Patient Information

KabiPac Glucose 5% Infusion Solution

Read this entire leaflet carefully before you start using this medicine because it contains important information for you.

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

KabiPacGlucosa 5% is a solution for intravenous infusion that is presented in 100 ml bottles containing 50 ml or 100 ml of solution, 250 ml bottles containing 100 ml or 250 ml of solution, 500 ml and 1000 ml bottles.

It belongs to the group of parenteral nutrition solutions intended for the provision of water and energy.

It is indicated for the treatment of hypertonic dehydration (vomiting, diarrhea, profuse sweating, gastrointestinal fistulas), as an energy supplement in parenteral nutrition when oral food intake is limited, in carbohydrate metabolism disorders (hypoglycemia, insulin coma, hepatic coma, acetone vomiting) and as a vehicle for the administration of compatible medications.

No use KabiPac Glucosa 5%

-if you are allergic (hypersensitive) to the active ingredient or any of the other components of KabiPac Glucosa 5%
5%

-if you have been diagnosed with hypotonic dehydration, loss of electrolytes, or decreased urine volume.

-in the first 24 hours after a head trauma.

-in states of hyperglycemia or increased blood glucose levels.

-in states of hyperhydration (fluid overload)

-in cases of generalized edema (accumulation of fluid in body tissues)

-if you have hyperlactacidemia (presence of lactic acid in the blood)

-if you have significant alterations in glucose tolerance, including hyperosmolar coma.

Advertencias y precauciones

-Blood glucose levels must be closely monitored in cases of intracranial hypertension.

-In cases of acute ischemic attacks (decreased or absent circulation in arteries), as hyperglycemia has been related to increased ischemic brain damage and difficulty in recovery.

-In cases of shock and acid-base balance disturbances, in patients with sodium deficiency,

the administration of sodium-free solutions may cause peripheral circulatory collapse and oliguria (scanty urine production).

-Regular blood glucose and electrolyte analyses, as well as water balance and acid-base balance, are recommended, as frequent and massive administration of glucose solutions through veins (parenteral) may cause fluid overload (hyperhydration) and significant ionic depletions. In this case, electrolyte supplements will be necessary.

-Potassium may be administered along with glucose solution to prevent hypokalemia (low potassium levels in the blood) produced during prolonged parenteral glucose feeding.

-If malnutrition is present, you may have a deficiency of vitamin B1. This vitamin is essential for glucose metabolism, so this deficiency must be corrected first if necessary.

-If you have diabetes. In this case, glucose solutions can be used as long as initial appropriate treatment (insulin) has been established. Blood glucose levels must be regularly monitored in diabetic patients and insulin requirements adjusted.

-Do not administer blood simultaneously using the same administration equipment as this medication.

-If administered continuously in the same perfusion site, it may cause thrombophlebitis (inflammation of the veins).

-Special attention should be given to elderly patients, as they may have impaired liver and/or kidney function.

-Do not administer by intramuscular route.

-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 acquiring low sodium levels in the blood (hyponatremia) in the hospital. (see the section "Use of KabiPac Glucosa 5% with other medications").

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 may cause headache, nausea, convulsions, 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.

Use of KabiPacGlucosa 5% withother 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.

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

-Insulin or oral antidiabetic medications (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): If intravenous glucose administration coincides with treatment with digitalis glycosides (digoxin), there is a risk of developing toxicity from these medications.

-Medications that increase the effect of vasopressin (see also the section "Advertencias y precauciones" above), 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 as vasopressin, called vasopressin analogs

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

In any case, the doctor must check the compatibility of the added 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 5% glucose solution, as it should be used with caution in this case. The administration of glucose by intravenous route during pregnancy may elevate glucose and insulin levels, as well as acidic components in the blood of the fetus.

No evidence suggests that 5% glucose 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

It is not recommended, due to the characteristics of its use.

Follow exactly the administration instructions for KabiPac Glucose 5% as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Administration by intravenous infusion at a rate according to your age, body weight, clinical condition, and metabolic state is generally recommended.

In adults, the maximum dose is 40 ml/kg body weight/day and the maximum infusion rate is 5 ml/kg body weight/hour = 0.25 g/kg body weight/hour.

In children, the infusion rate depends on the child's age and weight, and generally should not exceed

10-18 mg of glucose (0.2-0.36 ml of solution)/kg/min.

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

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

More than 20 kg: 1500 ml + 20 ml/kg/24h for weight above 20 kg.

If you use more KabiPac Glucose 5% than you should

In case of overdose, hyperglycemia, glucosuria (presence of glucose in urine), hyperhydration, or electrolyte disorders may appear. Administration will be suspended and symptomatic treatment will be sought.

Like all medications, KabiPac Glucosa 5% may produce adverse effects, although not everyone will experience them.

It may cause hyperglycemia, glucosuria (glucose in urine) or fluid and electrolyte balance alterations if administered too quickly or if the fluid volume is excessive, or in cases of metabolic insufficiency.

On the other hand, the resulting hyperglycemia from rapid infusion or excessive fluid volume should be monitored in severe cases of diabetes mellitus, and may be prevented by reducing the dose and infusion rate or by administering insulin.

A local reaction may occur at the injection site.

Headache, nausea, convulsions, lethargy. This may be caused by low sodium levels in the blood (hospital-acquired hyponatremia). 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.

Whenever any of these adverse reactions occur, you should inform your doctor, who will evaluate whether to discontinue the medication.

If used as a vehicle for administering other medications, the nature of the added medications will determine the likelihood of other adverse reactions.

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 on the safety of this medication.

No requires special conservation conditions.

Keep out of sight and reach of children.

Do not use KabiPac Glucose 5% after the expiration date that appears on the packaging.

Do not use KabiPac Glucose 5% 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.

KabiPac Glucosa 5% Composition

The active ingredient is glucose. Each 100 ml of solution contains 5 g of glucose (as monohydrate 5.5 g).

The other components are: water for injection, hydrochloric acid for pH adjustment.

Isotonic solution, apyrogenic and sterile.

Theoretical osmolality: 278 mosm/l pH: 3.5-6.5

Theoretical calories: 200 kcal/l

Product Appearance and Packaging Contents

KabiPac Glucosa 5% is a transparent and colorless solution, without visible particles.

KabiPac Glucosa 5% is presented in polyethylene bottles (KabiPac) of the following capacities and formats:

Only some sizes of packaging may be commercially marketed.

Marketing Authorization Holder and Responsible Manufacturer

Marketing Authorization Holder:

Fresenius Kabi España S.A.U.

C/ Marina 16-18

08005-Barcelona (Spain)

Responsible Manufacturer:

Fresenius Kabi Deutschland GmbH

Werk Friedberg

Freseniusstraße 1

D - 61169 Friedberg

Fresenius Kabi Polska. Sp. z o.o.

ul. Sienkiewicza 25

PL - 99-300 Kutno

Labesfal – Laboratórios Almiro, S.A.

Zona Industrial do Lagedo,

Santiago de Besteiros

3465 – 157 Portugal

Fresenius Kabi Italia S.r.l.

Via Camagre, 41

I - 37063 Isola della Scala – Verona

Fresenius Kabi España S.A.U.

C/ Dr. Ferran, 12

08339 Vilassar de Dalt (Barcelona)

This leaflet was revised in April 2021.

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

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

This medicine will be administered always by specialized personnel. It will be administered by perfusion, through a central or peripheral vein.

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

The content of each package is for a single perfusion, discard the unused fraction. Use an aseptic method to administer the solution and in case of preparation of mixtures.

Before adding medications to the solution or administering simultaneously with other medications, check that there are no incompatibilities.

Posology

General advice

It may be necessary to control the water 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 of serum sodium is especially important in products with a lower sodium concentration compared to the serum sodium concentration. After perfusion of KabiPac Glucosa 5%, a rapid and active transport of glucose 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.