Saline Grifols 0.9% solution for infusion

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Salina Fisiológica Grifols 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, talk to your doctor or nurse, even if it is a side effect not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Salina Fisiológica Grifols 0.9% is and what it is used for
2. What you need to know before using Salina Fisiológica Grifols 0.9%
3. How to use Salina Fisiológica Grifols 0.9%
4. Possible side effects
5. How to store Salina Fisiológica Grifols 0.9%
6. Contents of the pack and other information

1. What Salina Fisiológica Grifols 0.9% is and what it is used for

Salina Fisiológica Grifols 0.9% is an isotonic solution for restoring electrolyte balance.

Salina Fisiológica Grifols 0.9% is indicated for:

• States of dehydration accompanied by salt loss
• Mild alkalosis
• Hypovolemia (decreased blood volume in the body)
• As a vehicle for the administration of medications and electrolytes.

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

Do not use Salina Fisiológica Grifols 0.9%

• if you are allergic to sodium chloride or to any of the other components of this medicine (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 conditions in patients with cardiac, hepatic, or renal disorders and severe hypertension
• if you have low levels of potassium in the blood (hypokalemia), since administering this solution in such a state may cause cellular potassium to be replaced by sodium, thereby worsening the pre-existing electrolyte imbalance and potentially leading to 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 medicine should be administered with caution if you have hypertension, congestive heart failure, pulmonary or peripheral edema, severe renal failure, 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 existing or imminent acid-base imbalance, periodic monitoring of fluid and acid-base balance and serum electrolyte concentrations should be performed.

• Administration of large volumes requires special monitoring in patients with cardiac or pulmonary insufficiency and in patients with non-osmotic release of vasopressin (antidiuretic hormone) (including the syndrome of inappropriate antidiuretic hormone secretion, SIADH), due to the risk of hospital-acquired hyponatremia (low sodium levels in blood during hospitalization).

Hyponatremia:

Patients with non-osmotic release of vasopressin (e.g., in critical conditions, pain, postoperative stress, infections, burns, and central nervous system disorders), those with heart, liver, or kidney diseases, and those exposed to vasopressin agonists (see next subsection) are at special risk of developing acute hyponatremia following administration of hypotonic and even isotonic solutions.

Acute hyponatremia may cause acute hyponatremic encephalopathy (cerebral edema), characterized by headache, nausea, seizures, lethargy, and vomiting. Patients with cerebral edema are at special risk of suffering 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 developing severe and potentially fatal cerebral edema caused by acute hyponatremia.

• There is a risk of thrombophlebitis if the infusion is continuously administered at the same site.

• Particular attention should be paid when used in elderly patients, as kidney function may be impaired.

Children

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

Other medicines and Salina Fisiológica Grifols 0.9%

Inform your doctor if you are taking, have recently taken, or might need to take any other medicines.

Certain medicines may interact with Salina Fisiológica Grifols 0.9%. In such cases, it may be necessary to adjust the dose or discontinue treatment with one of the medicines.

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

• lithium carbonate, as administration of sodium chloride accelerates renal excretion of lithium, leading to reduced therapeutic effect of the latter.
• corticosteroids or adrenocorticotropic hormone, due to their capacity to retain water and sodium.
  • medicines that enhance the effect of antidiuretic hormone (such as chlorpropamide, clofibrate, carbamazepine, vincristine, selective serotonin reuptake inhibitors, 3,4-methylenedioxy-N-methamphetamine, ifosfamide, antipsychotics, narcotics, NSAIDs (non-steroidal anti-inflammatory drugs), cyclophosphamide, desmopressin, oxytocin, vasopressin, terlipressin). These medicines reduce water excretion in urine and increase the risk of hospital-acquired hyponatremia following inadequately balanced intravenous infusion therapy (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 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 labor, and special monitoring of serum sodium is required if administered in combination with oxytocin (see previous subsections and section 4).

During pregnancy or breastfeeding, your doctor will decide whether the use of physiological saline solution is appropriate.

Provided the administration of the product is correct and controlled, adverse reactions should not be expected during pregnancy, in the fetus, or in the newborn. Likewise, there is no evidence indicating that maternal administration of physiological saline solution during breastfeeding is harmful to the neonate. Nevertheless, it is recommended to use it with caution during these periods.

Driving and use of machines

There is no indication that this medicine may affect the ability to drive or operate machinery.

3. How to use Salina Fisiológica Grifols 0.9%

It is provided as a solution and will be used in a hospital setting by the appropriate healthcare personnel.

Salina Fisiológica Grifols 0.9% is administered intravenously by infusion.

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

Dosages may be adjusted at the physician's discretion, with the infused volume and average infusion rate tailored to the individual patient's clinical needs, taking into account age, weight, clinical condition (e.g., burns, surgery, head injury, infections), fluid balance, electrolyte levels, 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 body weight/day, and the maximum infusion rate is 5 mL/kg body weight/hour.

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

You may require monitoring of fluid balance, serum electrolytes, and acid-base balance before and during administration, with special attention to serum sodium levels if you have increased non-osmotic release of vasopressin (SIADH) or are receiving concomitant treatment with vasopressin agonists, due to the risk of hospital-acquired hyponatremia (see sections 2 and 4).

Your doctor will decide whether concomitant treatment is necessary (see sections 2 and 4).

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

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

In case of overdose, the following symptoms may occur: hyperhydration, hypernatremia, hyperchloremia, metabolic acidosis, or edema formation. In such cases, administration should be discontinued and symptomatic treatment initiated.

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Improper or excessive administration of physiological saline solution may lead to 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, in patients with heart, liver, or kidney diseases, and in patients treated with vasopressin agonists, the risk of developing acute hyponatremia increases after administration of hypotonic and even isotonic solutions. Hospital-acquired hyponatremia may cause irreversible brain damage and death due to cerebral edema (see sections 2 and 3).

If administered continuously at the same infusion site, pain or local reaction, fever, infection, extravasation, venous thrombosis, and phlebitis extending from the injection site may occur.

When used as a vehicle for the administration of other medications, the nature of the added drugs will determine the likelihood of other adverse reactions.

Reporting of 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 leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Salina Fisiológica Grifols 0.9%

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 container. The expiry date refers to the last day of the month indicated.

Once the container has been opened, the solution must be used immediately.

Do not use this medicine if you observe cloudiness or sedimentation (presence of particles at the bottom of the container), or if the container shows visible signs of deterioration.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point (SIGRE symbol) at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Saline Grifols 0.9%

The active substance 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 medicine packaged in glass bottles), sodium hydroxide (for pH adjustment) (for the medicine packaged in polypropylene bags “Fleboflex” and “Fleboflex Luer”), and water for injections.

Appearance of the product and contents of the pack

Saline Grifols 0.9% is a clear, colourless perfusion solution, available 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)

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 most recent revision of this leaflet: July 2018

Other sources of information

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)

This information is intended for healthcare professionals only:

Saline Grifols 0.9% is a solution for infusion.

The contents of each container of this medicine are intended for single use only. Any unused portion must be discarded.

Once the container has been opened, the solution must be administered immediately.

The solution must be clear and free from precipitates. Do not administer if otherwise.

Fleboflex and Fleboflex Luer bags:

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

To administer the solution and when mixing with other drugs, maximum aseptic conditions must be maintained during the addition of medications.

In order to allow the addition of medications to the solution when necessary, containers 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.

Prior to adding medications to the solution or administering concomitantly with other medicinal products, incompatibilities must be ruled out. The pH of the final solution should be taken into account.

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