PATIENT INFORMATION LEAFLET

Freeflex Glucosa 5% infusion solution

Glucose

1.What is Freeflex Glucosa 5% and what is it used for

2.Before using Freeflex Glucosa 5%

3.How to use Freeflex Glucosa 5%

4.Possible side effects

5.Storage of Freeflex Glucosa 5%

6.Further information

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

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.

Do not use Freeflex Glucosa 5%

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

-If you have been diagnosed with hypotonic dehydration, loss of electrolytes, or decreased urine volume.

-Within the first 24 hours after a head trauma.

-In states of hyperglycemia or increased blood glucose levels.

-In states of hyperhydration (fluid overload)

-In cases of generalized edema (accumulation of fluid in the 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

Be especially careful with Freeflex Glucosa 5%

-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 related to increased ischemic brain damage and difficulty in recovery.

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

-Regular blood glucose and electrolyte controls, as well as water balance and acid-base balance, are recommended, as frequent and massive administration of glucose solutions through veins (parenteral) may cause fluid overload (hyperhydration) and significant ionic depletions. In this case, electrolyte supplements may be necessary.

-Potassium may be administered along with glucose solution to prevent hypokalemia (low potassium levels in the blood) produced during prolonged parenteral glucose feeding.

-If you are malnourished, you may have a deficiency of vitamin B1. This vitamin is essential for glucose metabolism, so this deficiency must 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 must be regularly monitored in diabetic patients and insulin requirements adjusted.

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

-If administered continuously in the same perfusion site, it may cause thrombophlebitis (inflammation of the veins).

-Be especially cautious in 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, 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 developing hyponatremia (low sodium levels in the blood) in the hospital. (See the section Other medications and Freeflex Glucosa 5%)

All patients must 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 may 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 brain inflammation caused by acute hyponatremia.

Other medications and Freeflex Glucosa 5%

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 (glucosides): If intravenous glucose administration coincides with digoxin treatment, there is a risk of developing digoxin intoxication.

-Medications that increase the effect of vasopressin (see the section Warnings and precautions), for example:

• Medications that stimulate vasopressin release (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 must 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 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 may elevate blood glucose and insulin levels as well as acidic components in the blood of the fetus.

No evidence suggests that 5% glucose 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 machinery

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

Follow exactly the administration instructions for Freeflex Glucosa 5% 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 Freeflex Glucosa 5% 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 you are not admitted to a hospital, go to the nearest hospital or contact the Toxicological Information Service. Phone: 91 562 04 20.

Like all medications, Freeflex Glucosa 5% may produce adverse effects, although not everyone 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 fluid volume 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 can be prevented by reducing 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 sodium levels in the blood drop significantly, water enters the brain cells and causes inflammation. 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 whether or not to discontinue the medication.

If used as a vehicle for administering other medications, the nature of the added medications will determine the probability 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 conservation conditions are required.

Keep out of the reach and sight of children.

Do not use Freeflex Glucosa 5% after the expiration date that appears on the packaging.

Do not use Freeflex Glucosa 5% 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 medicines that you no longer need. This will help protect the

environment.

Composition of Freeflex Glucosa 5%

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

Appearance of the product and contents of the packaging

Freeflex Glucosa 5% is a transparent 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.

Holder of the marketing authorization and responsible for manufacturing

Holder:

Fresenius Kabi España S.A.U

C/ Marina 16-18

08005-Barcelona (Spain)

Responsible for manufacturing:

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 has been reviewed in February 2022

--------------------------------------------------------------------------------------------------------------------

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

This medication will be administered at all times by specialized personnel. It will be administered by perfusion, either 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 any unused portion.

Use an aseptic method to administer the solution and in the event of preparing mixtures.

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

General advice

You 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 release of vasopressin (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 Freeflex Glucosa 5%, 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.