BAXTER Chlorhexidine 0.1% Cetrimide 1% Solution AHF7978/7972/7986

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

chlorhexidine acetate, Quantity: 1 mg/mL; cetrimide, Quantity: 10 mg/mL

Available from:

Baxter Healthcare Pty Ltd

Pharmaceutical form:

Solution, irrigation

Composition:

Excipient Ingredients: water for injections; tartrazine; glacial acetic acid

Administration route:

Topical

Units in package:

1000mL AHF7968, 500mL AHF7972, 100mL AHF7973

Prescription type:

Not scheduled. Not considered by committee

Therapeutic indications:

Chlorhexidine Acetate (0.1 %) with Cetrimide (1 %) antiseptic solution is used as a general antiseptic. It is used for the cleaning and disinfecting of wounds and the antiseptic treatment of burns.

Product summary:

Visual Identification: Yellow coloured solution; Container Type: Bottle; Container Life Time: 24 Months; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Registered

Authorization date:

1991-09-30

Patient Information leaflet

________________________________________________________________________________
Chlorhexidine Acetate with Cetrimide CMI
Page 1 of 2
Baxter
CHLORHEXIDINE ACETATE WITH CETRIMIDE ANTISEPTIC
SOLUTION
CONSUMER MEDICINE INFORMATION
_ _
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Chlorhexidine Acetate with
Cetrimide Antiseptic Solutions. It
does not contain all of the
available information. All
medicines have risks and
benefits. Your doctor has
weighed the risks of you using
Chlorhexidine with Cetrimide
against the benefit they expect it
will have for you.
It does not take the place of
talking to your doctor or
pharmacist. If you have any
concerns about having this
product, ask your doctor or
pharmacist.
IF YOU HAVE ANY CONCERNS
ABOUT BEING GIVEN THIS
MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT CHLORHEXIDINE
ACETATE WITH CETRIMIDE IS
USED FOR
C
hlorhexidine Acetate with
Cetrimide is a sterile solution
used as a general antiseptic.
The solution is used for cleaning
and disinfecting wounds and as
the antiseptic treatment of
burns.
Chlorhexidine Acetate with
Cetrimide is used as a topical
(on the skin) solution (external
use on the skin) and must not
be administered intravenously
(via injection).
ASK YOUR DOCTOR IF YOU HAVE
ANY QUESTIONS ABOUT WHY THIS
MEDICINE HAS BEEN PRESCRIBED
FOR YOU.
Your doctor may have
prescribed it for another reason.
_ _
This medicine is not expected to
affect your ability to drive a car
or operate machinery.
BEFORE YOU START
CHLORHEXIDINE ACETATE WITH
CETRIMIDE
_ _
_WHEN YOU MUST NOT BE _
_GIVEN IT _
Do not use Chlorhexidine
Acetate with Cetrimide if you
have an allergy, or have a
history of allergy to any of the
ingredients of Chlorhexidine
Acetate with Cetrimide
Antiseptic Solutions (listed
under ‘Product Description’ at
the end of this leaflet).
Symptoms of an allergic
reaction may include:
•
shortness of breath,
wheezing, difficulty
breathing or a tight feeling
in your chest
•
fatigue, dizziness, light

Summary of Product characteristics

Baxter Chlorhexidine Acetate with Cetrimide Antiseptic Solution
Version 1.1
1 of 7
AUSTRALIAN PRODUCT INFORMATION –
BAXTER CHLORHEXIDINE ACETATE
(CHLORHEXIDINE ACETATE )
WITH CETRIMIDE (CETRIMIDE) ANTISEPTIC SOLUTION
1
NAME OF THE MEDICINE
Chlorhexidine Acetate and Cetrimide.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Baxter Chlorhexidine Acetate with Cetrimide antiseptic solutions are
yellow sterile solutions.
Baxter
Chlorhexidine
Acetate
with
Cetrimide
antiseptic
solutions
are
hypotonic
and
haemolytic. They are supplied in the following strengths:
Chlorhexidine Acetate 0.015% with Cetrimide 0.15%
Chlorhexidine Acetate 0.05% with Cetrimide 0.5%
Chlorhexidine Acetate 0.10% with Cetrimide 1.0%
Each strength is supplied in 3 pack sizes (see section 6.5 Nature and
Content of Container,
Table 1).
For the full list of excipients, see section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
Antiseptic solution.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Baxter Chlorhexidine Acetate with Cetrimide antiseptic solution is
used as a general antiseptic.
It is used for the cleaning and disinfecting of wounds as an
antiseptic treatment for burns.
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSAGE
As
required
to
disinfect
wound
area.
See
directions
for
use.
Dosage
and
duration
of
administration are to be individualized and depend upon the indication
for use, the patient’s
ages, weight, clinical condition, concomitant treatment and on
patient’s clinical response to
treatment.
NOT FOR INTRAVENOUS OR ORAL ROUTE OF ADMINISTRATION.
Product should be inspected visually for particulate matter and
discolouration prior to
administration whenever solution and container permit. Do not use
unless the solution is clear
and the seal is intact.
Baxter Chlorhexidine Acetate with Cetrimide Antiseptic Solution
Version 1.1
2 of 7
DIRECTIONS FOR USE
The area where Baxter Chlorhexidine Acetate with Cetrimide antiseptic
solution is to be used
should be rinsed thoroughly with water. Apply the minimum amount
necessary to cover the
wound area and