Glucosaline hypo-sodium Braun

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

GLUCOSALINO HYPOSODIC BRAUN

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

Read the entire leaflet carefully before you start using this medicine

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

Leaflet contents:

1. What Glucosalino Hiposódico Braun is and what it is used for
2. Before using Glucosalino Hiposódico Braun
3. How to use Glucosalino Hiposódico Braun
4. Possible side effects
5. How to store Glucosalino Hiposódico Braun
6. Further information

1. What Glucosalino Hiposódico Braun is and what it is used for

Glucosalino Hiposódico Braun is an infusion solution (administered intravenously via an infusion set) containing 5% glucose and 0.3% sodium chloride.

Glucosalino Hiposódico Braun is primarily used for:

• replacing water losses in the body (dehydration) resulting from various disturbances or disorders, especially when sodium levels in the body are elevated (hypernatremia),
• correcting mild increases in basic substances in tissues or blood (mild alkalosis) due to higher chloride concentrations,
• meeting energy requirements, as glucose is the body's primary energy source,
• serving as a solution for dissolving and administering compatible medicinal products.

2. Before using Glucosalino Hiposódico Braun

Do not use Glucosalino Hiposódico Braun:

• If you are allergic to the active substances or to any of the other components of Glucosalino Hiposódico Braun.
  • In conditions 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 states of elevated blood glucose levels (hyperglycemia).
  • In states of decreased potassium levels in blood (hypokalemia).
  • In states of decreased sodium levels in blood (hyponatremia).
  • In states of decreased chloride levels in blood (hypochloremia).
  • In states of loss of consciousness due to increased concentration of salts in blood (hyperosmolar coma).
  • In states of elevated lactic acid levels in blood (hyperlactacidemia).
  • In severe cases of heart, liver, or kidney failure.
  • During the first 24 hours after a head injury.

Take special care with Glucosalino Hiposódico Braun:

This medicine will be administered to you with caution if you suffer from the following conditions: hypertension, heart failure, peripheral or pulmonary edema, renal dysfunction, preeclampsia (symptoms preceding seizures and drop in blood pressure in pregnant women), heart, liver, or kidney disorders, or if you are an elderly patient.

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

If you have suffered an acute ischemic stroke (sudden onset of insufficient blood supply), this medicine must not be administered.

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

Administration of solutions containing glucose may cause thiamine (vitamin B1) deficiency, especially in cases of malnutrition. Adequate vitamin intake (particularly vitamin B1) must be ensured.

If you have diabetes mellitus, glucose-containing solutions may be used provided that appropriate initial treatment (insulin) has been established. Furthermore, these solutions should be used with caution if you have Addison's disease or carbohydrate intolerance.

Glucosalino Hiposódico Braun must not be administered using the same infusion equipment, either simultaneously, before, or after a blood transfusion, due to possible incompatibilities.

Blood glucose, electrolytes (especially potassium), and fluid balance should be monitored regularly.

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

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

Use of other medicines

Inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription, as it may be necessary to interrupt or adjust the dosage of one or more of them.

Certain medicines may interact with Glucosalino Hiposódico Braun. In such cases, it may be necessary to change the dose or discontinue treatment with one or more of the medicines.

It is important that you inform your doctor if you are taking any of the following medicines:

• Insulin or oral antidiabetic agents (biguanides, sulfonylureas), as these medicines reduce the effect of glucose.
• Corticosteroids, due to the risk of increased blood glucose levels or because these medicines may cause sodium and water retention.
• Digitalis glycosides (digoxin), as increased digitalis activity may occur, increasing the risk of toxicity.
• Lithium carbonate, as administration of sodium chloride accelerates renal excretion of lithium, leading to reduced therapeutic effect.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

The administration of Glucosalino Hiposódico Braun during pregnancy or breastfeeding should be carried out in accordance with the instructions detailed in this leaflet.

3. How to use Glucosalino Hiposódico 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 patients or those in intensive care, carbohydrate intake should be reduced, but fluid administration should be increased to the maximum daily dose.

Your doctor will determine the dose and frequency at which the solution will be administered, based on your age, weight, and clinical condition.

Follow exactly the administration instructions for Glucosalino Hiposódico Braun as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

If you use more Glucosalino Hiposódico Braun than you should

It is unlikely that this will occur, as your doctor will determine your daily doses. However, if you were to receive more Glucosalino Hiposódico Braun than recommended, this could cause you:

• excessive hydration
• an imbalance in electrolyte levels (electrically charged substances in the blood and other body fluids, such as: sodium, calcium, chlorides) and acid-base balance (loss of equilibrium in the levels of acidic and basic substances in the body, which must remain constant)
• an increase in blood sugar concentration.

If this occurs, treatment must be immediately discontinued and, depending on the severity, the following may be administered:

• medications that increase the elimination of water and salts (diuretics),
• electrolytes (such as sodium, calcium, chlorides…), or
• insulin.

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone (91) 562 04 20, indicating the medication and the amount used.

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

4. Possible adverse effects

Like all medicines, Glucosalino Hypotonic Braun may cause adverse effects, although not everyone experiences them.

Adverse reactions related to 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 also be associated with medications added to the solution; the nature of the added medications will determine the possibility of any additional undesirable effects.

If adverse reactions occur, administration should be discontinued.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Glucosalino Hiposódico Braun.

Keep out of the reach and sight of children.

No special storage conditions are required.

Do not use Glucosalino Hiposódico Braun after the expiry date stated on the packaging. The expiry date is the last day of the month indicated.

Do not use Glucosalino Hiposódico Braun if the solution is not clear, if you observe particles at the bottom, or if the container shows any visible signs of damage.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Additional information

Composition of Glucosalino Hypotonic Braun:

The other components are: water for injections.

Appearance of the medicinal product and contents of the container

Glucosaline Hypotonic Braun is a clear, colourless infusion solution supplied in plastic bottles (Ecoflac Plus®) of 100 ml and 500 ml (not all sizes may be marketed).

Marketing Authorization Holder and Manufacturing Responsible

B|BRAUN

• Braun Medical, S.A.

Ctra. de Terrassa, 121

08191-Rubí (Barcelona)

Spain

This summary of product characteristics was approved in December 2024

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (Agencia Española de Medicamentos y Productos Sanitarios).

This information is intended for healthcare professionals only:

The recommended infusion rate is approximately 5 mL per kg of body weight per hour, equivalent to 1.7 drops per kg of body weight per minute.

Single-use containers. Discard any unused residual contents after completion of infusion.

The solution should only be used if the container closure is undamaged and the solution is clear.

Use a sterile administration set for administration.

Before mixing this solution with other medicinal products, possible incompatibilities must be considered.

Glucosalino Hiposódico Braun must not be administered through the same infusion system, either simultaneously, before, or after a blood transfusion, due to potential incompatibilities.

In addition, incompatibility has been reported when certain medicinal products are diluted in glucose-containing solutions, including: sodium ampicillin, amrinone lactate, sodium amoxicillin/clavulanic acid, interferon alfa-2b, procainamide hydrochloride. However, amrinone lactate or sodium amoxicillin/clavulanic acid may be directly injected into the injection site while these infusion solutions are being administered.

Incompatibility has also been reported when certain medicinal products are diluted in solutions containing chloride, including amsacrine and trimetrexate glucuronate.

Disposal of unused medicinal product and all materials that have come into contact with it must be carried out in accordance with local regulations.