Phebra SODIUM CHLORIDE 23.4% 2.34 g in 10 mL concentrated injection for infusion vial

Country: Australia

Bahasa: Inggeris

Sumber: Department of Health (Therapeutic Goods Administration)

Bahan aktif:

sodium chloride, Quantity: 234 mg/mL

Boleh didapati daripada:

Phebra Pty Ltd

Borang farmaseutikal:

Injection, concentrated

Komposisi:

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

Laluan pentadbiran:

Intravenous Infusion

Unit dalam pakej:

10mL x 10

Jenis preskripsi:

Not scheduled. Not considered by committee

Tanda-tanda terapeutik:

INDICATIONS AS AT 01 JANUARY 1991 : As an additive to parenteral fluids in patients who have specific electrolyte needs for sodium or chloride ions. As a sclerosing agent for small symptomatic varicose veins.

Ringkasan produk:

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 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Status kebenaran:

Registered

Tarikh kebenaran:

1991-10-14

Risalah maklumat

Sodium Chloride 23.4%
concentrated injection for infusion V03
1
SODIUM CHLORIDE 23.4%
CONCENTRATED INJECTION FOR INFUSION
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 23.4%?
Sodium Chloride 23.4% contains the active ingredient sodium chloride.
Sodium Chloride 23.4% is added to intravenous solutions
(IV) to treat patients with lower than normal salt levels (sodium or
chloride ions) in their blood. It is also injected into small
varicose veins to close them.
For more information, see Section 1. Why am I using Sodium Chloride
23.4%? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE SODIUM CHLORIDE 23.4%?
Do not use if you have ever had an allergic reaction to Sodium
Chloride 23.4% 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 23.4%? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Sodium Chloride 23.4% 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 23.4%?
•
Sodium Chloride 23.4% must only give by a doctor or 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 23.4%? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING SODIUM CHLORIDE 23.4%?
THINGS YOU
SHOULD DO
•
If you become pregnant while being given Sodium Chloride 23.4%, tell
your doctor immediately.
•
Remind any doctor, dentist, pharmacist or nurse you visit that you
have been given Sodium Chloride
23.4%.
•
Before surgery, tell the surgeon or anaesthetis

Ciri produk

PRODUCT INFORMATION
Australian
Product Information – Sodium Chloride 20% and 23.4% concentrated
injection for infusion
Page 1 of 7
Version 04
SODIUM CHLORIDE 20% AND 23.4%
(SODIUM CHLORIDE)
CONCENTRATED INJECTION FOR INFUSION
1
NAME OF THE MEDICINE
Sodium chloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL of Sodium Chloride 20% contains 200 mg of sodium chloride
which is equivalent to 3.4 mmol of sodium
ions and 3.4 mmol of chloride ions.
Each mL of Sodium Chloride 23.4% contains 234 mg of sodium chloride
which is equivalent to 4.0 mmol of sodium
ions and 4.0 mmol of chloride ions.
For the full list of excipients, see Section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
Sodium Chloride 20% and 23.4% are hypertonic concentrated injections
for infusion. pH 4.5 to 7.0. Dilute before
use.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
As an additive to parenteral fluids in patients who have specific
electrolyte needs for sodium or chloride ions.
As a sclerosing agent for small symptomatic varicose veins.
4.2
D
OSE AND METHOD OF ADMINISTRATION
The dosage of sodium chloride as an additive in intravenous fluids
must be calculated after consideration of clinical
and laboratory data. The correct volume of sodium chloride 20% or
23.4% is then aseptically withdrawn and diluted
to the required concentration by addition to an appropriate
intravenous solution such as 5% glucose. The final
solution should be administered within 4 hours.
SCLEROTHERAPY
Inject required volume and concentration of hypertonic sodium chloride
20% or 23.4% into the affected vein and
apply a compression bandage.
Use in one patient on one occasion only and discard. Contains no
antimicrobial preservative. Solutions containing
visible, solid particles must not be used.
PRODUCT INFORMATION
SODIUM CHLORIDE 20% AND 23.4%
CONCENTRATED INJECTION FOR INFUSION
Australian
Product Information – Sodium Chloride 20% and 23.4% concentrated
injection for infusion
Page 2 of 7
Version 04
4.3
C
ONTRAINDICATIONS
•
Congestive heart failure.
•
Severe