STERILE WATER FOR INJECTION, USP LIQUID

国家: 加拿大

语言: 英文

来源: Health Canada

有效成分:

WATER

可用日期:

JUNO PHARMACEUTICALS CORP.

ATC代码:

V07AB

INN（国际名称）:

SOLVENTS AND DILUTING AGENTS, INCL IRRIGAT SOLUT

剂量:

100%

药物剂型:

LIQUID

组成:

WATER 100%

给药途径:

INTRAMUSCULAR

每包单位数:

100

处方类型:

Ethical

產品總結:

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

授权状态:

APPROVED

授权日期:

2023-06-12

产品特点

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