PROSPECTO: INFORMATION FOR THE USER

KabiPac Glucosaline Solution for Infusion

Glucose and Sodium Chloride

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

-Keep this prospect as you may need to read it again.

-If you have any questions, consult your doctor or nurse.

-If you experience any adverse effects, consult your doctor or nurse, even if theyare not listed in this prospect. See section 4.

KabiPacGlucosalino is a solution for intravenous infusion that is presented in 100 ml, 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.

KabiPac Glucosalino is indicated for:

-States of dehydration with moderate losses of electrolytes.

-Alterations of the hydrocarbonate metabolism.

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

No use KabiPac Glucosalino

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

-In states of hyperhydration (overload of fluid).

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

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

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

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

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

-During the first 24 hours after a head trauma.

Warnings and precautions

-Regular blood glucose, electrolyte, fluid balance, and acid-base balance tests should 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, electrolyte supplements will be necessary.

-This medication should 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), cardiac, hepatic, and/or renal alterations, or if you are an elderly patient.

-KabiPac Glucosalino should be administered with caution to premature and full-term infants.

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

-If you have had an acute ischemic stroke, this medication should not be administered.

-If you receive 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, solutions containing glucose may be used as long as you have been initially treated with insulin. Additionally, these solutions should be used with caution if you have Addison's disease or carbohydrate intolerance.

-Administration in the same location should be avoided 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 KabiPac Glucosalino)

All patients should be closely monitored. In cases where the normal regulation of blood water content is altered due to an increase in vasopressin secretion, also known as Antidiuretic Hormone (ADH), the infusion of fluids with a 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 the 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.

Use of KabiPac Glucosalino with other medications

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 KabiPac Glucosalino. 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, which may cause an increase in digital activity, with a 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 Warnings and precautions), 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, known as vasopressin analogs

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

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 KabiPac Glucosalino, as it should be used with caution in this case.

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

There is no evidence to suggest that KabiPac Glucosalino 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 machinery

There is no indication that KabiPac Glucosalino may affect the ability to drive or operate machinery.

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

Your fluid balance and plasma glucose and electrolyte (especially sodium) concentrations will be monitored during administration.

Your doctor will decide on the dose and frequency of the solution administration, 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:

-Weight 0 to 10 kg:100 ml/kg/24 h

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

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

If you use more KabiPac Glucosaline than you should

If the glucosaline solution administration is not performed correctly and under control, some of the following signs of overdosing 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, KabiPac Glucosalino may 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.

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.

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 infusion.

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.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or nurse, 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:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

No special conservation conditions are required.

Keep out of sight and reach of children.

Do not use KabiPac Glucosaline after the expiration date that appears on the packaging.

Do not use KabiPac Glucosaline 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.

Composition of KabiPacGlucosaline

The active principles are glucose and sodium chloride. Each 100 ml of solution contains 3.3 g of glucose (as monohydrate) and 0.3 g of sodium chloride.

The other components are: water for injection preparations

Osmolarity (theoretical): 285 mOsm/l

pH: 3.2 – 6.5

Cl-(theoretical): 51.3 mmol/l

Na+(theoretical): 51.3 mmol/l

Calories (theoretical): 132 kcal/l

Appearance of the product and contents of the package

KabiPac Glucosaline is a clear, transparent, and colorless solution.

KabiPac Glucosaline is presented in polyethyleneKabiPacbottles of the following capacities:

1 bottle of 100 ml

1 bottle of 250 ml

1 bottle of 500 ml

1 bottle of 1000 ml

20 bottles of 100 ml

20 bottles of 250 ml

10 bottles of 500 ml

10 bottles of 1000 ml

Only some sizes of packaging may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Fresenius Kabi España S.A.U.

Marina 16-18,

08005-Barcelona (Spain)

Responsible for manufacturing:

FRESENIUS KABI ESPAÑA, S.A.U. Dr. Ferran, 12 (Vilassar de Dalt) – 08339 - Spain

FRESENIUS KABI DEUTSCHLAND GMBH Freseniusstrasse 1 (Friedberg) - D-61169 - Germany

LABESFAL - LABORATORIOS ALMIRO S.A. Lagedo (Santiago de Besteiros) - P-3465 157 - Portugal

FRESENIUS KABI POLSKA SP. Z.O.O. Sienkiewicza, 25 (Kutno) - P-99-300 - Poland

This leaflet has been revised in April 2021------------------------------------------------------------------------------------------------------------------------

This information is intended solely for doctors or healthcare professionals:

KabiPac Glucosaline is presented in the form of a solution for intravenous administration and will be used in a hospital by the corresponding healthcare personnel.

KabiPac Glucosaline will be administered by infusion.

The contents of each KabiPac Glucosaline package are for a single infusion.

Once the package 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 withage: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 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.

To administer the solution and in the event 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 3.3% and sodium chloride of 0.3% 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.

Monitoring serum sodium is especially important when administering products with a lower sodium concentration compared to serum sodium. After perfusion of KabiPac Glucosaline, a rapid and active transport of glucose to the body's cells occurs. This condition promotes an effect that can be considered a free water supply and may lead to severe hyponatremia.