Sodium Chloride

Land: Nieuw-Zeeland

Taal: Engels

Bron: Medsafe (Medicines Safety Authority)

Werkstoffen:

Sodium chloride 0.45%

Beschikbaar vanaf:

Baxter Healthcare Ltd

INN (Algemene Internationale Benaming):

Sodium chloride 0.45%

Dosering:

0.45 %

farmaceutische vorm:

Solution for infusion

Samenstelling:

Active: Sodium chloride 0.45%

Eenheden in pakket:

Bag, plastic, (not marketed), 50 mL

klasse:

General sale

Prescription-type:

General sale

Geproduceerd door:

Baxter Healthcare Pty Ltd

therapeutische indicaties:

Hypotonic sodium chloride (0.45%) intravenous infusion is mainly used as a hydrating agent solution.

Product samenvatting:

Package - Contents - Shelf Life: Bag, plastic, - 50 mL - 24 months from date of manufacture stored at or below 30°C - Bag, plastic, - 100 mL - 24 months from date of manufacture stored at or below 30°C - Bag, plastic, - 250 mL - 24 months from date of manufacture stored at or below 30°C - Bag, plastic, - 500 mL - 24 months from date of manufacture stored at or below 30°C

Autorisatie datum:

1980-10-02

Productkenmerken

NEW ZEALAND DATA SHEET
Sodium Chloride (Viaflex) Data Sheet 14 August 2019
Page 1 of 11
Baxter Healthcare Ltd
1 Sodium Chloride (infusion, solution)
Sodium Chloride 0.45% Infusion, solution
Sodium Chloride 0.9% Infusion, solution
Sodium Chloride 3% Infusion, solution.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
_Active ingredient _
Sodium chloride, in Water for Injection.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Infusion, solution in Viaflex plastic bag (for intravenous infusion).
Sodium Chloride infusion solution preparations are sterile,
non‐pyrogenic solutions of sodium chloride
in Water for Injection.
The preparations do not contain an antimicrobial agent or added
buffer, and have a pH of 4.0 – 7.0.
Sodium Chloride 0.9% infusion solution is isotonic, Sodium Chloride 3%
(1026mOsmol/L) is hypertonic
and Sodium Chloride 0.45% (154mOsmol/L) is hypotonic, as indicated by
their osmolarities. The
concentration of sodium chloride in each preparation and their
osmolarities are shown in Table 1 (see
section 6.5). In a dilute condition, osmolarity/L is approximately the
same as osmolality/kg.
4 CLINICAL PARTICULARS
4.1
Therapeutic indications
Sodium Chloride 0.9% infusion solution 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.
Hypertonic Sodium Chloride 3% infusion solution is used in the
management of severe sodium
chloride depletion when electrolyte restoration is required.
Hypotonic Sodium Chloride 0.45% infusion solution is mainly used as a
hydrating agent solution.
4.2
Dose and method of administration
_General directive _
Sodium Chloride (0.45%, 0.9%, 3%) infusion solution 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