SODIUM CHLORIDE INJECTION BP 0.9%, sodium chloride, 20 mL ampoule

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv ingrediens:

sodium chloride, Quantity: 9 mg/mL

Tilgjengelig fra:

Fresenius Kabi Australia Pty Ltd

INN (International Name):

sodium chloride

Legemiddelform:

Injection, solution

Sammensetning:

Excipient Ingredients: hydrochloric acid; sodium hydroxide; water for injections

Administreringsrute:

Intramuscular, Intravenous, Subcutaneous

Enheter i pakken:

Carton of 20's

Resept typen:

Not scheduled. Not considered by committee

Indikasjoner:

As a 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.

Produkt oppsummering:

Visual Identification: Clear and colourless.; Container Type: Ampoule; Container Material: PP; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Autorisasjon status:

Licence status A

Autorisasjon dato:

2013-04-30

Informasjon til brukeren

Sodium Chloride Injection
1
SODIUM CHLORIDE INJECTION BP 0.9%
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING SODIUM CHLORIDE INJECTION BP 0.9% ?
Sodium chloride Injection BP 0.9% contains the active ingredient
sodium chloride. Sodium Chloride 0.9% is used to replace
lost body fluids and salts, dilute other medicines, and/or act as a
sterile liquid for washing wounds, nasal passages or during
surgery.
For more information, see Section 1. Why am I using Sodium Chloride
Injection BP 0.9% ? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE SODIUM CHLORIDE INJECTION BP 0.9%?
Do not use if you have ever had an allergic reaction to Sodium
Chloride Injection BP 0.9% or any of the ingredients listed at
the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
Sodium Chloride Injection BP 0.9% ? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Sodium Chloride 0.9% and affect how
it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE SODIUM CHLORIDE INJECTION BP 0.9% ?
•
Sodium Chloride Injection BP 0.9% will be given to you by your doctor
or specially trained nurse.
They will decide what dose and how long you will receive it for. This
depends on your medical condition and other factors.
•
More instructions can be found in Section 4. How do I use Sodium
Chloride Injection BP 0.9% ? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING SODIUM CHLORIDE INJECTION BP 0.9%?
THINGS YOU
SHOULD DO
•
If you become pregnant while being given Sodium Chloride Injection BP
0.9% tell your doctor
immediately.
•
Remind any doctor, dentist or pharmacist or nurse you visit that you
have been given using

Preparatomtale

AUSTRALIAN PRODUCT INFORMATION- SODIUM
CHLORIDE INJECTION BP 0.9% (SODIUM CHLORIDE)
1 NAME OF MEDICINE
Sodium chloride
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Sodium Chloride Injection BP 0.9% contains sodium chloride 0.9%
(9mg/mL) in Water for
Injections.
For the full list of excipients, see Section 6.1 List of excipients.
3 PHARMACEUTICAL FORM
Solution for Injection.
Sodium Chloride Injection BP 0.9% is a sterile, preservative-free
solution, pH 4.5-7.0
4 CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Sodium Chloride Injection BP 0.9% 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
To be used as directed by a physician.
Parenteral drug products should be inspected prior to administration
for particulate matter
and discolouration. Sodium Chloride Injection BP 0.9% does not contain
any antimicrobial
preservatives. Care should be taken with intravenous technique to
avoid injection site
reactions and infections.
Dosage is dependent on the age, weight, clinical and fluid/electrolyte
condition of the patient.
4.3
CONTRAINDICATIONS
•
Congestive heart failure
•
Severe renal impairment
•
Conditions of sodium retention and oedema
•
Liver cirrhosis
•
irrigation during electrosurgical procedures
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
•
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 diseases such as urinary tract obstruction,
pregnancy associated
hypertension, pulmonary or peripheral oedema, hypoproteinameia, those
receiving
corticosteroids or corticotrophin or any condition associated with
sodium retention.
•
Sodium chloride solutions should be used with caution in geriatric
patients and
infants.
•
Excessive administration of sodium chloride solution may result in