SODIUM CHLORIDE GRIFOLS 0.9% SOLUTION FOR INFUSION

2. What you need to know before you start using Sodium Chloride Grifols 0.9%

Do not useSodium Chloride Grifols 0.9%:

• if your blood chloride and/or sodium levels are high (hyperchloremia and hypernatremia respectively) or if you have hyperhydration (excess body water)
• if you have acidosis (pH below the normal range)

Warnings and Precautions

Sodium Chloride Grifols 0.9% is an isotonic solution.

Consult your doctor or nurse before starting to use Sodium Chloride Grifols 0.9%.

• This medicine should be administered with caution if you have hypertension, including pre-eclampsia (development of hypertension during pregnancy)/eclampsia (complication of severe pre-eclampsia), congestive heart failure, pulmonary edema or peripheral edema, severe renal failure, decompensated cirrhosis (liver disease with symptoms and potentially life-threatening complications), primary hyperaldosteronism (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 next subsection).

• This medicine should be administered with caution if your blood potassium levels are low (hypokalemia), as the 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 release of vasopressin (antidiuretic hormone) (including the syndrome of inappropriate secretion of antidiuretic hormone, SIADH), due to the risk of hospital hyponatremia (low sodium levels in the blood during hospitalization).

Hyponatremia:

If you are a patient with non-osmotic release of vasopressin (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 are at special risk of suffering from acute hyponatremia after the administration of hypotonic and even isotonic solutions.

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

Children, women of childbearing age, and patients with reduced brain distensibility (e.g., in case of meningitis, intracranial hemorrhage, and brain contusion) are at special risk of suffering from severe and potentially fatal brain edema caused by acute hyponatremia.

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

• Sodium rebalancing should not be carried out at too rapid a rate, especially due to the risk of serious neurological complications such as osmotic demyelination syndrome (brain disease caused by severe damage to the myelin sheath of brain cells) (see section 3).

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

• Due to the administration technique, during intravenous infusion, you may experience extravasation (a discharge or leakage of fluid from a vein to 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) at the injection site or along the vein. Thrombophlebitis may occur if administration is prolonged in the same injection site. In these cases, your doctor or nurse should interrupt the intravenous infusion and initiate the necessary therapeutic measures. They should periodically check for signs of inflammation at the injection site.

• Due to the risk of gas embolism (when one or more gas bubbles enter a vein or artery), your doctor or nurse should be especially careful when handling the administration sets.

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

Children and Adolescents

In premature and infant patients, sodium chloride should only be administered after determining the blood sodium levels.

There are no other specific warnings or precautions for children and adolescents.

Use ofSodium Chloride Grifols 0.9%withother medicines

Certain medicines may interact with Sodium Chloride Grifols 0.9%. In this case, it may be necessary to change the dose or interrupt the treatment of one of the medicines.

It is important that you inform your doctor if you are using any of the following medicines:

• lithium carbonate, as the administration of sodium chloride accelerates the 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.
• medicines that increase the effect of antidiuretic hormone (such as chlorpropamide, clofibrate, carbamazepine, vincristine, selective serotonin reuptake inhibitors, 3,4-methylenedioxymethamphetamine, ifosfamide, antipsychotics, narcotics, non-steroidal anti-inflammatory drugs, cyclophosphamide, desmopressin, oxytocin, vasopressin, terlipressin). These medicines reduce water excretion in urine and increase the risk of hospital hyponatremia after receiving insufficiently balanced treatment with solutions for intravenous infusion (see previous subsection and sections 3 and 4).
• diuretics in general and antiepileptics such as oxcarbazepine, which increase the risk of hyponatremia.

Tell your doctor if you are using, have recently used, or might use any other medicine.

Pregnancy, breast-feeding, and fertility

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

There is no evidence to suggest that maternal infusion of sodium chloride 0.9% during pregnancy has harmful effects on the fetus or the newborn.

This medicine should be administered with special caution in pregnant women during childbirth and special monitoring of serum sodium will be required if it is administered in combination with oxytocin (see previous subsections and section 4).

Special precautions should be taken during pregnancy in cases of pre-eclampsia (see Warnings and Precautions).

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

There are no data on fertility and the use of sodium chloride solutions, but no adverse effects are expected.

When this medicine is used as a vehicle for the administration of other compatible medicines and electrolytes, the nature of the additive and its use during pregnancy and breast-feeding should be evaluated separately.

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

Driving and using machines

Not applicable.

3. How to use Sodium Chloride Grifols 0.9%

This medicine will be administered by healthcare professionals.

It is administered intravenously by infusion.

Your doctor will decide the dose, speed, and duration of the infusion you should receive based on your age, weight, and clinical condition (e.g., burns, surgery, head injury, infections). In general, it is recommended to administer the solution at an average speed 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 non-osmotic release of vasopressin (SIADH) and if you receive simultaneous medication with vasopressin agonists, due to the risk of hospital hyponatremia (see sections 2 and 4).

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

When this solution is administered, 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 body weight: 100 ml/kg
• between 10-20 kg body weight: 1,000 ml + 50 ml/kg that exceeds 10 kg
• more than 20 kg 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 boys 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 medicine is used as a vehicle for the administration of other compatible medicines and electrolytes, the administered dose and infusion rate will depend on the nature and dose of the prescribed medicine.

If you receive moreSodium Chloride Grifols 0.9%than you should

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

If fluid overdose (hypervolemia, hyperhydration) occurs, you may experience pulmonary edema and/or peripheral edema and their consequent effects (heart failure).

With excessive sodium administration, you may develop hypernatremia, causing intracellular dehydration (water loss from cells that can lead to cellular dehydration), which should be treated in a specialized area. If this occurs, you may experience nausea, vomiting, diarrhea, abdominal cramps, reduced thirst, salivation, and lacrimation, fever, sweating, tachycardia, hypertension, headache, dizziness, agitation, irritability, weakness, lipotimia (transient loss of consciousness), muscle spasms and stiffness, 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 (brain disease caused by severe damage to the myelin sheath of brain cells) may occur several days after a too important and/or rapid correction of hyponatremia (see section 2). If this occurs, you may progressively feel the following clinical signs: 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 metabolic acidosis. Often, hyperchloremia does not cause any symptoms. In cases where symptoms develop, they are similar to those of hypernatremia.

When this medicine is used as a vehicle for the administration of other compatible medicines and electrolytes, other signs and symptoms of overdose related to the added medicine may occur. If this occurs, the treatment should be discontinued 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 further questions about the use of this medicine, ask your doctor or nurse.

4. Possible side effects

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

Inadequate or excessive administration of this medicine may cause 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 the tissues between body cells) or metabolic acidosis due to decreased bicarbonate concentration (increase in plasma acidity due to insufficient bicarbonate to effectively neutralize the effects of acid).

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

Side effects may also occur due to prolonged intravenous administration in the same infusion 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 the administration of other compatible medicines, other side effects may occur that are attributable to the nature of the added medicines.

Reporting of side effects

If you experience any side effects, talk to your doctor or nurse, even if they are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines (website: www.notificaRAM.es). By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Sodium Chloride Grifols 0.9%

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

Do not use this medicine after the expiry date stated on the packaging. The expiry date is the last day of the month indicated.

This medicine does not require special storage conditions.

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

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

6. Container Content and Additional Information

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 Container Content

Sodium Chloride Grifols 0.9% is a solution for infusion. It is a clear and colorless aqueous solution.

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

Marketing Authorization Holder

LABORATORIOS GRIFOLS, S.A.

Can Guasch, 2

08150 Parets del Vallès, Barcelona (SPAIN)

Manufacturer

Laboratorios Grifols, S.A.

Polígono Los Llanos. Calle Marte, 4

30565 Las Torres de Cotillas, Murcia (SPAIN)

This medication 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 revision of this prospectus:May 2024

Other sources of information

Detailed information about this medication 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:

Before administering Sodium Chloride Grifols 0.9%, it should be checked that:

• there are no leaks (by pressing the bag firmly)
• the solution is transparent and particle-free.

Do not administer in case of otherwise (see section 5).

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

Once the container is opened, the solution should be administered immediately.

To connect the infusion equipment, separate the protective tab from the infusion port, exposing the access membrane to the bag. Eliminate all air from the syringe and associated tubes before infusion to avoid the risk of gas embolism.

Discard after a single use.

Discard any unused portion.

Do not reconnect partially used bags.

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

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

When adding additives to the 0.9% sodium chloride solution, as well as when administering the solution, 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 should be administered immediately. Do not store solutions that contain additives.

This medication is physically incompatible with amphotericin B, an antifungal chemotherapeutic agent.

This medication should not be mixed with other medications unless their compatibility has been confirmed.

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