Glucose 40 braun
Poland
Table of Contents
PACKAGE LEAFLET: INFORMATION FOR THE USER
Glukoza 40 Braun, 400 mg/ml, solution for infusion
(Glucosum)
Read the package leaflet carefully before using the medicine, as it contains important information for the patient.
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Table of contents
- What Glukoza 40 Braun is and what it is used for
- Important information before using Glukoza 40 Braun
- How to use Glukoza 40 Braun
- Possible side effects
- How to store Glukoza 40 Braun
- Contents of the pack and other information
1. WHAT GLUKOZA 40 BRAUN IS AND WHAT IT IS USED FOR
Glukoza 40 Braun is a glucose solution administered through a cannula into a vein (intravenous infusion).
Glukoza 40 Braun is used to provide carbohydrates to patients when oral nutrition is impossible or insufficient, particularly in cases of high energy demand or when the volume of administered fluids needs to be limited.
The medicine is also used when necessary to increase blood glucose concentration if it is too low.
2. IMPORTANT INFORMATION BEFORE USING GLUKOZA 40 BRAUN
When not to use Glukoza 40 Braun:
if the patient has high blood sugar levels (hyperglycemia) 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 edema;
if the patient has severe heart failure.
Warnings and precautions
Before starting treatment with Glukoza 40 Braun, discuss this with a doctor or nurse.
This medicinal product 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 medicinal product, blood glucose, fluid and electrolyte levels (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 initiating administration of this medicinal product, fluid and electrolyte imbalances such as the following should be corrected:
- low blood potassium or sodium levels (hypokalemia, hyponatremia);
- fluid deficiency and excessive salt loss.
The doctor will carefully consider whether to administer this medicinal product if the patient has:
- diabetes or other carbohydrate intolerance;
- hypervolemia;
- other metabolic disorders (e.g. after surgery or trauma, in case of inadequate tissue oxygenation, or in case of organ diseases), which may be associated with excessive blood acidification;
- excessively high blood concentration (high blood osmolality);
- kidney or heart disorders.
In case of blood-brain barrier impairment, the doctor will exercise special caution, as this medicinal product may increase intracranial and intraspinal pressure.
Additional supplementation with electrolytes (especially potassium, magnesium, phosphates) and vitamins (especially vitamin B) should be provided.
Children
Particular caution should be exercised when administering this medicinal product to children under 2 years of age. Abrupt discontinuation of an infusion administered at a high rate may, especially in this patient group, lead to a significant drop in blood glucose levels.
Glukoza 40 Braun and other medicinal products
Inform the doctor about all medicinal products currently used or recently used by the patient, as well as any medicinal products the patient plans to use.
When mixing this medicinal product with other medicinal products or substances, the doctor will exercise caution and use only those medicinal products and substances compatible with Glukoza 40 Braun.
Glukoza 40 Braun must not be mixed with concentrated red blood cell preparations, must not be administered simultaneously with blood, nor administered immediately before or after blood through the same infusion set.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning pregnancy, she should consult a doctor before using this medicinal product.
Pregnancy
The doctor will decide whether this medicinal product should be used during pregnancy. Blood glucose levels should be monitored during treatment.
Breastfeeding
The doctor will decide whether this medicinal product should be used during breastfeeding.
Driving and operating machinery
Glukoza 40 Braun has no influence on the ability to drive or operate machinery.
3. HOW TO USE GLUKOZA 40 BRAUN
The dose of Glukoza 40 Braun will be determined by the physician according to the patient's health condition.
Dosage
For adults and adolescents above 15 years of age, the maximum dose is 15 ml per kg of body weight per day. The infusion rate must not exceed 0.62 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:
| Preterm infants: | 45 ml per kg of body weight |
| Neonates: | 37.5 ml per kg of body weight |
| Children aged 1–2 years: | 37.5 ml per kg of body weight |
| Children aged 3–5 years: | 30 ml per kg of body weight |
| Children aged 6–10 years: | 25 ml per kg of body weight |
| Children aged 11–14 years: | 20 ml per kg of body weight |
When determining the dose, the daily fluid intake should be taken into account, according to the following recommendations for children:
| first day of life: | 60 – 120 ml per kg body weight |
| second day of life: | 80 – 120 ml per kg body weight |
| third day of life: | 100 – 130 ml per kg body weight |
| fourth day of life: | 120 – 150 ml per kg body weight |
| fifth day of life: | 140 – 160 ml per kg body weight |
| sixth day of life: | 140 – 180 ml per kg body weight |
| 1 month, before stable growth phase: | 140 – 170 ml per kg body weight |
| 1 month, during stable growth phase: | 140 – 160 ml per kg body weight |
| from 2 to 12 months of life: | 120 – 150 ml per kg body weight |
| second year of life: | 80 – 120 ml per kg body weight |
| from 3 to 5 years of life: | 80 – 100 ml per kg body weight |
| from 6 to 12 years of life: | 60 – 80 ml per kg body weight |
| from 13 to 18 years of life: | 50 – 70 ml per kg body weight |
Special precautions
In cases of metabolic disorders (e.g. following surgery or trauma, inadequate tissue oxygenation, or organ diseases), glucose doses should be adjusted to maintain normal blood glucose concentration.
Method of administration
Glucose 40 Braun is administered through a cannula directly into a vein (intravenous infusion).
During parenteral nutrition, other nutrients are also administered to the patient, such as amino acids as protein building blocks, fat emulsions (so-called saturated fatty acids), electrolytes, vitamins, and trace elements.
Administration of a higher than recommended dose of Glucose 40 Braun
Since daily doses are determined by the physician, administration of an excessive dose is unlikely.
Overdose may lead to elevated blood sugar levels, excretion of glucose in urine, increased body fluid concentration, fluid deficiency, disturbances or loss of consciousness due to high blood glucose levels or excessive body fluid concentration, fluid overload associated with increased skin tension, venous thrombosis (sensation of heaviness and swelling of the legs), tissue edema (possible in case of fluid accumulation in the lungs or cerebral edema), and elevated blood electrolyte levels. In cases of severe overdose, fat accumulation in the liver may also occur.
In such cases, the infusion should be slowed down or, if necessary, stopped.
The physician will decide on further treatment steps, e.g. administration of insulin, fluids, or electrolytes.
Consult a physician or pharmacist if advice or additional information regarding the use of this medicinal product is needed.
4. POSSIBLE ADVERSE REACTIONS
Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
If this medicine is used according to recommendations, adverse reactions are not expected.
Reporting of suspected adverse reactions
After authorization 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 are required to 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 of adverse reactions will help collect further information on the safety of using this medicine.
5. HOW TO STORE GLUKOZA 40 BRAUN
Keep 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 packaging and closure are undamaged.
No special storage precautions are required.
6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION
What Glucoza 40 Braun contains
- The active substance is monohydrate glucose. One litre of this medicinal product contains 440 g of monohydrate glucose, equivalent to 400 g of glucose.
- Other ingredients: water for injections, hydrochloric acid (for pH adjustment).
Energy: 6700 kJ/l = 1600 kcal/l
Theoretical osmolarity: 2200 mOsm/l
Titratable acidity (to pH = 7): < 1 mmol/l
pH: 3.5 – 5.5
What Glucoza 40 Braun looks like and contents of the pack
Glukoza 40 Braun is an infusion solution (for administration via an infusion set).
It is a clear, colourless or slightly yellowish solution of monohydrate glucose in water.
Glukoza 40 Braun is supplied in:
- 500 ml colourless glass bottles, available in cardboard packs of 1 and 10 units
- 500 ml polyethylene Ecoflac plus containers, available in cardboard packs of 1 and 10 units
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 medical 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 is required when administering Glukoza 40 Braun to neonates.
Special precautions and warnings for use
Sudden discontinuation of glucose infusion administered at high rate may lead to severe hypoglycaemia due to high serum insulin concentration. This especially applies to 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 packaging
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 point of view, mixtures with additives or other infusion solutions should be used immediately. If not used immediately, the user is responsible for conditions and duration of storage prior to use. Storage should not exceed 24 hours at a temperature of 2 to 8°C, unless preparation was carried out under controlled and validated aseptic conditions.
Incompatibilities
Due to its acidic pH, the medicinal product may be incompatible with other medicinal products.
Due to the risk of pseudoagglutination, red blood cell concentrates must not be suspended in Glukoza 40 Braun.