0.9% SODIUM CHLORIDE INJECTION VIAFLEX PLASTIC CONTAINER

Land: Malaysia

Språk: engelska

Källa: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Aktiva substanser:

SODIUM CHLORIDE (SALT)

Tillgänglig från:

BAXTER HEALTHCARE (MALAYSIA) SDN. BHD.

INN (International namn):

SODIUM CHLORIDE (SALT)

Enheter i paketet:

50ml mL; 100ml mL; 250ml mL; 500 ml mL; 1000 ml mL

Tillverkad av:

BAXTER HEALTHCARE PTY LTD

Produktens egenskaper

Description
0.9% Sodium Chloride Injection 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 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 is indicated as a source of water and
electrolytes.
0.9% Sodium Chloride Injection is also indicated for use as a priming
solution in hemodialysis
procedures.
Contraindications
None known.
Warnings
0.9% Sodium Chloride Injection 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.
In patients with diminished renal function, administration of Sodium
Chloride Injection may result
in sodium retention.
_Hypersensitivity reactions_
•
Hypersensitivity/infusion reactions, including hypotension, pyrexia,
tremor, chills, urticaria,
rash, and pruritus, have been reported with Sodium Chloride Injection.
•
Stop the infusion immediately if signs or symptoms of
hypersensitivity/infusion reactions
develop. Appropriate therapeutic countermeasu