Bridgewest CHLORHEXIDINE 0.015% CETRIMIDE 0.15% irrigation solution ampoule

Land: Australien

Språk: engelska

Källa: Department of Health (Therapeutic Goods Administration)

Aktiva substanser:

chlorhexidine gluconate, Quantity: 4.5 mg; cetrimide, Quantity: 45 mg

Tillgänglig från:

Bridgewest Perth Pharma Pty Ltd

Läkemedelsform:

Solution, irrigation

Sammansättning:

Excipient Ingredients: sunset yellow FCF; sodium hydroxide; gluconic acid; water for injections

Administreringssätt:

Topical

Enheter i paketet:

30 x 30 mL

Receptbelagda typ:

Not scheduled. Not considered by committee

Terapeutiska indikationer:

For cleansing and irrigating the skin and dirty wounds.

Produktsammanfattning:

Visual Identification: clear, yellow-orange, foaming liquid, free from any visible impurities; Container Type: Ampoule; Container Material: LDPE; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Bemyndigande status:

Licence status A

Tillstånd datum:

1996-09-04

Bipacksedel

CHLORHEXIDINE AND
CETRIMIDE IRRIGATION
SOLUTION
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Chlorhexidine and
Cetrimide Irrigation Solution. 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 using Chlorhexidine and
Cetrimide Irrigation Solution against
the benefits this product is expected
to have for you.
This medicine is likely to be used
while you are at the clinic or in
hospital. If possible, 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
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT CHLORHEXIDINE
AND CETRIMIDE
IRRIGATION SOLUTION IS
USED FOR
Your doctor or nurse will use
Chlorhexidine and Cetrimide
Irrigation Solution for cleansing and
irrigating the skin or dirty wounds. It
contains antiseptics which will help
prevent infection.
BEFORE YOU USE
CHLORHEXIDINE AND
CETRIMIDE IRRIGATION
SOLUTION
DO NOT USE IT AFTER THE EXPIRY DATE
(EXP) PRINTED ON THE LABEL.
It may have no effect at all, or worse,
an entirely unexpected effect if you
take it after the expiry date.
DO NOT USE CHLORHEXIDINE AND
CETRIMIDE IRRIGATION SOLUTION IF THE
PACKAGING IS TORN OR SHOWS SIGNS OF
TAMPERING.
Wounds may take longer to heal if
cetrimide is used regularly. Therefore
it is important to use this product as
directed by the doctor.
YOU MUST TELL YOUR DOCTOR IF YOU
HAVE ALLERGIES TO:
•
chlorhexidine
•
cetrimide
•
any of the ingredients listed at the
end of this leaflet
•
any other substances, such as
foods, preservatives or dyes
If you have an allergic reaction, you
may get a skin rash.
BEFORE ANY CHLORHEXIDINE AND
CETRIMIDE IRRIGATION SOLUTION IS
USED PLEASE TELL YOUR DOCTOR ABOUT
ANY OF THESE THINGS AND ANYTHING
ELSE WHICH YOU FEEL I

Produktens egenskaper

Version: pfpchcet10320
Supersedes: pfpchcet10716
Page 1 of 6
AUSTRALIAN
PRODUCT
INFORMATION
–
CHLORHEXIDINE
AND
CETRIMIDE
IRRIGATION
SOLUTION
(CHLORHEXIDINE
GLUCONATE AND CETRIMIDE)
1.
NAME OF THE MEDICINE
Chlorhexidine gluconate and Cetrimide.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Chlorhexidine gluconate 4.5 mg/30 mL (0.015% w/v) and cetrimide 45
mg/30 mL (0.15%
w/v).
Chlorhexidine gluconate 15 mg/30 mL (0.05% w/v) and cetrimide 150
mg/30 mL (0.5% w/v).
3.
PHARMACEUTICAL FORM
Sterile, orange coloured irrigation solution containing chlorhexidine
gluconate and cetrimide
in purified water. The colouring agent is sunset yellow.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For cleansing and irrigating the skin and dirty wounds where an added
surfactant effect is
required.
4.2 DOSE AND METHOD OF ADMINISTRATION
Rinse the area to be cleaned with water, apply the minimum amount of
irrigation necessary to
cover the wound area and wash gently. Rinse again thoroughly. Apply to
wound as necessary.
Discard remaining solution after use.
4.3 CONTRAINDICATIONS
Known hypersensitivity to either chlorhexidine or cetrimide.
Do not use to irrigate the brain, meninges, eyes or perforated
eardrum.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
For external use only. Not for injection, for irrigation only. Not
isotonic and is haemolytic.
Version: pfpchcet10320
Supersedes: pfpchcet10716
Page 2 of 6
Cetrimide may have a prolonging effect on the wound healing process.
Use of this antiseptic
should be restricted to infection control and cleansing of wounds
rather than general wound
management.
USE IN THE ELDERLY
No data available.
PAEDIATRIC USE
Use with care in neonates, particularly in premature infants.
Chlorhexidine may cause irritation
or chemical burns.
EFFECTS ON LABORATORY TESTS
No data available.
4.5 INTERACTIONS WITH OTHER MEDICINES AND OTHER FORMS OF INTERACTIONS
No data available.
4.6 FERTILITY, PREGNANCY AND LACTATION
EFFECTS ON FERTILITY
No data available.
USE IN PREGNANCY
No data available.
USE IN LACTATION
No da