Sodium Chloride

Country: Նոր Զելանդիա

language: անգլերեն

source: Medsafe (Medicines Safety Authority)

active_ingredient:

Sodium chloride 3%

MAH:

Baxter Healthcare Ltd

INN:

Sodium chloride 3%

dosage:

3 %

pharmaceutical_form:

Solution for infusion

composition:

Active: Sodium chloride 3%

units_in_package:

Bag, plastic, 1000 mL

class:

General sale

prescription_type:

General sale

manufactured_by:

Baxter Healthcare Pty Ltd

therapeutic_indication:

Hypertonic sodium chloride (3%) intravenous infusion is used in the management of severe sodium chloride depletion when electrolyte restoration is required.

leaflet_short:

Package - Contents - Shelf Life: Bag, plastic, - 1000 mL - 24 months from date of manufacture stored at or below 30°C

authorization_date:

1980-10-02

SPC

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