PATIENT INFORMATION LEAFLET

Glucosalina Mein Infusion Solution

Glucose and Sodium Chloride

Glucosalina Mein is a solution for intravenous infusion that is presented in 250 ml, 500 ml, and 1000 ml bottles.

This medication belongs to the group of intravenous solutions that affect the electrolyte balance with carbohydrate hydrates.

Glucosalina Mein is indicated for:

-States of dehydration with moderate losses of electrolytes.

- Metabolic alterations of hydrocarbonate metabolism.

-As a vehicle for the administration of medications and electrolytes.

No use Glucosalina Mein

-If you are allergic (hypersensitive) to the active ingredient or any of the other components of Glucosalina Mein.

-In states of hyperhydration (excess fluid overload).

-In situations of generalized edema (accumulation of fluid in body tissues) or ascitic cirrhosis (chronic progressive liver disease with fluid accumulation).

-In states of hyperglycemia (elevated blood glucose levels).

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

-In states of hypochloremia (low chloride levels in blood).

-In states of hyperosmolar coma (loss of consciousness due to increased concentration of salts in blood).

-In states of hyperlactacidemia (presence of lactic acid in blood).

-In severe cases of heart, liver, or renal insufficiency.

-During the first 24 hours after a head trauma

Advertencias y precauciones

Tenga especial cuidado con Glucosalina Mein

-It is recommended that regular blood glucose, electrolyte, water balance, and acid-base equilibrium tests be performed, as frequent and massive administration of glucosaline solutions can cause fluid overload (hyperhydration), acid-base balance alterations, and significant ionic depletions. In these cases, you will need to administer electrolyte supplements.

-Administer this medication 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), cardiac, hepatic, and/or renal alterations, or if you are an elderly patient

-Glucosalina Mein will be administered with caution to premature and full-term infants.

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

-If you have had an acute ischemic stroke (sudden onset of blood flow deficiency), do not administer this medication

-If you are administered this medication for an extended 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.

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

• Avoid continuous administration in the same injection site due to the risk of thrombophlebitis.

• If you have critical states, pain, postoperative stress, infections, burns, or central nervous system diseases

• You have any type of heart, liver, and kidney disease and are being treated with a medication that increases the effect of vasopressin (a hormone that regulates water retention in the body) because it may increase the risk of developing low sodium levels in the blood (hyponatremia) in the hospital. (see the section Other medications and Glucosalina Mein)

All patients must be closely monitored. In cases where normal regulation of blood water content is altered due to increased secretion of vasopressin, also known as Antidiuretic Hormone (ADH), infusion of fluids with low sodium chloride concentration (hypotonic fluids) may result in low sodium levels in the blood (hyponatremia). This can cause headache, nausea, seizures, lethargy, coma, cerebral edema, and death; therefore, these symptoms (acute symptomatic hyponatremic encephalopathy) are considered a medical emergency. (See section 4. Possible side effects)

Children, fertile women, and patients with brain diseases such as meningitis, cerebral hemorrhage, cerebral contusion, and cerebral edema have a special risk of suffering from severe and potentially fatal brain inflammation caused by acute hyponatremia.

Other medications and Glucosalina Mein

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

Certain medications may interact with Glucosalina Mein. In this case, it may be necessary to change the dose or interrupt the treatment of one of the medications.

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

-Insulin or oral antidiabetic medications (biguanides, sulfonylureas), which decrease the effect of glucose.

-Corticosteroids due to the risk of increased blood glucose or the ability of these medications to retain sodium and water.

-Digitoxin glucosides (digoxin), which may cause increased digital activity, with the risk of developing intoxications.

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

-Medications that increase the effect of vasopressin (see the section Advertencias y precauciones), for example:

• Medications that stimulate the release of vasopressin (e.g., antipsychotics, narcotics)
• Medications that potentiate the action of vasopressin (e.g., nonsteroidal anti-inflammatory drugs)

• Medications that act like vasopressin, called vasopressin analogs

• Other medications that increase the risk of hyponatremia, including diuretics in general and antiepileptic medications such as oxcarbazepine.

Pregnancy and lactation

Consult your doctor or pharmacist before using any medication.

This medication should be administered with special caution in pregnant women during delivery, especially if it is administered in combination with oxytocin (a hormone that can be administered to induce labor and control bleeding) due to the risk of hyponatremia.

In the case of pregnancy, your doctor will decide whether to use a glucosaline solution, as it should be used with caution in this case.

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 Glucosalina Mein may cause adverse effects during the lactation period in the neonate. However, it is recommended to use with caution during this period.

Driving and operating machines

There is no indication that Glucosalina Mein may affect the ability to drive or operate machines.

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

Your doctor will monitor your fluid balance and plasma glucose and electrolyte concentrations (especially sodium) during administration.

Your doctor will decide the dose and frequency at which the solution will be administered, which will depend on your age, 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:

-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 weight above 10 kg

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

If you use more Glucosalina Mein than you should

If the administration of the glucose solution is not performed correctly and under control, some of the following signs of overdose may appear: hyperhydration, electrolyte imbalances, and acid-base balance disturbances.

In case these requirements are not met and symptoms of intoxication appear, administration will be suspended and symptomatic treatment will be sought.

In case of overdose or accidental ingestion, consult the Toxicological Information Service. Phone: 91 562 04 20.

Like all medications, Glucosalina Mein may produce adverse effects, although not all people 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 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, discontinue perfusion.

Headache, nausea, convulsions, lethargy. This may be caused by low sodium levels in the blood. When sodium levels in the blood drop significantly, water enters the brain cells and causes inflammation. This results in increased intracranial pressure and causes hyponatremic encephalopathy.

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 prospectus, inform your doctor or pharmacist.

No special conservation conditions are required.

Keep out of the reach and sight of children.

Do not use Glucosalina Mein after the expiration date that appears on the packaging.

Do not use Glucosalina Mein if the solution is not transparent and contains precipitates.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medicines that you do not need. In this way, you will help protect the environment.

Glucosamine Mein Composition

The active principles are glucose and sodium chloride. Each 100 ml of solution contains 3.5 g of glucose (as monohydrate) and 0.35 g of sodium chloride.

The other components are: water for injections

Osmolarity (theoretical): 313 mOsm/l

pH: 3.2 – 6.5

Cl- (theoretical): 60 mmol/l

Na++(theoretical): 60 mmol/l

Calories (theoretical): 140 kcal/l

Product Appearance and Packaging Contents

Glucosalina Mein is a clear, transparent, and colorless solution. It is presented in 250 ml, 500 ml, and 1000 ml bottles.

Marketing Authorization Holder

Fresenius Kabi España S.A.

C/ Marina 16-18

08005-Barcelona (Spain)

Manufacturer Responsible

Fresenius Kabi Italia S.R.L.

Via Camagre, 41/43

37063 Isola della Scala (VR) (Italy)

This leaflet was revised in

August 2018

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This information is intended solely for medical professionals or healthcare professionals:

Glucosalina Mein is presented as a solution for intravenous administration and will be used in a hospital by the corresponding healthcare staff.

Glucosalina Mein will be administered by infusion.

The contents of each Glucosalina Mein container are for a single infusion.

Once the container is opened, the solution must be administered immediately. Discard any unused portion.

The solution must be transparent and not contain precipitates. Do not administer otherwise.

Administration Rate:

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

In pediatric patients, the infusion 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 infusion 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 infants and children depending on age and total body mass.

To administer the solution and in case of adding medications, maximum asepsis should be maintained.

In order to be able to add medications to the solution or to administer them simultaneously with other medications, it must be checked that there are no incompatibilities.

It has been described that the glucosaline solution with a glucose content of 3.5% and sodium chloride of 0.35% is incompatible with mitomycin due to the low pH of this solution.

Similarly, incompatibility samples have been observed for different isotonic glucosaline solutions with: amoxicillin sodium, heparin sodium, imipenem-cilastatin sodium, and meropenem. However, these medications may be compatible with this type of solution depending on various factors such as the concentration of the medication (heparin sodium) or the time elapsed between dissolution and administration (amoxicillin sodium, imipenem-cilastatin sodium, and meropenem).

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

Also, incompatibility samples have been described when some medications are diluted in solutions containing chloride, including: amsacrine and trimetrexate glucuronate.

General Advice

It may be necessary to monitor fluid balance, serum glucose, serum sodium, and other electrolytes before and during administration, especially in patients with increased non-osmotic vasopressin release (SIADH syndrome) and in patients receiving concomitant medication with vasopressin agonists due to the risk of hyponatremia.

Serum sodium monitoring is especially important in products with a lower sodium concentration compared to serum sodium concentration. After Glucosalina Mein infusion, a rapid and active glucose transport to the body's cells occurs. This condition promotes an effect that can be considered as a free water supply and may lead to severe hyponatremia.