BAXTER-SODIUM CHLORIDE INJECTION USP 0.9% WV

国家: 新加坡

语言: 英文

来源: HSA (Health Sciences Authority)

有效成分:

Sodium Chloride

可用日期:

BAXTER HEALTHCARE (ASIA) PTE LTD

ATC代码:

B05XA03

药物剂型:

INFUSION, SOLUTION

组成:

Sodium Chloride 900mg per 100mL

给药途径:

INTRAVENOUS

处方类型:

General Sale List

厂商:

Baxter Healthcare Philppines, Inc.

授权状态:

ACTIVE

授权日期:

2022-09-14

产品特点

PHRMLXXX
0.9%
RX
SODIUM CHLORIDE INJECTION, USP
IN VIAFLEX PLASTIC CONTAINER
DESCRIPTION
0.9% Sodium Chloride Injection, USP is a sterile, nonpyrogenic
solution for fluid and
electrolyte replenishment in single dose containers for intravenous
administration. It contains
no antimicrobial agents. Composition, osmolarity, pH and ionic
concentration are shown in
Table 1,
The VIAFLEX plastic container is fabricated from a specially
formulated polyvinyl chloride
(PL 146
®
Plastic). The amount of water that can permeate from inside the
container into the
overwrap is insufficient to affect the solution significantly.
Solutions in contact with the plastic
container can leach out certain of its chemical components in very
small amounts within the
expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5
parts per million. However,
the safety of the plastic has been confirmed in tests in animals
according to USP biological
tests for plastic containers as well as by tissue culture toxicity
studies.
CLINICAL PHARMACOLOGY
0.9% Sodium Chloride Injection, USP has value as a source of water and
electrolytes. It is
capable of inducing diuresis depending on the clinical condition of
the patient.
INDICATIONS AND USAGE
0.9% Sodium Chloride Injection, USP is indicated as a source of water
and electrolytes.
0.9% Sodium Chloride Injection, USP is also indicated for use as a
priming solution in
hemodialysis procedures.
CONTRAINDICATIONS
None known.
WARNINGS
0.9% Sodium Chloride Injection, USP should be used with great care, if
at all, in patients
with congestive heart failure, severe renal insufficiency, and in
clinical states in which there
exists edema with sodium retention.
Hypersensitivity reactions
•
Hypersensitivity/infusion
reactions,
including
hypotension,
pyrexia,
tremor,
chills,
urticaria, rash, and pruritus, have been reported with Sodium Chloride
Injection, USP.
•
Stop
the
infusion
immediately
if
signs
or
symptoms
of
hypersensitivity/infusion
reactions develop. Appropriate therapeutic countermeasures must be
ins