Glucose 5 braun

Package leaflet: Information for the patient

Glukoza 5 Braun, 50 mg/ml, infusion solution
(Glucosum)
Please read all of this leaflet carefully before using this medicine, because it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

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

1. What Glukoza 5 Braun is and what it is used for

Glukoza 5 Braun is a sterile solution of glucose in water, which may be used to administer fluids and glucose or to dissolve other medicines. Glukoza 5 Braun is administered by intravenous infusion (i.e. intravenous infusion).

2. Important information before using Glukoza 5 Braun

When not to use Glukoza 5 Braun:

• if the patient is allergic to glucose or any of the other ingredients of this medicine (listed in section 6);
• if the patient has too high blood sugar levels (hyperglycaemia) requiring more than 6 units of insulin per hour to normalise;
• if the patient has elevated lactic acid levels in the blood (lactic acidosis).

Large volumes of this solution should not be administered to the patient in cases of:

• excessive body water (hypotonic or isotonic overhydration);
• acute heart failure (severe congestive heart failure);
• fluid in the lungs (pulmonary oedema).

Glukoza 5 Braun should not be used as monotherapy in the treatment of fluid deficiency, as it does not contain any mineral salts (electrolytes).
Warnings and precautions
Before starting treatment with Glukoza 5 Braun, discuss this with the doctor.
This medicine should not be used to treat fluid deficiency without appropriate supplementation of mineral salts (see also section above “When not to use Glukoza 5 Braun”), as this may significantly reduce electrolyte concentrations in the blood (especially potassium and sodium). Electrolyte deficiency may lead to heart disorders and brain damage. Children, elderly patients, and patients in poor general condition are particularly at risk.
During treatment with Glukoza 5 Braun, adequate intake of mineral salts (especially potassium and sodium) and vitamins (particularly vitamin B1) must be ensured.
Blood glucose levels, fluid balance, electrolytes (especially sodium and potassium), and acid-base balance will be monitored during infusion to ensure they remain within normal ranges. For this purpose, the doctor or nurse may take blood samples.
If necessary, blood glucose levels will be controlled by administering insulin. The doctor will consider that in such cases, the patient's blood potassium levels may decrease.
The doctor will carefully assess whether this medicine is appropriate if the patient has:

• diabetes;
• any disorders of glucose metabolism (e.g. due to previous surgery or trauma);
• impaired kidney function.

This medicine is generally not used in patients with stroke or after stroke, unless the doctor considers it necessary for the patient's recovery.
If the patient is receiving blood transfusions, these will be administered through a separate infusion set.
The doctor will take into account safety information regarding any medicine diluted or dissolved in Glukoza 5 Braun.

Children
Since children may have impaired ability to regulate fluid balance and electrolyte concentrations, caution must be exercised when administering this medicine to patients in this age group. Fluid status, urine output, and electrolyte concentrations in serum and urine should be closely monitored.
In certain conditions (in response to pain, anxiety, after surgery, in cases of nausea, vomiting, fever, sepsis, reduced blood volume, respiratory disorders, central nervous system infections, metabolic and hormonal disorders), the body may produce increased amounts of a particular hormone (ADH), which promotes water retention. If solutions with low electrolyte content such as Glukoza 5 Braun are administered simultaneously, this may lead to reduced sodium levels in the body (hyponatraemia). This may result in headache, nausea, seizures, drowsiness, coma, cerebral oedema due to excess water (brain swelling), and even death; therefore, such a situation should be treated as a medical emergency.

Glukoza 5 Braun and other medicines
Inform the doctor about all medicines currently used or recently used, as well as any medicines the patient plans to use.
The doctor will consider that certain medicines may affect glucose metabolism.
Safety information regarding any medicine diluted or dissolved in Glukoza 5 Braun should be taken into account.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor before using this medicine.
Pregnancy
The doctor will decide whether this solution should be used during pregnancy.
Breastfeeding
The doctor will decide whether this solution may be used during breastfeeding.

Driving and operating machinery
This medicine has no effect on the ability to drive or operate machinery.
Consider safety information regarding any medicine diluted or dissolved in Glukoza 5 Braun.

3. How to use Glukoza 5 Braun

Dosage
The dose of Glukoza 5 Braun will be determined by the physician.
When this medicinal product is used for fluid replacement, the dose depends on the patient's age, body weight, and medical and physical condition. The maximum doses indicated below must be taken into account.
When this medicinal product is used as a solvent for another medicinal product, the dose of Glukoza 5 Braun should be selected to achieve the desired concentration of the medicinal product for which Glukoza 5 Braun is to be used as a diluent, taking into account the maximum dose for Glukoza 5 Braun given below.

Adults
Maximum daily dose
Up to 40 ml/kg body weight per day, equivalent to 2 g of glucose/kg body weight per day.
Maximum infusion rate
Up to 5 ml per kg body weight per hour, equivalent to 250 mg of glucose/kg body weight per hour.
The total daily fluid and glucose requirements should be taken into account.

Use in children
When Glukoza 5 Braun is used in children, the smallest effective dose should be administered. Electrolytes should be supplemented if necessary. See also section 2, "Children".

This medicinal product is intended for intravenous administration (i.e., administered through a small tube directly into a vein). It may be administered into peripheral veins; however, this route of administration depends on the type of medicinal product to be diluted in Glukoza 5 Braun.

Overdose of Glukoza 5 Braun
This situation is unlikely, as the physician will determine the daily dose of the medicinal product.
Overdose of glucose may lead to:

• excessively high blood sugar levels (hyperglycaemia);
• loss of glucose in urine (glucosuria);
• fluid deficit with excessively high osmolarity of body fluids (hyperosmolar dehydration);
• disturbances or loss of consciousness due to excessively high blood sugar levels or excessively high osmolarity of body fluids (hyperglycaemic hyperosmolar coma).

Overdose of the solution may lead to fluid overload, and:

• increased skin tension;
• sensation of heaviness and swelling of the legs (venous thrombosis);
• tissue swelling (oedema), possibly with accumulation of fluid in the lungs (pulmonary oedema) or cerebral oedema;
• abnormally high or low levels of electrolytes in the blood, for example low sodium levels (hyponatraemia) or low potassium levels (hypokalaemia);
• acid-base imbalance.

In case of overdose, the patient may experience nausea, vomiting, or cramps.
Other symptoms of overdose may occur depending on the medicinal product dissolved or diluted in Glukoza 5 Braun.
In such cases, the physician or nurse will reduce the infusion rate or stop the infusion.
The physician will decide whether further treatment is necessary, for example administration of insulin, diuretics, or mineral salts.
If in doubt about the use of this medicinal product, consult a physician or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
Frequency unknown (frequency cannot be determined from the available data)

• abnormally high or low electrolyte levels in the blood, for example low sodium levels (hyponatremia) or potassium (hypokalemia),
• neurological disorders (hyponatremic encephalopathy). Hospital treatment-related hyponatremia may lead to irreversible brain damage and death due to the development of acute hyponatremic encephalopathy.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Glukoza 5 Braun

Keep this medicine out of sight and reach 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.
No special storage conditions apply.
Use only if the solution is clear and colourless or almost colourless, and the container and closure show no visible signs of damage.
The packaging is intended for single use only. Any unused contents and waste material must be discarded.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Glukoza 5 Braun contains

• The active substance in Glukoza 5 Braun is glucose. One litre of this medicinal product contains 55 g of monohydrated glucose, equivalent to 50 g of glucose.
• The other ingredient is water for injections.

Energy value: 835 kJ/l ≙ 200 kcal/l
Theoretical osmolarity: 278 mOsm/l
Acidity (titration to pH 7.4) < 0.5 mmol/l NaOH
pH: 3.5 – 5.5

What Glukoza 5 Braun looks like and contents of the pack
Glukoza 5 Braun is an infusion solution (for intravenous infusion).
It is a clear, colourless or almost colourless solution of glucose in water.
Glukoza 5 Braun is supplied in:

• Glass bottles with rubber stoppers, in volumes of: 250 ml, 500 ml and 1000 ml,
  available in pack sizes of:
  10 x 250 ml
  10 x 500 ml
  6 x 1000 ml
• Polyethylene Ecoflac-type containers, in volumes of: 250 ml, 500 ml and 1000 ml,
  available in pack sizes of:
  10 x 250 ml
  10 x 500 ml
  10 x 1000 ml

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder Manufacturers
B. Braun Melsungen AG B. Braun Melsungen AG
Carl-Braun-Strasse 1 Carl-Braun-Strasse 1
34212 Melsungen 34212 Melsungen
Germany Germany
B. Braun Medical SA
Carretera de Terrassa, 121
08191 Rubi (Barcelona)
Spain

For further information, please contact the local representative of the Marketing Authorisation Holder:
Contact details:
Tel. +48 61 44 20 100
Email: [email protected]

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Germany: Glucose 5% B. Braun Infusionslösung
Poland: Glukoza 5 Braun, infusion solution

Information intended exclusively for medical professionals:

Pharmaceutical incompatibilities
Since the Glucose 5 Braun infusion solution is acidic, incompatibilities may occur when mixed with other medicinal products and blood.
Information regarding compatibility can be obtained from the manufacturers of medicinal products intended to be co-administered with Glucose 5 Braun.
Due to the risk of pseudoagglutination, red blood cell concentrates should not be mixed with Glucose 5 Braun.

Special precautions for disposal and preparation of the medicinal product for administration
Administration of the product should begin immediately after connecting the container to the administration set or infusion device. Physical and chemical compatibility must be confirmed before adding any other medicinal product or preparing a mixture for nutrition. Since Glucose 5 Braun is acidic, incompatibilities may occur when mixed with other medicinal products. Information on compatibility can be obtained from the manufacturers of medicinal products to be co-administered with Glucose 5 Braun.
Strict aseptic techniques must be followed when adding another medicinal product to Glucose 5 Braun.

Shelf-life after first opening of the container
The product should be used immediately after opening the container.

Shelf-life after mixing with another substance
From a microbiological standpoint, the product should be used immediately. If the solution is not used immediately after preparation, the duration and conditions of storage are the responsibility of the user, provided that storage does not exceed 24 hours at 2–8°C, unless the preparation procedure has been carried out under controlled and validated aseptic conditions.

Further information on this medicinal product can be found in the Summary of Product Characteristics.