Label:Information for the User

Apiroserum Glucosalino 1/5 Solution for Infusion

Glucose - Sodium Chloride

Read this label carefully before starting to use this medication,because it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult yourdoctor or nurse.
• This medication has been prescribedonlyto you and should not be given to others, even ifthey presentthe same symptomsof the disease,as it may harm them.
• If you experience any adverse effects,consult your doctor or nurse,evenifthey are not listed in this label. See section 4.

1.What is Apiroserum Glucosalino 1/5 and how is it used

2.What you need to knowbeforestarting touse Apiroserum Glucosalino 1/5

3.How to use Apiroserum Glucosalino 1/5

4.Possible adverse effects

5Storage of Apiroserum Glucosalino 1/5

6.Contents of the package and additional information

Apiroserum Glucosalino 1/5 is a rehydrating solution thatbelongs to the group of intravenous solutions that affect the electrolyte balance.

Apiroserum Glucosalino 1/5is indicated for:

• Hyper or isotonic dehydration
• Mild alkalosis
• Vehicle solution for compatible electrolyte and medication concentrates
• Partial coverage of energy needs

No use Apiroserum Glucosalino 1/5

- If you are allergic to the active ingredients or any of the other components of this medication (listed in section 6).

- In cases of hyperhydration (excess of liquids in the body).

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

- In states of hyperglycemia (high levels of glucose in the blood).

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

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

- In states of hypokalemia (low levels of potassium in the blood).

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

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

- In severe cases of heart, liver, or kidney failure (failure of the heart, liver, or kidneys respectively).

- During the first 24 hours after a head trauma.

Advertencias y precauciones

Consult your doctor or nurse before starting to use Apiroserum Glucosalino 1/5.

Apiroserum Glucosalino 1/5 should be injected totally or partially once connected to the vial the injector equipment, to avoid possible contaminations.

In the case of mixing with other products, it should be stored with maximum asepsis during the addition of these medications to the intravenous liquids, and use these mixtures within 6 hours from their preparation.

- It is recommended that regular blood analyses be performed for glucose, electrolytes, water balance, and acid-base balance, as frequent and massive administration of glucosaline solutions can cause fluid overload (hyperhydration), acid-base balance alterations, and significant ionic depletions, including hypomagnesemia (low levels of magnesium in the blood), hypokalemia (low levels of potassium in the blood), and hypophosphatemia (low levels of phosphates in the blood). In these cases, you will need to administer electrolyte supplements. For this reason, it is recommended that regular glucose, serum electrolyte, water balance, and acid-base balance controls be performed. To avoid hypokalemia produced during prolonged infusions with glucosaline solutions, it is recommended to add potassium to the solution as a safety measure.

- The concentration of glucose in the blood should be closely monitored during episodes of intracranial hypertension.

- You should be administered 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, and if your heart, liver, and/or kidneys do not function correctly, especially if you are elderly.

- Apiroserum Glucosalino 1/5 should be administered with caution to premature and full-term infants.

- If you have had an acute ischemic attack (decrease or absence of blood supply), you should not be administered this medication.

- 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, such as this one, can cause vitamin B1 deficiency, especially in cases of malnutrition.

- If you have diabetes mellitus, glucose-containing solutions can be used as long as you have been initially established with the appropriate treatment (insulin). In addition, 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 developing thrombophlebitis.

Interaction of Apiroserum Glucosalino 1/5 with other medications

Inform your doctor that you are using, have used recently, or may need to use any other medication.

If Apiroserum Glucosalino 1/5 is mixed with other substances, other incompatibilities may appear.

It is essential to inform your doctor if you are using 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 glucose in the blood or the ability of these medications to retain sodium and water.

- Digitalis glycosides (digoxin), which can cause an increase in digital activity, with the risk of developing intoxications.

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

Pregnancy, lactation, and fertility

Consult your doctor before using this medication if you are pregnant or breastfeeding, or if you think you may be pregnant or plan to become pregnant.

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.

The excessive administration of glucose-containing solutions during pregnancy can cause hyperglycemia, hyperinsulinemia (high levels of insulin in the blood), and acidosis in the fetus, and can therefore be harmful to the newborn.

There is no evidence to suggest that Apiroserum Glucosalino 1/5 can cause adverse effects during the lactation period in the neonate. However, it is recommended to use with caution during this period.

Driving and operating machinery

There is no indication of this medication on the ability to drive and operate machinery.

Follow exactly the administration instructions for this medication as indicated by your doctor.This medication should be used exactly as prescribed by your doctor.Consult your doctor again if you are unsure.

Apiroserum Glucosalino 1/5 is presented as a solution that is administered by infusion (intravenous drip).

Your doctor will monitor the balance of fluids and plasma concentrations of glucose and electrolytes (especially sodium) during administration.

Your doctor will decide the dose and frequency at which the solution is administered, adjusting the mean infusion rate to the clinical needs of the patient based on age, weight, clinical condition, glucose levels, and fluid, electrolyte, and acid-base balance.

The recommended dose for adults is between 500 ml and 3 liters per 24 hours, and Apiroserum Glucosalino 1/5 will be administered at an approximate rate of 30 to 60 drops per minute (1.5 to 3 ml/min). The maximum infusion rate is 5 ml/kg body weight/hour = 0.24 g of glucose/kg body weight/hour.

Use in 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

In children, the infusion rate depends on the child's age and weight, and should not exceed: 10-18 mg of glucose (0.2-0.38 ml of solution)/kg/min.

If you use more Apiroserum Glucosalino 1/5 than you should

If the administration of the glucosaline 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.The administration will be suspended and symptomatic treatment will be sought.

If any symptoms derived from adverse effects appear due to not meeting these requirements, the administration will be suspended and symptomatic treatment will be sought.

In case of overdose or accidental ingestion, consult the Toxicological Information Service. Phone: 915 620 420.

If you have any other questions about the use of this medication, ask your doctor or nurse.

Like all medications,ApiroserumGlucosalino 1/5 may produce adverse effects, although not everyone will experience them.

Excessive administration of Apiroserum Glucosalino 1/5 may cause dehydration.

Provided the solution is administered correctly and under control, the only possible complications are those derived from the intravenous administration technique, which include fever, infection at the injection site, pain, reaction, and/or irritation at the injection site, venous thrombosis or phlebitis extending from the injection site, extravasation, and hypervolemia.

The frequencies of the possible adverse effects described are not established, as there are no clinical studies conducted with Apiroserum Glucosalino 1/5.

When used as a vehicle for administering other medications, the nature of the added medications will determine the probability of other adverse effects.

Discontinue infusion in case of adverse reactions.

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.

Store at a temperature below 25°C.

Keepthis medicationout of sight andout of reach of children.

Do not usethis medicationafter the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

Do not useApiroserumGlucosaline 1/5if the solution is not transparent and contains precipitates.

Medications should not be disposed of through drains or in the trash. Dispose of the containers and medications you no longer need at the SIGREcollection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Apiroserum Glucosalino 1/5

The active principles are glucose and sodium chloride. Each milliliter of solution contains 47 mg of anhydrous glucose (equivalent to 51.7 mg of monohydrate glucose) and 1.8 mg of sodium chloride

The other components (excipients) are: water for injectable preparations, c.s.

Miliequivalents/liter:

Chloride ion 30.8 mEq; Sodium ion 30.8 mEq

Calories: 188 kcal/liter

Osmolarity: 320 mOsmol/liter

Appearance of the product and contents of the package

Apiroserum Glucosalino 1/5 is a clear, transparent, and colorless solution. It is presented in:

Bottles with 250 and 500 ml.

Clinical packaging with 12 bottles of 250 and 500 ml.

Holder of the marketing authorization

Fresenius Kabi España, S.A.U.

Torre Mapfre – Vila Olímpica

C/ Marina 16-18, 08005-Barcelona

Responsible for manufacturing

Fresenius Kabi Italia S.r.l.

Via Camagre, 41/43

37063 Isolla della Scala - Verona

Italy

Last review date of this leaflet February 2022

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

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This information is intended solely for doctors or healthcare professionals:

Apiroserum Glucosalino 1/5 is presented in the form of a solution for intravenous administration and will be used in a hospital by the corresponding healthcare staff.

Apiroserum Glucosalino 1/5 will be administered by infusion.

The contents of each package of Apiroserum Glucosalino 1/5 are for a single infusion.

Once the package is opened, the solution must be administered immediately. The unused portion must be discarded.

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

Administration rate:

In adults, Apiroserum Glucosalino 1/5 will be administered at an approximate rate of 30 to 60 drops per minute (1.5 to 3 ml/min). The maximum infusion rate is 5 ml/kg body weight/hour = 0.24 g of glucose/kg body weight/hour.

In children, the preferred veins are the epicranial, or those on the back of the hand or foot, and the recommended doses are as follows:

Newborns 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.

In children, the infusion rate depends on the age and weight of the child, and generally should not exceed: 10-18 mg of glucose (0.2-0.38 ml of solution)/kg/min.

The infusion rate should not exceed the patient's glucose oxidation capacity in order to avoid hyperglycemia.

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 simultaneously with other medications, it must be checked that there are no incompatibilities.

Do not administer Apiroserum Glucosalino 1/5 with the same infusion equipment, nor at the same time, nor before or after a blood transfusion, as incompatibilities may occur.

Furthermore, incompatibility samples have been observed for different isotonic glucose 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 has been described when some medications are diluted in solutions containing glucose, including: ampicillin sodium, amrinone lactate, amoxicillin sodium/clavulanate acid, interferon alfa-2b, and procainamide chloride. However, amrinone lactate or amoxicillin sodium/clavulanate acid may be injected directly into the injection site while these infusion solutions are being administered.

Also, incompatibility has been described when some medications are diluted in solutions containing chloride. Among them, amsacrine and trimetrex glucuronate