2. QUALITATIVE AND QUANTITATIVE COMPOSITION 

Active substance: 

                                Sodium Chloride 0,045 g in 5 ml or 0,09 g in 10 ml.

                                Sodium content: 3.542 mg / ml, corresponding to 0.154 mmol / l. 

 

For a full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM 

Solution for injection 

Fluid clear, colorless 

4. 1 Therapeutic indications 

To prepare solutions and suspensions as a carrier solution for drugs, for supplementation of sodium and chloride ions. 

4.2 Posology and method of administration 

 Depends on age, weight and clinical condition of the patient.  It is necessary to control water balance and monitor the concentration of serum electrolytes. 

 To calculate the sodium deficit following  formula can be used: 

 Na + deficiency  = / 140 - (act.. Na +) / x weight in kg x 0.6 

4.3 Contraindications 

 Hypernatremia (above 145 mmol / l), hyperchloremia, acidosis, hypertonic dehydration, heart failure, pulmonary and cerebral edema, renal insufficiency with anuria, hepatic cirrhosis with ascites, treatment with drugs that cause sodium retention(eg steroids). 

4.4 Special warnings and precautions for use 

It is necessary to monitor the concentration of electrolytes in the serum. 

None known.

4.6 Pregnancy and lactation 

 Isotonic sodium chloride solution might be administered during pregnancy and lactation. 

Irrelevant.

 Not present in normal doses. (In inadequate infusion therapy: hypertension, edema, hypernatraemia, hyperchloremia with acidosis). 

According to the small amount of preparation the overdose is not possible. 

5. PHARMACOLOGICAL PROPERTIES 

5.1 Pharmacodynamic properties 

Pharmacotherapeutic group: Varia.

ATC code: B05BB01

Mechanism of effect 

 Isotonic sodium chloride solution.  Sodium is the major cation that determines the osmolarity of extracellular fluid, changes in its concentration in serum affects osmolality of all body fluids.  Hyponatremia is defined by a lower concentration of serum sodium than 135 mmol / l.  It may occur gradually or acutely.  Sodium chloride solutions are used to modify the extracellular hypovolemia, dehydration and sodium depletion. Isotonic saline solution is also suitable for sterile rinsing or washing organs and tissues. 

 It is used as a carrier of other injectable drugs. 

5.2 Pharmacokinetic properties 

After administration of sodium in the body a steady state in the extra-and intracellular fluid is formed, in sodium balance its excretion by the kidneys and its supply to body are equal.  Deficit arises when the equilibrium mechanisms is disturbed by rapid non-renal losses, or by impaired kidney function.  Isotonic sodium chloride solution remains in the bloodstream for couple of minutes, easily escapes extravasally. It has a slightly acid reaction. It is excreted by kidneys, the elimination rate is subject of mineralocorticoid regulation.  Water homeostasis is controlled mainly by antidiuretic hormone.

Sodium chloride is distributed in the extracellular fluid and from the body is excreted by  kidneys, sweating, or by gastrointestinal tract. 

 It is a completely safe solution, which composition is close to extracellular fluid. 

6. PHARMACEUTICAL PARTICULARS 

6.1 List of excipients 

Water for injection 

 None known. 

5 years

6.4 Special precautions for storage 

Store at temperatures between +10 ° C to +25 ° C, ampoules kept in a box.  Protect from frost.

6.5 Nature and contents of container 

Clear glass with a label, insert PVC box

Package size: 10 ampoules 5 ml 

                       10 ampoules of 10 ml

No special requirements.

BB Pharma Pod Višňovkou 1662/21, 140 00 Prague 4, Czech Republic

 87 / 777 / 92-S / C 

 December 14^th, 1992 / June 24^th, 1998

July 9^th, 2005