14.61 % w/v sodium chloride injection Solution is indicated for parenteral
restoration of sodium ion in patients with restricted oral intake. Sodium
replacement is specifically indicated in patients with hyponatremia or low salt
syndrome. 14.61 % w/v sodium chloride injection solution may also be added to
compatible carbohydrate solutions such as dextrose in water to provide
electrolytes.

Sodium chloride injection is administered intravenously only after addition to a
larger volume of fluid.
The dose, dilution and rate of injection are dependent upon the individual needs of
each patient.
All or part of the contents of one or more additive containers may be added to an
intravenous solution container. Concentrations of up to 5% sodium chloride have
been administered.
Parenteral drug products should be inspected visually for particulate matter and
discoloration prior to administration, whenever solution and container permit

Warning:
14.61 % w/v sodium chloride injection is hypertonic and must be diluted prior to
administration. Inadvertent direct injection or absorption of concentrated sodium
chloride solution may give rise to sudden hypernatremia and such complications as
cardiovascular shock, central nervous system disorders, extensive hemolysis,
cortical necrosis of the kidneys and severe local tissue necrosis (if administered
extravascularly).
Solutions containing sodium ions should be used with great care, if at all, in
patients with congestive heart failure, severe renal insufficiency and in clinical
states in which there exists edema with sodium retention.
In patients with diminished renal function, administration of solutions containing
sodium may result in sodium retention.
The intravenous administration of this solution (after appropriate dilution) can
cause fluid and/or solute overload resulting in dilution of other serum electrolyte
concentrations, over hydration, congested states or pulmonary edema.
Excessive administration of potassium free solutions may result in significant
hypokalemia.
Precautions
14.61 % w/v sodium chloride injection Additive Solution must be diluted before
infusion to avoid a sudden increase in the level of plasma sodium. Too rapid
administration should be avoided.
Special caution should be used in administering sodium containing solutions to
patients with severe renal impairment, cirrhosis of the liver, cardiac failure, or
other edematous or sodium retaining states.
Clinical evaluation and periodic laboratory determinations are necessary to monitor
changes in fluid balance, electrolyte concentrations, and acid-base balance during
prolonged parenteral therapy or whenever the condition of the patient warrants
such evaluation.

Caution must be exercised in the administration of parenteral fluids, especially
those containing sodium ions, to patients receiving corticosteroids or corticotropin.
Do not use unless the solution is clear and seal is intact. Discard unused portion.

No clinically significant indication known

Teratogenic Effects: Pregnancy Category C:
Animal reproduction studies have not been conducted with sodium chloride. It is
also not known whether sodium chloride can cause fetal harm when administered
to a pregnant woman or can affect reproduction capacity. Sodium chloride should
be given to a pregnant woman only if clearly needed.

Not stated

Non Known.

To report any side effect(s):
Saudi Arabia:
The National Pharmacovigilance and Drug Safety Centre (NPC)
Fax: +966-11-205-7662
Call NPC at +966-11-2038222, Exts: 2317-2356-2353-2354-2334-2340.
Toll free phone: 8002490000
E-mail: npc.drug@sfda.gov.sa
Website: www.sfda.gov.sa/npc
UAE PV address:
Pharmacovigilance & Medical Device section
P.O. Box: 1853
Tel: 80011111
Email: pv@moh.gov.ae
Drug Department

Ministry of Health & Prevention
Dubai
Other GCC States:
Please contact the relevant competent authority.

In the event of over hydration or solute overload, reevaluate the patient and
institute appropriate corrective measures. (See WARNINGS and
PRECAUTIONS.)

Pharmacotherapeutic group (ATC code): Electrolyte solutions B05XA03
Sodium is the principal cation in the extracellular fluid and is the main osmotic
component in the control of blood volume.

The body contains 40 - 60mmol of sodium per kg body weight, approximately
40% of which is found in the skeleton. The normal concentration range for
extracellular fluid is 135 - 154mmol per liter. The intracellular sodium
concentration is about 5 - 10mmol per liter.
There are between 0.1 - 1.0% chloride irons in the body, contained in extracellular
fluid surrounding the nerve cell and in gastric juices. 0.6% is found in the urine.

There are no additional data of significance to the prescriber.

Water for Injections

To minimize the risk of possible incompatibilities arising from mixing this solution
with other additives that may be prescribed, the final infuscate should be inspected

for cloudiness or precipitation immediately after mixing, prior to administration
and periodically during administration.

Store below 30°C.

50 ml Glass Vial

Hypertonic solution, dilute before use.
Discard unused portion.