STERILE WATER FOR INJECTION, USP LIQUID

Država: Kanada

Jezik: engleski

Izvor: Health Canada

Aktivni sastojci:

WATER

Dostupno od:

JUNO PHARMACEUTICALS CORP.

ATC koda:

V07AB

INN (International ime):

SOLVENTS AND DILUTING AGENTS, INCL IRRIGAT SOLUT

Doziranje:

100%

Farmaceutski oblik:

LIQUID

Sastav:

WATER 100%

Administracija rute:

INTRAMUSCULAR

Jedinice u paketu:

100

Tip recepta:

Ethical

Proizvod sažetak:

Active ingredient group (AIG) number: 0105143002; AHFS:

Status autorizacije:

APPROVED

Datum autorizacije:

2023-06-12

Svojstava lijeka

PRESCRIBING INFORMATION
SODIUM BICARBONATE INJECTION, USP
Single use 10 mL and 50 mL Vial
Solution, 8.4% (84 mg/mL), Intravenous
ALKALIZER
_FOR CORRECTION OF METABOLIC ACIDOSIS AND OTHER CONDITIONS REQUIRING _
_SYSTEMIC ALKALINIZATION. _
Juno Pharmaceuticals Corp.
402-2233 Argentia Road,
Mississauga, ON, L5N 2X7
Submission Control No.: 275220
Date of Initial Authorization:
June 12, 2023
Page 2 of 7
PRESCRIBING INFORMATION
SODIUM BICARBONATE INJECTION, USP
Single use 10 mL and 50 mL Vial
Solution, 8.4% (84 mg/mL), Intravenous
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