PRODUCT INFORMATION
DIN: 02150204
SODIUM CHLORIDE INJECTION USP
9 mg/mL
Isotonic Vehicle – Electrolyte Replenisher
I.M./ I.V./ S.C.
INDICATIONS
Sodium Chloride solutions can be used as an isotonic vehicle for many parenteral drugs and
as an electrolyte replenisher for maintenance or replacement of deficits of extracellular fluid.
SODIUM CHLORIDE INJECTION USP may also be administered subcutaneously to infants in
conjunction with hyaluronidase, which facilitates the absorption of the fluid.
PRECAUTIONS
Cardiovascular disease; patients receiving corticosteroids or corticotropin.
ADVERSE EFFECTS
Excessive amounts by any route may cause hypopotassemia and acidosis. Excessive amounts
by the parenteral route may precipitate congestive heart failure and acute pulmonary oedema,
especially in patients with cardiovascular disease.
DOSAGE
Parenterally, I.M., I.V., and S.C., amount varies with circumstances.
SUPPLIED
Vials:
10 mL, boxes of 10
30 mL, boxes of 10
50 mL, boxes of 10
SODIUM CHLORIDE INJECTION USP is a sterile isotonic (9 mg/mL) solution of Sodium
Chloride in Water for Injection. No preservative added; pH may be adjusted with
Hydrochloric Acid. Osmolarity approximately 0.308 mOsm/mL. Store at room temperature.
Do not freeze.
Omega Laboratories Limited
Montréal, Canada H3M 3A2
V-01
PRODUCT INFORMATION
BACTERIOSTATIC SODIUM CHLORIDE INJECTION USP 0.9%
270 mg/30 mL
9 mg/mL
Sterile Isotonic Vehicle – Electrolyte Replenisher
1.
INDICATIONS
Treatment or prophylaxis of sodium and/or chloride ion deficiency. Fluid replacement
in dehydration. Isotonic solution for vehicle in the parenteral administration of
compatible drugs.
2.
CONTRAINDICATIONS
Patients with conditions in which administration of sodium and/or chloride could be
clinically detrimental.
3.
PRECAUTIONS
Cardiovascular disease; patients receiving corticosteroids or corticotrophin; impaired
renal function; peripheral and pulmonary oedema; and toxemia of pregnancy.
Use with care in very young, geriatric and post-operative patients.
Drug interactions: High sodium intake may reduce serum lithium concentrations,
while restriction of sodium may increase serum lithium.
The administration of saline solutions may aggravate maternal pulmonary oedema
associated with ritodrine administration, particularly in patients receiving
corticosteroids.
Children: Bacteriostatic sodium chloride injection containing benzyl alcohol as a
preservative should not be used for diluting or reconstituting drugs for administration
in neonates nor should it be used to flush intravascular catheters in neonates. Benzyl
alcohol contained in bacteriostatic sodium chloride injection has been associated with
toxicity in newborns. Toxicity appears to have resulted from administration of large
amounts (99 to 404 mg/kg daily).
4.
ADVERSE EFFECTS
Excessive amounts by any route may cause hypernatremia; may also cause or
aggravate heart failure or hypertension and rarely causes hypokalemia or expansion
acidosis.
5.
OVERDOSE
Symptoms:
Overdosage may cause serious electrolyte disturbances and gastrointestinal irritation
(nausea, vomiting, diarrhoea and abdominal cramps). Manifestations of hypematremia
may include: weakness, restlessness, dizziness, headache, hypotension, tachycardia,
oedema, convulsions and coma.
Treatment:
Provide an adequate airway and ventilation. Correct fluid and electrolyte imbalance
slowly. Convulsions may be treated with I.V. diazepam. Hemodialysis or peritoneal
dialysis may be required for severe cases or in patients with renal failure.
6.
DOSAGE
Parenterally, I.V., I.M. and S.C.: Amount varies with circumstances.
7.
SUPPLIED
Each mL contains: Sodium chloride 9 mg with Benzyl alcohol 15 mg as a
preservative. Vials of 30 mL. Boxes of 10.
Omega Laboratories Limited
Montréal, Canada H3M 3A2
V-01