Glucose 5% Baxter

Patient Information Leaflet
Glucose 5% Baxter infusion solution
Active substance: glucose
Please read this leaflet carefully before this medicine is administered to you, as it
contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or nurse.
• If you experience any side effects, including those not listed in this leaflet, inform your doctor or nurse. Contents of this leaflet:

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

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

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

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

2. WHAT YOU SHOULD KNOW BEFORE GLUCOSE 5% IS ADMINISTERED TO YOU

BAXTER FOR INFUSION
DO NOT take Glucose 5% Baxter if you have any of the following conditions:

• untreated diabetes, causing your blood sugar levels to rise above normal (uncompensated diabetes)
• conditions of glucose intolerance, for example:
• metabolic stress (when the body's metabolism is not functioning properly, e.g. due to severe illness)
• hyperosmolar coma (a state of unconsciousness). This is a type of coma that may occur if you have diabetes and are not receiving sufficient medication
• abnormally high blood sugar levels (hyperglycemia)
• abnormally high levels of lactate in the blood (hyperlactatemia)
  If another medicine is added to your solution, please always read the package leaflet of that medicine carefully to understand whether the solution can be administered.

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

• heart failure
• respiratory problems (lung disease)
• impaired kidney function
• reduced urine output (oliguria or anuria)
• excess water in the body (water intoxication)
• head trauma within the previous 24 hours
• increased intracranial pressure (intracranial hypertension)
• stroke due to a blood clot in a cerebral vessel (ischemic stroke)
• allergy to wheat (Glucose 5% Baxter contains sugars derived from wheat)

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

• levels of chemical substances such as potassium in your blood (your plasma electrolytes)
• blood sugar (glucose) levels

Since Glucose 5% for infusion contains sugar (glucose), it may cause elevated blood sugar levels (hyperglycemia). If this occurs, 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 are diabetic
• if your kidneys are not functioning normally
• if you have recently had a stroke (severe ischemic stroke). High blood sugar levels may worsen the effects of the stroke and affect recovery

Glucose 5% for infusion must not be administered through the same needle used for a blood transfusion. This may damage red blood cells or cause them to clump together.
Your doctor will consider whether you are receiving parenteral nutrition (nutrition delivered by intravenous infusion).
During long-term treatment with Glucose 5% for infusion, you may require additional nutritional support.

Children
Infusion of Glucose 5% must be administered with special care in children.
Newborns—especially premature infants and those 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 close monitoring during treatment with intravenous glucose solutions to ensure adequate control of sugar levels and to avoid potential long-term adverse effects.
Low blood sugar levels in newborns may 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 hospitalization, and death.
When administered to a newborn, the solution bag may be connected to an infusion pump, which allows precise delivery of the required amount of solution over a defined time interval. Your doctor or nurse will monitor the device to ensure safe administration.

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

Glucose 5% Baxter with food and drink
Please ask your doctor what you may eat or drink.

Pregnancy and breastfeeding
Ask your doctor or pharmacist before taking any medicine.
Inform your doctor if you are pregnant or breastfeeding.
Glucose 5% may be safely used during pregnancy, childbirth, or breastfeeding.
However, if you are pregnant or breastfeeding and any medicine is to be added to your infusion solution, you must:

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

Driving and use of machines
Glucose 5% for infusion has no effect on your ability to drive or operate machinery.

3. HOW GLUCOSE 5% BAXTER FOR INFUSION WILL BE ADMINISTERED TO YOU

Glucose 5% for infusion will be administered to you by a doctor or nurse. Your doctor will decide how much of the product you need and when it will be administered. This will depend on your age, weight, condition, reason for treatment, and whether or not the infusion is being used to administer or dilute another medicine. The amount you receive will also depend on any other treatments you are undergoing.
GLUCOSE 5% FOR INFUSION MUST NOT BE ADMINISTERED TO YOU IF PARTICLES ARE PRESENT IN THE SOLUTION OR IF THE PACKAGE IS DAMAGED IN ANY WAY.
Glucose 5% for infusion is commonly administered intravenously through a plastic tube connected to a needle. Usually, a vein in your arm will be used to administer the solution. However, your doctor may choose a different route of administration.
Glucose 5% for infusion must be administered slowly to prevent excessive urine production (osmotic diuresis).
Any unused solution must be discarded. NEVER administer an infusion of Glucose 5% from a partially used bag.

If you are given more Glucose 5% than you should receive
If you are given too much Glucose 5% (over-infusion) or if it is administered too quickly, this may lead to the following symptoms:

• fluid accumulation in tissues causing swelling (edema) or water intoxication with lower than normal sodium levels in the blood (hyponatremia)
• increased urine production (osmotic diuresis)
• blood becoming too concentrated (hyperosmolarity)
• loss of water from the body (dehydration)
• high blood sugar levels (hyperglycemia)
• sugar in the urine (glucosuria)

If you develop any of these symptoms, you must inform your doctor immediately. Your infusion must be stopped and you will be given treatment depending on your symptoms.
If a medicine has been added to your Glucose 5% for infusion before the over-infusion, that medicine may also cause symptoms. You should read the package leaflet of the added medicine for a list of all possible side effects.

Stopping the Glucose 5% infusion
Your doctor will decide when to stop administering the infusion.
If you have further questions about the use of this product, you can speak to 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:

• changes in levels of chemical substances in the blood (electrolyte imbalances)
• higher than normal blood sugar levels (hyperglycaemia)
• loss of water from the body (dehydration)
• excessive urination (polyuria)
• hypersensitivity reactions, including a severe allergic reaction called anaphylaxis (potential occurrence in patients with wheat allergy)
• fever (pyrexia)
• chills
• reactions related to the administration technique:
• • Fever (febrile response)
• • Infection at the infusion site
• • Localized pain or reaction (redness and/or swelling) at the infusion site
• • Irritation and inflammation of the vein where the infusion was administered (phlebitis). This may cause redness, pain, burning, and swelling along the course of the vein
• • Formation of a blood clot (venous thrombosis) at the infusion site, causing pain, swelling or redness in the area of the clot
• • Leakage of the infused solution into the surrounding tissues (extravasation). This may damage tissues and lead to scarring

If a drug has been added to the infusion solution, the added drug may also cause adverse reactions. These side effects depend on the drug that has been added. You should read the package leaflet of the added medicine for a list of all possible symptoms.
If any of the adverse reactions worsen, or if you notice any adverse reaction not listed in this leaflet, inform your doctor or pharmacist.

5. HOW TO STORE GLUCOSE 5% BAXTER

Keep this medicine out of the sight and reach of children.
Bags of 50 and 100 ml: Do not store above 30°C
Bags of 250, 500 and 1000 ml: This medicine does not require any special storage conditions.
DO NOT use Glucose 5% for infusion after the expiry date stated on the packaging after "Exp". The expiry date refers to the last day of the month indicated.
DO NOT use Glucose 5% for infusion if particles are present in the solution or if the packaging is damaged in any way.

6. PACKAGING CONTENTS AND OTHER INFORMATION

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

Description of the appearance of Glucosio 5% Baxter and packaging contents
Glucosio 5% for infusion is a clear solution free from visible particles. It is supplied in polyolefin/polyamide bags (Viaflo).
Each bag is enclosed in a sealed protective plastic overwrap.

Bag sizes:

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

The bags are packed in cardboard boxes. Each box 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 Authorization Holder and Manufacturers
Marketing Authorization Holder:
Baxter S.p.A., Piazzale dell’Industria 20, 00144 Rome, Italy

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

This Patient Information Leaflet was last reviewed on ………….

The following information is intended exclusively for physicians and healthcare professionals:
Handling and Preparation
Use only if the solution is clear, free from visible particles, and the container is undamaged.
Administer immediately after inserting the infusion set.
Do not remove the unit from its packaging before it is ready for use.
The inner bag maintains the sterility of the product.
Do not use plastic containers connected in series. This practice may result in gas embolism due to residual air being drawn from the primary container before the fluid in the secondary container has been fully administered.
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 equipment and aseptic technique. The administration set must be filled with the solution in a way that prevents air from entering the system.
Additives may be introduced before or during infusion through the resealable access port.
When additives are used, isotonicity must be verified prior to parenteral administration.
Complete and careful aseptic mixing of any additive is mandatory.
Solutions containing additives must be administered immediately and must not be stored.
The addition of medicinal products or incorrect administration techniques may lead to febrile reactions due to the potential introduction of pyrogens. In case of adverse reactions, the infusion must be immediately stopped.
To avoid potentially fatal excessive intravenous fluid administration in neonates, special care must be taken during 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 administration set from the pump or before switching off the pump. This is required regardless of whether or not the administration set has a free-flow protection device.
The intravenous infusion device and administration equipment must be monitored frequently.
Discard after single use.
Dispose of any unused product remaining after administration.
Do not reconnect partially used bags.

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 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 or cloudiness is observed.

2. Preparation for administration

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

• firmly hold the tab on the neck of the outlet with one hand,
• with the other hand, grasp the tab on the cap and twist,
• the cap will open.

c. Use an aseptic technique to prepare the infusion.
d. Connect the infusion set. Refer to the instructions provided with the infusion set for connecting and priming the device, and for administering the solution.

3. Techniques for Adding Medication Additions

Warning: Medication additions may be incompatible (see section 5 below, "Incompatibility of Medication Additions").
Adding medications prior to administration
a. Disinfect the medication injection site
b. Using a syringe with a 19 (1.10 mm) to 22 gauge (0.70 mm) needle, puncture the resealable medication port and inject the medication.
c. Mix the solution and medication thoroughly. For high-density medications, such as potassium chloride, gently tap the access sites while keeping them in a vertical position, and mix well.
Caution: Do not store bags containing added medications.

Adding medications during administration
a. Close a clamp on the infusion set
b. Disinfect the medication injection site
c. Using a syringe with a 19 (1.10 mm) to 22 gauge (0.70 mm) needle, puncture the medication injection site and inject the medication
d. Remove the container from the infusion device pole and invert it
e. Remove any residual medication and solution from both access ports by gently tapping while the container is in an upright position
f. Mix the solution and added medication thoroughly
g. Return the container to its correct position for use, reopen the clamp, and continue administration

4 In-Use Stability: Medication Additions
The chemical and physical stability of each medication added to the pH of 5% Glucose solution in the Viaflo container must be evaluated before use. From a microbiological standpoint, the diluted product should be used immediately unless the dilution has been carried out under validated, controlled aseptic conditions.
If the solution is not used immediately, the storage times and conditions are the responsibility of the user.

5 Incompatibility of Medication Additions
As with all parenteral solutions, the incompatibility of medication additions with the solution in the Viaflo container must be assessed before administration.
In the absence of compatibility studies, this solution must not be mixed with other medicinal products.
It is the physician's responsibility to assess whether a medication addition is incompatible with 5% Glucose solution, by checking for any change in color and/or the formation of a precipitate, insoluble complexes, or crystals. The package insert of the medication to be added must be consulted.
Before adding a drug, verify whether it is soluble and/or stable in water at the same pH as the 5% Glucose solution.
When a compatible drug is added to 5% Glucose infusion solution, the mixture must be administered immediately.
Known incompatible additions must not be used.