Glukoza 5 Braun

Package Leaflet: Information for the Patient

Glucose 5% Braun, 50 mg/ml, Solution for Infusion
(Glucosum)

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Package Leaflet

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

1. What is Glucose 5% Braun and what is it used for

Glucose 5% Braun is a sterile solution of glucose in water, which can be used to administer fluids and glucose or to dissolve other medicines. Glucose 5% Braun is administered by intravenous infusion.

2. Important information before using Glucose 5% Braun

When not to use Glucose 5% Braun:

• if you are allergic to glucose or any of the other ingredients of this medicine (listed in section 6);
• if you have too high blood sugar levels (hyperglycemia), which require more than 6 units of insulin per hour to normalize;
• if you have elevated lactic acid levels in the blood (lactic acidosis).

Do not administer large volumes of the solution to the patient in the following cases:

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

Glucose 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 Glucose 5% Braun, discuss it with your doctor.
This medicine should not be used to treat fluid deficiency without proper administration of mineral salts (see also the section above "When not to use Glucose 5% Braun"), as it may significantly lower the levels of mineral salts in the blood (especially potassium and sodium). Mineral salt deficiency can lead to heart disease and brain damage. Children, elderly patients, and patients in poor general condition are particularly at risk.
During treatment with Glucose 5% Braun, ensure adequate intake of mineral salts (especially potassium and sodium) and vitamins (especially vitamin B1).
Blood sugar levels, fluid balance, electrolytes (especially sodium and potassium), and acid-base balance will be monitored during infusion to ensure they are normal. For this purpose, your doctor or nurse may take blood samples.
If necessary, blood sugar levels will be controlled by administering insulin. Your doctor will consider that in this case, the patient's potassium levels may decrease.
Your doctor will carefully consider whether the medicine is suitable if you have:

• diabetes;
• any glucose metabolism disorders (e.g., due to previous surgeries or injuries);
• kidney function disorders.

Usually, this medicine is not used in patients with stroke or after stroke, unless the doctor considers it necessary to improve the patient's health.
If the patient is receiving blood transfusions, they will be administered using a different infusion set.
Your doctor will consider the safety information of the medicine diluted or dissolved in Glucose 5% Braun.

Children

Since the ability to stabilize fluid and electrolyte levels in children may be impaired, caution should be exercised when administering the medicine to patients in this age group. Fluid intake, urine production, and electrolyte levels in serum and urine should be closely monitored.
In some conditions (in response to pain, anxiety, after surgery, nausea, vomiting, fever, sepsis, decreased blood volume, respiratory disorders, central nervous system infections, metabolic and hormonal disorders), the body may produce more of a certain hormone (ADH), increasing water retention in the body. If low-electrolyte medicines, such as Glucose 5% Braun, are administered at the same time, sodium levels in the body may decrease (hyponatremia). This can lead to headache, nausea, seizures, drowsiness, coma, brain edema caused by excess water (cerebral edema), and death, which is why such a situation should be treated as an emergency.

Glucose 5% Braun and other medicines

Tell your doctor about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
Your doctor will consider that certain medicines may affect glucose metabolism.
Consider the safety information of the medicine diluted or dissolved in Glucose 5% Braun.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor for advice before taking this medicine.
Pregnancy
Your doctor will decide whether you should use this solution during pregnancy.
Breastfeeding
Your doctor will decide whether you can use this solution while breastfeeding.

Driving and using machines

This medicine does not affect your ability to drive or use machines.
Consider the safety information of the medicine diluted or dissolved in Glucose 5% Braun.

3. How to use Glucose 5% Braun

Dosage

The dose of Glucose 5% Braun will be determined by your doctor.
In the case of using this medicine to supplement fluids, the dose depends on the patient's age, weight, and medical and physical condition. The maximum doses given below should be considered.
In the case of using this medicine as a solvent for another medicine, the dose of Glucose 5% Braun should be chosen to achieve the desired concentration of the medicine for which Glucose 5% Braun is to be used as a diluent, taking into account the maximum dose of Glucose 5% Braun given below.
Adults
Maximum daily dose
Up to 40 ml/kg body weight per day, which corresponds to 2 g glucose/kg body weight per day
Maximum infusion rate
Up to 5 ml/kg body weight per hour, which corresponds to 250 mg glucose/kg body weight per hour.
The total daily need for fluids and glucose should be considered.
Use in children
When using Glucose 5% Braun in children, the smallest effective dose should be used. Electrolytes should be supplemented if necessary. See also section 2, "Children".
This medicine is intended for intravenous administration (i.e., it is administered through a small tube directly into a vein). It can be administered into peripheral veins, but this route of administration depends on the type of medicine to be diluted in Glucose 5% Braun.

Using more than the recommended dose of Glucose 5% Braun

This situation is unlikely, as the doctor will determine the daily dose of the medicine.
Overdose of glucose may lead to:

• too high blood sugar levels (hyperglycemia);
• glucose loss in the urine (glycosuria);
• fluid deficiency with excessively high fluid osmolarity (hypersmolar dehydration);
• disorders or loss of consciousness due to too high blood sugar levels or too high fluid osmolarity (hyperglycemic hyperosmolar coma).

Overdose of the solution may lead to excess fluid in the body, and:

• increased skin tension;
• feeling of heaviness and swelling of the legs (phlebitis);
• swelling of tissues (edema), with possible fluid accumulation in the lungs (pulmonary edema) or brain edema;
• abnormally high or low electrolyte levels in the blood, such as low sodium levels (hyponatremia) or potassium levels (hypokalemia);
• acid-base balance disorders.

In case of overdose, the patient may experience nausea, vomiting, or cramps.
Other overdose symptoms may occur, depending on the medicine dissolved or diluted in Glucose 5% Braun.
In this case, the doctor or nurse will reduce the infusion rate or stop the infusion.
The doctor will decide whether further treatment is necessary, such as administering insulin, diuretics, or mineral salts.
If you have any doubts about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Glucose 5% Braun can cause side effects, although not everybody gets them.
Frequency not known (frequency cannot be estimated from the available data)

• abnormally high or low electrolyte levels in the blood, such as low sodium levels (hyponatremia) or potassium levels (hypokalemia),
• neurological disorders (hyponatremic encephalopathy) Hyponatremia associated with hospital treatment can cause irreversible brain damage and death due to the development of acute hyponatremic encephalopathy.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Glucose 5% Braun

Keep the medicine out of the 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 that month.
There are no special precautions for storage.
Use only if the solution is clear and colorless or almost colorless, and the packaging and closure show no visible signs of damage.
The packaging is intended for single use. Any unused contents and all remaining medicine should be discarded.
Medicines should 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 pack and other information

What Glucose 5% Braun contains

• The active substance is glucose. One liter of this medicine contains 55 g glucose monohydrate, which corresponds to 50 g glucose.
• The other ingredient is water for injections.

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

What Glucose 5% Braun looks like and contents of the pack

Glucose 5% Braun is a solution for infusion (for intravenous administration).
It is a clear, colorless or almost colorless solution of glucose in water.
Glucose 5% Braun is available in:
glass bottles with rubber stoppers, with a capacity of: 250ml, 500 ml, and 1000 ml
available in collective packaging
10 x 250 ml
10 x 500 ml
6 x 1000 ml
in polyethylene containers of the Ecoflac type, with a capacity of: 250 ml, 500 ml, and 1000 ml
available in collective packaging
10 x 250 ml
10 x 500 ml
10 x 1000 ml

Marketing authorization holder and manufacturer

Marketing authorization holder Manufacturer

• 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
For more detailed information, please contact your local representative of the marketing authorization holder:

Contact details:

phone: +48 61 44 20 100
e-mail address: [email protected]

This medicine is authorized in the Member States of the European Economic Area under the following names:

Germany:
Glucose 5% B. Braun Infusionslösung
Poland:
Glukoza 5 Braun, solution for infusion

Date of last revision of the package leaflet: ------------------------------------------------------------------------------------------------------------------------

Information intended for healthcare professionals only:

Incompatibilities

Since the solution for infusion Glucose 5% Braun has an acidic pH, incompatibilities may occur when mixed with other medicines and blood.
Information on compatibility can be obtained from the manufacturers of medicines administered together 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 medicine should be started immediately after connecting the container to the administration set or infusion device. Before adding another medicine or preparing a mixture for nutrition, physical and chemical compatibility should be confirmed. Since Glucose 5% Braun has an acidic pH, incompatibilities may occur when mixed with other medicines. Information on compatibility can be obtained from the manufacturers of medicines administered together with Glucose 5% Braun.
When adding another medicine to Glucose 5% Braun, strict aseptic rules should be followed.

Shelf life after opening the package

The medicine should be used immediately after opening the package.

Shelf life after mixing with another substance

From a microbiological point of view, the medicine should be used immediately. If the solution is not used immediately after preparation, the time and conditions of storage are the responsibility of the user, provided that the solution is not stored for longer than 24 hours at a temperature of 2-8°C, unless the preparation procedure is carried out under controlled and validated aseptic conditions.
More information about this medicine can be found in the Summary of Product Characteristics.