Prospecto: Information for the User

Grifols Sodium Chloride 0.9% Solution for Infusion

Read this prospectus carefully before starting to use this medication, because it contains important information for you.

• Keep this prospectus, as you may need to read 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 prospectus. See section 4.

1.What is Grifols Sodium Chloride 0.9% and what is it used for

2. What you need to know before starting to use Grifols Sodium Chloride 0.9%

3. How to use Grifols Sodium Chloride 0.9%

4. Possible adverse effects

5. Storage of Grifols Sodium Chloride 0.9%

6. Contents of the package and additional information

Grifols 0.9% Sodium Chloride belongs to the group of medications called intravenous solutions that affect the electrolyte balance – electrolytes (used to maintain bodily fluids in correct balance).

This medication provides sodium, chloride (both electrolytes) and water, and is indicated for:

-states of dehydration accompanied by salt loss

-metabolic alkalosis with hypochloremia

-treatment of hypovolemia (decrease in the amount of blood in the body)

-as a vehicle for the administration of compatible medications and electrolytes.

No useCloruro de Sodio Grifols 0.9%:

-If your blood levels of chloride and/or sodium are elevated (hyperchloremia and hypernatremia, respectively) or if you have hyperhydration (excess body water)

-If you have acidosis (pH below the normal range)

Advertencias y precauciones

Cloruro de Sodio Grifols 0.9% is an isotonic solution.

Consult your doctor or nurse before starting to use Cloruro de Sodio Grifols 0.9%.

-This medication should be administered with caution if you have hypertension, including preeclampsia (development of hypertension during pregnancy)/eclampsia (complication of severe preeclampsia), congestive heart failure, pulmonary or peripheral edema, severe renal insufficiency, decompensated cirrhosis (liver disease with symptoms and potential complications), primary aldosteronism (excessive production of aldosterone hormone), or if you are taking corticosteroids or adrenocorticotropic hormone (hormone that stimulates the secretion of cortisol and other steroid hormones) (see subsection below).

-This medication should be administered with caution if your blood levels of potassium are low (hypokalemia), as pre-existing electrolyte imbalance may worsen, causing cardiovascular complications, especially if you have heart problems.

-It should also be administered with special caution if you are elderly, as you may have heart or kidney problems.

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

Hypotremia:

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 acute hyponatremia after administration of hypotonic or even isotonic 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 severe 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 severe and potentially fatal cerebral edema caused by acute hyponatremia.

-In prolonged therapies or when your doctor considers it necessary, such as in cases of existing or impending acid-base imbalance, periodic monitoring of fluid balance, serum electrolyte concentration, and acid-base balance should be performed.

-The reequilibration of sodium should not be carried out too quickly, especially due to the risk of serious neurological complications such as osmotic demyelination syndrome (cerebral disease caused by severe damage to the myelin sheath of brain cells) (see section 3).

-This medication should be administered only in short-term therapies, as prolonged administration may lead to metabolic acidosis.

-Due to the administration technique, during intravenous perfusion, you may experience extravasation (a discharge or leakage of fluid from a vein into the tissues) and/or thrombophlebitis (inflammation of a vein with clot formation) (see section 4). Extravasation can cause tissue damage (local pain, erythema, burning, itching, swelling, and ulceration) in the injection area or along the vein. Thrombophlebitis may occur if administration is prolonged in the same injection area. In these cases, your doctor or nurse should interrupt intravenous perfusion and initiate necessary therapeutic measures. They should check periodically for signs of inflammation in the injection area.

-Due to the risk of gas embolism (when one or more gas bubbles enter a vein or artery), your doctor or nurse should exercise special care in the management of administration sets.

When adding a medication to the solution, your doctor or nurse should check for compatibility, clarity, and color before use. The mixture cannot be stored.

Children and adolescents

In premature and lactating infants, only sodium chloride should be administered after determining blood sodium levels.

No other warnings or precautions are specific to children and adolescents.

Use ofCloruro de Sodio Grifols 0.9%withother medications

Certain medications may interact with Cloruro de Sodio Grifols 0.9%. 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 are using 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.

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

Pregnancy,lactation,and fertility

If you are pregnant or breastfeeding, consult your doctor before using this medication.

No evidence indicates that maternal infusion of 0.9% sodium chloride during pregnancy has adverse effects on the fetus or newborn.

This medication should be administered with special caution in pregnant women during delivery and special monitoring of serum sodium levels should be performed if it is administered in combination with oxytocin (see previous subsections and section 4).

Extreme caution should be exercised during pregnancy in cases of preeclampsia (seeAdvertencias y precauciones).

Sodium chloride is excreted in breast milk, but, considering that it is a natural constituent of milk, no adverse effects are expected in the infant after maternal intravenous administration of therapeutic doses. However, it is recommended to use with caution during these periods.

No data are available on fertility and the use of sodium chloride solutions, but no adverse effects are anticipated.

When this medication is used as a vehicle for the administration of compatible medications and electrolytes, the nature of the additive and its use during pregnancy and lactation should be evaluated separately.

In any case, the doctor should evaluate whether the treatment is advisable.

Driving and operating machinery

Not applicable.

This medication will be administered by healthcare professionals.

It is administered via intravenous infusion.

Your doctor will decide on the dose, rate, and duration of the infusion you should receive based on your age, weight, and clinical condition (e.g., burns, surgery, head injury, infections). Generally, it is recommended to administer the solution at a medium rate of 40 to 60 drops per minute (120-180 ml/h).

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 concomitant medication with vasopressin agonists, due to the risk of hospital-acquired hyponatremia (see sections 2 and 4).

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

When administering this solution, the total daily fluid requirement should be taken into account.The recommended daily fluid dose is as follows:

- adults: between 25-35 ml/kg

- children: - less than 10 kg of body weight: 100 ml/kg

- between 10-20 kg of body weight: 1,000 ml + 50 ml/kg that exceeds 10 kg

- more than 20 kg of body weight: 1,500 ml + 20 ml/kg that exceeds 20 kg

In adults, the maximum daily fluid dose is 40 ml/kg (corresponding to 6 mmol of sodium/kg) without exceeding 3,000 ml, and the maximum infusion rate is 5 ml/kg/hour. The pediatric patient rarely needs more than 2,500 ml in the case of children and 2,000 ml in the case of girls.

In cases of acute plasma volume deficiency (e.g., impending or manifest hypovolemic shock), the amount of solution needed should be 3-4 times the volume of blood lost.

When this medication is used as a vehicle for the administration of compatible medications and electrolytes, the administered dose and infusion rate will depend on the nature and dose of the prescribed medication.

If you receive moreGrifols 0.9% Sodium Chloridethan you should

Excessive administration of 0.9% sodium chloride solution may result in fluid overload (hypervolemia, hyperhydration) and/or electrolyte overload (hypernatremia and hyperchloremia) (see section 4). In these cases, administration should be suspended and appropriate therapeutic measures should be applied.

Excessive fluid administration (hypervolemia, hyperhydration) may cause pulmonary and/or peripheral edema and its consequences (cardiac failure).

With excessive sodium administration, you may develop hypernatremia, causing intracellular dehydration (loss of water from cells that may lead to cellular desiccation), which should be treated in a specialized area. If this occurs, you may experience nausea, vomiting, diarrhea, abdominal cramps, thirst, reduced salivation and lacrimation, fever, sweating, tachycardia, hypertension, headache, dizziness, agitation, irritability, weakness, lipotimia (transient loss of consciousness), spasms, and muscle rigidity, somnolence, confusion that may evolve into seizures, coma, renal failure, cerebral, peripheral, and pulmonary edema, respiratory failure, and death.

Severe neurological complications, such as osmotic demyelination syndrome (a brain disease caused by severe damage to the myelin sheath of brain cells), may occur several days after a significant and/or rapid correction of hyponatremia (see section 2). If this occurs, you may experience the following clinical signs in a progressive manner: confusion, difficulty speaking and/or swallowing, weakness of the limbs, tetraplegia, delirium, and finally coma.

Excessive chloride administration may cause hyperchloremia and, therefore, a loss of bicarbonate and acidosis. Often, hyperchloremia does not cause any symptoms. In cases where symptoms develop, they are similar to those of hypernatremia.

When this medication is used as a vehicle for the administration of other compatible medications and electrolytes, other signs and symptoms of overdose related to the added medication may occur. If this occurs, treatment should be suspended and you should be monitored for symptoms and clinical signs related to the administered medication. You should receive symptomatic treatment and necessary support.

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 thismedication, ask your doctor or nurse.

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

Inadequate or excessive administration of this medication may produce hyperhydration, hypernatremia, hyperchloremia, hypervolemia (excess body water, plasma sodium, plasma chloride, and blood volume, respectively) and related manifestations, such as edema formation (abnormal accumulation of fluid in body tissues between cells) or metabolic acidosis due to decreased bicarbonate concentration (increased plasma acidity due to insufficient bicarbonate to effectively neutralize acid effects).

Patients with non-osmotic vasopressin release, patients with heart, liver, and kidney diseases, and patients treated with vasopressin agonists have a special risk of suffering acute hyponatremia after administration of hypotonic and even isotonic solutions. Hospital hyponatremia can cause irreversible brain damage and death due to the appearance of acute cerebral edema (see sections 2 and 3).

Other adverse effects may also occur due to prolonged intravenous administration in the same perfusion site. These effects include pain or reaction at the injection site, fever, infection, extravasation, venous thrombosis (formation of a blood clot within a vein obstructing blood flow) and phlebitis (inflammation of a vein) extending from the injection site.

If used as a vehicle for administration of other compatible medications, other adverse effects may occur attributable to the nature of the added medications.

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(website:www.notificaRAM.es).By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears onthe packaging.The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

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

Do not use this medication if you observe that the solution is not transparent or contains particles, or if the packaging is damaged.

Composition ofSodium Chloride Grifols 0.9%

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

The other component (excipient) is water for injectable preparations.

The calculated osmolarity of the solution is 308 mOsm/L and the pH is 4.5-7.0. The theoretical content in sodium and chloride is 154 mmol/L.

Appearance of the product and contents of the package

Sodium Chloride Grifols 0.9% is an infusion solution. It is a clear, transparent, and colorless aqueous solution.

This medicinal product is presented in flexible polypropylene bags (Fleboflex) containing 50 ml, 100 ml, 250 ml, 500 ml, and 1000 ml of solution.

Holder of the marketing authorization

LABORATORIOS GRIFOLS, S.A.

Can Guasch, 2

08150 Parets del Vallès, Barcelona (SPAIN)

Responsible for manufacturing

Laboratorios Grifols, S.A.

Polígono Los Llanos. Calle Marte, 4

30565 Las Torres de Cotillas, Murcia (SPAIN)

This medicinal product is authorized in the member states of the European Economic Areaand in the United Kingdom (Northern Ireland)with the following names:

Date of the last review of this leaflet:May 2024

Other sources of information

The detailed information on this medicinal product 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:

Before administering Sodium Chloride Grifols 0.9%, check that:

-there are no leaks(by pressing firmly on the bag)

-the solution is transparent and free of particles.

Do not administer otherwise (see section 5).

Do not remove the overbag until use. The bag maintains the sterility of the product.

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

To connect the infusion equipment, separate the protective sleeve from the infusion port, leaving the access membrane to the bag exposed. Remove all air from the syringe and associated tubes before infusion to avoid the risk of gas embolism.

Dispose of after single use.

Dispose of any unused portion.

Do not reconnect partially used bags.

The compatibility of additives with Sodium Chloride Grifols 0.9% solution must be checked before adding a medication.

It is the responsibility of the doctor to determine the incompatibility of the added medication with respect to Sodium Chloride Grifols 0.9% and the packaging, monitoring any discoloration and/or formation of precipitates, insoluble complexes, or crystals. The instructions for use of the added medication should be consulted.

Before adding a medication, verify if it is soluble and stable in water at the pH of Sodium Chloride Grifols 0.9%.

When additives are added to the 0.9% sodium chloride solution, as well as when the solution is administered, use an aseptic technique.

Mix the solution well when additives have been introduced.

When a compatible medication is added to Sodium Chloride Grifols 0.9%, the solution must be administered immediately. Do not store solutions containing additives.

This medicinal product is physically incompatible with amphotericin B, an antimycotic chemotherapeutic agent.

This medicinal product should not be mixed with other medications unless compatibility has been confirmed.

Due to the administration technique, extravasation and/or thrombophlebitis may occur during intravenous infusion (see section 4). In these cases, the intravenous infusion should be interrupted and the necessary therapeutic measures initiated. The possible signs of inflammation in the injection area should be checked periodically.