Glucose 20 braun

PACKAGE LEAFLET: INFORMATION FOR THE USER

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

Table of contents of the leaflet

1. What Glucose 20 Braun is and what it is 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 packaging and other information

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

Glucose 20 Braun is a glucose solution administered through an intravenous cannula (intravenous infusion).
Glucose 20 Braun is used to provide carbohydrates to patients when oral nutrition is impossible or insufficient.
The medicine is also used when necessary to increase blood glucose levels that are too low.

2. IMPORTANT INFORMATION BEFORE USING GLUKOZA 20 BRAUN

When not to use Glukoza 20 Braun:

• if the patient has excessively high blood sugar levels (hyperglycaemia) requiring administration of more than 6 units of insulin per hour;
• if the patient has delirium tremens accompanied by severe fluid deficiency;
• if the patient has severe circulatory disorders, i.e. in shock or circulatory collapse;
• if the patient has acidosis;
• if the patient is dehydrated;
• if the patient has pulmonary oedema;
• if the patient has severe heart failure.

Warnings and precautions
Before starting treatment with Glukoza 20 Braun, discuss this with the doctor or
nurse.
This medicine should not be administered to a patient during or after a stroke, unless the doctor
considers its use essential for treatment.
Before and during administration of this medicine, blood glucose levels, fluid balance, electrolytes (especially potassium), and acid-base balance should be monitored regularly. For this purpose, blood samples must be taken from the patient. If necessary, blood glucose levels should be controlled by administering insulin.
Before starting administration of this medicine, fluid and electrolyte imbalances should be corrected, such as:

• low blood potassium or sodium levels (hypokalaemia, hyponatraemia);
• water deficiency and excessive loss of salts.

The doctor will carefully consider whether to administer this medicine if the patient has:

• diabetes or other carbohydrate intolerance;
• increased blood volume;
• other metabolic disorders (e.g. after surgery or trauma, in case of inadequate tissue oxygenation, or in organ diseases), which may lead to excessive blood acidification;
• excessively high blood concentration (high blood osmolality);
• kidney or heart disorders.

In case of blood-brain barrier impairment, the doctor will take special precautions,
as this medicine may increase intracranial and intraspinal pressure.
Additional supplementation of electrolytes (especially potassium, magnesium,
phosphates) and vitamins (especially vitamin B ) should be provided.
Children
Particular caution should be exercised when using this medicine in children under
2 years of age. Abrupt discontinuation of infusion administered at a high rate may,
especially in this patient group, lead to a significant drop in blood glucose levels.
Glukoza 20 Braun and other medicines
Inform the doctor about all medicines currently or recently taken by the patient, as well as any medicines the patient plans to take.
When mixing this medicine with other medicines or substances, the doctor will exercise caution and will use only those medicines and substances compatible with Glukoza 20 Braun.
Glukoza 20 Braun must not be mixed with concentrated red blood cell preparations, nor should it be administered simultaneously with blood, or immediately before or after blood through the same infusion set.
Pregnancy, breastfeeding and effects on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor before using this medicine.
Pregnancy
The doctor will decide whether to use this medicine during pregnancy. Blood glucose levels should be monitored during treatment with this medicine.
Breastfeeding
The doctor will decide whether to use this medicine during breastfeeding.
Driving and operating machinery
Glukoza 20 Braun has no effect on the ability to drive or operate machinery.

3. HOW TO USE GLUKOZA 20 BRAUN

The dose of Glukoza 20 Braun will be determined by the physician according to the patient's medical condition.
Dosage
For adults and adolescents over 15 years of age, the maximum dose of Glukoza 20 Braun is 30 ml per kg of body weight per day. The infusion rate must not exceed 1.25 ml per kg of body weight per hour.
For children under 14 years of age, the maximum daily dose will be determined according to age and body weight:
Premature infants: 90 ml per kg of body weight
Newborns: 75 ml per kg of body weight
Children aged 1–2 years: 75 ml per kg of body weight
Children aged 3–5 years: 60 ml per kg of body weight
Children aged 6–10 years: 50 ml per kg of body weight
Children aged 11–14 years: 40 ml per kg of body weight

When determining the dose, daily fluid intake should be taken into account according to 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 of age, before stable growth phase: 140–170 ml per kg of body weight
1 month of age, during 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 cases of metabolic disturbances (e.g. after surgery or trauma, inadequate tissue oxygenation, or organ disease), glucose dosage should be adjusted to maintain normal blood glucose levels.

Method of administration
Glukoza 20 Braun is administered intravenously via a cannula (intravenous infusion).
During parenteral nutrition, other nutrients are also administered to the patient, including amino acids as protein building blocks, fat emulsions (so-called saturated fatty acids), electrolytes, vitamins, and trace elements.

Use of a higher than recommended dose of Glukoza 20 Braun
Since daily doses are determined by a physician, overdose is unlikely.
However, overdose may lead to elevated blood glucose levels, glucose excretion in urine, increased body fluid concentration, fluid depletion, disturbances or loss of consciousness due to high blood glucose levels or excessive body fluid concentration, fluid overload with associated skin tension, venous thrombosis (sensation of heaviness and swelling of the legs), tissue edema (possibly including pulmonary edema or cerebral edema), and elevated electrolyte levels in blood. In cases of severe overdose, fat accumulation in the liver may also occur.
In such cases, the infusion should be slowed or, if necessary, stopped.
The physician will decide on further treatment steps, such as administration of insulin, fluids, or electrolytes.
Please consult your doctor or pharmacist if you need advice or additional information regarding the use of this medicine.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everybody gets them.
If this medicine is used as recommended, adverse reactions should not be expected.
Reporting suspected adverse reactions
After authorisation of the medicinal product, it is important to report suspected adverse reactions.
This enables continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals should report any suspected adverse reactions via the Department of Monitoring Adverse Drug Reactions at the Office for Registration 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.
Reporting adverse reactions helps to gather further information on the safety of using this medicine.

5. HOW TO STORE GLUKOZA 20 BRAUN

Keep the medicine out of the reach and sight of 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 specified month.
Use the product only if the solution is clear or slightly yellowish, and the container and closure are undamaged.
No special storage precautions are required.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What Glukoza 20 Braun contains

• The active substance is monohydrate glucose. One litre of this medicinal product contains 220 g of monohydrate glucose, equivalent to 200 g of glucose.
• Other ingredients: water for injections, hydrochloric acid (for pH adjustment).
  Energy: 3350 kJ/l = 800 kcal/l
  Theoretical osmolarity: 1110 mOsm/l
  Titratable acidity (to pH = 7): < 1 mmol/l
  pH: 3.5 – 5.5

What Glukoza 20 Braun looks like and contents of the pack
Glukoza 20 Braun is a solution for infusion (for administration via an infusion set).
It is a clear, colourless or slightly yellowish solution of monohydrate glucose in water.
Glukoza 20 Braun is supplied in:

• colourless glass bottles with a capacity of: 500 ml, available in outer packs of 10 x 500 ml
• polyethylene containers of Ecoflac plus type, with a capacity of: 500 ml, available in outer packs of 10 x 500 ml

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
B. Braun Melsungen AG
Carl-Braun-Strasse 1
34212 Melsungen
Germany

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

B. Braun Medical SA
Carretera de Terrassa, 121
08191 Rubi (Barcelona)
Spain

Information intended exclusively for healthcare professionals:
Method of administration
For central venous infusion only.

Children
For the treatment of hypoglycaemia in children, a 10% glucose solution is recommended.
Due to its high osmolarity, particular caution must be exercised when administering Glukoza 20 Braun to neonates.

Special warnings and precautions for use
Sudden discontinuation of a rapidly administered glucose infusion may lead to severe hypoglycaemia due to high serum insulin concentrations. This particularly affects children under 2 years of age, diabetic patients, and patients with other diseases associated with impaired glucose homeostasis.
In evident cases, the glucose infusion should be tapered off over 30–60 minutes. As a precaution, it is recommended to monitor each patient for hypoglycaemia for 30 minutes during the first day after discontinuation of parenteral nutrition.

Shelf-life after first opening of the container
The infusion should be started immediately after connecting the container to the infusion set.

Shelf-life of the medicinal product after mixing with other components
From a microbiological standpoint, mixtures containing additives or other infusion solutions should be used immediately. If immediate use is not possible, the user is responsible for the conditions and duration of storage prior to use.
Storage time should not exceed 24 hours at a temperature of 2 to 8°C, unless preparation has been carried out under controlled and validated aseptic conditions.

Incompatibilities
Due to its acidic pH, the medicinal product may be incompatible with other medicinal products.
Because of the risk of pseudoagglutination, red blood cell concentrates must not be mixed with Glukoza 20 Braun.