PATIENT INFORMATION LEAFLET
Sodium Chloride Fresenius Kabi 5.84% Injectable Solution

In this leaflet:

1. What CLORURO DE SODIO FRESENIUS KABI is and what it is used for
2. Before using CLORURO DE SODIO FRESENIUS KABI
3. How to use CLORURO DE SODIO FRESENIUS KABI
4. Possible side effects
5. Storage of CLORURO DE SODIO FRESENIUS KABI
6. Further information

SODIUM CHLORIDE FRESENIUS KABI is an injectable solution, belonging to the group of medications known as electrolyte solutions.

SODIUM CHLORIDE FRESENIUS KABI is indicated for the treatment of severe hyponatremia (low sodium levels in the blood) of various causes

Do not use FRESSENIEU KABI SODIUM CHLORIDE:

• if you are allergic (hypersensitive) to the active ingredient or to any of the other components of Sodium Chloride Fresenius Kabi.
• if you have edema (excessive accumulation of fluid)
• if you have eclampsia (convulsions not attributed to another cause during pregnancy)
• if you have hypernatremia (high sodium content in blood)

Be especially careful with SODIUM CHLORIDE FRESSENIEU KABI:

Sodium chloride should be used with extreme caution in patients with heart failure, severe renal insufficiency (significant decrease in kidney function), liver cirrhosis (chronic progressive liver disease), and those receiving corticosteroids or corticotropin (medicines used as anti-inflammatory agents). It should also be used with caution in elderly patients and those recovering from surgery.

Excessive chlorine in the body may cause a loss of bicarbonate with a consequent decrease in pH. Excessive intravenous administration of sodium chloride may also lead to low potassium levels in the blood.

The coexistence of insufficient blood oxygenation and low sodium levels in the blood may cause brain damage even in the absence of any correction of low sodium levels in the blood.

It should be administered with caution in patients with high blood pressure.

If administered continuously in the same injection site, it may cause pain, infection, and phlebitis (inflammation of the wall of a vein).

Consult your doctor, even if any of the circumstances mentioned above have occurred at any time.

Use of other medications:

Before mixing with other medications, check the compatibility tables, take into account the pH, and control the ions.

The concurrent administration of sodium chloride and corticosteroids or corticotropin (medicines used as anti-inflammatory agents) may lead to excessive fluid accumulation due to the sodium they contain.

It is clinically important to consider the interaction of sodium with lithium (a medicine used for the treatment of some psychiatric diseases). Excessive sodium may prevent the establishment of adequate lithium levels, and conversely, a deficiency of sodium chloride may lead to an increase in lithium levels to toxic values.

Be aware that these instructions may also apply to medications that have been used before or may be used afterwards.

Inform your doctor or pharmacist if you are using or have used recently any other medication, including those acquired without a prescription.

Pregnancy and breastfeeding:

Consult your doctor or pharmacist before using any medication.

The safety of its use during pregnancy and breastfeeding has not been established. Therefore, it should be used only when clearly necessary and when the beneficial effects justify the possible risks to the fetus or infant.

Driving and operating machines:

It is not advisable due to its characteristics of use.

Follow exactly the administration instructions for Fresenius Kabi Sodium Chloride as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Doses will be adjusted according to the patient's needs based on medical criteria, including age, weight, clinical status, fluid balance, ion balance, and acid-base balance.

Fresenius Kabi Sodium Chloride is administered via intravenous, intramuscular, or subcutaneous routes.

No asepsis is required before opening the ampule. No cutting tool is necessary to open the ampule. Once the ampule is opened, the nozzle fits perfectly onto the cone of the syringe (Luer cone), making it unnecessary to use a needle.

To open, separate one ampule from the rest by rotating it counterclockwise without touching the head and neck of the ampules (1). Shake the ampule with a single motion as shown in the drawing to remove any liquid that may be in the stopper (2). To open the ampule, rotate the body and head of the ampule in opposite directions until it breaks at the neck (3). Connect the Luer or Luer-lock syringe as shown in the drawing (4).

The solution does not contain any type of preservative or bactericide, so opened and unused ampules must be discarded immediately.

If you use more FRESENIUS KABI SODIUM CHLORIDE than you should:

Accidental overdose may lead to symptoms described for excessive sodium in the blood, and measures will be taken to decrease the high sodium content in the blood.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, indicating the medication and amount used. It is recommended to bring the packaging and leaflet to the healthcare professional.

Like all medications, FRESENIUS KABI SODIUM CHLORIDE may have adverse effects.

Since sodium chloride is a normal component of the internal medium, adverse reactions would be related to its concentration, as it is higher than that of blood serum.

Adverse effects have been described due to excessive or too rapid administration. There are two forms of toxicity: the first is high sodium levels in the blood, and the second is an excess of sodium and water that conditions excessive fluid accumulation, which can affect the brain, lungs, or peripheral circulation. Symptoms of excessive sodium include nausea, vomiting, diarrhea, abdominal cramps, thirst, reduced tear and saliva production, excessive sweating, fever, tachycardia, increased blood pressure, kidney failure, excessive fluid accumulation in different parts of the body and in the lungs, respiratory arrest, headache, dizziness, restlessness, weakness, muscle tremors, and stiffness, seizures, coma, and death. However, most of the described hypernatremias have been the result of the use of sodium chloride solutions by oral route and not by the intravenous use of solutions with a sodium concentration higher than that of blood serum.

The administration of significant amounts of chlorine can lead to a decrease in the body's pH as a result of the decrease in bicarbonate concentration.

If you consider that any of the adverse effects you are experiencing are severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Keep out of the reach and sight of children.

No special storage conditions are required.

Do not use Sodium Chloride Fresenius Kabi after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not use this medication if you observe that the solution is not transparent, colorless, and free of particles.

Once the packaging is opened, the product must be used immediately.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and the medicines that you no longer need. In this way, you will help protect the environment.

Sodium Chloride Fresenius Kabi Composition

−The active ingredient is: sodium chloride. Each ml of solution contains 58.4 mg of sodium chloride (ionic content: Na+= Cl-= 1 mEq/ml).

−The other components are: injection water and hydrochloric acid or sodium hydroxide.

Appearance of the product and contents of the package

Sodium Chloride Fresenius Kabi is a transparent and colorless solution, free or practically free of particles.

Sodium Chloride Fresenius Kabi is presented in the following formats:

Box with 20 ampoules of 10 ml

Box with 50 ampoules of 10 ml

Box with 20 ampoules of 20 ml

Only some package sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing Holder of the marketing authorization and responsible for manufacturing

Fresenius Kabi España S.A.U. Marina 16-18

08005 – Barcelona

This leaflet was approved in October 2019

“Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gov.es/”

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

Infusion solution for intravenous administration.

The CLORURO DE SODIO FRESENIUS KABI ampoule must be diluted in a minimum volume of 50 ml of an infusion solution.

Use only if the solution is transparent and free of visible particles. If not all the contents are used, discard the remainder.

In severe acute hyponatremia, sodium levels of 1 mmol/l/hour are recommended to prevent neurological damage.

If hyponatremia is classified as chronic, it should be associated with furosemide or an osmotic diuretic with hypertonic saline.

The correction of hyponatremia should not be too rapid to avoid demyelinating lesions. Some authors recommend not exceeding a correction of 10 mEq/l in the first 24 hours and 21 mEq/l in the first 48 hours. In general, serum sodium levels should be monitored to stop replacement when normal values are reached.