SODIUM CHLORIDE FOR INJECTION 0.9% w/v sodium chloride for injection 10 mL ampoule

Maa: Australia

Kieli: englanti

Lähde: Department of Health (Therapeutic Goods Administration)

Aktiivinen ainesosa:

sodium chloride, Quantity: 90 mg

Saatavilla:

Interpharma Pty Ltd

INN (Kansainvälinen yleisnimi):

sodium chloride

Lääkemuoto:

Injection, solution

Koostumus:

Excipient Ingredients: water for injections

Antoreitti:

Intramuscular, Intravenous

Kpl paketissa:

50 ampoules

Prescription tyyppi:

Not scheduled. Not considered by committee

Käyttöaiheet:

Sodium chloride injection solution is used for the restoration and maintenance of salt and extracellular fluid levels or as a vehicle for the administration of parenteral drugs.

Tuoteyhteenveto:

Visual Identification: Clear, colourless solution; Container Type: Ampoule; Container Material: LDPE; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Valtuutuksen tilan:

Licence status A

Valtuutus päivämäärä:

2013-07-17

Pakkausseloste

SODIUM CHLORIDE FOR INJECTION BP 0.9%
NS_Proposed_CMI NS_2.0
Page 1 of 2
Sodium Chloride injection solution containing sodium chloride 0.9% w/v
ampoules
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Sodium Chloride 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 benefits
and risks. Your doctor has
weighed the risks of you being
given Sodium Chloride for
Injection BP 0.9% against the
benefits they expect it to have
for you.
This medicine is likely to be
used while you are at the clinic
or in hospital. If possible,
please read this leaflet
carefully before this medicine
is given to you. In some cases
this leaflet may be given to you
after the medicine has been
used.
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 FOR
INJECTION BP 0.9% IS USED
FOR
Sodium Chloride for Injection
BP 0.9% is given to patients
who have low levels of sodium
or chloride. These salts are
naturally present in body fluids
and are needed for normal
body function.
Sodium Chloride for Injection
BP 0.9% may also be used for
the dilution of other medicines
before injecting into the body.
Sodium Chloride for Injection
BP 0.9%may be used for the
management of other
conditions that are not
mentioned above. Your doctor
will be able to tell you about
the specific condition for
which you have been
prescribed Sodium Chloride.
BEFORE YOU ARE GIVEN
SODIUM CHLORIDE FOR
INJECTION BP 0.9%
WHEN YOU MUST NOT BE GIVEN
IT
It may not be safe for you to be
given sodium chloride, if you
are not sure, check with your
doctor.
TELL YOUR DOCTOR TELL YOUR
DOCTOR IF:
1. YOU HAVE ANY ALLERGIES TO:
•
ANY OTHER MEDICINE
•
ANY OTHER SUBSTANCES, SUCH
AS FOODS, PRESERVATIVES OR
DYES.
•
IF YOU ARE TAKING ANY OTHER
MEDICINES, INCLUDING
PRESCRIPTION MEDICINES OR
ANY THAT YOU BUY WITHOUT
A PRESCRIPTION FROM YOUR
PHA

Valmisteyhteenveto

_Version 2.0 _
PRODUCT INFORMATION
SODIUM CHLORIDE FOR INJECTION BP 0.9%
(SODIUM CHLORIDE INJECTION B.P. (0.9%W/V))
I)
NAME OF THE MEDICINE
Sodium Chloride
Molecular Formula: NaCl
Molecular Weight: 58.44
CAS Number: 7647-14-5
II)
DESCRIPTION
Sodium chloride is a white, crystalline powder or colourless crystals,
freely soluble in
water and practically insoluble in ethanol.
Sodium chloride injection solution is a sterile, isotonic,
preservative-free solutions
containing sodium chloride 0.9% in water for injections.
III)
PHARMACOLOGY
Sodium is the major cation of extracellular fluid and functions
principally in the control
of water distribution, fluid and electrolyte balance and osmotic
pressure of body fluids.
Chloride, the major extracellular anion, closely follows the
physiological disposition of
the sodium cation in maintenance of acid-base balance, isotonicity and
electrodynamic
characteristics of cells.
PHARMACOKINETICS
As the Sodium Chloride Intravenous preparations are directly
administered to the
circulation,
the
bioavailability
of
the
components
is
100%.
Excess
sodium
is
predominantly excreted by the kidneys, with small amounts lost in
faeces and sweat.
IV) INDICATIONS
Sodium chloride injection solution is used for the restoration and
maintenance of salt
and extracellular fluid levels or as a vehicle for the administration
of parenteral drugs.
_Version 2.0 _
V)
CONTRAINDICATIONS
Sodium chloride injection solution is contraindicated in:
-
congestive heart failure
-
severe renal impairment
-
conditions of sodium retention and oedema
-
liver cirrhosis
VI)
PRECAUTIONS
Solutions
containing
sodium
chloride
should
be
used
cautiously
in
patients
with
cardiovascular diseases such as congestive heart failure,
hypertension, impaired renal
function or other renal disease such as urinary tract obstruction,
pregnancy associated
hypertension, pulmonary or peripheral oedema, hypoproteinaemia, those
receiving
corticosteroids or corticotrophin or any condition associated with
sodium retention.
Congestive heart failure and p