SODIUM CHLORIDE*0.9% IV SOL 500ML PE

SODIO CLORURO B. BRAUN 0.9% solution for infusion
Sodium chloride

Equivalent medicinal product

What it is and what it is used for
SODIO CLORURO B. BRAUN 0.9% is a saline (electrolyte) solution that is injected intravenously.
This medicinal product contains the active substance sodium chloride.
SODIO CLORURO B. BRAUN 0.9% is indicated when:
• you have a low level of chloride in your blood and your blood pH is high (hypochloremic alkalosis);
• you have a loss of sodium or chloride;
• it is necessary to immediately restore blood volume after blood loss;
• you have a deficiency of body fluids and your blood sodium level is low (hypotonic dehydration);
• you have a deficiency of body fluids (isotonic dehydration);
• it is needed as a vehicle for other compatible electrolytes or medicinal products.

What you need to know before taking the medicine
Do not use Sodio Cloruro B. Braun 0.9%:
• if you are allergic to sodium chloride or any of the other ingredients of this medicinal product (listed in section 6);
• if you have an excessive amount of water in your body (hyperhydration);
• if you have a severe increase in the concentration of sodium or chloride in your blood (severe hypernatremia or severe hyperchloremia).

Warnings and precautions
Talk to your doctor or pharmacist before you are given Sodio Cloruro B. Braun 0.9%.

SODIO CLORURO B. Braun 0.9% will be administered with great caution if:
• you have a low potassium level in your blood (hypokalaemia);
• you have a high sodium level in your blood (hypernatremia);
• you have a high chloride level in your blood (hyperchloremia);
• you suffer from heart failure (inability of the heart to supply blood in adequate quantities to the body's needs);
• you suffer from severe kidney failure (severe decrease in kidney function);
• you have an accumulation of water in body tissues (generalized oedema), water in the lungs (pulmonary oedema), high blood pressure (hypertension), or a condition that occurs during pregnancy, with high blood pressure (eclampsia), or other conditions associated with sodium retention (see "Other medicines and SODIO CLORURO B. BRAUN 0.9%").

To avoid brain damage (osmotic demyelination syndrome), your doctor will ensure that your blood sodium level does not rise too quickly.

If you are receiving this medicinal product, your serum electrolyte levels, fluid balance, and acid-base status will be checked from time to time.

Your heart and lung functions will be monitored if rapid infusion of Sodio Cloruro B. Braun 0.9% is necessary.

Children
Premature infants or full-term infants may retain excess sodium due to insufficient kidney function. Therefore, repeated infusions of sodium chloride will only be administered by the doctor after determining the serum sodium level.

Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur:
Not known (frequency cannot be estimated from the available data)
- Increased sodium levels in the blood (hypernatremia), increased blood volume (hypervolemia), increased chloride levels in the blood (hyperchloremia) which can cause a loss of other salts (bicarbonates) resulting in increased blood acidity (acidosis);
- Headache, dizziness, restlessness, fever, irritability, weakness, muscle stiffness, convulsions, coma, death;
- Drowsiness, confusion;
- Reduced tearing;
- Increased heart rate (tachycardia);
- Lowering (hypotension) or increase (hypertension) in blood pressure, fluid accumulation in the lungs (pulmonary oedema) and in the legs and ankles (peripheral oedema);
- Difficulty breathing (dyspnoea), cessation of breathing (respiratory arrest);
- Thirst, reduced salivation, nausea, vomiting, diarrhoea, abdominal pain;
- Kidney function problems (kidney failure);
- Infection at the infusion site, pain or local reaction, vein irritation, blood clot formation in the vein (thrombosis) or inflammation of the vein (phlebitis) extending from the infusion site, leakage of the injected solution from the vein (extravasation).

Reporting of side effects
If you get any side effects, including any not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazionireazioni-avverse.
By reporting side effects you can help provide more information on the safety of this medicine.