FREEFLEX GLUCOSALINA SOLUTION FOR INFUSION

2. BEFORE USING FREEFLEX GLUCOSALINA

Do not use Freeflex Glucosalina

• If you are allergic (hypersensitive) to the active substance or to any of the other components of Freeflex Glucosalina.
• In states of hyperhydration (fluid overload).
• In situations of generalized edema (fluid accumulation in body tissues) or ascitic cirrhosis (chronic progressive liver disease with fluid accumulation).
• In states of hyperglycemia (elevated blood glucose levels).
• In states of hypernatremia (elevated sodium levels in the blood).
• In states of hyperchloremia (elevated chloride levels in the blood).
• In states of hyperosmolar coma (loss of consciousness due to increased salt concentration in the blood).
• In states of hyperlactatemia (presence of lactic acid in the blood). In severe cases of cardiac, hepatic, or renal failure.
• During the first 24 hours after a head injury.

Special warnings and precautions for use

• It is recommended that regular analytical controls be performed on blood 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, it will be necessary to administer electrolyte supplements.
• This medicine will be administered with caution if you have the following diseases: hypertension, heart failure, peripheral or pulmonary edema, renal dysfunction, preeclampsia (symptoms preceding convulsions and decreased blood pressure in pregnant women), cardiac, hepatic, and/or renal disorders, or if you are an elderly patient.
• Freeflex Glucosalina will be administered with caution to premature and full-term infants.
• Blood glucose levels will be carefully determined if you have intracranial hypertension.
• If you have had an acute ischemic attack (sudden lack of blood flow), this medicine should not be administered to you.
• If this medicine is administered 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 a deficiency of vitamin B1, especially in cases of malnutrition.

If you have diabetes mellitus, solutions containing glucose can be used as long as you have initially received adequate treatment (insulin). Similarly, these solutions should be used with caution if you have Addison's disease or carbohydrate intolerance.

• Continuous administration at the same injection site should be avoided due to the risk of thrombophlebitis.

Using other medicines

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

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

It is essential that you inform your doctor if you are using any of the following medicines:

• Insulin or oral antidiabetics (biguanides, sulfonylureas), as these medicines decrease the effect of glucose.
• Corticosteroids due to the risk of increased blood glucose levels or the ability of these medicines to retain sodium and water.
• Digitalis glycosides (digoxin), as an increase in digitalis activity may occur, with the risk of developing intoxication.
• Lithium carbonate, as the administration of sodium chloride accelerates the renal excretion of lithium, leading to a decrease in the therapeutic effect of the latter.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

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

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

There is no evidence to suggest that Freeflex Glucosalina can cause adverse effects during the breastfeeding period in the newborn. However, it is recommended to use with caution during this period.

Driving and using machines

There is no indication that Freeflex Glucosalina can affect the ability to drive or use machines.

3. HOW TO USE FREEFLEX GLUCOSALINA

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

They will monitor your fluid balance and plasma concentrations of glucose and electrolytes (especially sodium) during administration.

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

The recommended dosage is:

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

For babies and children:

• From 0 to 10 kg of body weight: 100 ml/kg/24 h
• From 10 to 20 kg of body weight: 1000 ml + 50 ml/kg/24 h for weight above 10 kg
• > 20 kg of body weight: 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 carried out correctly and under control, some signs of overdose may appear: hyperhydration, electrolyte alterations, and acid-base balance alterations.

In case of non-compliance with these requirements and the presence of symptoms of intoxication, administration will be suspended, and symptomatic treatment will be resorted to.

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

Phone: 91 562 04 20.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Freeflex Glucosalina can cause side effects, although not everybody gets them.

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

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

In case of adverse reactions, the infusion should be interrupted.

If you experience any of the following serious side effects, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. STORAGE OF FREEFLEX GLUCOSALINA

Store below 25°C.

Keep out of the reach and sight of children.

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

Do not use Freeflex Glucosalina 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 the packaging and any unused medicines. This will help protect the environment.

6. FURTHER INFORMATION

Composition of Freeflex Glucosalina

The active substances 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 injectables.

Osmolality (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 packaging contents

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

Marketing authorization holder and manufacturer

Marketing authorization holder

Fresenius Kabi España S.A.U.

Torre Mapfre-Vila Olímpica

C/ Marina 16-18

08005-Barcelona (Spain)

Manufacturer

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 was last revised in

December 2008

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This information is intended only for healthcare professionals:

Freeflex Glucosalina is presented as 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 single infusion only.

Once the package is opened, the solution should be administered immediately. The unused fraction should be discarded.

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

Administration rate:

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

In pediatric patients, the infusion 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 between 12-23 months, and 2-4 ml/kg/h for school-age children (2-11 years).

The infusion rate should not exceed the patient's glucose oxidation capacity 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 weight.

To administer the solution and in case of adding medications, maximum asepsis should be maintained.

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

On the other hand, samples of incompatibility have been described when certain medications are diluted in solutions containing glucose, among them: ampicillin sodium, amrinone lactate, amoxicillin sodium/acid clavulanic, interferon alfa-2b, procainamide hydrochloride. However, amrinone lactate or amoxicillin sodium/acid clavulanic can be injected directly into the injection point while these infusion solutions are being administered.

Additionally, samples of incompatibility have been described when certain medications are diluted in solutions containing chloride, among them: amsacrine and trimetrexate glucuronate.