SODIUM CHLORIDE INJECTION 0.9%

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

SODIUM CHLORIDE

Available from:

TEVA MEDICAL LTD

ATC code:

B05XA03

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

SODIUM CHLORIDE 0.9 G / 100 ML

Administration route:

I.V

Prescription type:

Required

Manufactured by:

TEVA MEDICAL LTD, ISRAEL

Therapeutic group:

SODIUM CHLORIDE

Therapeutic area:

SODIUM CHLORIDE

Therapeutic indications:

A source of water and electrolytes. Also indicated for use as priming solutions in hemodialysis procedures.

Authorization date:

2016-04-30

Summary of Product characteristics

Sodium Chloride Injection 0.9% Solution for Injection in Non PVC Bags
8 5. 2013, RH
."רשואו קדבנ ונכותו תואירבה דרשמ י"ע
עבקנ הז ןולע טמרופ"
:רשואמ ןולע
7/5/2013
“This leaflet format has been determined by the Ministry of Health
and the content thereof has been
checked and approved.” Date of approval: 7/5/2013
SODIUM CHLORIDE INJECTION 0.9%
SOLUTION FOR INJECTION.
IN NON PVC BAGS
DESCRIPTION
Sodium Chloride Injection 0.9% solution for injection in Non PVC Bags
is sterile,
nonpyrogenic solution for fluid and electrolytes replenishment in
single dose bags for
intravenous administration. It contains no antimicrobial agents. The
composition,
osmolarity, and pH values are shown in Table 1.
TABLE 1
COMPOSITION, OSMOLARITY, AND APPROXIMATE PH VALUES
Sodium Chloride Injection 0.9%
Solution for Injection
9.0
308
5.0
* Normal physiologic isotonicity range is approximately 280-310
mOsm/L.
Administration of substantially hypotonic solutions may cause
hemolysis, and administration
of substantially hypertonic solutions may cause vein damage.
**Approx. pH values are USP for applicable solutions, corporate
specification for non-USP solutions.
Approximate ionic concentrations (mEq/L) and calories per liter are
shown in Table 2.
TABLE 2
APPROXIMATE IONIC CONCENTRATIONS (MEQ/L) AND CALORIES PER LITER
Sodium Chloride Injection 0.9%
Solution for Injection
154
154
0
Sodium Chloride Injection 0.9% Solution for Injection in Non PVC Bags
8 5. 2013, RH
2
DESCRIPTION OF THE PRIMARY BAGS:
Type and size: Non PVC plastic bag +overpouch; size: 1000 ml.
Material composition:
- Non PVC plastic film, based on polyethylene, polyamide, and
polypropylene.
- Overpouch based on co-extruded blend:
polypropylene/polyamide/polypropylene
film.
CLINICAL PHARMACOLOGY
As a source of water and electrolytes and capable of inducing diuresis
depending on
the clinical condition of the patient.
For caloric value see Table 2.
INDICATIONS
A source of water and electrolytes.
Also indicated for use as priming sol