Natrium Chloratum Biotika 10% Injection

SUMMARY OF PRODUCT CHARACTERISTICS 

1.  NAME OF THE MEDICAL PRODUCT 

                                                                NATRIUM CHLORATUM Biotika 10%

2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
Active substance: 
                                Sodium Chloride 1000 mg in 10 ml or 500 mg in 5 ml.
                                The sodium concentration: 39,357 mg / ml, which corresponds to 1.711 mmol / ml.
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 
Managing the acute situation in water intoxication, in reduction of cerebrospinal fluid pressure, to increase diuresis, to stop bleeding, in acute volume replacement, in the first phase of hypovolaemic shock.

4.2 Posology and method of administration 
Dosage is always individual.  Doses range from 5 ml to 50 or 100 ml of 10% solution and are administered slowly intravenously.  It is necessary to control the water balance and to monitor the concentration of serum electrolytes. 

4.3 Contraindications 
Hypernatremia (above 145 mmol / l), hyperchloremia, acidosis, hypertonic dehydration, cardiac deficiencies, pulmonary and cerebral edema, renal insufficiency, liver cirrhosis with ascites.

4.4 Special warnings and precautions for use 
In severe hyponatremia associated with hyperhydration ,the administration of hypertonic solutions of sodium chloride in combination with a diuretic is necessary.  Particular caution is needed when applying to children and the elderly.
 
4.5 Interactions with other medicinal products and other forms of interaction
None known.

4.6 Pregnancy and lactation 
During pregnancy a caution is necessary in the administration of excessive doses, it can cause miscarriage.

4.7 Effects on ability to drive and use machines 
It is not known.

4.8 Undesirable effects 
Hypertension, edema, gastrointestinal difficulties. They appear as a result of iatrogenic hypertonic hyper-hydration.  There is shortness of breath and pulmonary edema, thirst, abnormal coagulation,decrease in platelet count, decrease in fibrinogen and in activity of proaccelerin.  High doses cause hypernatremia with dehydration of internal organs, especially the brain.  Excess in chloride may lead to a loss of bicarbonate and acidosis.
 
 4.9. Overdose 
 Hypernatremia and hyperchloremia are present in overdose. The amount of preparation that is needed to induce hypernatremia depends on the underlying cause of the electrolyte disorder and its origin.  Laboratory examination is a sign of increased levels of Na + above 145 mmol / l. The concentration of chloride is increased.  Changes in serum osmolality and in extracellular fluid volume might be present. 
 
Subjective symptoms include hypernatremia, thirsty, headaches, nausea, vomiting and muscle cramps. 
In severe cases, coma may develop.  In patients with decreased extracellular volume reduced skin turgor, hypotension and rapid pulse may occur. 
Treatment: It consists of the application of hypotonic fluids orally or intravenously.  It is possible to give parenterally  sodium chloride isotonic solution, half of sodium chloride solution and 3-5% glucose solution.  It is necessary to check serum electrolytes and control diuresis

5. PHARMACOLOGICAL PROPERTIES 
5.1 Pharmacodynamic properties 
Pharmacotherapeutic group: Varia (replacement of mineral elements).
ATC code: B05BB01
Mechanism of effect 
 Hypertonic sodium chloride solution greatly contributes to maintaining of acid-base balance 
 in the body. It is used to adjust the severe acute hyponatremia (serum sodium concentration is less than 115 mmol / l).  In hyponatremia the reduced extracellular fluid pressure is balanced by water entry into cells, which creates cellular edema.  Hypertonic solution of sodium chloride reduces the increased pressure of cerebro-spinal fluid by increasing the osmotic pressure of plasma, resulting in the movement of water from the interstitial fluid into the plasma and then from the cells into the interstitial fluid.
 
Cerebrospinal fluid is osmotically drawn into the blood vessels of the brain.  Hypertonic sodium chloride solution also increases diuresis and reduces blood clotting time. 

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.   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
Embryotoxic, cytotoxic, teratogenic and carcinogenic effects of sodium chloride are unknown. 

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 10-25 ° C. 

6.5 Nature and contents of container 
 Clear glass, insert PVC, paper box 
 Package size: 10 ampoules 5 ml 
 5 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) 
 87/776/92-S/C 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 December 14th, 1992 / June 24th,1998
10. DATE OF REVISION OF THE TEXT
December 28th, 2005

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