SALINE SOLUTION GRIFOLS 0.9% SOLUTION FOR INFUSION

2. What you need to know before starting to use Salina Fisiológica Grifols 0.9%

Do not use Salina Fisiológica Grifols 0.9%

• if you are allergic to sodium chloride or any of the other components of this medication (listed in section 6)
• if you have high levels of chloride and sodium in the blood (hyperchloremia and hypernatremia, respectively) or if you have hyperhydration (excess fluid in the body)
• if you have acidosis (pH below the normal range)
• in edematous states in patients with 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 Salina Fisiológica Grifols 0.9%.

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

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

• 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 cerebral distensibility (e.g., in cases of meningitis, intracranial hemorrhage, and cerebral 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, there is a risk of thrombophlebitis.

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

Children

If used in premature and breastfed infants, the administration of sodium chloride should only be given after determining serum sodium levels.

Other medicationsand Salina Fisiológica Grifols 0.9%

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

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

It is essential that you inform your doctor if you are using any of the following medications:

• 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.
  • medications 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 medications reduce water excretion in urine and increase the risk of hospital hyponatremia after receiving inadequately 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 medication.

This medication 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).

In case of pregnancy or breastfeeding, your doctor will decide on the convenience of using physiological saline solution.

As long as the administration of the product is correct and controlled, no adverse reactions are expected during pregnancy, in the fetus, or in the newborn. Similarly, there is no evidence to suggest that maternal administration of physiological saline solution during breastfeeding is harmful to the neonate. However, it is recommended to use it with caution during these periods.

Driving and using machines

There is no indication that this medication may affect the ability to drive or use machines.

3. How to use Salina Fisiológica Grifols 0.9%

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

Salina Fisiológica Grifols 0.9% is administered intravenously by infusion.

Your doctor will indicate the duration of your treatment with Salina Fisiológica Grifols 0.9%.

The doses may vary according to medical criteria, always adjusting the administered volume and the average infusion rate to the clinical need of each patient based on age, weight, clinical picture (e.g., burns, surgery, head injury, infections), fluid balance, electrolytes, and acid-base balance. In general, it is recommended to administer the solution at an average rate of 40 to 60 drops per minute (120-180 ml/h).

The maximum daily dose is 40 ml/kg of body weight/day, and the maximum infusion rate is 5 ml/kg of body weight/hour.

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

You may need to monitor 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).

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

If you receive more Salina Fisiológica Grifols 0.9% than you should

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

In case of overdose, the following symptoms may appear: hyperhydration, hypernatremia, hyperchloremia, metabolic acidosis, or edema formation. In these cases, administration will be suspended, and symptomatic treatment will be used.

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

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

4. Possible adverse effects

Like all medications, this medication can cause adverse effects, although not all people experience them.

Inadequate or excessive administration of physiological saline solution may cause hyperhydration, hypernatremia, hyperchloremia, and related manifestations, such as metabolic acidosis, due to decreased bicarbonate ion concentration, and edema formation.

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 and even isotonic solutions is increased. Hospital hyponatremia can cause irreversible brain damage and death due to 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, and phlebitis extending from the injection site may occur.

If it is used as a vehicle for the administration of other medications, the nature of the added medications will determine the likelihood of other adverse reactions.

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 it directly through the Spanish Pharmacovigilance System for Human Use Medications: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Salina Fisiológica Grifols 0.9%

It does not require special storage conditions.

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

Do not use this medication after the expiration date shown on the packaging. The expiration date is the last day of the month indicated.

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

Do not use this medication if you observe turbidity or sedimentation (presence of particles at the bottom of the packaging) or if the packaging shows visible signs of deterioration.

Medications should not be thrown away through the sewers or in the trash. Deposit the packaging and medications you no longer need in the SIGRE collection point (SIGRE symbol) at the pharmacy. If you have any doubts, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Salina Fisiológica Grifols 0.9%

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

The other components (excipients) are: hydrochloric acid (for pH adjustment) (for the medication packaged in glass vials), sodium hydroxide (for pH adjustment) (for the medication packaged in polypropylene bags "Fleboflex" and "Fleboflex Luer"), and water for injectable preparations.

Appearance of the product and package contents

Salina Fisiológica Grifols 0.9% is a clear and colorless infusion solution, presented in glass vials containing 50, 100, 250, and 500 ml; in polypropylene bags (Fleboflex) containing 50, 100, 250, 500, and 1000 ml; and in polypropylene bags (Fleboflex Luer) containing 50, 100, 250, 500, and 1000 ml.

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)

LABORATORIOS GRIFOLS, S.A.

Polígono Industrial Los Llanos. C/ Marte, 4

30565 Las Torres de Cotillas, Murcia (SPAIN)

Date of the last revision of this prospectus: July 2018

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:

Salina Fisiológica Grifols 0.9% is an infusion solution.

The content of each package of this medication is for a single infusion. The unused fraction must be discarded.

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

The solution must be transparent and not contain precipitates. Do not administer otherwise.

Fleboflex and Fleboflex Luer bags:

• Check for the absence of small leaks by pressing the bag firmly. If leaks are detected, discard the product.
• To connect the infusion equipment, separate the protective tab from the infusion port (for Fleboflex bags) or break the valve by twisting (for Fleboflex Luer bags), exposing the access membrane to the bag.

To administer the solution and in case of mixtures, maximum asepsis must be maintained during the addition of medications.

In order to add medications to the solution if necessary, packages with capacities of 100 ml, 250 ml, 500 ml, and 1000 ml are available, containing 50 ml, 100 ml, 250 ml, and 500 ml of solution, respectively.

Before adding medications to the solution or administering them simultaneously with other medications, it must be checked that there are no incompatibilities. The pH of the final solution must be taken into account.

The 0.9% sodium chloride solution is physically incompatible with amphotericin B, an antifungal chemotherapeutic agent.