Glucose 5% in sodium chloride 0.9% solution for infusion

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

KabiPac Glucose 5% in Sodium Chloride 0.9% infusion solution

Glucose and Sodium Chloride

Package leaflet contents:

1. What KabiPac Glucose 5% in 0.9% Sodium Chloride is and what it is used for
2. What you need to know before using KabiPac Glucose 5% in 0.9% Sodium Chloride
3. How to use KabiPac Glucose 5% in 0.9% Sodium Chloride
4. Possible side effects
5. Storage of KabiPac Glucose 5% in 0.9% Sodium Chloride
6. Contents of the pack and other information

1. What KabiPac Glucose 5% in Sodium Chloride 0.9% is and what it is used for

KabiPac Glucose 5% in Sodium Chloride 0.9% is an infusion solution used in conditions involving loss of water (dehydration) with moderate loss of salts (electrolytes), as a supportive solution for administering medications or electrolytes, or in cases of disturbances in carbohydrate (sugar) metabolism.

2. What you need to know before using 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 conditions of hyperhydration (fluid overload).
• In cases 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 cardiac, hepatic, or renal failure.
• During the first 24 hours following head trauma.

Warnings and precautions

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

• Regular blood tests to monitor glucose, electrolytes, fluid balance, and acid-base balance are advisable, as frequent and large-volume administration of glucose-saline solutions may cause fluid overload (hyperhydration), disturbances in acid-base balance, and significant ionic depletions. In such cases, electrolyte supplementation may be required.

• This medicine will be administered with caution if you have any of the following conditions: hypertension, heart failure, peripheral or pulmonary edema, renal dysfunction, preeclampsia (symptoms preceding seizures and drop in blood pressure in pregnant women), or cardiac, hepatic, and/or renal disorders, or if you are elderly.

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

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

• This medicine must not be administered if you have suffered an acute ischemic stroke (sudden onset of inadequate blood supply).

• If this medicine is administered over a prolonged period, it is recommended to add potassium to the solution as a safety measure.

• Administration of glucose-containing solutions may cause vitamin B1 deficiency, especially in cases of malnutrition.

• If you have diabetes mellitus, glucose-containing solutions may be used only if appropriate initial treatment (insulin) has been established. These solutions should also be used with caution if you have Addison's disease or carbohydrate intolerance.

• Repeated administration at the same injection site should be avoided due to the risk of thrombophlebitis.

Infusion of large volumes requires special monitoring in patients with cardiac or pulmonary insufficiency and in patients with non-osmotic release of vasopressin (including SIADH), due to the risk of hospital-acquired hyponatremia (see below).

Hyponatremia:

Patients with non-osmotic release of vasopressin (e.g., in critical conditions, pain, postoperative stress, infections, burns, and CNS disorders), patients with heart, liver, or kidney disease, and patients receiving vasopressin agonists are at particular risk of developing acute hyponatremia following infusion of hypotonic solutions.

Acute hyponatremia may cause acute hyponatremic encephalopathy (cerebral edema), characterized by headache, nausea, seizures, lethargy, and vomiting. Patients with cerebral edema are at particular risk of severe, irreversible, and potentially fatal brain damage.

Children, women of childbearing age, and patients with reduced cerebral compliance (e.g., in meningitis, intracranial hemorrhage, cerebral contusion, and cerebral edema) are at particular 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.

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Certain medicines may interact with KabiPac Glucose 5% in Sodium Chloride 0.9%. In such cases, it may be necessary to adjust the dose or discontinue treatment with one 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 these medicines reduce the effect of glucose.

• Corticosteroids, due to the risk of increased blood glucose or because of their ability to retain sodium and water.

• Digitalis glycosides (digoxin), as increased digitalis activity may occur, increasing the risk of toxicity.

• Lithium carbonate, as administration of sodium chloride accelerates renal excretion of lithium, leading to reduced therapeutic effect.

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 perfusion solutions (see sections 3 and 4).

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

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

? Vasopressin analogues; 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, breastfeeding, and fertility

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

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

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

There is no evidence suggesting that KabiPac Glucose 5% in Sodium Chloride 0.9% may cause adverse effects in the neonate during lactation. Nevertheless, caution is recommended during this period.

Driving and use of machines

There is no indication that KabiPac Glucose 5% in Sodium Chloride 0.9% affects the ability to drive or operate machinery.

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

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

Your fluid balance and plasma levels of glucose and electrolytes (especially sodium) will be monitored during administration.

Your doctor will decide the dose and frequency at which the solution will be administered, based on your age, body weight, clinical condition (particularly hydration status), and the nature of any medications 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:

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

• 20 kg body weight: 1500 ml + 20 ml/kg/24 h for body weight above 20 kg

You may need to have your fluid balance, serum glucose, serum sodium, and other electrolytes monitored before and during administration, especially if you have increased non-osmotic release of vasopressin (syndrome of inappropriate antidiuretic hormone secretion, SIADH), or if you are simultaneously receiving treatment with vasopressin agonists, due to the risk of hyponatremia. Monitoring of serum sodium is particularly important when physiologically hypotonic solutions are administered. 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 0.9% Sodium Chloride than you should

If the administration of the glucose-saline solution is not properly and carefully controlled, one or more of the following signs of overdose may occur: fluid overload, electrolyte disturbances, and acid-base imbalance.

If these requirements are not met and symptoms of intoxication occur, administration must be discontinued and symptomatic treatment initiated.

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

Telephone: 91 562 04 20.

If you forget to use KabiPac Glucose 5% in 0.9% Sodium Chloride

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

If you stop treatment with KabiPac Glucose 5% in 0.9% Sodium Chloride

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Adverse reactions related to the administration technique may occur, 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, or kidney disease, and in patients treated with vasopressin agonists, there is an increased risk of developing acute hyponatremia following administration of hypotonic solutions. Hospital-acquired hyponatremia may cause irreversible brain damage and death due to cerebral edema (see sections 2 and 3).

To minimize the risk of thrombophlebitis (inflammation of a vein due to a blood clot), it is recommended to rotate the catheter insertion site regularly (every 24–48 hours).

Adverse reactions may also be associated with medications added to the solution; the nature of the added medications will determine the possibility of any additional undesirable effects.

If adverse reactions occur, the infusion should be discontinued.

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 can also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

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

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 stated on the container after EXP. The expiry date refers to the last day of the month indicated.

Any unused solution should be discarded after treatment.

Do not use this medicine if you notice that the solution is not clear or contains precipitates.

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.

6. Package contents and other information

Composition of KabiPac 5% Glucose in 0.9% Sodium Chloride

The active substances 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 injections, 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)

Appearance of the product and contents of the pack

KabiPac 5% Glucose in 0.9% Sodium Chloride is a clear, colourless to slightly yellowish solution of glucose and sodium chloride in water for injections. The solution is packed in polyethylene bottles. It is available in pack sizes of 100 ml, 250 ml, 500 ml, and 1000 ml. Not all pack sizes may be commercially available.

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 – 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 most recent revision of this leaflet: 07/2021

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es

<----------------------------------------------------------------------------------------------------------------------

This information is intended for healthcare professionals only:

KabiPac 5% Glucose in 0.9% Sodium Chloride is provided as a solution for intravenous administration and will be used in a hospital setting by appropriate healthcare personnel.

KabiPac 5% Glucose in 0.9% Sodium Chloride is administered by infusion.

The contents of each KabiPac 5% Glucose in 0.9% Sodium Chloride container are intended for single infusion use only.

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

The solution should be clear and free from precipitates. Do not administer if otherwise.

Rate of administration:

The infusion rate is normally 40 ml/kg/24 hours in adults, elderly patients, and adolescents.

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

• 6–8 ml/kg/h for children weighing 0–10 kg,
• 4–6 ml/kg/h for children weighing 10–20 kg, and
• 2–4 ml/kg/h for children >20 kg 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 in adults and adolescents to 10–18 mg/kg/min in infants and children, depending on body weight and total body mass.

To administer the solution, and especially when adding medications, strict aseptic technique must be maintained.

When adding medications to the solution or administering concomitantly with other drugs, compatibility must be verified.

Incompatibilities have been reported for various isotonic glucose-saline solutions with the following: sodium amoxicillin, sodium heparin, sodium imipenem-cilastatin, and meropenem. However, these medications may be compatible with this type of solution depending on various factors, such as drug concentration (sodium heparin), or the time interval between reconstitution and administration (sodium amoxicillin, sodium imipenem-cilastatin, and meropenem).

In addition, incompatibilities have been described when certain medications are diluted in glucose-containing solutions, including: sodium ampicillin, amrinone lactate, sodium amoxicillin/clavulanic acid, interferon alfa-2b, and procainamide hydrochloride. Nevertheless, amrinone lactate or sodium amoxicillin/clavulanic acid may be injected directly into the injection site while these infusion solutions are being administered.

Incompatibilities have also been reported when certain drugs are diluted in chloride-containing solutions, including amsacrine and trimetrexate glucuronate.