Glukoza 40 Braun

LEAFLET INCLUDED IN THE PACKAGE: INFORMATION FOR THE PATIENT

Glucose 40 Braun, 400 mg/ml, solution for infusion
(Glucosum)

Table of contents of the leaflet

• 1. What is Glucose 40 Braun and what is it used for
• 2. Important information before using Glucose 40 Braun
• 3. How to use Glucose 40 Braun
• 4. Possible side effects
• 5. How to store Glucose 40 Braun
• 6. Contents of the package and other information

1. WHAT IS GLUCOSE 40 BRAUN AND WHAT IS IT USED FOR

Glucose 40 Braun is a glucose solution administered through a cannula into a vein (intravenous infusion).
Glucose 40 Braun is used to provide the patient with carbohydrates when oral nutrition is impossible or insufficient, particularly in cases of high energy requirements or when fluid intake needs to be limited.
The medicine is also used when it is necessary to increase low blood sugar levels.

2. IMPORTANT INFORMATION BEFORE USING GLUCOSE 40 BRAUN

When not to use Glucose 40 Braun:

if the patient has high blood sugar levels (hyperglycemia) that require more than 6 units of insulin per hour;
if the patient has delirium tremens along with significant fluid deficiency;
if the patient has severe circulatory disorders, i.e. 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 treatment with Glucose 40 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 treatment with this medicine, you should regularly check blood sugar levels, fluid, electrolyte (especially potassium) levels, and acid-base balance.
To do this, you should take blood samples from the patient. If necessary, you should adjust blood sugar levels by administering insulin.
Before starting treatment with this medicine, you should correct fluid and electrolyte disorders, such as:

• 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 organ disease), which may be associated with high blood acidification;
• high blood concentration (high osmolality of blood);
• kidney or heart disorders.

In cases of blood-brain barrier damage, the doctor will take special precautions, as this medicine may increase intracranial pressure and spinal cord pressure.
You should ensure additional supplementation of electrolytes (especially potassium, magnesium, phosphates) and vitamins (especially vitamin B).

Children

Special caution should be exercised when using this medicine in children under 2 years of age. Abrupt cessation of infusion administered at high speed may lead to significant hypoglycemia, especially in this patient group.

Glucose 40 Braun and other medicines

You should tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
In case 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 40 Braun.
Glucose 40 Braun should not be mixed with red blood cell concentrate, and it should not be administered simultaneously with blood or directly before or after it through the same infusion set.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor before using this medicine.
Pregnancy
The doctor will decide whether to use this medicine during pregnancy. During treatment with this medicine, you should monitor blood sugar levels.
Breastfeeding
The doctor will decide whether to use this medicine during breastfeeding.

Driving and using machines

Glucose 40 Braun does not affect the ability to drive or use machines.

3. HOW TO USE GLUCOSE 40 BRAUN

The dose of Glucose 40 Braun will be determined by your doctor, depending on your health condition.

Dosage

In the case of adults and adolescents over 15 years of age, the maximum dose of the medicine is 15 ml per kg of body weight per day. The medicine should not be administered at a rate greater than 0.62 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:
When determining the dose, you should take into account the daily fluid intake, according to the following recommendations for children:

Special conditions

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

Method of administration

Glucose 40 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 building block, fat emulsions, saturated fatty acids, electrolytes, vitamins, and trace elements.

Using a higher dose of Glucose 40 Braun than recommended

Since daily doses are determined by the doctor, using a higher dose is unlikely.

Overdose of the medicine may lead to increased blood sugar levels, glucose excretion in urine, increased fluid levels, fluid deficiency, disturbance 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 cases of fluid in the lungs or brain edema), and increased electrolyte levels in the blood. In cases of significant overdose, it may also lead to fat accumulation in the liver.
In such cases, 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 authorized, it is important to report any suspected side effects. This allows for continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected side effects via the Department of Post-Marketing Surveillance of Adverse Reactions to 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 40 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 40 Braun contains

• The active substance is glucose monohydrate. One liter of this medicine contains 440 g of glucose monohydrate, which corresponds to 400 g of glucose.
• Other ingredients: water for injections, hydrochloric acid (for pH adjustment).

Energy
6700 kJ/l = 1600 kcal/l
Theoretical osmolality:
2200 mOsm/l
Acid capacity (to pH = 7) <1 mmol l
pH:
3.5 – 5.5

What Glucose 40 Braun looks like and what the package contains

Glucose 40 Braun is a solution for infusion (for administration through an infusion fluid administration apparatus).
It is a clear, colorless or slightly yellowish glucose monohydrate solution in water.
Glucose 40 Braun is available in:

• colorless glass bottles with a capacity of 500 ml, available in cartons of 1 and 10 pieces
• Ecoflac plus polyethylene containers with a capacity of 500 ml, available in cartons of 1 and 10 pieces Not all pack sizes may be marketed.

Responsible entity and manufacturer:

Responsible entity with a marketing authorization

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 40 Braun in newborns.
Special warnings and precautions for use
Abrupt cessation of glucose infusion administered at high speed may lead to severe hypoglycemia due to high insulin levels in the blood. This applies especially to children under 2 years of age, patients with diabetes, and other diseases associated with impaired glucose homeostasis.
In obvious cases, glucose infusion should be discontinued over 30-60 minutes. As a precaution, it is recommended to monitor each patient for 30 minutes for hypoglycemia on the first day after stopping parenteral nutrition.
Shelf life after first opening of the package
Infusion should be started immediately after connecting the container with the medicine to the infusion fluid administration apparatus.
Shelf life of the medicinal product after mixing with other ingredients
From a microbiological point of view, mixtures with additives or other infusion solutions should be used immediately. If immediate use is not possible, the user is responsible for the conditions and storage time before administration. 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.
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 40 Braun.