Glucose isotonic Braun

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Glucosalino Isotonic B. Braun

Glucose 3.6% 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 questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you, and you should not give it to other people, even if they have the same symptoms, as it may harm them.
• If you consider any of the side effects you experience to be severe, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Leaflet contents:

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

1. What Glucosalino Isotonic B. Braun is and what it is used for

Glucosalino Isotonic B. Braun is an infusion solution used for the prevention of water deficit with minimal salt loss (hypertonic or isotonic dehydration) or as a vehicle solution for administering medications or electrolytes, along with a slight energy supply.

2. Before using Glucosalino Isotónico B. Braun

Do not use Glucosalino Isotónico B. Braun:

• if you are allergic to the active substances or to any of the other components of Glucosalino Isotónico B. Braun.

• In states of fluid overload (hyperhydration).

• In conditions involving accumulation of fluid 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 low potassium levels in blood (hypokalemia).

• In states of low sodium levels in blood (hyponatremia).

• In states of low 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 in blood (hyperlactacidemia).

• In severe heart, liver, or kidney failure.

• During the first 24 hours after head trauma.

Take special care with Glucosalino Isotónico B. Braun:

This medicine will be administered to you with caution if you suffer from the following conditions: hypertension, cardiac 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 should 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 vitamin B1 deficiency, especially in cases of malnutrition.

An adequate supply of vitamins (particularly vitamin B1) must be ensured.

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

Glucosalino Isotónico B. 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 must be monitored regularly.

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

Prolonged 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, have recently taken, or might take any other medicines, including those obtained without a prescription.

Certain medicines may interact with Glucosalino Isotónico B. Braun. In such cases, it may be necessary to adjust the dose or discontinue treatment with one of the medicines.

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

• Systemic corticosteroids with glucocorticoid activity (cortisol), diuretics, phenytoin, chlorpromazine may increase blood glucose levels. As for corticosteroids with mineralocorticoid activity, they should be administered with caution due to their capacity to retain water and sodium.

• Insulin or oral antidiabetics (biguanides, sulfonylureas) may result in reduced therapeutic efficacy of the latter.

• Digitalis glycosides (digoxin): increased digitalis activity may occur, with a risk of developing toxicity from these medicines.

• Lithium carbonate: administration of sodium chloride accelerates renal excretion of lithium, leading to reduced therapeutic effect of the latter.

Your doctor will check the compatibility of this solution with any additive before use. These solutions must not be administered using the same infusion sets used or intended for blood administration, due to the possibility of agglutination.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

During pregnancy, your doctor will decide whether the use of glucosaline solution is appropriate, as it should be used with caution.

Excessive administration of glucose-containing solutions during pregnancy may cause fetal hyperglycemia, hyperinsulinemia, and acidosis, and thus may be harmful to the newborn.

There is no evidence suggesting that Glucosalino Isotónico B. Braun may cause adverse effects during breastfeeding in the neonate. Nevertheless, caution is recommended during this period.

3. How to use Glucosalino Isotónico B. Braun

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

Your doctor will determine the dose and frequency with which the solution will be administered, based on your age, body weight, clinical condition (particularly hydration status), and the nature of any medication that may have been added to the solution.

The recommended dosage is:

For adults, elderly, and adolescents: 500 ml to 3000 ml every 24 hours.

For infants and children:

• Body weight 0 to 10 kg: 100 ml/kg/24 h
• Body weight 10 to 20 kg: 1000 ml + 50 ml/kg/24 h for weight above 10 kg

• 20 kg body weight: 1500 ml + 20 ml/kg/24 h for weight above 20 kg

If you use more Glucosalino Isotónico B. Braun than you should

This is unlikely to occur, as your doctor will determine your daily doses. However, if you receive more medication than prescribed, it may cause:

• excessive hydration,
• imbalance of electrolyte levels (electrically charged substances in 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),
• increased blood sugar concentration.

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

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

In case of overdose or accidental ingestion, contact the Toxicology Information Service (telephone: 91.562 04 20) or consult your doctor or pharmacist. Bring this leaflet with you.

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 Isotonic B. Braun may produce adverse effects, although not everyone will experience 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. To minimize the risk of thrombophlebitis (inflammation of a vein due to a blood clot), it is recommended to rotate the catheter insertion site (every 24–48 hours).

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 any adverse reactions occur, the infusion 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 via 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 Isotonic B. Braun

Keep out of the reach and sight of children.

No special storage conditions are required.

Do not use Glucosalino Isotonic B. Braun after the expiry date stated on the packaging. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.

6. Additional Information

Composition of Glucosalino Isotonic B. Braun:

The other components are: water for injections.

Appearance of the medicinal product and contents of the container

Glucosalino Isotonic B. Braun is an infusion solution available in plastic bottles (Ecoflac Plus® of 250 ml, 500 ml and 1000 ml. (not all sizes may be marketed).

Marketing Authorization Holder and Manufacturing Responsible Party

• Braun Medical, S.A.

Ctra. de Terrassa, 121

08191-Rubí (Barcelona)

Spain

This summary 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: http://www.aemps.gob.es/

This information is intended exclusively for physicians or healthcare professionals:

Rate of administration:

The usual infusion rate is normally 40 ml/kg/24 h in adults, elderly patients, and adolescents.

In pediatric patients, the infusion rate is on average 5 ml/kg/h, but this value varies with age: 6–8 ml/kg/h for children under 12 months, 4–6 ml/kg/h for children aged 12–23 months, and 2–4 ml/kg/h for school-aged children (2–11 years).

The infusion rate should not exceed the patient's glucose oxidation capacity in order to avoid hyperglycemia. Therefore, the maximum dose ranges from 5 mg/kg/min in adults to 10–18 mg/kg/min in infants and children, depending on age and total body mass.

The contents of each container are intended for single infusion use only. Any unused portion must be discarded.

The infusion solution should be visually inspected prior to use. The solution must be clear, free of precipitates, and the container must be intact. Do not administer if these conditions are not met.

An aseptic technique must be used when administering the solution and when adding medications, if necessary.

Before adding medications to the solution or administering concomitantly with other drugs, compatibility must be verified.

These solutions must not be administered through the same infusion equipment currently being used, previously used, or intended to be used for blood administration, due to the risk of pseudoagglutination.

A glucose-saline solution containing 3.6% glucose and 0.3% sodium chloride has been reported to be incompatible with mitomycin due to the low pH of this solution.

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

Incompatibilities have also been reported when certain drugs are diluted in chloride-containing solutions, 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.