SODIUM BICARBONATE INJECTION SOLUTION

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

SODIUM BICARBONATE

Commercializzato da:

PHEBRA CANADA INC

Codice ATC:

B05XA02

INN (Nome Internazionale):

SODIUM BICARBONATE

Dosaggio:

4200MG

Forma farmaceutica:

SOLUTION

Composizione:

SODIUM BICARBONATE 4200MG

Via di somministrazione:

INTRAVENOUS

Confezione:

100

Tipo di ricetta:

Ethical

Area terapeutica:

ALKALINIZING AGENTS

Dettagli prodotto:

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

Stato dell'autorizzazione:

APPROVED

Data dell'autorizzazione:

2023-03-30

Scheda tecnica

Sodium Bicarbonate Injection 8.4% w/v
Page 1 of 7
PRESCRIBING INFORMATION
SODIUM BICARBONATE INJECTION
8.4% W/V (84 MG/ML)
FOR INTRAVENOUS ADMINISTRATION
STERILE SOLUTION
_British Pharmacopeia _(B.P.)_ _
Alkalizer
For correction of metabolic acidosis and other conditions requiring
systemic
alkalinization
Phebra Canada Inc.
7171 rue Frederick-Banting, Suite 216
Montreal, QC, H4S 1Z9
Date of Preparation:
March 30, 2023
Submission Control No: 272809
Sodium Bicarbonate Injection 8.4% w/v
Page 2 of 7
PRESCRIBING INFORMATION
SODIUM BICARBONATE INJECTION
8.4% W/V (84 MG/ML)
FOR INTRAVENOUS ADMINISTRATION
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 is indicated in the treatment of
metabol