Unimeds ChlorSept 0.5% with Ethanol 77% Antiseptic Solution with Emollient

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

Chlorhexidine Gluconate 20% Solution; Ethanol Denat

Boleh didapati daripada:

KCK PHARMACEUTICAL INDUSTRIES SDN. BHD.

INN (Nama Antarabangsa):

Chlorhexidine Gluconate 20% Solution; Ethanol Denat

Unit dalam pakej:

500 ml

Dikeluarkan oleh:

KCK PHARMACEUTICAL INDUSTRIES SDN. BHD.

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
UNIMED’S CHLORSEPT 0.5% WITH ETHANOL 77%
ANTISEPTIC SOLUTION WITH EMOLLIENT
Chlorhexidine gluconate (0.5% w/v), Ethanol (77.0% v/v)
1
WHAT IS IN THIS LEAFLET
1.
What Unimed’s ChlorSept is used
for
2.
How Unimed’s ChlorSept works
3.
Before you use Unimed’s
ChlorSept
4.
How to use Unimed’s ChlorSept
5.
While you are using Unimed’s
ChlorSept
6.
Side effects
7.
Storage and disposal
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT UNIMED’S CHLORSEPT IS USED FOR
Unimed’s ChlorSept is used undiluted
for
pre
operation
surgical
hand
disinfection, antiseptic hand disinfection,
and disinfection of patient’s skin.
HOW UNIMED’S CHLORSEPT WORKS
Chlorhexidine gluconate has antiseptic
and disinfectant properties. Ethanol has
bactericidal
and
antiseptic
properties.
They inhibit the growth of bacteria.
BEFORE YOU USE UNIMED’S CHLORSEPT _ _
_-When you must not use it _
Tell your doctor before using Unimed’s
ChlorSept if you have hypersensitivity to
the product or any of its components.
_-Pregnancy and breastfeeding _
No information for use during pregnancy
or during breast-feeding.
_-Taking other medicines _
Inform your doctor or pharmacist before
taking these medicines, including any
that you get without a prescription from
your pharmacy, supermarket or health
food shop.
HOW TO USE UNIMED’S CHLORSEPT
_-How much to use _
Use
as
directed
by
your
doctor
or
pharmacist.
_ _
_ _
_The usual dose: _

_Pre-op _
_surgical _
_hand _
_disinfectant: _
Spread 5ml thoroughly over both
_ _
hands
and
forearms,
rubbing
vigorously.
When
dry
apply
a
further
5ml
and
repeat procedure.

_Antiseptic _
_hand _
_disinfection: _
Spread
3ml
thoroughly
over
the
hands
and
wrist rubbing vigorously until dry.

_Disinfection of patient's skin:_
Prior to
surgery, apply to a sterile swab and rub
thoroughly over the operation site for a
minimum of 2 mins.
_-When to use it _
Use
as
directed
by
your
doctor
or
pharmacist.
_ _
_-How long

Ciri produk

UNIMED’S CHLORSEPT 0.5% WITH ETHANOL 77%
ANTISEPTIC SOLUTION WITH EMOLLIENT
COMPOSITION AND STRENGTH OF ACTIVE INGREDIENTS:
Chlorhexidine
gluconate…………………………………………………………...…..
0.5% w/v
Ethanol
…………………………………………………………………………...……...77%
v/v
PRODUCT DESCRIPTION
A clear pink colour solution with rose fragrance.
PHARMACODYNAMICS
Chlorhexidine is effective against a wide range of Gram negative and
Gram positive vegetative bacteria, yeasts, dermatophyte fungi and
lipophilic viruses. It is inactive against bacterial spores except at
elevated temperatures.
Alcohol is bacteriostatic at low concentrations but has bactericidal
activity at higher concentrations; it does not, however, destroy
bacterial
spores. The mechanism of action appears to be denaturation of
proteins. Its bactericidal activity drops sharply when diluted below a
50 %
concentration and the optimal bactericidal concentration is 60 to 90%
by volume. Alcohol also has some fungicidal and virucidal activity.
PHARMACOKINETICS
Chlorhexidine is cationic nature it binds strongly to skin mucosa and
other tissues and is thus very poorly absorbed. There are, as a
consequence, no general pharmacological studies on chlorhexidine
available and its effects on internal organs are minimal. No
detectable
blood levels have been found in man following oral use and
percutaneous absorption, if it occurs at all, is insignificant.
Alcohol is rapidly distributed throughout the body. It readily crosses
the placenta. Alcohol is mainly metabolised in the liver and is
converted by alcohol dehydrogenase to acetaldehyde and is then further
oxidised to acetate. A hepatic microsomal oxidising system is also
involved. About 90% to 98% of alcohol is oxidised and the remainder is
excreted unchanged by the kidneys and the lungs and also in breast
milk, saliva, sweat and other secretions.
INDICATION
To be used undiluted for pre-operation surgical hand disinfection,
antiseptic hand disinfecti