SODIUM CHLORIDE 0.9 % INTRAVENOUS INFUSION BP

국가: 이스라엘

언어: 영어

출처: Ministry of Health

유효 성분:

SODIUM CHLORIDE

제공처:

TEVA MEDICAL MARKETING LTD.

ATC 코드:

B05XA03

약제 형태:

SOLUTION FOR INFUSION

구성:

SODIUM CHLORIDE 0.9 %W/V

관리 경로:

I.V

처방전 유형:

Required

Manufactured by:

BAXTER HEALTHCARE LTD. U.K.

치료 그룹:

SODIUM CHLORIDE

치료 영역:

SODIUM CHLORIDE

치료 징후:

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

승인 날짜:

2014-03-31

환자 정보 전단

לע העדוה לע העדוה לע העדוה
( הרמחה
( הרמחה
( הרמחה עדימ עדימ עדימ
ל ןולעב )תוחיטב
ל ןולעב )תוחיטב
ל ןולעב )תוחיטב
אפור
אפור
אפור
ןכדועמ(
ןכדועמ(
ןכדועמ(
.102.50
.102.50
.102.50
)
)
)
________ ךיראת
JULY 9, 2015
___
תילגנאב רישכת םש
םושירה רפסמו
_
SODIUM CHLORIDE 0.9% INTRAVENOUS INFUSION BP (VIAFLO®) CONTAINER
140 26 30794 00 ; 140 26 30794 01; 134 05 31396 00
לעב םש
םושירה
TEVA MEDICAL (MARKETING) LTD., HAORGIM ST 8, ASHDOD 77100
ה טורפל דעוימ הז ספוט
דבלב תורמחה
!
תושקובמה תורמחהה
ןולעב קרפ
יחכונ טסקט
שדח טסקט
INDICATION
CONTRA-
INDICATIONS
POSOLOGY,
DOSAGE &
ADMINISTRA-TION
The concentration and dosage, of sodium chloride
solution for intravenous use is determined by several
factors
including
the
age,
weight,
and
clinical
condition, of the patient and in particular the patient's
hydration state, clinical and laboratory response to
treatment.. Serum-electrolyte concentrations should
be carefully monitored.
Recommended dosage
The recommended dosage for treatment of isotonic
extracellular dehydration and sodium depletion is:
-
for adults : 500 ml to 3 liters /24h
-
for babies and children : 20 to 100 ml per 24 h and
per kg of body weight, depending on the age and
the total body mass.
The
infusion
rate
depends
on
the
patient
clinical
condition.
Method of administration
The
solution
is
for
administration
by
intravenous
infusion
The concentration and dosage, rate and duration of sodium
chloride solution for intravenous use administration is to be
individualized as determined by several factors including the
age, weight, and clinical condition, concomitant treatment of
the patient and in particular the patient's hydration state,
clinical and laboratory response to treatment. Fluid balance
and plasma electrolyte concentrations must be
monitored
during treatment. Serum-electrolyte concentrations shoul

제품 특성 요약

Sodium Chloride 0.9% Intravenous Infusion BP Notification 06.2022 N.A
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
particular the patient's hydration state, clinical and laboratory
response to treatment. Fluid
balance and plasma electrolyte concentrations must be monitored during
treatment.
Sodium Chloride 0.9% Intravenous Infusion BP Notification 06.2022 N.A
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