SODIUM BICARBONATE INJECTION USP SOLUTION

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

SODIUM BICARBONATE

Tilgjengelig fra:

JAMP PHARMA CORPORATION

ATC-kode:

B05XA02

INN (International Name):

SODIUM BICARBONATE

Dosering :

84MG

Legemiddelform:

SOLUTION

Sammensetning:

SODIUM BICARBONATE 84MG

Administreringsrute:

INTRAVENOUS

Enheter i pakken:

15G/50G

Resept typen:

Ethical

Terapeutisk område:

ALKALINIZING AGENTS

Produkt oppsummering:

Active ingredient group (AIG) number: 0104153005; AHFS:

Autorisasjon status:

APPROVED

Autorisasjon dato:

2021-05-21

Preparatomtale

PRESCRIBING INFORMATION
SODIUM BICARBONATE INJECTION USP
84 MG / ML (8.4%)
ALKALIZER
_FOR CORRECTION OF METABOLIC ACIDOSIS AND OTHER CONDITIONS REQUIRING _
_SYSTEMIC ALKALINIZATION_
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JAMP Pharma Corporation
1310 rue Nobel
Boucherville, Quebec
J4B 5H3, Canada
Control Number: 242168
DATE OF REVISION:
May 21, 2021
2
PRESCRIBING INFORMATION
SODIUM BICARBONATE INJECTION USP
84 MG / ML (8.4%)
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.
3
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
insufficiency due to shock
or
severe dehydration, extracorp