SODIUM CHLORIDE S.A.L.F. 0.9 %

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

SODIUM CHLORIDE

Available from:

RAZ PHARMACEUTICS LTD, ISRAEL

ATC code:

B05XA03

Pharmaceutical form:

SOLUTION FOR INFUSION

Composition:

SODIUM CHLORIDE 9 MG/ML

Administration route:

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

Prescription type:

Required

Manufactured by:

S.A.L.F. S.P.A. LABORATORIO FARMACOLOGICO, ITALY

Therapeutic area:

SODIUM CHLORIDE

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.

Authorization date:

2020-03-15

Summary of Product characteristics

Biotransformation
Although sodium and chloride are absorbed, distributed
and excreted, they are not metabolised in the strict sense.
The kidneys are the main regulators of sodium
and fluid balance. Together with hormonal control
mechanisms (renin-angiotensin-aldosterone system,
antidiuretic hormone) and with the hypothetical
natriuretic hormone, they are chiefly responsible for
keeping the volume of the extracellular space constant
and for its fluid composition.
Chloride is exchanged for hydrogen carbonate in the
tubule system and, in this way, is involved in the
regulation of the acid-base balance.
Elimination
Sodium and chloride are excreted via sweat, urine
and the gastrointestinal tract.
5.3 Preclinical safety data
No preclinical studies have been conducted with
Sodium chloride S.A.L.F. 0.9 %.
Given
that
sodium
and
chloride
ions
are
major
elements
of
the
human
body,
Sodium
chloride
S.A.L.F. 0.9 % is not expected to have any toxic
effects when used correctly.
6.
PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Water for injections
6.2 Incompatibilities
Possible incompatibilities are to be borne in mind
when mixed with other medicinal products.
6.3 Shelf life
The expiry date of the product is indicated on the
packaging materials.
6.4 Special precautions for storage
Store in its original package tightly closed below
25°C.
Do not freeze or refrigerate.
6.5 Nature and contents of container
Bag sizes:
PVC free bag of 100ml, 250ml, 500ml, 1,000ml and
2,000ml.
Bottle sizes:
PP bottles of 100ml, 250ml and 500ml.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal and other
handling
The containers are intended for single use only.
After administration, the container and any remai-
ning solution are to be discarded.
Do not use if the solution is not clear and colourless
or if the container and its closure show any visible
signs of damage.
7.
MARKETING AUTHORISATION HOLDER and
IMPORTER
RAZ PHARMACEUTICS LTD.,
31 Gesher Haetz, Industrial Park, Emek Hefer, Israel
8.
MARKETING AUTHORISATION NUMBER
163