KABIPAC GLUCOSE 5% SOLUTION FOR INFUSION

Introduction

Prospect: information for the user

KabiPac Glucose 5% solution for infusion

Read the entire prospectus carefully before starting to use this medicine, 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 side effects, consult your doctor or nurse, even if they are side effects not listed in this prospectus. See section 4.

Contents of the prospectus:

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

1. What KabiPac Glucose 5% is and what it is used for

KabiPac Glucose 5% is an intravenous infusion solution presented in vials of 100 ml containing 50 ml or 100 ml of solution, vials of 250 ml containing 100 ml or 250 ml of solution, vials of 500 ml and 1000 ml.

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

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, acetonemic vomiting) and as a vehicle for the administration of compatible medications.

2. What you need to know before using KabiPac Glucose 5%

Do not use KabiPac Glucose 5%

• if you are allergic (hypersensitive) to the active ingredient or to any of the other components of KabiPac Glucose 5%
• if you have been diagnosed with hypotonic dehydration, loss of salts, or decreased urine volume.
• in the first 24 hours after a head injury.
• in states of hyperglycemia or increased blood glucose levels.
• in states of hyperhydration (fluid overload)
• in situations of generalized edema (fluid accumulation in body tissues)
• if you have hyperlactacidemia (presence of lactic acid in the blood)
• if you suffer from significant glucose tolerance disorders, including hyperosmolar coma.

Warnings and precautions

• Blood glucose concentration should be carefully monitored in cases of intracranial hypertension.
• In case of having suffered acute ischemic attacks (decreased or absent circulation in arteries), since hyperglycemia has been linked to an increase in ischemic brain damage and difficulty in recovery.
• In case of shock and acid-base balance disorders, in patients with sodium deficiency,

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

• It is recommended that regular analytical controls be performed on blood glucose and electrolytes and water and acid-base balance, as frequent and massive administration of glucose solutions through the veins (parenterally) can cause fluid overload (hyperhydration) and significant ionic depletions. In this case, it will be necessary to administer electrolyte supplements.
• Along with glucose solution, potassium may be administered to avoid hypokalemia (low potassium levels in the blood) produced during prolonged parenteral feeding with glucose
• If you have malnutrition, you may have a vitamin B1 deficiency. This vitamin is essential for glucose metabolism, so if necessary, this deficiency should be corrected first.
• If you have diabetes. In this case, glucose solutions can be used as long as you have initially received adequate treatment (insulin). Blood glucose levels should be regularly monitored in diabetic patients and insulin requirements modified.
• Do not administer blood simultaneously using the same administration equipment as this medication.
• If administered continuously in the same infusion site, thrombophlebitis (inflammation of the veins) may occur.
• If you are an elderly patient, you will receive special attention, as you may have affected liver and/or kidney function.
• Do not administer intramuscularly.
• If you suffer from critical conditions, 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 the body's water retention) because it may increase the risk of acquiring low sodium levels in the blood (hyponatremia) in the hospital. (See the section on Using KabiPac Glucose 5% with other medications).

All patients should be closely monitored. In cases where normal regulation of blood water content is altered due to increased vasopressin secretion, 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, convulsions, lethargy, coma, brain inflammation (cerebral edema), and death; therefore, these symptoms (acute symptomatic hyponatremic encephalopathy) are considered a medical emergency. (See section 4. Possible side effects)

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

Using KabiPac Glucose 5% with other medications

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

It is essential that you inform your doctor if you use 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): If intravenous glucose administration coincides with treatment with digitalis glycosides (digoxin), there is a risk of developing toxicity from these medications.
• Medications that lead to an increased effect of vasopressin (see also the "Warnings and precautions" section above), 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 drugs)
  • Medications that act as vasopressin, called vasopressin analogs

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

In any case, the doctor should check the compatibility of the added medications.

Pregnancy and breastfeeding

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 a 5% glucose solution, as it should be used with caution in this case. The administration of glucose intravenously during pregnancy may increase glucose and insulin levels as well as acidic components in the fetus's blood.

There is no evidence to suggest that 5% Glucose can cause adverse effects during the breastfeeding period in the newborn. However, it is recommended to use with caution during this period.

Driving and using machines

This does not apply, due to the characteristics of its use.

3. How to use KabiPac Glucose 5%

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

It is generally recommended to administer intravenously, drop by drop, according to your age, body weight, clinical situation, and metabolic state.

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 (glucose in urine), hyperhydration, or electrolyte disorders may appear. Administration will be suspended, and symptomatic treatment will be resorted to.

4. Possible side effects

Like all medications, KabiPac Glucose 5% can cause side effects, although not everyone experiences them.

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

On the other hand, the hyperglycemia resulting from rapid or excessive infusion should be monitored in severe cases of diabetes mellitus, and can be avoided by decreasing the dose and infusion rate or by administering insulin.

A local reaction may occur at the injection site.

Headache, nausea, convulsions, lethargy. This can be caused by low sodium levels in the blood (hospital hyponatremia). When sodium levels in the blood drop significantly, water enters the brain cells, causing them to swell. This results in increased cranial pressure and causes hyponatremic encephalopathy.

If any of these adverse reactions occur, you should inform your doctor, who will assess whether or not to discontinue the medication.

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

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

Reporting side effects

If you experience any type of side effect, consult your doctor or nurse, even if it is a possible side 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 side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of KabiPac Glucose 5%

No special storage conditions are required.

Keep out of sight and reach of children.

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

Do not use KabiPac Glucose 5% 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 the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of KabiPac Glucose 5%

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 injectables, hydrochloric acid for pH adjustment.

Isotonic, apyrogenic, and sterile solution.

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

Theoretical calories: 200 kcal/l

Appearance of the product and package contents

KabiPac Glucose 5% is a clear and colorless solution, without visible particles.

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

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Holder:

Fresenius Kabi España S.A.U.

C/ Marina 16-18

08005-Barcelona (Spain)

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 prospectus was revised in April 2021.

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

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This information is intended only for doctors or healthcare professionals:

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

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

The contents of each package are for single infusion; the unused fraction must be discarded. Use an aseptic method to administer the solution and in case of preparation of mixtures.

Before adding medications to the solution or administering them simultaneously with other medications, it must be checked that there are no incompatibilities.

Dosage

General advice

It may be necessary to monitor water balance, blood 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 in products with a lower sodium concentration compared to serum sodium concentration. After infusion of KabiPac Glucose 5%, rapid and active transport of glucose to the body's cells occurs. This condition promotes an effect that can be considered as a supply of free water and may lead to severe hyponatremia.