0.9% SODIUM CHLORIDE INTRAVENOUS INFUSION

Pays: Australie

Langue: anglais

Source: Department of Health (Therapeutic Goods Administration)

Ingrédients actifs:

sodium chloride, Quantity: 2.25 g

Disponible depuis:

Baxter Healthcare Pty Ltd

DCI (Dénomination commune internationale):

sodium chloride

forme pharmaceutique:

Injection

Composition:

Excipient Ingredients: water for injections

Mode d'administration:

Intravenous

Unités en paquet:

1 x 250mL

Type d'ordonnance:

Not Scheduled after consideration by Committee

indications thérapeutiques:

Normal saline can be used as the vehicle for many parenteral drugs and as an electrolyte replenisher for maintenance or replacement of deficits of extracellular fluid. It can also be used as a sterile irrigation medium.

Descriptif du produit:

Visual Identification: Clear, colourless solution, practically free from visible particles; Container Type: Bag; Container Material: Plastic; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Statut de autorisation:

Licence status A

Date de l'autorisation:

2011-09-15

Notice patient

Sodium Chloride CMI (Aviva) Oct 2013
Page 1 of 4
Baxter
0.9% SODIUM CHLORIDE
IN AVIVA (NONPVC) PLASTIC CONTAINER (BAG)
_0.9% Sodium Chloride for Injection_
_ _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some
of the common questions
about 0.9% Sodium
Chloride for Injection.
It does not contain all the
available information.
It does not take the place
of talking to your doctor or
pharmacist.
All medicines have risks
and benefits. Your doctor
has prescribed Sodium
Chloride IV infusion for
you in the knowledge that
the benefits outweigh any
possible risks.IF YOU HAVE
ANY CONCERNS ABOUT
TAKING THE MEDICINE, ASK
YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE.
You may need to read it
again.
WHAT 0.9% SODIUM
CHLORIDE IS USED FOR
0.9% Sodium Chloride is
used for the control of
water, fluid and electrolyte
balance in the body.
It can be used for
reconstituting and
delivering other drug
products.
It can also be used as a
sterile irrigation fluid.
0.9% Sodium Chloride is
not addictive.
This medication is
available only with a
doctor’s prescription.
BEFORE YOU ARE GIVEN
0.9% SODIUM
CHLORIDE
Caution should be taken
with 0.9% Sodium
Chloride if you have, or
have had, any of the
following medical
conditions:
•
Heart failure
•
Impaired renal function
•
Cerebral oedema
•
Pulmonary, central or
peripheral oedema
•
Hypertension
•
Liver disease
•
Sodium retention
•
Swelling of the hands,
ankles or feet
•
Breathlessness
•
have ever had an
allergic reaction to
sodium chloride
injection
•
are pregnant
•
are breast feeding
Symptoms of an allergic
reaction to 0.9% Sodium
Chloride may include:
•
Shortness of breath,
wheezing, difficulty
breathing or a tight
feeling in your chest
•
Swelling of the face,
lips, tongue or other
parts of the body
•
Rash, itching, hives or
flushed, red skin
•
Dizziness or
lightheadedness
•
Pain at the injection
site
Caution should be taken
with 0.9% Sodium
Chloride under the
following situations:
Sodium Chloride CMI (Aviva) Oct 20

Résumé des caractéristiques du produit

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