Label: information for the user

Sodium chloride Mein 0.9% solution for infusion

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 read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you and should not be given to others even if they have the same symptoms, as it may harm them.
• If you experience any adverse effects,consult your doctor, pharmacist, or nurse,evenifthey do not appear in this label. See section 4.

Sodium Chloride Mein is an intravenous infusion solution available in 50 ml, 100 ml, 250 ml, 500 ml, and 1000 ml bottles.

It belongs to the group of medications known as electrolyte solutions.

It is used as an electrolyte supplement in cases of dehydration with loss of salts. In states of hypovolemia (decrease in blood volume). Mild alkalosis. As a vehicle for the administration of medications and electrolytes.

No use Cloruro de sodio Mein:

• if you are allergic to the active ingredient or any of the other components of this medication (listed in section 6).
• if you have been diagnosed or detected high blood pressure, edemas, kidney or liver diseases, or have any heart disorder.

• if you have hypernatremia (elevated sodium blood concentration), hyperchloremia (elevated chloride blood concentration), hypokalemia (decreased potassium blood concentration), or acidosis (blood pH below normal range).

or if you are in a state of hyperhydration (excess fluid overload).

Warnings and Precautions

Consult your doctor, pharmacist, or nurse before starting to use Sodium Chloride Mein.

Your doctor may request blood tests to monitor your condition since it is necessary to control the balance of water and salts in your body.

You should have regular blood electrolyte tests, especially in prolonged therapy and particularly if you have acid-base imbalance, cardiac, hepatic, and/or renal alterations, or if you are being treated with corticosteroids or adrenocorticotropic hormone.

You should be administered this medication with caution if you have hypertension, pre-eclampsia (a medical complication characterized by induced hypertension during pregnancy) or aldosteronism (a metabolic disorder characterized by overproduction and secretion of aldosterone hormone) or other conditions associated with sodium retention.

Sodium Chloride Mein should be administered with caution to premature and full-term infants.

If administered continuously in the same infusion site, it may cause pain, fever, infection, and phlebitis (inflammation of the veins).

Use of Sodium Chloride Mein with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use 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.

Before mixing with other medications, check the compatibility tables, consider the pH, and control the ions.

The administration of sodium chloride accelerates the renal excretion of lithium, leading to a decrease in its therapeutic effect.

It should be administered with caution in patients treated with corticosteroids or adrenocorticotropic hormone, as they may retain water and sodium.

Pregnancy and lactation

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.

As long as administration is correct and controlled, no adverse effects are expected during pregnancy and lactation.

However, there is currently no relevant epidemiological data, so it is recommended to use this medication with caution during these periods.

Driving and operating machinery

This is not applicable, due to the characteristics of its use.

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist.

Your doctor will indicate the most suitable dose for your needs. Generally, intravenous administration drop by drop is recommended according to your age, body weight, clinical condition, fluid balance, electrolyte balance, and acid-base balance.

Recommended dose:

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

For babies and children: 20 ml to 100 ml per kg of body weight every 24 hours

Generally, administration drop by drop is recommended at a rate of 120- 180 ml/hour, at a speed of 40-60 drops/minute.

It must be administered intravenously.

If you use more Sodium Chloride Mein than you should

In case of overdose, may appear hyperhydration (excess of water), hypernatremia (excess of sodium), hyperchloremia (excess of chloride) and related manifestations such as metabolic acidosis (blood pH below normal), heart overload, and edema formation. Administration will be suspended and symptomatic treatment will be sought.

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

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

Continuous administration in the same infusion site may cause pain, fever, infection, and phlebitis extending from the injection site, extravasation, and hypervolemia.

When used as a vehicle for administering other medications, the nature of the added medications will determine the likelihood of other adverse reactions.

In case of adverse reactions, discontinue 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.

Adverse Effect Reporting

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: https://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 Sodium Chloride Mein after the expiration date that appears on the packaging.

No special storage conditions are required.

Do not use Sodium Chloride Mein 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 containers and medications that you no longer need. In this way, you will help protect the environment.

Sodium Chloride Mein Composition

The active principle is sodium chloride. Each 100 ml of solution contains 0.9 g of sodium chloride.

- The only excipient is water for injectable preparations.

Ionic composition:

Sodium 154 mmol/l(154 meq/l)

Chloride 154 mmol/l(154 meq/l)

Theoretical osmolality: 308 mosm/l.

pH: 4.5 - 7

Appearance of the product and contents of the packaging

Sodium Chloride Mein is a transparent and colorless solution, without visible particles, sterile and apyrogenic. It is presented in type II glass bottles of the following capacities and formats:

Bottle of 50 ml

Bottle of 100 ml

Bottle of 250 ml

Bottle of 500 ml

Bottle of 1000 ml

It is also available in clinical packaging of the following presentations:

20 bottles of 50 ml

20 bottles of 100 ml

12 bottles of 250 ml

12 bottles of 500 ml

6 bottles of 1000 ml

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Fresenius Kabi España S.A.U.

Marina 16-18

08005-Barcelona

Spain

Responsible for manufacturing

Fresenius Kabi España S.A.U.

Marina 16-18

08005-Barcelona

Spain

or

Fresenius Kabi Italia S.r.l.

Via Camagre, 41/43

37063 Isola della Scala (VR)

Italy

or

Fresenius Kabi Deutschland GmbH

Else-Kröner Strasse 1 (Bad Homburg)

D-61352-Germany

Last review date of this leaflet:April 2019

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

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This information is intended solely for doctors or healthcare professionals:

This medicine will be administered only by specialized personnel. It will be administered by infusion, through a central or peripheral vein. The solution must be transparent without particles and not contain precipitates. Do not administer otherwise.

The contents of each package are for a single infusion, discard the unused fraction.

Use an aseptic method to administer the solution and in case of preparation of mixtures.

Before adding medications to the solution or administering simultaneously with other

medicines, check that there are no incompatibilities.

Discard after a single use. Discard partially used containers.

Do not reconnect partially used containers.