0.9% Sodium Chloride

Država: Novi Zeland

Jezik: engleski

Izvor: Medsafe (Medicines Safety Authority)

Kupi sada

Preuzimanje Svojstava lijeka (SPC)
19-04-2020

Aktivni sastojci:

Sodium chloride 9 g/L

Dostupno od:

Baxter Healthcare Ltd

INN (International ime):

Sodium chloride 9 g/L

Doziranje:

0.9 %

Farmaceutski oblik:

Solution for infusion

Sastav:

Active: Sodium chloride 9 g/L Excipient: Water for injection

Tip recepta:

General sale

Proizveden od:

Esco France SAS

Terapijske indikacije:

As a vehicle for the administration of Parenteral drugs. Also utilised as an 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.

Proizvod sažetak:

Package - Contents - Shelf Life: Bag, plastic, VIAFLO (PL 2442) polyethylene plastic bag - 250 mL - 24 months from date of manufacture stored at or below 25°C - Bag, plastic, VIAFLO (PL 2442) polyethylene plastic bag - 500 mL - 24 months from date of manufacture stored at or below 25°C - Bag, plastic, VIAFLO (PL 2442) polyethylene plastic bag - 1000 mL - 24 months from date of manufacture stored at or below 25°C

Datum autorizacije:

2013-03-13

Svojstava lijeka

                                NEW ZEALAND DATA SHEET
0.9% Sodium Chloride (VIAFLO) Data Sheet 14 August 2019
Page 1 of 10
Baxter Healthcare Ltd
1 0.9% Sodium Chloride (infusion, solution)
0.9% Sodium Chloride Infusion, solution.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
_Active ingredient _
9g/L (0.9%) sodium chloride (USP), in Water for Injection.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Infusion, solution, in VIAFLO bag (for intravenous infusion).
0.9% Sodium Chloride infusion solution preparations are clear,
colourless, practically free from visible
particles, sterile and non‐pyrogenic solutions of sodium chloride
(0.9%) in Water for Injections.
The preparations do not contain an antimicrobial agent or added
buffer, and have a pH of 4.5 – 7.0.
0.9% Sodium Chloride infusion solution is isotonic as indicated by
their osmolarity shown in the table
in section 6.5. In dilute conditions, osmolarity/L is approximately
the same as osmolality/kg.
4 CLINICAL PARTICULARS
4.1
Therapeutic indications
0.9% Sodium Chloride infusion solutions is indicated:

As a vehicle for the administration of parenteral drugs

Also utilised as an 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.
4.2
Dose and method of administration
0.9% Sodium Chloride 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 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.
Additives may be incompatible, se
                                
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