VIAFLO 0.9% SODIUM CHLORIDE sodium chloride 450 mg/50 mL injection intravenous infusion bag

País: Austràlia

Idioma: anglès

Font: Department of Health (Therapeutic Goods Administration)

ingredients actius:

sodium chloride, Quantity: 9 g/L

Disponible des:

Baxter Healthcare Pty Ltd

formulario farmacéutico:

Injection, intravenous infusion

Composición:

Excipient Ingredients: water for injections; hydrochloric acid

Vía de administración:

Intravenous

Unidades en paquete:

50 mL

tipo de receta:

Not scheduled. Not considered by committee

indicaciones terapéuticas:

INDICATIONS AS AT 9 October 2002: Sodium Chloride (0.9%) Intravenous Infusion is indicated for extracellular fluid replacement and in the management of metabolic alkalosis in the presence of fluid loss, and for restoring or maintaining the concentration of sodium and chloride ions.

Resumen del producto:

Visual Identification: Clear colourless solution; Container Type: Bag; Container Material: PVC; Container Life Time: 18 Months; Container Temperature: Store below 30 degrees Celsius

Estat d'Autorització:

Registered

Data d'autorització:

2018-03-15

Fitxa tècnica

SODIUM CHLORIDE 0.9% INTRAVENOUS INFUSION (sodium chloride) in VIAFLO
Plastic
Container
Version 2.0
1 of 12
AUSTRALIAN PRODUCT INFORMATION –
SODIUM CHLORIDE 0.9% INTRAVENOUS INFUSION
(SODIUM CHLORIDE) IN VIAFLO PLASTIC CONTAINER
1
NAME OF THE MEDICINE
Sodium chloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Sodium
Chloride
0.9%
Intravenous
(IV)
Infusion
preparations
are
clear,
colourless,
practically free from visible particles, sterile and non-pyrogenic
solutions of sodium chloride
(0.9%) in Water for Injections. They do not contain an antimicrobial
agent or added buffer,
and have a pH of 4.5 – 7.0. Sodium chloride 0.9% solutions are
isotonic as indicated by their
osmolarity shown in Table 1 (see Section 6.5 Nature and Contents of
Container). In a dilute
condition, osmolarity/L is approximately the same as osmolality/kg.
For the full list of excipients, see Section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
Solution for Intravenous Infusion.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Sodium Chloride 0.9% IV Infusion can be used as the vehicle for many
parenteral drugs and
as an electrolyte replenisher for maintenance or replacement of
deficits in extracellular fluid.
It can also be used as a sterile irrigation medium.
4.2
DOSE AND METHOD OF ADMINISTRATION
GENERAL DIRECTIVE
Sodium Chloride 0.9% IV Infusion is for intravenous infusion.
_ _
To be used as directed by the doctor.
Dosage, rate, and duration of administration are to be individualised
and depend upon the
indication for use, the patient’s age, weight, clinical condition,
and concomitant treatment,
and on the patient’s clinical and laboratory response to treatment.
Parenteral drug products should be inspected visually for particulate
matter and discolouration
prior to administration whenever solution and container permit. The
solution should be clear
and free from particles. Do not administer unless solution is clear
and seal is intact.
SODIUM CHLORIDE 0.9% INTRAVENOUS INFUSION (sodium chloride) in VIAFLO
Plastic
Container
Version 2.0