GLUCOSALINO HYPOSODIC BRAUN

Introduction

Leaflet:information for theuser

GLUCOSALINE HYPOSONIC BRAUN

Glucose 5% and Sodium Chloride 0.3%. Solution for infusion

Read the entire leaflet carefully before starting to use the medicine

• Keep this leaflet as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed to you and should not be given to others, even if they have the same symptoms, as it may harm them.

Contents of the leaflet:

1. What is Glucosamine Hypersonic Braun and what is it used for
2. Before using Glucosamine Hypersonic Braun
3. How to use Glucosamine Hypersonic Braun
4. Possible side effects
5. Storage of Glucosamine Hypersonic Braun
6. Additional information

1. What is Glucosamine Hypersonic Braun and what is it used for

Glucosamine Hypersonic Braun is an infusion solution (administered intravenously through a drip) that contains 5% glucose and 0.3% sodium chloride.

Glucosamine Hypersonic Braun is used mainly for:

• replacing water losses in the body (dehydration) as a result of various alterations or disorders, and when the amount of sodium in the body is also high (hypernatremia),
• regulating situations of mild increase in basic substances in tissues or blood (mild alkalosis), which are due to a higher concentration of chlorides,
• to cover energy needs, since glucose is the main source of energy for the body,
• as a solution that serves to dissolve and transport other compatible medicines.

2. Before using Glucosamine Hypersonic Braun

Do not use GlucosamineHypersonicBraun:

• If you are allergic to the active ingredients or to any of the other components of Glucosamine Hypersonic Braun.
  • In cases of fluid overload (hyperhydration).
  • In situations of fluid accumulation in body tissues (generalized edema) or chronic progressive liver disease with fluid accumulation (ascitic cirrhosis).
  • In cases of high blood sugar levels (hyperglycemia).
  • In cases of low potassium levels in the blood (hypokalemia).
  • In cases of low sodium levels in the blood (hyponatremia).
  • In cases of low chloride levels in the blood (hypochloremia).
  • In cases of loss of consciousness due to an increase in blood salt concentration (hyperosmolar coma).
  • In cases of lactic acid in the blood (hyperlactacidemia).
  • In severe cases of heart, liver, or kidney failure.
  • During the first 24 hours after a head injury.

Be careful with GlucosamineHypersonicBraun:

This medicine will be administered to you with caution if you have the following diseases: hypertension, heart failure, peripheral or pulmonary edema, renal dysfunction, preeclampsia (symptoms preceding convulsions and blood pressure drop in pregnant women), alterations in the heart, liver, or kidneys, or if you are an elderly patient.

Your blood glucose levels will be carefully determined if you have intracranial hypertension.

If you have had an acute ischemic attack (sudden lack of blood flow), this medicine should not be administered to you.

If this medicine is administered to you for a prolonged period, it is recommended to add potassium to the solution as a safety measure.

The administration of glucose-containing solutions can cause a deficiency of vitamin B1, especially in cases of malnutrition. An adequate intake of vitamins (especially vitamin B1) must be ensured.

If you have diabetes mellitus, glucose-containing solutions can be used as long as you have initially received adequate treatment (insulin). Similarly, these solutions should be used with caution if you have Addison's disease or carbohydrate intolerance.

Glucosamine Hypersonic Braun should not be administered with the same infusion equipment, either at the same time, before, or after a blood transfusion, as incompatibilities may occur.

Blood sugar, electrolytes (especially potassium), and water balance should be regularly monitored.

This type of solution should be administered with caution in children.

Continuous administration at the same injection site should be avoided due to the risk of thrombophlebitis.

Use of other medicines

Tell your doctor or pharmacist if you are using or have recently used any other medicine, even those purchased without a prescription, as it may be necessary to interrupt treatment or adjust the dose of one of them.

Certain medicines may interact with Glucosamine Hypersonic Braun. In this case, it may be necessary to change the dose or interrupt treatment with one of the medicines.

It is essential that you inform your doctor if you are using any of the following medicines:

• Insulin or oral antidiabetics (biguanides, sulfonylureas), as these medicines decrease the effect of glucose.
• Corticosteroids due to the risk of increased blood sugar or the ability of these medicines to retain sodium and water.
• Digitalis glycosides (digoxin), as an increase in digitalis activity may occur, with the risk of developing intoxication.
• Lithium carbonate, as the administration of sodium chloride accelerates the renal excretion of lithium, leading to a decrease in the therapeutic effect of the latter.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

The administration of Glucosamine Hypersonic Braun during pregnancy or breastfeeding should be carried out following the instructions detailed in this leaflet.

3. How to use Glucosamine Hypersonic Braun

This medicine will always be administered by healthcare personnel.

The normal daily dose is up to 40 ml per kg of body weight.

In postoperative or intensive care patients, the carbohydrate intake should be reduced, but the fluid administration should be increased to the maximum daily dose.

Your doctor will decide the dose and frequency at which the solution will be administered to you, depending on your age, weight, and clinical situation.

Follow exactly the administration instructions of Glucosamine Hypersonic Braun indicated by your doctor. Consult your doctor or pharmacist if you have doubts.

If you use more Glucosamine Hypersonic Braun than you should

This is unlikely to happen since your doctor will determine your daily doses. However, if you receive more Glucosamine Hypersonic Braun than you should, this could cause:

• excess hydration
• an imbalance of electrolyte levels (substances with an electric charge in the blood and other body fluids, such as sodium, calcium, chlorides) and acid-base balance (loss of balance in the levels of acidic and basic substances in the body, which must always be kept constant)
• an increase in blood sugar levels.

If this happens, treatment should be interrupted immediately and, depending on the severity, the following should be administered:

• medicines that increase water and salt elimination (diuretics),
• electrolytes (such as sodium, calcium, chlorides…), or
• insulin.

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicology Information Service, phone (91) 562 04 20, indicating the medicine and the amount used.

If you have any other doubts about the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Glucosamine Hypersonic Braun can cause side effects, although not everyone will experience them.

Adverse reactions associated with the administration technique may occur, including fever, infection at the injection site, local reaction or pain, venous irritation, venous thrombosis, or phlebitis extending from the injection site, extravasation, and hypervolemia.

Adverse reactions may be associated with the medicines added to the solution; the nature of the added medicines will determine the possibility of any other undesirable effect.

In case of adverse reactions, administration should be interrupted.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that is not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Glucosamine Hypersonic Braun

Keep out of the reach and sight of children.

No special storage conditions are required.

Do not use Glucosamine Hypersonic Braun after the expiration date shown on the packaging. The expiration date is the last day of the month indicated.

Do not use Glucosamine Hypersonic Braun if the solution is not transparent, if you observe particles at the bottom, or if the packaging shows visible signs of deterioration.

Medicines should not be disposed of through wastewater or household waste. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Additional information

Composition of Glucosamine Hypersonic Braun:

The other components are: water for injectable preparations.

Appearance of the product and packaging content

Glucosamine Hypersonic Braun is a clear and colorless infusion solution that is presented in Ecoflac Plus plastic bottles of 100 and 500 ml (not all sizes may be marketed).

Marketing authorization holder and manufacturer

B|BRAUN

• Braun Medical, S.A.

Ctra. de Terrassa, 121

08191-Rubí (Barcelona)

Spain

This leaflet was approved in December 2024

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products.

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This information is intended only for doctors or healthcare professionals:

The recommended infusion rate is approximately 5 ml per kg of body weight per hour, which corresponds to 1.7 drops per kg of body weight per minute.

Single-use containers. Discard any unused contents after completing the infusion.

The solution should only be used if the container closure is not damaged and the solution is clear.

Use the sterile administration set for administration.

Before mixing the solution with other medicines, possible incompatibilities should be considered.

Glucosamine Hypersonic Braun should not be administered with the same infusion equipment, either at the same time, before, or after a blood transfusion, as incompatibilities may occur.

On the other hand, samples of incompatibility have been described when certain medicines are diluted in glucose-containing solutions, including ampicillin sodium, amrinone lactate, amoxicillin sodium/acid clavulanic, interferon alfa-2b, and procainamide hydrochloride. However, amrinone lactate or amoxicillin sodium/acid clavulanic can be injected directly into the injection site while these infusion solutions are being administered.

Samples of incompatibility have also been described when certain medicines are diluted in chloride-containing solutions, including amsacrine and trimetrexate glucuronate.

The disposal of unused medicine and all materials that have come into contact with it will be carried out in accordance with local regulations.