SODIUM CHLORIDE MEIN 0.9% SOLUTION FOR INFUSION

Introduction

Package Leaflet: Information for the User

Sodium Chloride Mein 0.9% Solution for Infusion

Sodium Chloride

Read this package leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you experience any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet:

1. What is Sodium Chloride Mein and what is it used for
2. What you need to know before you use Sodium Chloride Mein
3. How to use Sodium Chloride Mein
4. Possible side effects
5. Storage of Sodium Chloride Mein
6. Contents of the pack and further information

1. What is Sodium Chloride Mein and what is it used for

Sodium Chloride Mein is a solution for intravenous infusion presented in bottles of 50 ml, 100 ml, 250 ml, 500 ml, and 1000 ml.

It belongs to the group of medicines called electrolyte solutions.

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

2. What you need to know before you start using Sodium Chloride Mein

Do not use Sodium Chloride Mein:

• if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).
• if you have ever been diagnosed with or detected high blood pressure, edema, kidney or liver disease, or suffer from any heart disorder.

• if you have hypernatremia (increased sodium concentration in the blood), hyperchloremia

(increased chloride concentration in the blood), hypokalemia (decreased potassium in the blood), or acidosis (pH below the normal range).

• in states of hyperhydration (fluid overload).

Warnings and Precautions

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

Your doctor may request that blood tests be performed to monitor your condition, as it is necessary to control the balance of water and salts in the body.

Regular analytical controls of blood electrolytes should be performed, especially in prolonged therapies and if you suffer from acid-base imbalance, cardiac, hepatic, and/or renal disorders, as well as if you are being treated with corticosteroids or adrenocorticotropic hormone.

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

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

If administered continuously in the same infusion site, pain, fever, infection, and phlebitis may occur.

Using Sodium Chloride Mein with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use 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.

Before mixing with other medicines, compatibility tables should be checked, taking into account the pH and controlling 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 Breastfeeding

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

Provided that administration is correct and controlled, no adverse effects are expected during pregnancy and breastfeeding.

Currently, there are no relevant epidemiological data available, so it is recommended that if used during these periods, it should be done with caution.

Driving and Using Machines

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

3. How to use Sodium Chloride Mein

Follow exactly the administration instructions of this medicine 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, it is recommended to administer intravenously, drop by drop, according to your age, body weight, clinical condition, fluid balance, electrolytes, 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, it is recommended to administer drop by drop at 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, hyperhydration (excess water), hypernatremia (excess sodium), hyperchloremia (excess chloride), and related manifestations such as metabolic acidosis (blood pH below normal), heart overload, and edema formation may occur. Administration will be discontinued and symptomatic treatment will be initiated.

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

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If administered continuously in the same infusion site, pain, fever, infection, and phlebitis may occur.

If used as a vehicle for the administration of other medicines, the nature of the added medicines will determine the likelihood of other adverse reactions.

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

If you consider that any of the side effects you are experiencing is serious or if you notice any side effect not mentioned in this package leaflet, tell your doctor or pharmacist.

Reporting of Side Effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this package leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Sodium Chloride Mein

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

Do not use Sodium Chloride Mein after the expiry date stated 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 via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the Pack and Further Information

Composition of Sodium Chloride Mein

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

• The only excipient is water for injections.

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 and Packaging of the Product

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

50 ml bottle

100 ml bottle

250 ml bottle

500 ml bottle

1000 ml bottle

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

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Fresenius Kabi España S.A.U.

Marina 16-18

08005-Barcelona

Spain

Manufacturer

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

Date of the Last Revision of this Package Leaflet:April 2019

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)

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This information is intended only for healthcare professionals:

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

The content of each package is for a single perfusion; the unused fraction must be discarded.

An aseptic method should be used to administer the solution and in the case of preparation of mixtures.

Before adding medicines to the solution or administering them simultaneously with other medicines, it should be checked that there are no incompatibilities.

Discard after a single use. Discard partially used packages.

Do not reconnect partially used packages.