PATIENT INFORMATION LEAFLET
Dextrose Fresenius Kabi 50% solution for infusion

Glucose

DEXTROSA FRESENIUS KABI 50% is a solution for infusion that is presented in glass bottles of 100 ml and 500 ml.

DEXTROSA FRESENIUS KABI 50% belongs to the group of Intravenous solutions for parenteral nutrition – carbohydrate hydrates and is indicated for:

-Treatment of hypertonic dehydration caused by vomiting, diarrhea, intense sweating, etc.

-Metabolic acid-base disturbances: hypoglycemia (decrease in blood glucose levels), insulin coma, acetone vomiting.

-Parenteral nutrition with volume restriction.

No use Dextrosa Fresenius Kabi 50%:

-If you are allergic (hypersensitive) to the active ingredient or any of the other components of Dextrosa Fresenius Kabi 50%.
Fresenius Kabi 50%.

-If there is an excess of glucose, diabetes mellitus, or intolerance to sugars.

-If there is hypotonic dehydration (loss of water along with electrolytes), electrolyte imbalance, and in patients who present with intracranial or intraspinal hemorrhages 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 flow, and therefore oxygen, to an area of the brain), as excessive glucose worsens ischemia and recovery.

Advertencias and precautions

Be especially careful with Dextrosa Fresenius Kabi 50%

It is especially important to perform frequent checks of the fluid balance, ionic balance (especially potassium and sodium) and blood sugar levels. If necessary, insulin will be administered: one unit per 10 g of glucose. Similarly, it is 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 glucoseuria. Similarly, patients should be monitored to observe the appearance of 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.

Prolonged treatments with glucose by intravenous route can reduce insulin production, so your doctor will evaluate the administration of insulin

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

For states of hypoglycemia (decrease in blood glucose levels) in newborns or young children, it is recommended to use less concentrated solutions (10-25%).

It should be checked for the compatibility of this solution with any additive before its use.

These solutions should not be administered through the same infusion equipment used or that will be used for the administration of blood, as there is a possibility of agglutination.

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

You have any type of heart, liver, and 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 normal regulation of blood water content is altered due to increased secretion of vasopressin, 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, cerebral edema, and death; therefore, these symptoms (acute symptomatic hyponatremic encephalopathy) are considered a medical emergency. (See section 4. Possible side effects)

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

Use of Dextrosa Fresenius Kabi 50% with other medications

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

The concomitant use of Dextrosa Fresenius Kabi 50% with other medications may 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 antidiabetic agents (biguanides, sulfonylureas) may lead to a reduction in the therapeutic effectiveness of these latter. If you are given glucose along with digitalis glycosides (digoxin), there may be an increase in digitalis activity, with the risk of developing intoxication by these medications.

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

Medications that lead to an increase in vasopressin effect (see section Advertencias and precautions), for example:

• Medications that stimulate the release of vasopressin (e.g. antipsychotics, narcotics)
• Medications that potentiate the action of vasopressin (e.g. non-steroidal anti-inflammatory drugs)

• Medications that act like vasopressin, called vasopressin analogs

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

Pregnancy and lactation

Consult your doctor or pharmacist before using any medication.

This medication should be administered with special caution in pregnant women during delivery, especially if it is 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, so the fetus itself is responsible for insulin synthesis. Therefore, it should be administered with caution in pregnant women. Infusions above 10 g/hour cause increases in fetal insulin.

The use of large amounts of glucose solution at the time of delivery, 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 with caution during the lactation period.

Driving and operating machinery

It is not recommended due to its characteristics of use.

S ee exactly the administration instructions for Dextrosa Fresenius Kabi 50% as 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 aseptic conditions for injectable solutions.

The dose and infusion rate will 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 excessive glucose include:

- excessive urine production that can lead to severe dehydration

- alterations in the balance of salts in the blood (hyperosmolar hyperglycemic state) that can cause altered consciousness, seizures, and coma.

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

Like all medications, Dextrosa Fresenius Kabi 50% may produce adverse effects, although not everyone will experience them.

The intravenous administration of glucose solutions may cause fluid and electrolyte imbalances, including edema (swelling), decreased levels of potassium, calcium, magnesium, and phosphorus. Elevated glucose concentrations may also occur due to decreased potassium levels. In these cases, glucose levels in the blood normalize by administering potassium without the need to administer insulin.

The direct intravenous administration of concentrated glucose solutions may cause pain, venous irritation, and thrombophlebitis (inflammation of the veins with a clot).

Exceeding the mentioned doses may result in abnormally elevated levels of bilirubin and lactate in the blood.

Headache, nausea, convulsions, lethargy. This may be caused by low sodium levels in the blood. When sodium levels in the blood decrease significantly, water enters the brain cells and causes inflammation. This results in increased intracranial pressure and causes hyponatremic encephalopathy.

If you consider any of the adverse effects you are experiencing to be severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Keep out of the reach and sight of children.

No special storage conditions are required.

Dextrosa Fresenius Kabi 50% Composition

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

The other components are: water for injection.

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

Theoretical calories: 2000 kcal/l

Product appearance and packaging contents

Dextrosa Fresenius Kabi 50% is a clear and particle-free solution in suspension. 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 revised in

August 2018

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This information is intended solely for medical professionals or healthcare professionals:

Handle in the usual aseptic conditions when using perfusion solutions.

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

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

Administer directly via central vein. When administered diluted to a concentration of 10% or less, a peripheral vein may be used.

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

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

General advice

May need to monitor water balance, serum glucose, serum sodium, and other electrolytes before and during administration, especially in patients with increased non-osmotic vasopressin release (SIADH syndrome) and patients receiving concomitant medication with vasopressin agonists due to the risk of hyponatremia.

Monitoring serum sodium is especially important in products with lower sodium concentrations compared to serum sodium concentrations. 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 free water supply and may lead to severe hyponatremia.