SYKES 0.9% SODIUM CHLORIDE- sodium chloride injection solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698)

Available from:

Sypharma Pty Ltd

INN (International Name):

SODIUM CHLORIDE

Composition:

SODIUM CHLORIDE 900 mg in 100 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION

Therapeutic indications:

Sykes 0.9% Sodium Chloride Intravenous Infusion is indicated as a source of water and electrolytes. None known.

Authorization status:

unapproved drug other

Summary of Product characteristics

SYKES 0.9% SODIUM CHLORIDE- SODIUM CHLORIDE INJECTION SOLUTION
SYPHARMA PTY LTD
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this labeling has not been_
_approved by FDA. For further information about unapproved drugs,
click here._
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SYKES 0.9% SODIUM CHLORIDE
STERILE NONPYROGENIC SOLUTION
For Animal Use Only
DES CRIPTION
Sykes 0.9% Sodium Chloride Intravenous Infusion is a sterile,
non-pyrogenic solution intended for
water and electrolytes replenishment in single dose containers. May be
administered intravenously using
aseptic technique. It contains no antimicrobial agents. Discard any
unused portion. Composition,
osmolarity, pH and ionic concentration are shown in Table 1.
Table 1
The container is free of PVC and phthalates. The container meets the
requirements of USP and is
registered with US FDA.
CLINICAL PHARMACOLOGY
Sykes 0.9% Sodium Chloride Intravenous Infusion is intended to restore
water and electrolytes. It is
capable of inducing diuresis, depending on the clinical condition of
the patient.
INDICATIONS AND USAGE
Sykes 0.9% Sodium Chloride Intravenous Infusion is indicated as a
source of water and electrolytes.
CONTRAINDICATIONS
None known.
WARNINGS
Sykes 0.9% Sodium Chloride Intravenous Infusion 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.
The intravenous administration of Sykes 0.9% Sodium Chloride
Intravenous Infusion can cause fluid
and/or solute overloading resulting in dilution of serum electrolyte
concentrations, over-hydration,
congested states, or pulmonary edema. The risk of dilutive states is
inversely proportional to the
electrolyte concentration of the injections. The risk of solute
overload causing congested states with
peripheral and pulmonary edema is directly proportional to the
electrolyte concentrations of the
injections.
In patients with diminished renal function, administration of Sykes
0.9% Sodium C