Kabipac Glucosalino glucose and sodium chloride solution for infusion

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

KabiPac Glucosalino solution for infusion

Glucose and Sodium chloride

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

Contents of this leaflet:

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

1. What KabiPac Glucosaline is and what it is used for

KabiPac Glucosaline is an intravenous infusion solution available in 100 ml, 250 ml, 500 ml, and 1000 ml bottles.

This medicine belongs to the group of intravenous solutions that affect electrolyte balance with carbohydrates.

KabiPac Glucosaline is indicated for:

• States of dehydration with moderate electrolyte losses.
• Alterations in carbohydrate metabolism.
• As a vehicle for the administration of drugs and electrolytes.

2. What you need to know before using KabiPac Glucosaline

Do not use KabiPac Glucosaline

• If you are allergic (hypersensitive) to the active substance or to any of the other components of
  KabiPac Glucosaline.
• In states of hyperhydration (fluid overload).
• In cases of generalized edema (accumulation of fluid in body tissues) or ascitic cirrhosis
  (chronic progressive liver disease with fluid accumulation).
• In states of hyperglycemia (increased blood glucose levels).
• In states of hyponatremia (decreased sodium levels in blood).
• In states of hypochloremia (decreased 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 after a head injury.

Warnings and precautions

• Regular blood tests to monitor glucose, electrolytes, fluid balance, and acid-base equilibrium are recommended, 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 necessary.

• 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 an elderly patient.

• KabiPac Glucosaline will be administered with caution in premature infants and full-term neonates.

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

• If you have suffered an acute ischemic stroke (sudden onset of insufficient blood supply), this medicine should not be administered to you.

• If this medicine is administered over a prolonged period, it is recommended to add potassium to the solution as a precautionary 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 provided that appropriate treatment (insulin) has been initiated. 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.

  • 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 medicine that enhances the effect of vasopressin (a hormone regulating the body's water retention), you may be at increased risk of developing hospital-acquired low blood sodium levels (hyponatremia). (See section "Other medicines and KabiPac Glucosaline.")

All patients must be closely monitored. In situations 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.

Use of KabiPac Glucosaline with other medicines

Inform your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription, as it may be necessary to interrupt treatment or adjust the dose of one or more of them.

Certain medicines may interact with KabiPac Glucosaline. In such cases, it may be necessary to change 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 these medicines reduce the effect of glucose.
• Corticosteroids, due to the risk of increased blood glucose levels or because of the ability of these medicines to retain sodium and water.
• Digitalis glycosides (digoxin), as increased digitalis activity may occur, increasing the risk of toxicity.
• Lithium carbonate, since administration of sodium chloride accelerates renal excretion of lithium,
  leading to a reduction in its therapeutic effect.
• Medicines that increase the effect of vasopressin (see section "Warnings and precautions"), for example:
  • Medicines that stimulate vasopressin release (e.g., antipsychotics, narcotics)
  • Medicines that potentiate the action of vasopressin (e.g., non-steroidal anti-inflammatory drugs)
  • Medicines that act like vasopressin, known as vasopressin analogues
  • Other medicines that increase the risk of hyponatremia, including diuretics in general and antiepileptic drugs.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

This medicine should be administered with special caution in pregnant women during childbirth, especially if administered in combination with oxytocin (a hormone that may be given to induce labor and control bleeding), due to the risk of hyponatremia.

During pregnancy, your doctor will decide whether it is appropriate to use KabiPac Glucosaline, as it should be used cautiously in this case.

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

There is no evidence suggesting that KabiPac Glucosaline may cause adverse effects during lactation in the neonate. Nevertheless, caution is recommended during this period.

Driving and using machines

There is no indication that KabiPac Glucosaline may affect the ability to drive or operate machinery.

3. How to use KabiPac Glucosalino

Follow exactly the administration instructions for KabiPac Glucosalino given by your doctor. Consult your doctor or pharmacist if you have any doubts.

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

Your doctor will determine the dose and frequency at which the solution will be administered, based on your age, weight, clinical condition (particularly hydration status), and the nature of any medications that may have been added to the solution.

The recommended dosage is:

For adults, elderly, and adolescents: 500 ml to 3000 ml 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 weight above 10 kg

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

If you use more KabiPac Glucosalino than you should

If the glucosaline solution is not administered correctly and under proper control, one or more of the following signs of overdose may occur: hyperhydration, electrolyte disturbances, and acid-base imbalance.

If these conditions 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.

4. Possible adverse effects

Like all medicines, KabiPac Glucosalino can cause adverse effects, although not everyone will experience them.

Adverse reactions related to the administration technique may occur, including fever, injection site infection, local reaction or pain, venous irritation, venous thrombosis or phlebitis extending from the injection site, extravasation, and hypervolemia.

Headache, nausea, seizures, lethargy. These may be caused by low sodium levels 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.

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

If adverse reactions occur, the infusion should be discontinued.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or nurse, 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 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 Glucosalino

No special storage conditions are required.

Keep out of the sight and reach of children.

Do not use KabiPac Glucosalino after the expiry date stated on the container.

Do not use KabiPac Glucosalino if the solution is not clear and contains precipitates.

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

6. Contents of the pack and other information

Composition of KabiPacGlucosalino

The active substances are glucose and sodium chloride. Each 100 ml of solution contains 3.3 g of glucose (as monohydrate) and 0.3 g of sodium chloride.

The other component is: water for injections.

Osmolality (theoretical): 285 mOsm/L
pH: 3.2 – 6.5
Cl⁻ (theoretical): 51.3 mmol/L
Na⁺ (theoretical): 51.3 mmol/L
Calories (theoretical): 132 kcal/L

Appearance of the product and pack contents

KabiPac Glucosalino is a clear, transparent and colourless solution.

KabiPac Glucosalino is available in polyethylene KabiPac bottles of the following capacities:

1 bottle of 100 ml
1 bottle of 250 ml
1 bottle of 500 ml
1 bottle of 1000 ml
20 bottles of 100 ml
20 bottles of 250 ml
10 bottles of 500 ml
10 bottles of 1000 ml

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Fresenius Kabi España S.A.U.
Marina 16-18,
08005-Barcelona (Spain)

Manufacturer:

FRESENIUS KABI ESPAÑA, S.A.U.
Dr. Ferran, 12 (Vilassar de Dalt) – 08339 - Spain

FRESENIUS KABI DEUTSCHLAND GMBH
Freseniusstrasse 1 (Friedberg) - D-61169 - Germany

LABESFAL - LABORATORIOS ALMIRO S.A.
Lagedo (Santiago de Besteiros) - P-3465 157 - Portugal

FRESENIUS KABI POLSKA SP. Z.O.O.
Sienkiewicza, 25 (Kutno) - P-99-300 - Poland

This leaflet was last reviewed in April 2021------------------------------------------------------------------------------------------------------------------------

This information is intended for healthcare professionals only:

KabiPac Glucosalino is supplied as a solution for intravenous administration and will be used in a hospital setting by appropriate medical staff.

KabiPac Glucosalino is administered by infusion.

The contents of each KabiPac Glucosalino container are intended for single infusion use only.

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

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

Rate of administration:

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

In pediatric patients, the infusion rate is on average 5 ml/kg/h, but this value varies with age: 6–8 ml/kg/h for children under 12 months, 4–6 ml/kg/h for children aged 12–23 months, and 2–4 ml/kg/h for school-aged children (2–11 years).

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 to 10–18 mg/kg/min in infants and children, depending on age and total body mass.

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

To add medications to the solution or to administer concomitantly with other drugs, compatibility must first be verified.

The 3.3% glucose and 0.3% sodium chloride solution has been reported to be incompatible with mitomycin due to the low pH of this solution.

In addition, incompatibilities have been observed with various isotonic glucose-saline solutions containing: sodium amoxicillin, sodium heparin, sodium imipenem-cilastatin, and meropenem. However, these medications may be compatible with such solutions 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).

Furthermore, incompatibilities have been reported when certain drugs are diluted in glucose-containing solutions, including: sodium ampicillin, amrinone lactate, sodium amoxicillin/clavulanic acid, interferon alfa-2b, and procainamide hydrochloride. However, 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.

General advice

Monitoring of fluid balance, serum glucose, serum sodium, and other electrolytes may be required before and during administration, particularly 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 especially important when administering products with a lower sodium concentration compared to serum sodium levels. Following infusion of KabiPac Glucosalino, there is rapid and active transport of glucose into body cells. This condition promotes an effect equivalent to the administration of free water and may lead to severe hyponatremia.