3% Sodium Chloride Injection, BP is a sterile, no pyrogenic, hypertonic solution
for fluid and electrolyte replenishment in single dose containers for intravenous
administration. The pH may have been adjusted with hydrochloric acid. It contains
no antimicrobial agents.
3% Sodium Chloride Injection, BP used in the treatment of acute sodium
deficiency and water intoxication.

Before receiving this medicine for the prevention or treatment of fluid or salt
imbalances, tell your doctor if you have any of the following conditions:
• Heart disease
• High blood pressure
• Breathlessness
• A kidney disorder
• A condition of pregnancy associated with increased blood pressure and
significant amounts of protein in urine (pre-eclampsia)
• swelling of the ankles
• Too much fat or protein in your blood, or if you suffer from diabetes.
• You are taking any other medicines containing sodium salts. If you are elderly or
are very young, care is required while administering this medicine to you.
Warning and Precaution
3% Sodium Chloride Injection, BP is strongly hypertonic and may cause vein
damage.
3% Sodium Chloride Injection, BP 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 3% Injection, BP may
result in sodium retention.
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 3% Sodium Chloride Injection,
BP to patients receiving corticosteroids or corticotropin.
Pregnancy: Teratogenic Effects
Pregnancy Category C. Animal reproduction studies have not been conducted
with 3% Sodium Chloride Injection, BP. It is also not known whether 3% Sodium
Chloride Injection, USP can cause fetal harm when administered to a pregnant
woman or can affect reproduction capacity. 3% Sodium Chloride Injection, USP
should be given to a pregnant woman only if clearly needed.

Pediatric Use
Safety and effectiveness of 3% Sodium Chloride Injection, BP in pediatric patients
have not been established by adequate and well controlled trials, however, the
use of sodium chloride solutions in the pediatric population is referenced in the
medical literature. The warnings, precautions and adverse reactions identified in
the label copy should be observed in the pediatric population.
Geriatric Use
Clinical studies of 3% Sodium Chloride Injection, BP, did not include sufficient
numbers of subjects aged 65 and over to determine whether they respond
differently from younger subjects. Other reported clinical experience has not
identified differences in responses between the elderly and younger patients. In
general, dose selection for an elderly patient should be cautious, usually starting
at the low end of the dosing range, reflecting the greater frequency of decreased
hepatic, renal, or cardiac function, and of concomitant disease or drug therapy.
This drug is known to be substantially excreted by the kidney, and the risk of toxic
reactions to this drug may be greater in patients with impaired renal function.
Because elderly patients are more likely to have decreased renal function, care
should be taken in dose selection, and it may be useful to monitor renal function.
Do not administer unless solution is clear and seal is intact.

These solutions are for intravenous use only.
Dosage is to be directed by a physician and is dependent upon age, weight,
clinical condition of the patient and laboratory determinations. Frequent laboratory
determinations and clinical evaluation are essential to monitor changes in blood
glucose and electrolyte concentrations, and fluid and electrolyte balance during
prolonged parenteral therapy.
When a hypertonic solution is to be administered peripherally, it should be slowly
infused through a small bore needle, placed well within the lumen of a large vein
to minimize venous irritation. Carefully avoid infiltration.
Maximum intravenous dosage should be 100 mL given over a period of one hour.
Before additional amounts are given, the serum electrolyte concentrations,
including chloride and bicarbonate, should be determined to evaluate the need for
more sodium chloride.
Intravenous administration of these solutions should not exceed 100 mL/hour or
400 mL/24 hours.
Fluid administration should be based on calculated maintenance or replacement
fluid requirements for each patient.
Some additives may be incompatible. Consult with pharmacist. When introducing
additives, use aseptic techniques. Mix thoroughly. Do not store.
Parenteral drug products should be inspected visually for particulate matter and
discoloration prior to administration, whenever solution and container permit.
Children
The rate of administration and volume infused will depend upon the requirements
of the individual patient and the judgement of the physician.
Elderly
Care should be taken to avoid circulatory overload, particularly in patients with
cardiac and renal insufficiency.

Reactions which may occur because of the solution or the technique of administration
include febrile response, infection at the site of injection, venous thrombosis
or phlebitis extending from the site of injection, extravasation and hypervolemia.
If an adverse reaction does occur, discontinue the infusion, evaluate the patient,
institute appropriate therapeutic countermeasures, and save the remainder of the
fluid for examination if deemed necessary.
Other medicines and 3% Sodium Chloride Injection
No information provided

OVERDOSE
No information provided.
Reporting of side effects
If you get any side effects, talk to your doctor or nurse. This includes any possible
side effects not listed in this leaflet. You can also report side effects directly (see
details below). By reporting side effects, you can help provide more information on
the safety of this medicine.

It is recommended the product be stored at room temperature (30oC); brief
exposure up to 40oC does not adversely affect the product.