Sodium Chloride 0.9% Freeflex

Land: New Zealand

Språk: engelsk

Kilde: Medsafe (Medicines Safety Authority)

Aktiv ingrediens:

Sodium chloride 9 g/L;  ;  ;  ;  ;  

Tilgjengelig fra:

Fresenius Kabi New Zealand Limited

INN (International Name):

Sodium chloride 9 g/L

Dosering :

0.9 %

Legemiddelform:

Solution for infusion

Sammensetning:

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

Enheter i pakken:

Bag, plastic, Polyolefin freeflex Bag, 100 mL

Klasse:

General sale

Resept typen:

General sale

Produsert av:

Esco France SAS

Indikasjoner:

For the restoration and maintenance of salt and extracellular fluid levels or as a vehicle for the administration of parenteral drugs.

Produkt oppsummering:

Package - Contents - Shelf Life: Bag, plastic, Polyolefin freeflex Bag - 50 mL - 24 months from date of manufacture stored at or below 25°C - Bag, plastic, Polyolefin freeflex Bag - 100 mL - 24 months from date of manufacture stored at or below 25°C - Bag, plastic, Polyolefin freeflex Bag - 250 mL - 36 months from date of manufacture stored at or below 25°C - Bag, plastic, Polyolefin freeflex Bag - 500 mL - 36 months from date of manufacture stored at or below 25°C - Bag, plastic, Polyolefin freeflex Bag - 1000 mL - 36 months from date of manufacture stored at or below 25°C

Autorisasjon dato:

2007-09-19

Informasjon til brukeren

CMI FOR SODIUM CHLORIDE 0.9% FREEFLEX
OCTOBER 2021
Filename: NaClCMIfreeflex
Page 1
Change: Address change
SODIUM CHLORIDE 0.9% FREEFLEX
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET?
This
leaflet
answers
some
common questions about Sodium
Chloride 0.9% Injection. It does not
take the place of talking to your
doctor or pharmacist.
All
medicines
have
risks
and
benefits.
Your
doctor
will
have
weighed
the
risks
of
you
being
given
Sodium
Chloride
0.9%
Injection against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING
THIS
MEDICINE,
ASK
YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET. You may need
to read it again.
WHAT SODIUM CHLORIDE
0.9% INJECTION IS USED
FOR
Sodium Chloride 0.9% Injection is
used to replace lost body fluids
and salts. Other medicines which
are given by injection or by drip
may
be
diluted
with
Sodium
Chloride 0.9% Injection.
Sodium
Chloride
0.9%
Injection
can
also
be
used
as
a
sterile
irrigation solution.
Your
doctor
will
have
explained
why
you
are
being
treated
with
Sodium
Chloride
0.9%
Injection
and told you what dose you will be
given.
YOUR
DOCTOR
MAY
HAVE
PRESCRIBED IT FOR ANOTHER REASON.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS
ABOUT
WHY
THIS
MEDICINE
HAS
BEEN
PRESCRIBED
FOR YOU.
BEFORE YOU ARE GIVEN
SODIUM CHLORIDE 0.9%
INJECTION
_ _
_WHEN YOU MUST NOT BE GIVEN IT _
YOU SHOULD NOT BE GIVEN SODIUM
CHLORIDE
0.9%
INJECTION
IF
YOU
HAVE,
OR
HAVE
HAD,
ANY
OF THE
FOLLOWING MEDICAL CONDITIONS:

Congestive heart failure

Severe kidney problems

Swelling due to excess fluid

Chronic liver disease
_BEFORE YOU ARE GIVEN IT _
TELL YOUR DOCTOR OR PHARMACIST IF
YOU HAVE ALLERGIES TO ANY OTHER
MEDICINES,
FOODS,
PRESERVATIVES
OR DYES.
TELL YOUR DOCTOR IF YOU HAVE OR
HAVE
HAD
ANY
MEDICAL
CONDITIONS,
ESPECIALLY
THE
FOLLOWING:

Heart problems

Excess fluid in the lungs

Swelling due to excess fluid

Kidney disease

High blood pressure including
high blood pressure due to
pregnancy

Problems with urinary tract
It may not be safe for you to be

Preparatomtale

Page 1 of 5
NEW ZEALAND DATA SHEET
1 SODIUM CHLORIDE 0.9% FREEFLEX
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Sterile isotonic solution of sodium chloride 9g/L in Water for
Injections, containing no
preservatives (normal saline).
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Infusion for solution
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
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.
4.2 DOSE AND METHOD OF ADMINISTRATION
The dosage of sodium chloride as a vehicle for parenteral drugs and as
an electrolyte
replenisher must be calculated after consideration of clinical and
laboratory data.
For use in one patient, on one occasion only. It does not contain
antimicrobials. Any
unused portion should be discarded. Care should be taken with
intravenous technique
to avoid injection site reactions and infections
4.3 CONTRAINDICATIONS
Sodium Chloride 0.9% is contraindicated in patients with congestive
heart failure,
severe renal impairment, conditions of sodium retention, oedema, liver
cirrhosis and
irrigation during electrosurgical procedures.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Do not use unless the solution is clear. The entire contents of the
bag should be used
promptly.
When used as a vehicle for intravenous drug delivery, the product
information document
of such drugs should be checked prior to use to ensure compatibility
with the sodium
chloride solution. Reconstitution instructions should be read
carefully.
Excessive
administration
of
sodium
chloride
causes
hypernatraemia,
resulting
in
dehydration
of
internal
organs,
hypokalaemia
and
acidosis.
Monitoring
of
fluid,
electrolyte and acid/base balance may be necessary. Congestive heart
failure and
pulmonary oedema may be precipitated, particularly in patients with
cardiovascular
disease or those receiving corticosteroids, corticotrophin or other
drugs that m