Natrium Chloratum Solutio Isotonica Injection

SUMMARY OF PRODUCT CHARACTERISTICS 

1. NAME OF THE MEDICINAL PRODUCT 

                NATRIUM CHLORATUM Biotika solutio isotonica

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. CLINICAL PARTICULARS
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. 

4.5 Interactions with other medicinal products and other forms of interaction
None known.

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

4.7 Effects on ability to drive and use machines 
Irrelevant.

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

4.9. Overdose 
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. 

5.3 Preclinical safety data
 It is a completely safe solution, which composition is close to extracellular fluid. 

6. PHARMACEUTICAL PARTICULARS 
6.1 List of excipients 
Water for injection 

6.2 Incompatibilities 
 None known. 

6.3 Shelf life 
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

6.6 Special precautions for disposal
No special requirements.

7. MARKETING AUTHORISATION HOLDER 
BB Pharma Pod Višňovkou 1662/21, 140 00 Prague 4, Czech Republic
8. MARKETING AUTHORISATION NUMBER(S) 
 87 / 777 / 92-S / C 
9. DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION 
 December 14th, 1992 / June 24th, 1998
10. DATE OF REVISION OF THE TEXT
July 9th, 2005