סודיום כלוריד % 0.9 לעירוי לתוך הוריד BP

מדינה: ישראל

שפה: עברית

מקור: Ministry of Health

מרכיב פעיל:

SODIUM CHLORIDE

זמין מ:

TEVA MEDICAL MARKETING LTD.

קוד ATC:

B05XA03

טופס פרצבטיות:

תמיסה לאינפוזיה

הרכב:

SODIUM CHLORIDE 0.9 %W/V

מסלול נתינה (של תרופות):

תוך-ורידי

סוג מרשם:

מרשם נדרש

תוצרת:

BAXTER HEALTHCARE LTD. U.K.

קבוצה תרפויטית:

SODIUM CHLORIDE

איזור תרפויטי:

SODIUM CHLORIDE

סממני תרפויטית:

Treatment of isotonic extracellular dehydration. Treatment of sodium depletion. Vehicle or diluent of compatible drugs for parenteral administration.

תאריך אישור:

2014-03-31

עלון מידע

Sodium Chloride 0.9% Intravenous Infusion BP ME 03.2020 Notification
SODIUM CHLORIDE 0.9% INTRAVENOUS INFUSION BP
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Sodium Chloride 0.9% Intravenous Infusion BP
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Sodium chloride: 9.0 g/l
Each ml contains 9 mg sodium chloride.
mmol/l:
Na+ : 154
Cl-: 154.
pH: 4.5 -7
For the full list of excipients: see section 6.1
3.
PHARMACEUTICAL FORM
Solution for infusion
Clear solution, free from visible particles.
4.
CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
Sodium Chloride 0.9%
intravenous infusion
is indicated for:
•
Treatment of isotonic extracellular dehydration
•
Treatment of sodium depletion
•
Vehicle or diluent of compatible drugs for parenteral administration.
4.2. POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults, older people and children: _
Doses may be expressed in terms of mEq or mmol of sodium, mass of
sodium, or mass of
sodium salt (1 g NaCl = 394 mg, 17.1 mEq or 17.1 mmol of Na and Cl).
The dosage, rate and duration of administration is to be
individualized as determined by
several
factors
including
age,
weight,
clinical
condition,
concomitant
treatment
and
in
Sodium Chloride 0.9% Intravenous Infusion BP ME 03.2020 Notification
particular the patient's hydration state, clinical and laboratory
response to treatment. Fluid
balance and plasma electrolyte concentrations must be monitored during
treatment.
Recommended dosage
The recommended dosage for treatment of isotonic extracellular
dehydration and sodium
depletion is:
•
For adults : 500 ml to 3 litres/24h
•
For babies and children: 20 to 100 ml per 24h and per kg of body
weight, depending
of the age and the total body mass.
The recommended dosage when used as a vehicle or diluent ranges from
50 to 250 ml per
dose of medicinal product to be administered.
When Sodium Chloride 0.9 % is used as a diluent for injectable
preparations of other drugs,
the dosage and the infusion rate will also be dictated by the nature
and the dose regimen