Sodium chloride Grifols 0.45% solution for infusion

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Sodium Chloride Grifols 0.45% solution for infusion

Read all of this 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 adverse effects, consult your doctor or nurse, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Sodium Chloride Grifols 0.45% is and what it is used for
2. What you need to know before using Sodium Chloride Grifols 0.45%
3. How to use Sodium Chloride Grifols 0.45%
4. Possible adverse effects
5. How to store Sodium Chloride Grifols 0.45%
6. Contents of the pack and other information

1. What Cloruro de Sodio Grifols 0.45% is and what it is used for

Cloruro de Sodio Grifols 0.45% is a hypotonic intravenous solution of sodium chloride, used to maintain body fluids in proper balance.

Cloruro de Sodio Grifols 0.45% is indicated in states of hypertonic dehydration due to increased sensible losses (primarily loss of water through the digestive, urinary systems, or sweating) or due to osmotic diuresis (a condition in which there is an increase in urine volume).

2. What you need to know before using 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 ingredients of this medicine (listed in section 6)

• in cases of hyperhydration (excess fluid in the body) or water intoxication

• in edematous conditions if you have cardiac, hepatic, or renal disorders or severe hypertension

• if you have low levels of potassium in the blood (hypokalemia), as 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 failure, especially in cardiovascular patients.

Warnings and precautions

Consult your doctor or nurse before starting treatment with Sodium Chloride Grifols 0.45%.

• This medicine 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).

• Administration of sodium chloride solutions immediately after surgery may result in excessive sodium retention.

• In prolonged therapies and if your condition requires it, such as in the presence or imminent risk of acid-base imbalance, you may need periodic laboratory tests and clinical evaluations to monitor changes in water and acid-base balance and serum electrolyte concentrations.

• The risk of hyperhydration can be avoided by carefully monitoring the total fluid intake and output of the patient.

• 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 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 solutions.

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

Children, women of reproductive age, and patients with reduced cerebral compliance (e.g., in cases of meningitis, intracranial hemorrhage, and cerebral contusion) are at special risk of severe and potentially fatal cerebral edema caused by acute hyponatremia.

• If administered continuously at the same infusion site, thrombophlebitis (vein inflammation associated with clot formation) may occur, although this is uncommon due to the hypotonic nature of this solution.

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

Other medicines and Sodium Chloride Grifols 0.45%

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

Certain medicines may interact with Sodium Chloride Grifols 0.45%. 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 when receiving inadequately balanced 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 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 levels 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 potential benefits outweigh the possible risks to the fetus or nursing infant.

Driving and use of 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 provided as a solution and will be administered in a hospital setting by qualified healthcare personnel.

Sodium Chloride Grifels 0.45% is administered intravenously by infusion.

Your doctor will determine the duration of your treatment with Sodium Chloride Grifels 0.45%.

The volume and rate of administration may be adjusted at the physician's discretion, based on individual patient requirements, age, weight, and clinical condition (e.g., burns, surgery, head injury, infections), as well as existing needs for water, sodium, and chloride. However, administration must be performed in such a way that the increase in plasma osmolality does not exceed 1 mOsm/kg/hour.

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 levels if you have increased non-osmotic release of vasopressin (SIADH) or if you are simultaneously receiving medications containing vasopressin agonists, due to the risk of hospital-acquired hyponatremia (see sections 2 and 4). Monitoring of serum sodium is particularly important when hypotonic solutions such as this medicinal product are administered.

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

If you receive more Sodium Chloride Grifels 0.45% than you should

Given the nature of the product, and provided that its indication and administration are correct and properly controlled, there is no risk of overdose. If these conditions are not met, symptoms related to adverse effects may occur. 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 Sodium Chloride Grifols 0.45% may lead to fluid overload with fluid retention and edema, including pulmonary edema (excessive accumulation of fluid in the lungs) and symptoms of congestive heart failure (impaired heart function).

When large amounts of this solution are administered, chloride ions may 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, or kidney diseases, and in patients treated with vasopressin agonists, the risk of developing acute hyponatremia after administration of hypotonic solutions is increased. 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 at the injection site, fever, infection, extravasation, venous thrombosis (blood clots in the vein), and phlebitis (vein inflammation) extending from the injection site may occur.

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 through the Spanish System of Pharmacovigilance of Human Medicines: www.notificaRAM.es. By reporting adverse 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 container.

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

6. Contents of the pack and other 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 injections.

Appearance of the medicinal product and content of the container

Sodium Chloride Grifols 0.45% is a clear, colourless infusion solution supplied in glass bottles of 100 ml (containing 50 or 100 ml of solution), 500 ml and 1000 ml. Clinical packs are also available for all presentations (20 bottles for the 100 ml presentation (containing 50 or 100 ml) and 10 bottles for the 500 ml and 1000 ml presentations).

Only certain 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 the most recent revision of this package 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:

Sodium Chloride Grifols 0.45% is an infusion solution.

The contents of each bottle of this medicinal product are intended for single use only. Any unused portion must be discarded.

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

Do not use this medicinal product if the solution is not clear or contains precipitates.

For administration of the solution and in cases of admixtures, maximum aseptic conditions must be maintained when adding medicinal products.

Signs of incompatibility have been reported when certain medicinal products such as amphotericin B, amsacrine or trimetrexate glucuronate are diluted in sodium chloride solutions. Compatibility tables should be consulted before adding any medicinal product.