SODIUM CHLORIDE GRIFOLS 0.45% SOLUTION FOR INFUSION

2. What you need to know before you use Sodium Chloride Grifols 0.45%

Do not use Sodium Chloride Grifols 0.45%

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

• if you have low potassium levels in the blood (hypokalemia), as administration in this state may replace cellular potassium with sodium, worsening the pre-existing electrolyte imbalance and potentially causing congestive heart failure, with acute pulmonary insufficiency, especially in cardiovascular patients.

Warnings and precautions

Consult your doctor or nurse before starting to use Sodium Chloride Grifols 0.45%.

• This medicine should be administered with caution if you have hypertension, congestive heart failure, pulmonary edema, or peripheral edema, severe renal insufficiency, decompensated cirrhosis (liver disease), or if you are being treated with corticosteroids or adrenocorticotropic hormone (hormone that stimulates the secretion of cortisol and other steroid hormones).

• The administration of sodium chloride solutions immediately after surgery 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, you may undergo laboratory tests and periodic clinical evaluations to monitor changes in water and acid-base balance, and electrolyte concentrations in the serum.

• 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 monitoring if you are a patient with heart or lung failure and if you are a patient with non-osmotic release of vasopressin (including the syndrome of inappropriate antidiuretic hormone secretion, 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 administration of hypotonic 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.

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

• Special attention should be paid if used in elderly patients, as they may have affected kidney function.

Other medicines and Sodium Chloride Grifols 0.45%

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

Certain medicines may interact with Sodium Chloride Grifols 0.45%. In this case, it may be necessary to change the dose or interrupt treatment with 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 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 breastfeeding

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

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).

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

Driving and using machines

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

3. How to use Sodium Chloride Grifols 0.45%

It is presented in the form of a solution and will be used in a hospital by the corresponding healthcare personnel.

Sodium Chloride Grifols 0.45% is administered intravenously by infusion.

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

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

You may need to monitor your 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 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). Monitoring of serum sodium is especially important when hypotonic solutions such as this medicine are administered.

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 as long as its indication and administration are correct and controlled, there is no risk of overdose. If these requirements are not met, some symptoms may occur due to side effects. Administration will be suspended, and symptomatic treatment will be resorted to.

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

If you have any further questions on 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 Sodium Chloride Grifols 0.45% may cause hyperhydration with fluid retention and edema, including pulmonary edema (excessive fluid accumulation in the lungs) and symptoms of congestive heart failure (heart failure).

When large amounts of this solution are administered, chloride ions can cause loss of bicarbonate ions, leading to acidosis (decrease in blood pH).

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

If it is administered continuously in the same infusion site, pain or reaction at the injection site, fever, infection, extravasation, venous thrombosis (clots in the vein), and phlebitis (inflammation of the vein) that extends from the injection site may occur.

Reporting of side effects

If you experience any side effects, talk to your doctor or nurse, even if it is possible side effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: 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 0.45%

No special storage conditions are required.

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

Do not use this medicine after the expiry date stated on the packaging.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the pharmacy's SIGRE (waste disposal) point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition of Sodium Chloride Grifols 0.45%

The active substance 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 pack contents

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

Not all pack sizes may be marketed.

Marketing authorization holder

LABORATORIOS GRIFOLS, S.A.

Can Guasch, 2

08150 Parets del Vallès, Barcelona (SPAIN)

Manufacturer

LABORATORIOS GRIFOLS, S.A.

Polígono Industrial Autopista. Passeig Fluvial, 24.

08150 Parets del Vallès, Barcelona (SPAIN)

Date of last revision of this leaflet:July 2018

Other sources of information

Detailed information on this medicine 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:

Sodium Chloride Grifols 0.45% is a solution for infusion.

The contents of each vial of this medicine are for single use only. The unused fraction should be discarded.

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

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

For administration of the solution and in case of mixtures, maximum asepsis should be maintained during the addition of medicines.

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