FREEFLEX GLUCOSA 5% SOLUTION FOR INFUSION

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Freeflex Glucose 5% solution for infusion

Glucose

Contents of the package leaflet:

1. What is Freeflex Glucose 5% and what is it used for
2. Before using Freeflex Glucose 5%
3. How to use Freeflex Glucose 5%
4. Possible side effects
5. Storage of Freeflex Glucose 5%
6. Further information

1. What is FREEFLEX GLUCOSE 5% and what is it used for

Freeflex Glucose 5% is an intravenous infusion solution presented in bags of 100 ml containing 50 ml or 100 ml of solution, bags of 250 ml, 500 ml, and 1000 ml.

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

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

2. Before using FREEFLEX GLUCOSA 5%

Do not use Freeflex Glucose 5%

• if you are allergic (hypersensitive) to the active substance or to any of the other components of Freeflex Glucose 5%
• if you have been diagnosed with hypotonic dehydration, loss of salts, or decreased urine volume.
• in the first 24 hours after a head injury.
• in states of hyperglycemia or increased blood glucose levels.
• in states of hyperhydration (fluid overload)
• in situations of generalized edema (fluid accumulation in body tissues)
• if you have hyperlactacidemia (presence of lactic acid in the blood)
• if you suffer from significant glucose tolerance disorders, including hyperosmolar coma.

Warnings and precautions

Be especially careful with Freeflex Glucose 5%

• Blood glucose levels should be carefully monitored in cases of intracranial hypertension.
• In case of having suffered acute ischemic attacks (decreased or absent circulation in arteries), since hyperglycemia has been related to an increase in ischemic cerebral damage and difficulty in recovery.
• In case of shock and acid-base balance disorders. In patients with sodium deficiency, the administration of sodium-free solutions can produce peripheral circulatory collapse and oliguria (low urine secretion).
• It is recommended that regular analytical controls be performed on blood glucose and electrolytes and water and acid-base balance, since the frequent and massive administration of glucose solutions through the veins (parenteral) can cause fluid overload (hyperhydration) and significant ionic depletions. In this case, it will be necessary to administer electrolyte supplements.
• Along with glucose solution, potassium may be administered to avoid hypokalemia (low potassium levels in the blood) produced during prolonged parenteral nutrition with glucose.
• If you have malnutrition, you may have a vitamin B1 deficiency. This vitamin is essential for glucose metabolism, so if necessary, this deficiency should be corrected first.
• If you have diabetes. In this case, glucose solutions can be used as long as you have initially received adequate treatment (insulin). Blood glucose levels should be regularly monitored in diabetic patients and insulin requirements modified.
• Do not administer blood simultaneously using the same administration equipment as this medication.
• If administered continuously in the same infusion site, thrombophlebitis (inflammation of the veins) may occur.
• If you are an elderly patient, special attention will be paid to you, as you may have affected liver and/or kidney function.
• Do not administer intramuscularly.
• 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 Freeflex Glucose 5%).

All patients should be closely monitored. In cases where normal blood water content regulation is altered due to increased vasopressin secretion, also known as Antidiuretic Hormone (ADH), the 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, brain inflammation (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 diseases such as meningitis, cerebral hemorrhage, cerebral contusion, and cerebral edema have a special risk of suffering severe and potentially fatal brain inflammation caused by acute hyponatremia.

Other medications and Freeflex Glucose 5%

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.

It is important that you inform your doctor if you are using any of the following medications:

• Insulin or oral antidiabetics (biguanides, sulfonylureas): these medications decrease the effect of glucose.
• Corticosteroids: due to the risk of increased blood glucose levels or the ability of these medications to retain sodium and water.
• Digitalis glycosides (digoxin): if intravenous glucose administration coincides with treatment with digitalis glycosides (digoxin), there is a risk of developing toxicity from these medications.
• Medications that lead to an increase in the effect of vasopressin (see the section Warnings 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 medications).
• Medications that act like vasopressin, called vasopressin analogs.

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

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

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. In case of pregnancy, your doctor will decide the convenience of using a 5% glucose solution, as it should be used with caution in this case. The administration of glucose intravenously during pregnancy may increase glucose and insulin levels as well as acidic components in the fetal blood.

There is no evidence to suggest that 5% Glucose can cause adverse effects during the breastfeeding period in the neonate. However, it is recommended to use with caution during this period.

Driving and using machines

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

3. How to use FREEFLEX GLUCOSE 5%

Follow the instructions for administration of Freeflex Glucose 5% indicated by your doctor. Consult your doctor or pharmacist if you have doubts.

It is generally recommended to administer intravenously drop by drop according to your age, body weight, clinical situation, and metabolic state.

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

In children, the infusion rate depends on the age and weight of the child 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.

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

If you use more Freeflex Glucose 5% than you should

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

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

4. Possible side effects

Like all medicines, Freeflex Glucose 5% can cause side effects, although not everybody gets them.

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

On the other hand, hyperglycemia resulting from rapid or excessive infusion should be monitored in severe cases of diabetes mellitus, and can be avoided by decreasing the dose and infusion rate or by administering insulin.

A local reaction may occur at the injection site.

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

Whenever any of these adverse reactions occur, you should inform your doctor, who will assess whether or not to discontinue the medication.

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

If you think any of the side effects that you are suffering from is serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. Storage of FREEFLEX GLUCOSE 5%

No special storage conditions are required.

Keep out of the reach and sight of children.

Do not use Freeflex Glucose 5% after the expiration date stated on the packaging.

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

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. FURTHER INFORMATION

Composition of Freeflex Glucose 5%

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

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

Isotonic, apyrogenic, and sterile solution

Theoretical osmolality: 278 mosm/l

pH: 3.5-6.5

Theoretical calories: 200 kcal/l

Appearance of the product and packaging contents

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

Marketing authorization holder and manufacturer

Holder:

Fresenius Kabi España S.A.U

C/ Marina 16-18

08005-Barcelona (Spain)

Manufacturer:

Fresenius Kabi France, S.A.

6, Rue du Rempart, B.P. 611

(Louviers) F-27400 France

Fresenius Kabi Deutschland, GmbH

Freseniusstraße 1

61169 Friedberg

Germany

HP Halden Pharma AS

Svinesundsveien 80

1788 Halden

Norway

This leaflet was last revised in February 2022

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This information is intended only for doctors or healthcare professionals:

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

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

The content of each package is for a single infusion; the unused fraction must be discarded.

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

Before adding medications to the solution or administering them simultaneously with other medications, it should be checked that there are no incompatibilities.

General advice

It may be necessary to monitor water balance, blood glucose, serum sodium, and other electrolytes before and during administration, especially in patients with increased non-osmotic vasopressin release (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 lower sodium concentration compared to serum sodium concentration. After infusion of Freeflex Glucose 5%, rapid and active transport of glucose to body cells occurs. This condition promotes an effect that can be considered as a supply of free water and can lead to severe hyponatremia.