PATIENT INFORMATION LEAFLET

Glucose 5% Mein solution for infusion

Glucose

Glucosa 5% Mein is an intravenous infusion solution presented in 100 ml bottles containing 50 ml or 100 ml of solution, 250 ml, 500 ml, and 1000 ml bottles.

It belongs to the group of parenteral nutrition solutions intended for the provision of water and energy.

It is indicated for the treatment of hypertonic dehydration (vomiting, diarrhea, profuse sweating, gastrointestinal fistulas), as an energy source in parenteral nutrition when oral food intake is limited, in carbohydrate metabolism disorders (hypoglycemia, insulin coma, hepatic coma, acetone vomiting) and as a vehicle for the administration of compatible medications.

No use Glucosa 5% Mein

-If you are allergic (hypersensitive) to the active ingredient or any of the other components of Glucosa 5% Mein

-If you have been diagnosed with hypotonic dehydration, electrolyte loss, or decreased urine volume

-Within the first 24 hours after a head trauma

-In states of hyperglycemia or elevated blood glucose levels

-In states of hyperhydration (fluid overload)

-In cases of generalized edema (fluid accumulation in body tissues)

-If you have hyperlactacidemia (presence of lactic acid in the blood)

-If you have significant alterations in glucose tolerance, including hyperosmolar coma

Warnings and Precautions

Take special care with Glucosa 5% Mein

-Blood glucose levels must be closely monitored in cases of intracranial hypertension

-In cases of acute ischemic attacks (decreased or absent circulation in arteries), as hyperglycemia has been associated with increased ischemic brain damage and difficulty in recovery

-In cases of shock and acid-base balance disturbances. In patients with sodium deficiency, the administration of sodium-free solutions may cause peripheral circulatory collapse and oliguria (scanty urine production)

-Regular blood glucose and electrolyte analyses, as well as water balance and acid-base balance, are recommended, as frequent and massive intravenous administration of glucose solutions may cause fluid overload and significant ionic depletions. In this case, electrolyte supplements may be necessary

-Potassium may be administered alongside glucose solution to prevent hypokalemia (low potassium levels in the blood) caused by prolonged parenteral glucose feeding

-If malnutrition is present, you may have a deficiency of vitamin B1, which is essential for glucose metabolism. This deficiency should be corrected first if necessary

-If you have diabetes. In this case, glucose solutions can be used as long as initial appropriate treatment (insulin) has been established. Blood glucose levels should be regularly monitored in diabetic patients and insulin requirements adjusted

-Do not administer blood simultaneously using the same administration equipment as this medication

-Continuous administration in the same perfusion site may cause thrombophlebitis (inflammation of the veins)

-Special attention should be given to elderly patients, as they may have impaired liver and/or kidney function

-Do not administer by intramuscular route

• If you have critical states, 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 developing hyponatremia (low sodium levels in the blood) in the hospital. (See the section Other Medications and Glucosa 5% Mein)

All patients should be closely monitored. In cases where normal regulation of blood water content is altered 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 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 the section 4. Possible Side Effects)

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

Other Medications and Glucosa 5% Mein

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.

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

-Insulin or oral antidiabetic medications (biguanides, sulfonylureas): these medications decrease the effect of glucose

-Corticosteroids: due to the risk of increased blood glucose or the ability of these medications to retain sodium and water

-Digoxin (glucoside): If intravenous glucose administration coincides with treatment with digoxin, there is a risk of developing digoxin toxicity

-Medications that increase 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., nonsteroidal anti-inflammatory drugs)

• Medications that act like vasopressin, known as vasopressin analogs

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

In any case, the doctor should check the compatibility of the added medications.

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.

In the case of pregnancy, your doctor will decide whether to use 5% glucose solution, as it should be used with caution in this case. The administration of glucose by intravenous route during pregnancy can elevate blood glucose and insulin levels as well as acidic components in the blood of the fetus.

No evidence suggests that 5% glucose solution may cause adverse effects during the lactation period in the neonate. However, it is recommended to use with caution during this period.

Driving and Operating Machines

It is not advisable, due to the characteristics of its use.

Follow exactly the administration instructions for Glucosa 5% Mein as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Administration is usually recommended intravenously drop by drop according to your age, body weight, clinical condition, and metabolic state.

In adults, the maximum dose is 40 ml/kg body weight/day and the maximum perfusion rate is 5 ml/kg body weight/hour = 0.25 g/kg body weight/hour.

In children, the perfusion rate depends on the child's age and weight, and generally should not exceed

10-18 mg of glucose (0.2-0.36 ml of solution)/kg/min.

0-10 kg: 100 ml/kg/24h

10-20 kg: 1000 ml + 50 ml/kg/24 h for weight above 10 kg.

More than 20 kg: 1500 ml + 20 ml/kg/24h for weight above 20 kg.

If you use more Glucosa 5% Mein than you should

In case of overdose, hyperglycemia, glucosuria (presence of glucose in urine), hyperhydration, or electrolyte disorders may appear. Administration will be suspended and symptomatic treatment will be sought.

If not admitted to a hospital, go to the nearest hospital or consult the Toxicological Information Service. Phone: 91 562 04 20.

Like all medications, Glucosa 5% Mein may produce adverse effects, although not all people will experience them.

It may cause hyperglycemia, glucosuria (glucose in urine) or alterations in fluid or electrolyte balance if administered too quickly or if the volume of fluid is excessive, or in cases of metabolic insufficiency.

On the other hand, hyperglycemia resulting from rapid infusion or excessive fluid volume should be monitored in severe cases of diabetes mellitus, and may be prevented by reducing the dose and infusion rate or by administering insulin.

A local reaction may occur at the site of injection.

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

Whenever any of these adverse reactions occur, you should inform your doctor, who will evaluate the need to discontinue the medication.

If used as a vehicle for administering other medications, the nature of the added medications will determine the likelihood of other adverse reactions.

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.

No special storage conditions are required.

Keep out of the reach and sight of children.

Do not use Glucose 5% Mein after the expiration date that appears on the packaging.

Do not use Glucose 5% Mein if the solution is not transparent and contains precipitates.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and unused medicines. This will help protect the environment.

Glucose 5% Mein Composition

The active ingredient is glucose. Each 100 ml of solution contains 5 g of glucose (as monohydrate 5.5 g).

The other components are: water for injection, hydrochloric acid for pH adjustment.

Isotonic solution, apyrogenic and sterile

Theoretical osmolality: 278 mosm/l pH: 3.5-6.5

Theoretical calories: 200 kcal/l

Product appearance and packaging contents

Glucose 5% Mein is a transparent and colorless solution, without visible particles. It is presented in 100 ml flasks containing 50 ml or 100 ml of solution, 250 ml, 500 ml and 1000 ml flasks

Marketing Authorization Holder

Fresenius Kabi España S.A.

C/ Marina 16-18

08005-Barcelona (Spain)

ManufacturerFresenius Kabi Italia S.R.L.

Via Camagre, 41/43

37063 Isola della Scala - Verona

(Italy)

This leaflet has been revised in

August 2018

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

This medication will be administered always by specialized personnel. It will be administered by perfusion, through a central or peripheral vein.

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

The contents of each package are for a single perfusion, discard the unused fraction.

Use an aseptic method to administer the solution and in case of preparation of mixtures.

Before adding medications to the solution or administering simultaneously with other medications, check that there are no incompatibilities.

General advice

May need to monitor the 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 in patients receiving concomitant medication with vasopressin agonists due to the risk of hyponatremia.

Monitoring serum sodium is especially important in products with a lower sodium concentration compared to serum sodium concentration. After perfusion of Glucosa 5% Mein, 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.