Glukoza 10 Braun

LEAFLET INCLUDED IN THE PACKAGE: INFORMATION FOR THE PATIENT

Glucose 10 Braun, 100 mg/ml, solution for infusion
(Glucosum)

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor, pharmacist or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Glucose 10 Braun and what is it used for
• 2. Important information before using Glucose 10 Braun
• 3. How to use Glucose 10 Braun
• 4. Possible side effects
• 5. How to store Glucose 10 Braun
• 6. Contents of the package and other information

1. WHAT IS GLUCOSE 10 BRAUN AND WHAT IS IT USED FOR

Glucose 10 Braun is a glucose solution administered through a cannula into a vein (intravenous infusion).
The medicine Glucose 10 Braun is used to provide the patient with carbohydrates when
oral nutrition is impossible or insufficient.
The medicine is also used when it is necessary to increase too low blood sugar levels.
This medicine can also be used to dissolve and dilute medicinal products that
are to be administered to the patient by infusion.

2. IMPORTANT INFORMATION BEFORE USING GLUCOSE 10 BRAUN

When not to use Glucose 10 Braun:

• if the patient has too high blood sugar levels (hyperglycemia) that require the administration of more than 6 units of insulin per hour;
• if the patient has delirium tremens at the same time as severe fluid deficiency;
• if the patient has severe circulatory disorders, i.e. in shock and circulatory collapse;
• if the patient has acidosis;
• if the patient is being dialyzed;
• if the patient has fluid in the lungs;
• if the patient has severe heart failure.

Warnings and precautions

Before starting to use Glucose 10 Braun, discuss it with your doctor or
nurse.
This medicine should not be administered to the patient during or after a stroke, unless the doctor
considers it necessary for treatment.
Before and during the use of this medicine, at regular intervals, check the blood sugar,
fluid, electrolyte (especially potassium) levels and acid-base balance. For this purpose,
blood samples should be taken from the patient. If necessary, adjust the blood sugar level
by administering insulin.
Before starting the administration of this medicine, correct fluid and electrolyte disorders, such
as:

• too low potassium or sodium levels in the blood (hypokalemia, hyponatremia);
• fluid and excessive salt loss.

The doctor will carefully consider the administration of this medicine in case the patient has:

• diabetes or other carbohydrate intolerance;
• large blood volume;
• other metabolic disorders (e.g. after surgery or injury, in case of insufficient tissue oxygenation or in case of organ diseases), which may be associated with too high blood acidification;
• too high blood concentration (high osmolality of blood);
• kidney or heart disorders.

In the event of damage to the blood-brain barrier, the doctor will take special precautions,
as this medicine may increase intracranial and spinal cord pressure.
In the event of irritation or inflammation of the vein wall at the injection site, the doctor will
consider changing the infusion set insertion site.
Additional supplementation of electrolytes (especially potassium, magnesium, phosphates) and
vitamins (especially vitamin B) should be ensured.

Children

Particular caution should be exercised when using this medicine in children under 2 years of age.
Sudden cessation of infusion administered at a high rate may, especially in this patient group,
lead to a significant decrease in blood sugar levels.

Glucose 10 Braun and other medicines

Tell your doctor about all medicines the patient is taking or has recently taken, as well
as medicines the patient plans to take.
In case of mixing this medicine with other medicines or substances, the doctor will exercise
caution and use only those medicines and substances that can be administered together with
Glucose 10 Braun.
Glucose 10 Braun should not be mixed with red blood cell concentrate, it should not be administered
at the same time as blood, or directly before or after through the same infusion set.

Pregnancy, breastfeeding and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant or plans to have a child,
they should consult a doctor before using this medicine.
Pregnancy
The doctor will decide on the use of this medicine during pregnancy. During the use of this
medicine, blood sugar levels should be monitored.
Breastfeeding
The doctor will decide on the use of this medicine during breastfeeding.

Driving and using machines

Glucose 10 Braun has no effect on the ability to drive and use machines.

3. HOW TO USE GLUCOSE 10 BRAUN

The dose of Glucose 10 Braun will be determined by the doctor, depending on the patient's health condition.

Dosage

In the case of adults and adolescents over 15 years of age, the maximum dose of the medicine
is 40 ml per kg of body weight per day. The medicine should not be administered at a rate
greater than 2.5 ml per kg of body weight per hour.
In the case of children under 14 years of age, the maximum daily dose of the medicine will
be determined based on age and body weight:
Preterm infants:
180 ml per kg of body weight
Newborns:
150 ml per kg of body weight
Children 1-2 years old:
150 ml per kg of body weight
Children 3-5 years old:
120 ml per kg of body weight
Children 6-10 years old:
100 ml per kg of body weight
Children 11-14 years old:
80 ml per kg of body weight
When determining the dose, the daily fluid intake should be taken into account, in accordance
with the following recommendations for children:
first day of life:

• 60-120 ml per kg of body weight second day of life:
• 80-120 ml per kg of body weight third day of life:
• 100-130 ml per kg of body weight fourth day of life:
• 120-150 ml per kg of body weight fifth day of life:
• 140-160 ml per kg of body weight sixth day of life:
• 140-180 ml per kg of body weight
• 1 month, before the phase of stable growth:
• 140-170 ml per kg of body weight
• 1 month, in the phase of stable growth:
• 140-160 ml per kg of body weight from 2 to 12 months of age:
• 120-150 ml per kg of body weight second year of life:
• 80-120 ml per kg of body weight from 3 to 5 years of age:
• 80-100 ml per kg of body weight from 6 to 12 years of age:
• 60-80 ml per kg of body weight from 13 to 18 years of age:
• 50-70 ml per kg of body weight

Special conditions

In the case of metabolic disorders (e.g. after surgery or injury, in case of insufficient tissue oxygenation or in case of organ diseases), the glucose dose should be adjusted to ensure normal blood glucose levels.

Method of administration

Glucose 10 Braun is administered through a cannula directly into a vein (intravenous infusion).

Use of a higher than recommended dose of Glucose 10 Braun

Since the daily doses are determined by the doctor, the use of a higher dose is unlikely.
Overdose of the medicine may lead to increased blood sugar levels, glucose excretion in the urine,
increased fluid levels, fluid deficiency, disturbance or loss of consciousness due to high blood sugar
levels or excessive fluid concentration, fluid excess with accompanying skin tension, venous thrombosis
(feeling of heaviness and swelling of the legs), tissue swelling (possible in case of fluid in the lungs
or brain edema) and increased electrolyte levels in the blood. In the event of a very large overdose,
there may also be an accumulation of fat in the liver.
In such a case, the infusion should be slowed down or stopped if necessary.
The doctor will decide on further treatment, e.g. administration of insulin, fluids or electrolytes.
Consult a doctor or pharmacist if advice or additional information on the use of this medicine is
needed.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If this medicine is used as recommended, side effects are not expected.

Reporting suspected side effects

If any side effects occur, including any side effects not listed in the leaflet, the doctor, pharmacist
or nurse should be informed. Side effects can be reported directly to the Department of
Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal
Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
tel.: 22 49-21-301
fax: 22 49-21-309,
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. HOW TO STORE GLUCOSE 10 BRAUN

Store in a place inaccessible and invisible to children.
Do not use this medicine after the expiry date stated on the label and carton. The expiry date
refers to the last day of the given month.
Use the product only if the solution is clear or almost colorless and the packaging and closure
are undamaged.
There are no special precautions for storage.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines that are no longer needed. This will help protect the environment.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What Glucose 10 Braun contains

• The active substance is glucose monohydrate. One liter of this medicine contains 110 g of glucose
  monohydrate, which corresponds to 100 g of glucose.
• Other ingredients: water for injections

Energy
1675 kJ/l = 400 kcal/l
Theoretical osmolality:
555 mOsm/l
Titration acidity (to pH = 7) <0.5 mmol/l
pH:
3.5 - 5.5

What Glucose 10 Braun looks like and what the package contains

Glucose 10 Braun is an infusion solution (for administration through an infusion fluid transfusion
apparatus
It is a clear, colorless or almost colorless solution of glucose monohydrate in water.
Glucose 10 Braun is available in:

• glass bottles made of colorless glass with a capacity of 500 ml, available in collective packaging 10 x 500 ml
• polyethylene containers of the Ecoflac plus type, with a capacity of: 500 ml and 1000 ml, available
  in collective packaging 10 x 500 ml and 10 x 1000 ml

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Manufacturers

• B. Braun Melsungen AG Carl-Braun-Strasse 1 34212 Melsungen Germany
• B. Braun Melsungen AG Carl-Braun-Strasse 1 34212 Melsungen Germany

B.Braun Medical SA
Carretera de Terrassa, 121
08191 Rubi (Barcelona)
Spain
Date of last update of the leaflet:2023-04-17

Information intended for healthcare professionals only:

Method of administration
Intravenous infusion. This medicine can be administered into large peripheral veins.
Special warnings and precautions for use
General
It is not recommended to administer glucose solutions to patients after ischemic stroke, as
there are known cases of worsening brain damage associated with ischemic stroke and
prolongation of the recovery period due to hyperglycemia.
Administration of hyperosmolar glucose solutions to patients with damaged blood-brain barrier
may lead to increased intracranial and spinal cord pressure.
Before starting glucose infusion, fluid and electrolyte deficiencies, such as dehydration,
hyponatremia, and hypokalemia, should be corrected.
This solution should be administered with caution in the following cases:

• hyperolemia
• renal failure
• heart failure
• increased osmolality of serum
• subclinical diabetes or carbohydrate intolerance.

Unstable metabolism (e.g. after surgery or injury, in a state of hypoxia or organ failure) disrupts
the oxidative metabolism of glucose and may lead to metabolic acidosis.
Cases of hyperglycemia should be closely monitored and treated with insulin. Insulin
administration is associated with additional potassium shift into cells, which may increase
hypoglycemia.
Sudden cessation of glucose infusion administered at a high rate may lead to severe
hypoglycemia, due to high insulin levels in the serum. This applies especially to children under
2 years of age, patients with diabetes, and patients with other diseases associated with impaired
glucose homeostasis. Obviously, in such cases, the glucose infusion should be tapered off over
30-60 minutes. As a precaution, it is recommended to monitor each patient for 30 minutes for
hypoglycemia on the first day after discontinuation of parenteral nutrition.
Clinical monitoring of the patient should include control of blood glucose levels, serum electrolyte
levels, fluid balance, and acid-base balance. Since the administration of glucose solutions is
associated with the supply of free water to the body, which may lead to or exacerbate hyponatremia,
the sodium level should be closely monitored. The frequency and type of laboratory tests depend
on the patient's general condition, metabolic state, administered dose, and duration of treatment.
It is also necessary to monitor the total amount of glucose administered.
Parenteral nutrition of malnourished patients with the use of maximum doses and maximum rate
from the beginning of therapy without additional potassium, magnesium, and phosphate supplementation
may lead to the development of refeeding syndrome, characterized by hypokalemia, hypophosphatemia,
and hypomagnesemia. Clinical symptoms may occur after a few days of starting parenteral nutrition.
In such patients, infusion schedules should be built up gradually. Additional electrolyte supplementation
is necessary, depending on deviations from normal values.
Particular caution should be exercised in patients with hypokalemia. Potassium supplementation is
necessary.
Electrolytes and vitamins can be administered as needed. For glucose metabolism, vitamins of the
B group, especially thiamine, are necessary.
Due to the risk of pseudoagglutination, glucose should not be administered through the same infusion
set as red blood cell concentrate, and it should not be administered at the same time as blood, or
directly before or after.
In case of observed signs of irritation, inflammation, or thrombophlebitis of the vein during infusion
into peripheral veins, consideration should be given to changing the infusion set insertion site.
Note: When using this medicine as a carrier for another medicinal product, the safety information
provided by the manufacturer of the medicinal product administered together with the glucose
solution should be taken into account.
Children
Children under 2 years of age are particularly at risk of hypoglycemia recurrence when the infusion
is suddenly stopped at a high rate; see above.
Shelf life after first opening the package
The infusion should be started immediately after connecting the container with the medicine to
the infusion fluid transfusion apparatus.
Shelf life of the medicinal product after reconstitution or dilution
From a microbiological point of view, mixtures with additives or other infusion solutions should be
used immediately. If immediate use is not possible, the conditions and storage time before
administration of the ready-to-use medicinal product are the responsibility of the user. The storage
time should not exceed 24 hours at a temperature of 2 to 8°C, unless preparation takes place in
controlled and validated aseptic conditions.
The instructions provided by the manufacturer of the medicinal product administered together or
diluted in Glucose 10 Braun should be followed.
Incompatibilities
Since glucose solutions have an acidic pH, incompatibilities may occur when mixed with other
medicinal products and blood. Information on compatibility can be obtained from the manufacturers
of the medicinal products administered together with Glucose 10 Braun.
Due to the risk of pseudoagglutination, a suspension should not be created with erythrocyte concentrates
in Glucose 10 Braun.