Phebra SODIUM CHLORIDE 0.9% 900 mg in 100 mL solution for injection vial

País: Australia

Idioma: inglés

Fuente: Department of Health (Therapeutic Goods Administration)

Ingredientes activos:

sodium chloride, Quantity: 9 mg/mL

Disponible desde:

Phebra Pty Ltd

formulario farmacéutico:

Injection, solution

Composición:

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

Vía de administración:

Subcutaneous, Intramuscular, Intravenous

Unidades en paquete:

100mL x 10

tipo de receta:

Not scheduled. Not considered by committee

indicaciones terapéuticas:

INDICATIONS AS AT 01 JAN 1991 : Prophylaxis of heat prostration or muscle cramps, chloride deficiency due to diuresis or salt restriction, prevention or treatment of extracellular volume depletion. Parenteral - 0.9% (Isotonic) NaCl is used to restore sodium and chloride losses; to dilute or dissolve drugs for IV, IM or SC use, flushing of IV catheters; extracellular fluid replacement; priming solution for hemodialysis; initiate and terminate blood transfusions so red blood cells will not hemolyze; metabolic alkalosis when there is fluid loss and mild sodium depletion. Topical or irrigation - relief of inflamed, dry or crusted nasal membranes or as a topical irrigating or flush solution.

Resumen del producto:

Visual Identification: Clear, colourless solution, practically free from visible particles.; Container Type: Vial; Container Material: Glass; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Estado de Autorización:

Registered

Fecha de autorización:

1994-05-23

Información para el usuario

Sodium Chloride 0.9%
solution for injection V03
1
SODIUM CHLORIDE 0.9%
SOLUTION FOR INJECTION
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 0.9%?
Sodium Chloride 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
0.9%? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE SODIUM CHLORIDE 0.9%?
Do not use if you have ever had an allergic reaction to Sodium
Chloride 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 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 0.9%?
•
Sodium Chloride Injection 0.9% must only give by a doctor or
healthcare professional. 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 0.9%? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING SODIUM CHLORIDE 0.9%?
THINGS YOU
SHOULD DO
•
If you become pregnant while being given Sodium Chloride 0.9%, tell
your doctor immediately.
•
Remind any doctor, dentist, pharmacist or nurse you visit that you
have been given Sodium Chloride
0.9%.
•
Before surgery, tell the surgeon or anaesthetist that you have been
given this medicine.
DRIVING OR

Ficha técnica

PRODUCT INFORMATION
Australian Product Information - Sodium Chloride 0.9% Solution for
Injection
Page 1 of 7
Version 04
SODIUM CHLORIDE 0.9%
(SODIUM CHLORIDE)
SOLUTION FOR INJECTION
1
NAME OF THE MEDICINE
Sodium chloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL contains 9 mg sodium chloride equivalent to 0.15 mmol sodium
ions and 0.15 mmol chloride ions.
For the full list of excipients, see Section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
Sodium Chloride 0.9% is an isotonic solution for injection. pH 4.5 to
8.0
.
Osmolality of 296 mOsm/L.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Prophylaxis of heat prostration or muscle cramps, chloride deficiency
due to diuresis or salt restriction, prevention
or treatment of extracellular volume depletion.
PARENTERAL
Sodium Chloride 0.9% (isotonic) is used to restore sodium chloride
losses; to dilute or dissolve drugs for
intravenous (IV), intramuscular (IM), or subcutaneous (SC) use;
flushing of IV catheters; extracellular fluid
replacement; priming solution for haemodialysis; initiate and
terminate blood transfusions so red blood cells will
not haemolyse; metabolic alkalosis when there is fluid loss and mild
sodium depletion.
TOPICAL OR IRRIGATION
Relief of inflamed, dry, or crusted nasal membranes or as a topical
irrigating or flush solution.
4.2
D
OSE 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.
Use in one patient on one occasion only and discard. Contains no
antimicrobial preservative. Solutions containing
visible, solid particles must not be used.
4.3
C
ONTRAINDICATIONS
•
Congestive heart failure
•
Severe renal impairment
•
Conditions of sodium retention and oedema
PRODUCT INFORMATION
SODIUM CHLORIDE 0.9%
SOLUTION FOR INJECTION
Australian Product Information - Sodium Chloride 0.9% Solution for
Injection
Page 2 of 7
Version 04
•
Liver cirrhosis
•
Irrigation during electrosurgical proced