the 5% Glucose solution
in the Viaflo container must be evaluated before use. From a microbiological point of view,
the diluted product must be used immediately unless the dilution has occurred under
validated and controlled aseptic conditions.
If the solution is not used immediately, the storage times and conditions are
the responsibility of the user.

5Incompatibility of medication additives
As with all parenteral solutions, the incompatibility of medication additives with the
solution in the Viaflo container must be evaluated before addition.
In the absence of compatibility studies, this solution should not be mixed with other medicinal
products.
It is the physician's responsibility to judge the incompatibility of a medication additive with the
5% Glucose solution, checking for any color change and/or the possible appearance
of a precipitate, insoluble complexes or crystals. The instructions for use of the medication to
be added must be consulted.
Before adding a drug, verify if it is soluble and/or stable in water at the same pH as the
5% Glucose solution.
When a compatible drug is added to the 5% Glucose infusion solution,
the mixture must be administered immediately.
Additives known to be incompatible should not be used.