Label: information for the user

Sodium Chloride Grifols0.45%solution for infusion

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 refer to it again.
• If you have any questions, consult your doctor or nurse.
• If you experience any adverse effects, consult your doctor or nurse, even if they are not listed in this label. See section 4.

6. Contents of the package andadditional information

Grifols 0.45% Sodium Chloride is a hypotonic intravenous solution of sodium chloride,used to maintain the body's fluid balance in correct equilibrium.

Grifols 0.45% Sodium Chloride is indicated in states of hypertonic dehydration due to increasedsensible losses (major loss of water through the digestive, urinary, or sweat systems) or osmotic diuresis (in which there is an increase in urine volume).

No use Cloruro de Sodio Grifols 0,45%

• if you are allergic to the active ingredient or any of the other components of this medication (listed in section 6)
• in states of hyperhydration (excess of fluids in the body) or water intoxication
• in edematous states if you have cardiac, hepatic, or renal alterations and severe hypertension

-if you have low levels of potassium in the blood (hypokalemia), since, if administered in this state, cellular potassium may be replaced by sodium, thus aggravating the existing electrolyte imbalance and potentially causing congestive heart failure, acute pulmonary insufficiency, especially in cardiovascular patients.

Warnings and precautions

Consult your doctor or nurse before starting to useCloruro de Sodio Grifols 0,45%.

• This medication should be administered with cautionif you have hypertension, congestive heart failure, pulmonary or peripheral edema, severe renal insufficiency, decompensated cirrhosis(liver disease),or if you are being treated with corticosteroids or adrenocorticotropic hormone.

• The administration of sodium chloride solutions immediately after a surgical operation may lead to excessive sodium retention.

• In prolonged therapies and if your condition requires it, such as in the case of existing or impending acid-base imbalance, laboratory determinations and clinical evaluations may be performed periodically to monitor changes in water and acid-base balance, and serum electrolyte concentrations.

-The possibility of hyperhydration can be avoided by making a total balance of the fluid incorporated and lost by the patient.

-The administration of large volumes will require special vigilance if the patient has heart or lung failure and if the patient has non-osmotic vasopressin release (including the syndrome of inappropriate antidiuretic hormone secretion, SIADH), due to the risk of hospital-acquired hyponatremia (low sodium levels in the blood during hospitalization).

Hypotonicity:

If you are a patient with non-osmotic vasopressin release (e.g., in the presence of critical states, pain, postoperative stress, infections, burns, and central nervous system diseases), if you have heart, liver, and kidney diseases, and if you are exposed to vasopressin agonists (see next subsection), you have a special risk of suffering from acute hyponatremia after the administration of hypotonic solutions.

Acute hyponatremia can cause acute hyponatremic encephalopathy (cerebral edema) characterized by headache, nausea, seizures, lethargy, and vomiting. Patients with cerebral edema have a special risk of suffering from severe, irreversible, and potentially fatal brain damage.

Children, fertile women, and patients with reduced cerebral compliance (e.g., in cases of meningitis, intracranial hemorrhage, and cerebral contusion) have a special risk of suffering from severe and potentially fatal cerebral edema caused by acute hyponatremia.

• If it is administered continuously in the same perfusion site, it may cause thrombophlebitis (inflammation of a vein associated with the formation of a clot), although given the hypotonic nature of this solution, this is not frequent.

• You should pay special attention if you use it in elderly patients, as they may have impaired renal function.

Other medications and Cloruro de Sodio Grifols 0,45%

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

Certain medications may interact with Cloruro de Sodio Grifols 0,45%. In this case, you may need to change the dose or discontinue treatment with one of the medications.

It is essential to inform your doctor if you use any of the following medications:

• lithium carbonate, as the administration of sodium chloride accelerates renal excretion of lithium, leading to a decrease in the therapeutic effect of the latter.
• corticosteroids or adrenocorticotropic hormone, due to their ability to retain water and sodium.
• medications that increase the effect of antidiuretic hormone (such as chlorpropamide, clofibrate, carbamazepine, vincristine, selective serotonin reuptake inhibitors, 3,4-methylenedioxy-N-methamphetamine, ifosfamide, antipsychotics, narcotics, nonsteroidal anti-inflammatory drugs, cyclophosphamide, desmopressin, oxytocin, vasopressin, terlipressin). These medications reduce water excretion in urine and increase the risk of hospital-acquired hyponatremia after receiving an insufficiently balanced treatment with intravenous infusion solutions (see previous subsection and sections 3 and 4).
• diuretics in general and antiepileptics such as oxcarbazepine, which increase the risk of hyponatremia.

Pregnancy and lactation

If you are pregnant or breastfeeding, or if you think you may be pregnant or plan to become pregnant, consultyour doctor before using this medication.

This medicationshould be administered with special caution in pregnant women during delivery and special vigilance of serum sodium levels will be required if it is administered in combination with oxytocin (see previous subsections and section 4).

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

Driving and operating machines

This solution is administered only to hospitalized patients, so no studies have been conducted on these effects.

This product is presented in solution form and will be used in a hospital by the corresponding healthcare staff.

Sodium Chloride Grifols 0.45% is administered intravenously via infusion.

Your doctor will inform you of the duration of your treatment with Sodium Chloride Grifols 0.45%.

The volume and rate of administration may be varied according to medical criteria, adjusting them according to the needs of each patient, their age, weight, and clinical condition (e.g., burns, surgery, head injury, infections) , and according to the needs of water, sodium, and chloride existing. However, administration must be carried out in such a way that the increase in plasma osmolality is not greater than 1 mOsm/kg/hour.

You may need to be monitored for fluid balance, serum electrolytes, and acid-base balance before and during administration, with special attention to serum sodium if you have an increase in non-osmotic vasopressin release (SIADH) and if you are receiving simultaneous medication with vasopressin agonists, due to the risk of hospital-acquired hyponatremia (see sections 2 and 4). Monitoring of serum sodium is especially important when administering hypotonic solutions such as this medication.

Your doctor will decide on the need for simultaneous treatment (see sections 2 and 4).

If you receive more Sodium Chloride Grifols 0.45% than you should

Given the nature of the product, and always that its indication and administration are correct and controlled, there is no risk of overdose. In the event that these requirements are not met, some symptoms may appear due to secondary effects. Administration will be suspended and symptomatic treatment will be sought.

In case of overdose or accidental ingestion, consult the Toxicological Information Service. Phone: 915 620 420.

If you have any other questions about the use of this medication, ask your doctor or nurse.

Like all medications,this medicationcan produce adverse effects, although not all people will experience them.

Improper or excessive administration ofGrifols Sodium Chloride 0.45%can produce hyperhydration with fluid retention and edema, including pulmonary edema(excessive accumulation of fluid in the lungs)and symptoms of congestive heart failure (heart function failure).

When large quantities of this solution are administered, chloride ions can cause bicarbonate ion loss resulting in acidosis(decrease in blood pH).

In patients with non-osmotic vasopressin release, in patients with heart, liver, and kidney diseases, and in patients treated with vasopressin agonists, the risk of acute hyponatremia increases after administration of hypotonic solutions. Hospital-acquired hyponatremia can cause irreversible brain damage and death due to the onset of cerebral edema (see sections 2 and 3).

If administered continuously in the same perfusion site, it may cause pain or reaction at the injection site, fever, infection, extravasation, venous thrombosis (clots in the vein) and phlebitis (vein inflammation) extending from the injection site.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or nurse, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es.By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

No requires special conditions for conservation.

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

Do not usethis medicationafter the expiration date that appears on the packaging.

Medications should not be thrown down the drains or in the trash.Deposit the containers and medications that you no longer need at the SIGRE collection point (SIGRE symbol) at the pharmacy.If in doubt, 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.

Composition of Sodium Chloride Grifols 0.45%

The active principle is sodium chloride. Each 100 ml of solution contains 0.45 g of sodium chloride.

The other components (excipients) are: hydrochloric acid (for pH adjustment) and water for injectable preparations.

Appearance of the product and contents of the packaging

Sodium Chloride Grifols 0.45% is a transparent and colorless infusion solution, presented in glass bottles of 100 (containing 50 or 100 ml of solution), 500 and 1000 ml. . It is also available in clinical packaging for all presentations (20 bottles for the 100 ml presentation (containing 50 or 100 ml) and 10 bottles for the 500 and 1000 ml presentations).

Only some sizes of packaging may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

LABORATORIOS GRIFOLS, S.A.

Can Guasch, 2

08150 Parets del Vallès , Barcelona (SPAIN)

Last review date of this leaflet: July 2018

Other sources of information

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

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This information is intended solely for healthcare professionals:

Sodium Chloride Grifols 0.45% is an infusion solution.

The contents of each bottle of this medicine are for a single infusion. Dispose of any unused portion.

Once the packaging is opened, the solution must be administered immediately.

Do not use this medicine if the solution is not transparent or contains precipitates.

When administering the solution and in the event of mixtures, the utmost asepsis must be maintained during the addition of medications.

Signs of incompatibility have been described when certain medications such as amphotericin B, amsacrine, or trimetrexate glucuronate are diluted in sodium chloride solutions. It is recommended to consult compatibility tables before adding medications.