SODIUM BICARBONATE INJECTION, USP Solution

Country: Canada

Language: French

Source: Health Canada

Active ingredient:

Bicarbonate de sodium

Available from:

FRESENIUS KABI CANADA LTD

ATC code:

B05XA02

INN (International Name):

SODIUM BICARBONATE

Dosage:

84MG

Pharmaceutical form:

Solution

Composition:

Bicarbonate de sodium 84MG

Administration route:

Intraveineuse

Units in package:

15G/50G

Prescription type:

Spécialité médicale

Therapeutic area:

ALKALINIZING AGENTS

Product summary:

Numéro de groupe d'ingrédients actifs (GIA) :0104153005; AHFS:

Authorization status:

APPROUVÉ

Authorization date:

2019-03-12

Summary of Product characteristics

2
PRESCRIBING INFORMATION
SODIUM BICARBONATE INJECTION, USP
42 MG / ML (4.2%), 84 MG / ML (8.4%)
STERILE SOLUTION
ALKALIZER
_FOR CORRECTION OF METABOLIC ACIDOSIS AND OTHER CONDITIONS REQUIRING
SYSTEMIC _
_ALKALINIZATION_
Fresenius Kabi Canada Ltd.
165 Galaxy Blvd, Suite 100
Toronto, ON M9W 0C8
Date of Preparation:
March 12, 2019
Submission Control Number: 216164
Sodium Bicarbonate Injection, USP
Page 2 of 6
PRESCRIBING INFORMATION
SODIUM BICARBONATE INJECTION, USP
42 MG / ML (4.2%), 84 MG / ML (8.4%)
STERILE SOLUTION
ALKALIZER
_FOR CORRECTION OF METABOLIC ACIDOSIS AND OTHER CONDITIONS REQUIRING _
_SYSTEMIC ALKALINIZATION_
ACTION AND CLINICAL PHARMACOLOGY
Intravenous sodium bicarbonate therapy increases plasma bicarbonate,
buffers excess hydrogen ion
concentration, raises blood pH and reverses the clinical
manifestations of acidosis.
Sodium bicarbonate in water dissociates to provide sodium (Na
+
) and bicarbonate (HCO
3
-
) ions. Sodium (Na
+
)
is the principal cation of extracellular fluid and plays a large part
in the therapy of fluid and electrolyte
disturbances. Bicarbonate (HCO
3
-
) is a normal constituent of body fluids and the normal plasma level
ranges
from 24 to 31 mmol (mEq) / liter. Plasma concentration is regulated by
the kidney through acidification of the
urine when there is a deficit or by alkalinization of the urine when
there is an excess. Bicarbonate anion is
considered “labile” since at a proper concentration of hydrogen
ion (H
+
) it may be converted to carbonic acid
(H
2
CO
3
) and thence to its volatile form, carbon dioxide (CO
2
) excreted by the lung. Normally a ratio of 1:20
(carbonic acid: bicarbonate) is present in the extracellular fluid. In
a healthy adult with normal kidney
function, practically all the glomerular filtered bicarbonate ion is
reabsorbed; less than 1% is excreted in the
urine.
INDICATIONS AND CLINICAL USE
Sodium Bicarbonate Injection, USP is indicated in the treatment of
metabolic acidosis which may occur in
severe renal disease, uncontrolled diabetes, circulatory