SODIUM CHLORIDE INJECTION USP SOLUTION

ประเทศ: แคนาดา

ภาษา: อังกฤษ

แหล่งที่มา: Health Canada

สารออกฤทธิ์:

SODIUM CHLORIDE

มีจำหน่ายจาก:

CHIEF MEDICAL SUPPLIES LTD

รหัส ATC:

B05XA03

INN (ชื่อสากล):

SODIUM CHLORIDE

ปริมาณ:

0.9%

แบบฟอร์มเภสัชกรรม:

SOLUTION

องค์ประกอบ:

SODIUM CHLORIDE 0.9%

เส้นทางการบริหาร:

INTRAVENOUS

หน่วยในแพ็คเกจ:

2000ML

ประเภทใบสั่งยา:

Ethical

พื้นที่บำบัด:

REPLACEMENT PREPARATIONS

สรุปสินค้า:

Active ingredient group (AIG) number: 0100053002; AHFS:

สถานะการอนุญาต:

APPROVED

วันที่อนุญาต:

2017-06-09

สรุปลักษณะสินค้า

Page 1 of 9
PRESCRIBING INFORMATION
SODIUM CHLORIDE INJECTION USP
(SODIUM CHLORIDE SOLUTION USP)
0.9%
Parenteral Electrolyte, Sodium
CHIEF MEDICAL SUPPLIES LTD.
DATE OF PREPARATION:
CALGARY, AB T2E 6J7
JUNE 9, 2017
CANADA
SUBMISSION CONTROL #: 196338
Page 2 of 9
Chief Medical Supplies Ltd.
SODIUM CHLORIDE INJECTION USP
(SODIUM CHLORIDE SOLUTION USP)
0.9%
Parenteral Electrolyte, Sodium
SUMMARY PRODUCT INFORMATION
ROUTE OF ADMINISTRATION
DOSAGE FORM/STRENGTH
ALL NONMEDICINAL
INGREDIENTS
Intravenous
Solution/0.9% w/v
Water for injection, USP
DESCRIPTION
Each 100 mL of 0.9% SODIUM CHLORIDE INJECTION USP contains:
Sodium Chloride USP 0.9 g; Water for Injection USP qs
pH: 5.6 (4.5-7.0)
Calculated Osmolarity: 308 mOsmol/liter
pH adjusted with Hydrochloric Acid NF
Concentration of Electrolytes (mEq/liter): Sodium 154 Chloride 154
Sodium Chloride Injection USP is sterile, nonpyrogenic, isotonic and
contains no bacteriostatic
or antimicrobial agents.
The formula of the active ingredient is:
INGREDIENT
MOLECULAR FORMULA
MOLECULAR WEIGHT
Sodium Chloride USP
NaCI
58.44
Not made with natural rubber latex, PVC, or DEHP.
The plastic container is made from a homogenous blend of polypropylene
and thermoplastic
modifier specifically developed for parenteral drugs. The container is
nontoxic and biologically
inert. The container is a closed system and is not dependent upon
entry of external air during
administration.
Addition of medication should be accomplished using complete aseptic
technique.
Refer to the Directions for Use of the container.
Page 3 of 9
INDICATIONS AND CLINICAL USE
This intravenous solution is indicated for use in adults and pediatric
patients as a source of
electrolytes and water for hydration.
0.9% Sodium Chloride Injection USP is indicated for extracellular
fluid replacement, treatment
of metabolic alkalosis in the presence of fluid loss and mild sodium
depletion.
0.9% Sodium Chloride Injection USP is also indicated for use as a
priming solution in
hemodialysis procedures and may be used to initiate and termina