BAXTER-SODIUM CHLORIDE INJECTION USP 0.9% WV

Pays: Singapour

Langue: anglais

Source: HSA (Health Sciences Authority)

Ingrédients actifs:

Sodium Chloride

Disponible depuis:

BAXTER HEALTHCARE (ASIA) PTE LTD

Code ATC:

B05XA03

forme pharmaceutique:

INFUSION, SOLUTION

Composition:

Sodium Chloride 900mg per 100mL

Mode d'administration:

INTRAVENOUS

Type d'ordonnance:

General Sale List

Fabriqué par:

Baxter Healthcare Philppines, Inc.

Statut de autorisation:

ACTIVE

Date de l'autorisation:

2022-09-14

Résumé des caractéristiques du produit

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