Leaflet: information for the user

KabiPac Glucosado 5% in Sodium Chloride 0.9% solution for infusion

Glucose and Sodium Chloride

KabiPac Glucosado 5% in Sodium Chloride 0.9% is a solution for infusion used in states of water loss (dehydration) with moderate losses of salts (electrolytes), as a supportive solution to administer medications or electrolytes or in cases of alterations in the metabolism of hydrocarbons (sugars).

Do not use KabiPac Glucosado 5% in Sodium Chloride 0.9%:

• If you are allergic to the active ingredient or any of the other components of this medication (listed in section 6).
• In states of hyperhydration (excess fluid overload).
• In situations of generalized edema (fluid accumulation in body tissues) or ascitic cirrhosis (chronic progressive liver disease with fluid accumulation).
• In states of hyperglycemia (elevated blood glucose levels).
• In states of hypernatremia (elevated sodium levels in blood).
• In states of hyperchloremia (elevated chloride levels in blood).
• In states of hyperosmolar coma (loss of consciousness due to increased concentration of salts in blood).
• In states of hyperlactacidemia (presence of lactic acid in blood).
• In severe cases of heart, liver, or kidney insufficiency.
• Within the first 24 hours after a head trauma

Warnings and precautions

Consult your doctor or pharmacist before starting to use KabiPac Glucosado 5% in Sodium Chloride 0.9%.

• Regular blood glucose, electrolyte, water balance, and acid-base equilibrium tests should be performed, as frequent and massive administration of glucose solutions can cause fluid overload (hyperhydration), acid-base imbalance, and significant ion depletion. In these cases, you may need to receive electrolyte supplements.

• Your blood glucose levels will be carefully monitored if you have intracranial hypertension.

• Do not administer this medication if you have had an acute ischemic stroke (sudden onset of blood flow deficiency).

• If you are administered this medication for an extended period, it is recommended to add potassium to the solution as a safety measure.

• The administration of glucose solutions may cause vitamin B1 deficiency, especially in cases of malnutrition.

• If you have diabetes mellitus, glucose solutions can be used as long as you have been initially treated with insulin. However, these solutions should be used with caution if you have Addison's disease or carbohydrate intolerance.

• Avoid continuous administration in the same injection site due to the risk of thrombophlebitis.

Large volume perfusion will require special monitoring in patients with heart or lung insufficiency and in patients with non-osmotic vasopressin release (including SIADH), due to the risk of hospital-acquired hyponatremia (see below).

Hypotonicity:

Patients with non-osmotic vasopressin release (e.g., in critical states, pain, postoperative stress, infections, burns, and CNS diseases), patients with heart, liver, and kidney diseases, and patients exposed to vasopressin agonists have a special risk of experiencing acute hyponatremia after infusion of hypotonic solutions.

Acute hyponatremia can cause acute hyponatremic encephalopathy (cerebral edema) characterized by headache, nausea, seizures, lethargy, and vomiting. Patients with cerebral edema have a special risk of suffering severe, irreversible, and potentially fatal brain damage.

Children, fertile women, and patients with reduced cerebral compliance (e.g., in cases of meningitis, intracranial hemorrhage, cerebral contusion, and cerebral edema) have a special risk of severe and potentially fatal cerebral edema caused by acute hyponatremia.

Other medications and KabiPac Glucosado 5% in Sodium Chloride 0.9%

Use of KabiPac Glucosado 5% in Sodium Chloride 0.9% with other medications.

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medications.

Certain medications may interact with KabiPac Glucosa 5% in Sodium Chloride 0.9%. In this case, you may need to change the dose or discontinue treatment with one of the medications.

It is essential to inform your doctor if you are using 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 levels or the ability of these medications to retain sodium and water.
• Digitalis glycosides (digoxin), which can cause increased digitalis activity, resulting in the risk of developing toxicity.

Carbonate lithium, as the administration of sodium chloride accelerates renal excretion of lithium, leading to a decrease in the therapeutic effect of this medication.

Medications that potentiate the effect of vasopressin

The following medications increase the effect of vasopressin, which reduces renal water excretion without electrolytes and increases the risk of hospital-acquired hyponatremia after an unbalanced treatment with IV perfusion solutions (see sections 3 and 4).

?Medications that stimulate vasopressin release; e.g.: chlorpropamide, clofibrate, carbamazepine, vincristine, selective serotonin reuptake inhibitors, 3,4-methylenedioxymethamphetamine, ifosfamide, antipsychotics, narcotics

?Medications that potentiate the action of vasopressin; e.g.: chlorpropamide, NSAIDs, cyclophosphamide

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

Other medications known to increase the risk of hyponatremia are also diuretics in general and antiepileptic drugs such as oxcarbazepine.

Pregnancy, lactation, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

In the case of pregnancy, your doctor will decide whether to use a glucose solution, as it should be used with caution in this case.

Excessive administration of glucose solutions during pregnancy can cause hyperglycemia, hyperinsulinemia, and fetal acidosis, which can be harmful to the newborn.

There is no evidence to suggest that KabiPac Glucosado 5% in Sodium Chloride 0.9% can 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 Glucosado 5% in Sodium Chloride 0.9% can affect your ability to drive or operate machinery.

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Your fluid balance and plasma glucose and electrolyte concentrations (especially sodium) 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 dose is:

For adults, elderly patients and adolescents: 500 ml to 3 liters every 24 hours.

For infants and children:

• From0 to10 kgof body weight:100 ml/kg/24 h
• From10 to20 kgof body weight:1000 ml + 50 ml/kg/24 h for weight above10 kg
• >20 kgof body weight:1500 ml + 20 ml/kg/24 h for weight above20 kg

You may need to be monitored for fluid balance, serum glucose, serum sodium and other electrolytes before and during administration, especially if you have an increased non-osmotic release of vasopressin (syndrome of inappropriate antidiuretic hormone secretion, SIADH) and if you are receiving medication with vasopressin agonists simultaneously, due to the risk of hyponatremia. Serum sodium monitoring is especially important when administering hypotonic solutions. This medication may become hypotonic after administration due to rapid glucose metabolism in the body (see sections 2 and 4).

If you use more KabiPac Glucosado 5% in Sodium Chloride 0.9% than you should

If the administration of the glucosaline solution is not performed correctly and under control, some of the following signs of overdose may appear: overhydration, 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.

If you forgot to useKabiPacGlucosado 5% in Sodium Chloride 0.9%

Do not take a double dose to compensate for the missed dose.

If you interrupt treatment withKabiPacGlucosado 5% in Sodium Chloride 0.9%

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

Like all medications, this medication may produce adverse effects, although not all people 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 extended phlebitis from the injection site, extravasation, and hypervolemia.

In patients with non-osmotic vasopressin release, in patients with heart, liver, and kidney diseases, and in patients treated with vasopressin agonists, the risk of acute hyponatremia after administration of hypotonic solutions is increased. Hospital-acquired hyponatremia can cause irreversible brain damage and death due to the development of cerebral edema (see sections 2 and 3).

To avoid the risk of thrombophlebitis (inflammation of a vein by a blood clot), it is recommended to vary the catheter insertion site (every 24-48 hours).

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

Reporting 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 prospectus. You can also report them directly through the Spanish System of Pharmacovigilance for 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.

Do not store at a temperature above 25°C.

Keepthis medicationout of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Any remaining solution must be discarded after treatment.

Do not usethis medicationif you observethat the solution is not transparent and contains precipitates.

Medications should not be thrown into the drains or trash. Ask your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment.

Composition of KabiPac Glucosado 5% in Sodium Chloride 0.9%

The active principles are glucose and sodium chloride. Each 100 ml of solution contains 5 g of anhydrous glucose (as glucose monohydrate) and 0.9 g of sodium chloride.

The other components are: water for injection preparations,hydrochloric acid (for pH adjustment) and sodium hydroxide (for pH adjustment).

Osmolarity (theoretical): 586 mOsm/l

pH: 3.5 – 6.5

Cl-(theoretical): 154 mEq/l

Na+(theoretical): 154 mEq/l

Calories (theoretical): 200 kcal/l (837 kJ/l)

Appearance of the product and contents of the packaging

KabiPac Glucosado 5% in Sodium Chloride 0.9% is a transparent, colorless to slightly yellowish solution of glucose and sodium chloride in water for injection preparations.The solution is packaged in polyethylene flasks.It is available in packaging sizes of 100 ml, 250 ml, 500 ml and 1000 ml.Not all packaging sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder:

Fresenius Kabi España S.A.U.

Torre Mapfre-Vila Olímpica

C/ Marina 16-18,

08005-Barcelona (Spain)

Responsible for manufacturing:

LABESFAL – Laboratorios Almiro, S.A.

Lagedo (Santiago de Besteiros)

P-3465 157 Portugal

Fresenius Kabi España S.A.U.

C/ Dr. Ferran, 4

08339 Vilassar de Dalt (Barcelona)

Date of the last review of this leaflet: 07/2021

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

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This information is intended solely for healthcare professionals:

KabiPac Glucosado 5% in Sodium Chloride 0.9% is presented as a solution for intravenous administration and will be used in a hospital by the corresponding healthcare personnel.

KabiPac Glucosado 5% in Sodium Chloride 0.9% will be administered by infusion.

The contents of each package of KabiPac Glucosado 5% in Sodium Chloride 0.9% are for a single infusion.

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

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 patients and adolescents.

In pediatric patients, the infusion rate is 5 ml/kg/h on average, but this value varies with weight:

6-8 ml/kg/h for children between 0-10 kg of body weight,

4-6 ml/kg/h for children between 10-20 kg of body weight and

2-4 ml/kg/h for children >20 kg of body weight.

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 and adolescents to 10-18 mg/kg/min for infants and children depending on weight and total body mass.

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

Compatibility samples have been observed for different isotonic glucose 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, compatibility 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, 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, compatibility samples have been described when some medications are diluted in solutions containing chloride. Among them, amsacrina and trimetrexate glucuronate.