SODIUM CHLORIDE 0.9% SOLUTION FOR INTRAVENOUS INFUSION 1 BOTTLE 500 ML

Name
SODIUM CHLORIDE B. BRAUN 0.9% solution for infusion
Sodium chloride

Equivalent medicine


What it is and what it is used for
SODIUM CHLORIDE B. BRAUN 0.9% is a saline (electrolyte) solution that is injected into a vein.
This medicine contains the active substance sodium chloride.
SODIUM CHLORIDE B. BRAUN 0.9% is indicated when:
• has low blood chloride and high blood pH (hypochloremic alkalosis);
• has a loss of sodium or chloride;
• it is necessary to immediately replenish the blood volume after you have lost blood;
• has a lack of body fluids and his blood sodium level is low (hypotonic dehydration);
• has a lack of body fluids (isotonic dehydration);
• is required as a vehicle for other compatible electrolytes or medications.


What you need to know before taking the medicine
Do not use Sodium Chloride B. Braun 0.9%:
• if you are allergic to sodium chloride or any of the other ingredients of this medicine (listed in section 6);
• if you have a high 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 Sodium Chloride B. Braun 0.9%.

SODIUM CHLORIDE B.Braun 0.9% will be administered to you with great caution if:
• has low blood potassium levels (hypokalemia);
• has a high sodium value in the blood (hypernatremia);
• has a high level of chloride in the blood (hyperchloremia);
• suffers from heart failure (inability of the heart to supply blood in adequate quantities to the body's needs);
• suffer from severe renal insufficiency (severe decrease in kidney function);
• have accumulation of water in the body tissues (generalized oedema), water in the lungs (pulmonary oedema), high blood pressure (hypertension), or a disease that occurs in pregnancy, with high blood pressure (eclampsia), or other conditions associated with sodium retention (see “Other medicines and SODIUM CHLORIDE B. BRAUN 0.9%”).

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

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

Your heart and lung function will be monitored in case a rapid infusion of Sodium Chloride B. Braun 0.9% is necessary.

Children
Premature or full-term infants may retain excess sodium due to poor kidney function. Therefore, repeated sodium chloride infusions will be administered by the doctor only 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 may cause a loss of other salts (bicarbonates) resulting in increased acidity of the blood (acidosis);
- Headache, dizziness, restlessness, fever, irritability, weakness, muscle stiffness, convulsions, coma, death;
- Drowsiness, confusional states;
- Reduced tear production;
- Increased heart rate (tachycardia);
- Lowering (hypotension) or increasing (hypertension) blood pressure, accumulation of fluid in the lungs (pulmonary edema) and in the legs and ankles (peripheral edema);
- Difficulty breathing (dyspnea), stopping breathing (respiratory arrest);
- Thirst, reduced salivation, nausea, vomiting, diarrhea, abdominal pain;
- Problems with kidney function (renal failure);
- Infection at the infusion site, pain or local reaction, irritation of the vein, formation of blood clots 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, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. 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.