SODIUM CHLORIDE B. BRAUN 0.9 %

País: Israel

Idioma: anglès

Font: Ministry of Health

ingredients actius:

SODIUM CHLORIDE

Disponible des:

LAPIDOT MEDICAL IMPORT AND MARKETING LTD

Codi ATC:

B05XA03

formulario farmacéutico:

SOLUTION FOR INJECTION

Composición:

SODIUM CHLORIDE 0.9 G / 100 ML

Vía de administración:

S.C, EXTERNAL, I.V, I.M

tipo de receta:

Required

Fabricat per:

B.BRAUN MELSUNGEN AG, GERMANY

Grupo terapéutico:

SODIUM CHLORIDE

Área terapéutica:

SODIUM CHLORIDE

indicaciones terapéuticas:

Short - term intravascular volume substitution. Hypotonic dehydration or isotonic dehydration.Vehicle solution for supplementary medication.Fluid and electrolyte replacement, hypochloremic alkalosis and chloride losses.Externally for wound irrigation and moistening of wound tamponade dressings.

Data d'autorització:

2013-11-30

Fitxa tècnica

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Sodium chloride B.Braun 0.9%
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1,000 mL solution for injection contain:
Sodium chloride
9.0 g
_Electrolytes_
_ _
Sodium
154 mmol/L
Chloride
154 mmol/L
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection
Clear, colourless, aqueous solution
Theoretical osmolarity 308 mOsm/L
Titration acidity (pH 7.4)
< 0.3 mmol/L
pH
4.5 – 7.0
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Short - term intravascular volume substitution.
Hypotonic dehydration or isotonic dehydration.
Vehicle solution for supplementary medication.
Fluid and electrolyte replacement, hypochloremic alkalosis and
chloride losses.
Externally for wound irrigation and moistening of wound tamponade
dressings.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Dosage
The dosage guideline for adults:
Average dose: 1000 ml per day.
Flow rate: Up to 180 drops/min, corresponding to 550 ml/h.
Maximum recommended dosage: 40 ml per KG body weight and per day, not
more than
2000 ml per day.
Dosage is dependent upon the age, weight and clinical condition of the
patient as well as laboratory
determination.
Route of administration
I.V., S.C., I.M. – in use as dissolvent and carrier; External.
When administering a solution packed in a flexible container via a
pressure infusion, all air must be
removed from the container and infusion system prior to administering
the infusion.
4.3
CONTRAINDICATIONS
Sodium chloride B.Braun 0.9 % may not be used in the event of
-
hyperhydration
-
severe hypernatraemia
-
severe hyperchloraemia
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Sodium chloride B.Braun 0.9 % should be used with caution only in
-
hypokalaemia
-
hypernatraemia
-
hyperchloraemia
-
Conditions requiring a restricted intake of sodium, such as heart
failure, generalised oedema,
pulmonary oedema, hypertension, eclampsia and severe renal failure.
In order prevent osmotic demyelination syndrome from developing, serum
sodium c