SODIUM CHLORIDE 0.45 % INJECTION

מדינה: ישראל

שפה: אנגלית

מקור: Ministry of Health

מרכיב פעיל:

SODIUM CHLORIDE

זמין מ:

TEVA MEDICAL MARKETING LTD.

קוד ATC:

B05XA03

טופס פרצבטיות:

SOLUTION FOR INFUSION

הרכב:

SODIUM CHLORIDE 450 MG / 100 ML

מסלול נתינה (של תרופות):

I.V

סוג מרשם:

Required

תוצרת:

TEVA MEDICAL LTD, ISRAEL

קבוצה תרפויטית:

SODIUM CHLORIDE

איזור תרפויטי:

SODIUM CHLORIDE

סממני תרפויטית:

Supply of water and electrolytes.

תאריך אישור:

2014-06-30

עלון מידע

לע העדוה לע העדוה לע העדוה
( הרמחה
( הרמחה
( הרמחה עדימ עדימ עדימ
ל ןולעב )תוחיטב
ל ןולעב )תוחיטב
ל ןולעב )תוחיטב
אפור
אפור
אפור :ךיראת
7102.
01
7
00
תילגנאב רישכת םש :
Sodium Chloride 0.45% Injection
ושיר רפסמ
ם :
041-21-23285-00
םושירה לעב םש :
Teva Medical LTD
ה טורפל דעוימ הז ספוט
דבלב תורמחה
!
תושקובמה תורמחהה
ןולעב קרפ
יחכונ טסקט
שדח טסקט
WARNINGS
Hypersensitivity/infusion
reactions,
including
hypotension,
pyrexia, tremor, chills, urticaria, rash, and pruritus may occur
with 0.45% Sodium Chloride Injection.
Stop the infusion immediately if signs or symptoms of a
hypersensitivity reaction develop, such as tachycardia, chest
pain,
dyspnea
and
flushing.
Appropriate
therapeutic
countermeasures must be instituted as clinically indicated.
Depending on the volume and rate of infusion, the intravenous
administration, 0.45% Sodium Chloride Injection can cause
fluid and/or solute overloading resulting in dilution of serum
electrolyte
concentrations,
overhydration/hypervolemia,
congested states, pulmonary edema, or acid-base imbalance.
The risk of dilutive states is inversely proportional to the
electrolyte concentration of the injection. The risk of solute
overload
causing
congested
states
with
peripheral
and
pulmonary edema is directly proportional to the electrolyte
concentrations of the injection.
Monitor changes in fluid balance, electrolyte concentrations,
and acid base balance during prolonged parenteral therapy or
whenever
the
condition
of
the
patient
or
the
rate
of
administration warrants such evaluation.
The
infusion
of
solutions
with
0.45%
Sodium
Chloride
Injection
may
result
in
hyponatremia.
Close
clinical
monitoring
may
be
warranted.
Hyponatremia
can
lead
to
headache, nausea, seizures, lethargy, coma, cerebral edema
and
death.
The
risk
for
hyponatremia
is
increased,
for
example,
in
children,
elderly,
women,

מאפייני מוצר

Reference ID: 3676997
ב ודי לע רשואו קדבנ ונכותו תואירבה
דרשמ י"ע עבקנ הז ןולע טמרופ
-
14.2.2017
0.45%SODIUM CHLORIDE INJECTION
SOLUTION FOR INFUSION
IN NON PVC BAGS
DESCRIPTION
0.45% Sodium Chloride Injection is a sterile, nonpyrogenic solution
for fluid and electrolyte replenishment
in single dose containers for intravenous administration. It contains
no antimicrobial agents. The nominal
pH is 5. Composition, osmolarity, and ionic concentration are shown
below:
0.45% Sodium Chloride Injection contains 4.5 g/L Sodium Chloride
(NaCl) and is hypotonic with an
osmolarity of 154 mOsmol/L (calc). It contains 77 mEq/L sodium and 77
mEq/L chloride.
The flexible container is a closed system, and air is prefilled in the
container to facilitate drainage. The
container does not require entry of external air during
administration.
The container has two ports: one is the administration outlet port for
attachment of an intravenous
administration set and the other port has a medication site for
addition of supplemental medication (See
DIRECTIONS FOR USE). The primary function of the overwrap is to
protect the container from the
physical environment.
CLINICAL PHARMACOLOGY
0.45% Sodium Chloride Injection has value as a source of water and
electrolytes. It is capable of inducing
diuresis depending on the clinical condition of the patient.
INDICATIONS AND USAGE
Sodium Chloride Injection is indicated for supply of water and
electrolytes.
CONTRAINDICATIONS
None known.
WARNINGS
Hypersensitivity/infusion reactions, including hypotension, pyrexia,
tremor, chills, urticaria, rash, and
pruritus may occur with 0.45% Sodium Chloride Injection.
Reference ID: 3676997
Stop the infusion immediately if signs or symptoms of a
hypersensitivity reaction develop, such as
tachycardia, chest pain, dyspnea and flushing. Appropriate therapeutic
countermeasures must be instituted
as clinically indicated.
Depending on the volume and rate of infusion, the intravenous
administration, 0.45% Sodium Chloride
In