SODIUM BICARBONATE INJECTION USP SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

SODIUM BICARBONATE

Available from:

PFIZER CANADA ULC

ATC code:

B05XA02

INN (International Name):

SODIUM BICARBONATE

Dosage:

42MG

Pharmaceutical form:

SOLUTION

Composition:

SODIUM BICARBONATE 42MG

Administration route:

INTRAVENOUS

Units in package:

10ML

Prescription type:

Ethical

Therapeutic area:

ALKALINIZING AGENTS

Product summary:

Active ingredient group (AIG) number: 0104153008; AHFS:

Authorization status:

APPROVED

Authorization date:

2004-04-23

Summary of Product characteristics

PRESCRIBING INFORMATION
SODIUM BICARBONATE INJECTION USP
42 MG/ML (4.2%), 75 MG/ML (7.5%), 84 MG/ML (8.4%)
STERILE SOLUTION
Lifeshield
®
ABBOJECT
®
Single-dose Syringes,
ABBOJECT
®
Single-dose Syringes and
Fliptop Vial
ALKALIZER
_FOR CORRECTION OF METABOLIC ACIDOSIS AND OTHER CONDITIONS REQUIRING _
_SYSTEMIC ALKALINIZATION_
Pfizer Canada ULC
17300 Trans-Canada Highway
Kirkland, Québec
H9J 2M5
Control Number: 263184
DATE OF REVISION:
AUG 19, 2022
2
PRESCRIBING INFORMATION
SODIUM BICARBONATE INJECTION USP
42 MG/ML (4.2%), 75 MG/ML (7.5%), 84 MG/ML (8.4%)
STERILE SOLUTION
Lifeshield
®
ABBOJECT
®
Single-dose Syringes and
ABBOJECT
®
Single-dose Syringes and
Fliptop Vial
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 Bi