Kabipac glucose 10% solution for infusion

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

KabiPac Glucose 10% solution for infusion

Glucose

Read the 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 pharmacist.

• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.

• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet:

1. What KabiPac Glucose 10% is and what it is used for
2. What you need to know before using KabiPac Glucose 10%
3. How to use KabiPac Glucose 10%
4. Possible side effects
5. How to store KabiPac Glucose 10%
6. Contents of the pack and other information

1. What KabiPac Glucose 10% is and what it is used for

KabiPac Glucose 10% is a clear infusion solution belonging to the group of intravenous solutions for parenteral nutrition, intended to provide water and energy.

KabiPac Glucose 10% is indicated for:

• Parenteral nutrition (as a source of energy) when oral intake of food is limited.
• Hypertonic dehydration states (without significant loss of salts), or in cases where ionic imbalances due to excess need to be corrected.
• Disorders of carbohydrate metabolism.

As a vehicle for the administration of drugs and electrolytes.

2. What you need to know before using KabiPac Glucose 10%

Do not use KabiPac Glucose 10%

• If you are allergic to the active substance or to any of the other components of this medicine (listed in section 6).
• In conditions of hyperglycemia (high blood glucose levels).
• In conditions of hyperhydration (excess water in the body), or edema due to fluid accumulation in tissues.
• If you have severe renal failure (severe impairment of kidney function) or anuria (absence of urine production).
• In case of electrolyte depletion (loss of salts).
• If you have hyperlactatemia (presence of lactic acid in blood).
• If you suffer from significant disturbances in glucose tolerance, including hyperosmolar coma.
• In case of hypotonic dehydration (with loss of salts), unless salts are simultaneously administered.
• If you have untreated diabetes.
• During the first 24 hours after a head injury.

Warnings and precautions

Consult your doctor or pharmacist before starting to use KabiPac Glucose 10%.

• Blood glucose concentration must be carefully monitored during episodes of intracranial hypertension.
• If you have suffered acute ischemic events (reduced or absent blood flow in arteries), as hyperglycemia has been associated with increased cerebral ischemic damage and impaired recovery.
• In cases of shock and acid-base imbalances, electrolytes should be administered according to individual requirements before initiating glucose solution infusion. In case of sodium deficit, administration of sodium-free solutions may lead to peripheral circulatory collapse and reduced urine output.
• Regular monitoring of serum electrolytes and fluid balance is recommended, as frequent and massive administration of parenteral glucose solutions may cause significant ionic depletions. In such cases, electrolyte supplementation may be necessary.
• To prevent hypokalemia (low blood potassium) occurring during prolonged parenteral nutrition with glucose, potassium may be added to the glucose solution as a precautionary measure.
• The risk of hyperhydration can be avoided by careful monitoring of total fluid intake and loss.
• Regular monitoring of blood glucose levels (glycemia) is recommended, especially if you are diabetic. In such cases, insulin requirements may need to be adjusted. These solutions should also be used with caution if you have Addison's disease or carbohydrate intolerance.
• If you have malnutrition, you may have a deficiency in vitamin B1 (thiamine). This vitamin is essential for glucose metabolism, so this deficiency should be corrected first if necessary.
• If the 10% glucose solution is administered via a peripheral vein, continuous infusion at the same injection site should be avoided due to the risk of thrombophlebitis (vein inflammation associated with blood clot formation).
• Special attention should be given when using this solution in elderly patients, as they may have impaired liver and/or kidney function.
• In prolonged treatments, insulin production may be reduced.
• If you are experiencing critical conditions, pain, postoperative stress, infections, burns, or central nervous system disorders.
• If you have any type of heart, liver, or kidney disease and are being treated with a medication that enhances the effect of vasopressin (a hormone regulating water retention in the body), as this may increase the risk of developing hospital-acquired low blood sodium levels (hyponatremia). (See section "Other medicines and KabiPac Glucose 10%")

All patients must be closely monitored. In cases where the normal regulation of blood water content is disrupted 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 blood sodium levels (hyponatremia). This can cause headache, nausea, seizures, lethargy, coma, brain swelling (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 disorders such as meningitis, cerebral hemorrhage, cerebral contusion, and cerebral edema are at special risk of developing severe and potentially fatal brain swelling caused by acute hyponatremia.

Other medicines and KabiPac Glucose 10%

Use of KabiPac Glucose 10% with other medicines. Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicine.

Certain medicines may interact with KabiPac Glucose 10%. In such cases, it may be necessary to adjust the dose or discontinue treatment with one or more of the medicines.

It is important that you inform your doctor if you are taking any of the following medicines:

• Insulin or oral antidiabetics (biguanides, sulfonylureas), as intravenous glucose administration in patients treated with these medicines may reduce their therapeutic efficacy (antagonistic effect).

• Corticosteroids: Intravenous glucose administration in patients treated with systemic corticosteroids having glucocorticoid activity (e.g., cortisol) may lead to a significant increase in plasma glucose levels due to the hyperglycemic effect of these agents. As for corticosteroids with mineralocorticoid activity, they should be administered with caution due to their capacity to retain water and sodium.

• Digitalis glycosides (e.g., digoxin), as intravenous glucose administration concurrent with therapy using these medicines may increase digitalis activity, increasing the risk of toxicity. This is due to hypokalemia that may result from glucose administration if potassium is not added to the solution.

Electrolyte-free glucose solutions must not be administered using the same infusion set, simultaneously, before, or after blood transfusion, due to the risk of pseudoagglutination.

Medicines that enhance the effect of vasopressin

The following medicines increase the effect of vasopressin, thereby reducing renal excretion of electrolyte-free water and increasing the risk of hospital-acquired hyponatremia following inadequately balanced intravenous infusion therapy:

• Medicines that stimulate vasopressin release; e.g.: chlorpropamide, clofibrate, carbamazepine, vincristine, selective serotonin reuptake inhibitors, 3,4-methylenedioxy-N-methamphetamine (MDMA), ifosfamide, antipsychotics, narcotics

• Medicines that potentiate vasopressin action; e.g.: chlorpropamide, NSAIDs, cyclophosphamide

• Vasopressin analogs; e.g.: desmopressin, oxytocin, vasopressin, terlipressin

Other medicines known to increase the risk of hyponatremia include diuretics in general and antiepileptic drugs such as oxcarbazepine.

Pregnancy, lactation and fertility

If you are pregnant or breastfeeding, think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

KabiPac Glucose 10% should be administered with special caution in pregnant women during labour, especially if administered in combination with oxytocin, due to the risk of hyponatraemia (see section 4).

During pregnancy, your doctor will decide whether the use of 10% glucose is appropriate, as it should be used with caution in such cases.

Excessive administration of glucose during pregnancy may cause hyperglycaemia (high blood glucose levels), hyperinsulinaemia (high blood insulin levels) and fetal acidosis (increased acidity in fetal blood), and consequently may be harmful to the newborn.

There is no evidence to suggest that KabiPac Glucose 10% solution may cause adverse effects during lactation in the neonate. However, caution is recommended when using it during this period.

Driving and use of machines

There is no indication that KabiPac Glucose 10% solution may affect the ability to drive or use machines.

3. How to use KabiPac Glucose 10%

Follow exactly the instructions for administration of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

KabiPac Glucose 10% is supplied as a solution and will be administered in the hospital by the appropriate healthcare personnel.

KabiPac Glucose 10% is administered intravenously by infusion.

Your doctor will determine the duration of your treatment with KabiPac Glucose 10%. The dose may be adjusted at the physician's discretion depending on age, body weight, clinical condition, fluid balance, electrolyte levels, and acid-base balance of the patient.

When used as a vehicle for the administration of other medications, the volume will depend on the drugs being administered.

For all other indications, and unless otherwise directed by the physician, the recommended dose is as follows:

Maximum daily dose

Adults

Maximum daily dose of 20 mL/kg body weight/day (equivalent to 2.0 g of glucose/kg body weight/day), which should only be exceeded in exceptional cases up to 6.0 g/kg body weight/day.

Maximum infusion rate

2.5 mL/kg body weight/hour (equivalent to 0.25 g of glucose/kg body weight/hour).

Due to the maximum rate of metabolic oxidation in the body, carbohydrate supply should be restricted to 300–400 g/day under normal metabolic conditions.

In cases of metabolic insufficiency, for example during post-stress metabolism, hypoxic conditions (lack of oxygen), or organ failure, the daily dose should be reduced to 200–300 g of glucose (equivalent to 3 g/kg body weight per day) to avoid elevated blood sugar levels (hyperglycemia), insulin resistance, and morbidity. Adequate monitoring is required for individualized dose adjustment.

Use in children

Newborns and premature neonates

The maximum glucose dose in premature neonates should be 11.5 g per kg body weight on the first day of life. From the second day of life onward, the maximum daily glucose dose should not exceed 17.3 g per kg body weight. In full-term newborns, the maximum glucose dose should be 7.2 g per kg body weight on the first day of life. From the second day of life onward, the maximum daily glucose dose should not exceed 17.3 g per kg body weight.

Infants and children

The maximum glucose dose depends on the body weight of the infant/child and the phase of critical illness, which can be divided into acute, stable, and recovery phases. The acute phase is defined as the resuscitation phase when the patient requires organ life support (sedation, mechanical ventilation, vasopressors, fluid resuscitation). The stable phase is defined as when the patient is stable or independent. The recovery phase is defined as when the patient is mobilizing. The recommended maximum daily glucose doses in grams per kg body weight per day are listed in the following table according to the phase of illness:

Recommended maximum daily glucose dose

Monitoring of blood sugar levels is recommended during the administration of carbohydrate solutions.

To prevent overdose, the use of infusion pumps is recommended, especially for the infusion of glucose solutions with higher concentrations.

Method of administration

Peripheral infusion (administration through a small vein) or central intravenous (administration through a large vein).

If you use more KabiPac Glucose 10% than you should

Given the nature of the product, if its indication and administration are correct and controlled, there is no risk of intoxication.

If the solution is not administered correctly and under control, one of the following signs of overdose may occur: hyperglycemia, glucosuria, fatty liver, hyperhydration, or electrolyte disturbances. In such cases, administration will be discontinued and symptomatic treatment initiated. In the event of elevated blood glucose, insulin will be administered.

If capillary blood glucose values exceed 200 mg/dL, insulin administration should be initiated. Likewise, in cases where glucose administration is used as a non-protein energy source in parenteral nutrition, the composition of the nutritional mixture should be modified (increasing lipid supply and reducing glucose supply).

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

If you have any further questions about the use of this product, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, KabiPac Glucose 10% may produce adverse effects, although not everyone will experience them.

If the solution is administered correctly and under control, the possible complications are those related to the technique of intravenous administration.

If administration is performed via a central vein, the main complications will be due to catheter placement and maintenance, or complications arising from infections.

If administration is performed via a peripheral vein, there is a risk of thrombophlebitis (inflammation of a vein associated with blood clot formation), especially when administration is prolonged. In such cases, it is recommended to periodically change the catheter insertion site (every 24–48 hours).

Hyperglycemia, glycosuria (glucose in urine), or disturbances in fluid or electrolyte balance may occur if the solution is administered too rapidly, if the fluid volume is excessive, or in cases of metabolic insufficiency.

Hyperglycemia resulting from rapid infusion or excessive volume must be especially monitored in severe cases of diabetes mellitus and can be avoided by reducing the dose and infusion rate or by administering insulin.

The following adverse reactions have been reported:

Metabolism and nutrition disorders:

• Hyperglycemia
• Electrolyte imbalance
• Fluid imbalance

General disorders and administration site conditions:

• Edema at the infusion site
• Pyrexia
• Extravasation at the injection site
• Infection at the injection site
• Reaction at the injection site
• Pain at the injection site

Renal and urinary disorders:

• Glycosuria

Vascular disorders:

• Thrombophlebitis

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

Hyponatremia:

Headache, nausea, seizures, lethargy. This may be caused by low levels of sodium 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 leads to hyponatremic encephalopathy.

Reporting of 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 leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of KabiPac Glucose 10%

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the container after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

No special storage conditions are required.

6. Package contents and other information

Composition of KabiPac Glucose 10%

• The active substance is glucose. Each 100 ml of solution contains 10 g of anhydrous glucose (equivalent to 11 g of glucose monohydrate).
• The other components are water for injections and hydrochloric acid and sodium hydroxide (for pH adjustment).

Appearance of the product and package contents

KabiPac Glucose 10% is a clear solution packaged in a closed polyethylene bottle. It is available in package sizes of 250, 500, and 1000 ml.

Clinical packs are also available in the following presentations:

• 20 bottles of 250 ml
• 10 bottles of 500 ml
• 20 bottles of 500 ml
• 10 bottles of 1000 ml

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Fresenius Kabi España S.A.U.

Torre Mapfre-Vila Olímpica

C/ Marina 16-18

08005-Barcelona (Spain)

Manufacturer

Labesfal – Laboratórios Almiro, S.A

Zona Industrial do Lagedo

3465-157 Santiago de Besteiros

Portugal

or

Fresenius Kabi España, S.A.U.

C/ Dr. Ferran, 12

Vilassar de Dalt (Barcelona)

08339 - Spain

Date of the most recent revision of this leaflet: March 2021

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (Agencia Española de Medicamentos y Productos Sanitarios, AEMPS) http://www.aemps.gob.es/

This information is intended for healthcare professionals only

KabiPac Glucose 10% is administered by intravenous infusion, via a central or peripheral vein.

Healthcare personnel must ensure proper placement of the needle in the vein, as this is a hypertonic solution and extravasation may cause significant tissue irritation.

The contents of each KabiPac Glucose 10% bottle are intended for single use only.

Once the container is opened, the solution should be administered immediately. Any unused portion must be discarded.

The solution must be clear and free from precipitates. Do not administer if this is not the case.

When administering the solution, and particularly when preparing mixtures or adding medications, strict aseptic technique must be maintained.

Within the context of parenteral nutrition, KabiPac Glucose 10% may be administered together with other nutritional preparations in a single bag or separately.

However, prior to mixing for parenteral nutrition, prior to adding medications to the solution, or prior to administering concomitantly with other medications, compatibility must be verified.

Various studies have reported incompatibility signs for 10% glucose solutions with the following: sodium ampicillin, calcium disodium edetate, α-erythropoietin, erythromycin lactobionate, sodium heparin, imipenem-cilastatin sodium, sodium indomethacin, meropenem, and sodium thiopental.

However, some of these drugs may be compatible with this infusion solution depending on various factors such as the pH of the solution (e.g., sodium heparin and erythromycin lactobionate), the drug concentration in the solution (e.g., sodium heparin), or the time interval between reconstitution and administration (e.g., imipenem-cilastatin sodium, meropenem).

In addition, incompatibility has been observed when certain drugs are diluted in glucose-containing solutions, including amrinone lactate, cisplatin, interferon alfa-2b, procainamide hydrochloride, sodium amoxicillin/clavulanic acid, teicoplanin, bleomycin sulfate, cladribine, melphalan hydrochloride, sodium phenytoin, mechloretamine hydrochloride, mitomycin, sodium amoxicillin, rifampicin, and trimethoprim-sulfamethoxazole. However, it should be noted that some of these drugs, such as amrinone lactate or sodium amoxicillin/clavulanic acid, may be administered directly at the injection site while these infusion solutions are being administered.

Electrolyte-free glucose solutions must not be administered through the same infusion set, simultaneously, before, or after blood transfusion, due to the risk of pseudoagglutination.

General advice

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

Monitoring of serum sodium is particularly important when physiologically hypotonic solutions are administered. KabiPac Glucose 10% may become extremely hypotonic after administration due to the metabolism of glucose in the body (see sections 2 and 4).