Sodium chloride Baxter S.p.A.: detailed information

Package leaflet: Information for the user

SODIUM CHLORIDE Baxter S.P.A. 0.9% infusion solution

Sodium chloride
Generic medicine
Read all of this leaflet carefully before you are given this medicine
because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or nurse.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or nurse. See section 4.

Contents of this leaflet:

What SODIUM CHLORIDE Baxter S.P.A. is and what it is used for
What you must know before you are given SODIUM CHLORIDE Baxter S.P.A.
How SODIUM CHLORIDE Baxter S.P.A. will be given to you
Possible side effects
How to store SODIUM CHLORIDE Baxter S.P.A.
Contents of the pack and other information

1. WHAT SODIO CLORURO BAXTER S.P.A. IS AND WHAT IT IS USED FOR

SODIO CLORURO Baxter S.P.A. is an infusion solution containing the active substance
sodium chloride and affects the electrolyte balance (electrolytes, essential substances
required for all cells to maintain a condition allowing them to perform their functions
optimally).
This medicinal product is used in adults and children for fluid and sodium chloride
replacement.

2. WHAT YOU SHOULD KNOW BEFORE SODIUM CHLORIDE IS ADMINISTERED TO YOU

SODIUM CHLORIDE BAXTER S.P.A.
Do not use SODIUM CHLORIDE BAXTER S.P.A.

If you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).
If you have high sodium levels in the blood (hypernatremia).
If you have fluid and salt retention (hypervolemia).

Warnings and precautions
Talk to your doctor or nurse before you are given SODIUM CHLORIDE BAXTER S.P.A.
SODIUM CHLORIDE BAXTER S.P.A. will be administered with great caution if:

You suffer from congestive heart failure (the heart's inability to supply sufficient blood to meet the body’s needs).
You suffer from severe renal failure (severely reduced kidney function).
You are in clinical conditions associated with edema and salt retention.

You are being treated with corticosteroid medicines (anti-inflammatory drugs) or
corticotropin agents (medicines used to assess adrenal gland function or
for the treatment of diseases requiring corticosteroid therapy).
SODIUM CHLORIDE BAXTER S.P.A. will be administered cautiously if you have:

Hypertension (high blood pressure).
Heart failure (reduced heart function).
Peripheral or pulmonary edema (fluid accumulation).
Excess sodium in the blood (hypernatremia), excess chloride in the blood (hyperchloremia), blood acidity (metabolic acidosis), increased blood volume (hypervolemia).
Primary or secondary hyperaldosteronism.
Liver dysfunction (including cirrhosis).
Reduced kidney function.
Pre-eclampsia (a specific pregnancy condition characterized by edema, protein in the urine, and high blood pressure).
Conditions associated with sodium retention (see "Other medicines and SODIUM CHLORIDE BAXTER S.P.A.").
If you are in a condition that may cause high levels of vasopressin, a hormone that regulates fluids in your body. You may have excessive vasopressin in your body, for example, if:
You have a sudden and serious illness.
You have pain.
You have undergone surgery.
You have infections, burns, or brain diseases.
You have conditions affecting your heart, liver, kidneys, or central nervous system.
You are taking certain medications (see "Other medicines and SODIUM CHLORIDE BAXTER S.P.A.").
This may increase the risk of low sodium levels in your blood and may lead to headache, seizures, lethargy, vomiting, and cerebral edema. Cerebral edema increases the risk of severe, irreversible, and life-threatening brain injury. People at higher risk of cerebral edema include:
Children.
Women (especially those of childbearing age).
Individuals with conditions affecting brain fluid levels, such as meningitis, intracranial hemorrhage, or brain injury.

Continuous administration of this medicine without additional potassium supplementation may cause hypokalemia (reduced potassium concentration in the blood).
Other medicines and SODIUM CHLORIDE BAXTER S.P.A.
Inform your doctor or nurse if you are taking, have recently taken, or might take any other medicines.
Some medicines increase the effect of the vasopressin hormone. These may include:

Antidiabetic drugs (chlorpropamide).
Cholesterol-lowering drugs (clofibrate).
Anticonvulsant drugs (carbamazepine).
Certain cancer drugs (vincristine, ifosfamide, cyclophosphamide).
Selective serotonin reuptake inhibitors (used to treat depression).
3,4-methylenedioxy-N-methamphetamine.
Antipsychotics.
Narcotics.
Painkillers and/or anti-inflammatory drugs (also known as NSAIDs).
Drugs that mimic or enhance the effect of vasopressin (desmopressin, oxytocin, vasopressin, terlipressin). Other medicines that increase the risk of hyponatremia also include diuretics in general and antiepileptic drugs such as oxcarbazepine. If you are receiving SODIUM CHLORIDE BAXTER S.P.A., caution should be exercised when taking corticosteroid drugs concomitantly, as these may cause sodium and water retention, leading to edema (swelling) and hypertension (increased blood pressure) (see "Warnings and precautions"). If you are taking lithium, inform your doctor or nurse before receiving SODIUM CHLORIDE BAXTER S.P.A., as it may decrease lithium levels.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding,
ask your doctor or nurse for advice before using this
medicine.
Pregnancy
If you are pregnant, inform your doctor or nurse before SODIUM CHLORIDE BAXTER S.P.A. is administered to you, as it will only be given if strictly necessary and only after your doctor or nurse has evaluated the benefit-risk ratio.
No adverse effects on fetal development have been reported.
SODIUM CHLORIDE BAXTER S.P.A. should be administered with particular caution in pregnant women during labor, especially regarding serum sodium levels, when administered in combination with oxytocin, due to the risk of hyponatremia (see sections "Warnings", "Interactions", and "Undesirable effects").
Breastfeeding
This medicine may be administered during breastfeeding.
Driving and using machines
SODIUM CHLORIDE BAXTER S.P.A. does not affect the ability to drive or operate
machinery.

3. HOW TO USE SODIUM CHLORIDE BAXTER S.P.A.

Your treatment with SODIUM CHLORIDE BAXTER S.P.A. will be supervised by a physician (qualified healthcare professional). The physician will determine the amount of SODIUM CHLORIDE BAXTER S.P.A. to administer and will prepare the medicinal product.
The medicine must be administered by intravenous infusion (into a vein).
During the infusion, monitoring of your fluid balance, electrolytes, plasma osmolarity (blood concentration), and acid-base balance will be required.

Adults and adolescents over 12 years of age
Treatment of isotonic fluid depletion (reduction in fluids with concentration equal to that of blood)
The recommended dose may range from 500 ml to 3000 ml administered over 24 hours.
If you suffer from renal insufficiency, the dose should be appropriately reduced.

Treatment of sodium deficit (reduction)
The recommended dose may vary depending on age, body weight, clinical condition, electrolyte status, and patient osmolarity, and is proportional to the calculated sodium deficit.

The solution must be clear, colourless, and free from visible particles. The solution should be used immediately after opening the container. The container is intended for single, uninterrupted administration, and any remaining solution must not be reused.

Use in children (up to 12 years of age) and neonates
Treatment of isotonic fluid depletion (reduction in fluids with concentration equal to that of blood)
The recommended dose may range from 20 ml to 100 ml per 24 hours per kg of body weight, depending on the child's body weight and age.
If the child suffers from renal insufficiency, the dose should be appropriately reduced.

Treatment of sodium deficit
The recommended dose may vary depending on the child's age, weight, clinical condition, electrolyte status, and osmolarity, and is proportional to the calculated sodium deficit.

If you use more SODIUM CHLORIDE BAXTER S.P.A. than you should
SODIUM CHLORIDE BAXTER S.P.A. will be administered by specialized medical personnel; therefore, it is unlikely that an excessive dose will be given.
Administration of an excessive dose of the medicine may lead, depending on your clinical condition, to the following:

Hypernatraemia (elevated sodium concentration in the blood) and excessive sodium retention, particularly in cases of impaired renal sodium excretion. These conditions may cause dehydration (loss of water) of internal organs, especially the brain, and accumulation of extracellular fluid (outside the cells), resulting in cerebral (brain), pulmonary, and peripheral oedema (fluid accumulation).
Hyperchloraemia (elevated chloride concentration in the blood); this condition leads to reduced bicarbonate ion concentration, causing acidosis (increased blood acidity) and/or hypervolaemia (increased circulating blood volume).

In case of administration of an excessive dose, treatment should be discontinued and you should be closely monitored for the appearance of any signs and symptoms related to the administered drug, with appropriate symptomatic and supportive measures implemented as needed.
Therapy should aim to restore physiological sodium ion concentrations; administration of 5% glucose intravenously or hypotonic or isotonic sodium chloride solutions (with lower or similar concentration compared to blood) is recommended.
Loop diuretics (medicines that increase urine production) may be used in cases of significantly elevated natraemia.
A natraemia (sodium concentration in blood) exceeding 200 mmol/L may require dialysis (a physical therapy that replaces renal function).

If you have any doubts about the use of this medicine, consult your doctor or nurse.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Possible adverse reactions that may occur with the use of this medicine include:

Hypernatraemia (elevated sodium concentration in the blood), hypervolaemia (increased volume of circulating blood in the body), hyperchloraemia (elevated chloride concentration in the blood, which may cause loss of bicarbonate with consequent increase in blood acidity).
Headache, dizziness, restlessness, fever, irritability, weakness, muscle rigidity, seizures, coma, death.
Drowsiness, confusion.
Dyspnoea (difficulty breathing), respiratory arrest.
Thirst, reduced salivation, nausea, vomiting, diarrhoea, abdominal pain.
Tachycardia (increased heart rate).
Reduced tear production.
Renal failure (reduced kidney function).
Hypotension (low blood pressure), hypertension (high blood pressure), pulmonary and peripheral oedema.
Infection at the infusion site, pain and local reaction, venous irritation, thrombosis (formation of blood clots in blood vessels), or phlebitis (vein inflammation) extending from the infusion site, extravasation (leakage of blood).
Allergic reactions presenting with symptoms such as hypotension, fever, tremors, chills, urticaria, rash, pruritus.
Low sodium levels in the blood (hospital-acquired hyponatraemia).
Acute hyponatraemic encephalopathy.
*Hyponatraemia may cause irreversible brain damage and death due to the development of acute hyponatraemic encephalopathy, frequency not known (see also section “Warnings and Precautions”).

Following the instructions contained in this leaflet reduces the risk of adverse reactions.
Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, please contact your doctor or nurse. You may also report adverse reactions via: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. HOW TO STORE SODIO CLORURO BAXTER S.P.A.

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label of the container. The expiry date refers to the last day of that month and to the product in its original, intact packaging, properly stored.
Store in a tightly closed container. Do not freeze or refrigerate.
Do not use this medicine if the solution is not clear, colourless, and free from visible particles.
Use the solution immediately after opening the container. The container is intended for single, uninterrupted administration; any remaining residue must not be used.

6. PACKAGING CONTENTS AND OTHER INFORMATION

What SODIO CLORURO Baxter S.P.A. contains
1000 ml of infusion solution contains:
Active substance: sodium chloride 9 g.
mEq/L: Na 154
Cl 154
Theoretical osmolarity (mOsm/L): 308
pH: 4.5–7
1 g NaCl = 394 mg Na or 17.1 mEq or 17.1 mmol of Na and Cl
1 mmol Na = 23 mg Na
Other components: water for injections, q.s.

Description of the appearance of SODIO CLORURO Baxter S.P.A. and packaging contents
Infusion solution.
Clear, colourless solution free from visible particles. Sterile and free from bacterial endotoxins.

Glass bottles
250 and 500 ml: single packaging
50, 100 ml: pack of 25 units
250 ml: pack of 30 units
500 ml: pack of 20 units

Clear Flex bags
50 and 2000 ml: single packaging
50, 100 ml: pack of 50 units
250 ml: pack of 36 units
500 ml: pack of 20 units
1000 ml: pack of 12 units
2000 ml: pack of 6 units
3000 ml: pack of 4 units
5000 ml: pack of 2 units

Marketing Authorization Holder
BAXTER S.p.A. - Piazzale dell’Industria 20 – 00144 Rome, Italy.

Manufacturer
Bieffe Medital S.p.A. - Via Nuova Provinciale - 23034 Grosotto (SO), Italy
Bieffe Medital S.A., Ctra de Biesca s/n, 22666 Sabiñanigo (Spain)
Baxter S.A., Boulevard René De Branquart 80, Lessines (Belgium)
Baxter Healthcare S.A., Moneen Road, Castlebar (Ireland)
Baxter Healthcare Ltd, Caxton Way, Thetford (UK)

The following information is intended exclusively for physicians or healthcare professionals

Dosage and administration
Electrolyte balance, serum electrolytes, and acid-base balance may need to be monitored before and during administration, with particular attention to serum sodium in patients with non-osmotic release of vasopressin (syndrome of inappropriate antidiuretic hormone secretion, SIADH) and in patients receiving concomitant therapy with vasopressin agonists, due to the risk of hospital-acquired hyponatremia (see sections Warnings, Interactions, and Undesirable effects).
Monitoring of serum sodium is particularly important for hypotonic solutions.
Sodium Chloride Baxter S.P.A. osmolarity: 308 mOsm/L
The infusion rate and volume depend on age, body weight, clinical condition (e.g., burns, surgery, head injuries, infections), and concomitant therapy, and must be determined by a physician experienced in pediatric intravenous fluid therapy (see sections Warnings and Undesidered effects).

Treatment of sodium deficit
The dose, rate, and duration of administration must be individualized and depend on the indication, the patient's clinical and laboratory response to treatment, the electrolyte profile and osmolarity, and are related to the calculated sodium deficit.
The theoretical sodium deficit can be calculated using the following formula:
DEFICIT (mEq) = (140 - P) × V
P = plasma sodium concentration (in mEq/L)
V = total body water (equal to 60% of body weight in children and adult males, 50% in adult females, and 50% and 45% respectively in elderly males and females).

When sodium chloride solutions, particularly 0.9% solutions, are used as diluents for intravenous administration of drugs requiring prior dilution, the compatibility of such medicinal products with sodium chloride and the most appropriate concentration for administration must be verified in advance in the SmPC of the drug to be diluted. If the concentration is not specified, use the 0.9% solution.
When other electrolytes or drugs are added to this solution, the dose and infusion rate will also be determined by the dosing regimen of the additives.
Parenteral drugs should be inspected visually for particulate matter and discoloration prior to administration, whenever the container permits. Do not administer if the solution is not clear or if the seal is not intact (see section “Special warnings and precautions for use”).

Special warnings and precautions for use
Infusion of large volumes should be used with specific monitoring in patients with cardiac or pulmonary insufficiency and in patients with non-osmotic vasopressin release (including SIADH), due to the risk of hospital-acquired hyponatremia (see below).

Hyponatremia
Patients with non-osmotic vasopressin release (e.g., during acute illness, pain, postoperative stress, infections, burns, and central nervous system disorders), patients with cardiac, hepatic, or renal diseases, and patients treated with vasopressin agonists (see section Interactions) are particularly at risk of acute hyponatremia following infusion 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 severe, irreversible, and life-threatening brain injury.
Children, women of childbearing age, and patients with reduced cerebral compliance (e.g., meningitis, intracranial hemorrhage, contusion, and cerebral edema) are particularly at risk of severe, life-threatening cerebral edema caused by acute hyponatremia.

Use in pediatric patients
Use with caution in children and monitor closely due to the solution’s ability to affect fluid and electrolyte balance.

Use in elderly patients
When selecting the type of infusion solution and the volume/infusion rate for elderly patients, consider that elderly patients are generally more likely to have cardiac, renal, or hepatic impairment or to be receiving concomitant medications.

Risk of gas embolism

Do not use flexible plastic containers connected in series, as they may cause gas embolism due to residual air from the primary container.
Pressurizing intravenous solutions contained in flexible plastic containers to increase flow rates may cause gas embolism if residual air in the container is not completely removed before administration.
Using an intravenous administration set with the vent in the open position may cause gas embolism. Intravenous administration sets with the vent in the open position must not be used with flexible plastic containers.

Hypersensitivity reactions
Hypersensitivity/infusion reactions have been reported; therefore, if signs or symptoms of such reactions occur (see section “Possible undesirable effects”), infusion must be stopped immediately. Appropriate therapeutic countermeasures should be initiated as directed by the physician.

Risk of fluid and/or solute overload and electrolyte imbalances
Depending on the volume and rate of infusion, intravenous administration of Sodium Chloride may cause:

Fluid and/or solute overload leading to overhydration/hypervolemia and, for example, congestive states, including central and peripheral edema
Clinically significant electrolyte imbalances and acid-base imbalance. Clinical assessment and periodic laboratory tests may be necessary to monitor changes in fluid balance, electrolyte concentrations, and acid-base balance during prolonged parenteral therapy or whenever the patient’s condition or infusion rate warrants such evaluation.

During infusion, it is good practice to monitor fluid balance, electrolytes, plasma osmolarity, and acid-base balance.
The solution must be clear, colorless, and free from visible particles. Use immediately after opening the container and ensure that preparation occurs as quickly as possible under conditions and procedures that preserve the sterility of the solution to the greatest extent possible. The container is intended for single, uninterrupted administration; any residual medicinal product must not be used and should be discarded.

Addition of additives
Before adding any substance or drug, first verify its compatibility with sodium chloride solution, and also confirm that it is soluble and/or stable in water and that the pH range is appropriate.
The instructions for use of the drug to be added and other relevant publications should be consulted.
When additives are added to Sodium Chloride, an aseptic technique must be used.
After addition, check for changes in color and/or formation of precipitates, complexes, or insoluble crystals.
Mix the solution thoroughly after the addition of any additives.

Overdose
Treatment
In case of accidental excessive infusion, treatment should be discontinued and the patient should be closely observed for the appearance of any signs and symptoms related to the administered drug, with appropriate symptomatic and supportive measures provided as needed.
In cases of overdose, therapy should aim to restore physiological sodium ion concentrations.
In these cases, intravenous administration of 5% glucose or hypotonic or isotonic sodium chloride solutions (which are hypotonic relative to the hypernatremic patient) is recommended.
In cases of marked hypernatremia, loop diuretics may be used.
A serum sodium concentration exceeding 200 mmol/L may require dialysis.
When assessing an overdose, additives to the solution must also be considered.

Incompatibilities
Additives may be incompatible with Sodium Chloride.
Although sodium chloride is compatible with a large number of solutions and medicinal products, compatibility should always be verified in the SmPC of the medicinal product intended for co-administration.
Additives known to be incompatible with sodium chloride or considered incompatible must not be used.

Shelf life
36 months for all pack sizes, except for the 50 mL Clear flex bag, which has a shelf life of 24 months.
Use immediately after opening the container. The container is intended for single, uninterrupted administration; any residual solution must not be used.