Sodium chloride Mein 0.9% solution for infusion

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Sodium Chloride Mein 0.9% solution for infusion

Sodium chloride

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

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

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

1. What Cloruro de sodio Mein is and what it is used for

Cloruro de sodio 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 medicines known as electrolyte solutions.

It is used to supply electrolytes in cases of dehydration with salt loss. In conditions of hypovolemia (decreased blood volume). Mild alkalosis. As a vehicle for the administration of medications and electrolytes.

2. What you need to know before using Cloruro de sodio Mein

Do not use Cloruro de sodio 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 have high blood pressure, edema, kidney or liver disease, or suffer from any heart disorder.

• if you have hypernatremia (increased concentration of sodium in the blood), hyperchloremia (increased concentration of chloride in the blood), hypokalemia (decreased potassium levels in the blood), or acidosis (pH below the normal range).

• in cases of hyperhydration (fluid overload).

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Cloruro de sodio Mein.

Your doctor may request blood tests to monitor your condition, as the body's water and electrolyte balance must be closely controlled.

Regular blood electrolyte monitoring should be performed during prolonged therapy, especially if you have: acid-base imbalance, cardiac, hepatic, and/or renal disorders, or 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 pregnancy-induced hypertension), aldosteronism (a metabolic disorder characterized by overproduction and secretion of the hormone aldosterone), or other conditions associated with sodium retention.

Cloruro de sodio Mein should be administered with caution in premature infants and full-term neonates.

If administered continuously at the same infusion site, pain, fever, infection, and phlebitis (vein inflammation) may occur.

Use of Cloruro de sodio Mein with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription, as it may be necessary to interrupt treatment or adjust the dose of one or more of them.

Before mixing with other medicines, compatibility tables should be checked, the pH taken into account, and ions monitored.

Administration of sodium chloride accelerates renal excretion of lithium, leading to a reduction 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 administration is appropriate and controlled, no adverse effects are expected during pregnancy or breastfeeding.

To date, relevant epidemiological data are lacking; therefore, it is recommended that use during these periods be done with caution.

Driving and use of machines

Not applicable, due to the nature of its use.

3. How to use Sodium Chloride Mein

Follow exactly the instructions for administration of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist.

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

Recommended dose:

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

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

Administration by slow intravenous drip is generally recommended at a rate of 120–180 ml/hour, corresponding to 40–60 drops/minute.

It must be administered by intravenous route.

If you use more Sodium Chloride Mein than you should

In case of overdose, overhydration (excess water), hypernatremia (excess sodium), hyperchloremia (excess chloride), and related manifestations such as metabolic acidosis (blood pH lower than normal), cardiac overload, and edema formation may occur. Administration should be discontinued and symptomatic treatment initiated.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.

If administered continuously at the same infusion site, pain, fever, infection, phlebitis extending from the injection site, extravasation, and hypervolemia 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 any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

Reporting of adverse effects

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 leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse 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 container.

No special storage conditions are required.

Do not use Sodium Chloride Mein if the solution is not clear or contains precipitates.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Cloruro de sodio 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 osmolarity: 308 mOsm/l.

pH: 4.5 - 7

Appearance of the product and contents of the container

Cloruro de sodio Mein is a clear, colourless solution without visible particles, sterile and pyrogen-free. It is supplied in Type II glass bottles of the following capacities and presentations:

50 ml bottle

100 ml bottle

250 ml bottle

500 ml bottle

1000 ml bottle

Clinical packs are also available in 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 most recent review of this summary: April 2019

Detailed and up-to-date information on this medicine is available on the website of the {Spanish Agency of Medicines and Medical Devices (AEMPS)} (http://www.aemps.gob.es/)

This information is intended for healthcare professionals only:

This medicine must always be administered by trained personnel. It is administered by intravenous infusion via a central or peripheral vein. The solution should be clear and free from particles and precipitates. Do not administer if this is not the case.

The contents of each container are intended for single use only; any unused portion must be discarded.

Use an aseptic technique when administering the solution and when preparing mixtures.

Before adding medications to the solution or administering it simultaneously with other medicines, compatibility must be verified.

Discard after single use. Discard partially used containers.

Do not reconnect partially used containers.