Patient Information

Grifols Physiological Saline 0.9% Solution for Infusion

Sodium Chloride

Read this entire leaflet carefully before you start using this medicine,because it contains important information for you.

- Keep this leaflet, as you may need to read it again.

- If you have any questions, ask your doctor or nurse.

- If you experience any side effects,consult your doctor or nurse, even if they are not listed in this leaflet.See section 4.

1. What is Grifols Physiological Saline 0.9% and what is it used for

2. What you need to know before using Grifols Physiological Saline 0.9%

3. How to use Grifols Physiological Saline 0.9%

4. Possible side effects

5. Storage of Grifols Physiological Saline 0.9%

6. Contents of the pack and additional information

Salina Fisiológica Grifols 0.9% is an isotonic restorative solution that restores electrolyte balance.

Salina Fisiológica Grifols 0.9% is indicated for:

- States of dehydration accompanied by salt loss

- Mild states of alkalosis

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

- As a vehicle for the administration of medications and electrolytes.

No 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 your blood (hyperchloremia and hypernatremia respectively) or if you are experiencing excessive fluid retention in your body

-if you have acidosis (a pH level below the normal range)

-in edematous states in patients with cardiac, hepatic, or renal alterations and severe hypertension

-if you have low levels of potassium in your blood (hypokalemia), as administering this medication in this state can lead to the replacement of potassium in cells with sodium, exacerbating 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 use Salina Fisiológica Grifols 0,9%.

-This medication should be administered with caution if 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 (a hormone that stimulates the secretion of cortisol and other steroid hormones).

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

-The administration of large volumes requires special vigilance 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 sodium levels in the blood during hospitalization).

Hypotonic Hyponatremia:

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 the 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.

-If you are administered continuously in the same perfusion site, there is a risk of thrombophlebitis.

• Special attention should be paidif used in elderly patients, as they may have impaired kidney function.

Children

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

Other Medications and Salina Fisiológica Grifols 0,9%

Inform your doctor if you are using, have used recentlyor may need to use anyother medication.

Certain medications may interact with Salina Fisiológica Grifols 0,9%. In this case, it may be necessary 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-methylenedioxymethamphetamine, ifosfamide, antipsychotics, narcotics, nonsteroidal anti-inflammatory drugs (NSAIDs), 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 antiepileptic drugs 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, consultyour doctor before using this medication.

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

Your doctor will decide whether to use physiological saline solution during pregnancy or lactation.

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

Driving and Operating Machinery

There is no indication that this medication can affect your ability to drive or operate machinery.

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

Salina Fisiológica Grifols 0.9% is administered intravenously through infusion.

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

Doses may be adjusted according to medical criteria, always adjusting the administered volume and the average infusion rate to the clinical needs of each patient based on age, weight, clinical condition (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., impending or manifest hypovolemic shock), the amount of solution needed should be 3-4 times the volume of blood lost.

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).

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 your 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 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 medication may produce adverse effects, although not all people will experience them.

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

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

Continuous administration in the same perfusion site may cause pain or reaction at the injection site, fever, infection, extravasation, venous thrombosis, and phlebitis extending from the injection site.

If used as a vehicle for the administration of other medications, the nature of the added medications will determine the probability 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 them directly through the Spanish 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.

This product does not require special conditions for conservation.

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

Do not use this medication after the expiration date that appears 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 usethis medicationif 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 disposed of through drains or in the trash. Dispose of the packaging and medications 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 packaging and medications you no longer need. In this way, you will help protect the environment.

Solution Composition of Salina Fisiológica Grifols 0.9%

The active ingredient is sodium chloride. Each 100 ml of solution contains0.9 gof sodium chloride.

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

Product Appearance and Packaging Contents

Salina Fisiológica Grifols 0.9% is a transparent and colorless perfusion solution, presented in glass bottles 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)

Responsible for Manufacturing

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)

Last Review Date of this Leaflet: July 2018

Other Information Sources

The detailed information of this medicament is available on the webpage of the Spanish Agency of Medicaments and Health Products (AEMPS)(http://www.aemps.gob.es/)

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This information is intended solely for healthcare professionals:

Salina Fisiológica Grifols 0.9% is a perfusion solution.

The content of each package of this medicament is for a single perfusion. It must be discarded unused.

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 firmly on the bag. If leaks are detected, discard the product.

-To connect the perfusion equipment, separate the protective tab from the infusion port(for Fleboflex bags) or break the valve by twisting (for Fleboflex Luer bags), leaving the access membrane to the bag exposed.

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

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

Before adding medications to the solution or administering 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.