GLUCOSALINO ISOTONIC BRAUN

2. Before using Glucosalino Isotónico B. Braun

Do not use Glucosalino Isotónico B. Braun:

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

• In states of fluid overload (hyperhydration).
• In situations of fluid accumulation in the body's tissues (generalized edema) or chronic progressive liver disease with fluid accumulation (ascitic cirrhosis).
• In states of increased blood glucose levels (hyperglycemia).
• In states of decreased potassium levels in the blood (hypokalemia).
• In states of decreased sodium levels in the blood (hyponatremia).
• In states of decreased chloride levels in the blood (hypochloremia).
• In states of loss of consciousness due to an increase in blood salt concentration (hyperosmolar coma).
• In states of presence of lactic acid in the blood (hyperlactatemia).
• In severe cases of heart, liver, or kidney failure.
• During the first 24 hours after a head injury.

Be careful with Glucosalino Isotónico B. Braun:

You will be administered this medicine 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), heart, liver, or kidney disorders, 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 onset of lack of blood flow), this medicine should not be administered to you.

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

The administration of glucose-containing solutions may cause vitamin B1 deficiency, especially in cases of malnutrition.

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.

Glucosalino Isotónico B. 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 other medicines, including those purchased without a prescription.

Certain medicines may interact with Glucosalino Isotónico B. 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 use any of the following medicines:

• Systemic corticosteroids with glucocorticoid activity (cortisol), diuretics, diphenylhydantoin, chlorpromazine increase blood glucose levels. Regarding corticosteroids with mineralocorticoid action, they should be administered with caution due to their ability to retain water and sodium.
• Insulin or oral antidiabetics (biguanides, sulfonylureas) may lead to a reduction in the therapeutic efficacy of the latter.
• Digitalis glycosides (digoxin) may cause an increase in digitalis activity, with the risk of developing intoxication with these medicines.

• Lithium carbonate, since the administration of sodium chloride accelerates the renal excretion of lithium, leading to a decrease in the therapeutic effect of the latter.

Your doctor will check the compatibility of this solution with any additive before using it. These solutions should not be administered with the same infusion equipment used or to be used for blood administration, as there is a possibility of agglutination.

Pregnancy and lactation

Consult your doctor or pharmacist before using any medicine.

In case of pregnancy, your doctor will decide whether to use glucose solution, as it should be used with caution.

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

There is no evidence to suggest that Glucosalino Isotónico B. Braun may cause adverse effects during the lactation period in the neonate. However, it is recommended to use with caution during this period.

3. How to use Glucosalino Isotónico B. Braun

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

Your doctor will decide the dose and frequency at which the solution will be administered to you, depending on your age, weight, clinical situation (particularly the state of hydration), 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 babies and children:

• From 0 to 10 kg of body weight: 100 ml/kg/24 h
• From 10 to 20 kg of body weight: 1000 ml + 50 ml/kg/24 h for weight above 10 kg
• > 20 kg of 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

It is unlikely that this will happen since your doctor will determine your daily doses. However, if you receive more medicine than you should, this may 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 constant),
• an increase in blood sugar concentration.

If this happens, treatment should be stopped immediately and, depending on the severity, the following may 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 the Toxicology Information Service (telephone: 91.562 04 20) or consult your doctor or pharmacist. Bring this leaflet with you.

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

4. Possible adverse effects

Like all medicines, Glucosalino Isotónico B. Braun can cause adverse 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. To avoid the risk of thrombophlebitis (inflammation of a vein due to a blood clot), it is recommended to vary the injection site (every 24-48 hours).

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

In case of adverse reactions, the perfusion should be stopped.

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 mentioned in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Glucosalino Isotónico B. Braun

Keep out of the reach and sight of children.

No special storage conditions are required.

Do not use Glucosalino Isotónico B. Braun after the expiration date stated on the packaging. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medicines in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Additional information

Composition of Glucosalino Isotónico B. Braun:

The other components are: water for injectable preparations.

Appearance of the product and packaging content

Glucosalino Isotónico B. Braun is a solution for perfusion presented in plastic vials (Ecoflac Plus® of 250 ml, 500 ml, and 1000 ml. Not all sizes may be marketed).

Marketing authorization holder and manufacturer

• 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.http://www.aemps.gob.es/

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This information is intended only for healthcare professionals:

Administration rate:

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

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

The perfusion rate should not exceed the patient's glucose oxidation capacity to avoid hyperglycemia. Therefore, the maximum dose ranges from 5 mg/kg/min for adults to 10-18 mg/kg/min for babies and children, depending on age and total body weight.

The content of each vial is for single perfusion. The unused fraction should be discarded.

The perfusion solution should be visually inspected before use. The solution should be transparent, not contain precipitates, and the vial should be intact. Do not administer otherwise.

An aseptic procedure should be used to administer the solution and add medications if necessary.

Before adding medications to the solution or administering them simultaneously with other medications, it should be checked that there are no incompatibilities.

These solutions should not be administered through the same infusion equipment used, or to be used, for blood administration, as there is a possibility of pseudoagglutination.

It has been described that a glucose solution with a glucose content of 3.6% and sodium chloride of 0.3% is incompatible with mitomycin, due to the low pH of this solution.

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

Additionally, samples of incompatibility have been described when some medications 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.