KABIPAC GLUCOSATED 5% IN SODIUM CHLORIDE 0.9% SOLUTION FOR INFUSION

2. What you need to know before you use KabiPac Glucose 5% in Sodium Chloride 0.9%

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

• If you are allergic to the active substance or to any of the other components of this medicine (listed in section 6).
• 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).
• In states of hyperglycemia (elevated blood glucose levels).
• In states of hypernatremia (elevated sodium levels in the blood).
• In states of hyperchloremia (elevated chloride levels in the blood).
• In states of hyperosmolar coma (loss of consciousness due to increased salt concentration in the blood).
• In states of hyperlactatemia (presence of lactic acid in the blood).
• In severe cases of heart, liver, or kidney failure.
• During the first 24 hours after a head injury.

Warnings and Precautions

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

• It is recommended that you undergo regular analytical controls in blood glucose, electrolyte, water balance, and acid-base balance, as frequent and massive administration of glucose-saline 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 medicine 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 decreased tension in pregnant women), cardiac, hepatic, and/or renal disorders, or if you are an elderly patient.

• KabiPac Glucose 5% in Sodium Chloride 0.9% will be administered with caution in premature infants and full-term infants.

• Blood glucose levels will be carefully determined if you have intracranial hypertension.

• If you have had an acute ischemic attack (sudden onset of lack of blood flow), this medicine should not be administered to you.

• If this medicine 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 provided that you have initially received appropriate treatment (insulin). 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.

The infusion of large volumes will require special monitoring in patients with heart or lung failure and in patients with non-osmotic vasopressin release (including SIADH), due to the risk of hospital-acquired hyponatremia (see below).

Hyponatremia:

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

Other Medicines and KabiPac Glucose 5% in Sodium Chloride 0.9%

Use of KabiPac Glucose 5% in Sodium Chloride 0.9% with other medicines.

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Certain medicines may interact with KabiPac Glucose 5% in Sodium Chloride 0.9%. In this case, it may be necessary to change the dose or interrupt treatment with one of the medicines.

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

• Insulin or oral antidiabetics (biguanides, sulfonylureas), as these medicines decrease the effect of glucose.
• Corticosteroids due to the risk of increased blood glucose levels or the ability of these medicines to retain sodium and water.
• Digitalis glycosides (digoxin), as there may be an increase in digitalis activity, 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.

Medicines that potentiate the effect of vasopressin

The following medicines increase the effect of vasopressin, which reduces the renal excretion of water without electrolytes and increases the risk of hospital-acquired hyponatremia after inadequately balanced treatment with intravenous infusion solutions (see sections 3 and 4).

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

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

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

Other medicines that are known to increase the risk of hyponatremia are also diuretics in general and antiepileptics such as oxcarbazepine.

Pregnancy, Breastfeeding, and Fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

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

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

There is no evidence to suggest that KabiPac Glucose 5% in Sodium Chloride 0.9% can cause adverse effects during the breastfeeding period in the neonate. However, it is recommended to use with caution during this period.

Driving and Using Machines

There is no indication that KabiPac Glucose 5% in Sodium Chloride 0.9% can affect the ability to drive or use machines.

3. How to Use KabiPac Glucose 5% in Sodium Chloride 0.9%

Follow exactly the administration instructions of this medicine as indicated by your doctor. If you are unsure, consult your doctor or pharmacist again.

They will monitor your fluid balance and plasma concentrations of glucose and electrolytes (especially sodium) during administration.

Your doctor will decide on the dose and frequency at which you will be administered the solution, depending on your age, weight, clinical situation (particularly the state of hydration), 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:

• From 0 to 10 kg body weight: 100 ml/kg/24 h
• From 10 to 20 kg body weight: 1000 ml + 50 ml/kg/24 h for weight above 10 kg
• > 20 kg body weight: 1500 ml + 20 ml/kg/24 h for weight above 20 kg

You may need to monitor your fluid balance, blood glucose, serum sodium, and other electrolytes before and during administration, especially if you have non-osmotic vasopressin release (SIADH) and if you are receiving vasopressin agonist medication simultaneously, due to the risk of hyponatremia. Monitoring of serum sodium is especially important when administering physiologically hypotonic solutions. This medicine may become hypotonic after administration due to the rapid metabolism of glucose in the body (see sections 2 and 4).

If You Use More KabiPac Glucose 5% in Sodium Chloride 0.9% Than You Should

If the administration of the glucose-saline solution is not carried out correctly and controlled, some 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 any symptoms of intoxication, administration will be suspended, and symptomatic treatment will be used.

In case of overdose or accidental ingestion, consult the Toxicology Information Service.

Telephone: 91 562 04 20.

If You Forget to Use KabiPac Glucose 5% in Sodium Chloride 0.9%

Do not take a double dose to make up for forgotten doses.

If You Stop Using KabiPac Glucose 5% in Sodium Chloride 0.9%

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

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Adverse reactions can occur associated with the administration technique, 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.

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

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

Adverse reactions can be associated with the medicines added to the solution; the nature of the added medicines will determine the possibility of any other undesirable effects.

In case of adverse reactions, the infusion should be discontinued.

Reporting of Side Effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of KabiPac Glucose 5% in Sodium Chloride 0.9%

Do not store above 25°C.

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

Do not use this medicine after the expiry date which is stated on the packaging after EXP. The expiry date is the last day of the month shown.

Any remaining solution should be discarded after treatment.

Do not use this medicine if you notice that the solution is not transparent and contains precipitates.

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

6. Container Contents and Additional Information

Composition of KabiPac Glucosated 5% in Sodium Chloride 0.9%

The active ingredients 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 injectable preparations, hydrochloric acid (for pH adjustment) and sodium hydroxide (for pH adjustment).

Osmolality (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)

Product Appearance and Container Contents

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

Marketing Authorization Holder and Manufacturer

Holder:

Fresenius Kabi España S.A.U.

Torre Mapfre-Vila Olímpica

C/ Marina 16-18,

08005-Barcelona (Spain)

Manufacturer:

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 Last Revision of this Prospectus: 07/2021

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 healthcare professionals:

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

KabiPac Glucosated 5% in Sodium Chloride 0.9% will be administered by perfusion.

The contents of each container of KabiPac Glucosated 5% in Sodium Chloride 0.9% are for a single perfusion.

Once the container 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 patients, and adolescents.

In pediatric patients, the perfusion 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 perfusion 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 addition of medications, maximum asepsis should be maintained.

In order to add medications to the solution or to administer them simultaneously with other medications, it should be checked that there are no incompatibilities.

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

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

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