KABIPAC GLUCOSALINO SOLUTION FOR INFUSION

Introduction

PROSPECT: INFORMATION FOR THE USER

KabiPac Glucosalino solution for infusion

Glucose and Sodium Chloride

Read the entire prospectus carefully before starting to use this medication, as it contains important information for you.

• Keep this prospectus as you may need to read it again.
• If you have any doubts, consult your doctor or nurse.
• If you experience adverse effects, consult your doctor or nurse, even if they are not listed in this prospectus. See section 4.

Contents of the prospectus:

1. What KabiPac Glucosalino is and what it is used for
2. What you need to know before using KabiPac Glucosalino
3. How to use KabiPac Glucosalino
4. Possible adverse effects
5. Storage of KabiPac Glucosalino
6. Package contents and additional information

1. What KabiPac Glucosalino is and what it is used for

KabiPac Glucosalino is an intravenous infusion solution presented in 100 ml, 250 ml, 500 ml, and 1000 ml vials.

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

KabiPac Glucosalino is indicated in:

• States of dehydration with moderate electrolyte losses.
• Alterations of carbohydrate metabolism.
• As a vehicle for the administration of medications and electrolytes.

2. What you need to know before using KabiPac Glucosalino

Do not use KabiPac Glucosalino

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

KabiPac Glucosalino.

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

ascitic (chronic progressive liver disease with fluid accumulation).

• In states of hyperglycemia (increased blood glucose level).
• In states of hyponatremia (decreased sodium in blood).
• In states of hypochloremia (decreased chloride in blood).
• In states of hyperosmolar coma (loss of consciousness due to increased salt concentration in blood).

of hyperosmolar coma (loss of consciousness due to increased salt concentration in blood).

• In states of hyperlactacidemia (presence of lactic acid in blood).
• In severe cases of heart, liver, or kidney failure.
• During the first 24 hours after a head trauma

Warnings and precautions

• It is recommended that regular analytical controls be performed on blood glucose, electrolyte, water balance, and acid-base balance, as frequent and massive administration of glucose solutions can cause fluid overload (hyperhydration), acid-base balance alterations, and significant ionic depletions. In these cases, it will be necessary to administer electrolyte supplements.
• This medication will be administered 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), cardiac, hepatic, and/or renal disorders, or if you are an elderly patient
• KabiPac Glucosalino will be administered with caution to premature and full-term infants.
• Blood glucose will be carefully determined in case of intracranial hypertension.
• If you have had an acute ischemic attack (sudden onset of lack of blood flow), this medication should not be administered
• If this medication is administered for a prolonged period, it is recommended to add potassium to the solution as a safety measure.
• The administration of glucose-containing solutions can cause vitamin B1 deficiency, especially in cases of malnutrition.
• If you have diabetes mellitus, glucose-containing solutions can be used as long as adequate treatment (insulin) has been initially established. Similarly, these solutions should be used with caution if you have Addison's disease or carbohydrate intolerance.
• Continuous administration at the same injection site should be avoided due to the risk of thrombophlebitis.
  • If you suffer from critical states, pain, postoperative stress, infections, burns, or central nervous system diseases

• You have any type of heart, liver, or 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 can increase the risk of acquiring low sodium levels in the blood (hyponatremia) in the hospital. (See the section Other medications and KabiPac Glucosalino)

Todos los pacientes deben estar estrechamente monitorizados. En casos donde la regulación normal del contenido de agua de la sangre se altera debido al aumento de la secreción de vasopressina, también llamada Hormona Antidiurética (ADH), la perfusión de fluidos con una baja concentración de cloruro de sodio (fluidos hipotónicos) puede dar como resultado un nivel bajo de sodio en la sangre (hiponatremia). Esto puede causar dolor de cabeza, náuseas, convulsiones, letargo, coma, inflamación del cerebro (edema cerebral) y la muerte; por lo tanto, estos síntomas (encefalopatía hiponatrémica aguda sintomática) se consideran una emergencia médica. (Ver la sección 4. Posibles efectos secundarios)

Los niños, las mujeres en edad fértil y los pacientes con enfermedades cerebrales como meningitis, hemorragia cerebral, contusión cerebral y edema cerebral tienen un riesgo especial de sufrir inflamación cerebral grave y potencialmente mortal causado por una hiponatremia aguda.

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 purchased 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 treatment with one of the medications.

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

• Insulin or oral antidiabetics (biguanides, sulfonylureas), these medications 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.
• Digitalis glycosides (digoxin), an increase in digitalis activity may occur, with the risk of developing intoxication.
• Lithium carbonate, as the administration of sodium chloride accelerates the renal excretion of lithium, resulting in a decrease in the therapeutic effect of the latter.

resulting in a decrease in the therapeutic effect of the latter.

• Medications that lead to an increased 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., non-steroidal anti-inflammatory medications)
  • Medications that act like vasopressin, called vasopressin analogs
  • Other medications that increase the risk of hyponatremia, including diuretics in general and antiepileptics.

Pregnancy and lactation

Consult your doctor or pharmacist before using any medication.

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

In case of pregnancy, your doctor will decide the convenience of using KabiPac Glucosalino, 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 KabiPac Glucosalino can cause adverse effects during the lactation period in newborns. However, it is recommended to use with caution during this period.

Driving and using machines

There is no indication that KabiPac Glucosalino can affect the ability to drive or use machines.

3. How to use KabiPac Glucosalino

Follow exactly the administration instructions of KabiPac Glucosalino indicated by your doctor. Consult your doctor or pharmacist if you have doubts.

Fluid balance and plasma concentrations of glucose and electrolytes (especially sodium) will be monitored during administration.

Your doctor will decide the dose and frequency at which the solution will be administered, depending on your age, weight, clinical situation (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:

• 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 KabiPac Glucosalino than you should

If the administration of the glucose solution is not carried out correctly and controlled, some of the following signs of overdose may appear: hyperhydration, electrolyte alterations, and acid-base balance alterations.

In case of non-compliance with these requirements and the presentation of some symptom of intoxication, administration will be suspended, and symptomatic treatment will be resorted to.

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

4. Possible adverse effects

Like all medications, KabiPac Glucosalino can cause adverse effects, although not all people 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, causing them to swell. This results in increased intracranial pressure and causes hyponatremic encephalopathy.

Adverse reactions may be associated with 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, perfusion should be interrupted.

If you consider that any of the adverse effects you are experiencing is serious or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Reporting of 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 Pharmacovigilance System for Human Use Medications: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Storage of KabiPac Glucosalino

No special storage conditions are required.

Keep out of sight and reach of children.

Do not use KabiPac Glucosalino after the expiration date stated on the packaging.

Do not use KabiPac Glucosalino if the solution is not transparent and contains precipitates.

Medications should not be disposed of through wastewater or household waste. Ask your pharmacist how to dispose of packaging and medications that are no longer needed. This will help protect the environment.

6. Package contents and additional information

Composition of KabiPac Glucosalino

The active ingredients 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 injectable preparations

Osmolality (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 package contents

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

KabiPac Glucosalino is presented in KabiPacpolyethylene vials of the following capacities:

1 vial of 100 ml

1 vial of 250 ml

1 vial of 500 ml

1 vial of 1000 ml

20 vials of 100 ml

20 vials of 250 ml

10 vials of 500 ml

10 vials of 1000 ml

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Fresenius Kabi España S.A.U.

Marina 16-18,

08005-Barcelona (Spain)

Manufacturer:

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 prospectus was revised in April 2021------------------------------------------------------------------------------------------------------------------------

This information is intended only for doctors or healthcare professionals:

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

KabiPac Glucosalino will be administered by perfusion.

The content of each KabiPac Glucosalino package is for single perfusion.

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

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

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 from 12 to 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 infants and children, depending on age and total body weight.

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

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

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

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

General advice

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

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