Label: information for the user

Freeflex Sodium Chloride 0.9%

sodium chloride

Read this label carefully before starting to use this medication, as it contains important information for you.

• Keep this label, as you may need to refer to it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only for you, and you should not give it to others who have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this label. See section 4.

Freeflex Sodium Chloride 0.9% is an intravenous infusion solution presented in freeflex 50 ml, 100 ml, 250 ml, 500 ml, and 1000 ml bags, with an overbag for intravascular administration of water, sodium, and chlorides.

It is indicated for:

• Ionic reequilibrium by chloride and sodium supply
• Extracellular dehydration
• Hypovolemia

Do not use Freeflex Sodium Chloride 0.9%

If you are allergic to the active ingredient or to any of the other components of this medication (listed in section 6).

If you have acidosis, hyperchloremia, hypokalemia, renal and/or cardiac insufficiency, hypernatremia, hyperhydration, general edema, hypertension, liver insufficiency, or if you are undergoing prolonged treatment with corticosteroids or ACTH.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Freeflex Sodium Chloride 0.9%.

Other medications and Freeflex Sodium Chloride 0.9%

No interactions have been observed with other preparations.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before using this medication.

No studies have been conducted on this population. Given the characteristics of the preparation, the benefit/risk ratio will be evaluated.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose should be adjusted according to the patient's weight and level of dehydration.

If you use more Freeflex Sodium Chloride 0.9% than you should

Given the nature of its components, overdoses have not been described.

Excessive dose intake may lead to hyponatremia with dehydration of internal organs and hyperchloremic acidosis.

Hypertension. Acute edema.

In case of overdose or accidental ingestion, consult the Toxicological Information Service. Phone (91) 562 04 20.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

No adverse effects have been described, but if any adverse reaction attributable to the medication is produced, consult your doctor or pharmacist.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacistorpharmacist, even if it is about possible adverse effects that do not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use website: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Composition of Freeflex Sodium Chloride 0.9%

• The active ingredient is sodium chloride. Each 100 ml of solution contains 0.9 g of sodium chloride.
• The only excipient is water for injection.

Theoretical osmolality: 308 mosmol/l

Appearance of the product and contents of the package

Injectable solution for intravenous infusion in freeflex® bags of 50 ml, 100 ml, 250 ml, 500 ml, and 1000 ml, with overbag.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Fresenius Kabi España, S.A.U.

C/ Marina 16-18,

08005-Barcelona

Responsible for manufacturing:

Fresenius Kabi Deutschland GmbH

Werk Friedberg Freseniusstraβe 1

D-61169 Friedberg

Fresenius Kabi France, S.A.

6, Rue du Rempart, B.P. 611

(Louviers) F-27400 France

HP Halden Pharma AS

Svinesundsveien 80

1788 Halden

Norway

Fresenius Kabi India PVT. LTD.

A-3 MIDC, Ranajangoan Ganpati, ‘tal. Shirur.

412220Maharashtra

India

Last review date of this leaflet: March 2023.

The detailed and updated information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.es

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This information is intended solely for healthcare professionals:

INSTRUCTIONS FOR THE CORRECT ADMINISTRATION OF THE PREPARATION

Visual inspection

1. Do not remove the freeflex?from its overbag until the moment immediately before its use.
2. Check the composition, batch number, and expiration date.
3. Inspect the set by checking the integrity of the primary packaging. Do not use if the primary packaging is not intact.

Removal of the overbag

Some freeflex?have an overbag as protection during storage. The overbag, with a "peel" opening system, can be removed as follows:

1. Locate the tabs at the end where the ports of the bag are.
2. Separate the two halves of the overbag, leaving the bag on a clean surface.

Preparation for administration

The freeflex?bags are designed for administration without air entry. If a perfusion equipment with air entry is to be used, ensure that it is always closed.

1. Press the freeflex?to ensure that it has no leaks and examine the solution to observe the presence of visible particles or precipitates. DO NOT ADMINISTER IF THE SOLUTION IS NOT TRANSPARENT AND/OR THE BAG IS NOT INTACT.
2. Using an aseptic technique, prepare the perfusion equipment with the closed flow regulator.
3. Identify the administration port (blue) in the form of an arrow indicating the exit of the bag.
4. Remove the protective cap from the administration port of the freeflex?, holding firmly the lower tabs with one hand and breaking the cap in the form of an arrow by a sustained rotation.
5. Hold the administration port, placing your fingers behind the protective cap and push the needle of the administration equipment into the port. You should feel a slight resistance when the membrane of the port breaks. To prevent leaks, insert the needle to the bottom of the administration port.
6. Suspend the bag on the hanger and purge the administration equipment according to the manufacturer's instructions. Perform the venipuncture and immediately connect the administration equipment to the intravenous cannula. Adjust the flow regulator to the desired flow rate.
7. The freeflex?are calibrated to indicate the approximate volume infused. The scale should be read by stretching the bag and reading the volume on the surface of the liquid. For a more accurate measurement of the volume of fluid, a perfusion equipment with a measurement chamber should be used.

Adding medication

The freeflex?have a port for the addition of medications independent and with a self-closing cap. Since the port is protected by a hermetically welded protective cap, it is not necessary to disinfect the addition site of the medication before its first use.

Adding medications with syringes

1. Identify the port for the addition of medications (white) in the form of an arrow indicating an entry flow into the bag.
2. Using an aseptic technique, prepare a syringe with the medication, using a 20-22 G needle.
3. Remove the protective cap from the port for the addition of medications from the bag, holding firmly the lower tabs with one hand and breaking the cap in the form of an arrow by a sustained rotation.
4. Hold the port for the addition of medications, placing your fingers behind the protective cap and insert the needle completely, so that it penetrates the outer cap and the internal membrane. Its rigid construction prevents the needle from penetrating the sides of the port.
5. Add the medication and withdraw the needle. To prevent any aerosol formation, you should maintain a sterile cotton swab around the cap.

The following maximum volumes of addition are recommended:

Freeflex?bag size (ml)Maximum recommended addition (ml)

1. 50

1. 50

1. 100

1. 150

1. 250

NOTE: Additives may be incompatible, so expert advice should be sought before adding medication to freeflex?. If the doctor decides to add medication, it must be used with an aseptic technique. It is recommended that the medication be added only under the supervision of a pharmacist. Do not store solutions to which medication has been added.

1. Shake and press the freeflex?to ensure a complete mixing of the medication. With dense medications such as potassium chloride, it is recommended to press both ports while the bag is in a vertical position and invert the bag several times.
2. If necessary, a protective cap can be placed over the port for the addition of medications to prevent further additions.

Adding medications with reconstitution equipment

1. Identify the port for the addition of medications (white) in the form of an arrow indicating an entry flow into the bag.
2. Remove the protective cap from the port for the addition of medications from the bag, holding firmly the lower tabs with one hand and breaking the cap in the form of an arrow by a sustained rotation.
3. Using an aseptic technique, remove the reconstitution equipment from its packaging and push the narrow end onto the port for the addition of medications so that the tabs of the port adjust with the grooves of the reconstitution equipment. Stop when the upper surface of the tabs reaches the first stop of the groove. In this position, the upper surface of the needle of the reconstitution equipment is between the cap and the internal membrane, so that fluid cannot escape from the freeflex?.
4. Using an aseptic technique, prepare the vial of the medication and connect it to the open end of the reconstitution equipment.
5. Connect the medication to the intravenous solution by rotating the reconstitution equipment so that the tabs of the port adjust with the internal groove and push the vial and the reconstitution equipment until the upper surface of the tabs reaches the second stop.
6. With the vial inverted, press and release the freeflex?several times to transfer solution to the vial of the medication. Shake to dissolve the medication.NOTE:If the medication is a liquid, this step 6 can be omitted.
7. Invert the freeflex?so that the vial is on top of the bag and transfer the medication to the bag by pressing and releasing the bag several times to push the sterile air out of the vial.
8. If the solubility of the medication is low, it may be necessary to repeat steps 6 and 7.
9. When the transfer is complete, remove the reconstitution equipment from the freeflex?and dispose of the vial and reconstitution equipment in a safe place. The reconstitution equipment is designed for single use and should not be used for further additions to this or another freeflex?.

NOTE: Additives may be incompatible, so expert advice should be sought before adding medication to freeflex?. If the doctor decides to add medication, it must be used with an aseptic technique. It is recommended that the medication be added only under the supervision of a pharmacist. Do not store solutions to which medication has been added.

1. Shake and press the freeflex?to ensure a complete mixing of the medication. With dense medications such as potassium chloride, it is recommended to press both ports while the bag is in a vertical position and invert the bag several times.
2. If necessary, a protective cap can be placed over the port for the addition of medications to prevent further additions.

Warnings:

1. Do not vent
2. Do not administer if the solution is not transparent and the freeflex?is not intact
3. Stop the perfusion if adverse reactions appear
4. It is recommended that the perfusion equipment be changed at least once every 24 hours