DEXTROSE FRESENIUS KABI 50% SOLUTION FOR INFUSION

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USERDextrosa Fresenius Kabi 50% solution for infusion

Glucose

Contents of the pack:

1. What Dextrosa Fresenius Kabi 50% is and what it is used for
2. Before you use Dextrosa Fresenius Kabi 50%
3. How to use Dextrosa Fresenius Kabi 50%
4. Possible side effects
5. Storage of Dextrosa Fresenius Kabi 50%
6. Further information

1. What DEXTROSA FRESENIUS KABI 50% is and what it is used for

Dextrosa Fresenius Kabi 50% is a solution for infusion presented in glass bottles of 100 ml and 500 ml.

Dextrosa Fresenius Kabi 50% belongs to the group of Intravenous solutions for parenteral nutrition - carbohydrates and is indicated for:

• Treatment of hypertonic dehydration caused by vomiting, diarrhea, excessive sweating, etc.
• Disorders of carbohydrate metabolism: hypoglycemia (decreased glucose levels in the blood), insulin coma, acetonemic vomiting.
• Parenteral nutrition with volume restriction.

2. Before using DEXTROSA FRESENIUS KABI 50%

Do not use Dextrosa Fresenius Kabi 50%:

• If you are allergic (hypersensitive) to the active substance or any of the other components of Dextrosa Fresenius Kabi 50%.
• If there is an excess of glucose, diabetes mellitus, or sugar intolerance.
• If there is hypotonic dehydration (loss of water along with electrolytes), electrolyte imbalance, and in patients with intracranial or intraspinal hemorrhage and in cases of delirium tremens with dehydration.

In patients with anuria (suppression of urine formation) and in diabetic coma, hepatic coma.

• In patients with ischemic cerebral vascular accidents (deficient blood supply, and therefore oxygen, to an area of the brain), since excess glucose worsens ischemia and recovery.

Warnings and precautions

Be especially careful with Dextrosa Fresenius Kabi 50%.

It is especially important to frequently monitor the balance of fluids, ions (especially potassium and sodium), and blood sugar levels. If necessary, insulin will be administered: one unit per 10 g of glucose. It is also advisable to monitor the possible decrease in potassium (hypokalemia) and sodium (hyponatremia) levels in the blood.

In patients with sodium deficiency, the administration of sodium-free solutions may cause peripheral circulatory collapse and oliguria (decreased urine production).

The too rapid administration of glucose solutions at high concentrations can cause an increase in blood glucose levels and hyperosmolar syndrome. It is recommended to monitor glucosuria. Similarly, patients should be monitored for signs of mental confusion and loss of consciousness, especially those with chronic uremia or carbohydrate intolerance.

Your doctor will pay special attention if you are elderly.

Long-term treatments with glucose by intravenous route can reduce insulin production, so your doctor will assess the administration of insulin.

When the administration of concentrated glucose solutions is discontinued, it may be convenient to administer glucose at 5-10% to alleviate possible rebound hypoglycemia.

For states of hypoglycemia (decreased glucose levels in the blood) in neonates or young children, the use of less concentrated solutions (10-25%) is recommended.

The compatibility of this solution with any additive should be checked before use. These solutions should not be administered using the same infusion equipment used or to be used for blood administration, as there is a possibility of agglutination.

If you suffer from critical conditions, pain, postoperative stress, infections, burns, or central nervous system diseases.

You have any type of heart, liver, or kidney disease and are being treated with a medication that increases the effect of vasopressin (a hormone that regulates water retention in the body) because it may increase the risk of acquiring low sodium levels in the blood (hyponatremia) in the hospital (see the section "Other medications and Dextrosa Fresenius Kabi 50%").

All patients should be closely monitored. In cases where the normal regulation of blood water content is altered due to increased vasopressin secretion, also called Antidiuretic Hormone (ADH), the perfusion of fluids with a low concentration of sodium chloride (hypotonic fluids) may result in low sodium levels in the blood (hyponatremia). This can cause headache, nausea, convulsions, lethargy, coma, brain inflammation (cerebral edema), and death; therefore, these symptoms (acute symptomatic hyponatremic encephalopathy) are considered a medical emergency (see the section 4. Possible side effects).

Children, women of childbearing age, and patients with brain diseases such as meningitis, cerebral hemorrhage, brain contusion, and cerebral edema have a special risk of suffering from severe and potentially fatal brain inflammation caused by acute hyponatremia.

Using Dextrosa Fresenius Kabi 50% with other medications

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

The combined use of Dextrosa Fresenius Kabi 50% with other medications can alter the effectiveness of both treatments.

The administration of glucocorticoids, diuretics, diphenylhydantoin, chlorpromazine increases blood glucose levels.

The intravenous administration of glucose in patients treated with insulin or oral antidiabetics (biguanides, sulfonylureas) may lead to a reduction in the therapeutic effectiveness of these medications. If glucose is administered together with digitalis glycosides (digoxin), an increase in digitalis activity may occur, with the risk of developing intoxication from these medications.

Your doctor will check the compatibility of this solution with any additive before use. These solutions should not be administered using the same infusion equipment used or to be used for blood administration, as there is a possibility of agglutination.

Medications that lead to an increase in the effect of vasopressin (see the section "Warnings and precautions"), such as:

• Medications that stimulate the release of vasopressin (e.g., antipsychotics, narcotics)
• Medications that potentiate the action of vasopressin (e.g., non-steroidal anti-inflammatory medications)
• Medications that act like vasopressin, called vasopressin analogs

Other medications that increase the risk of hyponatremia, including diuretics in general and antiepileptics.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

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

Glucose crosses the placenta, while insulin does not. Therefore, the fetus itself is responsible for insulin synthesis. For this reason, it should be administered with caution in pregnant women. Infusions greater than 10 g/hour cause increases in fetal insulin.

The use of large amounts of glucose solution during childbirth, especially in complicated deliveries, may lead to hyperglycemia (high blood glucose levels), hyperinsulinemia (high insulin levels), and fetal acidosis, and may be harmful to the newborn. Therefore, it should be used with caution during pregnancy.

It is also recommended to use it with caution during the breastfeeding period.

Driving and using machines

This is not applicable due to the characteristics of its use.

3. How to use DEXTROSA FRESENIUS KABI 50%

Follow the instructions for administration of Dextrosa Fresenius Kabi 50% indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Dextrosa Fresenius Kabi 50% will be administered by healthcare personnel, only by intravenous infusion (directly into a vein) under the usual conditions of asepsis for the use of injectable solutions.

The dose and infusion rate depend on the patient's weight, needs, and clinical situation. In most cases, the recommended dose is 1.5-3.0 g/kg/day or 0.5 g/kg/h.

The time and infusion rate will be controlled by a healthcare professional.

If you use more Dextrosa Fresenius Kabi 50% than you should

The symptoms of excess glucose include:

• excessive urine production that can lead to severe dehydration
• alterations in the balance of salts in the blood (plasma hyperosmolarity) that can cause alterations in consciousness, convulsions, and coma.

If you are not hospitalized, go to the nearest hospital or consult the Toxicology Information Service. Phone: 91 562 04 20.

4. Possible side effects

Like all medications, Dextrosa Fresenius Kabi 50% can cause side effects, although not everyone gets them.

Intravenous administration of glucose solutions can cause alterations in fluids and electrolytes, including edema (swelling), decreased potassium, calcium, magnesium, and phosphorus levels. High glucose concentrations due to decreased potassium may also occur. In these cases, blood glucose levels are normalized by administering potassium and without the need for insulin.

Direct administration of concentrated glucose solutions into a vein can cause pain, venous irritation, and thrombophlebitis (inflammation of the veins with a clot).

If the mentioned doses are exceeded, bilirubin and lactate values in the blood may reach abnormally high levels.

Headache, nausea, convulsions, lethargy. This can 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 cranial pressure and causes hyponatremic encephalopathy.

If you experience any of the side effects, talk to your doctor or pharmacist.

5. Storage of DEXTROSA FRESENIUS KABI 50%

Keep out of the reach and sight of children.

No special storage conditions are required.

6. FURTHER INFORMATION

Composition of Dextrosa Fresenius Kabi 50%

The active substance is glucose. Each 100 ml of solution contains 50 g of glucose (as monohydrate 55 g).

The other components are: water for injectables.

Theoretical osmolality: 2775 mosm/l pH: 3.5-6.5

Theoretical calories: 2000 kcal/l

Appearance of the product and package contents

Dextrosa Fresenius Kabi 50% is a clear and particle-free solution. It is presented in 100 ml and 500 ml bottles.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Fresenius Kabi España S.A.

C/ Marina 16-18

08005-Barcelona (Spain)

Manufacturer:

Fresenius Kabi Italia S.r.l.

Via Camagre, 41/43

37063 Isola della Scala – Verona

Italy

This leaflet was last revised in

August 2018

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This information is intended only for healthcare professionals:

Handle under the usual conditions of asepsis for the use of infusion solutions.

Once the package is opened, discard the unused portion of the solution. The contents of each package of Dextrosa Fresenius Kabi 50% are for single use only.

When administering the solution, ensure the proper placement of the needle in the vein, as this is a hypertonic solution, and its extravasation can cause significant tissue irritation.

In case of direct administration, it will be done through a central vein. When administered diluted to a concentration of 10% or less, a peripheral vein can be used.

The solution must be transparent and free of precipitates. Do not administer otherwise.

Before adding medications to the solution or administering them simultaneously with other medications, check for incompatibilities.

General advice

It may be necessary to monitor the balance of fluids, blood glucose, serum sodium, and other electrolytes 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 medication with vasopressin agonists due to the risk of hyponatremia.

Monitoring of serum sodium is especially important in products with a lower concentration of sodium compared to serum sodium concentration. After perfusion of Dextrosa Fresenius Kabi 50%, a rapid and active transport of glucose to the body's cells occurs. This condition promotes an effect that can be considered as a supply of free water and may lead to severe hyponatremia.