PATIENT INFORMATION LEAFLET

Freeflex Glucosalina infusion solution

Glucose and Sodium Chloride

1.What Freeflex Glucosalina is and what it is used for

2.Before using Freeflex Glucosalina

3.How to use Freeflex Glucosalina

4.Possible side effects

5.Storage of Freeflex Glucosalina

6.Further information

Freeflex Glucosalina is an intravenous infusion solution available in 250 ml, 500 ml, and 1000 ml bags.

This medication belongs to the group of intravenous solutions that affect electrolyte balance with carbohydrate hydrates.

Freeflex Glucosalina is indicated for:

-States of dehydration with moderate losses of electrolytes.

-Alterations of the hydrocarbonate metabolism.

-As a vehicle for the administration of medications and electrolytes.

Do not use Freeflex Glucosalina

-If you are allergic (hypersensitive) to the active ingredient or any of the other components of Freeflex Glucosalina.
Glucosalina.

-In states of hyperhydration (overload of fluid).

-In situations of generalized edema (accumulation of fluid in the body tissues) or ascitic cirrhosis (chronic progressive liver disease with fluid accumulation).

-In states of hyperglycemia (increase in blood glucose level).

-In states of hypernatremia (increase in sodium in the blood).

-In states of hyperchloremia (increase in chloride in the blood).

-In states of hyperosmolar coma (loss of consciousness due to an increase in the concentration of salts in the blood).

-In states of hyperlactacidemia (presence of lactic acid in the blood).
-In severe cases of heart, liver, or kidney failure.

-During the first 24 hours after a head trauma

Be especially careful with Freeflex Glucosalina

-It is recommended that regular blood tests be performed for glucose, electrolytes, water balance, and acid-base balance, as frequent and massive administration of glucosaline solutions can cause fluid overload (hyperhydration), acid-base balance alterations, and significant ionic depletions. In these cases, you will need to administer electrolyte supplements.

-You will be administered this medication with caution if you have the following diseases: hypertension, heart failure, peripheral or pulmonary edema, renal dysfunction, preeclampsia (symptoms that precede seizures and blood pressure drop in pregnant women), cardiac, hepatic, and/or renal alterations, or if you are an elderly patient

-Freeflex glucosalina will be administered with caution to premature and full-term infants.

-Your blood glucose level will be carefully determined if you have intracranial hypertension.

-If you have had an acute ischemic attack (sudden onset of blood flow deficiency), this medication should not be administered to you

-If you are administered this medication for a prolonged period, it is recommended to add potassium to the solution, as a safety measure.

-The administration of solutions containing glucose may cause vitamin B1 deficiency,

especially in cases of malnutrition.

-If you have diabetes mellitus, glucose-containing solutions can be used always

that initial appropriate treatment (insulin) has been established. Similarly, these solutions should be used with caution if you have Addison's disease or carbohydrate intolerance.

-Administration should be avoided in the same injection site due to the risk of thrombophlebitis.

Use of 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.

Certain medications may interact with Freeflex Glucosalina. In this case, it may be necessary to change the dose or interrupt the treatment of one of the medications.

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

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

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

-Digitalis glycosides (digoxin), there is a risk of increased digital activity, leading to the possibility of developing intoxications.

-Lithium carbonate, as the administration of sodium chloride accelerates renal excretion of lithium, resulting in a decrease in the therapeutic effect of the latter.

Pregnancy and lactation

Consult your doctor or pharmacist before using any medication.

In the case of pregnancy, your doctor will decide whether to use glucosaline solution, as it should be used with caution in this case.

Excessive administration of glucose-containing solutions during pregnancy can cause hyperglycemia, hyperinsulinemia, and fetal acidosis, and may be harmful to the newborn.

There is no evidence to suggest that Freeflex Glucosalina 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

There is no indication that Freeflex Glucosalina may affect the ability to drive or operate machines.

Follow exactly the administration instructions for Freeflex Glucosalina as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Your doctor will monitor your fluid balance and plasma glucose and electrolyte concentrations (especially sodium) during administration.

Your doctor will decide the dose and frequency at which the solution will be administered, which will depend on your age, weight, clinical condition (particularly hydration status) and the nature of any medication that may have been added to the solution.

Recommended dosing is:

For adults, elderly and adolescents: 500 ml to 3000 ml every 24 hours.

For infants and children:

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

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

-Weight above 20 kg:1500 ml + 20 ml/kg/24 h for weight above 20 kg

If you use more Freeflex Glucosalina than you should

If the administration of the glucosaline solution is not performed correctly and under control, some of the following signs of overdose may appear: hyperhydration, electrolyte imbalances and acid-base balance disturbances.

In case these requirements are not met and symptoms of intoxication appear, administration will be suspended and symptomatic treatment will be sought.

In case of overdose or accidental ingestion, consult the Toxicological Information Service.

Phone: 91 562 04 20.

Like all medications, Freeflex Glucosalina may produce adverse effects, although not all people will experience them.

Adverse reactions associated with the administration technique may include fever, infection at the injection site, local reaction or pain, venous irritation, venous thrombosis, or extended phlebitis from the injection site, extravasation, and hypervolemia.

Adverse reactions may be associated with the added medications in the solution; the nature of the added medications will determine the possibility of any other undesirable effect.

In case of adverse reactions, discontinue the infusion.

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.

Store below 25°C.

Keep out of the reach and sight of children.

Do not use Freeflex Glucosalina after the expiration date that appears on the packaging.

Do not use Freeflex Glucosalina if the solution is not transparent and contains precipitates.

Medicines should not be disposed of through the 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 Glucosalina

The active principles are glucose and sodium chloride. Each 100 ml of solution contains 3.5 g of anhydrous glucose (as monohydrate) and 0.35 g of sodium chloride.

The other components are: water for injections

Osmolarity (theoretical): 313 mOsm/l

pH: 3.2 – 6.5

Cl-(theoretical): 60 mmol/l

Na+(theoretical): 60 mmol/l

Calories (theoretical): 140 kcal/l

Appearance of the product and contents of the package

Freeflex Glucosalina is a clear, transparent, and colorless solution. It is presented in bags of 250 ml, 500 ml, and 1000 ml.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Fresenius Kabi España S.A.U

Torre Mapfre-Vila Olímpica

C/ Marina 16-18

08005-Barcelona (Spain)

Responsible for manufacturing

Fresenius Kabi España, S.A.U

Dr. Ferran, 4

Vilassar de Dalt (Barcelona)

08339, Spain

Fresenius Kabi Deutschland GmbH

Freseniusstraße, 1

61169 Friedberg

Germany

This leaflet has been revised in

December 2008

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This information is intended solely for doctors or healthcare professionals:

Freeflex Glucosalina is presented in the form of a solution for intravenous administration and will be used in a hospital by the corresponding healthcare personnel.

Freeflex Glucosalina will be administered by infusion.

The contents of each package of Freeflex Glucosalina are for a single infusion.

Once the package is opened, the solution must be administered immediately. Any unused portion must be discarded.

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

Administration rate:

The administration rate is normally 40 ml/kg/24 h in adults, elderly, and adolescents.

In pediatric patients, the administration rate is 5 ml/kg/h on average, but this value varies with age: 6-8 ml/kg/h for children under 12 months, 4-6 ml/kg/h for children 12-23 months, and 2-4 ml/kg/h for school-age children (2-11 years).

The administration rate should not exceed the patient's glucose oxidation capacity in order to avoid hyperglycemia. Therefore, the maximum dose ranges from 5 mg/kg/min for adults to 10-18 mg/kg/min for infants and children depending on age and total body mass.

To administer the solution and in the event of adding medications, maximum asepsis must be maintained.

In order to be able to add medications to the solution or administer them simultaneously with other medications, it must be checked that there are no incompatibilities.

It has been described that the glucosaline solution with a glucose content of 3.5% and sodium chloride of 0.35% is incompatible with mitomycin due to the low pH of this solution.

Similarly, incompatibility samples have been observed for different isotonic glucosaline solutions with: amoxicillin sodium, heparin sodium, imipenem-cilastatin sodium, and meropenem. However, these medications may be compatible with this type of solution depending on various factors such as the concentration of the medication (heparin sodium) or the time elapsed between dissolution and administration (amoxicillin sodium, imipenem-cilastatin sodium, and meropenem).

On the other hand, incompatibility samples have been described when some medications are diluted in solutions containing glucose, including: ampicillin sodium, lactate of amrinone, amoxicillin sodium/clavulanate acid, interferon alfa-2b, and procainamide chloride. However, lactate of amrinone or amoxicillin sodium/clavulanate acid may be injected directly into the injection site while these infusion solutions are being administered.

Also, incompatibility samples have been described when some medications are diluted in solutions containing chloride, including amsacrine and trimetrexate glucuronate.