Patient Information

Sodium Chloride Meinsol 9 mg/ml Solution for Parenteral Use

Sodium Chloride

Please read this entire leaflet carefully before you start using this medicine, as it contains important information for you.

-Keep this leaflet, as you may need to read it again.

-If you have any questions, consult your doctor or pharmacist.

-This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms, as it may harm them.

-If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Sodium Chloride Meinsol is indicated as a solvent for medications that must be administered

intravenously, intramuscularly, or subcutaneously and as a support for the addition of medications.

No use Cloruro de sodio Meinsol:

-If you have had any allergic or unusual reaction to sodium chloride.

-If you have a high concentration of sodium in your blood (hypernatremia)

-If you have increased muscle tone (hypertonia)

-If you suffer from heart failure (inability of the heart to pump the necessary amount of blood)

-If you have any heart, liver, or kidney alterations and suffer from water accumulation (edema)
in the body

-If you have severe high blood pressure (severe hypertension)

-If you have an excess of acidity in the blood (metabolic acidosis)

Warnings and precautions

Consult your doctor or pharmacist before starting to use Sodium Chloride Meinsol

-Solutions, once opened, must be used immediately.

-In case of subcutaneous administration, do not add any supplement that may change the isotonicity of the solution.

-Do not use the solution if it is not transparent and without precipitates.

-Ensure physical-chemical compatibility when adding medication to the ampule.

-Alcohol should be avoided in sodium chloride solutions.

Children

The newborns may present excessively high sodium levels due to the immaturity of their kidneys. Therefore, repeated injections of sodium chloride can only be administered once the sodium levels in the blood have been determined.

Sodium chloride should be used with caution in patients with hypertension, heart failure, pulmonary or peripheral edema, altered renal function, pre-eclampsia, hyperaldosteronism, cirrhosis, and other liver diseases, hypervolemia, urinary tract obstruction, hypoproteinemia, and other diseases and treatments (e.g. corticosteroids) associated with sodium retention.

Use of Sodium Chloride Meinsol with other medications:

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

The interactions with other medications depend on the medication added.

The 9 mg/ml sodium chloride solution presents incompatibilities with hydrocortisone, amphotericin B, tetracyclines, cephalothin, erythromycin, lactobionate, and lithium salts.

It is incompatible with non-soluble active principles in the sodium chloride solution, which may precipitate the active principle, as well as with medications whose stability or solubility require a very acidic or markedly alkaline pH.

Pregnancy and lactation:

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using a medication.

Given the characteristics of the product, no effect is expected on the pregnant woman and in the lactation period, provided the administration is correct and controlled.

Driving and operating machines:

No indication exists that the isotonic sodium chloride solution may affect the ability to drive or operate machines.

Follow these instructions unless your doctor has given you different instructions. Sodium Chloride Meinsol is administered intravenously, intramuscularly, or subcutaneously.

No asepsis of the ampoule is required before opening it.

No cutting tool is necessary to open the ampoule.

Once the ampoule is opened, the nozzle fits perfectly onto the cone of the syringe (Luer cone), making it unnecessary to use a needle.

To open:

To separate an ampoule from the rest, turn an ampoule around itself against the rest of the ampoules on the strip without touching the head and neck of the ampoules (1). Shake the ampoule with a single movement as shown in the drawing to remove the liquid that may be in the stopper (2). To open the ampoule, turn the body and head of the ampoule in opposite directions until it breaks at the neck (3). Connect the Luer or Luer-lock syringe as shown in the drawing (4).

Therefore, no needle is needed to extract the solution. Extract the liquid.

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

The amount to be used will be variable depending on the concentration to be administered of the medication to be dissolved.

Your doctor will indicate the duration of treatment with your medication.

If you estimate that the action of Sodium Chloride Meinsol is too strong or too weak, inform your doctor.

If you use more Sodium Chloride Meinsol than you need:

If you have received more Sodium Chloride Meinsol than you need, consult your doctor immediately.

Given the nature of the product, if your indication and administration are correct and controlled, there is no risk of intoxication.

However, an excess of sodium chloride, in its most acute form, produces dehydration of internal organs, nausea, vomiting, diarrhea, abdominal cramps, thirst, decreased salivation and lacrimation, sweating, fever, hypotension, tachycardia, renal failure, pulmonary edema, acidosis, respiratory arrest, headache, dizziness, irritability, muscle spasms, rigidity, coma, and death.

In case of presenting any symptoms of intoxication, administration will be suspended and symptomatic treatment will be sought.

In children, coma and convulsions can persist until producing vascular lesions. Difficulty breathing with tachypnea and nasal wing erythema may also appear.

In case of overdose or accidental ingestion, go immediately to a medical center, or call the Toxicological Information Service at tel. 91 562 04 20.

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

Administration of the physiological saline solution in an inadequate or excessive manner may produce hyperhydration, hypernatremia, hyperchloremia, and related manifestations, such as metabolic acidosis, due to a decrease in bicarbonate concentration, and edema formation

Excessive sodium chloride may produce nausea, vomiting, and headache

Adverse reactions may also be related to the added medication

Reporting 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 prospectus. You may also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use, http:\www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication

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

No special storage conditions are required.

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.

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

- The active ingredient is Sodium Chloride. Each 100 ml contains 0.9 g of sodium chloride.

- The excipients are injectable preparation water, hydrochloric acid, and sodium hydroxide.

Centesimal composition:

Electrolytesmmol/lmEq/l

Sodium chloride0.9 gNa+154154

Injectable preparation water c.s.p. 100 mlCl-154154

Osmolarity: 308 mOsmol/liter.

Appearance of the product and contents of the packaging

Sodium Chloride Meinsol 9mg/ml parenteral solvent is a transparent and colorless solution, free or practically free of particles.

Sodium Chloride Meinsol is a parenteral solvent that is presented in the following formats:

Box with 20 ampoules of 5 ml (Clinical Packaging) Box with 50 ampoules of 5 ml (Clinical Packaging) Box with 20 ampoules of 10 ml (Clinical Packaging) Box with 50 ampoules of 10 ml (Clinical Packaging) Box with 20 ampoules of 20 ml (Clinical Packaging)

Only some sizes of packaging may be commercially available.

Marketing authorization holder:

FRESENIUS KABI ESPAÑA, S.A.U.

C/ Marina, 16-18

08005-Barcelona (Spain)

Responsible for manufacturing:

FRESENIUS KABI ESPAÑA, S.A.U.

C/ Dr. Ferran, 12

08339 Vilassar de Dalt

Spain

This medicinal product is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet: January 2015

For detailed and updated information on this medicinal product, please visit the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/