Glukoza 20 Braun

LEAFLET INCLUDED IN THE PACKAGE: INFORMATION FOR THE PATIENT

Glucose 20 Braun, 200 mg/ml, solution for infusion
(Glucosum)

Table of contents of the leaflet

• 1. What is Glucose 20 Braun and what is it used for
• 2. Important information before using Glucose 20 Braun
• 3. How to use Glucose 20 Braun
• 4. Possible side effects
• 5. How to store Glucose 20 Braun
• 6. Contents of the package and other information

1. WHAT IS GLUCOSE 20 BRAUN AND WHAT IS IT USED FOR

Glucose 20 Braun is a glucose solution administered through a cannula into a vein (intravenous infusion).
The medicine Glucose 20 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.

2. IMPORTANT INFORMATION BEFORE USING GLUCOSE 20 BRAUN

When not to use Glucose 20 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 tremensalong with significant 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 in a state of dehydration;
• if the patient has pulmonary edema;
• if the patient has severe heart failure.

Warnings and precautions

Before starting to use Glucose 20 Braun, you should discuss it with your doctor or nurse.
This medicine should not be administered to a 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, you should check the blood sugar, fluid, electrolyte (especially potassium), and acid-base balance levels. For this purpose, blood samples should be taken from the patient. If necessary, the blood sugar level should be adjusted by administering insulin.
Before starting to administer this medicine, you should 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 administering this medicine in cases where the patient has:

• diabetes or other cases of carbohydrate intolerance;
• high blood volume;
• other metabolic disorders (e.g. after surgery or injury, in cases of insufficient tissue oxygenation, or in cases 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 blood-brain barrier damage, the doctor will take special precautions, as this medicine may increase intracranial and spinal cord pressure.
Additional supplementation of electrolytes (especially potassium, magnesium, phosphates) and vitamins (especially vitamin B) should be ensured.

Children

Special 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 lead to a significant decrease in blood sugar levels, especially in this patient group.

Glucose 20 Braun and other medicines

You should tell your doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
In the event of mixing this medicine with other medicines or substances, the doctor will exercise caution and only use medicines and substances that can be administered together with Glucose 20 Braun.
Glucose 20 Braun should not be mixed with red blood cell concentrate, nor should it be administered simultaneously with blood, or directly before or after through the same infusion set.

Pregnancy, breastfeeding, and fertility

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

Driving and using machines

Glucose 20 Braun does not affect the ability to drive and use machines.

3. HOW TO USE GLUCOSE 20 BRAUN

The dose of Glucose 20 Braun will be determined by the doctor based 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 30 ml per kg of body weight per day. The medicine should not be administered at a rate greater than 1.25 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:
90 ml per kg of body weight
Newborns:
75 ml per kg of body weight
Children 1-2 years old:
75 ml per kg of body weight
Children 3-5 years old:
60 ml per kg of body weight
Children 6-10 years old:
50 ml per kg of body weight
Children 11-14 years old:
40 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 stable growth phase:
• 140 – 170 ml per kg of body weight 1 month, in the stable growth phase:
• 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 cases of insufficient tissue oxygenation, or in cases of organ diseases), the glucose dose should be adjusted to ensure normal blood glucose levels.

Method of administration

Glucose 20 Braun is administered through a cannula directly into a vein (intravenous infusion).
During parenteral nutrition, the patient is also administered other nutrients, such as amino acids as a protein builder, fat emulsions, saturated fatty acids, electrolytes, vitamins, and trace elements.

Using a higher dose of Glucose 20 Braun than recommended

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, disorder or loss of consciousness due to high blood sugar levels or excessive fluid concentration, fluid overload with accompanying skin tension, venous thrombosis (feeling of heaviness and swelling of the legs), tissue edema (possible in the event of fluid accumulation in the lungs or brain edema), and increased electrolyte levels in the blood. In the event of a very high overdose, it may also lead to fat accumulation in the liver.
In such a case, the infusion should be slowed down or stopped if necessary.
The doctor will decide on further treatment steps, e.g. administration of insulin, fluids, or electrolytes.
You should consult a doctor or pharmacist if you need advice or additional information about using this medicine.

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, you should not expect side effects.

Reporting suspected side effects

After the medicinal product has been placed on the market, it is important to report suspected side effects. This allows for continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals should report any suspected side effects via the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE GLUCOSE 20 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 slightly yellowish and the packaging and closure are undamaged.
There are no special precautions for storage.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What Glucose 20 Braun contains

• The active substance is glucose monohydrate. One liter of this medicine contains 220 g of glucose monohydrate, which corresponds to 200 g of glucose.
• Other ingredients: water for injections, hydrochloric acid (for pH adjustment). Energy 3350 kJ/l = 800 kcal/l Osmolality theoretical: 1110 mOsm/l Acid-base capacity (to pH = 7) <1 mmol l ph: 3.5 - 5.5< li>

What Glucose 20 Braun looks like and what the package contains

Glucose 20 Braun is a solution for infusion (for administration through an infusion fluid transfusion apparatus.
It is a clear, colorless or slightly yellowish glucose monohydrate solution in water.
Glucose 20 Braun is supplied 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 available in collective packaging 10 x 500 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
For intravenous infusion only.
Children
For the treatment of hypoglycemia in children, a 10% glucose solution is recommended.
Due to the high osmolality, special caution should be exercised when using Glucose 20 Braun in newborns.
Special warnings and precautions for use
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 other diseases associated with impaired glucose homeostasis.
Obviously, 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.
Shelf life after first opening of 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 mixing with other substances
From a microbiological point of view, mixtures with additives or other infusion solutions should be used immediately. If not used immediately, the user is responsible for the storage conditions and storage time before administration of the medicine. The storage time should not exceed 24 hours at a temperature of 2 to 8°C, unless the preparation was carried out under controlled and validated aseptic conditions.
Incompatibilities
Due to the acidic pH, the medicine may not be compatible with other medicinal products.
Due to the risk of pseudoagglutination, a suspension should not be created with erythrocyte concentrates in Glucose 20 Braun.