Label:information for theuser

Glucosalino Isotónico B. Braun

Glucose 3.6% and Sodium Chloride 0.3%. Solution for infusion

Read the entire label carefully before starting to use the medication

• Keep this label as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed for you. Do not give it to others, even if they have the same symptoms, as it may harm them.
• If you consider any of the adverse effects you are experiencing to be severe or if you notice any adverse effect not mentioned in this label, inform your doctor or pharmacist.

Glucosalino Isotónico B. Braun is a perfusion solution used in the prevention of water deficit with low salt loss (hypertonic or isotonic dehydration) or as a supportive solution to administer medications or electrolytes, along with a mild energy supply.

Do not use Glucosalino Isotónico B. Braun:

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

• In states of fluid overload (hyperhydration).
• In situations of fluid accumulation in the body 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 in the blood (hypokalemia).
• In states of decreased sodium in the blood (hyponatremia).
• In states of decreased chloride in the blood (hypochloremia).
• In states of loss of consciousness due to an increase in blood osmolality (hypersomal coma).
• In states of presence of lactic acid in the blood (hyperlactacidemia).
• In severe cases of heart, liver, or kidney insufficiency.
• During the first 24 hours after a head trauma.

Be especially careful with Glucosalino Isotónico B. Braun:

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

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

Do not administer this medication if you have had an acute ischemic attack (sudden onset of blood flow deficiency).

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

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

Adequate vitamin intake (particularly vitamin B1) must be ensured.

If you have diabetes mellitus, solutions containing glucose may be used as long as initial appropriate treatment (insulin) has been established. These solutions should also be used with caution if you have Addison's disease or carbohydrate intolerance.

Do not administer Glucosalino Isotónico B. Braun with the same infusion equipment, at the same time, or before or after blood transfusion, as incompatibilities may occur.

Your blood glucose, electrolytes (especially potassium), and water balance should be regularly monitored.

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

Administration in the same injection site should be avoided due to the risk of thrombophlebitis.

Use of other medications

Inform your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription.

Certain medications may interact with Glucosalino Isotónico B. Braun. In this case, the dose of one or more medications may need to be changed or discontinued.

It is essential to inform your doctor if you are using any of the following medications:

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

- Insulin or oral antidiabetic agents (biguanides, sulfonylureas) may lead to a reduction in the therapeutic efficacy of these medications.

- Digitalis glycosides (digoxin), an increased digitalis activity may occur, with the risk of developing digitalis toxicity.

- Lithium carbonate, as the administration of sodium chloride accelerates renal excretion of lithium, leading to a decrease in the therapeutic effect of this medication.

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

Pregnancy and lactation

Consult your doctor or pharmacist before using any medication.

In case of pregnancy, your doctor will decide whether to use a 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.

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 decide the dose and frequency at which the solution will be administered to you, which will depend on your age, weight, patient clinical condition (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:

- 0 to 10 kg body weight: 100 ml/kg/24 h

- 10 to 20 kg body weight: 1000 ml + 50 ml/kg/24 h for the weight above 10 kg

- > 20 kg body weight: 1500 ml + 20 ml/kg/24 h for the weight above 20 kg

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

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

• excessive hydration,
• an imbalance of electrolyte levels (substances with electric charge in the blood and other bodily 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 always remain constant),
• an increase in blood sugar concentration.

If this happens, treatment should be stopped immediately and depending on the severity, administer:

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

In case of overdose or accidental ingestion, consult the Toxicological Information Service (phone: 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.

Like all medications, Glucosalino Isotónico B. Braun may produce 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 extended phlebitis from the injection site, extravasation, and hypervolemia. To avoid the risk of thrombophlebitis (inflammation of a vein by a blood clot), it is recommended to vary the catheter insertion site (every 24-48 hours).

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

In case of adverse reactions, infusion should be interrupted.

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep out of the reach and sight of children.

No special storage conditions are required.

Do not use Glucosaline Isotonic B. Braun after the expiration date appearing on the packaging. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medicines at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Composition of Glucosalino Isotónico B. Braun:

The other components are: water for injectable preparations.

Appearance of the product and contents of the package

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

Holder of the marketing authorization and responsible for manufacturing

B. Braun Medical, S.A.

Ctra. de Terrassa, 121

08191-Rubí (Barcelona)

Spain

This prospectus was approved in December 2024

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices.http://www.aemps.gob.es/

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This information is intended solely for doctors or healthcare professionals:

Administration rate:

The perfusion rate is normally 40 ml/kg/24 h in adults, the 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 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 in order to avoid hyperglycemia. Therefore, the maximum dose ranges from 5 mg/kg/min for adults to 10-18 mg/kg/min for infants and children depending on age and total body mass.

The contents of each package are for a single perfusion. The unused portion should be discarded.

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

Use an aseptic procedure to administer the solution and add medications if necessary.

Before adding medications to the solution or administering simultaneously with other medications, check for incompatibilities.

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

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

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

Similarly, incompatibility samples have been described when some medications are diluted in solutions containing chloride. Among them, amsacrina and trimetrexate glucuronate.

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