SODIUM BICARBONATE INJECTION USP SOLUTION

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Compra

Scheda tecnica Scheda tecnica (SPC)
19-08-2022

Principio attivo:

SODIUM BICARBONATE

Commercializzato da:

PFIZER CANADA ULC

Codice ATC:

B05XA02

INN (Nome Internazionale):

SODIUM BICARBONATE

Dosaggio:

42MG

Forma farmaceutica:

SOLUTION

Composizione:

SODIUM BICARBONATE 42MG

Via di somministrazione:

INTRAVENOUS

Confezione:

10ML

Tipo di ricetta:

Ethical

Area terapeutica:

ALKALINIZING AGENTS

Dettagli prodotto:

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

Stato dell'autorizzazione:

APPROVED

Data dell'autorizzazione:

2004-04-23

Scheda tecnica

                                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
                                
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