Sodium chloride Diaco

Patient Information Leaflet

Sodium Chloride DIACO 0.9% infusion solution

Please read all of this leaflet carefully before you start using this medicine, as it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor, pharmacist, or nurse has instructed you.

• Keep this leaflet. You may need to read it again.
• If you would like more information or advice, please consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.
• Contact your doctor if you do not notice any improvement or if you notice a worsening of symptoms.

Contents of this leaflet:

1. What Sodio Cloruro DIACO is and what it is used for
2. What you need to know before using Sodio Cloruro DIACO
3. How to use Sodio Cloruro DIACO
4. Possible side effects
5. How to store Sodio Cloruro DIACO
6. Package contents and other information

1. What Sodio Cloruro DIACO is and what it is used for

Sodio Cloruro DIACO contains the active substance sodium chloride and belongs to the category of electrolyte-replenishing solutions.
Sodio Cloruro DIACO is indicated for the replacement of fluids and sodium chloride.
Consult your doctor if you do not feel better or if you feel worse.

2. What you need to know before using Sodio Cloruro DIACO

Do not use Sodio Cloruro DIACO

• if you are allergic to sodium chloride or to any of the other ingredients of this medicine (listed in section 6).
• if you have increased levels of sodium in the blood (hypernatremia).
• if you have fluid and salt accumulation in the body (hydrosaline overload).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Sodio Cloruro DIACO.
Sodium salts should be administered with caution if you suffer from hypertension (high blood pressure), heart failure, peripheral edema (excessive fluid accumulation in a body area) or pulmonary edema, reduced kidney function, pre-eclampsia (a syndrome characterized by edema), proteinuria (presence of proteins in urine), hypertension during pregnancy, or other conditions associated with sodium retention (see section “Other medicines and Sodio Cloruro DIACO”).
Solutions with a concentration higher than 0.9% (hypertonic solutions) must be used with caution, administered intravenously at a controlled infusion rate, and only when specifically prescribed.
Use this medicine with great caution if you have congestive heart failure (reduced heart function), severe renal failure, or clinical conditions associated with edema and salt retention, or if you are being treated with corticosteroid or corticotropin drugs (corticosteroids). Continuous administration without potassium supplementation may cause hypokalemia, i.e. decreased potassium concentration in the blood.
During infusion, it is advisable to monitor fluid balance, electrolytes, plasma osmolarity, and acid-base balance.
The solution must be clear, colourless, and free from visible particles.
Use this medicine immediately after opening the container.
The container is intended for single and uninterrupted administration; any residual solution must not be used.

Children
Use this medicine with caution in children.

Other medicines and Sodio Cloruro DIACO
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Corticosteroids and corticosteroid-like drugs are associated with sodium and water retention, which may lead to edema and hypertension. Therefore, caution is required if you are receiving sodium salts together with corticosteroids or corticosteroid-like drugs (see section “Warnings and precautions”).
Although sodium chloride is compatible with a large number of solutions and medicines, your doctor should always verify compatibility with the medicine you intend to administer concomitantly.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
This medicine should only be administered if clearly needed, and only after careful assessment of the risk/benefit ratio.
You may take this medicine during breastfeeding.

Driving and using machines
This medicine does not affect the ability to drive vehicles or operate machinery.

3. How to use Sodio Cloruro DIACO

Take this medicine exactly as stated in this leaflet or as directed by your doctor, pharmacist, or nurse. If you have any doubts, consult your doctor, pharmacist, or nurse.
This medicine must be administered by intravenous infusion by healthcare personnel or by individuals specifically trained to do so.
Treatment of isotonic fluid depletion (extracellular dehydration)
Your doctor will carefully determine the dosage of this medicine based on your clinical condition and, in the case of children, according to age and body weight.
Dosage should be appropriately reduced if you have renal insufficiency.
Treatment of sodium deficit
Your doctor will determine the dose based on your age, weight, clinical condition, electrolyte profile, osmolarity, and the calculated sodium deficit.
If you take more Sodio Cloruro DIACO than you should
Administration of excessive doses of this medicine may lead, depending on your clinical condition, to hypernatremia (increased sodium concentration in the blood), hyperchloremia (increased chloride in the blood), and/or hypervolemia (increased volume of the liquid component of blood).
Hypernatremia (mainly associated with administration of hypertonic solutions) and excessive sodium retention when impaired renal elimination of sodium exists may cause dehydration of internal organs, especially the brain, and accumulation of extracellular fluids with edema (fluid accumulation), which may affect the cerebral, pulmonary, and peripheral circulation, leading to pulmonary and peripheral edema.
Accumulation of chloride ions leads to a reduction in bicarbonate ion concentration, resulting in acidosis.
Treatment
In case of accidental ingestion/overdose of Sodio Cloruro DIACO, inform your doctor immediately or go to the nearest hospital.
If you have any doubts about how to use this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicinal product may cause side effects, although not everyone experiences them.
Below are the side effects associated with sodium chloride. There are insufficient data available to determine the frequency of the individual side effects listed.

Disorders of water and electrolyte balance

• Hypernatraemia, hypervolaemia, plasma hypoosmolality (with 0.45% solutions), hyperchloraemia (which may lead to bicarbonate loss resulting in acidosis, i.e. increased blood acidity).

Disorders of the nervous system

• Headache, dizziness, restlessness, fever, irritability, weakness, muscle rigidity, convulsions, coma, death.

Psychiatric disorders

• Drowsiness, confusion.

Respiratory, thoracic and mediastinal disorders

• Dyspnoea (difficulty breathing), respiratory arrest.

Gastrointestinal disorders

• Thirst, reduced salivation, nausea, vomiting, diarrhoea, abdominal pain.

Cardiac disorders

• Tachycardia (increased heart rate).

Eye disorders

• Reduced lacrimation.

Renal and urinary disorders

• Renal failure.

Vascular disorders

• Hypotension, hypertension, pulmonary and peripheral oedema.

Systemic disorders and administration site conditions

• Infusion site infection (where the intravenous line was placed), pain or local reaction, venous irritation, thrombosis (formation of clots within blood vessels) or venous phlebitis (inflammation of veins) extending from the infusion site, extravasation (leakage of fluid from the vein into surrounding tissues).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor, pharmacist, or nurse. You may also report side effects directly via the national reporting system at
http://www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicinal product.

5. How to store Sodium Chloride DIACO

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the product in its original, unopened packaging, properly stored.
Use this medicine immediately after opening the container. The container is intended for single, uninterrupted administration, and any remaining residue must not be used.
Store in a tightly closed container.
Do not refrigerate or freeze.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to properly dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Sodio Cloruro DIACO contains

• The active substance is sodium chloride. 1000 ml of solution contain 9.0 g of Sodium chloride.

mEq/l: Na+ 154
Cl- 154
Theoretical osmolarity: (mOsm/l) 308
pH: 4.5 – 7.0
1 g NaCl = 394 mg Na or 17.1 mEq or 17.1 mmol of Na and Cl
1 mmol Na = 23 mg Na

• The other component is water for injections, q.s.

Description of the appearance of Sodio Cloruro DIACO and contents of the package
Infusion solution
Bottles of 50-100-250-500-1000 ml
Sterile, pyrogen-free, clear and colourless solution.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Diaco Biofarmaceutici S.r.l.
Via Flavia 124 – 34147 Trieste

Manufacturers
S.M. Farmaceutici s.r.l.
Via Flavia 124 – 34147 – Trieste (Italy)

Information for healthcare professionals

Dosage and method of administration
This medicinal product must be administered by intravenous infusion.

Treatment of isotonic fluid depletion (extracellular dehydration)
Adults and adolescents: 500 ml to 3 litres within 24 hours.
Neonates and children (up to 12 years of age): 20 to 100 ml per kg body weight within 24 hours, depending on age and total body weight.
Dosage should be appropriately reduced in patients with renal impairment.

Treatment of sodium deficit
The dose depends on age, weight, clinical condition, electrolyte profile and osmolarity, and is related to the calculated sodium deficit.
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 men and women).

When using hypertonic solutions (2%-3%-5%), administer half the dose over the first 8 hours, up to a maximum of 100 ml/hour; then administer the remaining dose until plasma sodium concentration reaches 130 mEq/l or until symptoms improve.
In cases of severe sodium depletion and in the treatment of severe symptoms related to chronic hyponatremia, administer hypertonic sodium chloride solutions to increase plasma sodium concentration by 1-2 mmol/l/hour. Ensure that correction does not exceed 10-12 mmol/l in 24 hours and 18 mmol/l in 48 hours.

When sodium chloride solutions, particularly 0.9% solutions, are used as diluents for intravenous administration of drugs requiring prior dilution, verify the compatibility of such medicinal products with sodium chloride and the most suitable concentration for administration, as specified in the SmPC of the drug to be diluted. If concentration is not specified, use the 0.9% solution.

Overdose

Symptoms
The 0.45% solution is hypotonic relative to blood and causes a reduction in plasma osmolarity: therefore, overdose may lead to plasma hypoosmolarity.
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 renal sodium excretion is impaired lead to dehydration of internal organs, particularly the brain, and accumulation of extracellular fluid causing oedema that may affect cerebral, pulmonary and peripheral circulation, resulting in pulmonary and peripheral oedema.
Chloride ion accumulation leads to reduced bicarbonate ion concentration, causing acidosis.

Treatment
In case of accidental excessive infusion, treatment should be discontinued and the patient should be closely monitored for signs and symptoms related to the administered drug, with appropriate symptomatic and supportive measures provided as needed.
In case of overdose, therapy should aim at restoring physiological chloride ion concentrations.
In such cases, intravenous administration of 5% glucose or hypotonic or isotonic sodium chloride solutions (which are hypotonic relative to the hypernatraemic patient) is recommended.
Loop diuretics may be used in cases of marked hypernatraemia.
A serum sodium concentration exceeding 200 mmol/l may require dialysis.

Incompatibilities
Sodium chloride is a water-soluble salt and is rarely incompatible with other solutes.

Shelf life
Sodio Cloruro DIACO 0.9%: 3 years
Use immediately after opening. The container is intended for single, uninterrupted administration; any residual solution must not be used.

Special precautions for storage
Store in a tightly closed container. Do not freeze or refrigerate.