Pfizer (Australia) SODIUM CHLORIDE 0.9% (450mg/50mL) intravenous infusion

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv ingrediens:

sodium chloride, Quantity: 450 mg

Tilgjengelig fra:

Pfizer Australia Pty Ltd

Legemiddelform:

Injection, intravenous infusion

Sammensetning:

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

Administreringsrute:

Intravenous, Intramuscular

Enheter i pakken:

50mL x 10

Klasse:

Medicine Registered

Resept typen:

Not scheduled. Not considered by committee

Indikasjoner:

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

Produkt oppsummering:

Visual Identification: Clear, colourless solution, free from visible particles; Container Type: Vial; Container Material: PP; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Autorisasjon status:

Registered

Autorisasjon dato:

1991-07-09

Informasjon til brukeren

SODIUM CHLORIDE
_INJECTION & INTRAVENOUS INFUSION_
_ _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Sodium Chloride
Injection and Sodium Chloride
Intravenous Infusion. 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 Injection or Sodium
Chloride Intravenous Infusion
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
USING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT SODIUM
CHLORIDE
INJECTION AND
SODIUM CHLORIDE
INTRAVENOUS
INFUSION ARE USED FOR
Sodium Chloride Injection and
Sodium Chloride Intravenous
Infusion are given to patients who
have low levels of sodium or
chloride. These chemicals are
naturally present in body fluids and
are needed for normal body function.
Sodium Chloride Injection and
Sodium Chloride Intravenous
Infusion may also be used for the
dilution of other medicines before
injecting into the body.
Sodium Chloride Injection and
Sodium Chloride Intravenous
Infusion 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.
This medicine is available only with
a doctor's prescription.
BEFORE YOU ARE TREATED
WITH SODIUM
CHLORIDE
INJECTION OR
SODIUM CHLORIDE
INTRAVENOUS
INFUSION
_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.
DO NOT USE IT AFTER THE EXPIRY DATE
(EXP) PRINTED ON THE LABEL.
DO NOT USE IF THE PACKAGING I

Preparatomtale

Version: pfpsodii10821
Supersedes: pfpsodii10320
Page 1 of 7
AUSTRALIAN PRODUCT INFORMATION –
SODIUM CHLORIDE 0.9% (SODIUM
CHLORIDE) INJECTION BP
SODIUM CHLORIDE 0.9% (SODIUM
CHLORIDE) INTRAVEOUS INFUSION BP
1.
NAME OF THE MEDICINE
Sodium chloride
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Sodium Chloride Injection BP 0.9% 5 mL ampoule contains sodium
chloride 45 mg per 5 mL.
Sodium Chloride Injection BP 0.9% 10 mL ampoule contains sodium
chloride 90 mg per
10 mL.
Sodium Chloride Injection BP 0.9% 20 mL ampoule contains sodium
chloride 180 mg per
20 mL.
Sodium Chloride Intravenous Infusion BP 0.9% 50 mL vial contains
sodium chloride 450 mg
per 50 mL.
Sodium Chloride Intravenous Infusion BP 0.9% 100 mL vial contains
sodium chloride 900 mg
per 100 mL.
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Sodium Chloride Injection: Solution for injection.
Sodium Chloride Intravenous Infusion: Injection for intravenous
infusion.
Sodium Chloride Injection and Sodium Chloride Intravenous Infusion are
sterile, isotonic,
preservative-free solutions.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the restoration and maintenance of salt and extracellular fluid
levels or as a vehicle for the
administration of parenteral drugs.
Version: pfpsodii10821
Supersedes: pfpsodii10320
Page 2 of 7
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.
DOSAGE
Dosage is dependent on the age, weight, clinical and fluid/electrolyte
condition of the patient.
Adult requirements are usually fulfilled by daily IV infusion of 1
L 0.9% sodium chloride
solution.
Sodium Chloride Injection 0.9% provides a source of sodium ions (154
mmol/L), chloride ions
(154
mmol/L) and water.
4.3 CONTRAINDICATIONS
•
Congestive heart failure
•
Severe renal impairment
•
Conditions of sodium retention and oedema
•
Liver cirrhosis
•
Irrigation during electrosurgical procedure