SODIUM BICARBONATE INJECTION USP SOLUTION

Država: Kanada

Jezik: engleski

Izvor: Health Canada

Aktivni sastojci:

SODIUM BICARBONATE

Dostupno od:

OMEGA LABORATORIES LIMITED

ATC koda:

B05XA02

INN (International ime):

SODIUM BICARBONATE

Doziranje:

84MG

Farmaceutski oblik:

SOLUTION

Sastav:

SODIUM BICARBONATE 84MG

Administracija rute:

INTRAVENOUS

Jedinice u paketu:

15G/50G

Tip recepta:

Ethical

Područje terapije:

ALKALINIZING AGENTS

Proizvod sažetak:

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

Status autorizacije:

APPROVED

Datum autorizacije:

2017-08-18

Svojstava lijeka

PRESCRIBING INFORMATION
SODIUM BICARBONATE INJECTION USP
Single use 10 mL and 50 mL Vial
8.4% (84 mg/mL)
ALKALIZER
_FOR CORRECTION OF METABOLIC ACIDOSIS AND OTHER CONDITIONS REQUIRING _
_SYSTEMIC ALKALINIZATION. _
Omega Laboratories, Ltd.
11 177 Hamon
Montreal, Canada
H3M 3E4
Submission Control No. : 220314
Date of revision: April 30, 2019
Page 2 of 7
PRESCRIBING INFORMATION
SODIUM BICARBONATE INJECTION USP
Single use 10 and 50 mL Vial
8.4% (84 mg/mL)
THERAPEUTIC CLASSIFICATION
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
insufficiency
due
to
shock
or
severe
de