Sodium chloride S.A.L.F.: detailed information

Package leaflet: Information for the user

SODIO CLORURO S.A.L.F. 2 mEq/ml concentrate for solution for infusion, 3 mEq/ml concentrate for solution for infusion

Sodium chloride
Please read all of this leaflet carefully before you start using 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, pharmacist or nurse.
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of this leaflet:

What SODIO CLORURO S.A.L.F. is and what it is used for
What you need to know before you use SODIO CLORURO S.A.L.F.
How to use SODIO CLORURO S.A.L.F.
Possible side effects
How to store SODIO CLORURO S.A.L.F.
Contents of the pack and other information

1. What SODIO CLORURO S.A.L.F. is and what it is used for

SODIO CLORURO S.A.L.F. is a solution containing sodium and chlorine, indicated to supply the body with sodium and chlorine:

during direct intravenous administration of nutrients in adults and children who have a deficiency of sodium and chlorine due to excessive diuresis (excretion) or inadequate intake of salts;
in the treatment of diseases where it is necessary to restore the concentration of substances present in the blood.

2. What you need to know before using SODIO CLORURO S.A.L.F.

Do not use SODIO CLORURO S.A.L.F. if you have:

hypernatraemia (high concentration of sodium in the blood);
hydro-saline plethoric conditions (increased concentration of salts in the body).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using SODIO CLORURO S.A.L.F.
This medicine should be administered with caution if:

you suffer from hypertension (high blood pressure);
you have peripheral oedema (fluid accumulation in the extremities, such as legs, ankles, and hands) or pulmonary oedema (fluid accumulation in the lungs);
you have reduced renal function (your kidneys are poorly functioning);
you have been diagnosed with pre-eclampsia (if you are pregnant and have developed high blood pressure or worsening hypertension, along with swelling due to fluid retention).

This medicine must be administered with particular caution if:

you have congestive heart failure (the heart is unable to pump sufficient blood to meet the body’s needs);
you have severe renal insufficiency (serious kidney problems);
you have oedema with salt retention (fluid accumulation due to salt retention);
you are taking corticosteroids (medicines used to treat inflammation) or corticotropins (medicines that stimulate hormone production) (see Other medicines and SODIO CLORURO S.A.L.F.). If prolonged treatment is required, this medicine may be administered to prevent depletion. During treatment, you will be monitored to check fluid levels in the body, blood electrolyte levels, and blood acid levels.

Children
This medicine should be administered with caution in children.

Other medicines and SODIO CLORURO S.A.L.F.
Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines.
Inform your doctor if you are taking corticosteroids (medicines for treating inflammation) or corticotropins (medicines that stimulate hormone production), as they may cause fluid retention and increase blood pressure.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Your doctor will prescribe SODIO CLORURO S.A.L.F. only if strictly necessary.
Breastfeeding
This medicine may be used during breastfeeding.

Driving and using machines
SODIO CLORURO S.A.L.F. does not impair the ability to drive or operate machinery.

SODIO CLORURO S.A.L.F. 3 mEq/ml concentrate for infusion solution in vial
contains benzyl alcohol
This medicine contains 9 mg of benzyl alcohol per ml.
Benzyl alcohol may cause allergic reactions.
Benzyl alcohol has been associated with a risk of serious adverse effects, including respiratory problems (gasping syndrome), in young children. SODIO CLORURO S.A.L.F. must not be administered to neonates up to 4 weeks of age unless otherwise recommended by the doctor.
Do not use for more than one week in young children (under 3 years of age) unless otherwise recommended by the doctor or pharmacist.
Consult your doctor or pharmacist if you are pregnant or breastfeeding. Large amounts of benzyl alcohol may accumulate in the body and cause adverse effects (such as metabolic acidosis).
Consult your doctor or pharmacist if you have liver or kidney disease. Large amounts of benzyl alcohol may accumulate in the body and cause adverse effects (such as metabolic acidosis).

3. How to use SODIO CLORURO S.A.L.F.

Use this medicine exactly as instructed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
This medicine will be administered to you by a doctor or nurse.
The medicine will be injected intravenously after dilution.
The doctor will adjust the dose according to your age, body weight, and laboratory test results.
If you use more SODIO CLORURO S.A.L.F. than you should
If you are given an excessive amount of this medicine, it may cause an increase in blood levels of certain salts, such as sodium and chloride, and an increase in blood volume.
If sodium levels in the blood rise too much, you may experience dehydration (fluid loss), which could lead to organ damage, such as in the brain and kidneys, as well as pulmonary and peripheral edema (fluid accumulation in the lungs and extremities, such as legs and ankles).
In case of overdose, treatment should be stopped and you will be closely monitored and appropriately managed.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
The following side effects have been reported with unknown frequency (frequency cannot be estimated
from the available data):

hypernatraemia (increased sodium concentration in the blood),
hypervolaemia (increased blood volume),
hyperchloraemia (increased chloride concentration in the blood);
headache,
dizziness (sensation of movement or spinning),
restlessness,
fever,
irritability,
weakness,
muscle rigidity,
seizures (sudden, involuntary, uncontrolled muscle movements),
coma (deep unconsciousness),
death;
drowsiness,
confusion;
dyspnoea (difficulty breathing),
respiratory arrest (cessation of breathing),
thirst,
reduced salivation,
nausea,
vomiting,
diarrhoea,
abdominal pain,
tachycardia (increased heart rate),
reduced lacrimation,
renal failure (impaired kidney function),
hypotension (low blood pressure),
hypertension (high blood pressure),
pulmonary oedema (fluid accumulation in the lungs),
peripheral oedema (fluid accumulation in the extremities, such as legs, ankles and hands),
infusion site infection,
pain or local reaction,
vein irritation,
venous thrombosis (blood clot formation in the vein) or phlebitis (vein inflammation) extending from the infusion site,
extravasation (leakage of the injected solution from the vein).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You may also report side effects directly via the Italian Medicines Agency (Agenzia Italiana del Farmaco) at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store SODIUM CHLORIDE S.A.L.F.

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging, indicated after “Expiry” for SODIUM CHLORIDE S.A.L.F. in ampoules and after “Exp.” for SODIUM CHLORIDE S.A.L.F. in bottles.
The expiry date refers to the last day of that month.
Do not freeze or refrigerate.
The solution must not be used if it is not clear, colourless, and free from visible particles.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What SODIO CLORURO S.A.L.F. contains
SODIO CLORURO S.A.L.F. 2 mEq/ml concentrate for solution for infusion

The active substance is sodium chloride. Each ml of solution contains 0.117 g of sodium chloride, mEq/ml: Na 2, mEq/ml: Cl 2, Theoretical osmolarity (mOsm/l): 4000, pH: 4.5 - 7.0.
The other component is water for injections.

SODIO CLORURO S.A.L.F. 3 mEq/ml concentrate for solution for infusion
The active substance is sodium chloride. Each ml of solution contains 0.175 g of sodium chloride, mEq/ml: Na 3,
mEq/ml: Cl 3, Theoretical osmolarity (mOsm/l): 6000, pH: 4.5 - 7.0.

The other component is water for injections.
Benzyl alcohol is also present in the 30 ml vials.

Description of the appearance of SODIO CLORURO S.A.L.F. and package contents
Sterile, clear and colourless concentrate for infusion solution.
SODIO CLORURO S.A.L.F. 2 mEq/ml
Pack containing 5 glass vials of 10 ml.
SODIO CLORURO S.A.L.F. 3 mEq/ml
Pack containing 5 glass vials of 10 ml, and 1 and 5 vials of 30 ml.
Marketing Authorization Holder and Manufacturer
S.A.L.F. S.p.A. Laboratorio Farmacologico, via Marconi, 2 – 24069 Cenate Sotto (BG) – Italy.

The following information is intended for healthcare professionals only:

Dosage and administration
Dosage
The dose depends on age, body weight, clinical condition, electrolyte status and osmolarity.
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).
Use hypertonic solutions and administer half of the calculated dose over the first 8 hours, at a maximum rate of 100 mL/hour. Administer the remaining dose until symptoms improve or until a plasma sodium concentration of 130 mEq/L is achieved.
In cases of severe sodium depletion or chronic hyponatremia, administer hypertonic sodium chloride solutions to increase plasma sodium concentration by 1–2 mmol/L/hour. Correction should not exceed 10–12 mmol/L in 24 hours or 18 mmol/L in 48 hours.
Route of administration
Administer by intravenous infusion at a controlled rate, after appropriate dilution.
For dilution instructions prior to administration, see Precautions on disposal and handling.

Overdose
Symptoms
Excessive administration of isotonic or hypertonic sodium chloride solutions may lead, depending on the patient's clinical condition, to hypernatremia, hyperchloremia, and/or hypervolemia.
Hypernatremia (mainly associated with hypertonic solutions) and excessive sodium retention—particularly when impaired renal sodium excretion exists—can cause intracellular dehydration, especially in the brain, and accumulation of extracellular fluid leading to edema affecting the cerebral, pulmonary, and peripheral circulation, potentially resulting in pulmonary and peripheral edema.
Excessive chloride ion accumulation reduces bicarbonate ion concentration, leading to acidosis.
Treatment
In case of accidental excessive infusion, treatment should be discontinued and the patient should be closely monitored for any signs or symptoms related to the administered drug. Appropriate symptomatic and supportive measures should be provided as needed.
In cases of overdose, therapy should aim to restore physiological sodium ion concentrations.
In such cases, intravenous administration of 5% glucose or hypotonic or isotonic sodium chloride solutions (which are effectively hypotonic in hypernatremic patients) is recommended.
Loop diuretics may be used in cases of marked hypernatremia.
A serum sodium concentration exceeding 200 mmol/L may require dialysis.

Special precautions for disposal and handling
Sodium chloride S.A.L.F. must not be injected undiluted.
It should be used exclusively as an additive solution for parenteral nutrition mixtures (see Dosage and administration).
The solution must be clear, colourless and free from visible particles.
Use immediately after opening.
Preparation should be carried out as quickly as possible under sterile conditions.
For single use only. Any unused portion must be discarded.
Although sodium chloride is compatible with a wide range of solutions and medicinal products, compatibility should always be verified.
Unused medicine and waste materials derived from this medicine should be disposed of in accordance with local regulations.

Package leaflet: information for the user

SODIUM CHLORIDE S.A.L.F. 0.9% infusion solution

Sodium chloride
Please read this leaflet carefully before using this medicine because it contains important information for you.

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

Contents of this leaflet:

What SODIUM CHLORIDE S.A.L.F. is and what it is used for
What you need to know before using SODIUM CHLORIDE S.A.L.F.
How to use SODIUM CHLORIDE S.A.L.F.
Possible side effects
How to store SODIUM CHLORIDE S.A.L.F.
Contents of the pack and other information

1. What SODIO CLORURO S.A.L.F. is and what it is used for

SODIO CLORURO S.A.L.F. is a solution containing sodium and chlorine, indicated for replenishing
the body's fluids, sodium, and chlorine.

2. What you need to know before using SODIUM CHLORIDE S.A.L.F.

Do not use SODIUM CHLORIDE S.A.L.F. if you have

hypernatremia (high concentration of sodium in the blood);
hypervolemia (increased concentration of salts in the body).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using SODIUM CHLORIDE S.A.L.F.
This medicine should be administered to you with caution if:

you suffer from hypertension (high blood pressure);
you have peripheral edema (fluid accumulation in the extremities, such as legs, ankles, and hands) or pulmonary edema (fluid accumulation in the lungs);
you have reduced renal function (your kidneys are not working properly);
you have been diagnosed with pre-eclampsia (if you are pregnant and have started experiencing high blood pressure or worsening of existing hypertension, along with swelling due to fluid retention).

This medicine should be administered to you with particular caution if:

you have congestive heart failure (the heart's inability to pump enough blood to meet the body's needs);
you have severe renal insufficiency (serious kidney problems);
you have edema with salt retention (fluid accumulation due to salt retention);
you are taking corticosteroids (medicines used to treat inflammation) or corticotropics (medicines that stimulate hormone production) (see Other medicines and SODIUM CHLORIDE S.A.L.F.).

If prolonged treatment is required, it should be administered to prevent depletion. During treatment, you will be monitored to check fluid levels in the body, blood electrolyte levels, and acid-base balance in the blood.

Children
This medicine should be administered with caution in children.

Other medicines and SODIUM CHLORIDE S.A.L.F.
Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines.
Tell your doctor if you are taking corticosteroids (medicines for treating inflammation) or corticotropics (medicines that stimulate hormone production), as they may cause fluid retention and increase blood pressure.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
Your doctor will prescribe SODIUM CHLORIDE S.A.L.F. only if clearly necessary.

Breastfeeding
This medicine may be used during breastfeeding.

Driving and using machines
SODIUM CHLORIDE S.A.L.F. does not affect the ability to drive or operate machinery.

3. How to use SODIUM CHLORIDE S.A.L.F.

Use this medicine exactly as your doctor has instructed you. If you have any doubts, consult your
doctor or pharmacist.
This medicine will be administered to you by a doctor or a nurse.
This medicine will be given intravenously as an infusion.

Treatment of fluid loss (extracellular dehydration)
Adults and adolescents: administer from 500 ml to 3 litres within 24 hours.
Newborns and children up to 12 years of age: 20 to 100 ml within 24 hours, depending on age and total body weight.
Renal impairment: if you have kidney problems, the dosage will be reduced.

Treatment of sodium loss (sodium deficit)
Your doctor will adjust the dose according to your age, body weight, and laboratory test results.

If you use more SODIUM CHLORIDE S.A.L.F. than you should
If you are given too much of this medicine, it may cause an increase in blood levels of certain salts, such as sodium and chloride, and an increase in blood volume.
If sodium levels in the blood rise too much, you may experience dehydration (fluid loss), which can lead to organ damage, such as in the brain and kidneys, as well as pulmonary and peripheral edema (fluid accumulation in the lungs and extremities, such as legs and ankles).
In case of overdose, treatment must be stopped and you will be closely monitored and appropriately managed.

If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

hypernatraemia (increased concentration of sodium in the blood),
hypervolaemia (increased blood volume),
hyperchloraemia (increased concentration of chloride in the blood);
headache,
dizziness (sensation of movement or spinning),
restlessness,
fever,
irritability,
weakness,
muscle rigidity,
seizures (involuntary, sudden and uncontrolled muscle movements),
coma (deep state of unconsciousness),
death;
drowsiness,
confusion;
dyspnoea (difficulty breathing),
respiratory arrest (cessation of breathing),
thirst,
reduced salivation,
nausea,
vomiting,
diarrhoea,
abdominal pain,
tachycardia (increased heart rate),
reduced lacrimation,
renal failure (impaired kidney function),
hypotension (low blood pressure),
hypertension (high blood pressure),
pulmonary oedema (fluid accumulation in the lungs),
peripheral oedema (fluid accumulation in the extremities, such as legs, ankles and hands),
infusion site infection,
pain or local reaction,
vein irritation,
venous thrombosis (blood clot formation in the vein) or phlebitis (vein inflammation) extending from the infusion site,
extravasation (leakage of the infused solution out of the vein).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the Italian Medicines Agency (Agenzia Italiana del Farmaco) at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store SODIUM CHLORIDE S.A.L.F.

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Expiry".
The expiry date refers to the last day of that month.
Store in a tightly closed container. Do not freeze or refrigerate.
The solution should not be used if it is not clear, colourless and free from visible particles.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What SODIO CLORURO S.A.L.F. contains
SODIO CLORURO S.A.L.F. 0.9% infusion solution

The active substance is sodium chloride. 1000 ml of solution contain 9 g of sodium chloride, mEq/ml: Na 154, mEq/ml: Cl 154, theoretical osmolarity (mOsm/l): 308, pH: 4.5 - 7.0.
The other component is water for injections.

Description of the appearance of SODIO CLORURO S.A.L.F. and package contents
Sterile, clear and colourless infusion solution.
SODIO CLORURO S.A.L.F. 0.9% infusion solution
Glass bottles of 50, 100, 250, 500 and 1000 ml;
PP bottles of 100, 250, 500 and 1000 ml;
PVC bags of 100, 250, 500, 1000, 2000, 3000, 4000 and 5000 ml;
PP bags of 100, 250, 500, 1000, 2000, 3000 and 5000 ml.
Marketing Authorisation Holder and Manufacturer
S.A.L.F. S.p.A. Laboratorio Farmacologico, via Marconi, 2 – 24069 Cenate Sotto (BG) – Italy.

The following information is intended exclusively for healthcare professionals:

Dosage and administration
Treatment of isotonic fluid depletion (extracellular dehydration)
Dosage
Adults and adolescents: 500 ml to 3 litres within 24 hours.
Neonates and children (up to 12 years of age): 20 to 100 ml within 24 hours, depending on age and body weight.
Renal impairment
Dosage reduction is recommended in case of renal impairment.
Treatment of sodium deficit
Dosage
The dose depends on age, weight, clinical condition, electrolyte profile, and osmolarity.
The theoretical sodium deficit can be calculated using the following formula:
DEFICIT (mEq) = (140 – P) x V
P = plasma sodium concentration (in mEq/l)
V = total body water volume (equal to 60% of body weight in children and adult males,
50% in adult females, 50% and 45% respectively in elderly males and females).
In cases of severe sodium depletion and chronic hyponatraemia, administer hypertonic sodium chloride solutions to increase plasma sodium concentration by 1-2 mmol/l/hour. Correction should not exceed 10-12 mmol/l in 24 hours and 18 mmol/l in 48 hours.
Method of administration
Administer by intravenous infusion.
For instructions on dilution of the medicinal product prior to administration, see Precautions for disposal and handling.
Overdose
Symptoms
Excessive administration of isotonic and hypertonic sodium chloride solutions may lead, depending on the patient's clinical condition, to hypernatraemia, hyperchloraemia and/or hypervolaemia.
Hypernatraemia (mainly associated with administration of hypertonic solutions) and excessive sodium retention when impaired renal sodium excretion exists, causes dehydration of internal organs, especially the brain, and accumulation of extracellular fluid with oedema affecting the cerebral, pulmonary and peripheral circulation, possibly leading to pulmonary and peripheral oedema.
Accumulation of chloride ions leads to reduced bicarbonate ion concentration, resulting in acidosis.
Treatment
In case of accidental excessive infusion, treatment should be discontinued and the patient should be closely monitored for the appearance of any signs and symptoms related to the administered drug, ensuring appropriate symptomatic and supportive measures as needed.
In case of overdose, therapy should aim at restoring physiological sodium ion concentrations.
In these cases, intravenous administration of 5% glucose or hypotonic or isotonic sodium chloride solutions (which are effectively hypotonic in hypernatraemic patients) is recommended.
Loop diuretics may be used in cases of markedly elevated natraemia.
A serum sodium concentration exceeding 200 mmol/l may require dialysis.
Special precautions for disposal and handling
The solution must be clear, colourless, and free from visible particles.
Use immediately after opening.
Preparation should be carried out as quickly as possible under sterile conditions (see Dosage and administration).
For single use only. Discard any unused residue. Although sodium chloride is compatible with a large number of solutions and medicinal products, compatibility should be verified.
Any unused medicinal product and waste materials derived from such medicinal product should be disposed of in accordance with local applicable regulations.

Package leaflet: Information for the user

SODIUM CHLORIDE S.A.L.F. 0.9% irrigation solution

Sodium chloride
Please read this leaflet carefully before using 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, pharmacist or nurse.
If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

What SODIUM CHLORIDE S.A.L.F. is and what it is used for
What you need to know before using SODIUM CHLORIDE S.A.L.F.
How to use SODIUM CHLORIDE S.A.L.F.
Possible side effects
How to store SODIUM CHLORIDE S.A.L.F.
Contents of the pack and other information

1. What SODIO CLORURO S.A.L.F. is and what it is used for

SODIO CLORURO S.A.L.F. is a solution containing sodium and chlorine, indicated for the cleansing of hollow organs and celomatic cavities (cavities containing viscera).

2. What you need to know before using SODIUM CHLORIDE S.A.L.F.

Do not use SODIUM CHLORIDE S.A.L.F. if you have:

hypernatremia (high sodium concentration in the blood);
hypervolemia (increased concentration of salts in the body).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using SODIUM CHLORIDE S.A.L.F.
This medicine should be administered only if:

you suffer from hypertension (high blood pressure);
you suffer from heart failure (inability of the heart to pump adequate blood to meet the body's needs);
you have peripheral edema (fluid accumulation in the extremities, such as legs, ankles, and hands) or pulmonary edema (fluid accumulation in the lungs);
you have reduced renal function (your kidneys are not functioning properly);
you have been diagnosed with pre-eclampsia (if you are pregnant and have developed high blood pressure or worsening of existing hypertension, accompanied by swelling due to fluid retention and presence of proteins in the urine).

Other medicines and SODIUM CHLORIDE S.A.L.F.
Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines.
Inform your doctor if you are taking corticosteroids (medicines used to treat inflammation) or corticotropin agents (medicines that stimulate hormone production), as they may cause fluid retention and increase blood pressure.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Your doctor will prescribe SODIUM CHLORIDE S.A.L.F. only if clearly necessary.
Breastfeeding
This medicine may be used during breastfeeding.

Driving and using machines
SODIUM CHLORIDE S.A.L.F. does not affect the ability to drive vehicles or operate machinery.

3. How to use SODIO CLORURO S.A.L.F.

Use this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
This medicine will be administered to you by a doctor or a nurse.
The doctor will choose the volume of the solution to use based on the type and duration of the procedure.
If you use more SODIO CLORURO S.A.L.F. than you should
Use this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
If you are given an excessive amount of this medicine, it may cause an increase in the concentration of certain salts in the blood, such as sodium and chloride, and an increase in blood volume.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody experiences them.
The following adverse reactions have been reported with unknown frequency (frequency cannot be estimated from the available data):

hypernatraemia (increased sodium concentration in the blood),
hyperchloraemia (increased chloride concentration in the blood).

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. You may also report adverse reactions directly via the Italian Medicines Agency - website: 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 SODIUM CHLORIDE S.A.L.F.

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Expiry".
The expiry date refers to the last day of that month.
Store in a tightly closed container. Do not freeze or refrigerate.
The solution should not be used if it is not clear, colourless, and free from visible particles.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What SODIO CLORURO S.A.L.F. contains
SODIO CLORURO S.A.L.F. 0.9% solution for irrigation

The active substance is sodium chloride. 100 ml of solution contain 0.9 g of sodium chloride, mEq/ml: Na 0.154, mEq/ml: Cl 0.154, theoretical osmolarity (mOsm/l): 308, pH: 4.5 - 7.0.
The other component is water for injections.

Description of the appearance of SODIO CLORURO S.A.L.F. and the contents of the pack
Solution for irrigation.
SODIO CLORURO S.A.L.F. 0.9% solution for irrigation
PVC bag of 100 ml.
PP bag of 100 ml.
Marketing Authorization Holder and Manufacturer
S.A.L.F. S.p.A. Laboratorio Farmacologico, via Marconi, 2 – 24069 Cenate Sotto (BG) – Italy.

The following information is intended exclusively for healthcare professionals:

The solution must be clear, colorless, and free from visible particles.
Use immediately after opening.
For single use only. Discard any unused residue.
Unused medicine and waste material derived from this medicine must be disposed of in accordance with
local applicable regulations.

Package leaflet: information for the user

SODIUM CHLORIDE S.A.L.F. 0.9% solvent for parenteral use

Sodium chloride
Please read this leaflet carefully before using 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, pharmacist or nurse.
If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

What SODIUM CHLORIDE S.A.L.F. is and what it is used for
What you need to know before using SODIUM CHLORIDE S.A.L.F.
How to use SODIUM CHLORIDE S.A.L.F.
Possible side effects
How to store SODIUM CHLORIDE S.A.L.F.
Contents of the pack and other information

1. What SODIO CLORURO S.A.L.F. is and what it is used for

SODIO CLORURO S.A.L.F. is a solution containing sodium and chlorine, indicated for the preparation of injectable formulations.

2. What you need to know before using SODIUM CHLORIDE S.A.L.F.

Do not use SODIUM CHLORIDE S.A.L.F. if you have:

hypernatremia (high concentration of sodium in the blood);
hypervolemia (increased volume of salts and fluids in the body).

Warnings and precautions
Talk to your doctor, pharmacist or nurse before using SODIUM CHLORIDE S.A.L.F.
This medicine should be administered with caution if:

you suffer from hypertension (high blood pressure);
you suffer from heart failure (inability of the heart to pump enough blood to meet the body's needs);
you have peripheral edema (fluid accumulation in the extremities, such as legs, ankles and hands) or pulmonary edema (fluid accumulation in the lungs);
you have reduced kidney function (your kidneys do not work properly);
you have been diagnosed with pre-eclampsia (if you are pregnant and have developed high blood pressure or worsening of existing hypertension, accompanied by swelling due to fluid retention and presence of protein in the urine).

Other medicines and SODIUM CHLORIDE S.A.L.F.
Inform your doctor, pharmacist or nurse if you are taking, have recently taken, or might take any other medicines.
Tell your doctor if you are taking corticosteroids (medicines used to treat inflammation) or corticotropin agents (medicines that stimulate hormone production), as these may cause fluid retention and increase blood pressure.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Your doctor will prescribe SODIUM CHLORIDE S.A.L.F. only if clearly necessary.
Breastfeeding
This medicine may be used during breastfeeding.

Driving and using machines
SODIUM CHLORIDE S.A.L.F. does not impair the ability to drive or operate machinery.

3. How to use SODIO CLORURO S.A.L.F.

Use this medicine exactly as directed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
This medicine will be administered to you by a doctor or nurse.
Use for solutions, dilutions, or extemporaneous suspensions of injectable medicines or other
sterile preparations.
Choose the volume to use based on the dilution requirements of the injectable preparation.
If you use more SODIO CLORURO S.A.L.F. than you should
If you are given too much of this medicine, it may cause an increase in the blood concentration
of certain salts, such as sodium and chloride, and an increase in blood volume.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The following adverse reactions have been reported with unknown frequency (frequency cannot be
estimated from the available data):

hypernatraemia (increased concentration of sodium in the blood),
hyperchloraemia (increased concentration of chlorine in the blood);
hypervolaemia (increased blood volume),
infusion site infection,
pain or local reaction,
venous irritation,
venous thrombosis (formation of blood clots in the vein) or phlebitis (vein inflammation) extending from the infusion site,
extravasation (leakage of the injected solution out of the vein).

Reporting of adverse reactions

If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist.
You may also report adverse reactions directly via the Italian Medicines Agency website: 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 SODIUM CHLORIDE S.A.L.F.

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Expiry".
The expiry date refers to the last day of that month.
Store in a tightly closed container. Do not freeze or refrigerate.
Please also refer to the storage conditions of the medicine intended for administration.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What SODIO CLORURO S.A.L.F. contains
SODIO CLORURO S.A.L.F. 0.9% solvent for parenteral use

The active substance is sodium chloride. 100 ml of solution contain 0.9 g of sodium chloride, mEq/ml: Na 0.154, mEq/ml: Cl 0.154, theoretical osmolarity (mOsm/l): 308, pH: 4.5 - 7.0.
The other component is water for injections.

Description of the appearance of SODIO CLORURO S.A.L.F. and contents of the pack
Solvent for parenteral use.
SODIO CLORURO S.A.L.F. 0.9% solvent for parenteral use
Packages containing 5 glass vials of 2, 5 and 10 ml.
Marketing Authorization Holder and Manufacturer
S.A.L.F. S.p.A. Laboratorio Farmacologico, Via Marconi 2, 24069 Cenate Sotto (BG), Italy.

The following information is intended exclusively for healthcare professionals:

The solution must be clear, colorless, and free from visible particles.
Use immediately after opening.
Preparation must be carried out as soon as possible under sterile conditions.
For single use only. Discard any unused residue.
Unused medicine and waste material derived from this medicine must be disposed of in accordance with
local applicable regulations.